689份中药制剂不良反应报告分析  

Analysis of 689 ADR reports of Chinese medicine preparations

作　　者：王玉荣[1] 徐玉红[1] 李东 姚苑梅[1] 钟芬 丘晓清 吴斌 

机构地区：[1]广东省深圳市第四人民医院,广东深圳518033 [2]暨南大学第二临床医学院.深圳市人民医院,广东深圳518020 [3]广东省深圳市药品不良反应监测中心,广东深圳518034

出　　处：《中国药业》2009年第14期48-49,共2页China Pharmaceuticals

摘　　要：目的了解该地区中药制剂药品不良反应(ADR)总体发生情况、特点及规律,促进中药合理应用。方法采用回顾性研究方法。从广东省药品不良反应监测中心数据库下载2007年深圳市各单位上报的ADR报告表,筛选出中药制剂ADR报告进行分类统计、分析。结果中药制剂ADR报告689份,涉及226个品种。31个中药注射剂品种导致ADR357例次(51.81%),绝大多数采用静脉滴注给药;161个口服制剂导致ADR276例次(40.06%)。ADR主要表现为皮肤及其附件损害,其次为消化系统反应、全身性损害、神经系统反应等。新的ADR390例次(56.60%),严重的ADR较少。绝大多数ADR的转归良好。结论应加强对中药制剂特别是注射制剂ADR的监测,加强对中药制剂说明书ADR项的监管,以保障患者用药安全。Objective To find out the essential features of adverse drug reactions （ADR） of Chinese medicine preparations in Shenzhen, and to improve the rational use of Chinese medicine preparations. Methods The retrospective analysis was used. All reported ADR cases from Shenzhen in 2007 were downloaded from the Guangdong Center for ADR Monitoring. ADR reports of Chinese medicine preparations were screened and analyzed. Results 689 ADR cases of Chinese medicine preparations were screened out and involved 226 Chinese medicine products. 31 Chinese medicine injections led to 357 ADR cases （51.81%）. Injection was the primary dosage form causing ADR and the intravenous route of administration caused 355 ADR cases. All kinds of oral dosage forms, which led to 40. 06% of ADR cases, ranked secondly. The lesions of ADR involved primarily were skin and its accessories, followed by the gastrointestinal system, systemic lesions, the nerve system, etc. The new cases of ADR were 390 （56.60%）. Severe ADR reports were few. Most of the ADR cases had good prognosis. Conclusion ADR of Chinese medicine preparations has universality. Both the monitoring of ADR of Chinese medicine preparations and the supervision of the instruction of the Chinese medicine preparation should be enhanced to reduce and （or） avoid the occurrence of ADR for ensuring the patient＇s safety.

关 键 词：中药制剂 药品不良反应 分析 

分 类 号：R969.3[医药卫生—药理学]