摘要
该文旨在通过概况性综述(Scoping review)研究方法了解口服中成药治疗高脂血症的临床研究证据的现状,为临床实践和医疗卫生决策提供依据。首先检索相关药物目录获得用于治疗高脂血症(血脂异常)的中成药,再按照药品说明书明确是否治疗高脂血症(血脂异常)为依据进行筛选。根据所筛选的中成药检索中英文电子数据库获得相关文献,按照纳排标准对文献进行筛选,进行数据提取和分析,采用文字与图表相结合的方式进行结果展示。结果显示,(1)筛选相关药品32种,最终获得临床研究文献1010篇;(2)该研究纳入的所有中成药成分均来源于中药材,其中,5种为中药提取物,剩余的27种为纯中药制剂(1种药物组成为保密方);(3)32种中成药的药品说明书均明确指出可用于治疗高脂血症,其主要证型以痰瘀互结为主,治疗功效以活血化瘀为主;(4)在所纳入32种中成药中,血脂康片(胶囊)、绞股蓝总甙片价格最低;(5)重点分析的328项临床研究中,随机对照试验为248项,非随机对照试验为80项;(6)样本量分析中,随机对照试验的样本量波动范围为28~579例,非随机对照试验样本量波动为24~152例,样本量>200例的大样本临床研究占比为9.3%(12/129);(7)干预措施中最常见的类型为中成药VS西药(36.5%),最常用对照的西药为阿托伐他汀钙片,观察时最常使用的疗程为56 d(8周);(8)临床常使用血脂水平下降绝对值及有效率(总有效率)来进行疗效判定标准,有效率常用参考标准以《中药新药临床指导原则》最为常见。口服中成药的临床研究整体质量参差不齐,缺乏高质量临床研究证据,存在不同程度的不合理使用和不容易使用风险。建议本领域中成药临床研究需进一步拓宽研究思路及注重研究方案的顶层设计,规范研究过程,为中成药的临床使用提供高质量研究证据;建议加大力度建立健全中成药信息收集及反馈机制,减少中成药不容易使用风险;希望由监管部门牵头,价格、经济、质量评价等多部门联合研究,通过广泛深入的调研,实现药品价格的正确、合理和公平,共同促进中成药的合理使用。
To summarize the status quo of clinical evidence on oral Chinese patent medicine in the treatment of hyperlipidemia through scoping review and thereby provide a reference for clinical application and decision-making in health care.Proprietary Chinese medicines for the treatment of hyperlipidemia(dyslipidemia)were retrieved from relevant catalogs and then screened based on their instructions.Articles on the selected Chinese patent medicines were searched from Chinese and english electronic databases and screened according to the inclusion criteria,followed by data extraction and analysis.The results were described with text and graphs.(1)A total of 32 Chinese patent medicines and 1010 related articles were screened out.(2)All the included Chinese patent medicines were made from Chinese medicinal materials,of which 5 were Chinese medicinal extracts,and the remaining 27 were pure Chinese medicinal preparations(the compositions of 1 prescription is confidential).(3)As indicated in the instructions,all the 32 Chinese patent medicines can be used to treat hyperlipidemia with the main syndrome of combined phlegm and blood stasis,and the main effect of them is activating blood and resolving stasis.(4)Among the 32 medicines,Xuezhikang tablets(Capsules)and Gypenosides Tablets have the lowest price.(5)For the 328 key clinical studies,248 were randomized controlled trials and 80 non-randomized controlled trials.(6)As for the sample size,randomized controlled trials generally included 28-579 cases,and non-randomized controlled trials 24-152 cases.Clinical studies with more than 200 cases accounted for 9.3%(12/129).(7)The most common method was the comparison of the intervention effect of Chinese patent medicine and western medicine(36.5%)and Atorvastatin Calcium Tablets was the preferred western medicine control.The observation duration was generally 56 days(8 weeks).(8)In clinical practice,the absolute value of blood lipid decrease and(total)effective rate were often used to evaluate the efficacy,and the effective rate was generally determined based on Clinical Guidelines for New Chinese Medicines.The overall quality of clinical studies on oral Chinese patent medicines is uneven and there is a lack of high-quality clinical evidence.Moreover,there are the risks of unreasonable use and uneasy use of Chinese patent medicine.It is recommended that researchers on proprietary Chinese medicine should further broaden the research ideas,focus on the top-level design of the research plan,and standardize the research process,thereby provide high-quality research evidence for the clinical use of proprietary Chinese medicine.Moreover,more efforts should be made to establish a sound mechanism for information collection and feedback of proprietary Chinese medicine,so as to reduce the risk of uneasy use.We hope that in-depth investigation and discussion should be launched by price,economy,quality evaluation,and other departments headed by the supervision department to make the price of Chinese patent medicine reasonable and fair,thereby promoting the rational use of Chinese patent medicine.
作者
庞晴
杨亚男
吴倩
倪青
廖星
PANG Qing;YANG Ya-nan;WU Qian;NI Qing;LIAO Xing(Guang'anmen Hospital,China Academy of Chinese Medical Sciences,Beijing 100053,China;Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100007,China)
出处
《中国实验方剂学杂志》
CAS
CSCD
北大核心
2022年第8期214-221,共8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)
中国中医科学院基本科研业务·优秀青年科技人才(创新类)培养专项(ZZ13-YQ-075)
国家自然科学基金面上项目(82174239)
中国中医药循证医学中心“业务研究室主任专项”(2020YJSZX-2)。
关键词
高脂血症
血脂异常
中成药
临床研究
概况性综述
合理用药
hyperlipidemia
dyslipidemia
Chinese patent medicine
clinical research
scoping review
rational use of drugs
作者简介
第一作者:庞晴,在读博士,从事内分泌代谢病的中医药防治研究,E-mail:820291484@qq.com;通信作者:倪青,博士,主任医师,科主任,从事内分泌代谢病的中医药防治研究,E-mail:niqing669@163.com;通信作者:廖星,研究员,博士生导师,从事循证中医药方法学研究和中医脑病循证评价研究,E-mail:okfrom2008@hotmail.com。
