利那洛肽联合复方聚乙二醇电解质散用于结肠镜肠道准备的临床研究

A clinical study of linaclotide combined with compound polyethylene glycol electrolytes powder for bowel preparation for colonoscopy

摘要:

目的 探讨利那洛肽联合复方聚乙二醇电解质散（polyethylene glycol electrolytes powder，PEG）作为结肠镜肠道准备方案的价值。方法 采用随机、单盲的前瞻性临床研究，纳入2021年6—8月于南方医科大学深圳医院消化内科门诊行结肠镜检查的患者。将行结肠镜肠道准备的患者分成2组，试验组152例患者采用580 μg利那洛肽+2 L PEG方案，对照组152例患者采用3 L PEG方案。比较两组患者肠道准备效果（波士顿肠道准备量表评分、气泡评分和病变检出率）及安全性（不良事件）。结果 试验组与对照组相比，波士顿肠道准备量表评分［总评分9（8，9）分比9（9，9）分，Z=0.141，P=0.888］，气泡评分［1（1，2）分比1（1，1）分，Z=1.788，P=0.074］及总体病变检出率［37.50%（57/152）比33.55%（51/152），χ2=0.517，P=0.472］差异均无统计学意义。在安全性方面，试验组与对照组相比，恶心［7.24%（11/152）比13.16%（20/152），χ2=2.910，P=0.088］、呕吐［2.63%（4/152）比7.24%（11/152），χ2=3.436，P=0.064］、腹胀［7.89%（12/152）比11.84%（18/152），χ2=1.331，P=0.249］、腹痛［2.63%（4/152）比4.61%（7/152），χ2=0.849，P=0.357］的发生率差异均无统计学意义。结论 利那洛肽联合PEG用于结肠镜肠道准备可减少饮水量，且清洁效果和安全性与采用3 L PEG相当，可作为结肠镜检查的肠道准备推荐方案。

Abstract:

Objective To explore the value of linaclotide combined with compound polyethylene glycol electrolytes powder (PEG) for bowel preparation for colonoscopy. Methods A randomized and single blind prospective clinical study was conducted in patients who intended to receive colonoscopy at the Department of Gastroenterology in Shenzhen Hospital, Southern Medical University from June 2021 to August 2021. One hundred and fifty‑two patients in the experimental group were treated with 580 μg linaclotide + 2 L PEG, and 152 patients in the control group were treated with 3 L PEG. The bowel preparation effects including Boston bowel preparation scale (BBPS) score, bubble score and lesion detection rate, and safety (adverse events) were compared between the two groups. Results The total BBPS scores were 9 (8, 9) in the experimental group, and 9 (9, 9) in the control group with no significant difference (Z=0.141, P=0.888). The bubble scores were 1 (1, 2) in the experimental group, and 1 (1, 1) in the control group with no significant difference (Z=1.788, P=0.074). There was no significant difference in detection rate of lesions between the experimental group and the control group [37.50% (57/152) VS 33.55% (51/152), χ2=0.517, P=0.472]. There was no significant difference in safety including incidence of nausea [7.24% (11/152) VS 13.16% (20/152), χ2=2.910,P=0.088], vomiting [2.63% (4/152) VS 7.24% (11/152), χ2=3.436,P=0.064], abdominal distension [7.89% (12/152) VS 11.84% (18/152), χ2=1.331, P=0.249] and abdominal pain [2.63% (4/152) VS 4.61% (7/152), χ2=0.849,P=0.357] between the experimental group and the control group. Conclusion Linaclotide combined with PEG for colonoscopic bowel preparation reduces drinking water volume. The cleaning effect and safety are comparable to using 3 L PEG. It can be recommended for bowel preparation for colonoscopy.