振源胶囊治疗气阴两虚证稳定型心绞痛合并糖脂代谢异常的多中心、随机、双盲、安慰剂平行对照临床研究

Zhenyuan Capsules( 振源胶囊) in the Treatment of Stable Angina with Abnormal Glucolipid Metabolism Patients of Deficiency of Both Qi and Yin Type: A Multicentered,Randomized,Double-blind,Placebocontrolled Clinical Trial

目的观察振源胶囊治疗气阴两虚证稳定型心绞痛合并糖脂代谢异常患者的有效性和安全性。方法采用多中心、随机、双盲、安慰剂对照设计,收集200例气阴两虚证稳定型心绞痛合并糖脂代谢异常患者随机分为试验组100例和对照组100例。在西医常规治疗基础上,试验组和对照组患者分别服用振源胶囊和安慰剂,每次500mg,每日3次,两组疗程均为12周。观察两组患者治疗前后血糖、血脂代谢水平[包括糖化血红蛋白(HbA1c)、空腹血糖(FBG)、餐后2小时血糖(2h PPG)及甘油三酯(TG)]、心绞痛症状积分、中医症状积分及西雅图心绞痛量表(SAQ)评分,并评价两组患者心绞痛症状疗效、中医证候疗效及安全性。结果共有188例受试者完成本试验,其中试验组96例、对照组92例。与治疗前比较,试验组和对照组治疗后HbA1c、2h PPG、FBG及TG均显著降低(P<0.05),心绞痛症状积分及中医证候积分显著降低(P<0.01),SAQ评分显著升高(P<0.01)。与对照组比较,试验组治疗后HbA1c及FBG均显著降低(P<0.05),心绞痛症状积分及中医证候积分显著降低(P<0.01),心绞痛症状疗效及中医证候疗效显著升高(P<0.01),SAQ评分显著升高(P<0.01);两组2h PPG及TG水平有下降趋势,但无统计学意义(P>0.05)。试验组有心肌梗死史者的心绞痛症状疗效、中医证候疗效均优于无心肌梗死史者(P<0.05)及SAQ评分的疗效均优于无心肌梗死史者(P<0.01)。治疗过程中未发生不良反应。结论振源胶囊可改善气阴两虚证稳定型心绞痛合并糖脂代谢异常患者的糖脂代谢和心绞痛症状,尤其对有心肌梗死病史的患者疗效更佳,且无明显不良反应。

Objective To observe effectiveness and safety of Zhenyuan Capsules(振源胶囊, ZYC) in the treatment of stable angina(SA) with abnormal glycolipid metabolism patients of deficiency of both qi and yin type. Methods A multicentered, randomized, double-blind, placebo-controlled design was applied. A total of 200 SA patients with abnormal glycolipid metabolism of deficiency of both qi and yin were randomized to test group(100 cases) and control group(100 cases). On the basis of conventional treatment in western medicine, the patients in the test group and control group were given ZYC or placebo 500 mg each time respectively, three times a day for 12 weeks. Levels of blood glucose metabolism and blood lipid metabolism including glycosylated hemoglobin(HbA1 c), fasting blood glucose(FBG), 2 h postprandial glucose(2 h PPG), and triglyceride(TG), and the score of angina symptoms, the score of traditional Chinese medicine(TCM) symptoms, as well as the score of Seattle angina questionnaire(SAQ) of both groups before and after the treatment were observed. The efficacy for angina symptoms, TCM syndrome efficacy and safety both groups were evaluated. Results A total of 188 patients finally completed this trial, including 96 cases in the test group and 92 cases in the control group. HbA1 c, 2 h PPG, FBG and TG in test groups were significantly decreased after the treatment(P<0.05). The angina symptom scores and the TCM syndrome scores were also significantly decreased(P<0.01), and the scores of SAQ were significantly increased(P<0.01) after treatment. Compared with the control group, HbA1 c and FBG were significantly decreased in the test group after the treatment(P<0.05);angina symptom score and the TCM syndrome score were significantly decreased(P<0.01), the efficacy for angina symptoms and the efficacy for TCM syndromes were significantly increased(P<0.01);and the score of SAQ was significantly increased(P<0.01). The levels of 2 h PPG and TG showed a declining trend in both groups, but there is no statistical significance(P>0.05). The efficacy for angina symptoms, TCM syndromes(P<0.05), and SAQ scores(P<0.01) in patients with history of myocardial infarction(MI) in the test group was better than those in patients without history of MI. No adverse reactions occurred during the treatment. Conclusion ZYC can improve symptoms of glycolipid metabolism and angina in SA patients with abnormal glycolipid metabolism of deficiency of both qi and yin type, especially for the patients with a history of MI, the treatment didn′t show adverse reactions.