赵宾江;王振中;罗惠平;郭家奎;吉海旺;王健;杨林勇;萧伟;
ZHAO Bin-jiang;WANG Zhen-zhong;LUO Hui-ping;GUO Jia-kui;JI Hai-wang;WANG Jian;YANG Lin-yong;XIAO Wei;Jiangsu Kanion Pharmaceutical Co.,Ltd.;State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process;Hubei Province Hospital of Traditional Chinese Medicine;The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine;Shanxi Provincial People' s Hospital;The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine;

• 1:江苏康缘药业股份有限公司
• 2:中药制药过程新技术国家重点实验室
• 3:湖北省中医院
• 4:天津中医药大学第二附属医院

摘要(Abstract)：

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 infarction convalescence with blood-stasis syndrome,a double-blind,randomized controlled,multi-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 ITT analysis. The neurological function deficits scale showed a decrease of 5. 17 ± 2. 60 in the treatment group,while4. 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 comprehensive curative effect by ITT,the effective rates 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,including 1 case of diarrhea in treatment group and 2 cases 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 atherosclerotic 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.

关键词(KeyWords)： 龙血通络胶囊;动脉粥样硬化性血栓性脑梗死;血瘀证;临床试验
Longxue Tongluo capsule;atherosclerotic thrombotic cerebral infarction;blood-stasis syndrome;clinical trial

Abstract:

Keywords:

基金项目(Foundation): 国家“重大新药创制”科技重大专项(2011ZX09401-014)

作者(Authors): 赵宾江;王振中;罗惠平;郭家奎;吉海旺;王健;杨林勇;萧伟;
ZHAO Bin-jiang;WANG Zhen-zhong;LUO Hui-ping;GUO Jia-kui;JI Hai-wang;WANG Jian;YANG Lin-yong;XIAO Wei;Jiangsu Kanion Pharmaceutical Co.,Ltd.;State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process;Hubei Province Hospital of Traditional Chinese Medicine;The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine;Shanxi Provincial People' s Hospital;The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine;

参考文献(References)：

• [1]中华中医药学会.中医内科常见病诊疗指南(西医疾病部分)[M].北京:中国中医药出版社,2008:260.
• [2]饶明俐.中国脑血管病防治指南[M].北京:人民卫生出版社,2007.
• [3]郑筱萸.中药新药临床研究指导原则(试行)[M].北京:中国医药科技出版社,2002:99.
• [4]国家中医药管理局脑病急症协作组.中风病诊断与疗效评定标准[J].北京中医药大学学报,1996,19(1):55.
• [5]赖世隆,郭新峰,梁伟雄,等.中风病疗效评价指标体系的初步研究[J].中国中西医结合杂志,2004(3):197.
• [6]国家食品药品监督管理局.中药新药治疗中风(脑卒中)临床试验指导原则(2012)[EB/OL].(2012-06-12).http://www.cde.org.cn/news.do?method=large Info&id=312701.
• [7]国家食品药品监督管理局审评一部临床组.中药新药治疗脑梗死临床试验关键技术问题的考虑(2010)[EB/OL].(2010-11-15).http://www.cde.org.cn/dzkw.do?method=large Page&id=311943.
• [8]Adams H P,Bendixen B H,Kappelle L J,et al.Classification of subtype of acute ischemic stroke definition for use in a multicenter clinical trial[J].Stroke,1993,24(1):35.
• [9]Bamford J,Sandercock P,Dennis M,et a1.Classification and history of clinically identifiable subtypes of cerebral infarction[J].Lancet,1991,337(8):1521.
• [10]许晓辉,许予明,谈颂,等.缺血性卒中改良的TOAST分型与OCSP分型关系的研究[J].中国实用内科杂志,2008(7):538.
• [11]中华医学会神经病学分会脑血管病学组缺血性脑卒中二级预防指南撰写组.中国缺血性脑卒中和短暂性脑缺血发作二级预防指南2010[J].中国医学前沿杂志:电子版,2011(3):84.
• [12]秦建平,林夏,潘有智,等.基于指纹图谱分析和多成分同时定量的龙血通络胶囊质量评价研究[J].中草药,2015,46(20):3028.