State key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.
Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University, Xian, China.
Am J Gastroenterol. 2018 Apr;113(4):601-610. doi: 10.1038/ajg.2018.25. Epub 2018 Mar 13.
Split dose of 4 l polyethylene glycol (PEG) is currently the standard regimen for bowel preparation (BP). However, it may be unnecessary for patients without high risks (e.g., old age, constipation, and diabetes, and so on) for inadequate BP. The study aimed to compare the efficacy of bowel cleansing between low-risk patients receiving same-day, single dose of low-volume (SSL) PEG vs. standard regimen.
This prospective, randomized, observer-blinded, non-inferiority study enrolled low-risk patients in three centers. Patients undergoing colonoscopy were randomized (1:1) to the SSL or standard group. The primary outcome was adequate BP, defined by Boston Bowel Preparation Score (BBPS) ≥6 and each segmental score ≥2. Secondary outcomes included adverse events, cecal intubation rate, and patient willingness to repeat BP, and so on.
Among 2,532 patients eligible for the study, 940 (37.1%) were at low risk and 792 (31.3%) at high risk for inadequate BP. The low-risk patients were randomly allocated to the SSL (n=470) or standard group (n=470). The baseline characteristics of the two groups were similar. Intention-to-treat analysis showed that adequate BP was achieved in 88.1% in the SSL group and 87.0% in the standard group (relative risk (RR) 1.10, 95% confidence interval (CI): 0.75-1.63, P=0.621). The overall BBPS was 7.3±1.2 and 7.3±1.3, respectively (P=0.948). No significant differences were found between the two groups with regards to the right, transverse, and left-segmental colon BBPS (all P>0.05). However, in terms of adverse events, patients in the SSL group reported less nausea (19.6% vs. 29.9%), vomiting (5.3% vs. 11.4%), and abdominal discomfort (2.2% vs. 6.0%) compared with those in the standard group. More patients in the SSL group were willing to repeat BP (94.0% vs. 89.5%, P=0.015).
For low-risk patients, the SSL regimen was not inferior to the split dose of 4 l PEG for adequacy of BP. Single dose of low-volume regimen had significantly fewer adverse events. This simplified regimen may be preferable in the "easy-to prepare" population.
目前，4L 聚乙二醇（PEG）分剂量是肠道准备（BP）的标准方案。然而，对于没有高风险（如高龄、便秘和糖尿病等）的患者，低风险患者可能不需要进行不充分的 BP。本研究旨在比较低风险患者接受当天单次低容量（SSL）PEG 与标准方案的肠道清洁效果。
这是一项前瞻性、随机、观察者盲、非劣效性研究，在三个中心纳入低风险患者。接受结肠镜检查的患者按 1:1 随机分为 SSL 组或标准组。主要结局是波士顿肠道准备评分（BBPS）≥6 分且各节段评分≥2 分的充分 BP。次要结局包括不良事件、盲肠插管率以及患者重复 BP 的意愿等。
在 2532 名符合条件的患者中，940 名（37.1%）为低风险，792 名（31.3%）为低风险，BP 不充分。低风险患者被随机分配到 SSL 组（n=470）或标准组（n=470）。两组的基线特征相似。意向治疗分析显示，SSL 组的充分 BP 率为 88.1%，标准组为 87.0%（相对风险（RR）1.10，95%置信区间（CI）：0.75-1.63，P=0.621）。总体 BBPS 分别为 7.3±1.2 和 7.3±1.3（P=0.948）。两组间右、横、左结肠节段 BBPS 无显著差异（均 P>0.05）。然而，在不良事件方面，SSL 组患者报告的恶心（19.6%比 29.9%）、呕吐（5.3%比 11.4%）和腹部不适（2.2%比 6.0%）发生率低于标准组。SSL 组中有更多的患者愿意重复 BP（94.0%比 89.5%，P=0.015）。
对于低风险患者，SSL 方案在 BP 充分性方面并不逊于 4L PEG 分剂量方案。单次低容量方案的不良反应明显更少。这种简化方案可能在“易于准备”的人群中更受欢迎。
