脑栓通胶囊治疗缺血性中风的最新证据：一项随机对照试验的系统评价和荟萃分析
Updated evidence of the Naoshuantong capsule against ischemic stroke: a systematic review and meta-analysis of randomized controlled trials.
作者信息
Que Cuilin, Wei Yupeng, Yin Guanxiang, Zhou Congren, Liu Zhenhong, Lai Xinxing, Qin Mingzhen, Xiong Xuejiao, Zheng Xiangyi, Dong Xinglu, Gao Ying
机构信息
Department of Neurology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.
Institute for Brain Disorders, Beijing University of Chinese Medicine, Beijing, China.
出版信息
Front Pharmacol. 2024 Sep 26;15:1434764. doi: 10.3389/fphar.2024.1434764. eCollection 2024.
BACKGROUND
Stroke is a serious health issue that can result in death or disability, leading to a significant economic strain on society and families. A growing number of studies have shown that the Naoshuantong capsule (NSTC) is beneficial as a treatment for ischemic stroke (IS) in recent years. Our study aims to provide an update on the safety and efficacy of the NSTC in IS patients.
METHODS
We thoroughly searched eight databases to identify suitable randomized controlled trials (RCTs) assessing the effectiveness of the NSTC in the treatment of IS. The National Institute of Health Stroke Scale (NIHSS) for an acute period and modified Rankin Scale (mRS) at 3 months for a non-acute period were considered the primary outcome, and secondary outcomes included the NIHSS for a non-acute period, mRS, Barthel Index (BI), modified Barthel Index (MBI), Stroke-specific Quality of life (SS-QOL), and the recurrence rate of cerebrovascular events. Subsequently, its quality was assessed using the Cochrane risk assessment scale. Statistical analysis was conducted using RevMan 5.3 and Stata 14.0.
RESULTS
A total of 27 RCTs were included, which involved 3,139 patients. The results showed that the NSTC improved neurological function not only in the acute period (MD = -2.53; 95% CI: -2.91, -2.15; < 0.00001) but also in the non-acute period (MD = -3.70; 95% CI: -5.82, -1.58; = 0.0006) and improved the long-term functional outcomes with lower mRS scores (MD = -0.68; 95% CI: -1.09, -0.26; = 0.001). At the same time, the NSTC decreased the risk of cerebrovascular disease recurrence (RR = 0.43; 95% CI: 0.27, 0.70; = 0.0006) and increased the quality of life in the acute period (MD = 23.88; 95% CI: 16.63, 31.13; < 0.00001). Significant disparities in the incidence of adverse events between the NSTC and control groups were not observed. The certainty of evidence was estimated as moderate to very low.
CONCLUSION
The NSTC emerges as a potentially efficacious and safe treatment option for IS. NSTC could improve neurological function in different period of IS, and it has certain clinical value in secondary prevention. As a result of the poor quality and heterogeneity of the included trials, larger and standardized RCTs are needed to validate NSTC in IS treatment.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=482981, identifier CRD42023482981.
背景
中风是一个严重的健康问题，可导致死亡或残疾，给社会和家庭带来巨大的经济负担。近年来，越来越多的研究表明，脑栓通胶囊（NSTC）对缺血性中风（IS）的治疗有益。我们的研究旨在提供脑栓通胶囊治疗IS患者安全性和有效性的最新信息。
方法
我们全面检索了八个数据库，以确定评估脑栓通胶囊治疗IS有效性的合适随机对照试验（RCT）。急性期采用美国国立卫生研究院卒中量表（NIHSS），非急性期采用改良Rankin量表（mRS）作为主要结局指标，次要结局指标包括非急性期NIHSS、mRS、Barthel指数（BI）、改良Barthel指数（MBI）、卒中特异性生活质量（SS-QOL）以及脑血管事件复发率。随后，使用Cochrane风险评估量表对其质量进行评估。使用RevMan 5.3和Stata 14.0进行统计分析。
结果
共纳入27项RCT，涉及3139例患者。结果显示，脑栓通胶囊不仅在急性期改善了神经功能（MD = -2.53；95%CI：-2.91，-2.15；P < 0.00001），在非急性期也有改善（MD = -3.70；95%CI：-5.82，-1.58；P = 0.0006），并通过降低mRS评分改善了长期功能结局（MD = -0.68；95%CI：-1.09，-0.26；P = 0.001）。同时，脑栓通胶囊降低了脑血管疾病复发风险（RR = 0.43；95%CI：0.27，0.70；P = 0.0006），并提高了急性期的生活质量（MD = 23.88；95%CI：16.63，31.13；P < 0.00001）。未观察到脑栓通胶囊组与对照组之间不良事件发生率的显著差异。证据的确定性估计为中等至非常低。
结论
脑栓通胶囊是一种潜在有效且安全的IS治疗选择。脑栓通胶囊可改善IS不同时期的神经功能，在二级预防中具有一定临床价值。由于纳入试验质量差且存在异质性，需要开展更大规模、标准化的RCT来验证脑栓通胶囊在IS治疗中的效果。
系统评价注册
https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=482981，标识符CRD42023482981 。
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