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结肠镜检查前极低容量准备的效果:一项前瞻性、多中心观察性研究。

Effectiveness of very low-volume preparation for colonoscopy: A prospective, multicenter observational study.

机构信息

Gastroenterology and Endoscopy Unit, S. Elia-Raimondi Hospital, Caltanissetta 93100, Italy.

Gastroenterology and Endoscopy Unit, Istituto San Raffaele Giglio, Cefalù 90015, Italy.

出版信息

World J Gastroenterol. 2020 Apr 28;26(16):1950-1961. doi: 10.3748/wjg.v26.i16.1950.

Abstract

BACKGROUND

The effectiveness of colonoscopy strictly depends on adequate bowel cleansing. Recently, a 1 L polyethylene glycol plus ascorbate (PEG-ASC) solution (Plenvu; Norgine, Harefield, United Kingdom) has been introduced on the evidence of three phase-3 randomized controlled trials, but it had never been tested in the real-life.

AIM

To assess the effectiveness and tolerability of the 1 L preparation compared to 4 L and 2 L- PEG solutions in a real-life setting.

METHODS

All patients undergoing a screening or diagnostic colonoscopy after a 4, 2 or 1 L PEG preparation, were consecutively enrolled in 5 Italian centers from September 2018 to February 2019. The primary endpoints of the study were the assessment of bowel cleansing success and high-quality cleansing of the right colon. The secondary endpoints were the evaluation of tolerability, adherence and safety of the different bowel preparations. Bowel cleansing was assessed through the Boston Bowel Preparation Scale. Adherence was defined as consumption of at least 75% of each dose, while tolerability was evaluated through a semi-quantitative scale. Safety was systematically monitored through adverse events reporting.

RESULTS

Overall, 1289 met the inclusion criteria and were enrolled in the study. Of these, 490 patients performed a 4 L-PEG preparation (Selgesse), 566 a 2 L-PEG cleansing (Moviprep or Clensia) and 233 a 1 L-PEG preparation (Plenvu). Bowel cleansing by Boston Bowel Preparation Scale was 6.5 ± 1.5 overall and 6.3 ± 1.5, 6.2 ± 1.5, 7.3 ± 1.5 ( < 0.001) in the subgroups of 4 L, 2 L and 1 L-PEG preparation, respectively. Cleansing success was achieved in 72.4%, 74.1% and 90.1% ( < 0.001), while a high-quality cleansing of the right colon in 15.9%, 12.0% and 41.4% ( < 0.001) for 4 L, 2 L and 1 L-PEG preparation groups, respectively. The 1 L preparation was the most tolerated compared to the 2 and 4 L-PEG solutions in the absence of serious adverse events within any of the three groups. Multiple regression models confirmed 1 L PEG-ASC preparation as an independent predictor of overall cleansing success, high-quality cleansing of the right colon and of tolerability.

CONCLUSION

This study supports the effectiveness and tolerability of 1 L PEG-ASC, also showing it is an independent predictor of overall cleansing success, high-quality cleansing of the right colon and of tolerability.

摘要

背景

结肠镜检查的有效性严格依赖于充分的肠道清洁。最近,一种 1 升聚乙二醇加抗坏血酸(PEG-ASC)溶液(Plenvu;Norgine,Harefield,英国)已经在三项 3 期随机对照试验的证据基础上推出,但从未在实际生活中进行过测试。

目的

评估 1 升制剂与 4 升和 2 升 PEG 溶液在真实环境中的有效性和耐受性。

方法

所有在 2018 年 9 月至 2019 年 2 月期间接受 4 升、2 升或 1 升 PEG 制剂进行筛查或诊断结肠镜检查的患者,连续在意大利的 5 个中心入组。该研究的主要终点是评估肠道清洁成功率和右结肠的高质量清洁。次要终点是评估不同肠道准备的耐受性、依从性和安全性。肠道清洁通过波士顿肠道准备量表进行评估。依从性定义为至少消耗每个剂量的 75%,而耐受性通过半定量量表进行评估。通过不良事件报告系统对安全性进行了系统监测。

结果

总体而言,共有 1289 名符合纳入标准的患者入组该研究。其中,490 名患者接受 4 升 PEG 制剂(Selgesse)治疗,566 名患者接受 2 升 PEG 制剂(Moviprep 或 Clensia)治疗,233 名患者接受 1 升 PEG 制剂(Plenvu)治疗。按波士顿肠道准备量表评分,总体肠道清洁率为 6.5 ± 1.5,4 升 PEG、2 升 PEG 和 1 升 PEG 制剂组分别为 6.3 ± 1.5、6.2 ± 1.5 和 7.3 ± 1.5(<0.001)。肠道清洁成功率分别为 72.4%、74.1%和 90.1%(<0.001),而右结肠高质量清洁率分别为 15.9%、12.0%和 41.4%(<0.001)。1 升 PEG-ASC 制剂与 2 升和 4 升 PEG 溶液相比耐受性最好,三组均未发生任何严重不良事件。多回归模型证实 1 升 PEG-ASC 制剂是总体肠道清洁成功率、右结肠高质量清洁率和耐受性的独立预测因子。

结论

本研究支持 1 升 PEG-ASC 的有效性和耐受性,还表明其是总体肠道清洁成功率、右结肠高质量清洁率和耐受性的独立预测因子。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bccc/7201146/635284cd0d4b/WJG-26-1950-g001.jpg

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