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1L 聚乙二醇加抗坏血酸与 4L 聚乙二醇在门诊和住院患者结肠镜检查清洁中的疗效比较:一项多中心、随机试验(OVER 2019)。

Efficacy of 1 L polyethylene glycol plus ascorbate versus 4 L polyethylene glycol in split-dose for colonoscopy cleansing in out and inpatient: A multicentre, randomized trial (OVER 2019).

机构信息

Buccheri la Ferla Hospital, Palermo, Italy.

S. Elia-Raimondi Hospital, Caltanissetta, Italy.

出版信息

Dig Liver Dis. 2024 Mar;56(3):495-501. doi: 10.1016/j.dld.2023.07.032. Epub 2023 Aug 12.

Abstract

BACKGROUND AND AIMS

Adequate bowel cleansing is essential for colonoscopy quality. A novel 1 L polyethylene glycol plus ascorbate (1 L PEG+ASC) solution has been recently introduced. Nevertheless, the efficacy of 1 L PEG+ASC as compared to that of high-volume bowel preparation in both inpatients and outpatients is still unclear.

PATIENTS AND METHODS

This single-blinded, non-inferiority study randomized patients undergoing colonoscopy to receive split-dose 1 L PEG+ASC or 4 L PEG. The primary endpoint was the overall cleansing success. Secondary endpoints were excellent cleansing and high-quality cleansing of the right colon, as well as lesions detection rate, patient compliance, tolerability and safety.

RESULTS

Overall, 478 patients were randomized to 1 L PEG+ASC (N = 236) or 4 L PEG (N = 242). The 1 L PEG+ASC showed higher cleansing success rate (91.8% vs 83.6%; P=0.01) and a high-quality cleansing of the right colon (52.3% and 38.5%; P=0.004) compared to 4 L PEG. Moreover, 1 L PEG+ASC achieved a higher cleansing success in out-patients (96.3%% vs 88.6%; P=0.018), and a similar success rate in the in-patients (84.7% vs 76.7%; P=0.18). Adenoma detection rate, tolerability and incidence of adverse events were comparable between preparations.

CONCLUSIONS

The 1 L PEG+ASC showed higher efficacy in achieving adequate colon cleansing compared with 4 L PEG, particularly in the right colon. No differences in the tolerability and safety were detected.

摘要

背景和目的

充分的肠道清洁对于结肠镜检查质量至关重要。最近推出了一种新型的 1 升聚乙二醇加抗坏血酸(1 L PEG+ASC)溶液。然而,1 L PEG+ASC 与大容量肠道准备在住院患者和门诊患者中的疗效仍不清楚。

患者和方法

这项单盲、非劣效性研究将接受结肠镜检查的患者随机分为接受分剂量 1 L PEG+ASC 或 4 L PEG 的组。主要终点是总体清洁成功。次要终点是右结肠的良好清洁和高质量清洁、病变检出率、患者依从性、耐受性和安全性。

结果

共有 478 名患者被随机分为 1 L PEG+ASC 组(N = 236)或 4 L PEG 组(N = 242)。1 L PEG+ASC 显示出更高的清洁成功率(91.8% vs 83.6%;P=0.01)和高质量的右结肠清洁(52.3%和 38.5%;P=0.004),与 4 L PEG 相比。此外,1 L PEG+ASC 在门诊患者中达到更高的清洁成功率(96.3% vs 88.6%;P=0.018),在住院患者中达到相似的成功率(84.7% vs 76.7%;P=0.18)。腺瘤检出率、耐受性和不良事件发生率在两种准备方法之间无差异。

结论

1 L PEG+ASC 与 4 L PEG 相比,在实现充分的结肠清洁方面更有效,特别是在右结肠。在耐受性和安全性方面没有差异。

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