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_临床医学论文.docVIP

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_临床医学论文 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_临床医学论文 作者：庆慧,范军铭,王守富,杜廷海,马春林,徐重白,王莎萍 【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 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. 　　Key words：stable angina pectoris；Compound Longxuejie Capsules；randomized controlled trials；cariac blood stasis syndrome 冠心病心绞痛是由于冠状动脉粥样硬化和冠状动脉功能性改变(痉挛)而引起的发作性胸痛或以胸部不适为主要临床表现的临床综合征。稳定型心绞痛是指冠心病患者在劳累、运动或情绪激动时,加重心绞痛发作,而在休息和硝酸甘油等治疗后缓解,且这种情况一般在大于3个月内不变。该病是心血管疾病研究中的重点和难点,而中医药在预防和治疗稳定型心绞痛方面已取得了很大的进展。本研究根据国家食品药品监督管理局新药临床研究批件(第2004ZL04482号文)及其相关法规,由国家药物临床试验机构河南省中医药研究院等5家单位,对中药、天然药物6类新药制剂——复方龙血竭胶囊进行了治疗稳定型心绞痛(心血瘀阻证)多中心临床研究,并与复方丹参胶囊进行随机、双盲对照,以评价复方龙血竭胶囊的临床疗效和安全性。现报道如下。 　　1 临床资料 　　1.1 一般资料 入组418例患者均为2006年1月－2006年9月间在河南省中