在随机对照试验(RCT)中,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)患者生存率和良好功能恢复的影响。
本研究是对随机对照试验的系统评价和荟萃分析。
MEDLINE/PubMed,EMBASE,Springer,Cochrane协作数据库,中国国家知识基础设施(CNKI)数据库,从开始到2019年6月1日,我们在这些英文和中文电子数据库中全面搜索了有关MMCAI患者中DHC与药物治疗效果的RCT。两名审阅者独立检索RCT并提取相关信息。使用Cochrane偏倚风险工具估计纳入试验的方法学质量。采用ReviewManager5.3.5软件进行统计分析。荟萃分析的统计能力由Power和Precision估计,版本4软件。
9项RCT共425例MMCAI患者,DHC组210例,药物治疗组215例,符合纳入标准的被纳入。主要结果是通过生存率来衡量的,定义为改良Rankin量表(mRS)评分0-5,良好的功能恢复为mRS评分0-3。所有研究的随访时间均为6-12个月。
首先,与医疗组相比,DHC可显著提高生存率(RR:1.96,95CI1.61-2.38,P<0.00001)和良好的功能恢复(RR:1.62,95CI1.11-2.37,P=0.01)。第二,亚组分析:(1)年龄≤60岁的患者与药物治疗组比较,DHC与生存率有统计学意义(RR=2.20,95CI1.60-3.04,P<0.00001);(2)年龄>60岁的患者与药物治疗组相比,DHC也与统计学上显着的生存率增加相关(RR:1.93,95CI1.45-2.59,P<0.00001);(3)与药物治疗组相比,DHC的时间在卒中发病后48h内进行,可显著提高生存率(RR:2.16,95CI1.69-2.75,P<0.00001).第三,测量结果的敏感性分析是一致的,表明结果是稳定的。第四,统计学功效分析结果≥80%。最后,包括9个RCT的生存率漏斗图显示无明显的发表偏倚.
我们的研究结果表明,DHC可以提高年龄≤60岁或>60岁患者的生存率和良好的功能恢复。DHC的最佳时间可能不超过症状发作48小时。然而,由于本研究的局限性,有必要设计高质量,大规模随机对照试验以进一步评估这些发现。
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.