Bahiana School of Medicine and Public Health, Salvador, Bahia, Brazil.
Division of Neurosurgery, University of São Paulo, São Paulo, São Paulo, Brazil.
Neurol India. 2022 Jul-Aug;70(4):1454-1459. doi: 10.4103/0028-3886.355108.
Tenecteplase (TNK) has been shown to be noninferior to Alteplase (ALT) for long term efficacy and safety outcomes. Whether this also applies to short term efficacy outcomes such as early clinical improvement and recanalization is unknown. To compare TNK and ALT regarding the short term efficacy outcomes: early neurological improvement and recanalization. The PRISMA was used to conduct a meta analysis, adapted to noninferiority analysis. The primary outcome was early (24-72 h) neurological improvement, defined as either NIHSS score 0 or reduction of at least 8 points compared to baseline. Recanalization was a secondary outcome. The noninferiority margin was set at 6.5%. Search strategy yielded 5 randomized clinical trials (1585 patients: 828 TNK, 757 ALT). Mean age was 70.8, 58.8% were men, mean baseline NIHSS was 7, and mean onset to treatment time was 148 min. Patients in intervention group received TNK at doses of 0.1 mg/kg (6.8%), 0.25 mg/kg (24.6%), and 0.4 mg/kg (68.6%), while all ALT patients received 0.9 mg/kg. In random effects meta analysis, TNK was noninferior to ALT for the primary outcome, early major neurological improvement (risk difference 8% in favor of TNK, 95% CI 1%-15%). Recanalization was also noninferior for the TNK compared to the ALT group (risk difference 9% in favor of TNK, 95% CI 6% to 23%). Fixed effects models yielded similarly noninferior results and signaled for a possible TNK superiority for both early neurological improvement and recanalization. TNK is noninferior to ALT at the short term efficacy outcomes: early neurological improvement and recanalization.
替奈普酶(TNK)在长期疗效和安全性方面已被证明不劣于阿替普酶(ALT)。对于早期临床改善和再通等短期疗效结果,这是否同样适用尚不清楚。本研究旨在比较 TNK 和 ALT 在短期疗效结果(早期神经功能改善和再通)方面的差异。采用 PRISMA 进行荟萃分析,并对非劣效性分析进行了调整。主要结局为早期(24-72 小时)神经功能改善,定义为 NIHSS 评分较基线降低 0 分或至少 8 分。再通为次要结局。非劣效性边界设为 6.5%。检索策略共获得 5 项随机临床试验(1585 例患者:828 例 TNK,757 例 ALT)。平均年龄为 70.8 岁,58.8%为男性,平均基线 NIHSS 评分为 7 分,平均发病至治疗时间为 148 分钟。干预组患者接受的 TNK 剂量分别为 0.1mg/kg(6.8%)、0.25mg/kg(24.6%)和 0.4mg/kg(68.6%),而所有 ALT 患者均接受 0.9mg/kg。在随机效应荟萃分析中,TNK 在早期主要神经功能改善方面不劣于 ALT(TNK 组更优的风险差异为 8%,95%CI 为 1%-15%)。与 ALT 组相比,TNK 组的再通率也不劣(TNK 组更优的风险差异为 9%,95%CI 为 6%-23%)。固定效应模型也得出了类似的非劣效结果,并提示 TNK 在早期神经功能改善和再通方面可能具有优势。TNK 在短期疗效结果(早期神经功能改善和再通)方面不劣于 ALT。