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甘露醇用于结肠镜检查肠道准备患者的患者报告结局指标评估:满意度研究

Assessment of Patient-Reported Outcome Measures in Patients Undergoing Bowel Preparation With Mannitol for Colonoscopy: The SATISFACTION Study.

作者信息

Tontini Gian Eugenio, Spada Cristiano, Uebel Peter, Cannizzaro Renato, Ciprandi Giorgio, Vecchi Maurizio

机构信息

Department of Pathophysiology and Organ Transplantation University of Milan Milan Italy.

Gastroenterology and Endoscopy Unit Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan Italy.

出版信息

JGH Open. 2025 Aug 7;9(8):e70237. doi: 10.1002/jgh3.70237. eCollection 2025 Aug.

DOI:10.1002/jgh3.70237
PMID:40786127
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12332180/
Abstract

BACKGROUND

Bowel preparation for colonoscopy causes significant discomfort to patients. Large volumes, unpleasant taste, and split-dosing are the main disadvantages of most laxatives. Oral mannitol could be an attractive option because it acts quickly, requires low volumes, and has a pleasant taste.

AIMS

A Phase III study (SATISFACTION) compared oral mannitol with polyethylene glycol-ascorbate (PEG-ADC). This analysis investigated the effects on patient-reported outcomes (PROMs), mainly concerning the perception of using the preparations.

METHODS

The SATISFACTION Phase III study was an international, multicenter, randomized (1:1), parallel-group, endoscopist-blinded, non-inferiority trial. Taste of preparations, ease of use, and willingness to repeat the preparation with the same product were scored and assessed by the patients.

RESULTS

Bowel preparation with oral mannitol resulted in a better patient satisfaction profile for all PROMs evaluated.

CONCLUSION

Oral mannitol for bowel preparation achieved high patient satisfaction and might be a valuable option for colonoscopy.

TRIAL REGISTRATION

ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT04759885).

摘要

背景

结肠镜检查的肠道准备会给患者带来极大不适。大多数泻药的主要缺点是用量大、味道不佳和分剂量服用。口服甘露醇可能是一个有吸引力的选择,因为它起效快、用量少且味道宜人。

目的

一项III期研究(满意度研究)比较了口服甘露醇与聚乙二醇 - 抗坏血酸盐(PEG - ADC)。该分析调查了对患者报告结局(PROMs)的影响,主要涉及对使用这些制剂的感受。

方法

满意度III期研究是一项国际多中心、随机(1:1)、平行组、内镜医师盲法、非劣效性试验。患者对制剂的味道、易用性以及是否愿意使用同一产品重复进行肠道准备进行评分和评估。

结果

对于所有评估的患者报告结局,口服甘露醇进行肠道准备的患者满意度更高。

结论

口服甘露醇进行肠道准备获得了较高的患者满意度,可能是结肠镜检查的一个有价值的选择。

试验注册

ClinicalTrials.gov(https://clinicaltrials.gov/ct2/show/NCT04759885)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0df4/12332180/55f8eb42f52c/JGH3-9-e70237-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0df4/12332180/40a84c53563d/JGH3-9-e70237-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0df4/12332180/55f8eb42f52c/JGH3-9-e70237-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0df4/12332180/40a84c53563d/JGH3-9-e70237-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0df4/12332180/55f8eb42f52c/JGH3-9-e70237-g002.jpg

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本文引用的文献

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Mannitol for bowel preparation: Efficacy and safety results from the SATISFACTION randomised clinical trial.
Dig Liver Dis. 2025 Feb;57(2):574-583. doi: 10.1016/j.dld.2024.09.024. Epub 2024 Nov 18.
2
Pharmacokinetics of oral mannitol for bowel preparation for colonoscopy.口服甘露醇肠道准备用于结肠镜检查的药代动力学。
Clin Transl Sci. 2022 Oct;15(10):2448-2457. doi: 10.1111/cts.13373. Epub 2022 Aug 8.
3
Factors influencing the presence of potentially explosive gases during colonoscopy: Results of the SATISFACTION study.影响结肠镜检查中潜在爆炸性气体存在的因素:SATISFACTION 研究结果。
Clin Transl Sci. 2023 May;16(5):759-769. doi: 10.1111/cts.13486. Epub 2023 Feb 17.
4
Oral mannitol for bowel preparation: a dose-finding phase II study.口服甘露醇肠道准备:一项剂量探索的 II 期研究。
Eur J Clin Pharmacol. 2022 Dec;78(12):1991-2002. doi: 10.1007/s00228-022-03405-z. Epub 2022 Oct 26.
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The Patient Experience of an Inadequate-Quality Bowel Preparation During the Colonoscopy Process: A Qualitative Study.患者在结肠镜检查过程中经历的肠道准备不充分的体验:一项定性研究。
Gastroenterol Nurs. 2022;45(4):244-253. doi: 10.1097/SGA.0000000000000654. Epub 2022 Jun 25.
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The unmet needs for identifying the ideal bowel preparation.确定理想肠道准备方法的未满足需求。
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