国家食品药品监管局3月14日发布了2012年药品不良反应监测年度报告。2012年，国家药品不良反应监测网络共收到药品不良反应/事件报告120多万份，医疗机构仍是报告主体。按照药品类别统计，化学药不良反应/事件报告数占81.6%，中药占17.1%，生物制品占1.3%。按照药品剂型统计，注射剂占56.7%，口服制剂占39.5%，其他制剂占3.8%。

On March 14, the state food and drug supervision bureau released the 2012 annual report adverse drug reaction monitoring.In 2012,,National adverse drug reaction monitoring network received adverse drug reaction/event reports more than 120 copies,Medical institutions is still the reporting entity.According to the statistical drug category,Chemical medicine adverse reactions/events report number accounts for 81.6%,Traditional Chinese medicine accounted for 17.1%,Biological products accounted for 1.3%.According to the statistics of pharmaceutical dosage forms,Injection (56.7%),Oral preparations accounted for 39.5%,Other agents accounted for 3.8%.

　　国家食药监局经过统计分析，理出2012年药品不良反应/事件报告的几个特点，并给出建议。

National food drug administration through statistical analysis,Out of 2012 several features of adverse drug reactions/events report,And give advice.

警惕头孢菌素类抗感染药过敏反应 Alert to cephalosporin class anti-infection medicine allergic reactions

　　纵观2012年药品不良反应/事件报告，抗感染药病例报告数量仍居首位。其中，排名第一的是头孢菌素。

Throughout the 2012 report adverse drug reactions/events,Anti-infection medicine case report number is still in the lead.Among them,Cephalosporins ranked first.

　　国家食药监局表示，此前已多次通报头孢菌素类药品的不良反应，提示其存在过敏反应等风险。食药监局相关专家介绍，过敏反应是头孢菌素类较为严重的不良反应，可累及多个器官系统，主要表现有皮疹、瘙痒、呕吐、腹泻、心悸、胸闷、呼吸困难、血压下降等，严重可致过敏性休克，危及生命。

The national food food and drug administration says,Already many times notify the cephalosporin class drug adverse reaction,Prompt the existence of risk of allergic reactions, etc.Eat food and relevant experts,Allergic reaction is cephalosporin class serious adverse reactions,Usually multiple organ systems,Main performance has a rash/The itch/vomiting/diarrhea/Heart palpitations./Chest tightness/Difficulty in breathing/Drop in blood pressure, etc.,Serious can cause anaphylactic shock,life-threatening.

　　专家表示，引起头孢菌素类过敏反应的原因比较复杂，除药物本身的结构外，也可能与生产质量、包材、储运条件等有关。研究还表明，聚合物可能是头孢菌素类的过敏原之一，其在药品中的含量与过敏反应发生率之间有一定的量效关系。食药监局提示，对于过敏反应的发生机制，药品生产企业应开展深入研究。

Experts say,Cause of cephalosporin class allergic reactions is more complex,In addition to the structure of the drug itself,Also may be related to the production quality/Packaging materials/Storage and transportation conditions and so on.Studies also suggest that,Polymer may be one of cephalosporin class of allergens,Its in the drug content and have certain concentration-response relationship between incidence of allergic reactions.Food, food safety tips,Mechanism for causing the allergic reaction,Drug manufacturers shall conduct in-depth research.

静脉注射风险较高 Intravenous risk is higher

　　2012年药品不良反应/事件报告的剂型分布中，注射剂占半壁江山，严重药品不良反应/事件报告中注射剂更高达77.6%。其中，静脉注射占53.5%，其他途径注射，如肌内注射仅占2.7%。这说明，静脉注射是临床用药的较高风险因素——2012年，全国药品不良反应监测网络收到的过敏性休克导致患者死亡的病例中，85%以上为静脉给药。

Adverse drug reactions/events in 2012 report the dosage forms of distribution,Injection of half,Severe adverse drug reactions/events injection was 77.6% higher in the report.Among them,Intravenous injection (53.5%),Other ways to inject,Such as accounted for only 2.7% of intramuscular injection.This shows that,Intravenous therapy, is the high risk factors - 2012,The national adverse drug reaction monitoring network received anaphylactic shock cases that resulted in the deaths of patients,More than 85% for intravenous administration.

　　很多患者认为，静脉注射效果“来得快”，甚至主动要求医生给自己输液。专家解释说，这实际上是一种误区。静脉注射主要用于急症、重症和不能口服给药的病人。口服等其他方式虽然起效较静脉给药稍慢，但只要达到治疗必须的血药浓度，即可取得相同的治疗效果，且风险较低。以莫西沙星为例，口服吸收良好，生物利用度约90%，但其注射剂不良反应报告比例高达65.8%。专家提示，医疗机构应加强对注射剂使用的监管，而患者也应消除认识上的误区，改变对注射剂的心理依赖。

Many patients think that,Effect of intravenous"Come fast",Even ask for doctor to infusion.Experts said,This is actually a kind of myth.Intravenous injection is mainly used for emergency/Intensive and oral dosing in patients.Other approaches such as oral effect is intravenous drug delivery is a bit slow though,But as long as the treatment of must achieve blood drug concentration,You can get the same treatment effect,And a lower risk.Moxifloxacin, for example,Oral absorption is good,Bioavailability of about 90%,But the injection adverse reaction reports are as high as 65.8%.Expert clew,Medical institutions should strengthen the supervision over the use of injection,And also should eliminate the misunderstanding on the patients,Change the psychological dependence on injection.

中西药复方制剂不能当纯中药 Chinese and western medicine combination can't when new

　　2012年中成药不良反应/事件报告数排名前20名的品种中，口服制剂有3个，分别是咳特灵片(胶囊、颗粒)、维C银翘片(胶囊等)和鼻炎康片。其实，这三种并不是纯中药，而是含化学药成分的中成药品种，即中西药复方制剂。例如，维C银翘片既有金银花、连翘、荆芥等十种中药成分，也含有马来酸氯苯那敏、对乙酰氨基酚、维生素C三种化学药成分。

Proprietary Chinese medicine adverse reactions/events report number 2012 in the top 20 varieties,There are three oral preparations,Is cough trane, respectively(capsule/particles)/Vitamin C fructus forsythiae piece(Capsule, etc.)And rhinitis health piece.In fact,These three are not new,But with Chinese medicines, chemical medicine composition of varieties,That Chinese and western medicine compound preparations.Such as the,Vitamin C both flos lonicerae fructus forsythiae/St John's wort/Fineleaf schizonepeta herb and other ten kinds of Chinese medicine ingredients,Also contain maleic acid chlorobenzene that min/acetaminophen/Vitamin C three kinds of chemical medicine composition.

　　有些医师和患者把这类药品当作“纯中药”使用，增加了临床使用中的潜在风险。国家食药监局提示，使用此类药品需要特别注意，以免超剂量用药或重复使用等不合理现象。

Take such drugs as some doctors and patients"new"use,Increased the potential risks in clinical use.National food safety tips,Use of such drugs require special attention,In order to prevent drug overdosage or unreasonable phenomenon such as repeated use.

企业要重视无菌药品的质量安全 Enterprises should attach great importance to the quality of sterile drug safety

　　国家食药监局表示，2012年药品风险自动预警系统显示，个别品种不良事件存在聚集信号。所谓“聚集信号”是指同一生产厂家、同一药品和同一批号发生的、在一定时期内报告的多例药品不良反应/事件。

The national food food and drug administration says,Drug risk early warning system automatically display in 2012,Some varieties of adverse events gathered signal.The so-called"Gathered signal"Means the same manufacturer/The same drug and the same batch number/In a certain period report more cases of adverse drug reactions/events.

　　经相关部门检验，这主要与药品热原、细菌内毒素、有关物质等不合格相关。国家食药监局表示，对此类情况已及时采取措施，停止生产销售并召回问题药品。国家食药监局建议相关药品生产企业高度重视无菌药品的生产环节管理，改进工艺提升产品质量，加强出厂环节的检验频次。(本报记者 齐芳)

Inspection by the relevant department,The main and drug pyrogen/Bacterial endotoxin/About the unqualified material, etc.The national food food and drug administration says,To this kind of situation has take timely measures,Sales and recall problem products to stop production.National food drug administration Suggestions related to pharmaceutical production enterprise attaches great importance to the sterile drug production management,Improve improve the quality of the product,Strengthen the link of the inspection frequency.(Our reporter JiFang)