我院2003_2012年338例中药不良反应报告分析.pdf

我院2003－2012年338例中药不良反应报告分析Δ ＊ # 王宏蕾 ，范 峥，郭桂明 （首都医科大学附属北京中医医院药学部，北京 100010） 中图分类号 R969.3；R283 文献标志码 A 文章编号 1001-0408（2014）11-0964-04 DOI 10.6039/j.issn. 1001-0408.2014.11.02 摘 要 目的：了解中药不良反应（ADR）发生的原因及特点，为临床合理用药提供参考。方法：对338例ADR 报告从患者情况、 药品分类、剂型、ADR 发生时间、严重ADR 、ADR 累及器官和/或系统等多个方面进行分析。结果：我院中药ADR 大多发生于中老 年及女性患者，剂型以中药注射剂为主，近10年ADR 数量有波动，ADR 主要累及皮肤及其附件损害。结论：中药ADR 不容忽视， 中成药上市前研究和上市后的ADR 汇总同样重要，应完善ADR 报表的填报，进一步保障临床安全、合理用药。 关键词 中药；不良反应；回顾性分析 Analysis of 338Cases of ADR Induced by TCM in Our Hospital during 2003－2012 WANG Hong-lei ，FAN Zheng ，GUO Gui-ming （Dept. of Pharmacy ，Beijing Hospital of TCM ，Capital Medical University ，Beijing 100010，China） ABSTRACT OBJECTIVE ：To know the causes and characteristics of adverse drug reactions （ADR）induced by TCM ，and to provide reference for clinical rational drug use. METHODS ：338TCM-induced ADR cases were analyzed statistically in respects of patients ’character ，drug classification ，dosage forms ，occurrence time ，serious ADR，organs or systems involved in ADR. RE- SULTS：Most of ADR appeared in senile patients and female patients. TCM injections caused the largest number of ADR. During the past 10years ，the number of ADR was fluctuations. The incidence of the lesion of skin and its appendants were higher than oth- er systems. CONCLUSIONS ：Great importance should be attached to TCM-induced ADR ，Chinese patent medicine research before listing and post-marketed drug ADR both play an important role. Better ADR monitoring and reporting could guarantee the safe and rational drug use. KEYWORDS TCM ；Adverse drug reaction ；Retrospective analysis 中药在我国有几千年的临床使用历史。随着制剂技术的 338例报告中，男性患者108例，占31.9％；女性患者230 发展，中药已包含注射剂、片剂、胶囊剂、丸剂等多种剂型，一 例，占68.1％。既往有ADR 史者91例，占26.9％；既往无ADR 方面可方便患者携带、服用；另一方面拓展了中药治疗疾病的 史者196例，占58.0％；情况不详者51例，占1