低分子肝素治疗急性脑梗死的前瞻性多中心随机对照临床研究

Low Molecular Weight Heparin Treatment in Acute Cerebral Infarction

目的:评价低分子肝素治疗急性脑梗死的临床有效性与安全性。方法:前瞻性、多中心、随机叠加对照法,对856例发病48 h内的上海18家医院的急性脑梗死病者,443例接受低分子肝素+低分子右旋糖酐,413例接受低分子右旋糖酐治疗。以中国神经功能缺失评分(CSS),日常生活能力(ADL)和出血并发症、病死率为指标进行比较。结果:443例LMWH治疗和413例对照组的性别、年龄、既往史、伴发病和入组时GSS和ADL均无差异(P<0.05)。治疗第10天和第21天时,LMWH组的GSS进步与对照组相比,两者均有显著差异(P<0.01、0.05)。第21天和3个月的ADL比较,两组无差异。安全性比较显示,LMWH组并发各种出血26例(5.87％),对照组7例(1.69％);两组有差异(P<0.01);治疗组死亡6例(1.35％),对照组10例(2.42％),两组均无差异(P>0.05)。结论:低分子肝素治疗急性期脑梗死是安全的,不增加致命性出血,但有一定近期疗效。

Aim: To evaluate the efficacy and the safety of low molecular weight heparin(LMWH) in treatment of acute cerebral infarction. Methods: A prospective, multi-centers, randomized add on control design were used. A total 856 cases of acute cerebral infarction were corrected from 18 hospitals of Shanghai,443 patients were treated with 4100 unites of LMWH twice daily and 500 ml of low molecular dextran for 10 days, 413 patients were only given 500 ml of low molecular dextran for 19 days. Chinese Stroke Scoree( CCS) and Ability of Daily Life( ADL) were used as effective parameters, the hemorrhagic events and the mortality of hospitalization were used as adverse parameters. Results: The background of this two groups including sex,age,past history,accompanied disorders and CCS, ADL at entry time was no difference( P > 0.05) .The CCS improvement was significantly higher in LWMH group than that in control at days 10 ( P < 0.01) and days 21 ( P < 0.05). But ADL was not found any difference between two groups at day 21 ( P > 0.05). Neither CSS nor ADL was found any difference between this two groups at 3 months after onset of stroke. The hemorrhagic events in LMWH group (5.87%) was statistically higher than that in control ( 1.69%), P < 0.01. But the mortality of hospitolization in this two groups was( 1.35% < 2.42% respectively)no difference. Conclusion: LMWH in acute cerebral infarction is not increased the mortality, of safety and be some benefits in short period of outcome.