Department of Neurology, Hubei Provincial Hospital of Integrated Chinese and Western Medicine, Hubei University of Chinese Medicine, Wuhan 430000, China.
Biosci Rep. 2020 Jan 31;40(1). doi: 10.1042/BSR20191448.
To estimate evidence for decompressive hemicraniectomy (DHC) versus medical treatment effects on survival rate and favorable functional recovery among patients of malignant middle cerebral artery infarction (MMCAI) in randomized controlled trials (RCTs).
The present study is a systematic review and meta-analysis of RCTs.
The MEDLINE/PubMed, EMBASE, Springer, Cochrane Collaboration database, China National Knowledge Infrastructure (CNKI) database, and Wanfang database were comprehensively searched for RCTs regarding the effects of DHC versus medical treatment among patients of MMCAI in these English and Chinese electronic databases from inception to 1 June 2019. Two reviewers independently retrieved RCTs and extracted relevant information. The methodological quality of the included trials was estimated using the Cochrane risk of bias tool. Review Manager5.3.5 software was used for statistical analyses. The statistical power of meta-analysis was estimated by Power and Precision, version 4 software.
Nine RCTs with a total of 425 patients with MMCAI, containing 210 cases in the DHC group and 215 cases in the medical treatment group, met the inclusion criteria were included. Primary outcomes were measured by survival rate, defined as modified Rankin scale (mRS) score 0-5 and favorable functional recovery as mRS score 0-3. The follow-up time of all studies was at 6-12months.
First, compared with the medical treatment group, DHC was associated with a statistically significant increase survival rate (RR: 1.96, 95%CI 1.61-2.38, P < 0.00001) and favorable functional recovery (RR: 1.62, 95%CI 1.11-2.37, P = 0.01). Second, subgroup analysis: (1) Compared with the medical treatment group among patients age ≤60 years, DHC was associated with a statistically significant increase survival rate (RR = 2.20, 95%CI 1.60-3.04, P < 0.00001); (2) Compared with the medical treatment group among patients of age >60 years, DHC was also associated with a statistically significant increase survival rate (RR: 1.93, 95%CI 1.45-2.59, P < 0.00001); (3) Compared with the medical treatment group, the time of DHC was preformed within 48 h from the onset of stroke that could statistically significant increase survival rate (RR: 2.16, 95%CI 1.69-2.75, P < 0.00001). Third, sensitivity analyses that measured the results were consistent, indicating that the results were stable. Fourth, the results of statistical power analysis were ≥80%. Finally, the funnel plot of the survival rate included nine RCTs showed no remarkable publication bias.
Our study results indicated that DHC could increase survival rate and favorable functional recovery among patients age ≤60 or >60 years. The optimal time for DHC might be no more than 48 h from the onset of symptoms. However, due to the limitations of this research, it is necessary to design high quality, large-scale RCTs to further evaluate these findings.
评估去骨瓣减压术（DHC）与药物治疗对恶性大脑中动脉梗死（MMCAI）患者生存率和功能恢复的影响。
本研究为系统评价和荟萃分析随机对照试验（RCT）。
通过 MEDLINE/PubMed、EMBASE、Springer、Cochrane 协作数据库、中国知网（CNKI）数据库和万方数据库全面检索了这些英文和中文电子数据库中关于 DHC 与 MMCAI 患者药物治疗效果的 RCT，检索时间为从成立至 2019 年 6 月 1 日。两名评审员独立检索 RCT 并提取相关信息。使用 Cochrane 偏倚风险工具评估纳入试验的方法学质量。使用 Review Manager5.3.5 软件进行统计分析。通过 Power and Precision，version 4 软件估计荟萃分析的统计功效。
9 项 RCT 共纳入 425 例 MMCAI 患者，DHC 组 210 例，药物治疗组 215 例，符合纳入标准。主要结局指标为生存率，定义为改良 Rankin 量表（mRS）评分 0-5 分和功能恢复良好，mRS 评分 0-3 分。所有研究的随访时间均为 6-12 个月。
首先，与药物治疗组相比，DHC 组的生存率（RR：1.96，95%CI 1.61-2.38，P < 0.00001）和功能恢复良好（RR：1.62，95%CI 1.11-2.37，P = 0.01）显著提高。其次，亚组分析：（1）与药物治疗组相比，年龄≤60 岁的患者中，DHC 组的生存率显著提高（RR = 2.20，95%CI 1.60-3.04，P < 0.00001）；（2）与药物治疗组相比，年龄>60 岁的患者中，DHC 组的生存率也显著提高（RR：1.93，95%CI 1.45-2.59，P < 0.00001）；（3）与药物治疗组相比，DHC 组在发病 48 小时内进行可显著提高生存率（RR：2.16，95%CI 1.69-2.75，P < 0.00001）。第三，敏感性分析的结果一致，表明结果稳定。第四，统计功效分析的结果≥80%。最后，包含 9 项 RCT 的生存率漏斗图显示无显著发表偏倚。
我们的研究结果表明，DHC 可提高≤60 岁或>60 岁患者的生存率和功能恢复良好率。DHC 的最佳时间可能不超过发病后 48 小时。但是，由于本研究的局限性，有必要设计高质量、大规模的 RCT 进一步评估这些发现。
