Hagège Hervé, Laugier René, Nahon Stéphane, Coulom Pierre, Isnard-Bagnis Corinne, Albert-Marty Annaïck
CHI de Créteil, Service d'Hépato-gastroentérologie, Créteil, France.
Hôpital de la Timone, Service de Gastroentérologie, Marseille, France.
Endosc Int Open. 2015 Aug;3(4):E346-53. doi: 10.1055/s-0034-1391847. Epub 2015 May 5.
The purpose of this study was to describe the real-life conditions of use, efficacy, safety, and acceptability of sodium phosphate (NaP) tablets for colon cleansing in routine medical practice in France.
A total of 996 patients undergoing bowel preparation were enrolled by 108 gastroenterologists in this observational, longitudinal, prospective, multicenter study. The conditions of use of NaP tablets were assessed with a composite endpoint, which included six criteria for patient compliance with the recommended administration scheme and a criterion for the absence of contraindications to NaP use.
Adequate use of NaP was reported for 75.1 % of the patients. The main reasons for misuse were a smaller fluid intake than expected with a dose of 4 tablets and noncompliance with age-related contraindications. The quality of cleansing was satisfactory: the Boston Bowel Preparation Scale (BBPS) total score was 7 or higher in 75.4 % of the patients. Gastroscopy associated with colonoscopy in 38.9 % of the patients revealed gastric lesions, which were considered as possibly related to the use of NaP tablets in 10.3 % of them. Vomiting occurred in 9.8 % of the patients, and 0.6 % discontinued bowel preparation after an adverse event. No electrolyte disorders or renal impairment was reported, even if not systematically sought. The acceptability of the NaP tablets was high, particularly among patients who previously had undergone other methods of bowel preparation.
Despite being defined according to strict criteria, adequate use of NaP tablets was observed in a high percentage of patients. The quality of colon cleansing and the safety and acceptability of NaP tablets were satisfactory and consistent with data from randomized clinical studies.
本研究旨在描述法国常规医疗实践中用于结肠清洁的磷酸钠(NaP)片剂的实际使用情况、疗效、安全性和可接受性。
108名胃肠病学家在这项观察性、纵向、前瞻性、多中心研究中纳入了总共996名接受肠道准备的患者。使用一个综合终点评估NaP片剂的使用情况,该终点包括患者遵守推荐给药方案的六项标准以及NaP使用无禁忌证的一项标准。
75.1%的患者报告NaP使用充分。误用的主要原因是服用4片时液体摄入量低于预期以及未遵守年龄相关禁忌证。清洁质量令人满意:75.4%的患者波士顿肠道准备量表(BBPS)总分达到7分或更高。38.9%的患者在胃镜检查联合结肠镜检查时发现胃部病变,其中10.3%的病变被认为可能与NaP片剂的使用有关。9.8%的患者出现呕吐,0.6%的患者在发生不良事件后停止肠道准备。即使未进行系统检查,也未报告电解质紊乱或肾功能损害。NaP片剂的可接受性较高,尤其是在之前接受过其他肠道准备方法的患者中。
尽管根据严格标准定义,但仍观察到高比例患者对NaP片剂使用充分。结肠清洁质量以及NaP片剂的安全性和可接受性令人满意,且与随机临床研究数据一致。