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Patient dissatisfaction with medical therapy for chronic constipation or irritable bowel syndrome with constipation: analysis of N-of-1 prospective trials in 81 patients.

患者对药物治疗慢性便秘或肠易激综合征伴便秘的不满: 81 例患者 N-of-1 前瞻性试验分析。

  • 影响因子:4.08
  • DOI:10.1111/apt.15657
  • 作者列表:"Basilisco G","Italian Society of Neurogastroenterology Motility (SINGEM) Study Group.
  • 发表时间:2020-02-12
Abstract

BACKGROUND:Patients with chronic constipation (CC) or with irritable bowel syndrome with constipation are often dissatisfied about their medical therapy, but their condition remains poorly defined. AIMS:To evaluate the patients' satisfaction rates and which factors predict favourable outcomes through the aggregate analysis of N-of-1 trials. METHODS:Eighty-one outpatients with CC or with irritable bowel syndrome with constipation underwent N-of-1 trials with at least a one-month cycle of effective treatment. Three primary endpoints (satisfaction with therapy, improvement after treatment and an extended satisfaction criterion including both endpoints) were adopted to define satisfaction with therapy. Dyssynergia, resting anal pressure, colonic transit time and somatisation were assessed. The Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire and its Modified version (M-PAC-SYM) measured constipation severity. Straining at defecation, stool frequency and form were daily recorded. K statistics for agreement and logistic regression were used at statistical analysis. RESULTS:Satisfaction with therapy was not achieved by 43% of patients, who had a significantly lower Body Mass Index (BMI) and more severe constipation at baseline. Only the change in constipation severity according to M-PAC-SYM remained significantly associated with satisfaction with therapy (OR = 4.3; P < 0.001) at multivariate analysis. CONCLUSIONS:Satisfaction with therapy is often an unmet need for patients with CC or with irritable bowel syndrome with constipation. Lower BMI and more severe constipation are associated with worse outcome. Changes in M-PAC-SYM reflect satisfaction with therapy. ClinicalTrials.gov no. NCT02813616.

摘要

背景: 慢性便秘 (CC) 或伴有便秘的肠易激综合征患者往往对其药物治疗不满意,但其病情仍不明确。 目的: 通过 N-of-1 试验的汇总分析,评估患者的满意率和预测有利结果的因素。 方法: 81 例 CC 或肠易激综合征伴便秘的门诊患者接受了至少 1 个月周期有效治疗的 N-of-1 试验。采用三个主要终点 (治疗满意度、治疗后改善和包括两个终点的扩展满意度标准) 来定义治疗满意度。评估协同失调、静息肛门压、结肠传输时间和躯体化。便秘症状患者评估 (PAC-SYM) 问卷及其修订版 (M-PAC-SYM) 测量便秘严重程度。每日记录排便用力情况、大便次数和大便形态。统计学分析采用 K 统计学进行一致性分析和 logistic 回归。 结果: 43% 的患者没有达到对治疗的满意度,他们在基线时体重指数 (BMI) 显著降低,便秘更严重。根据 M-PAC-SYM,只有便秘严重程度的变化仍然与治疗满意度显著相关 (OR = 4.3; P

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作者列表:["Prathapan KM","Ramos Rivers C","Anderson A","Koutroumpakis F","Koutroubakis IE","Babichenko D","Tan X","Tang G","Schwartz M","Proksell S","Johnston E","Hashash JG","Dunn M","Wilson A","Barrie A","Harrison J","Hartman D","Kim SC","Binion DG"]

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影响因子:3.72
发表时间:2020-01-21
DOI:10.1093/ibd/izz331
作者列表:["Ronchetti S","Gentili M","Ricci E","Migliorati G","Riccardi C"]

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关键词: GILZ IBD 自身免疫 炎症
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