Division of Neurosurgery, Department of Surgery, Thammasat University Hospital, Faculty of Medicine, Thammasat University, Pathumthani, Thailand.
Division of Neurosurgery, Department of Surgery, Thammasat University Hospital, Faculty of Medicine, Thammasat University, Pathumthani, Thailand.
World Neurosurg. 2023 Apr;172:e555-e564. doi: 10.1016/j.wneu.2023.01.080. Epub 2023 Jan 24.
Intraventricular fibrinolysis (IVF) and endoscopic surgery (ES) are the new promising treatment strategies to enhance the rate of hematoma clearance, which might improve functional outcome. This study investigated and compared the outcomes among these interventions.
A randomized (1:1) double-blinded trial was carried out between August 2018 and December 2021. The intervention and control groups comprised patients receiving IVF and/or ES and external ventricular drainage (EVD), respectively. All participants had experienced primary or secondary intraventricular hemorrhage (IVH) from spontaneous intracerebral hemorrhage with obstructive hydrocephalus complications. The primary outcome was modified Rankin Scale score 180 days post treatment. Interim assessments were planned for every 50 participants enrolled to ensure safety and efficacy.
After enrollment of 110 participants (55 participants in each group), there was a difference in 30-day mortality (2 [3.6%] vs. 13 [32.7%] in the EVD group, P = 0.002), reaching the predetermined boundaries for termination of the trial. We demonstrated a better favorable outcome (modified Rankin Scale score 0-3) at 180 days in the intervention group, compared with the control group (35 [63.6%] vs. 24 [43.6%], P = 0.04). Participants in the intervention group experienced a higher IVH removal rate (91% [9.0] vs. 69.5% [38.0], P < 0.01) and had lower shunt conversion (1 [1.8%] vs. 16 [29.3%], P < 0.01). Treatment complications were comparable between the two groups.
This study demonstrated that combined ES and IVF is safe and effective for the treatment of IVH. In addition, it concluded that aggressive but safe procedures used to remove IVH could improve clinical outcome in patients with IVH.
脑室内纤维蛋白溶解（IVF）和内镜手术（ES）是增强血肿清除率、可能改善功能预后的新的有前途的治疗策略。本研究调查并比较了这些干预措施的结果。
一项 2018 年 8 月至 2021 年 12 月期间进行的随机（1:1）双盲试验。干预组和对照组分别包括接受 IVF 和/或 ES 联合外部脑室引流（EVD）的患者。所有参与者均经历了原发性或继发性脑室出血（IVH）合并梗阻性脑积水并发症的自发性脑出血。主要结局为治疗后 180 天改良 Rankin 量表评分。每招募 50 名参与者时计划进行中期评估，以确保安全性和有效性。
纳入 110 名参与者（每组 55 名）后，EVD 组 30 天死亡率有差异（2[3.6%]比 13[32.7%]，P=0.002），达到试验终止的预定界限。与对照组相比，干预组在 180 天时的预后更好（改良 Rankin 量表评分 0-3）（35[63.6%]比 24[43.6%]，P=0.04）。干预组的 IVH 清除率更高（91%[9.0]比 69.5%[38.0]，P<0.01），分流转换率更低（1[1.8%]比 16[29.3%]，P<0.01）。两组治疗并发症相当。
本研究表明，ES 和 IVF 联合治疗 IVH 安全有效。此外，它还得出结论，积极但安全地清除 IVH 可以改善 IVH 患者的临床预后。
