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静脉溶栓的安全性和有效性:对93057例轻度中风患者的系统评价和荟萃分析。

Safety and efficacy of intravenous thrombolysis: a systematic review and meta-analysis of 93,057 minor stroke patients.

作者信息

Moawad Mostafa Hossam El Din, Salem Talal, Alaaeldin Anas, Elaraby Youssef, Awad Peter D, Khalifa Amr Ahmed, Naggar Ahmed El, Mohamed Khaled Ashraf, Elhalal Mohamed, Badr Mostafa, Abdelnaby Ramy

机构信息

Faculty of Medicine, Suez Canal University, Ismailia, Egypt.

Alexandria Main University Hospital, Alexandria, Egypt.

出版信息

BMC Neurol. 2025 Jan 22;25(1):33. doi: 10.1186/s12883-024-04000-8.

Abstract

BACKGROUND

The definition of minor ischemic stroke (MIS) is a topic of debate, however, the most accepted definition is a stroke with National Institutes of Health Stroke Scale (NIHSS) ≤ 5. Intravenous thrombolysis (IVT) is a crucial treatment option for acute ischemic stroke (AIS) including: alteplase, recombinant human tissue-type plasminogen activator (r-tPA), and the recently approved tenecteplase. However, there is a debate regarding its safety and efficacy. Therefore, our objective was to determine the safety and efficacy of IVT in treating minor stroke patients (NIHSS ≤ 5).

METHODS

Using the search strategy assigned which was based on three keywords: "mild" or "minor", "stroke", and "intravenous thrombolysis", we searched for eligible articles on PubMed, Web of Science, Embase, and Scopus from inception till 10th January 2024. We conducted this meta-analysis using the random effect model to account for the heterogeneity among the studies. For the dichotomous variables, we calculated the odds ratio (OR) from the event and total of these variables. While for the continuous variables, we calculated the mean difference (MD) of these variables. Pooling of OR for the occurrence of events was also conducted.

RESULTS

A total of 21 articles with 93,057 patients with MIS were included. The mean age of the participants ranged from 62.3 to 79.6. Most of the included patients had comorbidities such as hypertension, diabetes, previous stroke, smoking, atrial fibrillation, and hyperlipidemia. Of these, 10,850 received IVT while 82,207 did not. The use of IVT was statistically significant associated with 90-day modified Rankin score (mRs) 0-1 when compared with control with OR of 1.67 (95%CI: 1.46, 1.91, p < 0.00001) and was statistically significantly associated with improvement of NIHSS on discharge with OR of 2.19 (95%CI: 1.56, 3.08, p < 0.00001). In terms of safety outcomes, IVT has proven a safe profile, as there was no significant difference in intracranial hemorrhage (ICH) and mortality rates between the IVT and control groups with OR of 1.75 (95CI: 0.95, 3.23, p = 0.07) and 0.93 (95%CI: 0.77, 1.11, p = 0.41), respectively.

CONCLUSION

Although some studies have not found any benefits of IVT in MIS patients, a substantial body of literature strongly endorses IVT as an effective and safe treatment for MIS. IVT has been shown to improve the mRs and NIHSS scores at the 90-day mark without an increased risk of ICH or mortality.

摘要

背景

轻度缺血性卒中(MIS)的定义是一个存在争议的话题,然而,最被认可的定义是美国国立卫生研究院卒中量表(NIHSS)评分≤5分的卒中。静脉溶栓(IVT)是急性缺血性卒中(AIS)的一种关键治疗选择,包括:阿替普酶、重组人组织型纤溶酶原激活剂(r - tPA)以及最近获批的替奈普酶。然而,关于其安全性和有效性存在争议。因此,我们的目的是确定静脉溶栓治疗轻度卒中患者(NIHSS≤5)的安全性和有效性。

方法

使用基于三个关键词“轻度”或“轻微”、“卒中”和“静脉溶栓”分配的检索策略,我们在PubMed、科学网、Embase和Scopus上从创刊至2024年1月10日搜索符合条件的文章。我们使用随机效应模型进行这项荟萃分析,以考虑研究之间的异质性。对于二分变量,我们从这些变量的事件数和总数计算比值比(OR)。而对于连续变量,我们计算这些变量的平均差(MD)。还对事件发生的OR进行了合并。

结果

共纳入21篇文章,涉及93057例轻度缺血性卒中患者。参与者的平均年龄在62.3至79.6岁之间。大多数纳入患者患有合并症,如高血压、糖尿病、既往卒中、吸烟、心房颤动和高脂血症。其中,10850例接受了静脉溶栓治疗,而82207例未接受。与对照组相比,静脉溶栓治疗在90天改良Rankin量表(mRs)评分为0 - 1时具有统计学显著相关性,OR为1.67(95%CI:1.46,1.91,p < 0.00001),并且在出院时NIHSS改善方面具有统计学显著相关性,OR为2.19(95%CI:1.56,3.08,p < 0.00001)。在安全性结果方面,静脉溶栓已被证明具有安全的概况,因为静脉溶栓组和对照组之间的颅内出血(ICH)和死亡率没有显著差异,OR分别为1.75(95CI:0.95,3.23,p = 0.07)和0.93(95%CI:0.77,1.11,p = 0.41)。

结论

尽管一些研究未发现静脉溶栓对轻度缺血性卒中患者有任何益处,但大量文献强烈支持静脉溶栓作为轻度缺血性卒中的有效且安全的治疗方法。静脉溶栓已被证明在90天时可改善mRs和NIHSS评分,且不会增加颅内出血或死亡风险。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1e78/11752810/6e571dc2fa24/12883_2024_4000_Fig1_HTML.jpg

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