利那洛肽联合复方聚乙二醇在结肠镜肠道准备中应用的初步研究

A preliminary research of the effect of linaclotide combined with compound polyethylene glycol on bowel preparation for colonoscopy

摘要:

目的 初步探索利那洛肽联合复方聚乙二醇（polyethylene glycol，PEG）在结肠镜肠道准备中的作用。方法 本试验是一项多中心随机对照研究。连续纳入2021年11月—2022年3月在上海长海医院、山西省人民医院和联勤保障部队第九〇〇医院3家消化内镜中心接受结肠镜检查的受试者，采用完全随机法分成3组，A组肠道准备方案为3 d利那洛肽+3 L PEG，B组为仅3 L PEG，C组为3 d利那洛肽+2 L PEG。主要观察指标为肠道准备合格率，次要观察指标包括肠道准备优秀率、肠道准备完成率以及肠道准备愿意重复率。结果 共入组130例受试者，其中A组46例，B组43例，C组41例，3组受试者肠道准备合格率［95.7%（44/46）、93.0%（40/43）和95.1%（39/41），χ2=0.465，P=0.893］，肠道准备优秀率［43.5%（20/46）、25.6%（11/43）和34.1%（14/41），χ2=3.151，P=0.207］及肠道准备完成率［95.7%（44/46）、95.3%（41/43）和100.0%（41/41），χ2=1.909，P=0.544］差异均无统计学意义。3组受试者愿意再次行相应肠道准备方案的愿意重复率差异有统计学意义［89.1%（41/46）、74.4%（32/43）和100.0%（41/41），χ2=12.862，P=0.002］。C组受试者肠道准备完成率和愿意重复率均为100.0%，较A、B两组有升高趋势。结论 利那洛肽有提高肠道准备质量的趋势，可以减少PEG用量。

Abstract:

Objective To evaluate the effect of linaclotide combined with compound polyethylene glycol (PEG) on bowel preparation for colonoscopy. Methods This trial was a multicenter randomized controlled study. Subjects scheduled for colonoscopy in 3 digestive endoscopy centers of The First Affiliated Hospital of Naval Medical University, Shanxi Province People""s Hospital and the 900th Hospital of Joint Logistics Support Force from November 2021 to March 2022 were randomly assigned to 3 groups using completely random method. The bowel preparation of group A was 3-day linaclotide with 3 L PEG, that of group B was only 3 L PEG, and group C was 3-day linaclotide with 2 L PEG. The primary outcome was the rate of adequate bowel preparation, and the secondary outcomes were the rate of excellent bowel preparation, the completion rate of bowel preparation and the willingness to repeat the corresponding bowel preparation regimen. Results A total of 130 subjects were enrolled, including 46 in group A, 43 in group B, and 41 in group C. There was no significant difference among the 3 groups in the rate of adequate bowel preparation [95.7% (44/46), 93.0% (40/43) and 95.1% (39/41), χ2=0.465, P=0.893], the rate of excellent bowel preparation [43.5%(20/46), 25.6% (11/43) and 34.1% (14/41), χ2=3.151, P=0.207], or the completion rate of bowel preparation [95.7% (44/46), 95.3% (41/43) and 100.0% (41/41), χ2=1.909, P=0.544]. However, there were significant differences in the willingness to repeat the corresponding bowel preparation regimen among the 3 groups [89.1% (41/46), 74.4% (32/43) and 100.0% (41/41), χ2=12.862, P=0.002]. The bowel preparation completion and willingness rate of subjects in group C were both 100.0%, which were higher than those in group A and group B. Conclusion Linaclotide is able to improve the quality of bowel preparation and reduce the amount of PEG.