近十年中成药治疗高脂血症的临床研究证据图分析  

Evidence map of clinical studies about treatment of hyperlipidemia with Chinese patent medicines in recent ten years

作　　者：汪燕红 崔丹阳 楼一方 张文杰 WANG Yan-hong;CUI Dan-yang;LOU Yi-fang;ZHANG Wen-jie(Department of Traditional Chinese Medicine,General Hospital of Northern Theater Command,Shenyang 110016,China;Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;the Fourth Affliated Hospital of Zhejiang University School of Medicine,Yiwu 322000,China;Beijing University of Chinese Medicine,Beijing 100029,China)

机构地区：[1]中国人民解放军北部战区总医院中医科,辽宁沈阳110016 [2]中国中医科学院中医临床基础医学研究所,北京100700 [3]浙江大学医学院附属第四医院,浙江义乌322000 [4]北京中医药大学,北京100029

出　　处：《中国中药杂志》2024年第22期6214-6223,共10页China Journal of Chinese Materia Medica

基　　金：辽宁省自然科学基金项目(2021JH2/10300109,2022-YGJC-05)。

摘　　要：利用证据图系统梳理了近十年中成药干预高脂血症的临床研究证据。通过检索中、英文数据库,对近十年常用的45种中成药治疗高脂血症,共387篇临床研究、18篇系统评价/Meta分析进行证据图分析。通过阅读摘要和全文提取文献信息,梳理发文趋势、联合用药、干预疗程、合并症及结局指标的证据,采用Cochrane偏倚工具对部分随机对照试验(randomized controlled trial,RCT)进行质量评价,结果以图、表结合的方式展现。发现文献贡献较大的依次是血脂康胶囊、银丹心脑通胶囊、荷丹片、蒲参胶囊、复方丹参滴丸;结局指标包括血脂水平(总胆固醇、低密度脂蛋白等)、临床疗效(以显效、有效、无效划分)、不良反应(主要包括胃肠道反应等)、血液流变学指标、肝肾功能等;高脂血症的中成药研究存在样本量小、周期偏短、中医证型关注度低等不足,且RCT、系统评价/Meta分析的整体质量偏低,结果可信度降低。另外,中成药临床研究对不良反应的关注度较高,联合干预措施多样,中成药种类繁多,针对不同合并疾病选择多样。建议中医药临床研究提高研究质量,规范研究方案,关注中医证候,进一步增强中成药影响力。Evidence mapping was performed to review the clinical trials and systematic reviews about the treatment of hyperlipidemia with Chinese patent medicines in recent ten years.A total of 387 clinical studies and 18 systematic reviews/Meta-analysis involving 45 Chinese patent medicines commonly used in the treatment of hyperlipidemia in recent ten years were retrieved from Chinese and English academic publication databases.The article information was extracted by reading the abstract and full text,and the evidence of publication trend,combined medication,intervention course,complications,and outcome indicators was sorted out.The Cochrane risk-of-bias assessment tool was used to evaluate the quality of some randomized controlled trial(RCT),and the research results were presented by figures combined with tables.The Chinese patent medicines mostly mentioned included Xuezhikang Capsules,Yindan Xinnaotong Capsules,Hedan Tablets,Pushen Capsules,and Compound Danshen Dropping Pills.The outcome indicators included blood lipid levels(total cholesterol,low-density lipoprotein,etc.),clinical efficacy(markedly effective,effective,and ineffective),adverse reactions(mainly including gastrointestinal reactions),hemorheological indicators,and liver and kidney functions.The available studies generally had small sample sizes,short period,and insufficient attention to traditional Chinese medicine(TCM)syndromes.The RCT and systematic reviews/Meta-analysis generally had low quality,and thus the results had low reliability.Nevertheless,the studies demonstrated a heightened focus on adverse reactions,diverse combined intervention measures,and varied options for addressing different complications.It is recommended that the clinical research on Chinese patent medicines for hyperlipidemia should strive to improve research quality,standardize research protocols,and devote greater attention to TCM syndromes,thereby enhancing the influence and effectiveness of these medicines.

关 键 词：证据图 中成药 高脂血症 临床研究 

分 类 号：R259[医药卫生—中西医结合]