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目的观察稳斑汤辅助治疗急性冠状动脉综合征(ACS)痰浊血瘀证患者的疗效及可能的作用机制。方法选取ACS痰浊血瘀证患者180例随机分为对照组和治疗组各90例,另选择健康志愿者40例作为正常组。对照组予经皮冠状动脉介入术及常规西药治疗,治疗组在此基础上联合中药稳斑汤口服,每日1剂,两组均治疗1个月。采用甲基化特异性PCR法检测正常组及两组患者治疗前后血浆血栓调节蛋白(TM)基因启动子甲基化水平,并观察治疗前后对照组及治疗组患者中医证候积分变化与临床疗效。结果两组患者TM基因启动子甲基化率为45.0%(81/180),显著高于正常组的17.5%(7/40)(P<0.05)。治疗后治疗组与对照组TM基因启动子甲基化率及中医证候积分均较本组治疗前显著降低,且治疗组均显著低于对照组(P<0.05)。治疗组临床疗效总有效率为91.11%,显著高于对照组的77.78%(P<0.05)。结论稳斑汤辅助西医治疗可显著降低ACS痰浊血瘀证患者中医证候积分,临床疗效优于单纯西医治疗,其作用机制可能与降低患者TM基因启动子甲基化水平有关。
Objective To observe the efficacy and possible mechanism of Wenban Decoction in the treatment of patients with phlegm and blood stasis syndrome of acute coronary syndrome (ACS). Methods One hundred and eighty ACS patients with phlegm and blood stasis syndrome were randomly divided into control group and treatment group with 90 cases each, and another 40 healthy volunteers were selected as normal group. The control group was treated with percutaneous coronary intervention and routine western medicine. On the basis of the above, the treatment group was orally administered with Chinese herbal medicine Wenban Decoction orally daily for 1 month. Both groups were treated for 1 month. The methylation level of plasma thrombomodulin (TM) gene promoter in normal group and two groups before and after treatment was detected by methylation-specific PCR and the changes of TCM syndrome score and clinical efficacy in control group and treatment group before and after treatment were observed . Results The promoter methylation rate of TM gene was 45.0% (81/180) in both groups, which was significantly higher than that in normal group (17.5%, 7/40) (P <0.05). After treatment, the promoter methylation rates and TCM syndrome scores of TM gene in treatment group and control group were significantly lower than those before treatment, and the treatment group were significantly lower than the control group (P <0.05). The total effective rate of the treatment group was 91.11%, which was significantly higher than that of the control group (77.78%, P <0.05). Conclusion Wenban decoction can help to reduce TCM syndrome score in ACS patients with phlegm and blood stasis syndrome. The clinical curative effect is better than that of western medicine alone. The possible mechanism may be related to the decrease of TM gene promoter methylation level.