目的:这篇综述旨在分析目前使用A型肉毒杆菌毒素(BTX-A)治疗三叉神经痛(TN)的数据,并强调其有效性和安全性的证据。TN患者的疼痛管理具有挑战性,因为面部疼痛通常对常规疗法反应不佳。BTX-A已被建议作为一种潜在的治疗选择,但关于其长期疗效的证据有限.
方法:在各种数据库中进行了全面搜索(PubMed,Scopus,Embase,临床试验和Cochrane图书馆),以确定评估在2023年10月之前在TN中使用BTX-A的临床研究。随机对照试验,单臂研究,和分层研究纳入分析.平均差(MD),效果大小(ES),并对视觉模拟量表(VAS)评分进行95%置信区间(CI)估计,疼痛发作频率和响应者比例。
结果:分析包括23项研究,包括四项随机对照试验,14项单臂研究,和五个分层研究。在随机对照试验中,与基线相比,BTX-A显着降低平均VAS评分(ES:-4.05;95%CI:-6.13,-1.97;P=0.002)。在19个非RCT中,汇总单臂分析显示,BTX-A从基线至随访结束时降低了VAS评分(ES:-5.19,95%CI:-6.05,-4.33,P<0.001)和疼痛发作频率(ES:-17.85,95%CI:-23.36,-12.34,P<0.001).BTX-A治疗的应答者的总比例也是显著的(95CI:0.653,0.761,P=0.003)。
结论:目前的证据表明,BTX-A注射对于难治性TN或对药物或手术治疗无反应的患者是一种有效且安全的选择。然而,需要更多高质量的研究来进一步证实其疗效.
OBJECTIVE: Pain management in patients with TN is challenging, as facial pain often does not respond well to conventional therapies. Botulinum toxin type A (BTX-A) has been suggested as a potential treatment option, but there is limited evidence regarding its long-term efficacy. This review aimed to analyze the current data for the use of in the treatment of trigeminal neuralgia (TN) and highlight the evidence for its efficacy and safety.
METHODS: A comprehensive search was conducted in various databases (PubMed, Scopus, Embase, ClinicalTrials, and Cochrane Library) to identify clinical studies evaluating the use of BTX-A in TN until October 2023. Randomized controlled trials (RCTs), single-arm studies, and stratified studies were included in the analysis. The mean difference (MD), effect size (ES), and 95% confidence interval (CI) were estimated for visual analogue scale (VAS) scores, pain episode frequency, and the proportion of responders.
RESULTS: The analysis included 23 studies, including 4 RCTs, 14 single-arm studies, and 5 stratified studies. In the RCTs, BTX-A was found to significantly reduce mean VAS scores compared with baseline (ES: -4.05; 95% CI: -6.13, -1.97; P =0.002). In 19 non-RCTs, the pooled single-arm analysis revealed that BTX-A decreased VAS scores (ES: -5.19, 95% CI: -6.05, -4.33, P <0.001) and pain attack frequency (ES: -17.85, 95% CI: -23.36, -12.34, P <0.001) from baseline to the end of follow-up. The overall proportion of responders to BTX-A treatment was also significant (95% CI: 0.653, 0.761, P =0.003).
CONCLUSIONS: Current evidence indicates that BTX-A injection is an effective and safe option for patients with refractory TN or not responding to medical or surgical management. However, more high-quality studies are needed to further confirm its efficacy.