丹参酮Ⅱ_A磺酸钠注射液不良反应的流行病学特征研究

Study on Pharmacoepidemiological Characteristics of Adverse Reactions Induced by Sodium Tanshinone Ⅱ_A Sulfonate Injection

目的探讨丹参酮ⅡA磺酸钠注射液所致不良反应的流行病学特点,为临床安全用药提供参考。方法以"丹参酮""不良反应""安全性"等为检索词,检索中国医院知识仓库(CHKD)和万方数据库收录的1994年至2013年所有中文文献。阅读、筛选所有描述丹参酮ⅡA磺酸钠注射液不良反应的文献资料,按纳入和排除标准筛选后进行统计、分析。结果共检索报道丹参酮ⅡA磺酸钠注射液不良反应的文献22篇,收集其不良反应27例。丹参酮ⅡA磺酸钠注射液所致不良反应在高年龄组发生率较高;不良反应累及机体多个系统,临床表现复杂多样,主要表现为皮肤及其附件损害、全身性反应,严重者可出现过敏性休克。不良反应/事件多发生在给药后30 min以内,绝大多数经治疗后转归良好。结论丹参酮ⅡA磺酸钠注射液可致过敏性休克等严重不良反应,应提高临床合理用药水平,加强用药监护,以避免或减少不良反应的发生,保障患者用药安全。

Objective To investigate the epidemiological characteristics of adverse drug reactions/events （ADR/ADE）induced by Sodium Tanshinone ⅡA Sulfonate Injection to provide reference for its rational use in clinic. Methods Sodium Tanshinone ⅡA Sulfonate Injection induced ADR case reports were searched from the databases of the Chinese National Knowledge Infrastructure and Wanfang Data from 1994 to 2013 with the terms of tanshinone,adverse drug reaction and safety. All literatures associated with ADR of Sodium Tanshinone ⅡA Sulfonate Injection were reviewed and screened according to the inclusion and exclusion criteria. Results Total 27 cases of ADR were collected from 22 articles. The higher occurrence rate of ADR was occurred in the high age group;multiple organs and systems were involved in ADR and the clinical manifestations were various and complex. The lesions of ADR were primarily involved in skin and its accessories, followed by systemic reactions. The allergic shock was observed in some severe ADR. The onset time of most ADR/ADE was within 30 min after medication and most ADR/ADE had good prognosis after treatment. Conclusion Sodium Tanshinone ⅡA Sulfonate Injection could lead to severe ADR/ADE,such as allergic shock. The level of rational drug use should be increased and the medication monitoring should be strengthened so as to avoid or decrease the occurrence of ADR/ADE and ensure the patient＇s medication safety.