中药注射剂不良反应特点与规律的文献调研

目的：探讨中药注射剂（TCMI）不良反应特点与发生规律,为临床合理用药提供参考。方法：检索1990-2009年中国期刊全文数据库、1989-2009年中文科技期刊数据库,收集TCMI不良反应文献,统计和分析与TCMI不良反应特点与发生规律相关的指标,包括患者性别及年龄分布、不良反应发生时间、累及器官或系统分类及临床表现、不良反应的分级、严重程度等。结果：TCMI不良反应比较常见,发生率可能明显高于口服制剂;随着年龄增长,TCMI不良反应的构成比明显增加;不良反应发生在用药后1d之内的占84.85%;不良反应以皮肤及附件损害最常见,其次为全身性损害,其中过敏性休克比较常见。结论：TCMI不良反应占全部中药不良反应的构成比较高,亟待开展其安全性再评价工作,以降低临床用药风险。

Characteristic and regularity of adverse drug reaction induced by traditional Chinese medicine injection based on database

Objective：To investigate the characteristic and regularity of adverse drug reaction（ADR） induced by traditional Chinese medicine injection（TCMI）,and to provide reference for rational drug use.Methods：Databases of domestic medical periodicals were searched,such as CNKI（from 1990 to 2009） and VIP（from 1989 to 2009）,and 8442 cases of ADRs induced by TCMI were analyzed by bibliometric and statistic methods in respect of the distribution of the gender and age of the patients,occurrence time of ADRs,organs or systems involved in ADRs and main clinical manifestations,classification and serious degree of ADRs,etc.Results：Incidence rate of ADRs induced by TCMI was higher than that induced by oral preparation.The proportion of ADRs induced by TCMI increased with the raising of age.ADRs occurred within 1 day after medication accounted for 84.85%.Lesions of skin and its appendages were the most common symptoms,and followed by the systemic lesion,especially anaphylactic shock.Conclusion：Proportion of adverse drug reactions induced by TCMI is higher than that induced by other TCM preparations,and safety reevaluation of TCMI should be developed to decrease the danger of clinical medication.