Tamaki Hiroyuki, Noda Teruyo, Morita Masahiro, Omura Akina, Kubo Atsushi, Ogawa Chikara, Matsunaka Toshihiro, Shibatoge Mitsushige
Department of Gastroenterology, Takamatsu Red Cross Hospital, Takamatsu, Kagawa 760-0017, Japan.
World J Clin Cases. 2019 Feb 26;7(4):452-465. doi: 10.12998/wjcc.v7.i4.452.
A low-volume polyethylene glycol (PEG) solution that combines ascorbic acid with PEG-based electrolyte solution (PEG-ASC) is gaining mainstream acceptance for bowel preparation due to reduced volume and improved taste. Although several reports showed that bowel preparation with PEG-ASC volume lower than 2.0 L with laxative agents could be an alternative to traditional preparation regimen, the cleansing protocols have not been fully investigated.
To evaluate the cleansing efficacy of 1.2 L PEG-ASC solution comparing with 2.0 L PEG electrolyte (PEG-ELS) for bowel preparations.
A randomized, single-blinded, open-label, single-center, non-inferiority study was conducted. In total, 312 Japanese adult patients (aged > 18 years) who underwent colonoscopy were enrolled. Patients were randomly allocated to bowel lavage with either 1.2 L of PEG-ASC solution with at least 0.6 L of an additional clear fluid (1.2 L PEG-ASC group) or 2.0 L of PEG-ELS (PEG-ELS group). Then, 48 mg of sennoside was administered at bedtime on the day before colonoscopy, and the designated drug solution was administered at the hospital on the day of colonoscopy. Bowel cleansing was evaluated using the Boston Bowel Preparation Scale (BBPS). The volume of fluid intake and required time for bowel preparation were evaluated. Furthermore, compliance, patient tolerance, and overall acceptability were evaluated using a patient questionnaire, which was assessed using a visual analog scale.
In total, 291 patients (1.2 L PEG-ASC group, 148; PEG-ELS group, 143) completed the study. There was no significant difference in successful cleansing, defined as a BBPS score ≥ 2 in each segment, between the two groups (1.2 L PEG-ASC group, 91.9%; PEG-ELS group, 90.2%; 95%CI: -0.03-0.09). The required time for bowel preparation was significantly shorter (164.95 min ± 68.95 min 202.16 min ± 68.69 min, < 0.001) and the total fluid intake volume was significantly lower (2.23 L ± 0.55 L 2.47 L ± 0.56 L, < 0.001) in the 1.2 L PEG-ASC group than in the PEG-ELS group. Palatability, acceptability of the volume of solution, and overall acceptability evaluated using a patient questionnaire, which was assessed by the visual analog scale, were significantly better in the 1.2 L PEG-ASC group than in the PEG-ELS group (7.70 cm ± 2.57 cm 5.80 cm ± 3.24 cm, < 0.001). No severe adverse event was observed in each group.
The 1.2 L PEG-ASC solution was non-inferior to the 2.0 L PEG-ELS solution in terms of cleansing efficacy and had better acceptability among Japanese patients.
一种将抗坏血酸与基于聚乙二醇的电解质溶液（PEG - ASC）相结合的小容量聚乙二醇（PEG）溶液，因其体积减小和口感改善，在肠道准备中越来越受到主流认可。尽管有几份报告显示，使用低于2.0 L的PEG - ASC溶液并联合缓泻剂进行肠道准备可能是传统准备方案的一种替代方法，但清洁方案尚未得到充分研究。
评估1.2 L PEG - ASC溶液与2.0 L聚乙二醇电解质（PEG - ELS）用于肠道准备的清洁效果。
进行了一项随机、单盲、开放标签、单中心、非劣效性研究。总共纳入了312例接受结肠镜检查的日本成年患者（年龄>18岁）。患者被随机分配接受以下肠道灌洗：1.2 L PEG - ASC溶液并至少额外摄入0.6 L清亮液体（1.2 L PEG - ASC组）或2.0 L PEG - ELS（PEG - ELS组）。然后，在结肠镜检查前一天晚上服用48 mg番泻苷，并在结肠镜检查当天在医院服用指定的药物溶液。使用波士顿肠道准备量表（BBPS）评估肠道清洁情况。评估液体摄入量和肠道准备所需时间。此外，使用患者问卷评估依从性、患者耐受性和总体可接受性，该问卷通过视觉模拟量表进行评估。
总共291例患者（1.2 L PEG - ASC组148例；PEG - ELS组143例）完成了研究。两组在各节段BBPS评分≥2定义的成功清洁方面无显著差异（1.2 L PEG - ASC组为91.9%；PEG - ELS组为90.2%；95%CI： - 0.03 - 0.09）。1.2 L PEG - ASC组肠道准备所需时间显著更短（164.95分钟±68.95分钟对202.16分钟±68.69分钟，P<0.001），总液体摄入量显著更低（2.23 L±0.55 L对2.47 L±0.56 L，P<0.001）。使用视觉模拟量表评估的患者问卷中，1.2 L PEG - ASC组在口感、溶液量的可接受性和总体可接受性方面显著优于PEG - ELS组（7.70 cm±2.57 cm对5.80 cm±3.24 cm，P<0.001）。每组均未观察到严重不良事件。
1.2 L PEG - ASC溶液在清洁效果方面不劣于2.0 L PEG - ELS溶液，且在日本患者中具有更好的可接受性。
