甘肃省2011-2013年痰热清注射液致不良反应报告分析

Analysis of ADR Induced by Tanreqing Injection in Gansu Province during 2011-2013

目的：揭示痰热清注射液致不良反应（ADR）发生的成因和特点，为临床合理用药提供参考。方法：从甘肃省ADR监测中心数据库中提取2011—2013年痰热清注射液致ADR报告136例，就ADR的相关情况进行回顾性统计分析。结果：儿童（0～14岁）发生ADR最多见（占44．1％）；多为一般的ADR（占97．1％），严重的ADR有4例（占2．9％），而所有ADR中新的ADR有30例（占22．1％）；ADR累及器官／系统以皮肤及其附件损害最多（占45．1％），其次为全身性损害（占19．5％），排第3位的是消化系统损害（占11．6％）；所有病例经停药并积极给予对症治疗后ADR症状均好转或痊愈，无死亡病例及后遗症发生。结论：临床应重视痰热清注射液致ADR的各种因素，严格掌握用药适应证、禁忌证，加强用药过程监护，确保临床安全、有效、合理用药。

OBJECTIVE： To investigate the cause and characteristics of ADR induced by Tanreqing injection in Gansu province for nearly three years, and to provide reference for rational drug use in the clinic. METHODS： In retrospective study, 136 cases of ADR induced by Tanreqing injection from 2011- 2013 were analyzed statistically, which were extracted from ADR monitoring cen- ter database in Gansu province. RESULTS： Most of ADR occurred in children （0-14 years old）, accounting for 44.1%. Most of them were common ADR, accounting for 97.1% ; severe ADR accounted for 2.9% （4 cases） ; while new ADR accounted for 22.1% （30 cases）. Most damages were occurred in skin and its appendents, accounting for 45.1%, followed by systemic damage, account- ing for 19.5 %. The third was the digestive system damage, accounting for 11.6 %. The symptom of ADR were improved or recov- ered after drug withdrawal and symptomatic treatment; no deaths and complications occurred. CONCLUSIONS： Great importance should be attached to various cause of ADR induced by Tanreqing injection, and master indication and contradiction strictly and strengthen medication process monitoring in order to guarantee safe, effective and rational drug use in the clinic.