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一项前瞻性随机试验,比较低剂量口服磷酸钠加刺激性泻药与大剂量聚乙二醇溶液用于结肠清洁的效果。

A prospective randomized trial comparing low-dose oral sodium phosphate plus stimulant laxatives with large volume polyethylene glycol solution for colon cleansing.

作者信息

Hookey Lawrence C, Depew William T, Vanner Stephen J

机构信息

Gastrointestinal Diseases Research Unit, Queen's University, Kingston, Ontario, Canada.

出版信息

Am J Gastroenterol. 2004 Nov;99(11):2217-22. doi: 10.1111/j.1572-0241.2004.40482.x.

Abstract

This study examined whether the combination of a single dose (45 ml) oral sodium phosphate (NaP), four bisacodyl tablets (5 mg), and one bisacodyl enema (10 mg) preparation, Fleet Prep Kit 3 (FPK #3), was better tolerated and more efficacious than 4 L polyethylene glycol solution (PEG) for colonic cleansing prior to colonoscopy. One hundred and seventy-one patients were enrolled in this prospective, randomized, single-blinded study designed to detect a 20% or greater difference in patient tolerance and effectiveness in colonic cleansing between the two agents. The single dose of NaP and the bisacodyl tablets were administered at 1900 h and at 2100 h, respectively, the evening prior to colonoscopy and the bisacodyl enema 2 h before the procedure. PEG was consumed over 1-2 h the evening prior to colonoscopy. Most patients (84%) found the FPK #3 easy or tolerable compared to only 33% receiving PEG (p < 0.001). Over 40% could not complete the PEG. There was no detectable difference in the efficacy between the two preparations (p= 0.74). Comparison of biochemical and hemodynamic values obtained before and after colonic cleansing did not reveal any significant differences apart from hyperphosphatemia in a few patients (16%) receiving FPK #3 and minor changes in blood urea nitrogen and chloride. These findings suggest that FPK #3 is better tolerated and as safe as PEG but does not provide more efficacious cleansing of the colon.

摘要

本研究旨在探讨单剂量(45毫升)口服磷酸钠(NaP)、四片比沙可啶片(5毫克)和一支比沙可啶灌肠剂(10毫克)组成的Fleet Prep Kit 3(FPK #3)在结肠镜检查前进行结肠清洁时,是否比4升聚乙二醇溶液(PEG)耐受性更好且更有效。171名患者参与了这项前瞻性、随机、单盲研究,该研究旨在检测两种药物在患者耐受性和结肠清洁效果方面是否存在20%或更大的差异。单剂量的NaP和比沙可啶片分别在结肠镜检查前一晚的19:00和21:00服用,比沙可啶灌肠剂在检查前2小时使用。PEG在结肠镜检查前一晚的1 - 2小时内服用。与仅33%接受PEG的患者相比,大多数患者(84%)认为FPK #3容易耐受或可以接受(p < 0.001)。超过40%的接受PEG的患者无法完成服用。两种制剂在疗效上没有可检测到的差异(p = 0.74)。结肠清洁前后获得的生化和血流动力学值比较显示,除了少数接受FPK #3的患者(16%)出现高磷血症以及血尿素氮和氯有轻微变化外,没有发现任何显著差异。这些发现表明,FPK #3耐受性更好,与PEG一样安全,但在结肠清洁方面并没有更有效。

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