丹参注射剂561例临床不良反应/事件分析

Analysis on 561 Cases of Clinical Adverse Drug Reaction/event Caused by Danshen Injection

目的:分析丹参注射剂所致不良反应发生的特点,为临床安全用药提供参考。方法:采用回顾性研究方法,对2012~2014年湖北省药品不良反应监测中心收集的561例丹参注射剂所致不良反应/事件(ADR/ADE),以患者性别、年龄、过敏史,ADR/ADE发生时间、临床表现及转归等指标作为考查项,进行统计分析。结果:561例ADR/ADE患者男女比例为1∶1.109,主要发生人群为40岁以上的患者(85.93%)。共发生ADR/ADE 784例次,主要发生时间为给药后30 min以内(56.86%),主要临床表现为皮肤及其附件损害(34.31%)、全身性损害(16.45%)、心率及心律紊乱(12.76%),其中严重不良反应构成比为4.5%。结论:丹参注射液可引起不同程度的不良反应,临床用药时应给予足够重视,需加强ADR/ADE监测,提高用药安全性。

Objective： According to analyzing the characteristics of the ADR/ADE caused by Danshen injection,provide reference information for clinical rational drug use. Methods： By a retrospective study,561 cases with ADR/ADE induced by Danshen njection in Hubei province from January 2012 to December 2014,was analyzed with patient＇s gender,age,occurrence time of adverse drug reaction/event（ ADR/ADE）,allergic history,clinical manifestations and prognosis.Results： Among the 561 cases with ADR/ADE,the male/female ratio was 1 ∶ 1. 109,most of them（ 85. 93%） were aged above 40 and the occurrence time of ADR/ADE cases mainly happened within 30 min after the treatment（ 56. 86%）. Totally 561 ADR/ADE cases were reported that mainly damaged in skin and its adnexa（ 34. 31%）,systemic lesion（ 16. 45%）,heart rate and rhythm disorders（ 12. 76%）,etc. And the incidence of serious adverse reaction was 4. 5%. Conclusion：Different degrees of ADR/ADE can be induced by Danshen njection,while enough attention should be paid to the clinical use of the injections. And ADR/ADE monitoring also should be strengthened to improve the safety of medication.