National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
BMC Musculoskelet Disord. 2022 Mar 25;23(1):286. doi: 10.1186/s12891-022-05175-2.
To explore the efficacy and safety of botulinum toxin in patients who received distraction osteogenesis of the lower extremities.
We searched the PubMed, Medline, Cochrane Library, and Web of Science databases for randomized controlled trials that administered botulinum toxin to individuals who underwent distraction osteogenesis of the lower limbs. The final search was conducted on July 6, 2021. Quality assessments were conducted using the Cochrane risk of bias tool and the Jadad scale. We performed random-effects meta-analysis to calculate the standardized mean differences (SMDs) and confidence intervals (CIs) of the pooled effect sizes, and subgroup analysis and meta-regression were performed for potential moderators.
Our analysis of four randomized controlled trials, which enrolled a total of 257 participants, revealed that the difference in pain during the distraction phase was not statistically significant between groups (SMD, - 0.165; 95% CI, - 0.379 to 0.050, p = 0.133, I = 0.0%). The meta-regression analyses did not find any influence on the effect size, considering age (β = - 0.0092; p = 0.61) and the amount of lengthening (β = 0.0023; p = 0.99). Subgroup analysis did not reveal difference between different doses of botulinum toxin and single or multi-site study design. An analysis of two randomized controlled trials enrolling a total of 177 individuals demonstrated a limited effect of botulinum toxin in reducing postoperative pain (SMD, - 0.239; 95% CI, - 0.641 to 0.162, p = 0.24, I = 37.6%), total adverse events (SMD, - 0.207; 95% CI, - 0.505 to 0.090, p = 0.17, I = 0.0%), and infection of pin site (SMD, - 0.131; 95% CI, - 0.428 to 0.165, p = 0.39, I = 0.0%). No botulinum toxin-related adverse events were reported.
The current evidence does not support the administration of botulinum toxin in patients who receive distraction osteogenesis of the lower limbs. However, we were unable to draw decisive conclusions because of the limitations of our meta-analysis. Future well-designed, large-scale randomized controlled trials are necessary to confirm our conclusions.
探讨下肢延长术患者应用肉毒毒素的疗效和安全性。
我们检索了 PubMed、Medline、Cochrane 图书馆和 Web of Science 数据库，纳入了对接受下肢延长术的患者应用肉毒毒素的随机对照试验。最终检索时间为 2021 年 7 月 6 日。使用 Cochrane 偏倚风险工具和 Jadad 量表对质量进行评估。我们进行了随机效应荟萃分析，计算了汇总效应大小的标准化均数差（SMD）和置信区间（CI），并进行了亚组分析和 meta 回归以分析潜在的调节因素。
我们对 4 项随机对照试验进行分析，共纳入 257 名患者，结果显示两组患者在牵引期疼痛方面的差异无统计学意义（SMD，-0.165；95%CI，-0.379 至 0.050，p=0.133，I=0.0%）。meta 回归分析未发现年龄（β=-0.0092；p=0.61）和延长量（β=0.0023；p=0.99）对效应大小有影响。亚组分析未发现不同剂量的肉毒毒素与单部位或多部位研究设计之间存在差异。对纳入 177 名患者的 2 项随机对照试验的分析表明，肉毒毒素在减轻术后疼痛方面的效果有限（SMD，-0.239；95%CI，-0.641 至 0.162，p=0.24，I=37.6%），总不良事件（SMD，-0.207；95%CI，-0.505 至 0.090，p=0.17，I=0.0%）和针道感染（SMD，-0.131；95%CI，-0.428 至 0.165，p=0.39，I=0.0%）的差异无统计学意义。未报告与肉毒毒素相关的不良事件。
目前的证据不支持下肢延长术患者应用肉毒毒素。然而，由于我们的荟萃分析存在局限性，我们无法得出确定的结论。未来需要进行设计良好、规模较大的随机对照试验来证实我们的结论。
