小柯机器人

澳大利亚神经科学研究所James H McAuley团队研究了肌肉松弛剂治疗成人非特异性腰痛的疗效、依从性和安全性。相关论文于2021年7月8日发表在《英国医学杂志》上。

为了探讨肌肉松弛剂治疗腰痛的有效性、依从性和安全性，研究组在Medline、Embase、ClinicalTrials.gov等大型数据库中检索从建库至2021年2月23日的文献，筛选出比较肌肉松弛剂与安慰剂、常规护理、等待治疗或不治疗成人（≥18岁）非特异性腰痛的随机对照试验，并进行系统回顾和荟萃分析。

两名评审员分别使用Cochrane偏倚风险工具和推荐分级、评估、发展和测评，独立鉴定研究、提取数据并评估证据的偏倚风险和确定性。随机效应荟萃分析模型通过限制最大似然估计用来评估合并效应和相应的95%置信区间。结果包括疼痛强度（按0-100分量表测量）、残疾（0-100分量表）、依从性（治疗期间因任何原因停药）和安全性（不良事件、严重不良事件和因不良事件退出试验的参与者人数）。

研究组共纳入49个临床试验，其中31个抽样6505人进行定量分析。对于急性腰痛，极低确定性证据表明，与对照组相比，在两周或更短的时间内，非苯二氮卓类解痉药与疼痛强度降低相关，而与减少残疾无关。低确定性和极低确定性证据表明，与对照组相比，非苯二氮卓类解痉药可能会增加不良事件的风险，但可能对急性腰痛的依从性几乎没有影响。研究其他肌肉松弛剂和不同腰痛持续时间的试验数量很少，证据确定性大幅下降，因为大多数试验都有很高的偏倚风险。

研究结果表明，肌肉松弛剂的临床疗效和安全性存在很大的不确定性。极低和低确定性的证据表明，非苯二氮卓类解痉药可能在两周时或两周内造成轻微但不具临床意义的疼痛强度减轻，并可能分别增加急性腰痛不良事件的风险。

附：英文原文

Title: Efficacy, acceptability, and safety of muscle relaxants for adults with non-specific low back pain: systematic review and meta-analysis

Author: Aidan G Cashin, Thiago Folly, Matthew K Bagg, Michael A Wewege, Matthew D Jones, Michael C Ferraro, Hayley B Leake, Rodrigo R N Rizzo, Siobhan M Schabrun, Sylvia M Gustin, Richard Day, Christopher M Williams, James H McAuley

Issue&Volume: 2021/07/08

Abstract:

Objective To investigate the efficacy, acceptability, and safety of muscle relaxants for low back pain.

Design Systematic review and meta-analysis of randomised controlled trials.

Data sources Medline, Embase, CINAHL, CENTRAL, ClinicalTrials.gov, clinicialtrialsregister.eu, and WHO ICTRP from inception to 23 February 2021.

Eligibility criteria for study selection Randomised controlled trials of muscle relaxants compared with placebo, usual care, waiting list, or no treatment in adults (≥18 years) reporting non-specific low back pain.

Data extraction and synthesis Two reviewers independently identified studies, extracted data, and assessed the risk of bias and certainty of the evidence using the Cochrane risk-of-bias tool and Grading of Recommendations, Assessment, Development and Evaluations, respectively. Random effects meta-analytical models through restricted maximum likelihood estimation were used to estimate pooled effects and corresponding 95% confidence intervals. Outcomes included pain intensity (measured on a 0-100 point scale), disability (0-100 point scale), acceptability (discontinuation of the drug for any reason during treatment), and safety (adverse events, serious adverse events, and number of participants who withdrew from the trial because of an adverse event).

Results 49 trials were included in the review, of which 31, sampling 6505 participants, were quantitatively analysed. For acute low back pain, very low certainty evidence showed that at two weeks or less non-benzodiazepine antispasmodics were associated with a reduction in pain intensity compared with control (mean difference 7.7, 95% confidence interval12.1 to3.3) but not a reduction in disability (3.3, 7.3 to 0.7). Low and very low certainty evidence showed that non-benzodiazepine antispasmodics might increase the risk of an adverse event (relative risk 1.6, 1.2 to 2.0) and might have little to no effect on acceptability (0.8, 0.6 to 1.1) compared with control for acute low back pain, respectively. The number of trials investigating other muscle relaxants and different durations of low back pain were small and the certainty of evidence was reduced because most trials were at high risk of bias.

Conclusions Considerable uncertainty exists about the clinical efficacy and safety of muscle relaxants. Very low and low certainty evidence shows that non-benzodiazepine antispasmodics might provide small but not clinically important reductions in pain intensity at or before two weeks and might increase the risk of an adverse event in acute low back pain, respectively. Large, high quality, placebo controlled trials are urgently needed to resolve uncertainty.

DOI: 10.1136/bmj.n1446

Source: https://www.bmj.com/content/374/bmj.n1446

BMJ-British Medical Journal:《英国医学杂志》，创刊于1840年。隶属于BMJ出版集团，最新IF：93.333
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