【摘要】 目的评价复方龙血竭胶囊治疗稳定型心绞痛(心血瘀阻证)的有效性和安全性。方法采用随机、双盲、阳性药平行对照、多中心临床研究,418例病例中,试验组(314例)给予口服复方龙血竭胶囊,对照组(104例)给予口服复方丹参胶囊,疗程均为28d。结果试验组心绞痛疗效和心电图疗效明显优于对照组(P<0.05);而中医证候疗效、硝酸甘油停减率比较,2组差异无统计学意义(P>0.05)。试验组没有出现严重不良事件。结论复方龙血竭胶囊在治疗稳定型心绞痛(心脉瘀阻证)方面是有效和安全的。更多还原

【Abstract】 Objective To evaluate the therapeutic effect and safety of Compound Longxuejie Capsules for treatment of stable angina pectoris with cariac blood stasis syndrome. Methods A randomized, double-blind, positive drug parallel controlled, multi-center clinical trial was adopted. 418 patients with stable angina pectoris with cariac blood stasis syndrome were randomly chosen and divided into two groups:test group (314 cases) and control group (104 cases). The test group was treated with Compound Longxuejie Capsules and the control group received Compound Danshen Capsules. Treatment course of each group was 28 days. Results The antiangina effect and changes electrocardiogram in test group were better than that of the control group (P<0.05), but was almost the same as the control group in the effective rate of TCM syndrome and the dosage reduction of glycerol trinitrate (P>0.05). The test group had no obvious side effect. Conclusion Compound Longxuejie Capsules was proved safe and effective in treating stable angina pectoris of stable angina pectoris with cariac blood stasis syndrome.更多还原