Fischoff Debra K, Spivakovsky Silvia
NYU College of Dentistry, New York, USA.
Evid Based Dent. 2018 Jun;19(2):57-58. doi: 10.1038/sj.ebd.6401310.
Data sourcesMedline via PubMed, the Web of Science and the Cochrane Library were searched until April 2014.Study selectionRandomised controlled trials (RCTs) comparing the efficacy of botulinum toxin type A (BoTN-A) with placebo in patients with painful trigeminal (TN) and postherpetic neuralgia (PHN) reporting changes in pain intensity in patients aged 19 years and older available in English were included.Data extraction and synthesisThree authors independently assessed for inclusion, extracted standard data and assessed for risk of bias. The primary outcomes were baseline and post treatment intensity of pain and patients reporting pain relief of 50% or greater.For continuous outcomes the treatment effect was measured as mean differences with 95% confidence intervals (CIs). For dichotomous outcome of reduction of pain of 50% or more, relative risk (risk ratio) with 95% CIs was reported. Statistical heterogeneity was tested with Cochran's test for heterogeneity and quantified by the I2 statistic. Results were combined using random-effects model in the presence of statistical heterogeneity otherwise fixed effect model was used.ResultsSix studies were included. The effects of the interventions were presented in three meta-analyses. Mean difference in post treatment pain (six studies) pooled results showed a reduction of -3.009 in the VAS (95% CI -4.566 to -1.453 p<0.001) with the use of BoTN-A. Standardised difference in mean post treatment pain (six studies) was -0.918 (95% CI -1.197 to -0.639 p<0.001) in favor of BoTN-A. For the percentage of patients experiencing 50% pain reduction (three studies) absolute risk difference and relative risk were calculated (RR 2.892, 95% CI 1.726 to 4.848 p<0.001) in favour of the use of BoTN-A.ConclusionsThe authors concluded that there is moderate evidence regarding the efficacy of BoTN-A in treating patients with trigeminal neuralgia and postherpetic neuralgia.
数据来源
通过PubMed检索Medline、科学网和考克兰图书馆,检索截至2014年4月。
研究选择
纳入年龄在19岁及以上、以英文发表的、比较A型肉毒杆菌毒素(BoTN-A)与安慰剂对疼痛性三叉神经痛(TN)和带状疱疹后神经痛(PHN)患者疼痛强度变化疗效的随机对照试验(RCT)。
数据提取与综合分析
三位作者独立评估纳入情况、提取标准数据并评估偏倚风险。主要结局为基线和治疗后疼痛强度,以及报告疼痛缓解50%或以上的患者。
对于连续性结局,治疗效果以95%置信区间(CI)的平均差异衡量。对于疼痛减轻50%或更多的二分结局,报告95%CI的相对风险(风险比)。采用Cochran异质性检验检测统计异质性,并通过I²统计量进行量化。存在统计异质性时,采用随机效应模型合并结果,否则采用固定效应模型。
结果
纳入六项研究。三项荟萃分析展示了干预措施的效果。使用BoTN-A后,治疗后疼痛的平均差异(六项研究)汇总结果显示视觉模拟评分(VAS)降低了-3.009(95%CI -4.566至-1.453,p<0.001)。治疗后疼痛平均标准化差异(六项研究)为-0.918(95%CI -1.197至-0.639,p<0.001),支持使用BoTN-A。对于经历疼痛减轻50%的患者百分比(三项研究),计算了绝对风险差异和相对风险(RR 2.8