Nickel J Curtis, Herschorn Sender, Whitmore Kristene E, Forrest John B, Hu Peter, Friedman Andrew J, Baseman Alan S
Queen's University, Kingston General Hospital, Kingston, Ontario, Canada.
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
J Urol. 2015 Mar;193(3):857-62. doi: 10.1016/j.juro.2014.09.036. Epub 2014 Sep 20.
We compared the efficacy and safety of the currently recommended dose of pentosan polysulfate sodium with a third of the daily dose and with placebo.
In this multicenter, double-blind, randomized, placebo controlled study 368 adults with interstitial cystitis/bladder pain syndrome, defined as an ICSI total score of 8 or greater and a score of greater than 0 on the 4 ICSI component items, received pentosan polysulfate sodium 100 mg once daily or 3 times daily, or matching placebo for 24 weeks. Study eligibility was not based on cystoscopy findings. ICSI was administered at baseline, and at weeks 4, 8, 12, 18 and 24. Unblinded interim analysis performed at 6 years with 54% of the target number of 645 patients enrolled resulted in early study termination.
There was no statistically significant difference between the pentosan polysulfate sodium group and the placebo group or between the 2 pentosan polysulfate sodium groups for the primary end point, defined as responder achieving a 30% or greater reduction from the baseline ICSI total score at study end. This primary end point was achieved by 48 of 118 patients (40.7%) in the placebo group, and by 51 of 128 (39.8%) and 52 of 122 (42.6%) in the pentosan polysulfate sodium 100 mg once daily and 3 times daily groups, respectively. Pentosan polysulfate sodium was well tolerated with a similar percent of patients (range 10.2% to 13.3%) across the groups discontinuing due to an adverse event.
Results of this study in a broad population of patients with symptoms consistent with interstitial cystitis revealed no treatment effect vs placebo for pentosan polysulfate sodium at the currently established dose or at a third of the daily dose.
我们比较了目前推荐剂量的戊聚糖多硫酸钠与每日剂量的三分之一以及安慰剂的疗效和安全性。
在这项多中心、双盲、随机、安慰剂对照研究中，368名间质性膀胱炎/膀胱疼痛综合征成人患者，定义为ICSI总分8分或更高且4项ICSI组成项目得分大于0，接受每日一次或每日三次100毫克戊聚糖多硫酸钠或匹配安慰剂治疗24周。研究入选标准不基于膀胱镜检查结果。在基线时以及第4、8、12、18和24周进行ICSI评估。在纳入645名目标患者的54%时进行了6年的非盲期中分析，导致研究提前终止。
对于主要终点，即研究结束时应答者的ICSI总分较基线降低30%或更多，戊聚糖多硫酸钠组与安慰剂组之间或两个戊聚糖多硫酸钠组之间无统计学显著差异。安慰剂组118名患者中有48名（40.7%）达到该主要终点，每日一次100毫克戊聚糖多硫酸钠组128名患者中有51名（39.8%），每日三次100毫克戊聚糖多硫酸钠组122名患者中有52名（42.6%）达到该主要终点。戊聚糖多硫酸钠耐受性良好，各治疗组因不良事件停药的患者百分比相似（范围为10.2%至13.3%）。
这项针对广泛的有间质性膀胱炎症状患者群体的研究结果显示，目前既定剂量或每日剂量三分之一的戊聚糖多硫酸钠与安慰剂相比无治疗效果。
