昨日，国家食品药品监督管理局在官网发布2012年药品不良反应监测年度报告。去年，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120万余份，其中化学药不良反应数量继续位居首位，抗感染药不合理使用现象仍然突出，注射剂尤其是中药注射剂带来的用药风险值得关注。

yesterday,The state food and drug administration in's official website released 2012 annual report adverse drug reaction monitoring.Last year,,National adverse drug reaction monitoring network report adverse drug reactions/events were received more than 1.2 million copies,Number of chemical medicine adverse reaction to continue in the first place,Anti-infection drug use unreasonable phenomenon is still outstanding,Injection especially TCM injections of risk is a concern.

抗感染药不良反应报告减少 Anti-infection drug adverse reactions reports

按药品类别统计，化学药以81.6%继续位列不良反应榜首。按照药品剂型统计，注射剂占56.7%，口服制剂占39.5%，其它制剂占3.8%。化学药中，抗感染药的次数仍居首位，占48.8%。

According to the statistical drug category,Chemical medicine to continue in adverse reactions to the top 81.6%.According to the statistics of pharmaceutical dosage forms,Injection (56.7%),Oral preparations accounted for 39.5%,Other agents accounted for 3.8%.In the chemical medicine,The number of anti-infective medicine is still in the lead,Accounted for 48.8%.

报告显示，近年来，抗感染药的不良反应/事件报告占比持续下降。2012年抗感染药报告占总报告数量的40.2%，较2011年降低了4.7%，一定程度上反映出抗感染类药物的使用得到了初步控制。

According to the report,In recent years,Anti-infection drug adverse reactions/events report declining proportion.Anti-infection medicine 2012 report the total number of 40.2%,From 2011, was reduced by 4.7%,To some extent reflects the use of anti-infective drugs got preliminary control.

但从抗感染药不良反应报告分析看，不合理使用现象仍然存在，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，生物利用度约90%，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。

But look from the anti-infective drug adverse reactions report analysis,Not reasonable use phenomenon still exist,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,Bioavailability of about 90%,But the injection report up to 65.8%,Many patients with mild to intravenous drug delivery.

中药注射剂问题严重 Serious problems of the traditional Chinese medicine injections

报告显示，静脉注射给药安全风险较高。2012年药品不良反应/事件报告的剂型分布中，注射剂占56.7%，严重药品不良反应/事件报告中注射剂占77.6%；药品不良反应/事件的给药途径分布，静脉注射给药占53.5%，其他途径注射给药(如肌内注射)仅占2.7%。

According to the report,Intravenous drug safety risk is higher.Adverse drug reactions/events in 2012 report the dosage forms of distribution,Injection (56.7%),Severe adverse drug reactions/events report injection (77.6%);Adverse drug reactions/events to drug distribution,Intravenous drugs accounted for 53.5%,The other way injected(Such as intramuscular injection)Accounted for only 2.7% of.

报告指出，口服给药虽然起效较静脉给药稍慢，而一旦达到治疗必须的血药浓度后，即可达到与静脉给药相同的治疗效果。同时，口服给药的不良反应发生风险较静脉给药低，尤其是严重过敏反应的发生风险。

According to the report,Oral medicine effect is intravenous drug delivery is a bit slow though,And once after reaching treatment must be blood drug concentration,Can achieve the same as the intravenous administration of therapeutic effect.At the same time,Oral dosing of the risk of adverse reactions was lower than those of intravenous medication,Especially the risk of serious allergic reaction.

在静脉注射剂中，中药注射剂问题最为严重。2012年全国药品不良反应监测网络共收到14个大类中药注射剂报告10.3万例次，其中严重报告5500余例次，占5.3%。与2011年相比，中药注射剂报告数量同比增长58.2%，高于国家药品不良反应监测数据总体报告增长率；严重报告同比增长37.2%，低于总体严重报告增长率。(记者/牛思远)

In the intravenous injection,Traditional Chinese medicine injection problem is most severe.2012 national adverse drug reaction monitoring network received 14 kinds of Chinese medicine injections reported 103000 cases,Reports more than 5500 serious cases,Accounted for 5.3%.Compared with 2011,Traditional Chinese medicine injection report quantity increased 58.2% year on year,Higher than the national adverse drug reaction monitoring data report of growth as a whole;Serious reporting year-on-year growth of 37.2%,Below report serious growth as a whole.(The reporter/NiuSiYuan)