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高分辨率测压法揭示了聚乙二醇、比沙可啶和普芦卡必利对健康受试者结肠运动的不同影响:一项具有潜在临床意义的急性、开放标签、随机、交叉、读者盲法研究。

High-resolution manometry reveals different effect of polyethylene glycol, bisacodyl, and prucalopride on colonic motility in healthy subjects: An acute, open label, randomized, crossover, reader-blinded study with potential clinical implications.

机构信息

Translational Research Center for Gastrointestinal Disorders (TARGID, Catholic University of Leuven, KU Leuven, Leuven, Belgium.

NIHR Nottingham Biomedical Research Centre (BRC), Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, UK.

出版信息

Neurogastroenterol Motil. 2021 May;33(5):e14040. doi: 10.1111/nmo.14040. Epub 2020 Dec 10.

Abstract

BACKGROUND

Polyethylene glycol (PEG), bisacodyl, and prucalopride have been reported to be more effective than placebo in treating patients with constipation but about 50% of the patients still do not respond to these medications. Only bisacodyl and prucalopride are expected to directly stimulate the colonic motility in humans in vivo. As no previous study has done this, the aim of the study was to investigate the effect of PEG, bisacodyl, and prucalopride as compared to placebo on colonic motility assessed by means of the high-resolution manometry (HRM) in healthy subjects.

METHODS

Ten healthy subjects have been enrolled in an acute, open label, randomized, reader-blinded, crossover study and requested to undergo a colonoscopy-assisted HRM measuring their colonic motility before and after oral administration of 13.8 g (two doses) PEG, 10 mg bisacodyl, 2 mg prucalopride, and placebo.

KEY RESULTS

In the human prepared colon, oral administration of PEG significantly increases the number of low-amplitude long distance propagating contractions (p = 0.007 vs placebo) while bisacodyl significantly increases the number of high-amplitude propagating contractions (HAPCs) (all p < 0.01 vs PEG, prucalopride, and placebo). Prucalopride has no major effect on the number of propagating contractions but increases HAPCs amplitude (p = 0.01).

CONCLUSIONS & INFERENCES: In humans, PEG, prucalopride, and bisacodyl have distinct effects on colonic motility. This information has clinical implication, as it indicates that the combination of prucalopride and bisacodyl, normally not considered in clinical practice, could be effective in treating patients with constipation refractory to single medications.

摘要

背景

聚乙二醇(PEG)、比沙可啶和普芦卡必利已被报道在治疗便秘患者方面比安慰剂更有效,但仍有约 50%的患者对这些药物没有反应。只有比沙可啶和普芦卡必利有望在体内直接刺激结肠蠕动。由于以前没有研究过这一点,因此本研究的目的是比较 PEG、比沙可啶和普芦卡必利与安慰剂对健康受试者通过高分辨率测压(HRM)评估的结肠动力的影响。

方法

10 名健康受试者被纳入一项急性、开放标签、随机、读者盲法、交叉研究,并要求在口服 13.8 g(两剂)PEG、10 mg 比沙可啶、2 mg 普芦卡必利和安慰剂前后接受结肠镜辅助 HRM 测量其结肠动力。

主要结果

在人类准备好的结肠中,口服 PEG 可显著增加低幅度长距离传播收缩的数量(p=0.007 与安慰剂相比),而比沙可啶可显著增加高幅度传播收缩的数量(与 PEG、普芦卡必利和安慰剂相比,均 p<0.01)。普芦卡必利对传播收缩的数量没有主要影响,但增加了 HAPCs 的幅度(p=0.01)。

结论和推断

在人类中,PEG、普芦卡必利和比沙可啶对结肠动力有不同的影响。这些信息具有临床意义,因为它表明普芦卡必利和比沙可啶的联合应用,通常在临床实践中不被考虑,可能对治疗对单一药物难治的便秘患者有效。

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