目的 探讨痰热清注射液临床使用中不良反应（ADR）的特点及规律，以合理用药。方法 检索2003年5月-2013年5月中国主要科技文献数据库，对ADR资料进行回顾性分析，总结ADR的一般规律和特点。结果 获得文献48篇56例，其中男性占66.07%、女性占33.93%，男性ADR发生率高于女性；ADR在各年龄段均有分布，平均年龄（32.6±24.9）岁；10岁以内儿童ADR发生率（35.71%）较高；用药30 min内出现的居多（71.43%）；ADR造成多个系统–器官损害，类型为过敏反应（51.79%）和皮肤反应（30.36%）；55例患者状态恢复正常、预后良好，死亡1例。稀释溶液、稀释浓度、给药速度等均与ADR相关。结论 根据适应症合理使用并加强ADR监测，确保用药安全有效。

Objective To explore the features of adverse drug reactions (ADRs) of Tanreqing Injection occurring in clinical use. Methods With the searching term of Tanreqing, download the original case report of its ADR from China main database from May, 2003 to May, 2013 to investigate the general rules and characteristics of ADR. Results In the 56 adverse reaction cases, the male accounted for 66.07%, as well as the female accounted for 33.93%, the incidence rate of adverse reactions was higher in males than that in females. The adverse reaction cases with an average age of (32.6 ± 24.9) years old, Cases of adverse reactions in all the age distribution; Ten-year-old children reported more incidences of adverse reactions than other ages, and accounted for 35.71% of the total proportion of adverse reactions. Most patients demonstrated ADRs within 30 min after using the drug, and accounted for 71.43% of the total number of cases. The main adverse reaction caused by Tanreqing Injection involved in multiple system-organ damage involved in which 29 cases and 17 cases were mainly reflected by allergic reactions and skin reactions. After the treatment of cases with corresponding measures, 55 patients recovered to normal , and only one case of death was reported. It showed that the incidence of adverse reactions was related to dilute solvents, dilute concentration, velosity of administration. Conclusion Strengthening the monitoring of adverse reactions and rational use of Tanreqing is necessary to ensure drug use safely and effectively.

天津市中医药管理局中医﹑中西医结合科研课题（13050）