Consensus Recommendations on Initiating Prescription Therapies for Opioid‐Induced Constipation

C. Argoff, M. Brennan, M. Camilleri, A. Davies, J. Fudin, K. Galluzzi, J. Gudin, A. Lembo, S. Stanos, L. Webster
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引用次数: 99

Abstract

Abstract Objective Aims of this consensus panel were to determine (1) an optimal symptom‐based method for assessing opioid‐induced constipation in clinical practice and (2) a threshold of symptom severity to prompt consideration of prescription therapy. Methods A multidisciplinary panel of 10 experts with extensive knowledge/experience with opioid‐associated adverse events convened to discuss the literature on assessment methods used for opioid‐induced constipation and reach consensus on each objective using the nominal group technique. Results Five validated assessment tools were evaluated: the Patient Assessment of Constipation–Symptoms (PAC‐SYM), Patient Assessment of Constipation–Quality of Life (PAC‐QOL), Stool Symptom Screener (SSS), Bowel Function Index (BFI), and Bowel Function Diary (BF‐Diary). The 3‐item BFI and 4‐item SSS, both clinician administered, are the shortest tools. In published trials, the BFI and 12‐item PAC‐SYM are most commonly used. The 11‐item BF‐Diary is highly relevant in opioid‐induced constipation and was developed and validated in accordance with US Food and Drug Administration guidelines. However, the panel believes that the complex scoring for this tool and the SSS, PAC‐SYM, and 28‐item PAC‐QOL may be unfeasible for clinical practice. The BFI is psychometrically validated and responsive to changes in symptom severity; scores range from 0 to 100, with higher scores indicating greater severity and scores >28.8 points indicating constipation. Conclusions The BFI is a simple assessment tool with a validated threshold of clinically significant constipation. Prescription treatments for opioid‐induced constipation should be considered for patients who have a BFI score of ≥30 points and an inadequate response to first‐line interventions.
阿片类药物引起的便秘启动处方治疗的共识建议
该共识小组的目的是确定(1)在临床实践中评估阿片类药物引起的便秘的最佳基于症状的方法;(2)症状严重程度的阈值,以提示考虑处方治疗。方法一个由10名具有丰富阿片类药物相关不良事件知识/经验的专家组成的多学科小组召开会议,讨论阿片类药物引起的便秘评估方法的文献,并使用名义小组技术就每个目标达成共识。结果评估了5种有效的评估工具:患者便秘症状评估(PAC‐SYM)、患者便秘生活质量评估(PAC‐QOL)、大便症状筛查(SSS)、肠功能指数(BFI)和肠功能日记(BF‐Diary)。3项BFI和4项SSS均由临床医生管理,是最短的工具。在已发表的试验中,BFI和12项PAC - SYM是最常用的。11项BF日记与阿片类药物引起的便秘高度相关,并根据美国食品和药物管理局的指南开发和验证。然而,专家组认为,该工具与SSS、PAC - SYM和28项PAC - QOL的复杂评分在临床实践中可能不可行。BFI经过心理测量学验证,对症状严重程度的变化有反应;得分范围为0 ~ 100分,得分越高说明便秘越严重,得分>28.8分说明便秘。结论BFI是一种简单的评估工具,具有临床显著便秘的有效阈值。对于BFI评分≥30分且对一线干预反应不足的患者,应考虑处方治疗阿片类药物引起的便秘。
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