目的 通过证据图对中医药治疗高脂血症的临床研究进行全面梳理，了解该领域的证据分布。方法 检索 2004 年 1 月－2023 年 12 月中国知网 （CNKI）、万方数据库 （Wangfang）、维普中文期刊 （VIP）、中国生物医学文献服务系统 （SinoMed）、PubMed、Cochrane Library、Embase 等数据库中中医药治疗高脂血症的相关临床研究、系统评价/Meta 分析、指南及临床路径的文献，依据纳、排标准进行筛选后将结果以图表结合的形式进行分析与展示，并采用系统评价的质量评价工具（AMSTAR-2）、中医药系统评价和 Meta 分析的报告规范（PRISMA-CHM） 对系统评价/Meta 分析进行质量评价。结果 依据人群、干预、对照、结局、研究设计（Population，Intervention，Comparison，Outcome，Study design，PICOS）原则进行分析，共纳入 1 223 篇研究，包括随机对照试验 920 篇、非随机对照试验 249 篇、系统评价/Meta 分析 49 篇，5 篇指南/专家共识。近年来中医药治疗高脂血症的临床研究整体发文量呈下降趋势。高脂血症好发于中老年人，且趋于年轻化，随机对照研究的样本量大多集中在 60~300 例；中医药治疗高脂血症的临床研究治疗方案种类较多，其中中药汤剂（50.13%） 和中成药 （38.41%）占比较高，最低的为中医运动疗法 （0.51%），干预措施中试验组中药汤剂对降脂汤关注度最高，中成药对血脂康胶囊关注度最高；方法学设计方面，明确提及随机序列产生方法的有 199 篇（21.63%），提及分配隐藏的有 17 篇 （1.85%）；提及盲法的有 37 篇 （4.02%）；对照组以他汀类药物为主，主要为辛伐他汀和阿托伐他汀；在结局指标方面主要包括总有效率、中医证候积分，血脂水平、凝血指标、不良反应，而中医特色疗效指标、炎症指标、氧化应激指标、血管内皮指标关注度较低。系统评价/Meta 分析的方法学质量和报告质量普遍不高，AMSTAR-2 评价等级均为极低，PRISMA-CHM 得分平均为 15 分。结论 中医药治疗高脂血症具有一定优势，但高质量循证证据较少，后续仍需要更多高质量的临床研究进一步提供证据支撑，提示未来应开展更多大样本、多中心的临床研究，以临床实践问题为导向制定系统评价/Meta 分析、指南/专家共识的同时，参考国际规范标准，提升其规范性、可靠性，从而提升其证据质量。

Objective To comprehensively review the clinical research on the treatment of hyperlipidemia with traditional Chinese Medicine（TCM）through the evidence mapping，and to understand the distribution of evidence in this field. Methods Databases including CNKI，Wangfang，VIP，SinoMed，PubMed，Cochrane Library，and Embase were searched from January 2004 to December 2023 to collect clinical studies，systematic reviews/meta-analyses，guidelines and clinical pathways related to the treatment of hyperlipidemia with TCM. The results were analyzed and displayed in charts and graphs according to the screening criteria，and the Assessment of Multiple Systematic Reviews 2 （AMSTAR 2） tool and the Preferred Reporting Item for Systematic Review and Meta-analysis of Chinese herbal medicine （PRISMA-CHM） were used to evaluate the quality of the systematic review/meta-analysis. Results A total of 1 223 studies were included in the analysis according to Population，Intervention，Comparison，Outcome and Study design（PICOS） principles，involving 920 RCTs，249 non-RCTs，49 systematic reviews /meta-analyses，and 5 guidelines /expert consensus. In recent years，the overall number of clinical research publications has shown a downward trend. Hyperlipidemia frequently occurs in middle-aged and elderly people，and age of onset tends to be younger. The sample size of randomized controlled studies is mostly concentrated in 60-300 cases. There are many types of clinical treatment regimens for the treatment of hyperlipidemia with TCM，among which TCM decoction （50.13%） and Chinese patent medicine （38.41%） account for a relatively high proportion，and TCM exercise therapy （0.51%） is the lowest treatment. Jiangzhi Decoction has attracted more attention in trial group of TCM decoction，while Xuezhikang Capsule has attracted more attention in trial group of Chinese patent medicine. In terms of methodological design，199 papers（21.63%） explicitly mentioned the method of generating random sequence，17 papers（1.85%） mentioned allocation concealment，37 papers （4.02%） mentioned blinding. The control group was dominated by the statins， including simvastatin and atorvastatin. The outcome indicators mainly include the total effective rate TCM syndrome score blood lipid level coagulation index and adverse reactions，while the attention of TCM characteristic efficacy，inflammation，oxidative stress，and vascular endothelial index were low. The methodological and reporting quality of the systematic review/Meta-analysis were generally not high. AMSTAR-2 evaluation was extremely low， and the average PRISMA-CHM score was 15. Conclusion TCM has certain advantages in the treatment of hyperlipidemia，but there is a lack of high-quality evidence-based proof，and more high-quality clinical studies are still needed to further provide evidence supports in the future. It has been suggested that more large-sample and multi-center clinical studies should be carried out in the future. We should formulate systematic reviews/Meta analysis and guidelines /expert consensus according to the guidelines of clinical practice issues，also consult international standards and regulations，enhance normativity and reliability to improve the quality of their evidence.

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河南省科技攻关课题 （232102310469）；国家自然科学基金项目 （82004178，82030120）；河南省医学科技攻关计划项目 （LHGJ20220572）；河南中医药大学研究生科研创新项目 （2023KYCX032）；河南省自然科学基金项目 （222300420218）。