4种中西药复方制剂不良反应文献分析

ADRs of 4 Chinese-western Compound Preparations:Literature Analysis

目的:研究4种常用中西药复方制剂(消渴丸、维C银翘片、珍菊降压片和重感灵)不良反应的发生规律。方法:收集1994-2010年国内文献报道的81例中西药复方制剂致不良反应病例,并进行统计分析。结果:4种中西药复方制剂不良反应发生年龄<60岁的占48%,>60岁的占52%;不良反应主要表现为过敏(消渴丸4.5%,维C银翘片36.8%,珍菊降压片36.8%,重感灵42.9%)、低血糖(消渴丸93.2%)及休克(消渴丸2.3%,维C银翘片9.1%,珍菊降压片5.3%);不良反应发生时间集中在1997-1999年、2004年和2006-2010年,且2006-2010年报道的例数占63%。结论:临床应加强对中西药复方制剂的合理应用,避免或减少不良反应的发生。

OBJECTIVE： To evaluate the regularity of adverse drug reactions （ADRs） of 4 common Chinese-western compound preparations （Xiaoke pills, Wei C yinqiao tablet, Zhenju jiangya tablet and Zhongganling）. METHODS： A total of 81 ADR cases induced by Chinese-western compound preparations reported in domestic literatures during 1994-2010 were collected for sta- tistical analysis. RESULTS： 39 patients aged below 60 years, suffering from ADR induced by 4 Chinese-western compound prepara- tions, accounted for 48% ; 42 patients aged beyond 60 years accounted for 52%. ADR mainly manifested as allergy （Xiaoke pills 4.5%, Wei C yinqiao tablet 81.8%, Zhenju jiangya tablet 36.8% and Zhongganling 42.9% ）, hypoglycemia （Xiaoke pills 93.2% ） and shock （Xiaoke pills 2.3%, Wei C yinqiao tablet 9.1% and Zhenju jiangya tablet 5.3% ）. ADR case occurred during 1997 - 1999, in 2004 and during 2006-2010. Moreover, ADR case reported during 2006-2010 accounted for 63%. CONCLUSION： The rational use of Chinese-western compound preparations should be emphasized to avoid and reduce the incidence of adverse drug reactions.