Mouly Stéphane, Mahé Isabelle, Knellwolf Anne-Laure, Simoneau Guy, Bergmann Jean-François
Unit of Therapeutic Research, Department of Internal Medicine, Lariboisière Hospital, Paris, France.
Curr Ther Res Clin Exp. 2005 Nov;66(6):486-500. doi: 10.1016/j.curtheres.2005.12.002.
Polyethylene glycol (PEG) solutions, with or without osmotic agents, are used to empty the large intestine before procedures such as colonoscopy or colonic surgery. Data concerning the effectiveness of vitamin C as an ingredient in colonic preparations are scant.
The aim of this article was to assess the effectiveness, acceptability, and tolerability of 6 preparations of a standard PEG electrolyte solution containing different doses of PEG, vitamin C (as an osmotic agent), and sodium sulfate in colonic cleansing.
This double-blind, randomized, 2-period crossover study was conducted at the Lariboisière Hospital, Paris, France. Healthy adult volunteers were randomly assigned to receive 2 of 6 colonic cleansing preparations, each containing different doses of PEG (100 or 125 g/L), vitamin C (0, 5, or 10 g/L, in the form of sodium ascorbate, ascorbic acid, or a mixture of both), and sodium sulfate (5 or 7.5 g/L), diluted in water to a volume of 2 L. Study drug administration was separated by a washout period of 7 to 15 days, after which the volunteers received an alternate preparation. Stools were collected for 10 hours after the start of solution ingestion. The primary efficacy end point was stool volume. Secondary end points included acceptability of taste, assessed using a 100-mm visual analog scale (VAS) (0 = excellent to 100 = execrable), taste criteria (saltiness, acidity, and sweetness, assessed on a 4-point Likert-type scale [0 = very pleasant to 3 = intolerable]) and tolerability (clinical effects [changes in body weight, blood pressure, heart rate, and nausea and vomiting] and biologic effects [changes in serum electrolytes, creatinine, hematocrit, and ascorbic acid]).
Thirty volunteers (15 men, 15 women; mean [SD] age, 29.8 [8.2] years [range, 20-45 years]) were enrolled and completed the study. Mean (SD) stool volume obtained with preparations containing 10 g/L of vitamin C did not differ significantly from the volume obtained without vitamin C (2.54 [0.54] L vs 1.93 [0.62] L; 95% CI, -0.13 to 1.47). Mean (SD) VAS scores for acceptability of taste ranged from 54.4 (25.0) (preparation E) to 74.4 (20.1) (preparation C) (P = 0.03 preparation E vs all other preparations). The only significant difference in taste criteria was in acidity, with preparation A being the least acidic according to patients' ratings on the VAS (1.4 [0.7] vs 1.8 [0.4] [mean of the other 5 preparations combined]; P = 0.04 preparation A vs all other preparations). Mild dehydration occurred in 6 subjects (1 for each preparation). No clinical or biological adverse effects were found.
In this study of 6 colonic cleansing preparations in healthy volunteers, the use of high-dose vitamin C as an osmotic agent in addition to PEG did not significantly increase stool output. All 6 preparations were well tolerated.
聚乙二醇（PEG）溶液，无论是否含有渗透剂，都用于在结肠镜检查或结肠手术等操作前清空大肠。关于维生素C作为结肠制剂成分有效性的数据很少。
本文旨在评估6种含有不同剂量PEG、维生素C（作为渗透剂）和硫酸钠的标准PEG电解质溶液制剂在结肠清洁中的有效性、可接受性和耐受性。
这项双盲、随机、两阶段交叉研究在法国巴黎拉里博伊斯医院进行。健康成年志愿者被随机分配接受6种结肠清洁制剂中的2种，每种制剂含有不同剂量的PEG（100或125 g/L）、维生素C（0、5或10 g/L，以抗坏血酸钠、抗坏血酸或两者混合物的形式）和硫酸钠（5或7.5 g/L），用水稀释至2 L体积。研究药物给药间隔7至15天的洗脱期，之后志愿者接受另一种制剂。在开始摄入溶液后收集10小时的粪便。主要疗效终点是粪便体积。次要终点包括使用100毫米视觉模拟量表（VAS）评估的口味可接受性（0 = 极佳至100 = 极差）、口味标准（咸味、酸度和甜度，根据4点李克特量表评估[0 = 非常宜人至3 = 无法忍受]）和耐受性（临床效应[体重、血压、心率以及恶心和呕吐的变化]和生物学效应[血清电解质、肌酐、血细胞比容和抗坏血酸的变化]）。
30名志愿者（15名男性，15名女性；平均[标准差]年龄，29.8 [8.2]岁[范围，20 - 45岁]）入组并完成研究。含10 g/L维生素C的制剂获得的平均（标准差）粪便体积与不含维生素C的制剂获得的体积相比无显著差异（2.54 [0.54] L对1.93 [0.62] L；95%置信区间， - 0.13至1.47）。口味可接受性的平均（标准差）VAS评分范围为54.4（25.0）（制剂E）至74.4（20.1）（制剂C）（制剂E与所有其他制剂相比，P = 0.03）。口味标准中唯一的显著差异在于酸度，根据患者在VAS上的评分，制剂A酸性最低（1.4 [0.7]对1.8 [0.4][其他5种制剂组合的平均值]；制剂A与所有其他制剂相比，P = 0.04）。6名受试者（每种制剂1名）出现轻度脱水。未发现临床或生物学不良反应。
在这项针对健康志愿者的6种结肠清洁制剂的研究中，除PEG外使用高剂量维生素C作为渗透剂并未显著增加粪便排出量。所有6种制剂耐受性良好。
