国内外药品临床综合评价指标体系研究的系统评价

Clinical comprehensive evaluation system of drugs:a systematic review

目的系统评价国内外有关药品临床综合评价指标体系的研究。方法计算机检索PubMed、EMbase、Cochrane Library、CNKI、WanFang Data、VIP和CBM数据库,搜集国内外有关药品临床综合评价指标体系的文献和政策文件,检索时限均为建库至2022年10月31日。对其评价机构、评价视角、应用范围、维度和指标等进行梳理,并针对不同类别药物的评价情况进行具体分析。结果纳入药品综合评价指标体系101个。发表时间分布在2009—2022年,发文量总体呈增长趋势。第一作者单位主要涉及26个国家,包括中国(n=34)、加拿大(n=11)、美国(n=10)、西班牙(n=10)等。48个研究报告了评价视角。所有评估框架均可用于药品评价,其中43个应用范围不限,可作为普适性评价工具,58个可用于特定药物的评价,主要包括抗肿瘤药物(n=15)、孤儿药(n=10)和中药(n=7)。评价维度数量从2到22个不等,指标数量从4到56个不等,其中经济性(n=73)、有效性(n=72)、安全性(n=54)、疾病需求/负担(n=34)、创新性(n=24)是出现频率最高的评价维度。结论国内外关于药品临床综合评价的研究日益成熟。在中成药临床综合评价的实施过程中,需要明确评价视角、规定评价范围、确定评价维度。

Objective To systematically review the studies on the clinical comprehensive evaluation system of drugs at home and abroad.Methods The Pub Med,EMbase,Cochrane Library,CNKI,Wan Fang Data,VIP and CBM databases were electronically searched to collect the literature and policy documents of the clinical comprehensive evaluation system of drugs from inception to October 31,2022.The evaluation organization,evaluation perspective,application scope,domains and criteria were sorted out,and the evaluation of different types of drugs was analyzed in detail.Results A total of 101 clinical comprehensive evaluation systems of drugs were included.The publishing time was from 2009 to 2022,and the number of published articles increased.The first author mainly came from 26 countries,including China(n=34),Canada(n=11),the United States(n=10),and Spain(n=10).Forty-seven articles reported the evaluation perspective.All evaluation systems could be used for drug evaluation,of which 43 could be used as universal evaluation tools,and 58 could be used for the evaluation of specific drugs,mainly including anti-tumor drugs(n=15),orphan drugs(n=10)and traditional Chinese medicine(n=7).The number of evaluation domains varied from 2 to 22,and the number of criteria varied from 4 to 56.Among them,economics(n=73),effectiveness(n=72),safety(n=54),disease demand/burden(n=34),and innovation(n=24)were the most frequent evaluation domains.Conclusion The research on clinical comprehensive evaluation of drugs at home and abroad has grown up.During the implementation of clinical comprehensive evaluation of Chinese patent medicine,it is necessary to clarify the evaluation perspective,define the evaluation scope,and determine the evaluation domains.