北京地区丹参注射液不良反应10年回顾性分析

Adverse reaction induced by salvia miltiorrhiza injection: a 10-year review of reported cases in Beijing

目的:调查北京地区丹参注射液所致药品不良反应(adverse drug reaction,ADR)发生情况,为临床合理用药提供参考。方法:对北京地区2003—2013年丹参注射液ADR上报信息进行统计归类,对发生人群、ADR症状及累及器官、发生时间、合并用药情况及处理预后情况进行回顾性分析。结果:在233例不良反应报告中,老年患者的ADR发生率>青壮年患者,女性患者发生率>男性患者。丹参注射液ADR累及多个器官/系统,其中皮肤及其附件的损害居首位,共95例,占总例数的40.77%。主要表现为皮疹、皮肤过敏等。常见的累及器官/系统还有神经系统、循环系统等。给药期间ADR发生时间无规律可循,ADR会发生在给药期间的任何时间段。ADR报告中存在许多合并用药情况,其中,合并应用低分子右旋糖酐最为常见,出现7例,占合并用药患者比例29.17%。结论:合理使用丹参注射液,保证临床用药安全,减少ADR的发生。

Objective： To get a fair idea of adverse drug reaction（ADR） induced by Danshen injection in Beijing, and to provide reference for clinical applications.Methods：The ADRs during 2003-2013 in Beijing were collected and statistically analyzed using retrospective method.Results： In the 233 cases, higher ADR occurrence was observed in elderly patient group than that in the younger＆amp;nbsp;group, and women were more easily to suffer ADR, which covers 66.52%.ADR of Danshen injection involved in multiple organs, including skin and its accessories damage in the ifrst place, with a total of 95 cases accounting for 40.77% of the total number of cases. The main symptoms of ADR were rash, skin allergy, etc. There were no rules to follow about the occurrence time of ADR induced by Dansheninjection. Adverse reactions happened any time during the delivery. The combined application of low molecular dextran was most common, which covered 7 cases and account for 29.17% of the cases with drug combination. Conclusion： Danshen injection should be used reasonably to ensure the safety of clinical medication and reduce the incidence of ADR.