内容提要
美国警示直接抗丙肝病毒药物的乙肝复燃风险
加拿大评估非典型抗精神病药物导致的尿潴留风险
加拿大提示芬戈莫德的癌症风险
加拿大提示氟维司群因雌二醇水平假性升高导致不必要治疗的风险
yingguodiaozhengyituokaoxideshiyongjiliang
美国警示直接抗丙肝病毒药物的乙肝复燃风险
2016nian10yue4ri，meiguoshipinyaopinjianduguanliju（fda）fabujingshixinxi，jinggaodangqianhuojiwangganranyiganbingdu（hbv）bingjieshoumouxiezhijiekangbingganbingduyaowu（direct-acting antiviral，daa）zhiliaobinggandehuanzhedoukenenghuidaozhihbvfurandefengxian。zaishaoshuqingkuangxia，jieshoudaayaowuzhiliaodehuanzheruguofashenghbvfuranhuizaochengyanzhongganzangsunhaihuosiwang。hbvfurantongchangfashengzaizhiliaohou4-8zhounei。zhijiekangbingganbingduyaowuyongyuzhiliaomanxingbingganbingdu（hcv）ganran，zheixieyaowunengtongguozuzhihcvfuzhidadaojianshaojitineihcvhanliangdemude，zaidaduoshuqingkuangxianengzhiyuhcv。rubujiyuzhiliao，hcvkedaozhiyanzhongganzangsunhai，baokuoganyinghua、ganaihesiwang。zheixieyaowubaokuosuofeibuwei、dakatawei、ximipiweideng。
2013nian11yue22rizhi2016nian7yue18ride31geyuenei，fdaquerenle24libaogaojifdayijiwenxianbaodaodehbv/hcvgongtongganranhuanzhejieshoudaazhiliaohoufashenghbvfurandebingli。zheixiebinglijinbaokuobaogaojifdadebingli，yincikenenghaiyouqitaweibaogaodebingli。zaizheixiebaogaodebinglizhong，you2lihuanzhesiwang，1lihuanzhexuyaoganyizhi。zaidaadelinchuangshiyanzhongweibaogaohbvfurandebuliangshijian，yinweilinchuangshiyanpaichulefashenghbvgongtongganrandehuanzhe。
fdamuqianzhengzaixiugaidaayaopinshuomingshu，zengjiaheikuangjinggao，jingshihbvfurandefengxian，zhidaoyiwurenyuanzaisuoyoujieshoudaazhiliaodehuanzhezhongshaixuanbingjiancehbv。jianyizaikaishidaazhiliaoqian，yiwurenyuanyingcongsuoyouhuanzhezhongshaixuandangqianhuojiwanghbvganrandezhengju，bingzaizhiliaoqihezhiliaohousuifang，tongguoxueyejianchajiancehuanzhedehbvtufahuofuranqingkuang。huanzheyinggaozhiyiwurenyuanzaizhiliaobingganqianshifoujuyouyiganganranhuoqitaganzangbingshi。ruochuxianpifa、wuli、shiyubuzhen、exinheoutu、yanjinghuopifufahuanghuozhedansedabianqinglijijiuyi，yinweizheixiebiaoxiankenengshiyanzhongganzangwentidetizheng。
（美国FDA网站）
加拿大评估非典型抗精神病药物导致的尿潴留风险
jianadaweishengbujinqikaizhanleyixianganquanxingshencha，zhizaikaochafeidianxingkangjingshenbingyaowudeshiyongyupainiaokunnanhuobangguangpaikongbuwanquan（niaozhuliu）defengxian，zheixiezhengzhuangkenengshixuyaojiuyidejizheng。kaizhancixiangshenchadeyuanyinshisiruikang（kuiliuping）deshengchanchangjiashoudaoleshiyongsiruikangdehuanzhefashengniaozhuliubaogaodexindeanquanxingxinxi。jianadaweishengbuyeshenchalebiaomingcifuzuoyongyujianadaqitafeidianxingkangjingshenbingyaowuyoulianxidezhengju。
feidianxingkangjingshenbingyaowuyongyuzhiliaojingshenjibing，lirujingshenfenliezheng、shuangxiangqingganzhangaihetedingqingkuangxiadeyiyuzheng。lipeitongyeyongyuduanqiduizhengzhiliaozhongduaercihaimoxingchidaidegongjixingweihejingshenbingzhengzhuang。zi1991niankaishiyou9gefeidianxingkangjingshenbingyaowuzaijianadashangshi，zhei9geyaowujinkepingchufanghuoqu：anlifu（alipaizuo）、saphris（asaineiping）、kezhilv（lvdanping）、latuda（lulaxitong）、zaipule（aodanping）、ruida（palipaitong）、siruikang（kuiliuping）、weisitong（lipeitong）hezhuoleding（qilaxitong）。qizhongyouxieyaowuyifangzhiyaoxingshicunzai。
zaikaizhancixiangshenchashi，jianadaweishengbuyishoudao38fenguanyuniaozhuliuhefeidianxingkangjingshenbingyaowu（weishiyonglulaxitong）shiyongdebaogao。yishangbaogaoyijilaizifabiaowenxiandebaogaozhichu，zaitingyongkangjingshenbingyaowuhou，daduoshuhuanzhezhiyuhuozhengzaihaozhuan。zaimouxieqingkuangxia，zaiciyongyaoshiniaozhuliuhuifufa，jinyibuzhichifeidianxingkangjingshenbingyaowuyuniaozhuliudeqianzailianxi。zaikaizhancixiangshenchashi，shoudaole1254fenyufeidianxingkangjingshenbingyaowushiyongxiangguandeniaozhuliudeguojibaogao。daduoshufeidianxingkangjingshenbingyaowudechanpinanquanxingxinxijunhuitijiniaozhuliufengxian。raner，jieshiyipizhunyaowuaodanpingyinqiniaochuliufengxiandecuociyuyishenchazhengjubuyizhi。
jianadaweishengbudeanquanxingshenchafaxian，yiyouzhengjuzhichifeidianxingkangjingshenbingyaowudeshiyongyuniaozhuliucunzaiqianzailianxi。jianadaweishengbuzhengyuaodanpingshengchanshanghezuogengxinchanpinanquanxingxinxi，yiqianghuaniaozhuliuqianzaifengxianxiangguandejinggao。muqiancigengxinyuqitakangjingshenbingyaowutigongdeanquanxingxinxiyizhi，beirenweizuyitixinghuanzheniaozhuliudefengxian。jianadaweishengbujiangjixujiancefeidianxingkangjingshenbingyaowudeanquanxingxinxiyiquedinghepingguqiqianzaifengxian。
（jianadaweishengbuwangzhan）
加拿大提示芬戈莫德的癌症风险
fengemodeyu2011nian3yuehuozhunzaijianadashangshi，yongyuzhiliaoduofaxingyinghua（yizhongyinshenjingxitongsunhaierzhicandejibing），youqituijianyongyuqitazhiliaoxiaoguobujiahuobunengnaishouqitazhiliaodehuanzhe，fengemodekeyijiangdiduofaxingyinghuadetizhenghefazuopinlv，congeryanhuandaozhishenticanjidejinzhan。
jianadaweishengbucengyu2014nianzhenduifengemodedeaizheng（zuzhiyichangshengzhang）kaizhanlepinggugongzuo，bingyaoqiushengchanqiyetigonggengduodexinxiyihuoqugengduodezhengju。cicipinggushizhenduishengchanqiyetigongdeshujukaizhandehouxupinggu。
评估的数据显示，目前又收到了更多的皮肤癌病例的报告，但与之前的数据相比没有显示出报告频率增加。皮肤癌的风险已经在产品说明书中进行了提示。
jieshoumianyixitongyizhiji（rufengemode）dehuanzhefashengaizhengdefengxianzengjia，weicileichanpindeyizhifengxian，zaichanpinshuomingshuzhongjunyitiji。
fengemodedechanpinshuomingshuyijingzai“jinggaohezhuyishixiang”、“buliangfanying”he“huanzhexuzhi”dengzhangjiemiaoshuleaizheng（tebieshipifuai）defengxian。tongshi，haijianyizaifengemodezhiliaokaishiqianhezhiliaoqijiandingqijianchayisipifubingbian，bingxunsuduizheileibingbianjinxingpinggu。
（jianadaweishengbuwangzhan）
加拿大提示氟维司群因雌二醇水平假性升高导致不必要治疗的风险
fuweisiqunyongyuzhiliaojingkangcijisuzhiliaohoujibingrengyoujinzhanderenhenianlingduandejuejinghoujubuwanqihuozhuanyixingruxianai。duijisuminganxingruxianaieryan，cijisu（nvxingjisu）nengcujinzhongliushengzhang，fuweisiquntongguojingzhengcijisushouti，nengjiangdijiticijisuliang，congeryizhiruxianaizhongliushengzhang。
ruxianaihuanzhetineidecierchunshuipingkenengfashenggaibian，yincizaifuweisiqunzhiliaoqijiankeyitongguoxueyejiancecierchunshuipinglaiquerenjuejingzhuangtai。danyouyufuweisiqunhecierchundejiegouxiangsi，fuweisiqunkenenghuiganraoyikangtiweijichudecierchunceliang，guerzaochengcierchunshuipingjiaxingshenggao。muqianguojishangyijingshoudaohenshaoliangdecierchunshuipingjiayangxingbaogao。cierchundejiayangxingjiancejieguohuiwupannvxingjuejingzhuangtai，congerdaozhihuanzhekenengmianlinbubiyaodeshoushuhuoneifenmizhiliaogaibiandefengxian。
yinci，zaiduishiyongfuweisiqundehuanzhejinxingyikangtiweijichudecierchunshuipingjianceshiyingjinshen，yingkaolvshifouxuyaoduijiwangjianchajieguojinxinghedui。biyaoshiyiwurenyuanyingkaolvcaiyongqitafangfa（liruyexiangsepu-chuanlianzhipufa）zaicipinggufuweisiqunzhiliaoqijianhuanzhedejuejingzhuangtai。dangxuyaojinxingbaohancierchunshuipingzaineidexueyejianchashi，yingquerenhuanzheshifouzhengzaishiyongfuweisiqun。
muqianshangquefajuejinghounvxingcierchundishuipingdejiancebiaozhun，erqiebutongmianyifenxidelingmindu／teyiduyoujiaodachabie，yincidishuipingcierchundejiancenandujiaoda。yanjiubiaoming，shiyongbutongshengchanshangdezhijiemianyifenxishijihehuidedaobutongjieguo，yincizheixieshijihebunengwanquanzhunquejiancechujieshoufuweisiqunzhiliaohuanzhedecierchunshuiping。
jianadaweishengbuyijingyaoqiushengchanqiyeasilikangjianadagongsiduifuweisiqunde“jianadachanpinzhuanlun”jinxinggengxin，tongshiduiyaopinshuomingshujinxinglegengxin，zengjialexindejingshixinxi，yitishixiangguanfengxian。
（jianadaweishengbuwangzhan）
英国调整依托考昔的使用剂量
yingguoyaopinhejiankangchanpinguanliju（mhra）zai2016nian10de《drug safety update》shangfabuxinxicheng，yituokaoxichufangyaoxinxiyijinggengxin，yongyuzhiliaoleifengshiguanjieyanheqiangzhixingjizhuyandetuijianjiyaojiliangjiangwei60 mg，meitianyici。
yituokaoxi（etoricoxib）shuyuxuanzexinghuanyanghuamei2（cox-2）yizhijileiyaowu。shiyonggaiyaodefengxianbaokuo：zengjiaguanzhuangdongmaihexueshuanxingchengshijian、xinlishuaijie、gaoxueyayijishuizhong（yuanweijiheyixiefeizaitikangyanyaoxiangbi）。qitaxuyaokaolvdezhongyaofengxianbaokuoduiweichangxitongchanshengdexiaoying，tebieshichuankong、kuiyangxingchenghuochuxue。zaiyituokaoxi“chanpintezhengzhaiyao”de4.4bufenduizheixiefengxianzuolejinyibujieshao。
genjuzai2008niankaizhandequanoumengfanweiguanyuyituokaoxihuoyi/fengxiandepinggu，shangshixukechiyourenxuyaokaizhanlinchuangshiyan，yipingguyituokaoxi60mgmeitianyicizhiliaoleifengshiguanjieyanheqiangzhixingjizhuyandeliaoxiaoheanquanxing，qizhongbaokuoyuyituokaoxi90mgdebijiao。genjuzheixieshiyan，youzhengjubiaoming60mgjiliangduileifengshiguanjieyanheqiangzhixingjizhuyanyouxiao。raner，youxiehuanzheshiyong90mgjiliangkenenggengyouxiao，danshangwufayucenaxiehuanzheshiyonggenggaojiliangjianghuoyi。
yinci，mhrajianyijiangzhiliaoleifengshiguanjieyanhuoqiangzhixingjizhuyandetuijianqishijiliangjiangzhi60mgmeitianyici，biyaoshikexuanzezengjiazhizuidajiliang90 mgmeitianyici。
mhraduiyiwurenyuantichujianyi：yituokaoxidexinxueguanfengxianheqitazhongyaofengxiankenengsuijilianghebaoluchixushijianzengjia，yinci，yingshiyongzuidideyouxiaorijiliang，bingdingqiduizhiliaoxuqiujinxingzaipinggu；tuijiandejiliangwei60 mgmeitianyici；zaizhengzhuanghuanjiebuchongfendehuanzhezhong，jiangjiliangzengjiazhi90mgmeitianyicikenenghuitigaoliaoxiao；yidanhuanzhedelinchuangbingqingwending，keyishiqingkuangjiangjiliangxiadiaozhi60 mgmeitianyici；ruguomeiyouzhiliaohuoyi，yingkaolvqitazhiliaoxuanze。
