11种名贵中成药临床研究证据的概况性分析  

Clinical Evidence Profile of Eleven Expensive Chinese Patent Medicines:A Scoping Analysis

作　　者：李雅婧 李苗苗 张乐 王文雅 赵晖 廖星[1] LI Yajing;LI Miaomiao;ZHANG Le;WANG Wenya;ZHAO Hui;LIAO Xing(Center for Evidence-Based Chinese Medicine,Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Science,Beijing 100700,China;Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Science,Beijing 100700,China;China Center for Evidence-Based Traditional Chinese Medicine,Beijing 100700,China)

机构地区：[1]中国中医科学院中医临床基础医学研究所循证医学基础研究室,北京100700 [2]中国中医科学院中医基础理论研究所,北京100700 [3]中国中医药循证医学中心,北京100700

出　　处：《中国实验方剂学杂志》2025年第2期227-238,共12页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：中国中医科学院科技创新工程项目(CI2021A00701-3);国家自然科学基金项目(82174239)。

摘　　要：目的:采用概况性综述方法,对名贵中成药的基本信息和临床研究证据展开系统检索和深入分析,以期为未来相关研究和临床应用提供依据。方法:系统检索8个中英文数据库,围绕名贵中成药的临床研究证据进行分析。结果:遴选了11种名贵中成药(安宫牛黄丸、局方至宝丸、苏合香丸、片仔癀、牛黄清心丸、清宫寿桃丸、复方黄黛片、西黄丸、定坤丹、八宝丹、龟龄集),共纳入相关研究365篇,包括331篇临床研究(其中随机对照试验291篇)、30篇系统评价及Meta分析、3篇专家共识和1篇快速卫生技术评估。成人每日用药价格在500元以上的名贵中成药有2种,为安宫牛黄丸和局方至宝丸;涉及的名贵中药材有麝香(7次)、牛黄(7次)、冰片(5次)等;药物剂型有丸剂、胶囊剂、口服液、片剂、锭剂5种;治疗疾病主要包括恶性肿瘤、脑血管疾病、妇科疾病、肝胆系统疾病等;临床研究的样本量主要集中在51~100例,研究中对照形式主要为名贵中成药+西医基础治疗对照西医基础治疗;331篇临床研究文献中,共发生44例不良事件,其中36例判定为不良反应。结论:名贵中成药因原料稀缺而价格昂贵,临床研究难度大,且其治疗疾病多为危急重症,大样本临床研究证据不足。文献分布不均、药品说明书信息不全、研究设计不规范等问题亟待改进。Objective:This study employed the scoping review method to systematically retrieve and analyze the basic information and clinical research evidence of expensive Chinese patent medicines(CPMs),aiming to provide a basis for future related research and clinical applications.Methods:Eight Chinese and English databases were systematically searched for the clinical research evidence on expensive CPMs.Results:Eleven expensive CPMs(Angong Niuhuang Wan,Jufang Zhibao Wan,Suhexiang Wan,Pien Tze Huang,Niuhuang Qingxin Wan,Qinggong Shoutao Wan,Compound Realgar Natural Indigo Tablets,Xihuang Wan,Dingkun Wan,Babao Wan,and Guilingji Capsules)were selected.A total of 365 related studies were included in this review,comprising 331 clinical studies(of which 291 were randomized controlled trials),30 systematic reviews and Metaanalyses,3 expert consensus,and 1 rapid health technology assessment.Among the 11 CPMs,2(Angong Niuhuang Wan and Jufang Zhibao Wan)had a daily price over 500 yuan.The famous and precious Chinese medicinal materials involved included Moschus(frequency of 7),Bovisc Alculus(7),and Borneol(5).The dosage forms included pills,capsules,oral liquid,tablets,and lozenges.The diseases treated by these CPMs mainly included malignant tumors,cerebrovascular diseases,gynecological diseases,and hepatobiliary system diseases.The sample sizes of the clinical studies were mainly concentrated within the range of 51-100 cases,and the main control form was CPM+basic Western medicine treatment vs.basic Western medicine treatment.The 331 clinical studies reported a total of 44 adverse events occurred,of which 36 were determined to be adverse reactions.Conclusion:The scarcity of raw materials leads to the high prices of expensive CPMs.The difficulty of conducting clinical research and the critical and severe cases treated lead to a lack of clinical research evidence with large sample sizes.The uneven distribution of existing studies,incomplete information on medicine package,and non-standard clinical research designs remain to be addre

关 键 词：名贵中成药 临床证据 概况性分析 随机对照试验 合理用药 

分 类 号：R242[医药卫生—中医临床基础] R287[医药卫生—中医学] R277