热毒宁注射液不良反应／事件监测及安全性评价  

Adverse drug reaction/event monitoring and safety evaluation of Reduning injection

作　　者：李蓉[1] 董志[1] 路晓钦[2] 朱舒兵 

机构地区：[1]重庆医科大学药学院.重庆400016 [2]重庆市第九人民医院.重庆400700 [3]重庆市药品不良反应监测中心,重庆400014

出　　处：《中国新药与临床杂志》2014年第3期233-236,共4页Chinese Journal of New Drugs and Clinical Remedies

基　　金：重庆市北碚区科技计划项目(2012-26)

摘　　要：目的了解热毒宁注射液所致药物不良反应/事件(ADR/ADE)特点,为临床合理用药提供参考依据。方法利用Excel 2003及SPSS 17.0软件对重庆市2010年1月至2013年6月热毒宁注射液所致的125例ADR/ADE进行回顾性分析,并以报告比值比法(ROR)对热毒宁注射液与利巴韦林作对比评价。结果在125例发生ADR/ADE的患者中,29例ADE(23.20%)为超适应证用药引起:男性81例(64.8%),女性44例(35.2%);2岁以下婴幼儿发生率较高(48.0%);89.6%的患者在用药30 min内发生ADR/ADE。共发生ADR/ADE 207例次,73.9%为药物性皮疹、瘙痒等皮肤及其附件损害,20.3%为新的ADR。热毒宁注射液与利巴韦林发生严重ADR的安全风险比为1.176。结论儿童在热毒宁注射液ADR中发生率较高,临床需规范化应用,并密切关注用药30 min内的临床表现,重视ADR/ADE的监测工作,提高用药安全性。AIM To study the characteristics of adverse drug reactions/event （ADR/ADE） of Reduning injection and provide reference for clinical rational medication. METHODS With the use of Excel 2003 and SPSS 17.0, a total of 125 patients with ADR/ADE caused by Reduning injection in Chongqing from Jan 2010 to June 2013 were retrospectively analyzed, and compared with ribavirin by reporting odds ratio. RESULTS In the 125 patients with ADR/ADE, 29 （23.2%） patients with ADE were caused by off-label use of the drug; males were 81 （64.8%） and females were 44 （35.2%）; the occurrence of children under 2 years old were higher（48.0%） ; 89.6% of the ADR/ADE happened within 30 min of medication. Totally 207 ADR/ADE happened, 73.9% of which were damages on skin and its appendages, such as rash and itching. And 20.3% of which were new ADR. The safety risk ratio of Reduning injection and ribavirin was 1.176. CONCLUSION Children has a high incidence of ADR induced by Reduning injection in clinical application. It is necessary to regulate the use of Reduning injection and pay attention to clinical features within 30 min of injection and the monitoring of ADR, so as to enhance the medication security.

关 键 词：热毒宁注射液 药物不良反应 安全 药物评价 产品监测 售后 

分 类 号：R978[医药卫生—药品]