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1L聚乙二醇+抗坏血酸在现实环境中的肠道清洁效果及安全性:对13000多名患者的观察性、回顾性、多中心研究

Bowel cleansing effectiveness and safety of 1L PEG + Asc in the real-world setting: Observational, retrospective, multicenter study of over 13000 patients.

作者信息

López-Jamar José Miguel Esteban, Gorjão Ricardo, Cotter José, Lorenzo-Zúñiga García Vicente, Pantaleón Sánchez Miguel Angel, Carral Martínez David, Sábado Fernando, Pérez Arellano Elena, Gómez Rodríguez Blas José, López Cano Antonio, Machlab Salvador, Arieira Cátia, Akriche Fatma, Turbí Disla Carmen, Rodriguez Muñoz Sarbelio

机构信息

Gastroenterology, Hospital Clínico Universitario San Carlos, Madrid, Spain.

Gastroenterology, Hospital CUF Descobertas, Lisboa, Portugal.

出版信息

Endosc Int Open. 2023 Aug 16;11(8):E785-E793. doi: 10.1055/a-2125-0025. eCollection 2023 Aug.

Abstract

Effective bowel cleansing is critical for detecting lesions during colonoscopy, highlighting the importance of bowel preparations. 1L polyethylene glycol (PEG) + ascorbate (Asc) is the only recommended 1L PEG product in Europe and the United States. Its efficacy was demonstrated in large-scale controlled trials and confirmed in smaller-scale real-world studies. However, no large-scale real-world data exist. This observational, retrospective, multicenter study, used outpatient follow-up data from medical records from 10 centers in Spain and two in Portugal. Outpatients aged ≥18 years using 1L PEG + Asc as bowel preparation were included. The main outcome measures were overall adequate colon cleansing (Boston Bowel Preparation Scale [BBPS] score ≥6 with BBPS score ≥2 in each segment) and high-quality cleansing of the right colon (BBPS score=3). Data from 13169 eligible patients were included. Overall cleansing success was achieved in 89.3% (95%CI 88.7%-89.8%) and high-quality cleansing in the right colon in 49.3% (95%CI 48.4%-50.2%) of patients. For the overnight split-dose and same-day regimens, overall adequate quality cleansing success rate was 94.7% and 86.7% ( <0.0001) and high-quality cleansing of the right colon rate was 65.4% and 41.4% ( <0.0001), respectively. Colonoscopy was completed in 97.3% of patients, with non-completion due to poor preparation in only 0.8%; 2.3% of patients experienced at least one adverse event (AE). This large-scale, real-world study demonstrates the effectiveness of 1L PEG + Asc in the total and right colon, with a low percentage of patients with AEs in routine clinical practice.

摘要

有效的肠道清洁对于结肠镜检查期间检测病变至关重要,凸显了肠道准备的重要性。1L聚乙二醇(PEG)+抗坏血酸盐(Asc)是欧洲和美国唯一推荐的1L PEG产品。其疗效在大规模对照试验中得到证实,并在小规模的真实世界研究中得到确认。然而,尚无大规模的真实世界数据。这项观察性、回顾性、多中心研究使用了来自西班牙10个中心和葡萄牙2个中心的门诊病历随访数据。纳入年龄≥18岁使用1L PEG + Asc进行肠道准备的门诊患者。主要结局指标为总体充分的结肠清洁(波士顿肠道准备量表[BBPS]评分≥6且各节段BBPS评分≥2)和右半结肠的高质量清洁(BBPS评分为3)。纳入了13169例符合条件患者的数据。89.3%(95%CI 88.7%-89.8%)的患者实现了总体清洁成功,49.3%(95%CI 48.4%-50.2%)的患者右半结肠实现了高质量清洁。对于过夜分剂量和当日方案,总体充分的高质量清洁成功率分别为94.7%和86.7%(<0.0001),右半结肠的高质量清洁率分别为65.4%和41.4%(<0.0001)。97.3%的患者完成了结肠镜检查,仅0.8%因准备不佳而未完成;2.3%的患者经历了至少一次不良事件(AE)。这项大规模的真实世界研究证明了1L PEG + Asc在全结肠和右半结肠的有效性,在常规临床实践中发生AE的患者比例较低。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f29d/10431968/d168636657cf/10-1055-a-2125-0025_21259616.jpg

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