环磷酰胺和秋水仙碱联合应用治疗急性脑梗死患者的多中心随机对照试验

目的　评价环磷酰胺、秋水仙碱联合应用治疗急性脑梗死的有效性、安全性。方法　多中心、随机对照临床试验将 32 5例发病 72h内入院的脑梗死患者分为两组 ,对照组 16 2例 ,接受急性脑梗死的基本治疗 ;处理组 16 3例 ,接受环磷酰胺 0 .1～ 0 .2g/d、秋水仙碱 1mg/d和基本治疗 ,共 10d。两组患者分别于入院时、发病后 2周及 1、2、3个月进行改良爱丁堡 斯堪的纳维亚脑卒中量表 (MESSS)评分 ,于发病后 2周及 1、2、3个月行日常生活活动能力评分 (BI)。同时测定部分患者治疗前后血清烯醇酶 (NSE)水平。采用发病后 3个月减少的MESSS百分数和 3个月末BI评分评价疗效。结果　 (1)处理组神经功能缺损评分较对照组明显减低 (P <0 .0 5 ) ,而日常生活活动能力评分处理组显著高于对照组 (P <0 .0 5 ) ;(2 )处理组NSE治疗后下降较对照组有显著性差异 (P<0 .0 5 ) ;(3)处理组有2 2例发生副作用 (占 13.8% ) ,其中白细胞减少 7例 ,恶心 11例 ,呕吐 3例 ,腹泻 8例。对照组 5例发生副作用 ,腹泻2例 ,恶心不适 3例。结论　环磷酰胺、秋水仙碱联合应用治疗急性脑梗死患者 ,能显著减轻患者神经功能缺损 ,改善预后 ;但此疗法有一定的副作用 ,临床使用时应严密观察

Multicentric randomized controlled trial of treatment of patients with acute cerebral infarction with cyclophosphamide and colchicine

Objective To evaluate the validity and safety of combination of cyclophosphamide and colchicine in treatment of patients with acute cerebral infarction.Methods 325 patients within 72 hours after the onset of cerebral infarction were divided into control group (162 patients) and treatment group (163 patients) in a multicentric randomizcd controlled trial.The control group was given general therapy.The cyclophosphamide 0.1～0.2 g/d and the colchicine 1 mg/d were given to the treatment group for 10 days besides the general therapy. The neurofunctional deficits were evaluated with MESSS at admission, 2nd week, 4th week, 8th week and 12th week after the onset of stroke. The activity of daily living (ADL) was evaluated with Barthel Index (BI) at 2nd week,4th week, 8th week and 12th week.The serum level of enolase (NSE) was determined before and after treatment in part of the patients.Evaluation of therapeutic effectiveness was done with BI at 12th week and the decrease percentage of MESSS at 12th week.Results (1) Compared with those of the control group, the decrease in neurofunctional deficit scores in the treatment group was more obvious(P<0.05), the scores of BI were significantly increased (P<0.05). (2)The decrease in the serum level of NSE in treatment group was more obvious than that in control group (P<0.05).(3)Side effects were found in 22 patients ( 13.8%) in treatment group,including 7 patients with leukocytopenia, 11 patients with nausea, 3 patients with vomiting and 8 patients with diarrhea.Five patients had side reactions in control group,including 2 patients with diarrhea and 3 patients with nausea.Conclusions Combined therapy with cyclophosphamide and colchicine can not only reduce the neurofunctional deficits,but also improve the prognosis of the acute cerebral infarction patients. Side effects should be observed carefully when this therapy is used.