龙血通络胶囊治疗动脉粥样硬化性血栓性脑梗死恢复期血瘀证的随机、双盲、安慰剂对照、多中心临床试验

A multi-center,double-blind,placebo-controlled,randomized trial for effect of Longxue Tongluo capsule in treatment of patients of atherosclerotic thrombotic cerebral infarction with blood-stasis syndrome in convalescence

为评价龙血通络胶囊治疗动脉粥样硬化性血栓性脑梗死恢复期血瘀证患者的有效性和安全性开展临床试验。该试验采用随机、双盲、安慰剂对照、多中心临床试验设计,将160例患者随机分为2组,每组80例。全部病人在口服曲克芦丁片(3粒/次,3次/日)的基础上,试验组与对照组分别服用龙血通络胶囊及其模拟剂(2粒/次,3次/日),连服4周。试验结果经ITT分析显示,在主要疗效指标神经功能缺损程度下降值方面,试验组下降5.17±2.60,对照组下降4.31±2.31,试验组下降值明显大于对照组(P<0.05);试验组下降率为(37.2±15.8)%,对照组下降率为(29.9±15.3)%,试验组下降率明显大于对照组(P<0.05)。综合疗效ITT分析,试验组显著进步率为31.6%,对照组为13.5%,试验组明显优于对照组(P<0.05)。中医证候的ITT分析,试验组总有效率为88.2%,对照组为68.9%,试验组高于对照组(P<0.05)。试验中共发生不良事件3例,试验组出现1例,为"腹泻",对照组出现2例,分别表现为"皮肤瘙痒"、"上呼吸道感染"。说明龙血通络胶囊治疗动脉粥样硬化性血栓性脑梗死恢复期疗效确切,安全性较好,能有效改善患者神经功能缺损程度和病残情况,对中医血瘀证候也有较好的改善作用。

To evaluate the effectiveness and safety of Longxue Tongluo capsule on patients of atherosclerotic thrombotic cerebral in-farction convalescence with blood-stasis syndrome, a double-blind, randomized controlled, muhi-center clinical trial was conducted. A total of 160 eligible patients were randomly divided into treatment group and control group, with 80 patients in each group, and all of them were orally given Troxerutin pill（ three pills each time, three times daily）. Longxue Tongluo capsule was applied in the treatment group, while placebo was applied in the control group （ two capsules each time, three times daily） for 4 weeks. Main outcomes were measured by ITr analysis. The neurological function deficits scale showed a decrease of 5.17 ± 2.60 in the treatment group, while 4.31± 2.31 in the control group, with significant differences between the two groups（ P 〈 0.05 ） ; the reduction rate in the treatment group （ 37.2 ± 15.8 ） % was significantly higher than that in the control group （ 29.9 ± 15.3 ） % （ P 〈 0.05 ）. In terms of the compre- hensive curative effect by ITT, the effective rales in the treatment and control group were 31.6% and 13.5% , respectively （P 〈 0. 05 ）. With respect to the efficacy of traditional Chinese medicine syndrome by ITT, the total effective rate of the treatment group was significantly higher than the control group 88.2% vs 68.9% , P 〈0. 05. Three cases of adverse events occurred in this study, inclu- ding 1 case of diarrhea in treatment group and 2 eases of skin itch and upper respiratory infection in control group. In conclusion, Longxue Tongluo capsule is effective and safe in the treatment of patients of atherosclerotie thrombotic cerebral infarction convalescence with blood-stasis syndrome, and can effectively alleviate the patients＇ nerve function defect degree and invalidism, with a good effect on blood stasis syndrome.