Jiang Ling, Fan Wen, Zhou Fangyu, Liu Lihan, Pan Maoxing, Yang Qinhe, Zhang Yupei
School of Chinese Medicine, Jinan University, Guangzhou, China.
Department of Traditional Chinese Medicine, Xiangdong Hospital Affiliated to Hunan Normal University, Liling, China.
Front Pharmacol. 2025 Aug 5;16:1614767. doi: 10.3389/fphar.2025.1614767. eCollection 2025.
Hyperlipidemia drives global cardiovascular mortality by elevating risks of atherosclerosis and stroke. While statins are foundational, traditional Chinese medicines (TCMs) are widely combined with statins to boost efficacy. However, diverse TCM formulations lack comparative evidence in combination regimens, necessitating urgent evidence-based optimization.
Based on preliminary literature review and component usage frequency analysis, 8 TCMs were included firstly. Then, we conducted a systematic search for RCTs that assessed 8 TCMs with traditional statin drugs (TT) for the treatment of hyperlipidemia. The search was conducted through September 30, 2024, and encompassed China National Knowledge Infrastructure (CNKI), Chinese Biomedical Literature Database (CBM), Database of Chinese Sci-Tech Periodicals (VIP), Wanfang Database, PubMed, Web of Science, and Cochrane Library. Outcomes included clinical total effective rate, total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C). Risk of bias in RCTs was evaluated using Cochrane's bias risk tool. Evidence synthesis was performed utilizing both direct and Bayesian network meta-analyses (NMA). Meta-regression analysis, subgroup analysis, publication bias analysis, and sensitivity analysis were employed to evaluate heterogeneity sources and efficacy robustness. Ranking analysis was implemented to comparatively assess clinical efficacy among eight TCMs. Evidence quality for each outcome was assessed using Grading of Recommendations, Assessment, Development, and Evaluation approach (GRADE). Overall, the proposed structured framework integrated high-frequency TCM screening, NMA-driven efficacy ranking, methodological validation, and mechanistic investigation to holistically evaluate therapeutic interventions for the first time.
67 RCTs involving 7327 individuals and 8 TCMs were encompassed. Related analyses indicated TT + TCMs were more efficacious than TT monotherapy. Among 8 TCMs + TT, TT combined with Jiangzhi Tongmai Capsule (TT + JZTM) demonstrated the highest clinical total effective rate, TT combined with Dantian Jiangzhi Pill (TT + DTJZ) was the most effective in reducing TC, TT combined with Pushen Capsule (TT + PS) was the most effective in reducing TG, and TT combined with Jiangzhiling Tablet (TT + JZL) was the most effective in increasing HDL-C and reducing LDL-C.
NMA revealed the overall clinical efficacy of TT + JZL, TT + DTJZ, and TT + JZTM were ranked at the forefront in treating hyperlipidemia. These findings provide evidence-based guidance for tailoring TCM-statin combinations to target individualized lipid profiles.
https://www.crd.york.ac.uk/PROSPERO/view/CRD42024603979, identifier [CRD42024603979].
高脂血症通过增加动脉粥样硬化和中风风险，导致全球心血管疾病死亡率上升。虽然他汀类药物是基础用药，但中药常与他汀类药物联合使用以提高疗效。然而，多种中药配方在联合用药方案中缺乏对比证据，因此迫切需要基于证据进行优化。
基于初步文献综述和成分使用频率分析，首先纳入了8种中药。然后，我们系统检索了评估8种中药与传统他汀类药物（TT）联合治疗高脂血症的随机对照试验（RCT）。检索截至2024年9月30日，涵盖中国知网（CNKI）、中国生物医学文献数据库（CBM）、中文科技期刊数据库（VIP）、万方数据库、PubMed、Web of Science和Cochrane图书馆。结局指标包括临床总有效率、总胆固醇（TC）、甘油三酯（TG）、高密度脂蛋白胆固醇（HDL-C）和低密度脂蛋白胆固醇（LDL-C）。使用Cochrane偏倚风险工具评估RCT中的偏倚风险。采用直接和贝叶斯网络meta分析（NMA）进行证据合成。采用meta回归分析、亚组分析、发表偏倚分析和敏感性分析来评估异质性来源和疗效稳健性。进行排序分析以比较评估8种中药之间的临床疗效。使用推荐分级、评估、制定和评价方法（GRADE）评估每个结局指标的证据质量。总体而言，所提出的结构化框架首次整合了高频中药筛选、NMA驱动的疗效排序、方法学验证和机制研究，以全面评估治疗干预措施。
纳入了涉及7327名个体和8种中药的67项RCT。相关分析表明，TT加中药比TT单药治疗更有效。在8种中药加TT中，TT联合降脂通脉胶囊（TT + JZTM）临床总有效率最高，TT联合丹田降脂丸（TT + DTJZ）降低TC最有效，TT联合蒲参胶囊（TT + PS）降低TG最有效，TT联合降脂灵片（TT + JZL）升高HDL-C和降低LDL-C最有效。
NMA显示，TT + JZL、TT + DTJZ和TT + JZTM在治疗高脂血症方面的总体临床疗效位居前列。这些发现为根据个体血脂谱定制中药-他汀类药物联合用药提供了循证指导。
https://www.crd.york.ac.uk/PROSPERO/view/CRD42024603979，标识符[CRD42024603979]
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