Department of Rehabilitation Medicine, The Queen Elizabeth Hospital, 28 Woodville Road, Adelaide, South Australia, 5011, Australia.
School of Medicine, University of Adelaide, Adelaide, South Australia, Australia.
Syst Rev. 2018 Jan 5;7(1):1. doi: 10.1186/s13643-017-0670-9.
Improved walking is one of the highest priorities in people living with stroke. Post-stroke lower limb spasticity (PSLLS) impedes walking and quality of life (QOL). The understanding of the evidence of improved walking and QOL following botulinum toxin (BoNTA) injection is not clear. We performed a systematic review of the randomized control trials (RCT) to evaluate the effectiveness of BoNTA injection on walking and QOL in PSLLS.
We searched PubMed, Web of Science, Embase, CINAHL, ProQuest Thesis and Dissertation checks, Google Scholar, WHO International Clinical Trial Registry Platform, ClinicalTrials.gov , Cochrane, and ANZ and EU Clinical Trials Register for RCTs looking at improvement in walking and QOL following injection of BoNTA in PSLLS. The original search was carried out prior to 16 September 2015. We conducted an additional verifying search on CINHAL, EMBASE, and MEDLINE (via PubMed) from 16 September 2015 to 6 June 2017 using the same clauses as the previous search. Methodological quality of the individual studies was critically appraised using Joanna Briggs Institute's instrument. Only placebo-controlled RCTs looking at improvement in walking and QOL were included in the review.
Of 2026 records, we found 107 full-text records. Amongst them, we found five RCTs qualifying our criteria. No new trials were found from the verifying search. Two independent reviewers assessed methodological validity prior to inclusion in the review using Joanna Briggs Institute's appraisal instrument. Two studies reported significant improvement in gait velocity (p = 0.020) and < 0.05, respectively. One study showed significant improvement in 2-min-walking distance (p < 0.05). QOL was recorded in one study without any significant improvement. Meta-analysis of reviewed studies could not be performed because of different methods of assessing walking ability, small sample size with large confidence interval and issues such as lack of power calculations in some studies. Findings from our systematic and detailed study identify the need for a well-designed RCT to adequately investigate the issues highlighted.
This review could not conclude there was sufficient evidence to support or refute improvement on walking or QOL following BoNTA injection. Reasons for this are discussed, and methods for future RCTs are developed.
提高步行能力是脑卒中患者的首要目标之一。脑卒中后下肢痉挛（PSLLS）会阻碍患者行走并降低其生活质量（QOL）。目前尚不清楚肉毒毒素（BoNTA）注射后对 PSLLS 患者行走能力和 QOL 的改善作用。本研究对 BoNTA 注射治疗 PSLLS 患者的随机对照试验（RCT）进行了系统评价，以评估其对行走能力和 QOL 的改善效果。
我们检索了 PubMed、Web of Science、Embase、CINAHL、ProQuest 学位论文全文库、Google Scholar、世界卫生组织国际临床试验注册平台、ClinicalTrials.gov、Cochrane 以及澳大利亚和新西兰临床试验注册中心，以寻找评估 BoNTA 注射对 PSLLS 患者行走能力和 QOL 改善作用的 RCT 研究。原始检索于 2015 年 9 月 16 日之前完成，之后于 2015 年 9 月 16 日至 2017 年 6 月 6 日在 CINAHL、EMBASE 和 MEDLINE（通过 PubMed）上使用与之前相同的检索词进行了额外的验证性检索。使用 Joanna Briggs 研究所的评价工具对每项研究的方法学质量进行了严格评价。仅纳入评估 BoNTA 注射对行走能力和 QOL 改善作用的安慰剂对照 RCT 研究。
在 2026 条记录中，我们找到了 107 篇全文记录。其中，有 5 项 RCT 符合我们的纳入标准。验证性检索未发现新的试验。两位独立的评审员使用 Joanna Briggs 研究所的评价工具对纳入研究的方法学质量进行了评估。两项研究报道了步行速度有显著改善（p=0.020），且均<0.05。一项研究显示 2 分钟步行距离有显著改善（p<0.05）。一项研究记录了 QOL，但无显著改善。由于评估行走能力的方法不同、样本量小且置信区间大，以及部分研究缺乏功效计算等原因，无法对纳入研究进行荟萃分析。我们的系统和详细研究结果表明，需要进行设计良好的 RCT 来充分调查突出的问题。
本综述无法得出充分的证据来支持或反驳 BoNTA 注射后对行走或 QOL 的改善作用。我们讨论了原因，并提出了未来 RCT 的研究方法。
