DataSheet1_Updated evidence of the Naoshuantong capsule against ischemic stroke: a systematic review and meta-analysis of randomized controlled trials.docx

BackgroundStroke 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.
MethodsWe 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.
ResultsA 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; p < 0.00001) but also in the non-acute period (MD = −3.70; 95% CI: −5.82, −1.58; p = 0.0006) and improved the long-term functional outcomes with lower mRS scores (MD = −0.68; 95% CI: −1.09, −0.26; p = 0.001). At the same time, the NSTC decreased the risk of cerebrovascular disease recurrence (RR = 0.43; 95% CI: 0.27, 0.70; p = 0.0006) and increased the quality of life in the acute period (MD = 23.88; 95% CI: 16.63, 31.13; p < 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.
ConclusionThe 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：脑卒中（Stroke）是一类严重危害人类健康的疾病，可导致患者死亡或残疾，给社会与家庭带来沉重的经济负担。近年来，越来越多的研究表明，脑栓通胶囊（Naoshuantong capsule, NSTC）用于缺血性脑卒中（ischemic stroke, IS）的治疗具有临床获益。本研究旨在更新脑栓通胶囊治疗缺血性脑卒中患者的安全性与有效性证据。

方法：我们全面检索了8个数据库，以筛选评估脑栓通胶囊治疗缺血性脑卒中有效性的合格随机对照试验（randomized controlled trial, RCT）。本研究的主要结局指标为急性期采用的美国国立卫生研究院卒中量表（National Institute of Health Stroke Scale, NIHSS）评分，以及非急性期3个月随访时的改良Rankin量表（modified Rankin Scale, mRS）评分；次要结局指标包括非急性期NIHSS评分、改良Rankin量表评分、巴氏指数（Barthel Index, BI）、改良巴氏指数（modified Barthel Index, MBI）、脑卒中专用生活质量量表（Stroke-specific Quality of Life, SS-QOL）以及脑血管事件复发率。随后采用Cochrane风险偏倚评估工具对纳入研究的质量进行评价。统计学分析采用RevMan 5.3与Stata 14.0软件完成。

结果：最终纳入27项随机对照试验，共涉及3139例患者。结果显示，脑栓通胶囊不仅可改善急性期患者的神经功能（均数差MD=-2.53，95%置信区间CI：-2.91~-2.15，P<0.00001），对非急性期患者的神经功能亦有改善作用（MD=-3.70，95%CI：-5.82~-1.58，P=0.0006）；同时可降低mRS评分，改善长期功能结局（MD=-0.68，95%CI：-1.09~-0.26，P=0.001）。此外，脑栓通胶囊可降低脑血管事件复发风险（相对风险RR=0.43，95%CI：0.27~0.70，P=0.0006），并改善急性期患者的生活质量（MD=23.88，95%CI：16.63~31.13，P<0.00001）。脑栓通胶囊组与对照组的不良事件发生率无显著差异。本研究证据质量被评为中等至极低质量。

结论：脑栓通胶囊有望成为缺血性脑卒中的有效且安全的治疗方案。其可改善不同病程阶段缺血性脑卒中患者的神经功能，在二级预防中具有一定临床价值。但由于纳入研究的质量较低且存在异质性，未来需开展更大样本量、标准化的随机对照试验以进一步验证脑栓通胶囊治疗缺血性脑卒中的疗效与安全性。

系统评价注册信息：https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=482981，注册编号CRD42023482981。