在患有不充分肠道准备风险增加的患者中,短期利纳克洛提德加聚乙烯甘醇:一个随机的,双盲的,多中心试验
Hui Chen1, Jun Wang2, Caixia Fan3
1Xijing Hospital of Digestive Diseases, Air Force Medical University (Fourth Military Medical University), Xi'an, China.
概括
与聚乙烯糖醇 (PEG) 结合利纳克洛提德并没有改善高风险患者的肠道准备或腺瘤检测. 这种疗法确实增加了右结肠中的聚体检测,特别是在老年人中.
科学领域:
- 胃肠病学 胃肠病学
- 结肠直肠癌查 结肠直肠癌查
- 临床试验 临床试验
背景情况:
- 评估与聚乙烯糖醇 (PEG) 结合的利纳克洛提德在提高肠道准备质量和检测腺瘤的高风险的患者中不充分准备的疗效.
- 围绕这种联合治疗的益处的不确定性需要进一步调查.
研究的目的:
- 为了评估与安慰剂加PEG相比,两天的林纳克洛提德加PEG治疗方案的疗效和安全性.
- 为了确定对肠道准备充分性和腺瘤检测率的影响.
主要方法:
- 一个多中心的随机试验,从2022年8月到2023年7月进行.
- 参与者接受了利纳克洛或安慰剂,两者与PEG相结合,持续2天.
- 主要终点包括充分的肠道准备率和每次结肠镜检测到的平均腺瘤.
主要成果:
- 在修改的治疗意图和每条协议分析中,在利纳克洛提德和安慰剂组之间没有观察到足够的肠道准备率或平均腺瘤检测的显著差异.
- 利纳克洛提德和PEG组合导致右结肠中检测到的多的平均数量在统计学上显著增加 (P=0.016).
- 这种右结肠多检测的增加在70岁及以上的患者中尤为明显 (P=0.033).
结论:
- 一个为期2天的利纳克洛提德治疗方案,当与PEG结合时,未能改善高风险患者的肠道准备充分性或腺瘤检测率.
- 组合疗法显示右结肠多检测的潜在增加,特别是在老年患者中,这需要进一步的研究.
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