国家食品药品监督管理局昨天发布2012年药品不良反应监测年度报告，去年共收到药品不良反应/事件报告120万余份，其中抗感染药报告数48万份，居首位。

The state food and drug administration yesterday released 2012 annual report adverse drug reaction monitoring,Last year received adverse drug reaction/event reporting more than 1.2 million copies,Including anti-infection medicine report number 480000,In the lead.

　　新建成的国家药品不良反应监测系统去年全面投入使用，去年收到的药品不良反应/事件报告同比增长40.8%，其中新的和严重的药品不良反应/事件报告达24万份。按药品类别统计，去年的不良反应报告中81.6%为化学药，其中的抗感染药的病例报告数比2011年增加29.5%，仍居首位。报告分析，不合理用药是导致抗感染药不良反应报告居多的原因之一，比如超适应症用药、超剂量用药、不合理的联合用药、给药途径不合理等。以莫西沙星为例，莫西沙星口服后吸收良好，但其注射剂报告比例高达65.8%，许多轻症患者可以不必静脉给药。

New national adverse drug reaction monitoring system fully operational last year,Adverse drug reactions/events report received last year, up 40.8% year on year,Including new and serious adverse drug reactions/events report 240000.According to the statistical drug category,Last year's 81.6% chemical medicine adverse reaction report,The anti-infection medicine case report for 29.5% more than in 2011,Still in the lead.The report analysis,Don't rational drug use is a cause of anti-infection drug adverse reactions report is in the majority,Such as super indications drugs/Ultra dose of medication/Unreasonable combination/Delivery way is not reasonable, etc.Moxifloxacin, for example,Moxifloxacin after oral absorption is good,But the injection report up to 65.8%,Many patients with mild to intravenous drug delivery.

　　国家食药监局药品安全监管司副司长颜敏介绍，抗感染药物中报告数量最多的头孢类菌素，其严重不良反应以过敏为主，引起这类反应的原因很复杂，可能与生产质量、包材、储运条件、药物中聚合物含量等有关，临床中应该加强对此类药品不良反应的监控。

National food drug administration and drug safety supervision, deputy director of the YanMin is introduced,Anti-infective drugs reported in the largest number of cephalosporins cephalosporins,The serious adverse reactions is given priority to with allergies,The causes of this kind of reaction is very complex,May be related to the production quality/Packaging materials/Storage and transportation conditions/Drug in the polymer content and so on,In the clinical should strengthen the monitoring of such adverse drug reactions.

　　从药品剂型来分，注射剂不良反应报告占56.7%，排在第一位。国家食药监局提醒，部分消费者主动要求输液治疗，但静脉注射安全风险较高，医疗机构要加强对注射剂使用的监管，患者也应改变对注射剂的心理依赖。

From pharmaceutical dosage forms,Injection adverse reaction report accounted for 56.7%,In the first place.National food drug administration to remind,Some consumers ask for infusion therapy,But intravenous security risk is higher,Medical institutions should strengthen the supervision over the use of injection,Patients should also change the injection of psychological dependence.

　　今年1月，有网友怀疑优卡丹小儿氨酚烷胺颗粒“对儿童肝肾有毒性”，仁和药业修改该产品说明书，注明“新生儿和1岁以下婴儿禁用本品”。但该公司表示，按照国家食药监局的通知，1岁以下婴幼儿禁用小儿氨酚烷胺颗粒并非“肝肾毒性”，而是因为“缺乏新生儿和1岁以下婴儿安全性和有效性的证据”。修改说明书并非质量问题，所以之前的产品仍然正常销售。与此事件类似，部分企业修改完说明书后，未修改说明书的药品依然在市面流通，甚至发现不良反应后，很多药品生产企业一两年时间都未修改说明书。

In January of this year,Some netizens doubt optimal cardin children acetaminophen alkyl amine particles"Hepatorenal toxicity for children",Renhe pharmaceutical modify the product manuals,Indicate the"To disable the [ newborns and infants under one year of age".But the company said,According to the national food the food and drug administration,Infants under one year of age disabled children acetaminophen alkyl amine particles is not"Liver and kidney toxicity",But because of who I"Lack of newborns and infants under one year of age evidence of safety and effectiveness".Modify specifications is not quality problem,So before the product is still normal sales.Similar to this event,Some enterprises after modify the instruction manual,Did not modify the instruction drugs are still in circulation,Found that even after the adverse reactions,Many drug manufacturers didn't modify the instructions one or two years time.

　　2012年，国家食药监局修改了鼻炎宁胶囊、保妇康栓等15种药品的说明书。国家食药监局相关负责人指出，完善药品说明书应是药品生产企业的常态化工作，国家食药监局正在考虑对企业修改药品说明书做出硬性要求，比如在规定时间内必须完成，修改之后国家食药监局也会在网上发布公告，以更好地提示公众。

In 2012,,, national food drug administration changed the rhinitis ning capsule/Bao fu Kang Shuan of 15 kinds of drug instructions.State the relevant person in charge of food and drug administration said,Improve the drug instruction should be a pharmaceutical production enterprise's routine work,National food drug administration are considering a requirement to modify leaflet the enterprise,For example, must be completed within the given time,National food drug administration after modify will be announced on the Internet,In order to better prompt public.

　　又讯(记者 任敏)山寨“同仁堂”药；山寨“白加黑”；没有中文标识的全英文“进口药”……昨天，市药监局在昌平集中销毁了近两年没收的50余吨假劣药。

Again -(The reporter Ren Min)shanzhai"tongrentang"medicine;shanzhai"White and black";No Chinese label all in English"JinKouYao"......yesterday,City food and drug administration in changping to destruct confiscated more than 50 tons JiaLie medicine for nearly two years.

　　此次集中销毁的假劣药品涉及200余种、近1800余件，均是市药监局与市公安局配合，在各类专项行动和查办案件过程中没收的。这些假劣药品多数是违法分子以虚构研究机构的名义，利用互联网站、新闻媒体发布假药广告，通过邮政信箱、邮政快递等非常规渠道销售。

The concentrated destruction JiaLie involved more than 200 kinds of drugs/Nearly 1800 pieces of,All is cooperate with municipal food and drug administration and the municipal public security bureau,In the process of all kinds of special operation and investigation cases confiscated.These JiaLie most drugs are illegal molecules in the name of the institute for the study of fiction,Using the Internet/News media published fake ads,Through the postal mail/Post express and other unconventional channel sales.

　　在位于昌平的北京金隅红树林环保技术有限责任公司的固体废弃物处理中心，假劣药品经碾压破碎后被送入水泥回转窑进行高温焚烧，窑内温度可达1800℃，能保证药品彻底焚烧无残渣，且排放的气体符合国家环保标准。

In changping of Beijing jinyu mangrove environmental protection technology co., LTD. Solid waste management center,JiaLie drugs after roller compaction breakage are fed into the cement rotary kiln for high temperature burning,Temperature can reach 1800 ℃,To ensure drug completely burned without residue,And emissions in line with national environmental standards.

　　2012年，本市区域内和周边省区进行综合整治和联动执法，持续开展药品生产流通领域集中整治、中药饮片专项整治等20余次专项行动。先后打击非法经营A型肉毒毒素假药、成人保健品店销售假避孕药等，查处333件案件，查获金额达3690余万元，向公安机关移送犯罪嫌疑人536人。

In 2012,,The city region and surrounding provinces and regions to carry on the comprehensive improvement and joint law enforcement,Centralized regulation sustained drug production and circulation field/Chinese medicine yinpian rectification of special operation such as more than 20 times.Successively to crack down on illegal business botulinum toxin A counterfeit drugs/Adult health food store sales fake birth control pills, etc,Investigated 333 cases,Seized $3690 more than ten thousand yuan,Transferred to the criminal suspect 536 people to the public security organ.

　　据市药监局副局长、新闻发言人梁洪介绍，目前查获的假药以避孕药、感冒药、糖尿病药、高血压药等为多，不少假药都会傍“名牌”，比如包装中含有“同仁堂”、“双鹤”等字样，消费者要注意识别。正规药品都有惟一的“身份证号”，一般是“国药准字”或者“国药进字”编号，可以根据编号在国家食品药品监督管理局网站上查询，以核对药品的名称、生产企业和规格，避免上当。(记者 任敏)

According to the deputy director of municipal food and drug administration/News spokesman Liang Hong,Now seized counterfeit drugs to the pill/Cold medicine/Diabetes drug/High blood pressure medicine, etc,A lot of counterfeit drugs will be split"Famous brand",Such as contained in the packaging"tongrentang"/"ShuangHe"With the words such as,Consumers should pay attention to identify.Licensed drugs are unique"Identity card number",Is generally"Approved by"or"Characters in the word"Serial number,Can according to the number in the query the state food and drug administration's web site,In order to check the name of the drug/Production enterprise and the specifications,To avoid fall for it.(The reporter Ren Min)