【目的】探讨心血通口服液治疗急性冠脉综合征 （ACS） 患者的临床疗效。【方法】将2023年1月~2023年9月在广州中医 药大学顺德医院住院的80例血瘀型ACS患者按随机数字表法随机分为治疗组和对照组，每组各40例。2组患者均给予常规 西医治疗，包括生活方式指导、行经皮冠状动脉介入 （PCI） 术以及常规西药治疗，在此基础上，治疗组患者加用心血通口 服液治疗，疗程为8周。观察2组患者治疗前后中医证候积分、血瘀证积分、心绞痛积分、血脂指标、颈动脉彩超指标、 心脏彩超指标及血清氧化三甲胺 （TMAO） 、一氧化氮 （NO） 、内皮素1 （ET-1） 、白细胞介素8 （IL-8） 、丝氨酸/苏氨酸蛋白激 酶1 （AKT-1） 、血管内皮生长因子A （VEGF-A） 水平的变化情况，并评价2组患者的中医证候疗效和相关治疗方案的安全性。 【结果】（1） 脱落情况方面，研究过程中，有2例患者失访和1例患者因肺炎而退出研究，最终共有77例患者完成全部疗程的 治疗观察，其中治疗组39例，对照组38例。 （2） 疗效方面，治疗8周后，治疗组的总有效率为89.74% （35/39） ，对照组为 63.16% （24/38） ，组间比较 （χ2 检验） ，治疗组的中医证候疗效明显优于对照组 （P < 0.01） 。 （3） 中医证候积分方面，治疗后，2组患 者的胸痛、胸闷、夜间加重、心悸等证候积分和治疗组的面色晦暗积分均较治疗前明显下降 （P < 0.05或P < 0.01） ，且治疗 组对胸闷、夜间加重、心悸等证候积分的降低作用均明显优于对照组 （P < 0.05或P < 0.01） 。 （4） 血瘀证积分和心绞痛积分方 面，治疗后，2组患者的血瘀证积分和心绞痛积分均较治疗前明显下降 （P < 0.01） ，且治疗组的下降作用均明显优于对照组 （P < 0.01） 。 （5） TMAO及相关炎症因子方面，治疗后，2组患者的血清TMAO、ET-1、IL-8、AKT-1、VEGF-A水平均较治疗 前明显降低 （P < 0.01） ，血清NO水平均较治疗前明显升高 （P < 0.01） ，且治疗组对血清TMAO、ET-1、IL-8、AKT-1、 VEGF-A水平的下降作用及对血清NO水平的升高作用均明显优于对照组 （P < 0.05或P < 0.01） 。 （6） 血脂指标方面，治疗后， 2组患者的总胆固醇 （TCHO）、低密度脂蛋白胆固醇 （LDL-C） 水平均较治疗前明显下降 （P < 0.01） ；治疗组的甘油三酯 （TG） 水平较治疗前明显下降 （P < 0.05） 、高密度脂蛋白胆固醇 （HDL-C） 水平较治疗前明显升高 （P < 0.01） ，而对照组的TG、HDL-C 水平较治疗前无明显变化 （P > 0.05） ；治疗后组间各项血脂指标比较，差异均无统计学意义 （P > 0.05） 。 （7） 颈动脉彩超指标方 面，治疗后，2组患者的颈动脉内膜中层厚度 （IMT） 和颈动脉斑块Crouse积分均较治疗前明显改善 （P < 0.01） ，治疗后组间IMT 和颈动脉斑块Crouse积分比较，差异均无统计学意义 （P > 0.05） 。 （8） 心脏彩超指标方面，治疗后，除治疗组的左心室内径 （LVd） 较治疗前明显增大 （P < 0.05） 外，2组患者的其余各项心脏彩超指标均较治疗前无明显变化 （P > 0.05） ，且治疗后组间比 较，差异也均无统计学意义 （P > 0.05） 。 （9） 安全性方面，治疗期间，2组患者均未出现严重的药物不良反应，也未发现与药物 相关的严重不良心血管事件及相关并发症。【结论】联合心血通口服液治疗，可有效改善血瘀型ACS患者临床症状，疗效确切， 安全性好，其可能通过改善血脂、炎症以及TMAO起作用。

Objective To investigate the clinical efficacy of Xinxuetong Oral Liquid in the treatment of patients with acute coronary syndrome（ACS）. Methods A total of 80 patients with ACS of blood stasis syndrome who were hospitalized in Shunde Hospital of Guangzhou University of Chinese Medicine from January 2023 to September 2023 were randomly divided into the treatment group and control group according to random number table method， 40 patients in each group. The patients in the two groups were given conventional western medicine treatment including lifestyle guidance， percutaneous coronary intervention （PCI）， and conventional western medicine therapy. Additionally，the treatment group was treated with Xinxuetong Oral Liquid. The course of treatment for the two groups covered eight weeks. Before and after treatment the two groups were observed in the changes of traditional Chinese medicine（TCM）syndrome score， blood stasis syndrome score， angina pectoris score， blood lipid indicators， carotid ultrasonography indicators， echocardiography indicators， and serum levels of trimethylamine-N-oxide（TMAO），nitric oxide（NO），endothelin 1（ET-1），interleukin 8（IL-8），serine/ threonine - protein kinase 1（AKT-1），and vascular endothelial growth factor A（VEGF-A）. After treatment，the efficacy on TCM syndrome efficacy and the safety of the regimen in the two groups were evaluated. Results（1）During the trial，there were two cases of loss to follow-up and one case of withdrawal due to pneumonia，and eventually a total of 77 patients completed the full course of treatment，among which 39 patients were in the treatment group and 38 patients were in the control group.（2）After eight weeks of treatment， the total effective rate of the treatment group was 89.74%（35 / 39）， and that of the control group was 63.16%（24 / 38）. The intergroup comparison（tested by chi-square test）showed that the effective rate of TCM syndrome efficacy in the treatment group was significantly superior to that in the control group（P < 0.01）.（3）After treatment，the scores of TCM symptoms such as chest pain，chest distress，symptom aggravation at night，and palpitation in the two groups，as well as the score of gloomy complexion in the treatment group，were significantly decreased compared with those before treatment（P < 0.05 or P < 0.01），and the decrease of scores of chest distress，symptom aggravation at night， and palpitation in the treatment group was significantly superior to that in the control group（P < 0.05 or P < 0.01）. （4）After treatment， the blood stasis syndrome score and angina pectoris symptom score of the two groups of patients were significantly decreased compared with those before treatment（P < 0.01），and the decrease in the treatment group was significantly superior to that in the control group（P < 0.01）.（5）After treatment，the serum TMAO，ET- 1，IL-8，AKT-1，and VEGF-A levels in the two groups were significantly decreased compared with those before treatment（P < 0.01），and the serum NO level was significantly increased compared with that before treatment（P < 0.01）. The decrease of serum TMAO，ET-1，IL-8，and AKT-1，VEGF-A levels and the increase of serum NO level in the treatment group were significantly superior to those of the control group（P < 0.05 or P < 0.01）.（6）After treatment，the total cholesterol（TCHO）and low-density lipoprotein cholesterol（LDL-C） levels of the two groups（P < 0.01）and the triglyceride（TG）level of the treatment group（P < 0.05）were decreased significantly compared with those before treatment， while the high-density lipoprotein cholesterol （HDL-C）level of the treatment group was increased significantly compared with that before treatment（P < 0.01）. No obvious changes of TG and HDL-C levels before and after treatment were shown in the control group（P > 0.05）. The comparison of blood lipid indicators after treatment between groups showed that there were no statistically significant differences（P > 0.05）. （7）After treatment， the carotid ultrasonography indicators of carotid intima-media thickness（IMT）and Crouse score of the carotid plaque in the two groups were significantly improved compared with those before treatment（P < 0.01）. However，there was no statistical significance in the comparison of the two indicators between the two groups after treatment （P > 0.05）.（8）The observation of echocardiography indicators showed that only the post-treatment left ventricular diameter（LVd）of the treatment group was significantly larger than that before treatment（P < 0.05）， while no obvious changes of the other echocardiography indicators before and after treatment were shown in the two groups（P > 0.05）. The comparison between the groups after treatment also showed no statistically significant differences（P > 0.05）.（9）During the treatment， no serious drug-induced adverse reactions or drug-related severe cardiovascular events and complications occurred in the two groups. Conclusion The combination of Xinxuetong Oral Liquid with conventional western medicine treatment exerts certain efficacy and safety on improving the clinical symptoms of patients with ACS of blood stasis syndrome，and its therapeutic mechanism may be related to the improvement of blood lipid levels，inflammatory response，and TMAO level.

R259.414

广东省中医药局科研项目 （编号：20231329） ；佛山市自筹经费类科技创新项目 （编号：2220001004746） ；佛山市顺德区医学骨干人 才培养项目 （编号：202404001） ；佛山市“十四五”医学重点专科和培育专科建设项目 （编号：FSGSP145105）； 广东省医学会面上科研项目 （编号：A202301028）