注射用骨瓜提取物不良反应报告相关因素分析及预防

目的通过对文献报道的注射用骨瓜提取物的不良反应报告的相关因素分析,了解注射用骨瓜提取物不良反应发生的特点及规律,为促进临床安全、有效、合理用药提供参考。方法采用回顾性研究方法,利用中国生物医学期刊、万方医学期刊数据库,对1989～2012年报道的骨瓜提取物不良反应病例,按患者的性别、年龄、药物过敏史、给药方式、累及系统-器官临床表现、关联性评价、严重程度及转归等项目进行分析。结果共检索到注射用骨瓜提取物不良反应报道14篇,共18例,发生不良反应人群男性多于女性,以中老年人为主,给药途径均为静脉滴注,累及系统以呼吸、心脏及循环、中枢神经系统为主。结论临床应重视注射用骨瓜提取物引起的不良反应,做到规范合理用药,保证用药安全。

Relative factors analysis and prevention of adverse reactions reports on cervus and cucumis polypeptide for injection

Objective To investigate the general pattern and characteristics of the adverse drug reaction （ADR） induced by cervus and cueumis polypeptide for injection by analysis of reports in literatures in order to provide reference for the safe, effective and rational use of drug. Methods The ADR cases induced by cervus and cucumis polypeptide for injection which were reported on Chinese medical citation index and Wanfang medical database from 1989 to 2012 were analyzed by a retrospective study. The data in respect of distribution of gender and age, allergic history of patients, method of administration, organs or system involved in the clinical manifestations, relevance evaluation, order of severity, outcomes and other items were analyzed. Results Total 14 reports and 18 ADR cases were retrieved. In the 18 cases of ADR reports, the proportion of males was higher than female; the elderly and the middle-aged were the main of age distribution; intravenous drip infusion was the major route of administration. The ADRs could involve multiple organs and the main clinical manifestations of ADRs were the lesions of respiratory, heart and circulation, the central nervous system. Conclusion Great attention should be paid to the monitoring and management of ADRs induced by cervus and cucumis polypeptide for injection to ensure clinical safe, effective and rational use of drugs.