网信彩票

证券代码:603368 ● CHINA
质量体系

2013年01月31日

国家食品药品监督管理局修订左氧氟沙星口服和

 
 

2013nian01yue30ri fabu

 

  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。

小贴士:

  shenmeshiyaopinshuomingshuxiuding?

  da:yaopinshuomingshushizaimingyaopindezhongyaoxinxidefadingwenjian,shixuanyongyaopindefadingzhinan,yongyizhidaoanquan、helishiyongyaopin,yingdangbaohanyaopinanquanxing、youxiaoxingdezhongyaokexueshuju、jielunhexinxi。


  yaopinshangshiguochengzhongxuyaobuduangenjukexuerenzhidegengxinhefengxianpingguqingkuang,caiquxiudingyongfayongliang、zengjiazhuyishixianghuoheikuangjinggaodengfangshixiudingshuomingshu,mudeshigenghaodezhidaoyaopindeshiyong、kongzhiqianzaidefengxian。


  qiyekeyigenjushangshihoujianceshujutichuxiugaishuomingshudeshenqing。guojiashipinyaopinjianduguanlijuyekeyigenjuyaopinbuliangfanyingjiance、yaopinzaipingjiadengxinxiyijiguoneiwaixiangguanyanjiuziliao,yaoqiuqiyexiugaiyaopinshuomingshu。

  yaopinshuomingshuhuozhunxiugaihou,yaopinshengchanqiyeyingdangjiangxiugaideneironglijitongzhixiangguanyaopinjingyingqiye、shiyongdanweijiqitabumen,binganyaoqiujishishiyongxiugaihoudeshuomingshu。

 

 

【相关链接】

 

 

guojiashipinyaopinjianduguanlijuguanyuxiudingzuoyangfushaxingkoufuhezhushejishuomingshudetongzhi

guoshiyaojianzhu[2012]373hao

2012nian12yue31ri fabu

 

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:
  (一)药品生产企业要尽快修订说明书及标签的相关内容,按照有关规定进行备案。 
  (er)yaopinshengchanqiyeyingdangjiangxiudingdeneirongjishitongzhixiangguanyiliaojigou、yaopinjingyingqiyedengdanwei,bingzhudonggenzongyaopinlinchuangyingyongdeanquanxingqingkuang,anguidingshoujibuliangfanyingbingjishibaogao。


  附件:1.  
     2.   
     3.   
     4.   
     5. 


                                 国家食品药品监督管理局
                                   2012nian12yue31ri

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

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

 

 

 

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、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

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


联系我们

guangxiliuyaojituangufenyouxiangongsi

dizhi:guangxiliuzhoushiguantangdadao68hao

邮编:545001

dianhua:+86-772-2514508

chuanzhen:+86-772-2514558

fanwubi:+86-772-2561873

tousurexian:+86-772-2520703

人人体育(中国)- App Store-官方网站 澳门金威尼斯游戏·(中国)官网登录入口 人人体育·(中国)官方网站-IOS版/安卓版/手机版APP下载 澳门金威尼斯游戏(中国)官方网站IOS/安卓通用版/手机APP 威斯尼斯人娱乐平台(中国)官方网站IOS/安卓通用版/手机APP