Abstract:

Objective　This study aims to explore the effect of heat-clearing and dampness-drying traditional Chinese medicine (TCM) on improving coronary heart disease with blood stasis syndrome, as well as its influence on patients' gut microbiota and immune function regulation. Methods　This randomized controlled trial divided 106 patients with coronary heart disease and blood stasis syndrome, who were admitted to Affiliated Hospital of Shaanxi University of Chinese Medicine from February 2020 to July 2022, into an experimental group and a control group with the random number table method, with 53 patients in each group. The control group consisted of 31 males and 22 females, aged (58.84±7.16) years; the duration of coronary heart disease was (2.04±0.87) years; the cardiac function classification was grade Ⅱ in 32 cases and grade Ⅲ in 21 cases. The experimental group consisted of 28 males and 25 females, aged (59.23±8.82) years; the duration of coronary heart disease was (2.21±0.91) years; the cardiac function classification was grade Ⅱ in 29 cases and grade Ⅲ in 24 cases. All the patients were treated with conventional western medicine (basic treatment: betaloc 12.5 mg/time, twice a day; aspirin enteric-coated tablets 100 mg/time, once a day), and the experimental group was added with heat-clearing and dampness-drying TCM on this basis, for 4 weeks continuously. The clinical efficacy, TCM syndrome score, gut microbiota level, plasma endothelin-1 (ET-1), immune function, serum oxidative stress indicators, and incidence of adverse reactions were observed and compared between the two groups. Statistical methods included t test and χ² test. Results　After 4 weeks of treatment, the clinical effective rate of the experimental group was 92.45% (49/53), which was higher than that of the control group [77.36% (41/53)], with a statistically significant difference (χ²=4.711, P=0.030). The TCM syndrome score of the experimental group was lower than that of the control group [(16.54±2.56) points vs. (19.88±3.07) points], with a statistically significant difference (t=6.083, P<0.001). The levels of trimethylamine oxide (TMAO) and ET-1 in the experimental group were lower than those in the control group [(5.21±0.84) µmol/L vs. (6.04±1.01) µmol/L, (43.76±4.17) ng/L vs. (51.94±4.82) ng/L], but the total content of short-chain fatty acids (acetate, propionate, and butyrate) was higher than that in the control group [(24.97±2.46) µmol/g vs. (23.61±2.67) µmol/g], with statistically significant differences (t=4.600, P<0.001; t=9.344, P<0.001; t=2.727, P=0.008). After 4 weeks of treatment, the CD4⁺ and CD4⁺/CD8⁺ in the experimental group were higher than those in the control group [(44.79±4.17)% vs. (43.12±4.22)%, (1.82±0.32) vs. (1.56±0.29)], with statistically significant differences (t=2.049, P=0.043; t=4.383, P<0.001), but there was no statistically significant difference in the CD8⁺ between the two groups (P>0.05). After 4 weeks of treatment, the levels of superoxide dismutase (SOD) and total antioxidant capacity (T-AOC) in the experimental group were higher than those in the control group [(91.83±10.13) U/L vs. (84.72±9.67) U/L, (1.96±0.19) U/mg vs. (1.53±0.21) U/mg], but the MDA level was lower than that in the control group [(5.13±1.01) µmol/L vs. (7.27±1.06) µmol/L], with statistically significant differences (t=3.696, 11.054, and 10.641, all P<0.001). There was no statistically significant difference in the incidence of adverse drug reactions between the two groups during treatment (χ²=0.210, P=0.647). Conclusion　Heat-clearing and dampness-drying TCM can significantly improve the recovery effect in patients with coronary heart disease with blood stasis syndrome, regulate the balance of gut microbiota, enhance the immune function, and optimize the serum oxidative stress indicators, demonstrating good clinical application value.

Key words:

Coronary heart disease, Blood stasis syndrome, Heat-clearing and dampness-drying TCM, Gut microbiota, Immune function

摘要：

目的　探讨清热燥湿中药在改善冠心病血瘀证方面的效果，以及其对患者肠道菌群和免疫功能调节的影响。方法　本研究为随机对照试验，按照随机数字表法将2020年2月至2022年7月于陕西中医药大学附属医院就诊的106例冠心病血瘀证患者分为试验组和对照组，每组53例。对照组男性31例，女性22例，年龄（58.84±7.16）岁；冠心病病程（2.04±0.87）年；心功能分级：Ⅱ级32例、Ⅲ级21例。试验组男性28例，女性25例；年龄（59.23±8.82）岁；冠心病病程（2.21±0.91）年；心功能分级：Ⅱ级29例、Ⅲ级24例。所有患者均给予常规西医治疗（倍他乐克12.5 mg/次，2次/d；阿司匹林肠溶片100 mg/次，1次/d等），而试验组则在此基础上增加清热燥湿中药，均连续治疗4周。观察并比较两组的临床疗效、中医证候积分、肠道微生物水平、血浆内皮素-1（ET-1）、免疫功能、血清氧化应激指标以及不良反应发生率。统计学方法采用t检验、χ²检验。结果　治疗4周后，试验组患者的临床总有效率为92.45%（49/53），高于对照组的77.36%（41/53），差异有统计学意义（χ²=4.711，P=0.030）；试验组的中医证候积分低于对照组［（16.54±2.56）分比（19.88±3.07）分］，差异有统计学意义（t=6.083，P<0.001）；试验组的氧化三甲胺（TMAO）和ET-1水平均低于对照组［（5.21±0.84）µmol/L比（6.04±1.01）µmol/L、（43.76±4.17）ng/L比（51.94±4.82）ng/L］，而短链脂肪酸（乙酸、丙酸、丁酸）总含量高于对照组［（24.97±2.46）µmol/g比（23.61±2.67）µmol/g］，差异均有统计学意义（t=4.600、P<0.001，t=9.344、P<0.001，t=2.727、P=0.008）；试验组的CD4⁺、CD4⁺/CD8⁺水平均高于对照组［（44.79±4.17）%比（43.12±4.22）%、（1.82±0.32）比（1.56±0.29）］，差异均有统计学意义（t=2.049、P=0.043，t=4.383、P<0.001）；而两组CD8⁺水平比较差异无统计学意义（P>0.05）；试验组的超氧化物歧化酶（SOD）、总抗氧化能力（T-AOC）水平均高于对照组［（91.83±10.13）U/L比（84.72±9.67）U/L、（1.96±0.19）U/mg比（1.53±0.21）U/mg］，MDA水平低于对照组［（5.13±1.01）µmol/L比（7.27±1.06）µmol/L］，差异均有统计学意义（t=3.696、11.054、10.641，均P<0.001）。治疗期间，两组患者的药物不良反应发生率比较差异无统计学意义（χ²=0.210，P=0.647）。结论　清热燥湿中药能显著提高冠心病血瘀证患者的康复效果，调节肠道微生物平衡，提高免疫功能，并优化血清氧化应激指标，具有良好的临床应用价值。

关键词:

冠心病, 血瘀证, 清热燥湿, 肠道微生物, 免疫功能