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内镜手术与传统开颅手术治疗自发性幕上脑内出血的疗效比较:一项随机对照试验。

Treatment outcomes between endoscopic surgery and conventional craniotomy for spontaneous supratentorial intracerebral hemorrhage: a randomized controlled trial.

机构信息

Division of Neurosurgery, Department of Surgery, Thammasat University Hospital, Faculty of Medicine, Thammasat University, Pathumthani, 12120, Thailand.

出版信息

Neurosurg Rev. 2023 Jun 6;46(1):136. doi: 10.1007/s10143-023-02035-y.

Abstract

Minimally invasive surgery (MIS) has been repeatedly evaluated in patients with ICH as a promising procedure for improved survival and functional outcome. Among MIS techniques, endoscopic surgery (ES) has shown superior efficacy for ICH removal due to rapid clot evacuation and immediate bleeding control. However, the results of ES are still uncertain due to insufficient data. In this study, participants with spontaneous supratentorial ICH who were indicated for surgery were randomly assigned (1:1) to undergo ES or conventional craniotomy (CC) between March 2019 and June 2022. The primary outcome was a difference in favorable modified Rankin Scale (mRS) outcome (0 to 3) at 180-day follow-up evaluated by blind assessors. There were 188 participants, 95 in the ES group and 93 in the CC group, who completed the trial. At 180-day follow-up, 46 (48.4%) participants in the ES group achieved favorable outcomes, compared to 33 (35.5%) in the CC group (risk difference [RD] 12.9, 95% CI - 1.1-27.0, p = 0.07). After covariate adjustment, the difference was slightly higher and significant (adjusted RD 17.3, 95% CI [4.6-30.0], p = 0.01). Moreover, the ES group had less operative duration and less intraoperative blood loss than the CC group. Clot evacuation rate and complications were similar between the two groups. Subgroup analyses showed a potential benefit of ES in age < 60 years, time to surgery ≥ 6 h, and deep ICH. This study showed that ES was safe and effective in ICH removal and provided a better functional outcome compared to CC.

摘要

微创手术 (MIS) 在脑出血 (ICH) 患者中已被反复评估,作为改善生存和功能预后的有前途的方法。在 MIS 技术中,由于快速清除血肿和立即控制出血,内镜手术 (ES) 显示出对 ICH 清除的更高疗效。然而,由于数据不足,ES 的结果仍不确定。在这项研究中,于 2019 年 3 月至 2022 年 6 月期间,符合手术指征的自发性幕上 ICH 患者被随机分配(1:1)接受 ES 或传统开颅术 (CC)。主要结局是盲法评估者在 180 天随访时改良 Rankin 量表(mRS)结局(0 至 3)的差异。共有 188 名参与者,ES 组 95 名,CC 组 93 名完成了试验。在 180 天随访时,ES 组 46 名(48.4%)参与者获得良好结局,而 CC 组 33 名(35.5%)(风险差 [RD] 12.9,95%CI-1.1-27.0,p=0.07)。在调整协变量后,差异略高且具有统计学意义(调整后的 RD 17.3,95%CI [4.6-30.0],p=0.01)。此外,ES 组的手术时间和术中出血量均少于 CC 组。两组的血肿清除率和并发症相似。亚组分析显示 ES 对年龄<60 岁、手术时间≥6 小时和深部 ICH 有潜在益处。本研究表明 ES 用于 ICH 清除是安全有效的,与 CC 相比提供了更好的功能结局。

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