广西2009年双黄连注射剂不良反应/不良事件报告分析

目的:了解广西2009年双黄连注射剂不良反应(ADR)/不良事件(ADE)发生的情况,为其临床应用和ADR监测提供参考。方法:对广西壮族自治区ADR监测中心2009年1月1日～2009年12月31日收集到的818例双黄连注射剂ADR/ADE报告进行分类统计和分析评价。结果:818例ADR患者中男性(437例)多于女性(381例),男女比例为1.15∶1;0～9岁的患者发生几率高于其他年龄组,占43.77%;88.39%的ADR患者原发疾病为呼吸系统疾病;27.25%的病例使用联合用药治疗;ADR的临床表现主要为皮肤及其附件损害,轻重程度不一,大多预后良好;大部分ADR发生时间较短;病例来源以基层医疗机构为主,有777例,占94.99%。结论:临床应重视双黄连注射液的用药监管,加强ADR监测,注重合理用药。

Analysis on ADR/ADE Reports Induced by Shuanghuanglian Injection in Guangxi of 2009

OBJECTIVE：To understand ADR and ADE reports induced by Shuanghuanglian injection in Guangxi Zhuang Na- tionality Autonomous Region of 2009 to provide reference for clinical application of Shuanghuanglian injection and ADR monitoring. METHODS：818 ADR and ADE cases induced by Shuanghuanglian injection from Jan. 1 and Dec. 31 of 2009 collected from Guangxi Center for ADR Monitoring were analyzed statistically. RESULTS：Male（n=437）involved in 818 ADR cases was more than female（n=381）.Ratio of male to female was equal to 1.15∶1.The ADR incidence of patients aged from 0 to 9 was higher than other age groups,accounting for 43.77%.88.39%of primary disease in ADR patients was respiratory diseases.27.25%of cassound prognosis. Occurrence time of ADR cases were short,777 cases were collected from primary hospitals,accounting for 94.99%. CONCLUSION：Great importance should be attached to the application of Shuanghuanglian injection,ADR monitoring and rational use of drugs.