急性期脑梗死静脉溶栓治疗的有效性评价

The efficacy and safety of thrombolysis in acute cerebral infarction in shanghai

目的探索静脉溶栓时间窗扩大到6h的有效性及安全性;分析影响静脉溶栓预后的相关因素、溶栓后颅内出血特别是症状性颅内出血的相关因素。方法回顾性分析1996年9月至2006年9月上海地区所有溶栓患者的数据,评价溶栓的时间、rt-PA使用剂量、溶栓后24h的美国国立卫生院神经功能缺损评分(NIHSS评分)、溶栓后3个月的NIHSS评分、(modified rankin scale,mRS)改良Rankin量表及Barthel指数(barthel index,BI)等数据,并以NINDS研究中的安慰剂对照组作为本研究的对照组,采用卡方检验的方法分析治疗组和对照组在安全性及有效性方面的差别,对影响溶栓治疗的有效性及安全性的因素分析采用二分类logistics多因素分析的方法。结果溶栓治疗有助于改善急性脑梗死的预后,溶栓后24h治疗组NIHSS即得到改善的患者达到57.8%,高于对照组的39.1%(P=0.001)。溶栓治疗同样可改善患者溶栓后3个月的NIHSS、mRS及BI(P<0.05)。另外溶栓可增加患者症状性颅内出血的发生率,但是不增加患者的总体死亡率。多元回归分析,发现仅TOAST分型与SICH的发生相关,其中心源性栓塞发生SICH的危险性要高于其他类别的卒中。结论本组数据表明卒中后6h内溶栓治疗是相对有效且安全的治疗方法,溶栓后24h症状改善越多,溶栓后3个月预后越好,心源性栓塞发生症状性颅内出血的危险较高,在选择溶栓患者时需慎重。

Objective To identify the efficacy of intravenous thrombolysis within 6 hours after the stroke onset; analyze the factors which can effect the outcome; to acquire the data of the intracerebral hemorrhage especially SICH; find out the possible risk factors of SICH.Methods Retrospectively analyze the data of all the patients who had taken thrombolysis therapy during Sep. 1996 to Sep. 2006 in Shanghai,collect the data of age,sex,weight,time from onset to treatment,blood pressure before ad mission and thrombolysis,the dosage of rt-PA,the ischemic change of cerebral CT before thrombolysis,the NIHSS of the patients before and after thrombolysis even 24 hours after the thrombolytic therapy,TOAST,antiplatelet agent and anticoagulation agent taken which followed thrombolytic therapy,the follow up of NIHSS,mRS and BI 90 days after the thrombolytic therapy.We choose the placebo group in NINDSrt-PA stroke study as control.Chi-square Test was used to compare the differences of the efficacy and safety between the treatment group and the placebo group. Multivariable logistic regression was used to determine the characteristics which exist on the outcome and intracerebral hemorrhage risk.Results Trombolysis is beneficial for the outcome of acute ischemic stroke.57.8% patients of the treatment group got early improvement,higher than the control group,and thrombolysis is trend to acquire more favorable outcome 90 days after onset. Early improvement is a predict marker of good outcome in 3 month after onset in the multivariable logistic regression model.Thrombolysis increased the risk of intracerebral hemorrhage compared with the placebo,but there was no difference of mortality between the two group.The stroke subtype of TOAST was a predict marker of SICH （symptomatic intracerebral hemorrhage）,patients who belonged to cardioembolic is more likely to suffer from SICH.Conclusions Trombolysis is efficacious and safe.The more early improvement the patients get,the more favourable outcome one will acquire at day 90.As cardioemoblic is a risk factor of SICH,it is important for us to be careful when thrombolysis is given to the patients of such stroke subtype.