复方龙血竭胶囊治疗稳定型心绞痛随机对照多中心临床研究.PDF

·10· Chinese Journal of Information on TCM Feb.2009 Vol.16 No.2 ·论著· 复方龙血竭胶囊治疗稳定型心绞痛 随机对照多中心临床研究 1 1 1 2 3 4 5 庆 慧 ,范军铭 ,王守富 ,杜廷海 ,马春林 ,徐重白 ,王莎萍 (1.河南省中医药研究院,河南 郑州 450004；2.河南中医学院第一附属医院,河南 郑州 450004； 3.广西中医学院第一附属医院,广西 南宁 530001；4.江苏省中西医结合医院,江苏 南京 210028； 5.陕西省中医药研究院,陕西 西安 710003) 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28 d。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。 关键词：稳定型心绞痛；复方龙血竭胶囊；随机对照试验；心血瘀阻证 中图分类号：R259.414 文献标识码：A 文章编号：1005-5304(2009)02-0010-03 Randomized Controlled Trials of Compound Longxuejie Capsules for Patients with Stable Angina Pectoris QING Hui, FAN Jun-ming, WANG Shou-fu, et al (Henan Academy of Chinese Medicine, Zhengzhou 450004, China) 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