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碟脉灵注射液治疗缺血性中风的随机对照临床研究
The randomizational control clinic study of Diemailing Injection treating ischemic apoplexy
【作者】 张伯礼; 王玉来; 高颖; 高利; 崔旦旦; 毛秉豫; 李涛; 胡学军; 林培政;
【Author】 ZHANG Bo-li~1,WANG Yu-lai~2,GAO Ying~3,et al (1.Tianjin University of TCM,Tianjin 300193,China;2.Beijing University of TCM,Beijing 100029,China; 3.The Affiliated Dongzhimen Hospital of Beijing University of TCM,Beijing 100700,China)
【机构】 天津中医药大学; 北京中医药大学; 北京中医药大学附属东直门医院; 首都医科大学宣武医院; 江苏省常州市第一人民医院; 河南省南阳市中心医院; 中国中医研究院西苑医院; 湖南省中医药研究院附属医院; 广州中医药大学第一附属医院;
【摘要】 [目的]评价以碟脉灵注射液治疗为主的通治方案对缺血性中风急性期的治疗作用。[方法]153例患者均经头颅计算机断扫描(CT)或磁共振扫描(MRI)确诊为脑梗死,依据随机化方案分组,进行随机方案的隐藏,开展随机对照研究。在内科基础治疗和规范护理康复的基础上,1)通治组(碟脉灵组)44例,予碟脉灵注射液静点。2)辨治组55例,予辨证论治口服汤药。3)西医组54例,治疗方法参照2000年广州全国脑血管病专题研讨会通过的"脑卒中的分型分期治疗建议(草案)"进行治疗。在入院当日、发病3、14、28 d和3个月随访时,对患者的神经功能和日常生活活动能力进行多时点的动态观察,根据美国国立卫生研究部卒中量表(NIHSS)分值的变化,参照1995年第四届全国脑血管病学术会议通过的关于卒中患者神经功能缺损程度的疗效评价方法,评价疗效。[结果]发病14 d时,碟脉灵组、辨治组和西医组的有效率分别为71.4%、66%和54%,碟脉灵组的疗效优于西医组。研究中未发现与使用药物有关的不良反应。[结论]碟脉灵注射液能明显改善缺血性中风急性期患者的神经功能。
【Abstract】 [Objective]To study the therapeutical effects on ischemic apoplexy at acute stage with uniform therapeutic scheme consisting of Diemailing Injection mainly.[Methods]One hundred and fifty-three cases of cerebral infarction definitely diagnosed by skull CT or MRI were randomly divided into groups.Concealment of random plan emphasized,random control studies of the uniform therapeutic one were made.Based on internal fundamental treatment,standard nurse and rehabilitation training,1 )44 cases in the uniform treatment group,which was Diemailing Injection group,were treated with Die Mai Ling by iv gtt;2)255 cases in the differentiation treatment group,treatment by differentiating syndrome(TDS) with decoction for oral use;3)354 cases in western medicinal treatment group were treated in accordance with the protocol of treatment of cerebral apoplexy by typing and staging,which was passed by nationwide seminar on cerebrovascular disease,2000,Guangzhou.in the western medicinal treatment group.The course of treatment was 28 days,followe-up once 3 months after onset.Neurologic functions and activities of daily living of the patients were observed dynamically at different phase points of 3,14,28 days and 3 months after hospital admission or onset.Curative effects were evaluated according to curative effect evaluation method of neurologic impairment of apoplexy patients,passed by the fourth nationwide academic conference on cerebrovascular disease, 1995,as well as NIHHS.[Result]As for the study of parallel comparison of three therapeutic schemes,effective rates of Diemailing Injection treatment group,differentiation treatment group and western medicinal treatment one were 71.4%,66% and 54%respectively at the phase point of 14 days after onset,indicating that curative effect of Diemailing Injection treatment group was better than that of western medicinal treatment one.There were no adverse effects resulting from using drugs in the research.[Conclusion]Diemailing Injection can obviously improve neurologic functions of the patients suffering from ischemic apoplexy at acute stage.
【Key words】 cerebral ischemic stroke; Diemailing Injection; randomizational control study;
- 【会议录名称】 中华中医药学会老年神经病专题学术研讨会论文专辑
- 【会议名称】中华中医药学会老年神经病专题学术研讨会
- 【会议时间】2006-04
- 【会议地点】中国天津
- 【分类号】R255.2
- 【主办单位】中华中医药学会脑病分会、天津中医药大学