Nalankilli Kumanan, Gibson David J, Anwar Shahzaib, Con Danny, Chen Helen, Secomb Robyn, Gibson Peter, Brown Gregor
Department of Gastroenterology Alfred Health Melbourne Victoria Australia.
Department of Gastroenterology Eastern Health Melbourne Victoria Australia.
JGH Open. 2021 Aug 17;5(9):1026-1032. doi: 10.1002/jgh3.12626. eCollection 2021 Sep.
Post-marketing studies comparing low-volume polyethylene glycol (PEG)-based regimens are limited. This randomized study aimed to compare the efficacy and tolerability of a novel 1-L low-volume PEG-based preparation: 1 L PEG+Asc (PEG3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride, and potassium chloride) with PEG+SPMC (PEG3350, sodium chloride, potassium chloride and sodium sulfate, sodium picosulfate, magnesium oxide, citric acid, and aspartame), prior to routine colonoscopy at an Australian tertiary referral center.
Outpatients undergoing colonoscopy were randomized to receive either split-dose 1 L PEG+Asc or split-dose PEG+SPMC. Bowel preparation quality using the Boston Bowel Preparation Scale (BPPS), modified Aronchick scores, procedure time, cecal intubation, and adenoma detection rates were recorded. Patient compliance and tolerability were captured using a standardized questionnaire.
A total of 173 patients were randomized, of whom 164 completed the study and were allocated to 1 L PEG+Asc ( = 82) or PEG+SPMC ( = 82). Non-inferiority of 1 L PEG+Asc was demonstrated with 89% achieving successful preparation (total BPPS ≥6 and each sub-score ≥2) compared with 85.4% in the PEG+SPMC group, resulting in an estimated difference of 3.7% (95% CI -6.6% to 13.9%). The median BBPS was non-inferior in all colonic segments with 1 L PEG+Asc (BBPS 3 [interquartile range 2-3]) PEG+SPMC (BBPS 2 [interquartile range 2-3]). More 1 L PEG+Asc patients reported moderate to severe nausea ( = 0.028), but overall tolerability was similar.
The quality of bowel preparation achieved with 1 L PEG+Asc is non-inferior to that with PEG+SPMC, with similar tolerability outcomes. Further studies are required in patients at risk of suboptimal bowel preparation.
比较小剂量聚乙二醇（PEG）灌肠方案的上市后研究较为有限。这项随机研究旨在比较一种新型1升小剂量PEG灌肠制剂（1升PEG+Asc，含聚乙二醇3350、抗坏血酸钠、硫酸钠、抗坏血酸、氯化钠和氯化钾）与PEG+SPMC（含聚乙二醇3350、氯化钠、氯化钾、硫酸钠、匹可硫酸钠、氧化镁、柠檬酸和阿斯巴甜）在澳大利亚一家三级转诊中心进行常规结肠镜检查前的疗效和耐受性。
将接受结肠镜检查的门诊患者随机分为两组，分别接受分次服用1升PEG+Asc或分次服用PEG+SPMC。记录使用波士顿肠道准备量表（BPPS）评估的肠道准备质量、改良的阿龙奇克评分、操作时间、盲肠插管情况和腺瘤检出率。使用标准化问卷收集患者的依从性和耐受性。
共有173例患者被随机分组，其中164例完成研究并被分配至1升PEG+Asc组（n = 82）或PEG+SPMC组（n = 82）。1升PEG+Asc组的肠道准备成功率为89%（BPPS总分≥6且各分项评分≥2），与PEG+SPMC组的85.4%相比，显示出非劣效性，估计差异为3.7%（95%CI -6.6%至13.9%）。在所有结肠段，1升PEG+Asc组的中位BPPS非劣于PEG+SPMC组（1升PEG+Asc组BPPS为3[四分位间距2 - 3]，PEG+SPMC组BPPS为2[四分位间距2 - 3]）。更多1升PEG+Asc组患者报告有中度至重度恶心（P = 0.028），但总体耐受性相似。
1升PEG+Asc实现的肠道准备质量不劣于PEG+SPMC，耐受性结果相似。对于肠道准备不佳风险较高的患者，还需要进一步研究。
