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Efficacy and tolerability of split-dose PEG compared with split-dose aqueous sodium phosphate for outpatient colonoscopy: a randomized, controlled trial.

机译:分剂量PEG与分剂量磷酸钠水溶液相比在门诊结肠镜检查中的疗效和耐受性:一项随机对照试验。

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摘要

BACKGROUND AND AIMS: Adequate bowel cleansing is essential for a high-quality, effective, and safe colonoscopy. The aims of this study were to compare the efficacy and tolerability of split-dose polyethylene glycol with aqueous sodium phosphate for outpatients who underwent scheduled colonoscopy. METHODS: In this prospective trial, 207 outpatients (aged between 18 and 65 years, with normal renal function, at low risk for renal damage) were randomized to receive split-dose preparation of PEG (2 L/2 L) (N = 103) or NaP (45 mL/45 mL, 12 h apart) (N = 104) without strict diet restriction the day before colonoscopy. The bowel cleansing efficacy of preparations was rated according to the Ottawa scale and the patient tolerability was assessed using a patient questionnaire. RESULTS: There was no significant difference between the two groups for the mean total score using the Ottawa bowel preparation scale (P = 0.181). Significantly greater residual colonic fluid was observed in the split-dose PEG group (1.24 +/- 0.49) than in the NaP group (1.04 +/- 0.53) (P = 0.007). Patient compliance, preference, and acceptance of a two preparation regimen were similar with no significant differences (P = 0.095, P = 0.280 and P = 0.408, respectively). The overall incidence of adverse events was not significantly different between the two groups; however, the split-dose PEG group tended to have fewer adverse events (52/103 [50.5%], 66/104 [63.5%], P = 0.059) and had significantly less nausea and vomiting (P = 0.036). CONCLUSIONS: Split-dose PEG, compared with split-dose NaP, is associated with more residual colonic fluid, but produces equivalent colon cleansing efficacy and results in less nausea and vomiting, which might improve patient tolerability (clinical trial registration number NCT01229800).
机译:背景与目的:充分的肠道清洁对于高质量,有效和安全的结肠镜检查至关重要。这项研究的目的是比较分剂量聚乙二醇和磷酸钠水溶液对接受定期结肠镜检查的门诊患者的疗效和耐受性。方法:在这项前瞻性试验中,将207名门诊患者(年龄在18至65岁之间,肾功能正常,肾损害风险低)随机接受分剂量制剂PEG(2 L / 2 L)(N = 103)。 )或NaP(45 mL / 45 mL,相隔12 h)(N = 104),无严格饮食限制的结肠镜检查前一天。根据渥太华量表对制剂的肠清洁功效进行评估,并使用患者问卷对患者的耐受性进行评估。结果:使用渥太华肠道准备量表,两组的总平均分之间无显着差异(P = 0.181)。分剂量PEG组(1.24 +/- 0.49)观察到的残留结肠液明显大于NaP组(1.04 +/- 0.53)(P = 0.007)。两种准备方案的患者依从性,偏好和接受程度相似,无显着差异(分别为P = 0.095,P = 0.280和P = 0.408)。两组之间不良事件的总发生率无显着差异。但是,分剂量PEG组的不良事件较少(52/103 [50.5%],66/104 [63.5%],P = 0.059),恶心和呕吐的发生率也明显较低(P = 0.036)。结论:与分剂量的NaP相比,分剂量的PEG与更多的残留结肠液有关,但产生等效的结肠清洗功效并导致较少的恶心和呕吐,这可能会提高患者的耐受性(临床试验注册号NCT01229800)。

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