Zhan Jie, Xu Xiaowen, Zhu Yanzhen, Liu Lin, Chen Hongxia, Zhan Lechang
Department of Rehabilitation, Guangdong Provincial Hospital of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.
The Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou, China.
Front Pharmacol. 2024 Oct 22;15:1407669. doi: 10.3389/fphar.2024.1407669. eCollection 2024.
Using Shuxuening injection (SXNI) for acute ischemic stroke (AIS) is popular in China, but its efficacy and safety remain controversial. This study aims to assess the efficacy and safety of SXNI as an add-on therapy for AIS. Systematic review and meta-analysis. We searched for randomized controlled trials (RCTs) on SXNI for AIS in seven databases and two clinical trial registration platforms from their inception to January 2023. We used the Cochrane risk of bias tool to assess the methodological quality of the included studies and performed the meta-analysis with R software. The primary outcome was clinical efficacy, assessed by the clinical effective rate (CER). The secondary outcomes were neurological function, activities of daily living (ADL), and adverse events (AEs). In total, 116 studies with 12,401 participants were included in this review. Fifteen (12.9%) studies were judged to be of moderate to high quality. SXNI plus conventional treatments (CTs) improved the CER compared with CTs alone (risk ratio [RR]: 1.21, 95% confidence interval [CI]: 1.17-1.25, < 0.0001) or CTs plus other injections (RR: 1.18, 95% CI: 1.15-1.21, < 0.0001). SXNI plus CTs reduced the National Institute of Health Stroke Scale score compared with CTs alone (mean difference [MD]: -4.00, 95% CI: -5.22 to -2.78, < 0.0001) or CTs plus other injections (MD: -2.28, 95% CI: -3.41 to -1.16, < 0.0001). SXNI plus CTs also decreased the Chinese Stroke Scale score compared with CTs alone (MD: -5.01, 95% CI: -7.38 to -2.65, < 0.0001) or CTs plus other injections (MD: -4.31, 95% CI: -5.75 to -2.88, < 0.0001). SXNI plus CTs was superior for increasing the Barthel index score compared with CTs alone (MD: 11.58, 95% CI: 8.27-14.90, < 0.0001) or CTs plus other injections (MD: 5.43, 95% CI: 0.48-10.39, = 0.0317). The level of evidence for each outcome was assessed as low to very low. The most common AEs of SXNI were cardiovascular system events, and all these AEs were mild. SXNI combined with CTs maybe better than CTs alone or CTs plus other injections for improving the clinical efficacy, neurological function, and ADL of AIS patients, with relatively reliable safety. However, due to the low quality of the included studies, more rigorously designed RCTs with large sample sizes should be conducted in the future.
www.crd.york.ac.uk, identifier (CRD42023418565).
在中国，使用舒血宁注射液（SXNI）治疗急性缺血性脑卒中（AIS）很普遍，但其疗效和安全性仍存在争议。本研究旨在评估SXNI作为AIS辅助治疗的疗效和安全性。系统评价和荟萃分析。我们在七个数据库和两个临床试验注册平台上检索了从创建至2023年1月关于SXNI治疗AIS的随机对照试验（RCT）。我们使用Cochrane偏倚风险工具评估纳入研究的方法学质量，并使用R软件进行荟萃分析。主要结局是临床疗效，通过临床有效率（CER）评估。次要结局是神经功能、日常生活活动能力（ADL）和不良事件（AE）。本评价共纳入116项研究，涉及12401名参与者。15项（12.9%）研究被判定为中等至高质量。与单纯常规治疗（CT）或CT加其他注射液相比，SXNI加CT可提高CER（风险比[RR]：1.21，95%置信区间[CI]：1.17 - 1.25，P < 0.0001）或CT加其他注射液（RR：1.18，95% CI：1.15 - 1.21，P < 0.0001）。与单纯CT或CT加其他注射液相比，SXNI加CT可降低美国国立卫生研究院卒中量表评分（平均差[MD]： - 4.00，95% CI： - 5.22至 - 2.78，P < 0.0001）或CT加其他注射液（MD： - 2.28，95% CI： - 3.41至 - 1.16，P < 0.0001）。与单纯CT或CT加其他注射液相比，SXNI加CT还可降低中国卒中量表评分（MD： - 5.01，95% CI： - 7.38至 - 2.65，P < 0.0001）或CT加其他注射液（MD： - 4.31，95% CI： - 5.75至 - 2.88，P < 0.0001）。与单纯CT或CT加其他注射液相比，SXNI加CT在提高Barthel指数评分方面更具优势（MD：11.58，95% CI：8.27 - 14.90，P < 0.0001）或CT加其他注射液（MD：5.43，95% CI：0.48 - 10.39，P = 0.0317）。每个结局的证据水平评估为低至极低。SXNI最常见的AE是心血管系统事件，所有这些AE均为轻度。SXNI联合CT在改善AIS患者的临床疗效、神经功能和ADL方面可能优于单纯CT或CT加其他注射液，安全性相对可靠。然而，由于纳入研究质量较低，未来应开展更严格设计的大样本RCT。
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