心悦胶囊对介入术后稳定性冠心病患者中医症状评分和hs-CRP、血脂水平影响的随机对照研究

Effect of Xinyue Capsule on Symptom Score Scale,hs-CRP and Serum Lipid Profiles in Patients with Stable Coronary Artery Disease After Percutaneous Coronary Intervention:A Randomized Controlled Trial

目的观察心悦胶囊对经皮冠状动脉介入术(PCI)后稳定性冠心病患者的中医症状、血脂及超敏C反应蛋白(hs-CRP)的作用。方法将1068例PCI术后稳定性冠心病患者随机分为药物组(534例)和安慰剂组(534例),药物组在西医常规治疗基础上加服心悦胶囊(2粒/次,1日3次),安慰剂组在西医常规治疗基础上加服同剂量安慰剂,治疗24周。评估治疗前、后中医症状评分(胸痛、胸闷、心悸、气短、疲倦乏力、自汗),检测治疗前、后hs-CRP、总胆固醇(TC)、甘油三酯(TG)、低密度脂蛋白(LDL-C)和高密度脂蛋白(HDL-C)水平。结果与本组治疗前比较,治疗24周两组胸痛、胸闷、气短评分及LDL-C水平降低,HDL-C水平升高(P<0.05,P<0.01),药物组疲倦乏力评分及hs-CRP水平降低(P<0.01)。与安慰剂组同期比较,药物组治疗24周胸闷、气短、疲倦乏力评分及hs-CRP水平降低(P<0.05,P<0.01),HDL-C水平升高(P<0.05)。结论心悦胶囊可改善PCI术后稳定性冠心病患者的胸闷、气短和疲倦乏力症状,降低hs-CRP水平,提高HDL-C水平。(研究注册编号:No.ChiCTRIPR-14005475)

Objective To evaluate the effect of Xinyue Capsule(XYC)on symptom score scale,high sensitivity C-reactive protein(hs-CRP)and serum lipid profiles in patients with stable coronary artery disease after percutaneous coronary intervention(PCI).Methods Totally 1068 participants were recruited and randomly assigned to XYC group(534 cases)and placebo group(534 cases).On basis of conventional drug therapy,patients in XYC group were treated with XYC(2 capsules once,thrice daily),and patients in placebo group were treated with the same dose of placebo,the treatment course was 24 weeks.Symptom score scale(chest pain,chest distress,palpitation,short of breathe,tiredness and spontaneous sweating)was assessed,hs-CRP,total cholesterol(TC),triacylglycerol(TG),low-density lipoprotein cholesterol(LDL-C)and high-denstity lipoprotein cholesterol(HDL-C)were tested before and after treatment.Results Compared with before treatment in the same group,chest pain,chest distress,short of breathe score and LDL-C level decreased,HDL-C level increased after treatment in both groups(P<0.05,P<0.01),tiredness score and hsCRP level decreased after treatment in XYC group(P<0.05).Compared with placebo group in the same time,chest distress,short of breathe,tiredness score and hs-CRP level decreased(P<0.05,P<0.01),HDL-C level increased after treatment in XYC group(P<0.05).Conclusion XYC is effective in relieving symptoms of chest distress,short of breathe,tiredness,reducing hs-CRP level,and increasing HDL-C level in patients with stable coronary artery disease after PCI.(Study registration number:No.ChiCTR-IPR-14005475)