复方丹参注射液不良反应病案数据库建立及流行病学特点研究  

Medical Records Database and Epidemiological Characteristics of Adverse Reaction Caused by Compound Salviae Miltiorrhizae Injection

作　　者：吴嘉瑞[1] 张冰[1] 

机构地区：[1]北京中医药大学,北京100102

出　　处：《中药新药与临床药理》2007年第2期152-154,172,共4页Traditional Chinese Drug Research and Clinical Pharmacology

基　　金：国家食品药品监督管理局药品评价中心项目(2005B0601)

摘　　要：目的探讨复方丹参注射液不良反应的流行病学特点。方法通过检索1978～2006年医药学期刊,收集复方丹参注射液不良反应详细病案115例,应用ACCESS建立病案数据库,并依托数据库平台,对病案的流行病学资料进行统计分析。结果病案中,中老年患者比例最高(70.43%);男性58例(50.43%),女性57例(49.57%);原发疾病中冠心病比例最高(32.00%);不良反应以全身性损害(37.40%)和皮肤及其附件损害(25.95%)为主,多发生在首次给药30min内(64.37%)。结论建立不良反应病案数据库有助于更好地储存分析病案信息。复方丹参注射液可引起多系统不良反应,其发生机制复杂,临床应用中应增强预防意识。Objective To investigate the epidemiological characteristics of adverse reaction（ADR） caused by compound Salviae miltiorrhizae injection. Methods By searching domestic medical periodicals issued in the years of 1978 - 2006, 115 cases of ADR detailed records of compound salviae miltiorrhizae injection were collected and database of ADR cases was established by ACCESS. On the basis of database, epidemiological characteristics of the cases were analyzed by statistic methods. Results The incidence of ADR was the highest （70. 43 % ） in the middle - aged and old sufferers, and was 50.43 % （58） in the male and 49.57 % （57） in the female. In the primary diseases, coronary artery disease shared the highest of incidence （32.00 % ）. The incidence of generalized lesion （37.40 % ） and that of lesion of skin and its ap- pendages （25.95 % ）dominated in ADRs, and ADRs usually occurred within 30 min after first injection （64. 37 % ） . Conclusion The establishment of ADR database is beneficial to the storage and analysis of ADR information. Compound Salviae miltiorrhizae injection can induce multi - systemic lesion, and its mechanism is complicated. Therefore, clinician should pay more attention to the prevention of ADR of compound Salviae miltiorrhizae injection.

关 键 词：复方丹参注射液 不良反应 数据库 流行病学 

分 类 号：R285.6[医药卫生—中药学]