A型肉毒毒素治疗三叉神经痛的疗效与安全性：一项随机对照试验的系统评价和荟萃分析

Therapeutic efficacy and safety of Botulinum Toxin A Therapy in Trigeminal Neuralgia: a systematic review and meta-analysis of randomized controlled trials.

作者信息

Morra Mostafa Ebraheem, Elgebaly Ahmed, Elmaraezy Ahmed, Khalil Adham M, Altibi Ahmed M A, Vu Tran Le-Huy, Mostafa Mostafa Reda, Huy Nguyen Tien, Hirayama Kenji

机构信息

Faculty of Medicine, Al Azhar University, Cairo, 11884, Egypt.

Faculty of Medicine, Zagazig University, Zagazig, 44519, Egypt.

出版信息

J Headache Pain. 2016 Dec;17(1):63. doi: 10.1186/s10194-016-0651-8. Epub 2016 Jul 5.

DOI:10.1186/s10194-016-0651-8

PMID:27377706

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4932020/

Abstract

BACKGROUND

Several different interventions have been examined to alleviate pain and reduce frequency of trigeminal neuralgia (TN) paroxysms. However, some patients continue to have persistent or recurrent painful attacks. Using a systematic review and meta-analysis approach, we aimed to synthesize evidence from published randomized controlled trials (RCTs) regarding safety and efficacy of botulinum toxin type A (BTX-A) as a possible emerging choice of treatment for TN.

METHODS

We conducted an electronic search in 10 databases/electronic search engines to access relevant publications. All articles in all languages reporting RCTs on the efficacy and safety of BTX-A in the treatment of TN were included for systematic review and meta-analysis.

RESULTS

A total of four RCTs (n = 178) were identified for final meta-analysis. The overall effect favored BTX-A versus placebo in terms of proportion of responders (risk ratio RR = 2.87, 95 % confidence interval CI [1.76, 4.69], p <0.0001) with no significant detected heterogeneity (p = 0.31; I(2) = 4 %). Paroxysms frequency per day was significantly lower for BTX-A group (mean difference MD = -29.79, 95 % CI [-38.50,-21.08], p <0.00001) with no significant heterogeneity (p = 0.21; I(2) = 36 %).

CONCLUSION

Despite limited data, our results suggest that BTX-A may be an effective and safe treatment option for patients with TN. Further larger and well-designed RCTs are encouraged to translate these findings into better clinical outcome and better quality of life for TN patients.

摘要

背景

已经对几种不同的干预措施进行了研究，以减轻疼痛并减少三叉神经痛（TN）发作的频率。然而，一些患者仍持续或反复出现疼痛发作。我们采用系统评价和荟萃分析的方法，旨在综合已发表的随机对照试验（RCT）中关于A型肉毒毒素（BTX-A）作为TN可能的新治疗选择的安全性和有效性的证据。

方法

我们在10个数据库/电子搜索引擎中进行了电子检索，以获取相关出版物。纳入所有语言报道BTX-A治疗TN有效性和安全性的RCT的所有文章进行系统评价和荟萃分析。

结果

共确定了四项RCT（n = 178）用于最终的荟萃分析。在反应者比例方面，总体效果显示BTX-A优于安慰剂（风险比RR = 2.87，95%置信区间CI [1.76, 4.69]，p <0.0001），未检测到显著异质性（p = 0.31；I(2)= 4%）。BTX-A组每天的发作频率显著更低（平均差MD = -29.79，95% CI [-38.50, -21.08]，p <0.00001），异质性不显著（p = 0.21；I(2)= 36%）。