A型肉毒毒素治疗慢性腰痛的疗效和安全性：系统评价、meta分析、试验序贯分析和meta回归

IF 3.5 2区医学 Q1 ANESTHESIOLOGY

European Journal of Pain Pub Date : 2025-02-21 DOI:10.1002/ejp.4796

Waseem Wagrees, Hesham Kelani, Hazem Mohamed Salamah, Abdelrahman Mahmoud, Yehya Khlidj, Mohamed R. Abdelraouf, Bahaa Sharaf, Moustafa Elnewishy, Nadia Albaramony, Ahmed Naeem, Ahmed Abd Elazim, Mohammad El-Ghanem, Diana Greene-Chandos, Mohammad Jadidi, David P. Lerner, Arthur D. Kay, Lisa R. Merlin, Charles Brock

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引用次数: 0

摘要

背景：慢性腰痛（CLBP）是致残的主要原因。A型肉毒杆菌神经毒素（BoNT-A）具有较强的抗痉挛和镇痛作用，提示与其他治疗方法相比，其局部肌肉注射可降低CLBP。在这项系统回顾和荟萃分析中，我们调查了BoNT-A对CLBP患者的疗效和安全性。方法我们检索PubMed、Scopus、Cochrane和Web of Science数据库，以比较BoNT-A与其他疗法在功能改善和疼痛改善方面的研究，这些研究以视觉模拟量表（VAS）和临床显著的疼痛改善（VAS评分降低50%或更多）来衡量。我们采用试验序列分析（TSA）来证实这些发现。采用GRADE方法评估证据的整体质量。结果共纳入9项研究，7项随机临床试验（rct）和2项前瞻性观察性研究。与对照组相比，BoNT-A增加了临床显著性疼痛改善（RR = 4.82, 95% CI (3.00, 7.76), p < 0.00001）和功能改善（RR = 3.81, 95% CI (2.40, 6.04), p < 0.00001）的发生率（低确定性证据），降低了VAS评分（MD = - 1.62, 95% CI (- 3.13, - 0.11), p = 0.04）（极低确定性证据）。亚组分析显示BoNT-A对生理盐水有效（中等确定性证据），与类固醇和局部麻醉剂相当（极低确定性证据）。TSA证实了有关疼痛和功能改善的临床改善的发现。结论BoNT-A治疗CLBP耐受性好，治疗效果好，治疗持续时间长。需要未来的高质量研究来证实我们的发现。本文提供了很好的证据，表明BoNT-A具有更高的疗效和更长的作用时间，可用于治疗生理盐水注射无效的顽固性慢性腰痛患者。与类固醇和局部麻醉注射相比，没有足够的数据得出确切的结论，需要进一步的研究。

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The Efficacy and Safety of Botulinum Neurotoxin Type A in Treating Chronic Low Back Pain: A Systematic Review, Meta-Analysis, Trial Sequential Analysis, and Meta-Regression

Background

Chronic low back pain (CLBP) is a leading cause of disability. Botulinum neurotoxin type A (BoNT-A) has strong anti-spasmodic and analgesic effects, suggesting that its local muscular injection can reduce CLBP compared to other therapies. In this systematic review and meta-analysis, we investigated the efficacy and safety of BoNT-A on patients with CLBP.

Methods

We searched PubMed, Scopus, Cochrane, and Web of Science databases for studies comparing BoNT-A to other therapies in terms of functional improvement and pain improvement as measured by visual analog scale (VAS) and clinically significant improvement in pain (50% or greater reduction in VAS score). We employed trial sequential analysis (TSA) to confirm the findings. The GRADE approach was employed to assess the overall quality of the evidence.

Results

The search yielded nine studies, seven randomised clinical trials (RCTs), and two prospective observational studies. Compared to the control, BoNT-A increased the incidence of clinically significant improvement in pain (RR = 4.82, 95% CI (3.00, 7.76), p < 0.00001) and functional improvement (RR = 3.81, 95% CI (2.40, 6.04), p < 0.00001) (low-certainty evidence), and reduced VAS score (MD = −1.62, 95% CI (−3.13, −0.11), p = 0.04) (very low-certainty evidence). Subgroup analysis showed that BoNT-A is effective against normal saline (moderate-certainty evidence), and it was comparable to steroids and local anaesthetics (very low-certainty evidence). TSA confirmed the findings regarding clinical improvement in pain and functional improvement.

Conclusion

BoNT-A is a tolerable and effective treatment for CLBP with a longer duration of action. Future high-quality studies are needed to confirm our findings.

Significance

This paper provides good evidence that BoNT-A may be employed in patients suffering from resistant chronic low back pain not responding to normal saline injection due to its higher efficacy and longer duration of action. Compared to steroids and local anaesthetics injections, there is not enough data to draw a firm conclusion and future studies are needed.

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来源期刊

European Journal of Pain 医学-临床神经学

CiteScore

7.50

自引率

5.60%

发文量

163

审稿时长

4-8 weeks

期刊介绍： European Journal of Pain (EJP) publishes clinical and basic science research papers relevant to all aspects of pain and its management, including specialties such as anaesthesia, dentistry, neurology and neurosurgery, orthopaedics, palliative care, pharmacology, physiology, psychiatry, psychology and rehabilitation; socio-economic aspects of pain are also covered. Regular sections in the journal are as follows: • Editorials and Commentaries • Position Papers and Guidelines • Reviews • Original Articles • Letters • Bookshelf The journal particularly welcomes clinical trials, which are published on an occasional basis. Research articles are published under the following subject headings: • Neurobiology • Neurology • Experimental Pharmacology • Clinical Pharmacology • Psychology • Behavioural Therapy • Epidemiology • Cancer Pain • Acute Pain • Clinical Trials.