网信彩票

证券代码:603368 ● CHINA
质量管理通知

2016年10月18日

药物警戒快讯 2016年第9期(总第161期)

 

内容提要

美国警告阿片类与苯二氮卓类等药物联合使用导致的严重风险
加拿大进一步限制可待因在儿童和青少年中的使用
加拿大评估氢可酮导致儿童与青少年呼吸抑制风险
加拿大警告抗抑郁药引起的闭角型青光眼风险
ribenfabuguoyangbenjiaxiandengyaopinshuomingshugengxinxinxi

美国警告阿片类与苯二氮卓类等药物联合使用导致的严重风险

  2016nian8yue31ri,meiguoshipinyaopinliju(fda)pinggufaxian,apianleiyaowuyubenerdanzhuoleihuoqitayizhizhongshushenjingxitong(cns)deyaowulianheshiyongdexianxiangriyizengduo,zheizhonglianheyongyaohuidaozhiyanzhongdefuzuoyong,baokuohuxijianmanhuohuxikunnan,shenzhisiwang。weijianshaoapianleiyubenerdanzhuoleihuoapianleiyuqitacnsyizhijilianheshiyongdeqingkuang,fdatichuyanzhongjinggao,yaoqiuzaiapianleizhentongyaohezhikeyaoyijibenerdanzhuoleiyaowudeshuomingshuzhongtianjiaheikuangjinggao。

  apianleiyaowushiqiangxiaomazuiyao,yongyuzhiliaowufashiyongqitazhentongyaohuoqitazhentongyaobunengchongfenhuanjietengtongdehuanzhe。apianleideyanzhongfengxianbaokuowuyong、lanyong、chengyin、guolianghesiwang。apianlei(rukedaiyinheqingketong)haibeipizhunyuqitayaowulianhezhiliaokesou。benerdanzhuoleiyaowuweiyileiguangfanshiyongdeyaowu,keyizhiliaobaokuojiaolv、shimianhedianxianfazuozaineidejibingzhengzhuang。apianleihebenerdanzhuoleiyaowudouhuiyizhicns。

  fdashenchadeduoxiangyanjiujieguoxianshi,lianheshiyongapianleihebenerdanzhuolei、qitayizhicnsyaowuhuojiujingkechuxianyanzhongfengxian。

  合并使用苯二氮卓类与阿片类药物

  fdakaizhandeliangxiangyanjiuxianshi,hebingshiyongapianleizhentongyaohebenerdanzhuoleiyaowuchengshangshengqushi,hebingshiyongbenerdanzhuoleiheapianleidewuyong、lanyongheguoliangdepincizengjia,zheishigenjuguojiajizhenke(national emergency department,ed)jiuzhenshujuheguoliangsiwanglvcesuansuodedejieguo。

  diyixiangyanjiupingguhebingshiyongapianleizhentongyaohebenerdanzhuoleideshiyongmoshi。2002nianzhi2014nianjian,meinianpeifaapianleiyaowudehuanzheshuliangzengjia8%,cong7500wanzengjiazhi8100wan,meinianpeifabenerdanzhuoleiyaowudehuanzheshuliangzengjia31%,cong2300wanzengjiazhi3000wan。zaiciqijian,apianleizhentongyaozhiliaohuanzhetongshijieshoubenerdanzhuoleichufangyaodebilizengjia41%,yejiushishuo,he2002nianxiangbi,2014nianapianleizhentongyaohebingbenerdanzhuoleidehuanzheshuliangzengjia250wanyishang。jieshouhebingchufangyaogailvzuigaodeyazushinvxinghe65suiyishangzhangqishiyongapianleizhentongyaodehuanzhe。raner,ruguocaiyongjueduishuzi,zeapianleizhentongyaodefeizhangqishiyongzhehebingyongyaodeshuliangzuiduo,yinweizheigehuanzhequndeshuliangyuanyuandayuzhangqishiyongzhe。

  dierxiangyanjiushiyongyaowulanyongjingshiwang(drug abuse warning network,dawn)fenxifeiyiliaomudeshiyongapianleizhentongyaohebenerdanzhuoleihouedjiuzhenshuju,shiyongguojiazhongyaotongjixitongduoyinsiwangwenjian(national vital statistics system multiple cause-of-death file)fenxiyuchufangapianleizhentongyaohebenerdanzhuoleiyaowuyouguandeyaowuguoliangsiwangshuju。cong2004nianzhi2011nian,feiyiliaomushiyonghouedjiuzhendefashenglv(baokuoapianleizhentongyaohebenerdanzhuolei),congmei10wanhuanzhe11lizengjiazhi34.2li(p<0.0001)。tongyishiqinei,apianleizhentongyaohebenerdanzhuoleiyaowuguoliangsiwanglv(baokuochufangjilianghedayuchufangjiliang)congmei10wanren0.6lizengjiazhi1.7li(p<0.0001)。zaizheiduanshijiannei,shiyongbenerdanzhuoleiyaowudehuanzhe,fashengapianleizhentongyaoguoliangsiwangdebili,cong18%zengjiazhi31%(p<0.0001)。

  yixuewenxianzhonglingwailiangxiangyanjiuxianshichushiyongapianleizhentongyaohebenerdanzhuoleiyaowudehuanzhefashengbuliangshijiandefengxianshangshengdegengzhijiezhengju。zaibeikaluolainazhoukaizhandeqianzhanxingguanchaxingduilieyanjiufaxian,lianheshiyongapianleizhentongyaohebenerdanzhuoleiyaowudehuanzhezhong,guoliangsiwanglv(7.0/10,000huanzhenian;95%ci:6.3-7.8)bidandushiyongapianleizhentongyaodehuanzhe(0.7/10,000huanzhenian;95% ci:0.6-0.9)gaochu10beiyishang。haiyouyixiangduilieyanjiupinggule2004-2009niandetuiwujunrenjiankangguanlishuju,faxianhebingshiyongapianleizhentongyaohebenerdanzhuoleiyaowudehuanzhe,yaowuguoliangsiwangdefengxianzengjia。yumeiyoubenerdanzhuoleiyongyaoshidehuanzhexiangbi,juyoubenerdanzhuoleiyongyaoshidehuanzheshiyongapianleizhentongyaoguoliangzhisidefengxianshenggao(hr= 2.33,95%ci: 2.05 2.64),neixiemuqianshiyongbenerdanzhuoleichufangyaodehuanzhefashengguoliangzhisidefengxianzengjialeisi(hr=3.86,95%ci: 3.49 4.26)。ciwai,suizhebenerdanzhuoleiyaowumeirijiliangzengjia,yaowuguoliangsiwangdefengxianzengjia。

  genjuzheisixiangyanjiumiaoshudehebingshiyongapianleizhentongyaohebenerdanzhuoleiyaowuxianxiangzengjiayijihebingshiyonghouweihaizengjiadequshi,fdayaoqiuzaiapianleizhentongyaoheapianleizhikeyaoyijibenerdanzhuoleiyaowudeshuomingshuzhongtianjiaxindeheikuangjinggaoxinxi。shuomingshudejinggaohezhuyishixiang、yaowuxianghuzuoyonghehuanzheyongyaojianyixinxibufenyeyaozuochuxiangyingxiuding。

合并使用阿片类药物和其他CNS抑制剂

  jinqiwenxianfabiaodeyanjiuxianshi,hebingshiyongapianleizhentongyaoyucnsyizhiji(chubenerdanzhuoleiwai,baokuojiujing)yeyuyanzhongbuliangshijianxiangguan。yixiangyanjiubaogaocheng,zaipandingbenerdanzhuoleiyaowushisiwangyuanyindebaogaozhong,hebingshiyongapianleizhentongyaodezhan77%,zaipandingapianleizhentongyaoshisiwangyuanyindebaogaozhong,hebingshiyongbenerdanzhuoleiyaowudezhan30%。zheixiangyanjiuhaifenxilezheixiesiwangbinglizhongqitacnsyizhiji(baokuobabituolei、kangjingshenbingyao、zhenjingcuimianyao、kangdianxianyao、kangpajinsenbingyao、mazuiyao、zizhushenjingxitongyaowuhejirousongchiji)deyingxiang,faxianbufenshiyongapianleizhentongyaodebingli,zheixiecnsyizhijiyeshisiwangdecufayinsu。dierxiangyanjiufenxile2010niandawnshuju,faxian18.5%deapianleizhentongyaolanyongxiangguanedjiuzhenyujiujingyouguan,22.1%deapianleizhentongyaoxiangguansiwangyujiujingyouguan。

  suoyouyanjiudoushijiyuapianleizhentongyaokaizhande,raneryouyuyaolitexingleisi,yinciyuqihebingshiyongapianleizhikeyaohebenerdanzhuolei、qitacnsyizhijihuojiujingdefengxianyuapianleijiejinshihelide。genjuzheixieyanjiu,apianleizhentongyaohezhikeyaodeheikuangjinggaoyehuiqiangdiaoyuqitacnsyizhijihebingshiyongdefengxian。

   kaolvdaoshiyongyaowufuzhuliaofa(mat)zhiliaoapianleichengyinheyilaideduteyiliaoxuqiuhehuoyi/fengxian,fdajiangjixupingguhebingshiyongbenerdanzhuoleihematyaowudekeyongzhengju。

  fdatixingyiwurenyuan,yinggaixianzhiapianleizhentongyaoyubenerdanzhuoleihuoqitacnsyizhijilianheshiyong,jinyongyuqitatidailiaofaliaoxiaobuchongfendehuanzhe。ruguohebingchufangzheixieyaowu,yinggaijiangmeizhongyaowudejiliangheliaochengxianzhizainenggoudadaolixianglinchuangliaoxiaodezuidishuiping。fdajinggaohuanzhehekanhuzhezhuyihuxijianman、huxikunnanhe/huozhenjingdefengxian,yijixiangguandetizhenghezhengzhuang。bimianjizhengzaishiyongbenerdanzhuoleihuoqitacnsyizhiji(baokuojiujing)dehuanzhechufangapianleizhikeyao。

  hebingshiyongapianleiyaowuyubenerdanzhuolei、qitacnsyizhijihuojiujingdehuanzhe,ruguochuxianshaojiandetouyunhuoxuanyun、jidushishui、huxijianman、huxikunnanhuowufanying,yinggailijijiuyi。wufanyingshizhihuanzhebunengzhengchanghuiyinghuozuochufanying,huozhebunenghuanxinghuanzhe。ruguoduishiyongapianleihuobenerdanzhuoleihaiyouyiwenhuodanyou,yingyuyiwurenyuangoutong。

FDA列出的阿片类、苯二氮卓类药物和其他CNS抑制剂如下:
·阿片类镇痛止咳处方药:阿芬太尼(alfentanil)、丁丙诺啡、布托啡诺、可待因、二氢可待因、芬太尼、氢可酮、氢吗啡酮、哌替啶、美沙酮、吗啡、羟考酮、羟吗啡酮(oxymorphone)、喷他佐辛、瑞芬太尼、舒芬太尼、他喷他多(tapentadol)、曲马多。
·苯二氮卓类:阿普唑仑、氯氮卓、氯巴占(clobazam)、氯硝西泮、氯拉卓酸(clorazepate )、地西泮、艾司唑仑、氟西泮、劳拉西泮、奥沙西泮、夸西泮(quazepam)、替马西泮(temazepam )、三唑仑。
·其他镇静催眠药:仲丁巴比妥钠(butabarbital sodium)、右佐匹克隆、戊巴比妥、雷美替胺(ramelteon)、司可巴比妥钠、苏沃雷生(suvorexant)、扎来普隆、唑吡坦。
·肌肉松弛剂:巴氯芬、卡立普多(carisoprodol)、氯唑沙宗、环苯扎林(cyclobenzaprine)、丹曲林钠、美他沙酮(metaxalone)、美索巴莫、奥芬那君(orphenadrine)、替扎尼定。
·kangjingshenbingyao:alipaizuo、asaineiping(asenapine)、kalilaqin(cariprazine)、lvbingqin、lvdanping、fufennaijing、fupaidingchun、yipanlitong(iloperidone)、luoshaping、lulaxitong(lurasidone)、mayintong(molindone)、aodanping、palipaitong、fennaijing、pimavanserin、kuiliuping、lipeitong、liulidaqin、tiwosaidun(thiothixene)、sanfulaqin、qilaxitong。

(美国FDA网站)


加拿大进一步限制可待因在儿童和青少年中的使用

  zai2013nianhe2015nian,yinhankedaiyinyaopinyuweijishengmingdehuxiwentideqianzaifengxianxiangguan,jianadaweishengbuduihankedaiyinyaopinshishileanquanxingshencha,dangshijianyi,zainianlingwei12suiyixiadeertongzhong,buzaishiyonghankedaiyindeyaopin。jianadaweishengbujinqishishilexindeanquanxingshencha,zhizaijinyibupinggukedaiyinzaiertongjiqingshaonianhuanzhezhongcunzaideyanzhonghuxiwenti,yijuedingzaigainianlingzuzhongshifouxuyaocaiqugengduocuoshilaiguanlicifengxian。

  kedaiyinjingganzangzhuanhuaweimafei,zheiliangzhongyaopinjunshuyuapianleiyaowu。yizhiapianleiyaowukeyijianhuanhuxisudu,sheruguoduoapianleiyaopinkejianhuanhuxiqiezuyiweijishengming。youxiehuanzheshichaokuaisudaixiezhe,zheiyiweizhetamenkeyigengxunsuhewanquandijiangkedaiyinzhuanhuaweimafei,zaisheruhankedaiyinyaopinhou,tamendexueyezhonggengkenenghanyoudayuyuqiliangdemafei,yincihuigengjiaweixian。zaijianada,hankedaiyinyaopinyongyuzhiliaotengtongjizhike。kedaiyinkedanyonghuoyuqitayaowulianyong,yixiehankedaiyinyaopinjinketongguochufanghuode,erqitaweifeichufangyao。duiyuhankedaiyindefeichufangyao,xiaofeizhezaigoumaiqian,bixuzixunyaojishi。hankedaiyinyaopindeanquanxingxinxitishi,ruguohuanzhehuanyoudaozhihuxikunnandejibing,ruxiaochuan、manxingfeibinghuoqitahuxiwenti,yingjinyonghankedaiyindeyaopin。

  zaianquanxingshenchajinxingqijian,jianadaweishengbugongshoudao8likenengyuchufangkedaiyinzhiliaotengtongyouguanqienianlingzai18suiyixiayouhuxiwentidejianadahuanzhebingli。zheixiebinglizhongde6lifashengzainianlingwei12suiyixiadeertongzhong,qizhong3lisiwang。8libinglizhongde4lifashengzaishoushuqiechubiantaotihuolinbazuzhihoudeertongzhong。zhidezhuyideshi,yuhankedaiyinyaopintongyishijiansherudeqitayaowuyekenengdaozhihuanzhedehuxiwenti。lingwaifaxian,zaifabiaodehuanzhenianlingwei18suiyixia、shiyongkedaiyinzhiliaotengtongde7liguojibinglizhong,chufangkedaiyinkenengyuyanzhonghuxiwentixiangguanlian。7lizhongde6liwei12suiyixiaertong,qizhong4lisiwang。7libinglizhongde5lifashengzaishoushuqiechubiantaotihuolinbazuzhideertongzhong。zhidezhuyideshi,zheixieertonglihuandeqitajibingyekenengdaozhihuxiwenti。

  zi2013shenchayilai,jianadaweishengbushangweishoudaorenheertonghuoqingshaonianshiyongkedaiyinfeichufangyaozhiliaotengtonghuozhikedaozhiyanzhonghuxiwentidebingli。zainianlingwei12suizhi18suidehuanzhe(baokuo2013shenchaqiandehuanzhe)deguojibinglibaogaozhong,yinxinxibuzuwufatuiduankedaiyindaozhisuobaogaodefuzuoyong。baogaozhongquefakedaiyinshiyongjiliangxiangguandexinxi,yijishifouyuzaijianadashiyongdefeichufangyaodeguigexiangsi。zi2013nianshenchayilai,kexuewenxianzhongweibaogaoshejishiyongfeichufangguigedekedaiyindexinbingli。zongtieryan,yu2013nianshenchafaxiandeqingkuangxiangbi,weifaxianxinzhengjubiaomingkedaiyinfeichufangyaodeshiyongdaozhideyanzhonghuxiwentifengxianyousuobianhua。

  yixiebaogaohenhaodimiaoshuleweiman18suihuanzheshiyongkedaiyinchufangyaozhiliaobiantaotihuolinbazuzhiqiechushuhoudetengtongshidaozhideweijishengmingdehuxiwenti。yinci,jianadaweishengbuyushengchanshanghezuo,gengxinlechanpinanquanxingxinxi,shikedaiyinchufangyaozaiertongheqingshaonianzhongbuzaiyongyucixiangzhiliao。

  jianadaweishengburengranjianyi,hankedaiyindeyaopinbuzai12suiyixiadeertongzhongshiyong。duiyucunzaihuxijibingdehuanzhe,wulunnianlingdaxiao,junjianyiyingjinshenshiyong。yujianadashichangzhongdesuoyoujiankangchanpinyiyang,jianadaweishengbujiangjixujiancekedaiyindefuzuoyongxinxi,quedinghepingguqiqianzaiweihai。

(jianadaweishengbuwangzhan)


加拿大评估氢可酮导致儿童与青少年呼吸抑制风险

  2016nian7yue28ri,jianadaweishengbufabuxinxi,jinggaoguoliangsheruqingketongdaozhiertongheqingshaonianhuxiyizhi。hanqingketongdechanpinshuomingshuyiduicifengxiantichulejinggao,zheiyifengxiancunzaiyubaokuoertongzaineidesuoyounianlingzuzhong。jianadaweishengbuzhenduiqingketongkaizhanleanquanxingpinggu,jinyibuyanjiuertongyuqingshaonianzhongdeyanzhonghuxiyizhifengxian,cicianquanxingpingguyuanyuzhenduikedaiyin(lingyizhongapianleiyaowu)deshencha,yimingqueshifouxuyaocaiqugengduodeanquanxingcuoshi。

  qingketongshiyizhongapianleichufangyaowu,yongyuhuanjiejulieganke(wutan),zi20shiji50niandaimozaijianadashangshixiaoshou。jianadajianyikejiangyixiehanqingketongchanpinyongyu6suiyixiaertong。ranerjinnianlai,qingketongzaiertongheqingshaonianzhongdechufangshuliang(shoucigouyaohezaicigouyao)cong2010niande42,000xiajiangzhi2014niande28,000。

  cicijianadaweishengbugongpinggule7lishejiertongheqingshaonianshiyongqingketongqijianchuxianyanzhonghuxiwentihuoqingketongguoliangdebaogao。2libaogaofenbiesheji7suihe15suiertong,1lirenweiyuqingketongshiyongxiangguan,ling1litigongdexinxibuzu,wufaduiyinguoguanxijinxingpinggu。sheji6suiyixiaertongbaogao5li,jinyibufenxifaxian3lirenweiyuqingketongshiyongxiangguan。qizhong2libaogaolesiwangshijian,fenbiesheji1ming2suiertonghe1ming5suiertong,1lirenweiyuqingketongshiyongxiangguan,ling1libaogaotigongdexinxibuzu,wufapandingsiwangshifouyuqingketongxiangguan。

  tongguoduiyifabiaowenxiansuojinxingjiansuo,faxianle1lisheji3suiertongdeguowaibingli,huanershiyongqingketonghoufashengleyanzhonghuxikunnanbingsiwang,jinyibushenchahoufaxiangaishijiankenengyuqingketongdeshiyongxiangguan。juedaduoshubinglizhong,ertongsuoshiyongdeqingketongjilianggaoyuqinianlingzutuijianjiliang。genjumuqianguanyuqingketongfuzuoyongdezhengju,shangbunengquedingqingketongyukedaiyinyiyang,shiyouyudaixiesulvwentizaochengdehuxikunnan。

  jianadaweishengbujiangyushengchanshanghezuo,gengxinqingketongdechanpinxinxi,shuomingbuzaituijian6suiyixiaertongshiyongbenpin。

(jianadaweishengbuwangzhan)


加拿大警告抗抑郁药引起的闭角型青光眼风险

  jianadaweishengbuwangzhan2016nian8yue12rifabuxinxicheng,zaihuoximeiguoshipinyaopinguanlijuzhengzaishenchakangyiyuyaodebijiaoxingqingguangyanfengxianhou,jianadaweishengbushishileyixianganquanxingpinggu。bencipingguzhizaiquedingjianadakangyiyuyaochanpinxinxizhongbijiaoxingqingguangyandexianyoufengxianxinxishifouzhunque,yijishifouyudangqiankexuezhengjuxiangfu。

  bijiaoxingqingguangyanshiyizhongyanzhongyanbujibing,biaoxianweiyanneifangshuipaichushouzuyinqiyanneiyazhouzeng,congerdaozhitengtongjishilimohu。rubujishizhiliao,bijiaoxingqingguangyankedaozhiyongjiuxingshilisangshi。kangyiyuyaoshiguangfanshiyongdeyaowu,zi20shiji50niandaiyilaizaijianadashangshixiaoshou,yongyuzhiliaoyiyuzheng、jiaolvzheng、qiangpozheng、shimianhechuangshanghouyingjizhangaidengjibing。zi2009nianyilai,jianadadekangyiyuyaochufangyimeinian5.6%depingjunsulvzengzhang,2013nianjugujiyikaiju4050wanfenkangyiyuyaochufang。jianadaweishengbuanquanxingshenchazhezhongyuzaijianadashangshidexialie23zhongkangyiyuyao:dixipaming、bingmiqin、lvmipaming、duosaiping、qumipaming、amitilin、qujiatilin、maputilin、midanping、benyijing、malvbeian、tranylcypromine、fuxiting、xitaipulan、paluoxiting、shequlin、fufushaming、aisixitaipulan、wenlafaxin、duluoxiting、qujiawenlafaxin、quzuotong、anfeitatong。

  zaishenchaqijian,congbutonglaiyuangongjiansuodao163lishiyongkangyiyuyaoxiangguandebijiaoxingqingguangyandebaogao,jianadaweishengbutongguojianadajingjiejihuashoudao2licileibaogao。zaishenchaqijian,congbutonglaiyuangongjiansuodao2226lishiyongkangyiyuyaoxiangguandetongkongkuodadebaogao,jianadaweishengbutongguojianadajingjiejihuashoudao130licileibaogao。zhongsuozhouzhi,tongkongfangdashiyixiangweixianyinsu,kedaozhimouxiehuanzhe(yanneifangshuitongdaoxiazhaihuanzhe)fashengbijiaoxingqingguangyan。

  shenchafaxiankangyiyuyaodeshiyongyubijiaoxingqingguangyanyouguanlian,qiebutongkangyiyuyaoyinqibijiaoxingqingguangyandefengxianshuipingwuchayi。yinci,jianadaweishengbujianyizaisuoyoukangyiyuyaodechanpinxinxizhongliechubijiaoxingqingguangyandeqianzaifengxian。jianadaweishengbuyukangyiyuyaochanpinshengchanshanghezuo,gengxinlejianadachanpinxinxi,naruyukangyiyuyaoshiyongxiangguandebijiaoxingqingguangyandefengxianjinggao。

(jianadaweishengbuwangzhan)


日本发布过氧苯甲酰等药品说明书更新信息

  ribenhoushenglaodongsheng(mhlw)heyaopinyiliaoqixieguanliju(pmda)jinqixuanbuleyouguanguoyangbenjiaxiandengyaopinshuomingshugengxinxinxi,zheixiexinxikanzaizai2016niandi4qi《who pharmaceuticals newsletter》shang。

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