Department of Surgical Specialties, Neurosurgery Teaching and Assistance Unit, Pedro Ernesto University Hospital, Rio de Janeiro State University, Rio de Janeiro , Rio de Janeiro , Brazil.
Hospital Regional de Presidente Prudente, Universidade do Oeste Paulista, São Paulo , Brazil.
Neurosurgery. 2023 Dec 1;93(6):1208-1219. doi: 10.1227/neu.0000000000002601. Epub 2023 Jul 18.
Clazosentan has been studied to treat cerebral vasospasm after aneurysmal subarachnoid hemorrhage (aSAH).This meta-analysis of randomized controlled trials updates the current knowledge regarding the efficacy and safety of clazosentan compared with placebo after aSAH.
Databases were systematically searched for randomized controlled trials directly comparing the use of clazosentan and placebo for the treatment of cerebral vasospasm after aSAH. Additional eligibility criteria were the report of any of the outcomes of interest (vasospasm, morbidity, functional outcome, or mortality). The primary outcome was vasospasm-related delayed cerebral ischemia (DCI). The analyses were stratified by clazosentan dosage (low or high dose) and aneurysm treatment modality (clipping or coiling). The Cochrane RoB-2 tool was used for studies quality assessment.
Six studies comprising 7 clinical trials were included, involving 2778 patients. Clazosentan decreased the risk of vasospasm-related DCI (risk ratio [RR] 0.56, 95% CI 0.38-0.81) and delayed ischemic neurological deficit (RR 0.63, 95% 0.50-0.80). Angiographic vasospasm (RR 0.54, 95% CI 0.47-0.61) was also decreased. Functional outcomes (favorable Glasgow Outcome Scale, RR 0.99, 95% CI 0.79-1.24) and death (RR 1.03, 95% CI 0.71-1.49) did not change. Meanwhile, adverse events were increased by clazosentan (RR 1.54, 95% CI 1.35-1.76).
Clazosentan decreased vasospasm-related DCI and angiographic vasospasm but did not improve functional outcomes or mortality. Adverse events were increased by clazosentan.
克拉生坦已被研究用于治疗蛛网膜下腔出血（aSAH）后的脑血管痉挛。本项荟萃分析对随机对照试验进行了更新，以评估克拉生坦与安慰剂治疗 aSAH 后脑血管痉挛的疗效和安全性。
系统检索了直接比较克拉生坦和安慰剂治疗 aSAH 后脑血管痉挛的随机对照试验数据库。额外的纳入标准为报告任何感兴趣的结局（血管痉挛、发病率、功能结局或死亡率）。主要结局为血管痉挛相关性迟发性脑缺血（DCI）。根据克拉生坦剂量（低剂量或高剂量）和动脉瘤治疗方式（夹闭或栓塞）对分析进行分层。使用 Cochrane RoB-2 工具评估研究质量。
纳入了 6 项研究，共 7 项临床试验，涉及 2778 例患者。克拉生坦降低了血管痉挛相关性 DCI（风险比[RR]0.56，95%CI 0.38-0.81）和迟发性缺血性神经功能缺损（RR 0.63，95%CI 0.50-0.80）的风险。血管造影性血管痉挛（RR 0.54，95%CI 0.47-0.61）也有所降低。功能结局（良好的格拉斯哥结局量表，RR 0.99，95%CI 0.79-1.24）和死亡率（RR 1.03，95%CI 0.71-1.49）没有变化。与此同时，克拉生坦增加了不良事件的发生（RR 1.54，95%CI 1.35-1.76）。
克拉生坦降低了血管痉挛相关性 DCI 和血管造影性血管痉挛，但并未改善功能结局或死亡率。克拉生坦增加了不良事件。
