基于一项随机试验数据的事后分析，与经皮胫神经刺激治疗粪便失禁疗效相关的因素。
Factors Associated With Efficacy of Percutaneous Tibial Nerve Stimulation for Fecal Incontinence, Based on Post-Hoc Analysis of Data From a Randomized Trial.
机构信息
National Centre for Bowel Research, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University, London, United Kingdom.
Minimally Invasive and Colorectal Surgery, Toronto Western Hospital, University Health Network, Toronto, Ontario, Canada.
出版信息
Clin Gastroenterol Hepatol. 2017 Dec;15(12):1915-1921.e2. doi: 10.1016/j.cgh.2017.06.032. Epub 2017 Jun 21.
BACKGROUND & AIMS: A recent randomized, multi-center, phase 3 trial, performed in the United Kingdom (Control of Fecal Incontinence using Distal Neuromodulation Trial), demonstrated no significant clinical benefit of percutaneous tibial nerve stimulation (PTNS) compared to sham stimulation in patients with fecal incontinence (FI). However, this study did not analyze predictors of response. We used data from this trial to identify factors that predict the efficacy of PTNS in adults with FI.
METHODS
The study population comprised 205 patients from the CONtrol of Fecal Incontinence using Distal NeuromodulaTion Trial. The primary outcome was a binary indicator of success (≥50% reduction in weekly FI episodes after 12 weeks of treatment) or failure, as per the original trial characteristics including baseline FI symptom type, defecatory urgency, and co-existent symptoms of baseline liquid stool consistency and obstructive defecation (OD) were defined a priori. Univariable and multivariable analyses were performed to explore these factors as predictors of response to PTNS and sham.
RESULTS
In both univariable and multivariable analysis, the presence of OD symptoms negatively predicted outcome in patients who received PTNS (OR, 0.38; 95% CI, 0.16-0.91; P = .029), and positively predicted sham response (OR, 3.45; 95% CI, 1.31-9.21; P = .012). No other tested variable affected outcome. Re-analysis of the primary outcome excluding patients with OD symptoms (n = 112) resulted in a significant clinical effect of PTNS compared to sham (48.9% vs 18.2% response, P = .002; multivariable OR, 4.71; 95% CI, 1.71-12.93; P = .003).
CONCLUSIONS
Concomitant OD symptoms negatively affected the clinical outcome of PTNS vs sham in a major randomized controlled trial. Future appropriately designed studies could further explore this observation with potential for future stratified patient selection.
背景与目的
最近在英国进行的一项多中心、随机、3 期临床试验（使用远端神经调节控制粪便失禁试验）表明，与假刺激相比，经皮胫神经刺激（PTNS）对粪便失禁（FI）患者没有显著的临床获益。然而，这项研究并未分析反应的预测因素。我们使用该试验的数据来确定预测成人 FI 患者 PTNS 疗效的因素。
方法
研究人群包括来自 CONtrol of Fecal Incontinence using Distal NeuromodulaTion Trial 的 205 名患者。主要结局是根据原始试验特征（包括 FI 症状类型、排便急迫感、基线液体粪便一致性和阻塞性排便（OD）共存症状），治疗 12 周后每周 FI 发作次数减少≥50%的二进制指标（成功）或失败。进行单变量和多变量分析，以探索这些因素作为预测 PTNS 和假刺激反应的因素。
结果
在单变量和多变量分析中，OD 症状的存在均预测了接受 PTNS 治疗的患者的结局（OR，0.38；95%CI，0.16-0.91；P=0.029），并预测了假刺激反应（OR，3.45；95%CI，1.31-9.21；P=0.012）。未测试的其他变量对结局无影响。排除 OD 症状患者（n=112）重新分析主要结局，与假刺激相比，PTNS 具有显著的临床效果（48.9% vs 18.2%的反应，P=0.002；多变量 OR，4.71；95%CI，1.71-12.93；P=0.003）。
结论
在一项主要的随机对照试验中，同时存在 OD 症状会对 PTNS 与假刺激的临床结局产生负面影响。未来的适当设计研究可以进一步探索这一观察结果，为未来的分层患者选择提供潜在可能性。
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