235例复方丹参注射液不良反应/事件文献分析

Analysis of 235 Adverse Drug Reaction/Event Cases of Compound Danshen Injection

目的探讨复方丹参注射液不良反应/事件发生发展情况。方法对1989～2007年国内医药期刊中报道的235例复方丹参注射液的不良反应/事件进行统计分析。结果复方丹参注射液的不良反应/事件累及神经、心血管、呼吸、消化、泌尿等多个系统;以全身性损害最多见,其次是皮肤及附件损害,两者均属过敏反应,合计177例,占75.32%。177例中,126例(71.19%)发生在开始用药后1小时内;100例(56.50%)发生在开始用药后30分钟内;132例(74.58%)首次用药出现过敏。235例中,229例预后良好,6例死亡。结论临床用药的前30分钟应当警惕不良反应/事件的发生,密切观察临床表现。

Objective To review adverse drug reaction/event （ADREADE） cases induced by Compound Danshen Injection. Methods 235 ADR/ADE cases induced by Compound Danshen Injection searched from domestic medical journals from 1989 to 2007 have been analyzed. Results ADR/ADE involved injuries of various systems and organs. Among the ADR/ADE, systemic damages appeared most frequently, and injury of skin and its appendages came secondly. The two types are allergy reactions, and figure up 177 cases which account for 75.32% of the total. As for 177 cases, 126（71.19%） had attacked within one hour since injection while 100 （56.50%） in 30 minutes. Allergies had occurred in 132 cases （74.58%） when patients took the first medication. In 235 cases, 229 cases recovered after treating while the other 6 died. Conclusion Clinicians should pay more attention to ADR/ADE in the first 30 minutes of injection.