微创血肿清除术治疗基底节区中量脑出血随机对照研究
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摘要
目的:比较颅内血肿微创穿刺粉碎清除术和内科保守治疗两种不同方法治疗基底节区中等量(25~40ml)自发性脑出血的临床疗效。
     方法:本研究是卫生部课题“微创清除技术治疗颅内血肿效果及效益再评价研究”(多中心随机对照临床研究)中的一部分。病人被随机分入内科保守治疗组(简称内科组)或颅内血肿微创穿刺粉碎清除术组(简称微创组)进行治疗。评价其治疗后第14天时斯堪的纳维亚卒中量表评分,第14与90天时改良Rankin量表评分,以及第90天时Barthel指数评分、再出血率和病死率。
     结果:共29例病人入选,其中微创组15例,内科组14例。治疗后第14天时两组斯堪的纳维亚卒中量表评分和改良Rankin量表评分无显著差异(P>0.05)。治疗后第90天时改良Rankin量表评分和Barthel指数评分,微创组明显好于内科组(P<0.05);以Barthel指数评分≤60分为明显依赖生存的标准,微创组的明显依赖生存率低于内科组(0 vs.41.7%,P=0.012)。治疗后第90天时两组再出血率(6.7% vs.7.1%,P=1.000)、病死率(6.7% vs.14.3%,P=0.598)均无显著差别。
     结论:与单纯内科保守治疗相比,颅内血肿微创穿刺粉碎清除术治疗基底节区中等量(25~40ml)自发性脑出血,可以明显提高患者的日常生活活动能力,降低明显依赖生存率,且不增加再出血率和病死率,是一项安全而有效的治疗方法。
Objective: To compare the clinical effect of the mini-invasive aspiration with conservative medical treatment in treating patients with 25~40ml spontaneous basal ganglia intracerebral hemorrhage.Methods: The study was a part of "the research of evaluating the clinical effect and cost of hospitalization in treating intracerebral hematoma with mini-invasive aspiration", which was a multi-center, randomized controlled research subject of Ministry of Health. Patients were randomly divided into "Aspiration group" and "Conservative group". The Scandinavian Stroke Scale (SSS) score in the 14th day, modified Rankin Scale (MRS) score in the 14~th and 90~th day, Barthel Index (BI) score, the rebleeding rate and mortality in the 90th day were used as the evaluating parameters.Results: Twenty-nine patients were involved in the study, 15 of them in Aspiration group and 14 of them in Conservative group. There was no significant difference between the two groups about the SSS score and MRS score in the 14~th day (P>0.05). In the 90th day after the therapy, the Aspiration group showed a remarkable improvement in MRS score and BI score (P<0.05). Taking the BI score < 60 as a remark of significant life dependency, the outcome of the Aspiration group were much better than that of Conservative group at the end of the study (0 vs. 41.7%, P=0.012). In the 90~th day of the study, no significant difference between the two groups in the rebleeding rate (6.7% vs.7.1%, P=1.000) and mortality (6.7% vs. 14.3%, P=0.598) was found.Conclusions: Compared with conservative therapy in treating 25~40ml spontaneous basal ganglia intracerebral hemorrhage, the mini-invasive aspiration therapy remarkably improved the patients' activities of daily life, decreased their dependency rate, indicating that the mini-invasive aspiration is a safe and effective method.
引文
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