微创穿刺术治疗基底节区脑出血临床随机对照研究

A randomized clinical control study on minimally invasive paracentesis in basal ganglion region cerebral hemorrhage

目的评价比较微创穿刺血肿粉碎清除术与内科保守治疗两种方法治疗基底节区脑出血(25～40m l)的疗效异同。方法采用多中心、随机对照试验的方法,42个参研医院共随机入选465例基底节区脑出血患者,根据纳入与排除标准共排除88例,其中资料不全者16例;不符合入选标准者72例,分别为Glasgow评分≤8分(64例)、术前出血量>40m l(7例)、从发病到达急诊室时间>72h(1例)。评价治疗14d时两组患者神经功能缺损程度和日常生活活动能力、治疗3个月时的日常生活活动能力以及3个月和住院期间病死率。结果最终符合入组标准的病例数为377例,其中微创治疗组195例,对照组182例。微创治疗组患者于治疗14d时,神经功能改善明显优于对照组(χ2=7.931,P=0.02);治疗3个月时达良好功能状态的患者比例明显多于对照组(35.91%vs21.82%;χ2=8.294P=0.004)。微创治疗组病,残率明显低于对照组(40.88%vs63.03%,χ2=16.948,P<0.01);两组病死率间差异无显著性意义(6.67%vs8.79%)。结论与单纯内科保守治疗相比,应用微创穿刺血肿粉碎清除术治疗基底节区小血肿不增加病死率,并可明显提高脑出血患者的日常生活活动能力,降低病残率。

Objective To evaluate the different effects between the minimally invasive paracentesis and conservative treatment in patients with hemorrhage in basal ganglion region of brain. Methods A multi-center, randomized case-control study including 465 cases of hemorrhage in the basal ganglion of the brain randomly selected from 42 hospitals were enrolled. According to the enrollment and the exclusion standard, 88 cases were excluded due to uncomplete medical records (16 cases), Glasgow score ≤ 8 (64 cases), preoperational hemorrhage > 40 ml (7 cases), duration from onset to emergency department > 72 h (1 case). The main indexes of evaluation were the neurological impairment degree at 14 th day after treatment, activities of daily life (ADL) at the end of the 3 rd month after treatment, and the fatality during 3 months. Results A total of 377 patients with intracerebral hemorrhage were satisfying the enrollment standard and randomly divided into minimally invasive paracentesis treatment group (n = 195) and conservative treatment (control) group (n = 182). This study revealed: (1) At the 14 th day after treatment, the neurofunction improvement in the minimally invasive treatment group was significantly superior to that in the control group (χ2 = 7.931, P = 0.02); (2) At the end of the 3 rd month after treatment, there was a significant difference in the proportion of patients with favorable functional outcome between the two groups (35.91% vs 21.82%, χ2 = 8.294, P = 0.004); (3) The disability rate in the minimally invasive paracentesis group was significantly lower than that in control group (40.88% vs 63.03%, χ2 = 16.948, P < 0.01) at the end of the 3 rd month after treatment; (4) There was no significant difference in fatality rate between the two groups (6.67% vs 8.79%) during 3 months in treatment. Conclusion As compared with the conservative treatment, the minimally invasive paracentesis technique can remarkably improve the ADL of patients with 25-40 ml hemorrhage in the basal ganglion, and decrease disability without increasing fatality.