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目的:采用随机、双盲、阳性药平行对照临床试验,观察复方单硝酸异山梨酯缓释片(复单硝)治疗冠心病心绞痛在我院试验中心的有效性和安全性。方法与结果:43例符合入选条件的冠心病心绞痛病人,随机口服复单硝,臣功再佳和阿司匹林,两组药物试验分别为复单硝23例,臣功再佳20例。两种药物治疗心绞痛的有效率分别为100%(23/23)和90%(18/20);治疗心电图的有效率分别为69.56%(16/23)和65%(13/20)。所有服药的病人均未见严重的不良反应和并发症。结论:复单硝和臣功再佳治疗冠心病心绞痛有同样的疗效,且无严重不良反应。
OBJECTIVE: To evaluate the safety and efficacy of a compound randomized, double-blind, positive-phase, parallel-controlled clinical trial of isosorbide mononitrate sustained release tablets (mononitrate) in the treatment of coronary heart disease in our trial center. Methods and Results: Forty-three patients with angina pectoris were enrolled in this study. Randomized single-dose nitrite was administered orally, followed by meritorious service and aspirin. There were 23 cases of single-drug and 20 cases of superior merit. The efficacy rates of the two drugs in the treatment of angina were 100% (23/23) and 90% (18/20), respectively. The effective rates for the treatment of ECG were 69.56% (16/23) and 65% (13/20), respectively. None of the patients taking the medication experienced serious adverse reactions and complications. CONCLUSIONS: The single curative effect of Mononitrate and Chen Gong on the treatment of angina pectoris has the same effect with no serious adverse reactions.