gongsijingguoliushiduonianlaizaiyiyaodajiankanglingyudeshengengxizuo,qixiayiyongyou40yujiagongsi,xingchengyi“yiyaopifa、yiyaolingshou、yiyaogongyeweizhuye,gongyinglianzengzhifuwu、yiyaohulianwangfuwu、zhongduanjiankangfuwudengchuangxinyewuxietongfazhan”dezonghexingyiyaodajiankangchanyejituan.
gongsijingguoliushiduonianlaizaiyiyaodajiankanglingyudeshengengxizuo,qixiayiyongyou40yujiagongsi,xingchengyi“yiyaopifa、yiyaolingshou、yiyaogongyeweizhuye,gongyinglianzengzhifuwu、yiyaohulianwangfuwu、zhongduanjiankangfuwudengchuangxinyewuxietongfazhan”dezonghexingyiyaodajiankangchanyejituan.
gongsijingguoliushiduonianlaizaiyiyaodajiankanglingyudeshengengxizuo,qixiayiyongyou40yujiagongsi,xingchengyi“yiyaopifa、yiyaolingshou、yiyaogongyeweizhuye,gongyinglianzengzhifuwu、yiyaohulianwangfuwu、zhongduanjiankangfuwudengchuangxinyewuxietongfazhan”dezonghexingyiyaodajiankangchanyejituan.
gongsijingguoliushiduonianlaizaiyiyaodajiankanglingyudeshengengxizuo,qixiayiyongyou40yujiagongsi,xingchengyi“yiyaopifa、yiyaolingshou、yiyaogongyeweizhuye,gongyinglianzengzhifuwu、yiyaohulianwangfuwu、zhongduanjiankangfuwudengchuangxinyewuxietongfazhan”dezonghexingyiyaodajiankangchanyejituan.
gongsijingguoliushiduonianlaizaiyiyaodajiankanglingyudeshengengxizuo,qixiayiyongyou40yujiagongsi,xingchengyi“yiyaopifa、yiyaolingshou、yiyaogongyeweizhuye,gongyinglianzengzhifuwu、yiyaohulianwangfuwu、zhongduanjiankangfuwudengchuangxinyewuxietongfazhan”dezonghexingyiyaodajiankangchanyejituan.
gongsijingguoliushiduonianlaizaiyiyaodajiankanglingyudeshengengxizuo,qixiayiyongyou40yujiagongsi,xingchengyi“yiyaopifa、yiyaolingshou、yiyaogongyeweizhuye,gongyinglianzengzhifuwu、yiyaohulianwangfuwu、zhongduanjiankangfuwudengchuangxinyewuxietongfazhan”dezonghexingyiyaodajiankangchanyejituan.
gongsijingguoliushiduonianlaizaiyiyaodajiankanglingyudeshengengxizuo,qixiayiyongyou40yujiagongsi,xingchengyi“yiyaopifa、yiyaolingshou、yiyaogongyeweizhuye,gongyinglianzengzhifuwu、yiyaohulianwangfuwu、zhongduanjiankangfuwudengchuangxinyewuxietongfazhan”dezonghexingyiyaodajiankangchanyejituan.
2013nian01yue30ri fabu |
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genjubuliangfanyingjiancejieguo,weikongzhiyaopinshiyongfengxian,guojiashipinyaopinjianduguanlijujuedingduizuoyangfushaxing(baokuoyansuanzuoyangfushaxing、jiahuangsuanzuoyangfushaxing、rusuanzuoyangfushaxing)koufuhezhushejishuomingshujinxingxiuding。
国家食品药品监督管理局要求各省(区、市)食品药品监督管理部门通知行政区域内药品生产企业做好相关工作。 shenmeshiyaopinshuomingshuxiuding? da:yaopinshuomingshushizaimingyaopindezhongyaoxinxidefadingwenjian,shixuanyongyaopindefadingzhinan,yongyizhidaoanquan、helishiyongyaopin,yingdangbaohanyaopinanquanxing、youxiaoxingdezhongyaokexueshuju、jielunhexinxi。
yaopinshuomingshuhuozhunxiugaihou,yaopinshengchanqiyeyingdangjiangxiugaideneironglijitongzhixiangguanyaopinjingyingqiye、shiyongdanweijiqitabumen,binganyaoqiujishishiyongxiugaihoudeshuomingshu。 |
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【相关链接】 |
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guojiashipinyaopinjianduguanlijuguanyuxiudingzuoyangfushaxingkoufuhezhushejishuomingshudetongzhi |
guoshiyaojianzhu[2012]373hao |
2012nian12yue31ri fabu |
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gesheng、zizhiqu、zhixiashishipinyaopinjianduguanliju(yaopinjianduguanliju): genjubuliangfanyingjiancejieguo,weikongzhiyaopinshiyongfengxian, guojiashipinyaopinjianduguanlijujuedingduizuoyangfushaxing(baokuoyansuanzuoyangfushaxing、jiahuangsuanzuoyangfushaxing、rusuanzuoyangfushaxing)koufuhezhushejishuomingshujinxingxiuding。xianjiangyouguanshixiangtongzhiruxia: yi、zuoyangfushaxingkoufuhezhushejishuomingshuxiangguanjingshiyu、buliangfanyinghezhuyishixiangdengxiangmuanzhaoyaoqiujinxingxiuding(jianfujian),shuomingshuqitaneirongyingdangyuyuanpizhunneirongyizhi。
二、请通知行政区域内药品生产企业做好相关工作:
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附件1
diyisangongzhiyao(beijing)youxiangongsizuoyangfushaxingkoufuhezhushejishuomingshu
qingzixiyuedushuomingshubingzaiyishizhidaoxiashiyong
警告: zaisuoyounianlingzuzhong,fukuinuotongleiyaowu,baokuozuoyangfushaxingkedaozhijijianyanhejijianduanliedefengxianzengjia。zaitongchang60suiyishangdelaonianhuanzhe、jieshoutangpizhijisuzhiliaodehuanzhehejieshoushenyizhi、xinzangyizhihuofeiyizhidehuanzhezhong,zheigefengxianjinyibuzengjia。 fukuinuotongleiyaowu,baokuozuoyangfushaxingkeshizhongzhengjiwulihuanzhedejiwuliehua。yingbimianyizhizhongzhengjiwulishidehuanzheshiyongzuoyangfushaxing。 |
【yaopinmingcheng】genjuyuanshenpiwenjianqueding
通用名称:
商品名称:
英文名称:
汉语拼音:
【成份】
benpinzhuyaochengfenweizuoyangfushaxing,qihuaxuemingchengwei:(-)-(s)-3-jiaji-9-fu-2,3-erqing-10-(4-jiaji-1-paiqinji)-7yangdai-7h-bidingbing[1,2,3-de]-1,4 benbingkoue qin-6-suosuanbanshuihewu。
其化学结构式:
fenzishi:c18h20fn3o4 ·h2o
fenziliang:370.38
benpinqitachengfenwei:genjuyuanshenpiwenjianqueding。
【xingzhuang】genjujutipinzhongqueding
【适应症】
weijianshaonaiyaojundechansheng,baozhengzuoyangfushaxingjiqitakangjunyaowudeyouxiaoxing,zuoyangfushaxingzhiyongyuzhiliaohuoyufangyizhengminghuogaoduhuaiyiyouminganxijunyinqideganran。zaixuanzehuoxiugaikangjunyaowuzhiliaofanganshi,yingkaolvxijunpeiyangheyaominshiyandejieguo。ruguomeiyouzheixieshiyandeshujuzuocankao,zeyinggenjudangdiliuxingbingxuehebingyuanjunminganxingjinxingjingyanxingzhiliao。
zaizhiliaoqianyingjinxingxijunpeiyangheyaominshiyanyifenlibingjiandingganranbingyuanjun,quedingqiduizuoyangfushaxingdeminganxing。zaihuodeyishangjianyanjieguozhiqiankeyixianshiyongzuoyangfushaxingjinxingzhiliao,dedaojianyanjieguozhihouzaixuanzeshidangdezhiliaofangfa。
yucileizhongdeqitayaowuxiangtong,shiyongzuoyangfushaxingjinxingzhiliaoshi,tonglvjiadanbaojundemouxiejunzhukeyihenkuaichanshengnaiyaoxing。zaizhiliaoqijianyingdingqijinxingxijunpeiyangheyaominshiyanyizhangwobingyuanjunshifouduikangjunyaowuchixumingan,bingzaixijunchuxiannaiyaoxinghounenggoujishifaxian。
zuoyangfushaxingkoufuzhijihezhushejikeyongyuzhiliaochengnianren(≥ 18sui)youxialiexijundeminganjunzhusuoyinqidexialieqing、zhong、zhongduganran。rujingmaidizhuduihuanzhegengweiyoulishi(ruhuanzhebunengnaishoukoufujiyaodeng)keshiyongzuoyangfushaxingzhusheye。
1.医院获得性肺炎
zhiliaoyouduijiayangxilinmingandejinhuangseputaoqiujun、tonglvjiadanbaojun、zhanzhishaleishijun、dachangaixijun、feiyankeleibaiganjun、liuganshixueganjunhuofeiyanlianqiujunyinqideyiyuanhuodexingfeiyan。tongshiyinggenjulinchuangxuyaocaiquqitafuzhuzhiliaocuoshi。ruguoyizhengminghuohuaiyishitonglvjiadanbaojunganran,jianyilianheyingyongkangjiadanbaojunβ-neixiananleiyaowujinxingzhiliao。
2.社区获得性肺炎
7~14tianzhiliaofangan:zhiliaoyouduijiayangxilinmingandejinhuangseputaoqiujun、feiyanlianqiujun[baokuoduozhongnaiyaoxingjunzhu(mdrsp*)]、liuganshixueganjun、fuliuganshixueganjun、feiyankeleibaiganjun、katamolajun、feiyanyiyuanti、feiyanjuntuanjunhuofeiyanzhiyuantiyinqideshequhuodexingfeiyan。
zhu:mdrsp(duozhongnaiyaoxingfeiyanlianqiujun)zhiduixialieliangzhonghuoduozhongkangjunyaowunaiyaodejunzhu:qingmeisu(mic ≥ 2 µg/ml),erdaitoubaojunsu(rutoubaofuxin)、dahuanneizhilei、sihuansujijiayangbiananmiding/huanganjiakouezuo。
5tianzhiliaofangan:zhiliaoyoufeiyanlianqiujun、liuganshixueganjun、fuliuganshixueganjun、feiyanzhiyuantihuofeiyanyiyuantiyinqideshequhuodexingfeiyan。
3.jixingxijunxingbidouyan
5tianzhiliaofangan:zhiliaoyoufeiyanlianqiujun、liuganshixueganjunjikatamolajunyinqidejixingxijunxingbidouyan。
10~14tianzhiliaofangan:zhiliaoyoufeiyanlianqiujun、liuganshixueganjunjikatamolajunyinqidejixingxijunxingbidouyan。
4.manxingzhiqiguanyandejixingxijunxingfazuo
zhiliaoyoujiayangxilinmingandejinhuangseputaoqiujun、feiyanlianqiujun、liuganshixueganjun、fuliuganshixueganjunhuokatamolajunyinqidemanxingzhiqiguanyandejixingxijunxingfazuo。
5.fuzaxingpifujipifujiegouganran
zhiliaoyoujiayangxilinmingandejinhuangseputaoqiujun、fenchangqiujun、huanongxinglianqiujunhuoqiyibianxingganjunyinqidefuzaxingpifujipifujiegouganran。
6.feifuzaxingpifujipifuruanzuzhiganran
zhiliaoyoujiayangxilinmingandejinhuangseputaoqiujunhuohuanongxinglianqiujunyinqidefeifuzaxingpifujipifujiegouganran(qingduzhizhongdu),baokuonongzhong、fengwozhiyan、jie、nongpaobing、nongpibing、shangkouganran。
7.manxingxijunxingqianliexianyan
zhiliaoyoudachangaixijun、fenchangqiujunhuojiayangxilinmingandebiaopiputaoqiujunyinqidemanxingxijunxingqianliexianyan。
8.复杂性尿路感染
5tianzhiliaofangan:zhiliaoyoudachangaixijun、feiyankeleibaiganjunhuoqiyibianxingganjunyinqidefuzaxingniaoluganran。
10tianzhiliaofangan:zhiliaoyoufenchangqiujun、yingouchangganjun、dachangaixijun、feiyankeleibaiganjun、qiyibianxingganjunhuotonglvjiadanbaojunyinqidefuzaxingniaoluganran(qingduzhizhongdu)。
9.急性肾盂肾炎
5tianzhiliaofangan:zhiliaoyoudachangaixijunyinqidejixingshenyushenyan,baokuohebingjunxuezhengdebingming。
10tianzhiliaofangan:zhiliaoyoudachangaixijunyinqidejixingshenyushenyan,baokuohebingjunxuezhengdebingming。
10.feifuzaxingniaoluganran:
zhiliaoyoudachangaixijun、feiyankeleibaiganjunhuofushengputaoqiujunyinqidefeifuzaxingniaoluganran(qingduzhizhongdu)。
11.xiruxingtanju(baoluhou)
shiyongyuxiruxingtanju(baoluhou)dezhiliao,zaibaoluyutanjuganjunpenwuzhihoujianshaojibingdefashenghuojianhuanjibingdejinzhan。zuoyangfushaxingdeyouxiaoxingjiyurentidexuejiangnongduzheiyitidaizhongdianlaiyucelinchuangliaoxiao。
zuoyangfushaxingduitanjuxirubaoluhoudeyufangzuoyongshangweiduirentijinxingshiyan。chengrenzhongchaoguo28tianliaochengzhiliaodezuoyangfushaxingdeanquanxingshangweiyanjiu。jinzaihuoyidayufengxianshi,cainengshiyongzuoyangfushaxingzhangqizhiliao。
【guige】 genjuyuanshenpiwenjianqueding
【用法用量】
zuoyangfushaxingkoufuzhijihezhushejiyongyushangshuganranxingjibing(xiangjianshiyingzheng)dezhiliao,tongyongdeyongfayongliangruxiasuoshi,danbixujiehejibingyanzhongchengduyoulinchuangyishengzuizhongqueding。
1.剂量和给药方法
(1)shengongnengzhengchanghuanzhezhongdejiliang
zuoyangfushaxingkoufuzhijidechangyongjiliangwei250 mghuo500 mghuo750 mg,mei24xiaoshikoufuyici。genjuganranqingkuanganzhaoxiabiao(biao1)suoshifuyong。
zuoyangfushaxingzhushejidechangyongjiliangwei250 mghuo500 mg,huanmandizhu,dizhushijianbushaoyu60fenzhong,mei24xiaoshijingdiyici;huo750 mg,huanmandizhu,shijianbushaoyu90fenzhong,mei24xiaoshijingdiyici。genjuganranqingkuanganzhaobiao1suoshishiyong。
jiganqingchulv≥ 50 ml/minshibuxudiaozhengyongliang。jiganqingchulv<50 ml/minshi,xudiaozhengyongliang。
biao1:shengongnengzhengchanghuanzhezhongdejiliang(jiganqingchulv≥50 ml/min)
感染类型1 |
每24小时剂量 |
疗程(天)2 |
医院内肺炎 |
750 mg |
7~14 |
社区获得性肺炎3 |
500 mg |
7~14 |
社区获得性肺炎4 |
750 mg |
5 |
急性细菌性鼻窦炎 |
750 mg |
5 |
500 mg |
10~14 |
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manxingzhiqiguanyandejixingxijunxingjiazhong |
500 mg |
7 |
fuzaxingpifujipifuruanzuzhiganran(csssi) |
750 mg |
7~14 |
feifuzaxingpifujipifuruanzuzhiganran(usssi) |
500 mg |
7~10 |
慢性细菌性前列腺炎 |
500 mg |
28 |
fuzaxingniaoluganran(cuti)huojixingshenyushenyan(ap)5 |
750 mg |
5 |
fuzaxingniaoluganran(cuti)huojixingshenyushenyan(ap)6 |
250 mg |
10 |
非复杂性尿路感染 |
250 mg |
3 |
xiruxingtanju(baoluhou),chengnianheerkehuanzhe>50 kghe≥6geyue7、8 erkehuanzhe<50 kghe≥6geyue7、8 |
500 mg 参见下表(表2) |
608 608 |
zhu:①youtedingbingyuanzaocheng(canjianshiyingzheng)。
②yishikeyigenjuzijidepanduancaiyonglianxuzhiliao(jingmaizhushehuokoufu)。
③youjiayangxilinminganxingjinhuangseputaoqiujun、feiyanlianqiujun[baokuoduozhongnaiyaoxingjunzhu(mdrsp)]、liuganshixueganjun、fuliuganshixueganjun、feiyankeleibojun、zhanmoyanmolajun、feiyanyiyuanti、shifeijuntuanganjunhuofeiyanzhiyuantidaozhi(canjianshiyingzheng)。
④youfeiyanlianqiujun[baokuoduozhongnaiyaoxingjunzhu(mdrsp)]、liuganshixueganjun、fuliuganshixueganjun、feiyanzhiyuantihuofeiyanyiyuantidaozhi(canjianshiyingzheng)。
⑤benfanganshiyongyuyoudachangganjun、feiyankeleibojun、qiyibianxingganjundaozhidecutiheyoudachangganjundaozhidejixingyixianyan,baokuotongshibanjunxuezhengdebingming。
⑥benfanganshiyongyuyoufenchangqiujun、yingouchangqiujun、dachangganjun、feiyankeleibojun、qiyibianxingganjun、tonglvjiadanbaojundaozhidecuti,yijiyoudachangganjundaozhidejixingyixianyan。
⑦yingdangzaihuaiyihuomingquedetanjuganjunpenwubaoluzhihoujinkuaiyongyao。zheiyizhizhengjiyutidaizhongdian。zairentizhongdadaodezuoyangfushaxingxuejiangnongdukenengyucelinchuangliaoxiao。
⑧zuoyangfushaxingzaichengrenzhongchaoguo28tian、erkehuanzhezhongchaoguo14tiandezhiliaoanquanxingweijingyanjiu。yuduizhaoxiangbi,zaierkehuanzhezhongguanchadaojirougugedebuliangfanyingfashenglvzengjia(xiangjianjinggaoyuzhuyishixiang)。jindanghuoyichaoguofengxianshi,caikecaiyongzuoyangfushaxingzhangqizhiliao。
(2) erkehuanzhe(< 18sui)zhongdejiliang
erkehuanzhe(≥6geyue)dejiliangmiaoshuyuxiabiao(biao2)。
biao2:erkehuanzhe(≥6geyue)dejiliang
感染类型1 |
剂量 |
每次给药频率 |
疗程2 |
xiruxingtanju(baoluhou)3,4 |
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|
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erkehuanzhe>50 kghe≥6geyue |
500 mg |
24小时 |
60天4 |
erkehuanzhe<50 kghe≥6geyue |
8 mg/kg(meicijiliangbuchaoguo250 mg) |
12小时 |
60天4 |
zhu:①youtanjuganjunzaocheng(canjianshiyingzheng)。
②yishikeyigenjuzijidepanduancaiyonglianxuzhiliao(jingmaizhushehuokoufu)。
③yingdangzaihuaiyihuomingquedetanjuganjunpenwubaoluzhihoujinkuaiyongyao。zheiyizhizhengjiyutidaizhongdian。zairentizhongdadaodezuoyangfushaxingxuejiangnongdukenengyucelinchuangliaoxiao。
④zuoyangfushaxingzaierkehuanzhezhongchaoguo14tiandezhiliaoanquanxingweijingyanjiu。yuduizhaoxiangbi,zaierkehuanzhezhongguanchadaojirougugedebuliangfanyingfashenglvzengjia(canjianjinggaoyuzhuyishixiang)。jindanghuoyichaoguofengxianshi,caikecaiyongzhangqizuoyangfushaxingzhiliao。
(3)shengongnengbuquanhuanzhezhongdejiliangdiaozheng
ruguocunzaishengongnengbuquan,yingshenyongzuoyangfushaxing。youyuzuoyangfushaxingdeqingchulvkenengxiajiang,zaikaishizhiliaoqianhezhiliaoguochengzhong,yingdangjinxingzixidelinchuangguanchaheshidangdeshiyanshiyanjiu。
duiyujiganqingchulv≥50 ml/minhuanzhemeiyoubiyaojinxingjiliangdiaozheng。
zaishengongnengbuquandehuanzhezhong(jiganqingchulv<50 ml/min),youyujiganqingchulvxiajiang,xuyaodiaozhengjiyaojiliang,yibimianzuoyangfushaxingdexuji(canjianzaiteshurenqunzhongdeshiyong)。
xiabiao(biao3)shiruhegenjujiganqingchulvdiaozhengjiliang。
biao3:shengongnengbuquanhuanzhezhongdejiliangdiaozheng(jiganqingchulv<50 ml/min)
shengongnengzhengchanghuanzhezhongmei24xiaoshidejiliang |
肌酐清除率 20 ~ 49 ml/min |
肌酐清除率 10 ~ 19 ml/min |
xueyetouxihuochixuxingfeiwochuangfumotouxi(capd) |
750 mg |
mei48xiaoshi750 mg |
diyicijiyao750 mg,cihoumei48xiaoshi500 mg |
diyicijiyao750 mg,cihoumei48xiaoshi500 mg |
500 mg |
shouji500 mg,cihoumei24xiaoshi250 mg |
diyicijiyao500 mg,cihoumei48xiaoshi250 mg |
diyicijiyao500 mg,cihoumei48xiaoshi250 mg |
250 mg |
无需剂量调整 |
mei48xiaoshi250 mg。duiyudanchunxingutizhiliao,wuxujiliangdiaozheng |
无剂量调整信息 |
(4)给药说明
yuaohejideyaowuxianghuzuoyong:kangsuanji、liutanglv、jinshuyanglizi、duozhongweishengsu
zuoyangfushaxingkoufuzhijiyingdangzaishiyongxiashuyaowuqianhouzhishao2xiaoshifuyong:hanmeikangsuanji、lv、liutanglv、jinshuyanglizirutielizi、hanxindeduozhongweishengsuzhiji、quqiangjiganjujiaopian/fensanpianhuoerkechongji。
zuoyangfushaxingzhushejibunengyurenhehanyouduojiayanglizi(rumeilizi)derongyetongguotongyitiaojingmaitonglutongshijiyao。
shiwuyuzuoyangfushaxingkoufuzhiji
zuoyangfushaxingkoufuzhijidefuyongkeyibukaolvjinshideyingxiang。jianyizaizhishaojinshiqian1xiaoshihuojinshihou2xiaoshifuyongzuoyangfushaxingkoufuzhiji。
左氧氟沙星注射剂
zhuyi: zuoyangfushaxingzhusheji®xunsujingmaijiyaohuotuizhukenengdaozhidixueya,yingdangbimian。zuoyangfushaxingzhushejiyingdangqujueyujiliang,zaibudiyu60huo90fenzhongdeshijianneihuanmanjingmaidizhu。zuoyangfushaxingzhushejijinkejingjingmaidizhujiyao,bukeyongyujinei、qiaonei、fumoneihuopixiajiyao。
jieshouzuoyangfushaxingkoufuzhijihezhushejidehuanzhedeshuisheru
koufuhuojingmaidizhukoufuzhijihezhushejidehuanzheyingbuchongzugoudeshuifen,yizuzhiniaozhongyaowunongduguogao。yiyoukuinuotongleiyaowuyinqiguanxingniaodebaogao。
2.jingmaidizhuyaowudezhibei
duiyufeikoufuyaowuzhiji,zhiyaorongyeherongqiyunxu,yingdangzaijiyaoqianmujianyouwukeliwuhetuosexianxiang。
youyujinkeyidedaoyouxiandeguanyuzuoyangfushaxingzhusheyeheqitajingmaiyongyaoxiangrongxingdeziliao,budexiangyicixingrouxingrongqizhongdeyuhunzuoyangfushaxingzhusheye、yicixingxiaopingzhongdezuoyangfushaxingzhusheyezhongjiarutianjiajihuoqitayaowu,huozheyuzhicongtongyitiaojingmaitonglushuzhu。ruguoshiyongtongyitiaojingmaitonglulianxushuzhuyixiebutongdeyaowu,yingdangzaishuzhuzuoyangfushaxingzhusheyeqianhou,shiyongyuzuoyangfushaxingzhusheyehetongguotongyitonglushuzhudeqitayaowuxiangrongdezhusheyechongxi。
zuoyangfushaxinglvhuanazhusheye(dashuye)keyizhijiejingmaidizhujiyao,dizhushijianyijujiliangbutongzhishaowei60fenzhonghuo90fenzhongyishang,dizhunongduyingwei5 mg/ml。
zuoyangfushaxingzhusheye(xiaozhen)zaijingmaidizhuqianbixuyaoyongshidangderongyejinyibuxishi,kepeiwudejingmairongyejianbiao4,shiyongqianrongyedezuizhongxishinongduyingwei5 mg/ml。
zhusheyongzuoyangfushaxingzaijingmaidizhuqianbixushouxianyongzhusheyongshuirongjie,ranhouzaiyongshidangderongyejinyibuxishi,kepeiwudejingmairongyejianxiabiao(biao4),shiyongqianrongyedezuizhongxishinongduyingwei5 mg/ml。
kepeiwudejingdirongye:keyiyongxialierenyijingmaizhusheyezhibeishidangphzhide5 mg/mlzuoyangfushaxingrongye。
biao4:kepeiwudejingdirongye
用于静滴的液体 |
zuoyangfushaxingrongyedezuizhongphzhi |
0.9%lvhuanazhusheye |
4.71 |
5%葡萄糖注射液 |
4.58 |
5%putaotang/0.9% naclzhusheye |
4.62 |
5%putaotangrusuanhualingeshiye |
4.92 |
5%putaotang,0.45%lvhuanahe0.15%lvhuajiazhusheye |
4.61 |
rusuannazhusheye(m/6) |
5.54 |
youyuyaowuzhongbuhanyoufangfujihuoyijunji,yincizaizhibeijingdirongyeshiyingcaiyongwujunjishu。
zaishiyongqianyingzixiguancharongyeneishifouhanyoukelizazhi。hanyourouyankejiankelideyaopinyingdiuqi。
xishihouzuoyangfushaxingzhusheyedewendingxing:yongkepeiwudejingmaizhusheyejiangzuoyangfushaxingzhusheyexishizhinongduwei5 mg/ml,zai25°c(77°f)huodiyu25°ctiaojianxiakeyibaocun72xiaoshi,zai5°c(41°f)bingxiangzhongzhiyujingmaidizhuyongdesuliaorongqizhongkebaocun14tian。yongkepeiwudejingmaizhusheyexishiderongye,lengdongyubolipinghuojingmaidizhuyongdesuliaorongqizhong,chucunyu-20°c(-4°f),zai6geyueneikeyibaochiwending。shiwen25°c(77°f)huozhiyu8°c(46°f)bingxiangzhongrongjieyilengdongderongye。buyaoyongweibohuoshuiyujiasuqirongjie。rongjieyicihoubuyaozaifanfudongrong。
zhusheyeshiyongshuoming:shiyongqianyaojiancharongqiyouwuweixiaoshenlou。ruguoyoushenlouhuofengkoubuwanzheng,zerongyeyingdiuqi,yinweirongyekenengyijingbushiwujunde。ruguorongyehunzhuohuochuxianchendianwuzebuyingshiyong。yingshiyongwujunshebei。
jingshi:buyaojiangrongqichuanlianqilai。zheiyangkenengzaierjirongqineideyetishuwanzhiqianyouyuxiruleyijirongqineidecanliukongqierdaozhikongqishuansai。
【不良反应】
1.yanzhongdeheqitazhongyaodebuliangfanying
xiashuyanzhongheqitazhongyaodebuliangfanyingyizai【zhuyishixiang】zhongxiangxishuoming:jijianyanhejijianduanlie、zhongzhengjiwuliehua、chaominfanying、qitayanzhongheyoushizhimingdefanying、ganduxing、zhongshushenjingxitongxiaoying、nanbiansuojunxiangguanxingfuxie、zhouweishenjingbing、qtjianqiyanzhang、erkehuanzhezhongdejirougugejibing、xuetangwenluan、guangminganxing/guangduxinghenaiyaoxijunchansheng。
zuoyangfushaxingkuaisujingmaidizhuhuozhetuizhukenengdaozhidixueya。yinggenjujiliang,jingmaidizhubushaoyu60~90fenzhong。
jubaogao,shiyongkuinuotongleiyaowu(baokuozuoyangfushaxing)kenengdaozhijiejingniaoheguanxingniao。yinci,duiyujieshouzuoyangfushaxingzhiliaodehuanzhe,yingdangweichishidangdeshuihua,yifangzhixingchenggaodunongsuoniao。
2.临床试验经验
youyulinchuangshiyanzaibutongdetiaojianxiawancheng,zailinchuangshiyanzhongguanchadaodeyizhongyaowudebuliangfanyinglvbunengzhijieheqitayaowuzailinchuangshiyanzhongdebuliangfanyinglvxiangbijiao,qieweibifanyingzaishijiyingyongzhongdebuliangfanyinglv。
xiamianmiaoshudeshuju,fanyingle29geⅲqilinchuangshiyande7537minghuanzheduizuoyangfushaxingdezonghebaolu。yanjiurenqunpingjunnianlingwei50sui(yue74%derenqun<65sui),qizhong50%weinanxing,71%weibaizhongren,17%weiheizhongren。huanzheyinweifanweiguangfandeganranxingjibingerjieshouzuoyangfushaxingzhiliao(canjianshiyingzheng)。huanzhejieshoudezuoyangfushaxingjiliangwei750 mgmeiriyici、250 mgmeiriyici、huo500 mgmeiri1huo2ci,liaochengtongchangwei3~14tian,pingjunliaochengwei10tian。
buliangfanyingdezongfashenglv、leixinghefenbuzaishiyongzuoyangfushaxing 750 mgmeiriyici、250 mgmeiriyici、huo500 mgmeiri1huo2cidehuanzhezhongleisi。zonggongyou4.3%dehuanzheyouyubuliangyaowufanyingertingyongzuoyangfushaxing,zaijieshou250 mghe500 mgmeirijiliangdehuanzhezhong,zheigebiliwei3.8%;zaijieshou750 mgmeirijiliangdehuanzhezhong,zheigebiliwei5.4%。zaijieshou250 mghe500 mgmeirijiliangdehuanzhezhongzuichangjiandedaozhitingyaodeyaowubuliangfanyingweiweichangdaofanying(1.4%),zhuyaoweiexin(0.6%)、outu(0.4%)、touyun(0.3%)hetoutong(0.2%)。zaijieshou750 mgmeirijiliangdehuanzhezhongzuichangjiandedaozhitingyaodebuliangyaowufanyingweiweichangdaofanying(1.2%),zhuyaoweiexin(0.6%)、outu(0.5%)、touyun(0.3%)hetoutong(0.3%)。
zaixiabiao(biao5hebiao6)zhongfenbieliejulefashengyu≥1%dejieshouzuoyangfushaxingzhiliaodehuanzhezhongdebuliangfanying,yijifashengyu0.1zhi<1% jieshouzuoyangfushaxingzhiliaodehuanzhezhongdebuliangfanying。zuichangjiandebuliangfanying(≥3%)weiexin、toutong、fuxie、shimian、bianmihetouyun。
biao5:zaizuoyangfushaxinglinchuangshiyanzhongbaogaodechangjian(≥1%)buliangfanying
系统/器官分类 |
不良反应 |
%(N=7537) |
感染及侵染类疾病 |
念珠菌病 |
1 |
精神病类 |
失眠 |
4 a |
各类神经系统疾病 |
头痛 |
6 |
头晕 |
3 |
|
huxixitong、xiongjizonggejibing |
呼吸困难 |
1 |
胃肠系统疾病 |
恶心 |
7 |
腹泻 |
5 |
|
便秘 |
3 |
|
腹痛 |
2 |
|
呕吐 |
2 |
|
消化不良 |
2 |
|
pifujipixiazuzhileijibing |
皮疹 瘙痒 |
2 1 |
生殖系统及乳腺疾病 |
阴道炎 |
1b |
quanshenxingjibingjijiyaobuweigezhongfanying |
水肿 注射部位各种反应 胸痛 |
1 1 1 |
zhu:a. n = 7274;
b. n=3758(nvxing)。
biao6:zuoyangfushaxinglinchuangshiyanzhongbaogaodejiaobuchangjian(0.1zhi1%)debuliangfanying(n=7537)
系统/器官分类 |
不良反应 |
感染和侵染 |
生殖器念珠菌病 |
血液及淋巴系统疾病 |
pinxue、xuexiaobanjianshaozheng、lixibaojianshaozheng |
免疫系统疾病 |
过敏反应 |
代谢及营养类疾病 |
gaoxuetangzheng、dixuetangzheng、gaoxuejiazheng |
精神病类 |
jiaolv、jidong、yishicuoluan、yiyu、huanjue、mengyan、shuimianzhangaia、yanshi |
各类神经系统疾病 |
zhandou、jingjue、ganjuecuoluan、xuanyun、gaozhangli、yundongguodu、butaiyichang、shishuia、yunjue |
huxidao、xiongbuhezonggejibing |
鼻衄 |
心脏器官疾病 |
xinzangtingbo、xinji、shixingxindongguosu、shixingxinlvbuqi |
血管疾病 |
静脉炎 |
胃肠系统疾病 |
weiyan、kouyan、yixianyan、shiguanyan、weichangyan、sheyan、jiamoxing/nanbiansuojunjiechangyan |
肝胆系统疾病 |
肝功能异常、肝酶增加、碱性磷酸酶增加 |
pifujipifuruanzuzhizuzhijibing |
荨麻疹 |
gezhongjirougugejijiedizuzhijibing |
guanjietong、jijianyan、jitong、gutong |
肾脏及泌尿系统疾病 |
shengongnengyichang、jixingshengongnengshuaijie |
zhu: a. n = 7274。
zaishiyongduocijiyaozhiliaodelinchuangshiyanzhong,zhuyidaozaijieshoukuinuotongleikangshengsu,baokuozuoyangfushaxingzhiliaodehuanzhezhong,chuxianyankeyichang,baokuobaineizhanghejingzhuangtiduofadianzhuangbanpian。muqianshangweijianliyaowuhezheixieshijiandelianxi。
3.上市后监测
xiabiao(biao7)liejulezuoyangfushaxinghuodeshangshipizhunzhihouzaishiyongzhongjianbiedebuliangfanying。youyuzheixiefanyingshicongshuliangbudingderenqunzhongzifabaogaode,youshiwufakekaodipingjiazheixieshijiandefashenglv,huojianliyaowubaoluyuzheixieshijiandeyinguoguanxi。
biao7:shangshihouyaowubuliangfanyingbaogao
系统/器官分类 |
不良反应 |
血液及淋巴系统疾病 |
全血细胞减少症、zaishengzhangaixingpinxue、baixibaojianshaozheng、rongxuexingpinxue、shisuanxinglixibaozengduozheng |
免疫系统疾病 |
guominfanying,youshizhiming,baokuo:guominfanying/guominyangfanying、guominxingxiuke、xueguanshenjingxingshuizhong、xueqingbing |
精神病类 |
jingshenbing、pianzhikuang、gebiebaogaodezishaweisuihezishaxiangfa |
各类神经系统疾病 |
zhongzhengjiwuliehua 、xiujuesangshi、weijuesangshi、xiujueyichang、weijuezhangai、zhouweishenjingbing、gebiebaogaodenaobing、naodiantu(eeg)yichang、fashengkunnan |
眼器官疾病 |
shijuezhangai,baokuofushi、shijuelingmindujiantui、shiwumohu、andian |
耳及迷路类疾病 |
听觉减退、耳鸣 |
心脏器官疾病 |
gebiebaogaodejianduanniuzhuanxingshixingxindongguosu、xindiantu qtjianqiyanzhang、xindongguosu |
血管疾病 |
血管舒张 |
huxidao、xiongbuhezonggejibing |
个别报告的过敏性肺炎 |
肝胆系统疾病 |
ganshuaijie(baokuozhimingbingming)、ganyan、huangdan |
pifujipifuruanzuzhijibing |
dapaoxingpizhen,baokuo:stevens-johnsonzonghezheng、zhongduxingbiaopihuaisi、duoxingxinghongban、guangmin/guangduxingfanying、baixibaopoliexingxueguanyan |
gezhongjirougugejijiedizuzhijibing |
jijianduanlie、jisunshang,baokuoduanlie、hengwenjirongjie |
肾脏及泌尿系统疾病 |
间质性肾炎 |
quanshenjibinghejiyaobuweiqingkuang |
多器官衰竭、发热 |
各类检查 |
ningxuemeiyuanshijianyanzhang、jimeizengjia |
【禁忌】
duikuinuotongleiyaowuguominzhe、renshenjiburuqifunv、18suiyixiahuanzhejinyong。
【注意事项】
1.jijianyanhejijianduanlie
suoyounianlingzuhuanzhe,shiyongbaokuozuoyangfushaxingzaineidefukuinuotongleikangshengsujinxingzhiliaodehuanzhekenengfashengjijianyanhejijianduanliedeweixianxingzengjia。zuichangjiandebuliangfanyingbaokuoachilles genjian,bingqieachilles genjianxuyaoshoushuxiubu。yiyoubaodaofashengjijianyanhejianpoliedebuweibaokuojianbu、shou、ertouji、muzhiheqitabuweidejijian。60suiyishangzhe,huotongshishiyongtangpizhijisu,huojieshoushenzang、xinzanghefeizangyizhizhefashengfukuinuotongxiangguandejijianyanhejijianduanliedeweixianxingjinyibuzengjia。chulenianlingheshiyongtangpizhijisu,nengyinqijijianduanlieweixianxingzengjiadeyinsuhaibaokuojuliedetilihuodong、shenshuaijiehejiwangyouleifengshiguanjieyandengjijiansunhaizhe。yiyoubaodaowushangshuweixianyinsucunzaidehuanzheshiyongfukuinuotongleiyinqilejijianyanhejijianduanlie。yongyaoguochengzhonghuoyongyaojieshuhoukeyifashengjijianduanlie,yiyouyongyaojieshuhoushuyuefashengjijianduanliedebaodao。ruguohuanzhechuxiantengtong、shuizhong、yanzhenghuojijianduanlieyingtingyongzuoyangfushaxing,yifaxianyoujijianyanhuojijianduanliedezhengzhuangyinglijijianyihuanzhexiuxi,binglianxitamendeyiliaofuwurenyuankaolvhuanyongfeikuinuotongleiyaowuzhiliao。
2.重症肌无力恶化
baokuozuoyangfushaxingzaineidefukuinuotongleikangshengsuhuiyinqishenjingjirouzuduan,kenengshizhongzhengjiwulihuanzhedejiwuliehua。baokuosiwanghexuyaotongqizhichizaineideshangshihouyanzhongbuliangshijian,hezhongzhengjiwulihuanzheshiyongfukuinuotongleiyouguan。bimianyizhizhongzhengjiwulishidehuanzheshiyongzuoyangfushaxing。
3.超敏反应
shiyongbaokuozuoyangfushaxingzaineidefukuinuotongleikangshengsujinxingzhiliaodehuanzheouerhuifashengyanzhongde、youshishenzhishizhimingxingdechaominhe/huoguominfanying,zheixiefanyingduofashengzaidiyiciyongyaohou。yixiefanyingkenenghuibanyouxinxueguanxingxutuo、dixueya/xiuke、dianxianfazuo、yishisangshi、macigan、xueguanshenjingxingshuizhong(baokuoshe、hou、yanhuomianbushuizhong/zhongzhang)、qidaozusai(baokuozhiqiguanjingluan、qicujijixinghuxijiongpo)、huxikunnan、qianmazhen、saoyangjiqitayanzhongpifufanying。zaishoucichuxianpizhenhuochaominfanyingrenheqitazhengzhuangshiyinglijitingzhishiyongzuoyangfushaxing。yanzhongdejixingchaominfanyingxushiyongshenshangxiansuyuyizhiliao,tongshigenjulinchuangxuyaocaiquqitafusucuoshiruxiyang、jingmaibuye、shiyongkangzuanji、pizhileiguchun、shengyaanleiyaojiqidaochuli。
4.qitayanzhongyoushizhimingdebuliangfanying
shiyongbaokuozuoyangfushaxingzaineidefukuinuotongleikangshengsujinxingzhiliaodehuanzhezaijishaoshuqingkuangxiahuifashengyanzhongde、youshishenzhishizhimingdebuliangfanying,zheixiebuliangfanyingyouxieshuyuchaominfanying,youxiebingyinbuming。zheixiebuliangfanyingkeyihenyanzhong,tongchangfashengzaiduociyongyaohou。linchuangbiaoxianbaokuoxiashuqingkuangdeyizhonghuoduozhong:
l fashao、pizhenhuoyanzhongdepifufanying(liruzhongduxingbiaopihuaisisongjiezheng、duoxingxinghongban)。
l xueguanyan、guanjietong、jitong、xueqingbing。
l guominxingfeiyan。
l jianzhixingshenyan、jixingshengongnengbuquanhuoshenshuai。
l ganyan、huangdan、jixingganhuaisihuoganshuaijie。
l pinxue,baokuorongxuexingpinxuehezaishengzhangaixingpinxue;xuexiaobanjianshaozheng,baokuoxueshuanxingxuexiaoban jianshaoxingzidian;baixibaojianshaozheng;lixibaoquefazheng;quanxuexibaojianshaozhenghe/huoqitaxueyebing。
zaishoucichuxianpizhenhuoqitachaominfanyingzhengzhuangshiyinglijitingzhiyongyaobingcaiquxiangyingdezhichicuoshi。
5.肝毒性
yishoudaojieshouzuoyangfushaxingzhiliaodehuanzhechuxianyanzhongganduxing(baokuojixingganyanhezhimingshijian)deshangshihoubaogao。zaiduichaoguo7,000minghuanzhedelinchuangshiyanzhong,weifaxianyanzhongyaowuxiangguanxingganduxingdezhengju。yanzhongganduxingtongchangzaikaishizhiliaohou14tianneichuxian,zaidaduoshubinglizhong,chuxianzaikaishizhiliao6tiannei。duoshuyanzhongganduxingbingliyuguominwuguan。daduoshuzhimingxingdeganduxingbaogaojianyunianling≥65suidehuanzhe,daduoshuyuchaominwuguan。ruguohuanzhechuxianganyandetizhenghezhengzhuang,yingdanglijitingzhishiyongzuoyangfushaxing。
6.zhongshushenjingxitongyingxiang
cengyoushiyongbaokuozuoyangfushaxingzaineidefukuinuotongleikangshengsudehuanzhechuxianjingjuehezhongduxingjingshenbingdebaodao。kuinuotongleikangshengsuyekeyidaozhiluneiyashenggaohezhongshushenjingxitongcijizhengzhuang,congeryinqizhenzhan、zaodong、jiaolv、touyun、yishimohu、huanjue、wangxiang、yiyu、emeng、shimian,jishaoshuqingkuanghaikedaozhihuanzhechanshengzishadeniantouhuoxingdong。shangshufanyingkenenghuizaidiyiciyongyaohouchuxian。ruguoshiyongzuoyangfushaxingdehuanzhechuxianzheixiefanying,yinglijitingyao,bingcaiqushidangdezhiliaocuoshi。yuqitakuinuotongleikangshengsuxiangtong,ruyizhihuohuaiyihuanzhehuanyourongyifashengdianxianhuodianxianfazuoyuzhijiangdi(liruyanzhongdenaodongmaiyinghua、dianxian)decnsjibinghuocunzaiqitaweixianyinsuerrongyifashengdianxianhuodianxianfazuoyuzhijiangdi(lirushiyongmouxieyaowujinxingzhiliao、shengongnengbuquan)dehuanzheyingshenyongzuoyangfushaxing。
7.nanbiansuojunxiangguanxingfuxie
jubaogao,jihusuoyoudekangshengsu(baokuozuoyangfushaxing)junyoukenengyinqinanbiansuojunxiangguanxingfuxie(cdad),yanzhongchengdukeyouqingdufuxiedaozhimingxingchangyan。kangshengsuzhiliaokeyigaibianjiechangdezhengchangjunqun,shinanbiansuojundaliangfanzhi。nanbiansuojunkeyichanshengdusuahedusub,jinercujincdaddefasheng。youyuganranbinglidekangjunzhiliaonanyiqixiaobingqiekenengxuyaojiechangqiechushuzhiliao,chanchaodusudenanbiansuojunjunzhukeyizengjiagaibingdefabinglvhesiwanglv。duiyushiyongkangshengsuhouchuxianfuxiedesuoyouhuanzheyingkaolvcdad。jubaogao,cdadchuxianzaishiyongkangshengsu2geyuehou,yinciyoubiyaozixixunwenbingshi。
ruguohuaiyihuozheyijingquezhencdad,zexuyaotingzhibuzhijiezhenduinanbiansuojundekangjunzhiliao。anzhaolinchuangxuyaojinxingheshideyetihedianjiezhiguanli、buchongdanbai、jiyukangnanbiansuojunzhiliaoyijijinxingshoushuzhiliaopingjia。
8.外周神经病变
使用包括左氧氟沙星在内的氟kuinuotongleikangshengsujinxingzhiliaodehuanzhehanyouchuxianganjueshenjinghuoganjueyundongshenjingzhoutudeduoshenjingyuanbing,bingbiankeleijixixiaozhoutuhe/huodaxingzhoutu,daozhiganjuecuoluan、ganjuechidun、chuwutongganhewuli。ruguohuanzhechuxianshenjingyuanbingdezhengzhuangrutengtong、shaozhuogan、macigan、mamuhe/huowulihuoqitaganjuecuoluanruqingchujue、tongjue、wendujue、weizhijuehezhendongjueyichangshi,yinglijitingzhishiyongzuoyangfushaxingyimianfazhanweibukenixingsunshang。
9.QT间期延长
baokuozuoyangfushaxingzaineidemouxiefukuinuotongleikangshengsukeyishixindiantudeqtjianqiyanzhang,shaoshuhuanzhekeyichuxianxinlvshichang。shangshihoujianceqijianzifabaogaojieshoubaokuozuoyangfushaxingzaineidekuinuotongleikangshengsuzhiliaodehuanzhechuxianjianduanniuzhuanxingshisudehuanzhehanjian。yizhiqtjianqiyanzhangdehuanzhe,weijiuzhengdedixuejiahuanzhejishiyongialei(kuiniding、pulukayinan)heⅲlei(andiantong、suotaluoer)kangxinlvshichangyaowudehuanzheyingbimianshiyongzuoyangfushaxing。laonianhuanzhegengrongyiyinqiyaowuxiangguandeqtjianqideyingxiang。
10.erkehuanzhezhongdejirougugejibinghedongwuzhongdeguanjiebingxiaoying
zaierkehuanzhe(≥6geyue)zhong,zuoyangfushaxingjinshiyongyutanjuxiru(baoluhou)debaohu。heduizhaoxiangbi,zaijieshouzuoyangfushaxingdeerkehuanzhezhongguanchadaojirougugejibing(guanjietong、guanjieyan、jijianbingzhenghebutaiyichang)fabinglvdezengjia。
zaiweichengniandedashuhegouzhong,koufuhejingmaijiyuzuoyangfushaxingdaozhiguruangubingdezengjia。duiyujieshouzuoyangfushaxingdeweichengniangouchengzhongguanjiedezuzhibinglixuejianchaxianshicunzairuangudechixusunshang。qitakuinuotongleiyaowuyekezaiduogewuzhongdeweichengniandongwuzhongchanshengchengzhongguanjieleisidemilan,yijiguanjiebingdeqitatizheng。
11.血糖紊乱
yuqitafukuinuotongleikangshengsuxiangtong,cengyouguanyuxuetangwenluanruzhengzhuangxinggaoxuetanghedixuetangdebaodao,zheizhongqingkuangduofashengyutongshikoufujiangtangyao(ruyoujiangtang/geliebenniao)huoshiyongyidaosudetangniaobinghuanzhe。yinciduiyucileihuanzhe,jianyiyingmiqiejianceqixuetangbianhuaqingkuang。ruguohuanzhezaijieshouzuoyangfushaxingzhiliaoshichuxiandixuetangfanying,yinglijitingzhishiyongzuoyangfushaxingbingcaiqushidangdezhiliaocuoshi。
12.guangminganxing/guangduxing
shiyongfukuinuotongleiyaowukenengdaozhiriguanghuoziwaiguangbaoluhouzhongduzhizhongdudeguangminganxing/guangduxingfanying,houzhekenengbiaoxianweibaoluyuguangzhaobuwei(dianxingzhebaokuomianbu,jingbuvqu,qianbeishence,shoubei)deguoduderishaifanying(liru,shaishang、hongban、shenchu、shuipao、dapao、shuizhong)。yinci,yingdangbimianguodubaoluyushangshuguangyuan。ruguofashengguangminganxing/guangduxingzeyingtingyao。
13. naiyaojundechansheng
zaishangweiquezhenhuogaoduhuaiyixijunganranyijibufuheyufangshiyingzhengdeqingkuangxiakaizuoyangfushaxingchufangbingbuhuiweihuanzhedailaiyichu,bingkezengjiachanshengnaiyaojundefengxian。
【yunfujiburuqifunvyongyao】
妊娠
huaiyunyongyaofenjic。dashukoufujilianggaoda810 mg/kg/tianshi,zuoyangfushaxingmeiyouzhijizuoyong,zheiyijiliangxiangdangyuxiangduitibiaomianjixiangtongshirenleizuidatuijianjiliangde9.4bei。jingmaidizhujiliangwei160 mg/kg/tianshi,zuoyangfushaxingyemeiyouzhijizuoyong,zheiyijiliangxiangdangyuxiangduitibiaomianjixiangtongshirenleizuidatuijianjiliangde1.9bei。dashukoufujiliangwei810 mg/kg/tianshikeyishitaishutizhongjiangdi,siwanglvzengjia。tukoufujiliangda50 mg/kg/tianshi,weiguanchadaozuoyangfushaxingjuyouzhijizuoyong,zheiyijiliangxiangdangyuxiangduitibiaomianjixiangtongshirenleizuidatuijianjiliangde1.1bei。jingmaidizhujiliangwei25 mg/kg/tianshi,zuoyangfushaxingyemeiyouzhijizuoyong,zheiyijiliangxiangdangyuxiangduitibiaomianjixiangtongshirenleizuidatuijianjiliangde0.5bei。
danduirenshenfunvhaiweijinxingzugoudesheyoulianghaoduizhaodeshiyan,bunengquebaorenshenfunvdeyongyaoanquan,suoyirenshenhuoyoukenengrenshendefunvjinyong。zhiyoudangduitaierdeqianzaiyichudayuqianzaiweixianshicainengjiangzuoyangfushaxingyongyurenshenfunv。
buruqifunv
genjuqitafukuinuotonghezuoyangfushaxingyouxiandeshuju,tuicezuoyangfushaxingyingkeyifenmizhirenleimuruzhong。youyuzuoyangfushaxingkenenghuiduimuruweiyangdeyingerchanshengyanzhongbuliangfanying,yinciburuqifunvjinyong。zhiyoudangduiburuqifunvqianzaiyichudayuqianzaiweixianshicainengjiangzuoyangfushaxingyongyuburuqifunv,danyingzantingburu。
【儿童用药】
baokuozuoyangfushaxingzaineidekuinuotongleikangshengsukeyiyinqimouxiezhongshudongwudeyoutifashengguanjiebingbianhegu/ruangubingbian。duiertongdeanquanxingshangweiqueli,gujinyongyuxiaoyu18suidehuanzhe,danyongyutanjuxiru(baoluhou)debaohuchuwai。
xiruxingtanju(baoluhou)
zuoyangfushaxingshiyongyuerkexiruxingtanju(baoluhou)huanzhe。fengxian-shouyipinggutishi,zaierkehuanzhezhongjiyuzuoyangfushaxingshishihede。shangweizaierkehuanzhezhongduiweiqi14tianyishangdezuoyangfushaxingzhiliaodeanquanxingjinxingyanjiu。zainianlingwei6geyuezhi16suideerkehuanzhezhong,duidancijingmaizhushezuoyangfushaxingdeyaodaidonglixuejinxingleyanjiu。zaiertonghuanzhezhong,zuoyangfushaxingdeqingchusudukuaiyuchengrenhuanzhe,yincizaitedingdemg/kgjiliangxia,suodedexuejiangbaolushuipingdiyuchengren。
不良反应
zailinchuangshiyanzhong,1534mingertong(nianling6geyuezhi16sui)jieshoulekoufuhejingmaizuoyangfushaxingzhiliao。nianlingzai6geyuezhi5suideertongjieshou10 mg/kgmeiri2cidezuoyangfushaxing,nianlingchaoguo5suideertongjieshou10 mg/kgmeiriyicidezuoyangfushaxing(zuidajiliangweimeiri500 mg),zongliaochengwei10tian。
zailinchuangshiyanzhongyigeyazudeertong(1340mingjieshouzuoyangfushaxingzhiliao,893mingjieshoufeifukuinuotongleiyaowuzhiliao)canyuleyixiangqianzhanxingzhangqijianceyanjiu,yipingguzaidiyicijiyuyanjiuyaowu60tianhe1nianhoudeshiyanfangandingyidejirougugejibing(guanjietong、guanjieyan、jijianbingzheng、butaiyichang)defashenglv。jieshouzuoyangfushaxingzhiliaodeertongjirougugejibingdefashenglvxianzhudigaoyufeifukuinuotongleiyaowuzhiliaodeertong,ruxiabiao
(表8)所示。
biao8:erkelinchuangshiyanzhongdejirougugejibingfashenglv
随访期 |
左氧氟沙星 N = 1340 |
非氟喹诺酮类a N = 893 |
p值b |
60天 |
28(2.1%) |
8(0.9%) |
p = 0.038 |
1年c |
46(3.4%) |
16(1.8%) |
p = 0.025 |
zhu:a.feifukuinuotonglei:toubaoqusong、amoxilin/kelaweisuan、kelameisu。
b.shuangcefisher’sjingquexingshiyan。
c.dui1199mingzuoyangfushaxingzhiliaodeertonghe804mingfeifukuinuotongleiyaowuzhiliaodeertongjinxingleweiqi1niandepingjiafangshi。raner,jirougugejibingdefabinglv,caiyongzaizhidingqijianneisuoyoucanyushiyanertongdesuoyoubaogaoshijianjisuan,buguantamenshifouwanchengweiqi1niandepingjiafangshi。
zailianggezhiliaozuzhong,guanjietongdoushizuichangfashengdejirougugejibing。zailianggezuzhong,juedaduoshujirougugejibingshejiduogechengzhongguanjie。jibingzai8/46(17%)zuoyangfushaxingzhiliaodeertongzhongweizhongdu,zai35/46(76%)zuoyangfushaxingzhiliaodeertongzhongweiqingdu,daduoshujieshoulezhentongjizhiliao。zuoyangfushaxingzhiliaozudezhongweihuanjieshijianwei7tian,zaifeifukuinuotongyaowuzhiliaozuzhongweihuanjieshijianwei9tian(zailianggezuzhong,junyouyue80%dehuanzhezai2geyueneihuanjie)。meiyouertongchuxianyanzhonghuozhongdadejibing,suoyougugejiroujibinghuanjieweiyiliuhouyizheng。
outuhefuxieshizuichangbaogaodebuliangshijian,zaizuoyangfushaxingzhiliaozuhefeifukuinuotongyaowuzhiliaozuzhongfashenglvxiangsi。
chulezaierkehuanzhelinchuangshiyanzhongbaogaodeshijian,zaichengrenhuanzhezhongyulinchuangshiyanhuoshouhoujiancezhongbaogaodeshijianyekenengfashengyuerkehuanzhezhong。
【老年用药】
laonianhuanzhezaijieshoufukuinuotongleiyaowu,liruzuoyangfushaxingqijian,yanzhongbuliangfanying(jijianbingzhengbaokuojijianduanlie)defengxianzengjia。zaijieshoutangpizhijisulianhezhiliaodehuanzhezhong,zheigefengxianjinyibuzengjia。jijianyanhuojijianduanliekeleijizhongbu、shoubu、jianbuhuoqitajijianbuwei,bingkezaizhiliaoqijianhuozhiliaojieshuhoufasheng。cengbaogaolefukuinuotongleiyaowuzhiliaojieshuhoujigeyuefashengdebingming。zailaonianhuanzhe,youqishijieshoutangpizhijisuzhiliaodehuanzhezhong,bixushenyongzuoyangfushaxing。bixujiangzheixieqianzaidefuzuoyonggaozhihuanzhe,ruguochuxianjijianyanhuojijianduanliederenhezhengzhuang,jianyitingzhizuoyangfushaxingzhiliao,bingyuyiliaobaojianrenyuanqudelianxi。
zaiⅲqilinchuangshiyanzhong, 1,945mingjieshouzuoyangfushaxingzhiliaodehuanzhe(26%)nianling≥ 65sui,1081ming(14%)nianlingjieyu65zhi74suizhijian,864ming(12%)nianlingdengyuhuodayu75sui。zheixiehuanzhehenianlingjiaoxiaohuanzheyaowudeanquanxingheyouxiaoxingwumingxianchayi,danbingbunengpaichumouxielaonianhuanzhedeminganxingkenenghuigenggao。
shangshibaogaozhong,yiyouyuzuoyangfushaxingyouguandeyanzhong,shenzhizhimingdeganduxing。zhuyaodezhimingxingganduxingbaogaofashengzai65suihuogengdanianlingzhong,qiedaduomeiyouguominfanying。ruguohuanzheyouganyandezhengzhuanghuozhizhengyinglijitingyongzuoyangfushaxing。
laonianhuanzhekenengduiqtjianqideyaowuxiangguanxingzuoyonggengmingan。yincitongshishiyongzuoyangfushaxinghemouxiekeyidaozhiqtjianqiyanzhangdeyaowu(liruiahuoⅲleikangxinlvshichangyao)huocunzaijianduanniuzhuanxingshisuweixianyinsu(ruyizhiqtjianqiyanzhang、wanguxingdixuejia)dehuanzheshiyongzuoyangfushaxingshiyingjinshen。
ruguokaolvjiganqingchulvdechayi,neimeqingnianshoushizhehelaonianshoushizhezuoyangfushaxingdeyaodaidonglixuetezhengmeiyouxianzhuchabie。danshiyouyuzuoyangfushaxingdabufenshicongshenzangpaixiede,yincishengongnengsunhaidehuanzhefashengyaowuduxingfanyingdeweixianxingjiaogao。erlaonianhuanzheshengongnengjiantuidekenengxingjiaoda,yincixuanzejiliangshiyingtebiejinshen,erqiexuyaotongshijianceshengongneng。
【药物相互作用】
1.aoheji:kangsuanji、liutanglv、jinshuyanglizi、duozhongweishengsuzhiji
左氧氟沙星口服制剂
suiranzuoyangfushaxingyuerjiayanglizideaohezuoyongruoyuqitafukuinuotongleikangshengsu,dantongshishiyongzuoyangfushaxingkoufuzhijihekangsuanjirumeihuolvyijiliutanglv、jinshuyanglizilirutiejihanxindeduozhongweishengsuzhijirengkeyiyingxiangzuoyangfushaxingdeweichangxishou,daozhiquanshenyaowunongduxianzhudiyuyuqinongdu。hanyoukangsuanjirumeihuolvyijiliutanglv、jinshuyanglizilirutiejihanxindeduozhongweishengsuzhijihuoquqiangjigandeyaowukeyimingxianyingxiangzuoyangfushaxingdeweichangxishou,daozhiquanshenyaowunongduxianzhudiyuyuqi。zheixieyaowuyingzhishaozaifuyongzuoyangfushaxingqianliangxiaoshihuofuyaohouliangxiaoshifuyong。
左氧氟沙星注射剂
shangwuguanyujingmaidizhukuinuotongleikangshengsuyukoufukangsuanji、liutanglv、duozhongweishengsuzhiji、quqiangjiganhuojinshuyanglizizhijianxianghuzuoyongdeshuju。danshikuinuotongleikangshengsubuyingyurenhehanyouduojiayanglizirumeiderongyetongguotongyijingmaishuyetongdaodizhu。
2.华法林
yixiangzaijiankangzhiyuanzhezhongjinxingdelinchuangshiyanxianshizuoyangfushaxingduir-hes-huafalindexuejiangfengnongdu、aucheqitadaixiecanshumeiyoumingxianzuoyong。tongyangyeweiguanchadaohuafalinduizuoyangfushaxingdexishouhedaixieyoumingxianzuoyong。cengyoushangshihoujiancebaogaozhichuzuoyangfushaxingkeyizengqianghuafalindeyaoxiao。tongshiyingyonghuafalinhezuoyangfushaxingkeyiyanzhangningxuemeiyuanshijian,congerdaozhichuxueshijianyanzhang。tongshiyingyongzuoyangfushaxinghehuafalinshiyingmiqiejianceningxuemeiyuanshijian、guojibiaozhunhuabizhi(inr)huoqitakangningshiyan,bingzhuyihuanzheyouwuchuxuedebiaoxian。
3.抗糖尿病药物
lianheyingyongkuinuotongleikangshengsuhekangtangniaobingyaowudehuanzhekenengchuxianxuetangwenluanrugaoxuetanghedixuetang。yinci,tongshiyingyongzheixieyaowushiyingmiqiejiancexuetangshuiping。
4.feizaitileikangyanyaowu
tongshishiyongfeizaitileikangyanyaowuhebaokuozuoyangfushaxingzaineidekuinuotongleikangshengsukeyizengjiafashengcnscijihechouchufazuodeweixian。
5.茶碱
zaiyixiangyou14mingjiankangzhiyuanzhecanjiadelinchuangshiyanzhongweifaxianzuoyangfushaxingduichajiandexuejiangnongdu、aucjiqitadaixiecanshuyoumingxianyingxiang。tongyangyeweiguanchadaochajianduizuoyangfushaxingdexishouhedaixieyoumingxianzuoyong。danshi,tongshiyingyongqitakuinuotongleikangshengsuhechajiankedaozhihuanzhechajiandeqingchubanshuaiqiyanzhang、xueyaonongdushenggao,congerzengjiachajianxiangguanbuliangfanyingdefashenglv。yinci,yuzuoyangfushaxingtongshishiyongshi,yingmiqiejiancechajianshuipingbingduiyaowujiliangjinxingshidangdiaozheng。wulunchajiandexueyaonongdushifoushenggaojunyoukenengchuxianbuliangfanyingrudianxian。
6.环孢霉素
yixiangzaijiankangzhiyuanzhezhongjinxingdelinchuangshiyanxianshizuoyangfushaxingduihuanbaomeisudexuejiangfengnongdu、aucheqitadaixiecanshumeiyoumingxianzuoyong。dancengyoubaodaoyuqitamouxiekuinuotongleikangshengsutongshishiyongshi,huanzhedehuanbaomeisuxueyaoshuipingshenggao。yuqitawubansuiyongyaodeshiyanxiangbi,tongshishiyonghuanbaomeisukeyiqingdujiangdizuoyangfushaxingdecmaxheke,ertmaxhet1/2shaoyouyanzhang,dancichayibingbujuyoulinchuangyiyi。yinci,tongshishiyongshibuxudiaozhengzuoyangfushaxinghehuanbaomeisudejiliang。
7. digaoxin
yixiangzaijiankangzhiyuanzhezhongjinxingdelinchuangshiyanxianshizuoyangfushaxingduidigaoxindexuejiangfengnongdu、aucheqitadaixiecanshumeiyoumingxianzuoyong。digaoxinduizuoyangfushaxingdexishouhedaixiedonglixueyemeiyouxianzhuyingxiang。yinci,tongshishiyongshibuxudiaozhengzuoyangfushaxinghedigaoxindejiliang。
8.binghuangshuheximitiding
yixiangzaijiankangzhiyuanzhezhongjinxingdelinchuangshiyanxianshibinghuangshuhuoximitidingduizuoyangfushaxingdexishousulvhexishouchengdumeiyoumingxianzuoyong。yuzuoyangfushaxingdanduyongyaoshixiangbi,yubinghuangshuhuoximitidinglianheyongyaoshi,zuoyangfushaxingdeauchet1/2fenbieshenggao27%~38%he30%,cl/fheclrjiangdi21%~35%。suiranzheiyichayijuyoutongjixuexianzhuxing,danyubinghuangshuhuoximitidinglianheyongyaoshibuxuyaodiaozhengzuoyangfushaxingdejiliang。
9.yushiyanshihuozhenduanjianchadexianghuzuoyong
baokuozuoyangfushaxingdefukuinuotong,yongshishoushijihejinxingniaoshaichaapianzhijikenenghuichanshengjiayangxingjieguo,youbiyaocaiyonggengteyidefangfaquedingapianyangxingjieguo。
【药物过量】
zuoyangfushaxingdejixingduxinghendi。dancijiyudajiliangzuoyangfushaxinghou,xiaoshu、dashu、gouhehoukeyichuxianxialielinchuangtizheng:gongjishidiao、shangjianxiachui、zifahuodongjianshao、huxikunnan、shuaijie、zhenzhanjijingjue。koufujiliangchaoguo1500 mg/kgjizhushejiliangchaoguo250 mg/kgshikeshiniechileidongwusiwanglvxianzhushenggao。
kuinuotongleiyaowuguoliangshi,kechuxianyixiazhengzhuang:exin、outu、weitong、weizhuore、fuxie、kouke、kouqiangyan、panshan、touyun、toutong、quanshenjuandai、mamugan、faleng、fare、zhuitiwaixizhengzhuang、xingfen、huanjue、chouchu、zhankuang、xiaonaogongjishidiao、luneiyashenggao(toutong、outu、shishenjingrutoushuizhong)、daixiexingsuanzhongdu、xuetangzenggao、got/gpt/alpzenggao、baixibaojianshao、shisuanxinglixibaozengjia、xuexiaobanjianshao、rongxuexingpinxue、xueniao、ruangu/guanjiezhangai、baineizhang、shilizhangai、sejueyichangjifushi。
jixingguoliangshiyingxiwei(jinzaifuyongkoufuzhijishi),guanchabingjiyushui、dianjiezhizhichiliaofa。xueyetouxihuofumotouxibunengyouxiaoqingchuzuoyangfushaxing。
急救措施及解毒药:
(1) shuye(jiabaoganyaowu):daixiexingsuanzhongdujiyutansuanqingnazhusheye,niaojianhuajiyutansuanqingnazhusheye,yizengjiabenpinyoushenzangdepaixie。
(2)qiangzhiliniao:jiyufunanbenansuanzhusheye。
(3)duizhengliaofa:chouchushiyingfanfujiyuandingjingmaizhusheye。
【临床试验】
zuoyangfushaxingdelinchuangshiyanqingkuangruxia:
1.医院获得性肺炎
jinglinchuanghefangshexuequezhenweiyiyuanhuodexingfeiyandechengnianhuanzheruxuanyixiangduozhongxin、suiji、kaifangshiyan,bijiaoliangzhongzhiliaofangandezhiliaoxiaoguo。yizhongzhiliaofanganshixianjingmaijiyuzuoyangfushaxing(meici750 mg,meiriyici)zaikoufuzuoyangfushaxing(meici750 mg,meiriyici),liaocheng7~15tian。lingyizhongzhiliaofanganshixianjingmaijiyuyaanpeinan/xisitading(meici500~1000 mg,mei6~8 xiaoshiyici)zaikoufuhuanbingshaxing(meici750 mg,mei12xiaoshiyici),liaocheng7~15tian。zuoyangfushaxingzhiliaozuhuanzhepingjunjieshoule7tianjingmaizhiliao(fanwei:1~16tian);erduizhaozuhuanzhepingjunjieshoule8tianjingmaizhiliao(fanwei:1~19tian)。
zaijieshoulinchuangheweishengwuxuepingjiadequanburenqunzhong,zuoyangfushaxingzude93minghuanzhezhongyou56ming(60.2%)huanzhezaishiyankaishishijigenjujingyanjiyulefuzhuzhiliao,erduizhaozude94minghuanzhezhongyou53ming(56.4%)。zuoyangfushaxingzufuzhuzhiliaopingjunchixu7tian,erduizhaozuyewei7tian。zaitonglvjiadanbaojunganrandeqiejinxinglelinchuangheweishengwuxuepingjiadehuanzhezhong,zuoyangfushaxingzu17minghuanzhezhongyou15ming(88.2%)jieshouletoubaotading(n=11)huopailaxilin/sanzuobatan(n=4)zhiliao,erduizhaozude17minghuanzhezhongyou16ming(94.1%)jieshouleanjitangganleikangshengsudezhiliao。zaiyiweinaijiayangxilinjinhuangseputaoqiujunganranqiejinxinglelinchuangheweishengwuxuepingjiadequanbuhuanzhezhong,zuoyangfushaxingzu93minghuanzhezhongde37ming(39.8%)tongshishiyonglewangumeisujinxingzhiliao,erduizhaozude94minghuanzhezhongyou28ming(29.8%)huanzhetongshishiyonglewangumeisujinxingzhiliao。
zhiliaohousuifang(jieshuzhiliaohoudi3~15tianduizhuyaoshiyanzhongdianjinxingpingjia)faxian,zaijinxinglelinchuangheweishengwuxuepingjiadehuanzhezhong,zuoyangfushaxingdelinchuangyouxiaolvwei58.1%,erduizhaozuwei60.6%。youxiaolvchayi(zuoyangfushaxingzujianquduizhaozu)de95% ciwei[-17.2, 12.0]。zhiliaohousuifangfaxian,zuoyangfushaxingzubingyuanjundeqingchulvwei66.7%,erduizhaozuwei60.6%。qingchulvchayi(zuoyangfushaxingzujianquduizhaozu)de95% ciwei[-8.3, 20.3]。genjubingyuanjunfenlei,qilinchuangyouxiaolvhebingyuanjunqingchulvfenbieruxiabiao(biao9)suoshi:
biao9:linchuangyouxiaolvhebingyuanjunqingchulv(yuanneifeiyan)
病原菌 |
N |
使用左氧氟沙星 患者人数(%) 微生物学/临床结果 |
N |
shiyongyaanpeinan/xisitadinghuanzherenshu(%) 微生物学/临床结果 |
MSSAa |
21 |
14 (66.7)/13 (61.9) |
19 |
13 (68.4)/15 (78.9) |
铜绿假单胞菌b |
17 |
10 (58.8)/11 (64.7) |
17 |
5 (29.4)/7 (41.2) |
粘质沙雷氏菌 |
11 |
9 (81.8)/7 (63.6) |
7 |
2 (28.6)/3 (42.9) |
埃希氏大肠杆菌 |
12 |
10 (83.3)/7 (58.3) |
11 |
7 (63.6)/8 (72.7) |
肺炎克雷白杆菌c |
11 |
9 (81.8)/5 (45.5) |
7 |
6 (85.7)/3 (42.9) |
流感嗜血杆菌 |
16 |
13 (81.3)/10 (62.5) |
15 |
14 (93.3)/11 (73.3) |
肺炎链球菌 |
4 |
3 (75.0)/3 (75.0) |
7 |
5 (71.4)/4 (57.1) |
zhu:a. jiayangxilinmingandejinhuangseputaoqiujun。
b. lianhezhiliaocanjianshangshuwenzi。
c. linchuangheweishengwuxuejieguobimingdechayikenengfanyinglebenshiyanzhongweikaolvdeyixieyinsu。
2.shequhuodexingxijunxingfeiyan
7~14天治疗方案
zailiangxiangzhongyaodelinchuangshiyanzhongduizhenduanweishequhuodexingxijunxingfeiyandechengnianzhuyuanbingrenhemenzhenbingrenjinxinglepingjia。590minghuanzheruxuandiyixiangqianzhanxing、duozhongxin、feimangfasuijishiyan,bijiaoleliangzhongzhiliaofangandeliaoxiao,diyizhongzhiliaofanganshikoufuhuojingmaijiyuzuoyangfushaxing500 mg,meiriyici,lianxujiyao7~14tian,dierzhongzhiliaofanganshijingmaijiyutoubaoqusong1~2 g,meiriyicihuojiangjiliangdengfen,meirijiyaoliangci,tongshifuyongtoubaofuxinzhi500 mg,meiriliangci,gongzhiliao7~14tian。ruguohuaiyihuoyizhengshiyoufeidianxingbingyuanjunyinqiganrandeduizhaozuhuanzhekeyishiyonghongmeisu(ruguobunengnaishouhongmeisu,keyiyongqianglimeisutidai)jinxingzhiliao。zhiliaoqijian、zhiliaohou5~7tianjizhiliaohou3~4zhoujinxinglinchuangheweishengwuxuepingjia。genjubenshiyanzhongsuoyongdezhuyaoyouxiaoxingcanshupanduan,zhiliaohou5~7tianzuoyangfushaxingdelinchuangyouxiaolv(zhiyujiagaishan)(95%)gaoyuduizhaozu(83%),tongjixuebijiaomingxianchayi(zuoyangfushaxingzujianquduizhaozu)de95% ciwei[-6, 19]。264minghuanzhecanjialedierxiangqianzhanxing、duozhongxin、feibijiaoshiyan,shiyanzhongkoufuhuojingmaijiyuzuoyangfushaxing500 mg,meiriyici,gong7~14tian,linchuangyouxiaolvwei93%。zaishangshuliangxiangshiyanzhong,duiyoufeiyanyiyuanti、feiyanzhiyuantihefeiyanjuntuanjunyinqidefeidianxingxingfeiyandelinchuangyouxiaolvfenbiewei96%、96%he70%,weishengwuqingchulvruxiabiao(biao10)suoshi:
biao10:shequhuodexingxijunxingfeiyanlinchuangyanjiudeweishengwuqingchulv
病原菌 |
存在病原菌人数 |
微生物清除率(%) |
流感嗜血杆菌 |
55 |
98 |
肺炎链球菌 |
83 |
95 |
金黄色葡萄球菌 |
17 |
88 |
卡他莫拉菌 |
18 |
94 |
副流感嗜血杆菌 |
19 |
95 |
肺炎克雷白杆菌 |
10 |
100 |
youduozhongnaiyaoxingfeiyanlianqiujun(mdrsp)yinqideshequhuodexingfeiyan
zuoyangfushaxingkeyiyouxiaozhiliaoyouduozhongnaiyaoxingfeiyanlianqiujun(mdrsp)yinqideshequhuodexingfeiyan。mdrsp(duozhongnaiyaoxingfeiyanlianqiujun)zhiduixialieliangzhonghuoduozhongkangjunyaowunaiyaodejunzhu:qingmeisu(mic ≥ 2 µg/ml),erdaitoubaojunsu(rutoubaofuxin)、dahuanneizhilei、sihuansujijiayangbiananmiding/huanganjiakouezuo。dui40mingganranmdrspdehuanzhejinxingleweishengwuxuepingjia,qizhong38minghuanzhe(95.0%)jingguozhiliaohouqudelelinchuanghexijunxuedechenggong。linchuanghexijunxuedeyouxiaolvjianxiabiao(biao11)。
biao11:zuoyangfushaxingzhiliaomdrspyinqidecapdelinchuanghexijunxueyouxiaolv(qunti:shihejinxingyouxiaolvyanjiu)
敏感性筛查 |
临床有效 |
细菌学有效c |
||
n/Na |
% |
n/Nb |
% |
|
青霉素耐药 |
16/17 |
94.1 |
16/17 |
94.1 |
二代头孢菌素耐药 |
31/32 |
96.9 |
31/32 |
96.9 |
dahuanneizhileikangshengsunaiyao |
28/29 |
96.6 |
28/29 |
96.6 |
jiayangbiananmiding/huanganjiawuzuonaiyao |
17/19 |
89.5 |
17/19 |
89.5 |
四环素耐药 |
12/12 |
100 |
12/12 |
100 |
zhu:a.n=jinxingweishengwuxuepingjiadelinchuangyouxiaodehuanzherenshu;n=zhidingnaiyaozujinxingweishengwuxuepingjiadehuanzherenshu。
b.n=jinxingweishengwuxuepingjiadehuanzhezhongmdrspjunqunbeiqingchuhuotuiceyibeiqingchudehuanzherenshu;n=zhidingnaiyaozumdrspzhongqungeshu。
c.cong1minghuanzheqihuxidaozhongfenlichuduisihuansu、toubaofuxin、dahuanneizhileikangshengsuhetmp/smxnaiyao,duiqingmeisuzhongdunaiyaodexijun,erxueyebiaobenzhongdexijunduiqingmeisuhetoubaofuxinzhongdunaiyao,duiqitaleikangshengsunaiyao。shujukuzhongbaokuodegaihuanzheshujushiqihuxidaofenlichudexijunshuju。
fenlichudejunqunbingfeiduisuoyoushiyandekangjunyaodounaiyao。xiabiao(biao12)zongjieleyouxiaolvheqingchulv。
biao12:naiyaofeiyanlianqiujundelinchuangyouxiaoxinghexijunqingchulv(shequhuodexingfeiyan)
duozhongnaiyaoxingfeiyanlianqiujun |
临床有效率 |
细菌学清除率 |
对2种药物耐药 |
17/18 (94.4%) |
17/18 (94.4%) |
对3种药物耐药 |
14/15 (93.3%) |
14/15 (93.3%) |
对4种药物耐药 |
7/7 (100%) |
7/7 (100%) |
对5种药物耐药 |
0 |
0 |
MDRSP菌血症 |
8/9 (89%) |
8/9 (89%) |
5天治疗方案
528mingjinglinchuanghefangshexuequezhenweiqingduzhizhongdushequhuodexingfeiyandemenzhenhezhuyuanchengnianhuanzhecanjialeyixiangshuangmang、suiji、qianzhanxing、duozhongxinshiyan,yipingjiazuoyangfushaxingzaijiliangjiaogaoheliaochengjiaoduanshideanquanxingheyouxiaoxing。shiyanduizuoyangfushaxing750 mglianxujingmaizhushehuokoufuyongyao5tianhougaiweizuoyangfushaxing500 mg jingmaizhushehuokoufulianxuyongyao10tianliangzhongzhiliaofanganjinxinglebijiao。
zuoyangfushaxing750 mgzulinchuangyouxiaolv(zhiyujiagaishan)wei90.9%,500 mgzuwei91.1%。youxiaolvchayi(zuoyangfushaxing750 mgzujianquzuoyangfushaxing500 mgzu)de95% ciwei[-5.9, 5.4]。zaijinxinglinchuangpingjiaderenqunzhong(canjiashiyanhou31~38tian),zuoyangfushaxing750 mgzude151minghuanzhezhongyou7mingfashengfeiyan,500 mgzude147minghuanzhezhongyou2mingfashengfeiyan,youyuyangbenliangjiaoxiao,chayibujuyoutongjixuexianzhuxing。xiabiao(biao13)miaoshule5tianzhiliaofanganduiyixiaweishengwuganrandeyouxiaoxing。
biao13:weishengwuqingchulv(shequhuodexingfeiyan)
|
清除率 |
qingmeisumingandefeiyanlianqiujun |
19/20 |
流感嗜血杆菌 |
12/12 |
副流感嗜血杆菌 |
10/10 |
肺炎支原体 |
26/27 |
肺炎衣原体 |
13/15 |
3.jixingxijunxingbidouyan
5tianhe14tianzhiliaofangan
zuoyangfushaxingyibeipizhunyongyuzhiliaojixingxijunxingbidouyan(abs),anzhao750 mg meiriyicilianxukoufu5tianhuo500 mgmeiriyicilianxukoufu10~14 tianjiyao。weilepingjiaduanqishiyonggenggaojiliangdezuoyangfushaxingdeanquanxingheliaoxiao,zaiyixiangshuangmang、suiji、qianzhanxing、duozhongxinyanjiuzhong,pingjiale780mingjinglinchuanghefangshexuequezhenweijixingxijunxingbidouyandechengnianmenzhenhuanzhe,yibijiaozuoyangfushaxing750 mg meiriyicilianxujiyao5tianhezuoyangfushaxing500 mg meiriyicilianxujiyao10tianliangzhongjiyaofangandechayi。
zaizhiyujianyanfangshishi,zuoyangfushaxing750 mgzuweishengwuxuepinggurenqundelinchuangchenggonglv(dingyiweizhiliaoqianabstizhengyuzhengzhuangchedihuobufenhuanjie:jirenweimeiyoubiyaojinxingjinyibudekangshengsuzhiliao)shi91.4%(139/152),zuoyangfushaxing500mgzushi88.6% (132/149),zuoyangfushaxing750mgjianquzuoyangfushaxing500mgde95%ci [-4.2, 10.0]。
zairuzuyanjiushitongguodouqingpai(antral tap)huodebiaobendeweishengwuxuepinggurenqunzhong,anbingyuanjunhuafendelinchuangchenggonglvbiaoming,5tianhe10tianfangandezhiliaohou22tiandezhiyujianyanfangshidejieguoxiangdang。
biao14:jinxingweishengwuxuepinggudedouchuancihuanzheanbingyuanjunhuafendelinchuangchenggonglv
(jixingxijunxingbidouyan)
病原菌 |
zuoyangfushaxing 750 mg ×5tian |
zuoyangfushaxing500 mg × 10 tian |
feiyanlianqiujun * |
25/27 (92.6%) |
26/27 (96.3%) |
liuganshixueganjun * |
19/21 (90.5%) |
25/27 (92.6%) |
zhanmoyanmolashijun * |
10/11 (90.9%) |
13/13 (100%) |
zhu:*benshiyanzhong40%deshoushizhetongguodouneikuijingfahuodebiaoben。yongneikuijingfadedaolaidebiaobendeshoushizhedeliaoxiaoshujuyushangbiaozhongjichudeshujuxiangdang。
4.fuzaxingpifuhepifuruanzuzhiganran
399minghuanzhecanjialeyixiangyouguanfuzaxingpifuhepifuruanzuzhiganrandekaifang、suiji、bijiaoshiyan。huanzhesuijijieshouzuoyangfushaxing750 mg (xianjingmaizaikoufu,meiriyici)huopizhundeduizhaoyaowuzhiliao,zhiliaoshijiandezhongweishuwei10 ± 4.7tian。zhengrusuoyuqide,duiyufuzaxingpifuhepifuruanzuzhiganran,zuoyangfushaxingzuheduizhaozujunyouhuanzhexuyaojinxingshoushuzhiliao。zuoyangfushaxingzhiliaozuheduizhaozuxushoushuzhiliao(qiekai,yinliuhuoqingchuang)dehuanzhefenbieyou45%he44%,shoushushaozaoyukangshengsuzhiliaohuozaikangshengsuzhiliaoqijianjinxing,shuyucileijibingdezhiliaofangfadeyibufen。
duiyuneixiezaishiyanyaowuzhiliaojieshuhou2~5tiankeyijinxinglinchuangpingjiadehuanzhe,zuoyangfushaxingzhiliaozuheduizhaozuzongtiyouxiaolv(gaishanhuozhiyu)fenbiewei116/138(84.1%)he106/132(80.3%)。
youxiaolvgenjuganranleixingeryousuochabie,kuiyangganranhuanzhedeyouxiaolvwei68%,ershangkouganranhenongzhonghuanzhedeyouxiaolvwei90%,qiyouxiaolvyuduizhaoyaopinxiangdang。
5.manxingxijunxingqianliexianyan
linchuangzhenduanweiqianliexianyandechengnianhuanzheruxuanyixiangduozhongxin、suiji、shuangmangshiyan,zheixiehuanzhezaijinxingqianliexiananmo(vb3)houcaijiniaoyebiaobenhuotongguomeares-stameyfenduanfahuodeqianliexiananmoye(eps)jinxingxijunpeiyang。zheixiangshiyanbijiaolemeicikoufuzuoyangfushaxing500 mg、meiriyici,yongyao28tianhemeicikoufuhuanbingshaxing500 mg、meiriliangci,yongyao28tiandezhiliaoxiaoguo。jinxingweishengwuxuepingjiahuanzhedezhuyaoxiaolizhongdianshiweishengwuxueyouxiaoxing。
zuoyangfushaxingzuhehuanbingshaxingzufenbieyou136minghe125minghuanzhejinxingleweishengwuxuepingjia。zuoyangfushaxingzuhehuanbingshaxingzuzaizhiliaojieshuhou5~18tiandeweishengwuxueqingchulvfenbiewei75.0%he76.8%[zuoyangfushaxingzujianquhuanbingshaxingzuhou95% ciwei(-12.58, 8.98)]。xiabiao(biao15)zhongliechulezhuyaobingyuanjundezongtiqingchulv:
biao15:bingyuanjundeqingchulv(manxingxijunxingqianliexianyan)
病原菌 |
zuoyangfushaxingzu(n=136) |
huanbingshaxingzu(n=125) |
||
N |
清除率 |
N |
清除率 |
|
埃希氏大肠杆菌 |
15 |
14(93.3%) |
11 |
9(81.8%) |
粪肠球菌 |
54 |
39(72.2%) |
44 |
33(75.0%) |
*表皮葡萄球菌 |
11 |
9(81.8%) |
14 |
11(78.6%) |
zhu:biaozhongsuolieqingchulvweizhiganranyizhongbingyuanjundehuanzhedeshuju,paichulehunhepeiyangdejieguo。
yuqitabingyuanjunhunheganranshibiaopiputaoqiujundeqingchulvyudanduganranshixiangtong。jinxingweishengwuxuepingjiadezuoyangfushaxingzhiliaozuhuanzhehehuanbingshaxingzhiliaozuhuanzhezaizhiliaojieshuhou5~18tiandelinchuangyouxiaolv(zhiyu+bingqinggaishanerbuxukangshengsuzhiliao)fenbiewei75.0%he72.8%[zuoyangfushaxingzujianquhuanbingshaxingzuhou95% ciwei(-8.87, 3.27)]。zuoyangfushaxingzhiliaozuhehuanbingshaxingzhiliaozudelinchuangzhangqiyouxiaolv(zhiliaojieshuhou24~45tian)fenbiewei66.7%he76.9%[zuoyangfushaxingzujianquhuanbingshaxingzuhou95% ciwei(-23.40, 2.89)]。
6.fuzaxingniaoluganranhejixingshenyushenyan
5天治疗方案:
meiguoyixiangsuiji、shuangmang、duozhongxindelinchuangshiyanpingjialezuoyangfushaxinggaojiliang、duanliaochengzhiliaodeanquanxingheyouxiaoxing,shijianzi2004nian11yuezhi2006nian4yue。gongyou1109mingcutiheaphuanzhecanyuleyanjiu。ciyanjiubijiaozuoyangfushaxing 750 mg jingmaizhushehuokoufumeiri1cigong5tiandeliaocheng(546minghuanzhe)hehuanbingsha
guangxiliuyaojituangufenyouxiangongsi
dizhi:guangxiliuzhoushiguantangdadao68hao
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