膀胱过度活动症治疗中安慰剂效应的影响因素分析

Analysis on influencing factors of the placebo response in overactive bladder

目的探讨膀胱过度活动症（OAB）治疗中安慰剂效应的影响因素。方法分析一项已完成的旨在评价OAB药物疗效的三期平行随机双盲安慰剂对照多中心临床试验的安慰剂组。将OAB治疗应答作为因变量，自变量包括人口学、OAB危险因素及OAB疾病的数据。先进行单因素logistic回归筛选出有统计学意义的可疑影响因素，再用多因素Logistic逐步回归进行分析。结果单因素logistic回归分析结果表明，是否摄入咖啡因、病程、OAB总体严重程度、尿急严重程度、既往是否接受过OAB治疗、是否发生不良事件6个因素在统计学上差异具有显著性（P〈0．1）。多因素logistic逐步回归分析进一步显示，轻中度OAB患者更易发生安慰剂效应，而不摄入咖啡因相对于摄入咖啡因的患者更易出现安慰剂效应，其比值比（95％可信区间）分别为3．094（1．348-7．099）、3．047（1．623—5．719）。结论OAB总体严重程度和是否摄人咖啡因是治疗OAB发生安慰剂效应的独立影响因素。

AIM To study the influencing factors of the placebo response in overactive bladder （OAB）. METH- ODS Data for analysis came from the placebo group of a completed phased 3, parallel, randomized, double-blind, placebo-controlled multicenter clinical trial which aimed at investigating the efficacy of OAB drug. Treatment response was taken as the dependent variable. Independent variables included demographic data, risk factors of OAB and OAB disease data. Variables of statistically significance found by the univariate logistic regression would be taken into the mul- tivariate logistic regression. RESULTS The univariate logistic regression showed that 6 variables had statistical signifi- cance（P 〈 0.1）. They were consumption of caffeine, duration of OAB, severity of urinary urgency, severity of OAB, prior OAB treatment and occurrence of adverse events. The multivariate logistic regression further showed that patients with mild to moderate OAB disease were more likely to have stronger placebo response and patients who did not consume caffeine were more likely to have stronger placebo response than patients who did consume caffeine . The odds ratio（95% confidence interval） was 3.094（1.348-7.099） and 3.047（1.623-5.719） ,respectively. CONCLUSION Severity of OAB and consumption of caffeine are the independent influencing factors of the placebo response in OAB.