目的 分析“脾不散精，痰瘀互结”理论组方联合西药治疗冠心病的有效性和安全性及对血脂异常患者TG水平的影响。方法 检索8个数据库建库至2024年11月收录的基于“脾不散精，痰瘀互结”理论组方治疗冠心病合并血脂异常的随机对照试验（Randomized controlled trials，RCTs），根据纳排标准，对文献进行筛选、数据提取。采用RevMan5.4进行Meta分析，TSA 0.9.5.10 Beta软件开展试验序贯分析，GRADE系统评价各结局指标的证据质量。结果 共纳入30篇RCTs，样本量2798例，其中试验组1402例，对照组1396例。Meta分析显示，化痰祛瘀法组相较于对照组能有效提高临床疗效（RR=1.26，95%CI[1.19，1.33]，P＜0.00001）、心绞痛疗效（RR=1.25，95%CI[1.14，1.37]，P＜0.00001）、心电图疗效（RR=1.27，95%CI[1.17，1.39]，P＜0.00001）以及中医症状疗效（RR=1.32，95%CI[1.23，1.42]，P＜0.00001），并降低TG水平（WMD =-0.44，95%CI[-0.52，-0.36]，P＜0.00001）及hs-CRP水平（WMD =-2.80，95%CI[-3.15，-2.45]，P＜0.00001）。在血液流变学方面，化痰祛瘀法同样展现出显著效果，能有效降低WBV（WMD =-1.34，95%CI[-1.65，-1.02]，P<0.00001）、PV水平（WMD =-0.44，95%CI[-0.45，-0.43]，P<0.00001）以及FIB水平（WMD =-0.46，95%CI[-0.75，-0.18]，P=0.001）。安全性方面，19项RCTs报道了不良反应，但病情普遍较轻，且治疗后症状消失。TSA显示，临床疗效的累积Z曲线穿过了传统界值和TSA界值，进一步肯定临床疗效。GRADE证据质量评价显示，上述结局指标的证据等级为中或低级。结论 基于“脾不散精，痰瘀互结”理论组方的中药在治疗冠心病及降血脂异常患者TG水平上是有效且安全的，但因纳入研究的质量局限性，仍需设计更为严谨、更大规模的RCTs加以验证。

Objective To analyze the efficacy and safety of the traditional Chinese medicine (TCM) in the treatment of treating coronary heart disease and their effects on TG levels of patients with dyslipidemia based on the theory of “Spleen failing to disperse essence and combined phlegm and stasis” combined with Western medicine. Methods Eight different electronic databases were searched to include randomized controlled trials (RCTs) of the TCM based on the theory of “Spleen failing to disperse essence and combined phlegm and stasis” for CHD complicated with dyslipidemias published from inception to November 2024. Literature screening and data extraction were performed based on the inclusion and exclusion criteria. Meta-analysis was performed by RevMan 5.4. The GRADE system and TSA 0.9.5.10 Beta were adopted to evaluate the certainty and conclusiveness of the evidence. Results A total of 30 RCTs involving 2798 subjects were included. There were 1402 subjects in the experimental group and 1396 subjects in the control group. Meta-analysis showed that the group of Huatan Quyu therapy was effective in improving the clinical efficacy (RR=1.26, 95%CI[1.19, 1.33], P<0.00001), angina symptoms (RR=1.25, 95%CI[1.14, 1.37], P<0.00001), electrocardiogram efficacy (RR=1.27, 95%CI[1.17, 1.39], P<0.00001), and TCM symptom efficacy (RR=1.32, 95%CI[1.23, 1.42], P<0.00001). Additionally, TG levels (WMD =-0.44, 95%CI[-0.52, -0.36], P<0.00001) and hs-CRP levels (WMD =-2.80, 95%CI[-3.15, -2.45], P<0.00001) decreased. Concerning hemorheology, Huatan Quyu therapy effectively reduced WBV(WMD =-1.34, 95%CI[-1.65, -1.02], P<0.00001)、PV(WMD =-0.44, 95%CI[-0.45, -0.43], P<0.00001) and FIB(WMD =-0.46, 95%CI[-0.75, -0.18], P=0.001). In terms of safety, 19 studies reported the adverse reactions in detail, but the severity was mild and symptoms disappeared after treatment. TSA showed that the cumulative Z-curve of the clinical efficacy crossed the traditional threshold and TSA threshold, which further affirmed the clinical efficacy. The GRADE graded the evidence of the above outcome indicators as moderate or low. Conclusion TCM based on the theory of “Spleen failing to disperse essence and combined phlegm and stasis” may be effective and safe in the treatment of patients with CHD and lowering TG levels in dyslipidemic patients. Since the quality of the literature included in this study was generally low, there is an urgent need for more RCTs with high quality, low bias risk and sufficient sample size to validate the above conclusions.

南京市医学重点科技发展项目（ZKX21060）：经典名方“温胆汤”干预不稳定性心绞痛患者易损斑块血清学与蛋白质组学生物标志物的临床研究，负责人：顾宁；第四批江苏省名老中医药专家（顾宁）传承工作室建设项目（苏中医科教[2021]7号），负责人：黄霞；江苏省研究生科研与实践创新计划项目（SJCX24_1077）：基于AMPK/SIRT1/PGC-1α通路探研加味温胆汤干预心肌缺血机制，负责人：肖志强。