Table5_Traditional Chinese medicine lowering lipid levels and cardiovascular events across baseline lipid levels among coronary heart disease: a meta-analysis of randomized controlled trials.docx

BackgroundDyslipidemia is a critical driver in the development of coronary heart disease (CHD), which further exacerbates the risk of major adverse cardiovascular events (MACEs). Chinese herbal medicine (CHM) plays an important role in the regulation of lipid levels and improvement of prognosis. However, few systematic reviews report whether the efficacy of CHM therapy for regulating lipid levels and lowering cardiovascular events is associated with baseline lipid levels.
MethodsRandomized controlled trials assessing efficacy of CHM for lipid profiles and MACEs among patients with CHD were searched in six databases. Two authors independently extracted studies according to a predesigned form. Cochrane risk of bias tool and Grading of Recommendations Assessment, Development, and Evaluation system were used to assess the methodological quality of the included studies. The primary outcomes were blood lipid levels and MACEs including cardiovascular mortality, non-fatal myocardial infarction, revascularization, angina pectoris, heart failure, and non-fatal stroke across baseline lipid levels. The secondary outcomes were individual components of the primary outcomes.
ResultsA total of 23 trials with 7,316 participants were included in this study. Altogether 377 cardiovascular events occurred in 3,670 patients in the CHM group, while 717 events occurred in 3,646 patients in the Western medicine–alone group. Compared with the Western medicine alone, additional CHM significantly lowered low-density lipoprotein cholesterol (LDL-C) [MD = −0.46, 95% CI (−0.60 to −0.32), P < 0.00001, I2 = 96%]. The risk reduction in MACEs associated with CHM vs. Western medicine therapy was 0.52 [95% CI (0.47–0.58), P < 0.00001, I2 = 0%], but varied by baseline LDL-C level (P = 0.03 for interaction). Triglycerides (TG) level was also significantly lowered by additional CHM vs. Western medicine alone [MD = −0.27, 95% CI (−0.34 to −0.20), P < 0.00001, I2 = 81%], and risk reduction for MACEs also varied with baseline TG, with greater risk reduction in higher baseline TG subgroups (P = 0.03 for interaction). Similar results were observed with total cholesterol and high-density lipoprotein cholesterol.
ConclusionCompared with Western medicine alone, additional CHM was associated with lower risk of cardiovascular events and improvement of lipid profiles. Risk reduction for cardiovascular events was associated with baseline LDL-C and TG levels.
Systematic Review Registrationhttps://www.crd.york.ac.uk/PROSPERO, identifier CRD42023425791.

背景 血脂异常是冠心病（coronary heart disease, CHD）发生发展的关键驱动因素，可进一步加重主要不良心血管事件（major adverse cardiovascular events, MACEs）的发生风险。中草药（Chinese herbal medicine, CHM）在调节血脂水平、改善预后方面发挥着重要作用。然而，目前鲜有系统评价探讨中草药调脂治疗与降低心血管事件的疗效是否与基线血脂水平相关。
方法 本研究在6个数据库中检索评估中草药用于冠心病患者血脂谱及主要不良心血管事件疗效的随机对照试验。由2名研究者独立按照预先设计的资料提取表进行研究筛选与数据提取。采用Cochrane偏倚风险工具与建议评估、发展和评价分级（Grading of Recommendations Assessment, Development, and Evaluation, GRADE）系统对纳入研究的方法学质量进行评价。主要结局指标为不同基线血脂水平下的血脂水平及主要不良心血管事件，后者包括心血管死亡率、非致死性心肌梗死、血运重建、心绞痛、心力衰竭及非致死性卒中；次要结局指标为主要结局指标的各组成部分。
结果 本研究共纳入23项随机对照试验，涉及7316名受试者。中草药组的3670例患者中共发生377例心血管事件，而单纯西医组的3646例患者中共发生717例心血管事件。与单纯西医治疗相比，联合中草药治疗可显著降低低密度脂蛋白胆固醇（low-density lipoprotein cholesterol, LDL-C）水平[均数差（mean difference, MD）=−0.46，95%置信区间（confidence interval, CI）：−0.60~−0.32，P<0.00001，I²=96%]。中草药联合治疗对比单纯西医治疗的主要不良心血管事件风险比为0.52（95%CI：0.47~0.58，P<0.00001，I²=0%），但该效应随基线低密度脂蛋白胆固醇水平存在异质性（交互作用P=0.03）。与单纯西医治疗相比，联合中草药治疗也可显著降低甘油三酯（triglycerides, TG）水平[MD=−0.27，95%CI：−0.34~−0.20，P<0.00001，I²=81%]，且主要不良心血管事件的风险降低效应同样随基线甘油三酯水平存在差异，在基线甘油三酯水平较高的亚组中风险降低更为显著（交互作用P=0.03）。总胆固醇与高密度脂蛋白胆固醇也观察到了相似的结果。
结论 与单纯西医治疗相比，联合中草药治疗可降低心血管事件发生风险并改善血脂谱。心血管事件的风险降低效应与基线低密度脂蛋白胆固醇及甘油三酯水平相关。
系统综述注册 本研究已在PROSPERO平台注册，注册号为CRD42023425791。