国内药物利用评价研究的文献计量学分析

Systematic Review of Domestic Drug Use Evaluation Research

目的：推动我国药物利用评价（DUE）研究的规范开展。方法：以＂药物利用评价＂＂药物利用评估＂＂DUR＂＂DUE＂等为关键词检索1991年1月-2013年12月中国期刊全文数据库、维普中文科技期刊数据库、万方数字化期刊数据库,并按照纳入与排除标准进行筛选,对相关研究文献涉及的药物或疾病、研究机构、评价标准及制定依据、样本数、数据来源、评价项目、结果等方面进行文献计量学统计和分析。结果：最后得到30篇真正意义上的DUE研究文献。国内发表的DUE研究多针对易滥用的抗菌药物和高发病率、用药方案复杂、严重危害人体健康的重大疾病。有83.33%（25/30）的研究建立了DUE标准,其中有13项研究对DUE标准建立的具体方法进行了描述,有3项还采用了专家咨询法。研究样本数在14例到507例之间,平均为87例。开展研究所在的医院83.33%（25/30）为三级甲等医院。研究的时间跨度为2~24个月,平均约为10.5个月。评价项目一般分为用药指征、治疗过程监测、临床治疗结果。结论：目前我国DUE研究数量较少,评价组织不完善,无专门评价标准,评价过程不规范。建议制订规范的DUE程序,尽快发布针对临床使用价值大、风险大、易滥用的药物或是重大疾病相应的临床指导原则,建立通行的评价标准,并鼓励各级医疗卫生机构开展DUE研究。

OBJECTIVE：To promote the development of drug use evaluation research in China. METHODS：Using＂drug use review＂,＂drug use evaluation＂,＂DUR＂and ＂DUE＂as keywords,the literatures were retrieved from CNKI,VIP,Wanfang during Jan. 1991 to Dec. 2013. The tabular comparison of 30 literatures was conducted from seven aspects,including medicine or disease,research institution,evaluation criterion and evidence,sample size,data sources,evaluation item and outcomes. RESULTS：According to exclusion criteria,30 DUE literatures meeting the criteria were collected. Domestic literatures of DUE research mainly focused on abusive antibacterial agents,high morbidity,complicated therapeutic regimen,serious diseases that severely impaired human＇s health. 83.33%（25/30）of domestic DUE researches had established DUE standards,among which 13 literatures specificly described the establishment of standards,and 3 literatures used Delphi method. The number of cases ranged from 14 to 507,and was87 in average. 83.33%（25/30）of DUE researches were carried out in third-grade class A hospitals. The time span of sample selection ranged from 2 months to 24 months,and was 10.5 months in average. Evaluation items generally were divided into medication indications,treatment process monitoring and clinical treatment results. CONCLUSIONS：At present,there are few DUE researches in our country;imcomplete evaluation institutions and absense of special evaluation criteria exist;the process of evaluation is not normative. It is suggested to issue clinical guidelines of serious diseases or medicines which have high clinical value,high risks and easily be abused as soon as possible;construct domestic standard procedure of DUE and encourage medical institutions at all levels to develop DUE research.