Humanitas University, Milan, Italy.
Centre Hospitalier Universitaire Hotel Dieu, Nantes, France.
Dig Liver Dis. 2019 Dec;51(12):1671-1677. doi: 10.1016/j.dld.2019.06.026. Epub 2019 Aug 10.
BACKGROUND & AIMS: Colonoscopy requires bowel cleansing for gut mucosa visualization; high-quality cleansing facilitates lesion detection. NER1006 is a 1L polyethylene glycol (PEG) bowel preparation. This post hoc analysis of two randomized trials investigated cleansing efficacy assessed, as in clinical practice, by site endoscopists.
Patients received NER1006, 2L PEG + ascorbate (2LPEG), or oral sulfate solution (OSS) as a 2-day evening/morning regimen (N2D) or NER1006 morning-only dosing (N1D). Treatment-blinded site endoscopists assessed cleansing using the Harefield Cleansing Scale (HCS). Analyses were conducted in a modified full analysis set, including (mFAS; n = 1378) or excluding (mFAS2; n = 1319) imputed failures, and in patients with 100% treatment adherence (mFAS100; n = 1047). Overall cleansing success (HCS grade A/B), overall high-quality cleansing (HCS grade A), and high-quality segments (HCS 3-4) per treatment population were analyzed.
Overall cleansing success was higher with N2D than 2LPEG (92.7-97.5% vs. 87.9-93.0%), and more patients had overall high-quality cleansing with N2D and N1D than 2LPEG (68.0-72.1% and 64.0-68.4% vs. 50.7-56.0%). Without imputed failures, N2D delivered more overall high-quality cleansing than OSS (74.5-77.3% vs. 67.8-69.8%). More high-quality segments were demonstrated with N2D and N1D versus 2 LPEG (82.5-87.1% and 79.4-84.4% vs. 70.4-76.3%) and with N2D versus OSS (82.7-89.5% vs. 78.1-84.4%).
When assessed by site endoscopists, NER1006 delivers greater high-quality cleansing than 2LPEG or OSS.
结肠镜检查需要进行肠道清洁以观察肠道黏膜；高质量的肠道清洁有助于提高病变检出率。NER1006 是一种 1L 聚乙二醇（PEG）肠道准备药物。这是两项随机试验的事后分析，评估了临床实践中由内镜医生评估的肠道清洁效果。
患者接受 NER1006、2L PEG+抗坏血酸（2LPEG）或口服硫酸盐溶液（OSS）作为 2 天的晚间/清晨方案（N2D）或 NER1006 仅在清晨给药（N1D）。经治疗设盲的内镜医生使用 Harefield 肠道清洁评分（HCS）评估肠道清洁效果。分析在改良全分析集（mFAS；n=1378）中进行，包括（mFAS）或排除（mFAS2；n=1319）推断失败的情况，以及在 100%接受治疗的患者（mFAS100；n=1047）中进行。按治疗人群分析总体清洁成功率（HCS 等级 A/B）、总体高质量清洁（HCS 等级 A）和高质量节段（HCS 3-4）。
N2D 方案的总体清洁成功率高于 2LPEG（92.7%-97.5%比 87.9%-93.0%），N2D 和 N1D 方案的总体高质量清洁患者比例也高于 2LPEG（68.0%-72.1%和 64.0%-68.4%比 50.7%-56.0%）。不考虑推断失败的情况下，N2D 方案的总体高质量清洁率高于 OSS（74.5%-77.3%比 67.8%-69.8%）。N2D 和 N1D 方案的高质量节段比例也高于 2LPEG（82.5%-87.1%和 79.4%-84.4%比 70.4%-76.3%），N2D 方案也高于 OSS（82.7%-89.5%比 78.1%-84.4%）。
由内镜医生评估，NER1006 比 2LPEG 或 OSS 更能提高高质量的肠道清洁效果。
