Division of Neurocritical Care, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.
Neurocrit Care. 2012 Oct;17(2):161-71. doi: 10.1007/s12028-012-9703-3.
Decompressive hemicraniectomy (DHC) has proven efficacious for the treatment of malignant middle cerebral artery infarction (mMCAI) only in patients less than 60 years. This study aimed to assess the effectiveness of DHC in patients up to 80.
This is a prospective, randomized, controlled trail comparing the outcomes with or without DHC in patients aged 18-80 with mMCAI (ChiCTR-TRC-11001757). The primary outcome measure was the modified Rankin Scale (mRS) scores at 6 months. The secondary outcome measures included the 6- and 12-month mortality and the mRS scores after 1 year. The prognosis of patients was evaluated independently by two blinded investigators. In addition, subgroup analyses were done for those above 60 years of age. All analyses were by intention-to-treat.
A significant reduction in the poor outcome (mRS > 4) following DHC was reached after 36 patients had completed the follow-up period of 6 months. The trial was then terminated when 47 participants (24 in the surgical group vs. 23 in the medical group) had been recruited. The final analysis, based on the outcome data of the 47 patients, showed that DHC significantly reduced mortality at 6 and 12 months (12.5 vs. 60.9 %, P = 0.001 and 16.7 vs. 69.6 %, P < 0.001, respectively), and significantly fewer patients had a mRS score >4 after surgery (33.3 vs. 82.6 %, P = 0.001 and 25.0 vs. 87.0 %, P < 0.001, respectively). Similar results were present in the subgroup analyses of elderly participants
For patients up to 80 years who suffered mMCAI, DHC within 48 h of stroke onset not only is a life-saving treatment, but also increases the possibility of surviving without severe disability (mRS = 5).
去骨瓣减压术（DHC）已被证明对 60 岁以下的恶性大脑中动脉梗死（mMCAI）患者有效。本研究旨在评估 DHC 在 18-80 岁患有 mMCAI 的患者中的疗效。
这是一项前瞻性、随机、对照试验，比较了发病后 48 小时内接受或不接受 DHC 的患者的结局（ChiCTR-TRC-11001757）。主要结局测量指标是 6 个月时改良 Rankin 量表（mRS）评分。次要结局测量指标包括 6 个月和 12 个月的死亡率以及 1 年后的 mRS 评分。由两名盲法研究者独立评估患者的预后。此外，还对年龄超过 60 岁的患者进行了亚组分析。所有分析均采用意向治疗。
在 36 例患者完成 6 个月的随访期后，DHC 显著降低了不良结局（mRS>4）的发生率。当 47 名参与者（手术组 24 名，对照组 23 名）入组后，试验即终止。基于 47 名患者的结局数据的最终分析显示，DHC 显著降低了 6 个月和 12 个月的死亡率（12.5% vs. 60.9%，P=0.001 和 16.7% vs. 69.6%，P<0.001），并且手术后 mRS 评分>4 的患者明显减少（33.3% vs. 82.6%，P=0.001 和 25.0% vs. 87.0%，P<0.001）。老年患者亚组分析也得到了类似的结果。
对于发病 80 岁以下的 mMCAI 患者，发病后 48 小时内进行 DHC 不仅是一种救命治疗，而且还增加了无严重残疾（mRS=5）存活的可能性。
