化瘀复元胶囊联合尼可地尔干预冠状动脉慢血流的临床研究

Clinical study on the intervention of Huayu Fuyuan Capsule combined with nicorandil in coronary slow flow

目的:观察化瘀复元胶囊联合尼可地尔治疗冠状动脉慢血流(coronary slow flow,CSF)慢血流的临床效果。方法:将符合CSF诊断的临床患者随机分为对照组(尼可地尔+常规西医治疗)和观察组(在对照组的基础上联合使用化瘀复元胶囊),疗程为12周。比较两组治疗前后凝血指标:凝血酶原时间、国际标准化比值;肝功能:AST、ALT;肾功能:血尿素氮、肌酐;疗效性指标:高敏C反应蛋白(high-sensitivity C-reactive protein,hs-CRP)、IL-6、胆固醇(cholesterol,CHOL)、低密度脂蛋白(low-density lipoprotein,LDL)、三酰甘油(triglycerides,TG);心绞痛改善情况(seattle angina questionnaire,SAQ标准积分)、中医证候疗效的变化。结果:两组治疗前后凝血指标、肝功能、肾功能比较差异均无统计学意义(均P>0.05)。两组治疗后hs-CRP、IL-6、血脂水平较治疗前明显下降(P<0.05);且治疗后两组hs-CRP、IL-6、CHOL、LDL、TG水平比较差异均有统计学意义(均P<0.05)。观察组西雅图心绞痛量表标准积分、中医证候疗效优于对照组(P<0.05)。结论:化瘀复元胶囊联合尼可地尔治疗CSF安全有效,能改善临床症状,提高生活质量,其机制可能与抑制炎症反应有关。

Objective:To observe the clinical efficacy of Huayu Fuyuan Capsule combined with nicorandil in the treatment of coronary slow flow(CSF).Methods:Patients with CSF diagnosis were randomly divided into the control group(treated with nicorandil and conventional western medicine)and the obversation group(treated with Huayu Fuyuan Capsules in combination on the basis of the control group).The course of treatment was 12 weeks.To compare the coagulation indicators:prothrombin time,International normalized ratio;liver function:AST,ALT;kidney function:blood urea nitrogen,creatinine;efficacy indicators:high-sensitivity C-reactive protein(hs-CRP),IL-6,cholesterol(CHOL),low-density lipoprotein(LDL),triglycerides(TG);improvement of angina pectoris seattle angina questionnaire(SAQ)standard score and efficacy of traditional Chinese medicine syndromes between two groups before and after treatment.Results:Compared with the before and after treatment in two groups,there was no statistically significant difference in coagulation indicators and liver and kidney function(all P>0.05).After treatment in two groups,hs-CRP,IL-6,the blood lipid level decreased,and there was a statistically significant difference within the group comparison(P<0.05).Comparison between groups,after treatment,the levels of hs-CRP,IL-6,CHOL,LDL,and TG in the treatment group were significantly lower than those in the control group(P<0.05).Comparison of the Seattle Angina Pectoris Scale standard scores and traditional Chinese Medicine syndrome efficacy between the two groups,the obversation group was better than the control group(P<0.05).Conclusions:Huayu Fuyuan Capsule combined with nicorandil in the treatment of CSF is safe and effective.It can improve clinical symptoms and the quality of life.The mechanism may be related to inhibiting the inflammatory response.