Pharmacokinetics of oral mannitol for bowel preparation for colonoscopy

被引:6
|
作者
Fiori, Giancarla [1 ]
Spada, Cristiano [2 ]
Soru, Pietro [1 ]
Tontini, Gian Eugenio [3 ,4 ]
Bravi, Ivana [1 ]
Cesana, Bruno Mario [5 ]
Cesaro, Paola [2 ]
Manes, Gianpiero [6 ]
Orsatti, Anna [7 ]
Prada, Alberto [8 ]
Quadarella, Alessandro [2 ]
Schettino, Mario [6 ]
Spina, Luisa [4 ]
Trovato, Cristina [1 ]
Carnovali, Marino [9 ]
Vecchi, Maurizio [3 ,4 ]
Cavallaro, Flaminia
Codazzi, Manuela
De Nucci, Germana
De Roberto, Giuseppe
Devani, Massimo
Di Paolo, Dhanai
Elli, Luca
Hinkel, Carsten
Jakobs, Ralf
Janke, Daniel
Lombardo, Vincenza
Lovera, Mauro
Radaelli, Franco
Ravizza, Davide
Uebel, Peter
Valats, Jean Christoph
Vollmar, Johanna
Zimmermann, Tim
Ciprandi, Giorgio
机构
[1] IRCCS, Div Endoscopia, Ist Europe Oncol, Milan, Italy
[2] Fdn Poliambulanza Ist Osped, UO Endoscopia Digest, Brescia, Italy
[3] Univ Milan, Dept Pathophysiol & Organ Transplantat, Milan, Italy
[4] IRCCS Fdn Ca Granda Osped Maggiore Policlin, Gastroenterol & Endoscopy Unit, Milan, Italy
[5] Univ Brescia, Fac Med & Surg, Stat & Biomath Unit, Dept Mol & Transact Med, Brescia, Italy
[6] ASST Rhodense Presidi Rho C Garbagnate, UOC Gastroenterol, Garbagnate Milanese, MI USA
[7] NTC, Med Affairs, Via Gracchi 35, I-20146 Milan, Italy
[8] Ist Auxol Italiano, Serv Gastroenterol & Endoscopia Digest, Milan, Italy
[9] Osped Papa Giovanni XXIII, Bergamo, Italy
来源
关键词
OSMOLALITY; EXPLOSION; QUALITY; VOLUME;
D O I
10.1111/cts.13373
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
This study aimed to define the pharmacokinetics (PKs) of oral mannitol used as an osmotic laxative for bowel preparation for colonoscopy. The PKs of oral mannitol was evaluated in a substudy as part of a phase II dose-finding, international, multicenter, randomized, parallel-group, endoscopist-blinded study. Patients were randomly assigned to take 50, 100, or 150 g mannitol. Venous blood samples were drawn at baseline (T-0), 1 h (T-1), 2 h (T-2), 4 h (T-4), and 8 h (T-8) after completion of mannitol self-administration. The mean mannitol plasma concentrations (mg/ml) were dose-dependent with a consistent difference among doses. The mean maximum concentration (C-max) +/- SD was 0.63 +/- 0.15, 1.02 +/- 0.28, and 1.36 +/- 0.39 mg/ml, in the three dosage groups, respectively. The mean area under the curve from zero to infinity (AUC(0-infinity)) was 2.667 +/- 0.668, 4.992 +/- 1.706, and 7.403 +/- 3.472 mg/ml*h in the 50, 100, and 150 g mannitol dose groups, respectively. Bioavailability was similar in the three dose groups and was just over 20% (0.243 +/- 0.073, 0.209 +/- 0.081, and 0.228 +/- 0.093 in the 50, 100, and 150 g mannitol dose groups, respectively). The present study showed that the bioavailability of oral mannitol is just over 20% and is similar for the three tested doses (50, 100, and 150 g). The linear increase in C-max, AUC(0-t8), and AUC(0-infinity) must be considered when choosing the oral mannitol dose for bowel preparation to avoid its systemic osmotic effects.
引用
收藏
页码:2448 / 2457
页数:10
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