瓜蒌皮注射液联合西药治疗痰瘀互结冠心病心绞痛随机平行对照研究

Gualoupi Injection combined with Western Medicine Treatment in Stable Angina Pectoris with Phlegmstasis Syndrome Random Parallel Control Study

[目的]观察瓜蒌皮注射液联合西药治疗痰瘀互结冠心病心绞痛疗效。[方法]使用随机平行对照方法,将58例住院患者按病案号抽签方法简单随机分为两组。对照组28例阿司匹林肠溶片100mg/次,1次/d,口服;阿托伐他汀20mg/次,每晚口服;单硝酸异山梨酯缓释20mg/次,2次/d,口服。治疗组30例以瓜蒌皮注射液8m L+5%的葡萄糖注射液(糖尿病+0.9%生理盐水)100m L,1次/d,静滴;西药治疗同对照组。治疗10d为1疗程。观测临床症状、体征、证候积分、心电图、同型半胱氨酸、不良反应。治疗1疗程(10d),判定疗效。随访1个月,观测不良事件。[结果]治疗组显效15例,有效13例,无效2例,加重0例,总有效率93.33%;对照组显效7例,有效13例,无效8例,加重0例,总有效率71.43%;治疗组疗效优于对照组(P<0.05)。心电图改善治疗组优于对照组(P<0.05)。中医证候积分、血浆同型半胱氨酸治疗组明显改善(P<0.05,P<0.01),治疗组改善优于对照组(P<0.05,P<0.01)。[结论]瓜蒌皮注射液联合西药治疗痰瘀互结冠心病心绞痛随机平行对照研究,疗效满意,无严重不良反应,值得推广。

[Objective] Observation of Gualoupi injection combined with western medicine treatment of phlegm- stasis of coronary heart disease with angina pectoris. [Methods] 58 patients with phlegm-stasis syndrome of coronary heart disease at according to the pathography draw using a randomized parallel control method into two groups randomly, 30 patients for observation group,and 28 patients for control group.The two group patients were given the Aspirin 1013 mg Qd, Atorvastatin 20mg Qn; Isosorbide mononitrate 20mg Bid.The treatment group was treated with gualoupi injection of Glucose Injection 8 mL＋5% （diabetes ＋0.9% saline） 100 mL, Qd, intravenous drip. Treatment with 10d for 1 courses. Observation of clinical symptoms, signs, syndrome points, ECG, homocysteine, adverse reactions. Treatment of 1 courses of treatment （10d）, determine the efficacy. Observation of cardiovascular events, sudden death, myocardial infarction, cardiac shock, recurrent myocardial ischemia, liver dysfunction, renal dysfunction, fever, rash, stroke or TIA, etc at follow up for 1 months. [Results] The treatment group, 15 cases were markedly effective, 13 cases were effective, 2 cases were ineffective, 0 cases were aggravated, the total effective rate was 93.33% vs the control group, 7 cases were markedly effective, 13 cases were effective, 8 cases were ineffective, 0 cases were aggravated, and the total effective rate was 71.43%. The curative effect of the treatment group was better than that of the control group （P〈0.05）. ECG improvement in treatment group than in the control group （P〈0.05）. TCM syndrome integral and plasma homocysteine treatment group was significantly improved （P〈0.05, P〈0.01）. [Conclusion] Gualoupi injection combined with western medicine in the treatment of Phlegm-stasis Syndrome of coronary heart disease angina pectoris curative effect is satisfactory, no serious adverse reactions, worthy of promotion.