Singh Alok, Singh Madhusudan Prasad, Gaikwad Nitin R, Kannauje Pankaj Kumar
Department of Pharmacology, All India Institute of Medical Sciences, Raipur, Chhattisgarh, India.
Department of General Medicine, All India Institute of Medical Sciences, Raipur, Chhattisgarh, India.
Ann Neurosci. 2024 Apr;31(2):132-142. doi: 10.1177/09727531231193242. Epub 2023 Nov 2.
A number of clinical trials have compared tenecteplase (TNK) and alteplase for the management of acute ischemic stroke (AIS) and the results are inconsistent.
Present systematic review and meta-analysis is undertaken to analyse the efficacy and safety of TNK in AIS compared to alteplase.
A thorough literature search was performed through the databases Embase, Cochrane Library, PubMed, and clinicaltrials.gov, for a period from inception to September 2022, with the keywords i.e., "tenecteplase" and "alteplase" and "acute ischemic stroke." Clinical trials published in English that compared the efficacy and safety of TNK to alteplase in AIS were included. The major outcomes of this meta-analysis were proportion of patients free from disability and functional independence at 90 days, early neurological improvement at 24 hours, all-cause mortality at 90 days, patients with intra cranial hemorrhage (ICH), and patients with severe disability at 90 days. A total of nine studies with 3,573 patients were included in the analysis. The proportion of patients with freedom from disability was comparable in both groups (relative risk [RR] = 1.04, 95 per cent CI = 0.92-1.17; p = .53). Similarly, proportion of patients with functional independence was comparable (RR = 1.12, 95 per cent CI = 0.96-1.31; p = .14). TNK group had a higher rate of early neurological recovery (RR = 1.56, 95 per cent CI = 0.96-2.54; p = .07). All-cause mortality at 90 days was comparable in both groups (RR = 0.97; 95 per cent CI = 0.72-1.29; p = .82). The proportion of patients with ICH was higher in TNK group (RR = 1.14, 95 per cent CI = 0.77-1.68; p = .52). The proportion of patients with severe disability was less in TNK group (RR =0.84, 95 per cent CI = 0.53-1.32; p = .44).
TNK was similar to alteplase in terms of efficacy and safety. The patients in TNK group showed early neurological improvement but were simultaneously at higher risk of ICH. The TNK can be an alternative to alteplase if the benefits outweigh the risks.
多项临床试验比较了替奈普酶(TNK)和阿替普酶用于急性缺血性卒中(AIS)治疗的效果,结果并不一致。
进行本系统评价和荟萃分析,以分析与阿替普酶相比,TNK治疗AIS的疗效和安全性。
通过Embase、Cochrane图书馆、PubMed和clinicaltrials.gov数据库进行了全面的文献检索,检索时间从建库至2022年9月,关键词为“替奈普酶”“阿替普酶”和“急性缺血性卒中”。纳入了以英文发表的比较TNK与阿替普酶治疗AIS疗效和安全性的临床试验。本荟萃分析的主要结局为90天时无残疾和功能独立的患者比例、24小时时早期神经功能改善情况、90天时全因死亡率、颅内出血(ICH)患者以及90天时严重残疾患者。分析共纳入9项研究,3573例患者。两组无残疾患者的比例相当(相对危险度[RR]=1.04,95%置信区间[CI]=0.92 - 1.17;p = 0.53)。同样,功能独立患者的比例也相当(RR = 1.12,95% CI = 0.96 - 1.31;p = 0.14)。TNK组早期神经功能恢复率更高(RR = 1.56,95% CI = 0.96 - 2.54;p = 0.07)。两组90天时的全因死亡率相当(RR = 0.97;95% CI = 0.72 - 1.29;p = 0.82)。TNK组ICH患者的比例更高(RR = 1.14,95% CI = 0.77 - 1.68;p = 0.52)。TNK组严重残疾患者的比例更低(RR = 0.84,95% CI = 0.53 - 1.32;p = 0.44)。
TNK在疗效和安全性方面与阿替普酶相似。TNK组患者早期神经功能有改善,但同时发生ICH的风险更高。如果获益大于风险,TNK可作为阿替普酶的替代药物。