Sun Haixin, Liu Hongmei, Li Di, Liu Liping, Yang Jun, Wang Wenzhi
Department of Neuroepidemiology, Beijing Neurosurgical Institute, Capital Medical University, Beijing, China.
Neurol Res. 2010 May;32(4):371-7. doi: 10.1179/016164110X12670144526147.
To evaluate and compare the curative effect between the minimally invasive craniopuncture combined with urokinase infusion therapy and the clearance of hematoma by craniotomy with small bone flap in treating patients with 30-80 ml hemorrhage in the basal ganglion part of the brain.
A multicenter, randomized control clinical trial was undertaken; it comprised of 22 hospitals in China. Three hundred and four patients with hemorrhage in the basal ganglion were randomly assigned to receive the craniopuncture combined with urokinase infusion therapy (n=159) or clearance of hematoma by craniotomy with small bone flap treatment (n=145). The main indexes of evaluation were the neurological impairment degree at day 14 after treatment, activities of daily living at day 90 and the case fatality by 90 days.
The main results were as follows: (1) there was a significant difference in favorable outcomes (Barthel index >or=95) between the two groups (chi(2)=3.95, p<0.05), which showed a better prognosis in the craniopuncture group, although there was no significant difference in improving the neurological functions and activities of daily living at day 90; (2) there was a remarkable decrease in case fatality by 90 days in the cranipuncture group, with statistically significant difference between the two groups (chi(2)=5.35, p=0.02); (3) the re-bleeding rate in cranipuncture group was 8.8%, significantly (chi(2)=9.51, p=0.002) lower than 21.4% in the craniotomy group.
The craniopuncture combined with urokinase infusion therapy could reduce the rate of re-bleeding after surgery and the case fatality by 90 days. It also could improve the activities of daily living (Barthel index >or=95) at day 90. Thus, this therapy was a safe and practical technique in treating cerebral hemorrhage (30-80 ml), especially suitable for hospitals in rural areas or developing countries.
评估并比较微创颅骨穿刺联合尿激酶注入疗法与小骨瓣开颅血肿清除术治疗基底节区脑出血30 - 80 ml患者的疗效。
进行一项多中心随机对照临床试验,该试验由中国22家医院参与。304例基底节区出血患者被随机分为接受颅骨穿刺联合尿激酶注入疗法组(n = 159)或小骨瓣开颅血肿清除术治疗组(n = 145)。主要评估指标为治疗后14天的神经功能缺损程度、90天的日常生活活动能力及90天内的病死率。
主要结果如下:(1)两组间良好预后(Barthel指数≥95)存在显著差异(χ² = 3.95,p < 0.05),尽管90天时两组在改善神经功能和日常生活活动能力方面无显著差异,但颅骨穿刺组预后更好;(2)颅骨穿刺组90天病死率显著降低,两组间差异有统计学意义(χ² = 5.35,p = 0.02);(3)颅骨穿刺组再出血率为8.8%,显著低于开颅手术组的21.4%(χ² = 9.51,p = 0.002)。
颅骨穿刺联合尿激酶注入疗法可降低术后再出血率及90天病死率,还可改善90天时的日常生活活动能力(Barthel指数≥95)。因此,该疗法是治疗脑出血(30 - 80 ml)安全实用的技术,尤其适用于农村地区或发展中国家的医院。