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基于证据的补阳还五汤治疗中风后遗症的评价:一项符合 PRISMA 标准的系统评价和随机对照试验的荟萃分析。

An evidence-based evaluation of Buyang Huanwu decoction for the treatment of the sequelae of stroke: A PRISMA-compliant systematic review and meta-analysis of randomized controlled trials.

机构信息

The First Hospital of Hunan University of Chinese Medicine, Changsha, Hunan, PR China.

Hunan University of Chinese Medicine, Changsha, Hunan, PR China.

出版信息

Phytomedicine. 2022 Sep;104:154312. doi: 10.1016/j.phymed.2022.154312. Epub 2022 Jul 3.

Abstract

BACKGROUND

Buyang Huanwu decoction (BYHWD) is a famous traditional Chinese formula that has been widely prescribed for sequelae of stroke in China. However, the efficacy and safety of BYHWD in treating sequelae of stroke have never been systematically evaluated.

PURPOSE

To evaluate the effectiveness and safety of BYHWD in the treatment of sequelae of stroke.

STUDY DESIGN

A Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA)-compliant systematic review and meta-analysis of randomized clinical trials (RCTs).

MATERIALS AND METHODS

A systematic review and meta-analysis was performed in accordance with the PRISMA guidelines. Five common electronic databases were searched for relevant RCTs from their inception until May 20, 2022. The Cochrane risk-of-bias tool was used to evaluate the methodological quality and the risk of bias of the included RCTs. Review Manager 5.4 was used to analyse all the data obtained. The clinical effective rate (CER) was the primary outcome, and National Institutes of Health Stroke Scale (NIHSS) and Fugl-Meyer Assessment (FMA) scores were the secondary outcomes. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) system was used to evaluate the quality of evidence for each outcome.

RESULTS

Thirty-two clinical studies that recruited 2,527 eligible patients were included in this meta-analysis. The results of the meta-analysis suggested that compared with conventional treatment alone, the addition of BYHWD significantly improved the CER (RR = 1.24, 95% CI: 1.20-1.29, p < 0.00001), decreased the NIHSS score (MD = -5.42, 95% CI: -5.87-4.97, p < 0.00001), and increased the FMA score (MD = 17.28, 95% CI: 15.12-19.45, p < 0.00001). There were no reported adverse events in the included studies. Most results were robust, and the quality of evidence was moderate.

CONCLUSION

Our study is the first meta-analysis of RCTs evaluating the effects of BYHWD on sequelae of stroke. The addition of BYHWD to conventional treatment for sequelae of stroke significantly improved the CER and promoted neurological rehabilitation in patients, and there were no reported adverse events associated with this combination therapy. The findings of our study support the use of BYHWD as an adjunct treatment to conventional treatment in this clinical population. However, due to the limitations of the included clinical trials, high-quality clinical trials with longer follow-ups are needed to assess the long-term effectiveness and safety of BYHWD for treating the sequelae of stroke.

摘要

背景

补阳还五汤(BYHWD)是一种著名的中药方剂,在中国被广泛用于治疗中风后遗症。然而,BYHWD 治疗中风后遗症的疗效和安全性从未得到系统评价。

目的

评估 BYHWD 治疗中风后遗症的疗效和安全性。

研究设计

符合系统评价和荟萃分析首选报告项目(PRISMA)的随机对照试验(RCT)的系统评价和荟萃分析。

材料和方法

按照 PRISMA 指南进行系统评价和荟萃分析。从成立到 2022 年 5 月 20 日,在五个常见的电子数据库中搜索相关的 RCT。使用 Cochrane 偏倚风险工具评估纳入 RCT 的方法学质量和偏倚风险。使用 Review Manager 5.4 分析所有获得的数据。临床有效率(CER)是主要结局,国立卫生研究院卒中量表(NIHSS)和 Fugl-Meyer 评估(FMA)评分是次要结局。使用推荐、评估、发展和评估分级(GRADE)系统评估每个结局的证据质量。

结果

这项荟萃分析纳入了 32 项临床研究,共招募了 2527 名合格患者。荟萃分析结果表明,与单纯常规治疗相比,加用 BYHWD 可显著提高 CER(RR=1.24,95%CI:1.20-1.29,p<0.00001),降低 NIHSS 评分(MD=-5.42,95%CI:-5.87-4.97,p<0.00001),并增加 FMA 评分(MD=17.28,95%CI:15.12-19.45,p<0.00001)。纳入研究均未报告不良事件。大多数结果是稳健的,证据质量为中等。

结论

这是第一项评估 BYHWD 治疗中风后遗症效果的 RCT 荟萃分析。在中风后遗症的常规治疗中加入 BYHWD 可显著提高 CER,促进患者神经康复,且与该联合治疗相关的不良事件未见报道。本研究结果支持在该临床人群中,将 BYHWD 作为常规治疗的辅助治疗。然而,由于纳入的临床试验存在局限性,需要进行高质量、随访时间更长的临床试验,以评估 BYHWD 治疗中风后遗症的长期疗效和安全性。

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