Efficacy of dextranomer in stabilised hyaluronic acid for treatment of faecal incontinence: a randomised, sham-controlled trial
Efficacy of dextranomer in stabilised hyaluronic acid for treatment of faecal incontinence: a randomised, sham-controlled trial
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DOI：
10.1016/s0140-6736(10)62297-0
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发表时间：
2011-03-19
期刊：
影响因子：
168.9
通讯作者：
Bernstein, Mitch
中科院分区：
文献类型：
--
作者：
Graf, Wilhelm;Mellgren, Anders;Bernstein, Mitch
背景肛管内注射填充剂是一种越来越多地用于治疗大便失禁的方法，但在对照试验中尚未显示其有效性。我们的目的是评估注射右旋糖酐在稳定的透明质酸（NASHA Dx）治疗大便失禁的疗效。方法在这个随机，双盲，假对照试验中，年龄在18-75岁的患者从美国和欧洲的中心被随机分配（2：1）接受经肛门粘膜下注射NASHA Dx或假注射。随机化按性别和地区分层，分为6个区组，并使用计算机生成的实时网络系统进行管理。患者和研究者在6个月内对分配情况保持盲态，通过2周日记和临床评估评估对大便失禁严重程度和生活质量的影响。主要终点是根据尿失禁发作次数对治疗的反应。治疗应答定义为发作次数减少50%或更多。积极治疗组的患者仍在随访中。该试验注册于ClinicalTrials.gov，编号NCT 00605826。结果筛选了278例患者以纳入研究，其中206例随机分配接受NASHA Dx（n=136）或假治疗（n=70）。与接受假治疗的22例患者相比，接受NASHA Dx的71例患者（52%）失禁发作次数减少50%或更多（31%;比值比2.36，95% CI 1.24-4.47，p=0.0089）。我们记录了128例治疗相关的不良事件，其中2例是严重的（1例直肠脓肿和1例前列腺脓肿）。对患者选择标准、最佳注射剂量、理想注射部位和长期结果的细化可能会进一步增加这种微创治疗的接受度。
Background Injection of a bulking agent in the anal canal is an increasingly used treatment for faecal incontinence, but efficacy has not been shown in a controlled trial. We aimed to assess the efficacy of injection of dextranomer in stabilised hyaluronic acid (NASHA Dx) for treatment of faecal incontinence.Methods In this randomised, double-blind, sham-controlled trial, patients aged 18-75 years from centres in USA and Europe were randomly assigned (2:1) to receive either transanal submucosal injections of NASHA Dx or sham injections. Randomisation was stratified by sex and region in blocks of six, and managed with a computer generated, real-time, web-based system. Patients and investigators were masked to assignment for 6 months when the effect on severity of faecal incontinence and quality of life was assessed with a 2-week diary and clinical assessments. The primary endpoint was response to treatment based on the number of incontinence episodes. A response to treatment was defined as a reduction in number of episodes by 50% or more. Patients in the active treatment group are still being followed up. This trial was registered with ClinicalTrials.gov, number NCT00605826.Findings 278 patients were screened for inclusion, of whom 206 were randomised assigned to receive NASHA Dx (n=136) or sham treatment (n=70). 71 patients who received NASHA Dx (52%) had a 50% or more reduction in the number of incontinence episode, compared with 22 patients who received sham treatment (31%; odds ratio 2.36, 95% CI 1.24-4.47, p=0.0089). We recorded 128 treatment-related adverse events, of which two were serious (1 rectal abscess and 1 prostatic abscess).Interpretation Anal injection of NASHA Dx is an effective treatment for faecal incontinence. A refinement of selection criteria for patients, optimum injected dose, ideal site of injection, and long-term results might further increase the acceptance of this minimally invasive treatment.