软、硬通道微创手术治疗幕上高血压脑出血的对比分析

Randomised trial of soft-channel minimally invasive operation versus hard-channel minimally invasive operation for supratentorial hypertensive intracerebral hemorrhage

目的对比软通道及硬通道微创手术治疗幕上高血压脑出血的疗效、安全性及手术时间。方法2008年10月1日至2011年10月1日,在南方医院神经外科收治的80例首次幕上高血压脑出血患者中进行了单盲随机对照临床试验。患者或接受软通道微创手术或实施硬通道微创手术,其他治疗相同,每组各40例。主要观察指标:手术时间,术后继发颅内血肿例数,治疗后1、6个月的格拉斯哥预后评分(Glasgow Outcome Scale,GOS)、巴氏指数(Barthel Index,BI)与死亡率。结果软通道组术后继发颅内血肿(1例)较硬通道组(8例)少(掊2=4.507,P<0.05)。软通道组的手术时间(58.88 min±11.21min)较硬通道组(45.60 min±7.31 min)长(t=6.276,P<0.05)。治疗后1、6个月GOS,治疗后1、6个月BI,治疗后1、6个月死亡率两组间比较差异均无统计学意义(P>0.05)。结论软、硬通道微创手术治疗幕上高血压脑出血均疗效确切。软通道微创手术较硬通道更加安全,但手术更加费时。

Objective To compare the clinical efficacy, safety and operating time between soft-channel minimally invasive operation and hard-channel minimally invasive operation in patients with supratentorial hypertensive intracerebral hemorrhage. Methods A single-blind, randomized controlled clinical trial was performed in 80 patients with the first supratentorial hypertensive intracerebral hemorrhage from the department of neurosurgery of Nanfang Hospital between October, 2008 to October, 2011, Patients were randomly assigned to either receive soft-channel minimally invasive operation （n = 40） or hard-channel minimally invasive operation （n = 40）. Primary objective endpoints were operating time, incidence of intracranial hematoma, Glasgow Outcome Scale （GOS）and Barthel index （BI） and mortality at 1 and 6 months after treatment. Results The incidence of intracranial hematoma was significantly lower in soft-channel minimally invasive operation than in hard-channel minimally invasive operation （1 case vs. 8 cases; Z2 = 4.507, P 〈 0.05）. The operating time was longer in soft-channel minimally invasive operation than in hard-channel minimally invasive operation （58.88 ±711.21 vs. 45.60 ±77.31 ; t = 6.276, P 〈 0.05）. There were no significant differences in GOS, BI and mortality between soft-channel minimally invasive operation and hard- channel minimally invasive operation （P 〉 0.05）. Conclusions Soft-channel operation demonstrates better safety and equivalent efficacy but spend longer operating time than hard-channel minimally invasive operation for supratentorial hypertensive intracerebral hemorrhage.