痰热清注射液不良反应的回顾性分析.pdfVIP

- 362 - Drug Evaluation Research 第 37 卷 第 4 期 2014 年 8 月 痰热清注射液不良反应的回顾性分析 王 琳，阎 姝* 天津市南开医院，天津 300100 摘 要：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。 关键词：痰热清注射液；用药安全；不良反应；回顾分析 中图分类号：R286 文献标志码：A 文章编号：1674 - 6376 (2014) 04 - 0362 - 05 DOI: 10.7501/j.issn.1674-6376.2014.04.017 Retrospective analysis of adverse reaction of Tanreqing Injection WANG Lin, YAN Shu Tianjin Nankai Hospital, Tianjin, 300100, China Abstract: 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 a