利那洛肽联合聚乙二醇方案对肠道准备效果的随机对照研究

A randomized controlled study on the effect of linaclotide with polyethylene glycol in bowel preparation

目的评估利那洛肽联合聚乙二醇方案对肠道准备的有效性和安全性。方法选择2021年9月至2022年2月就诊于江汉大学附属湖北省第三人民医院消化内科拟行结肠镜检查的240例患者。按照随机数字表以1∶1的比例分成利那洛肽联合聚乙二醇组和单纯聚乙二醇组各120例,利那洛肽联合聚乙二醇组患者服用580μg利那洛肽+2 L复方聚乙二醇电解质散溶液,单纯聚乙二醇组患者服用3 L复方聚乙二醇电解质散溶液。比较两组患者波士顿肠道准备量表(BBPS)评分、息肉或腺瘤检出率、进镜时间、退镜时间、首次排便间隔时间、排便次数、盲肠插管成功率、不良反应发生率、患者满意度等指标。统计学比较采用独立样本t检验和卡方检验。结果共235例患者完成肠道准备并接受结肠镜检查。利那洛肽联合聚乙二醇组BBPS评分、息肉或腺瘤检出率、进镜时间、退镜时间、盲肠插管成功率、排便次数与单纯聚乙二醇组比较[(7.3±1.1)分比(7.0±1.2)分、58.1%(68/117)比60.2%(71/118)、38.5%(45/117)比39.8%(47/118)、(4.2±1.9)min比(4.3±1.6)min、(5.9±2.7)min比(6.2±2.4)min、100.0%(117/117)比100.0%(118/118)、(5.3±2.3)次比(5.1±2.7)次]差异均无统计学意义(均P>0.05)。利那洛肽联合聚乙二醇组不良反应发生率低于单纯聚乙二醇组[25.6%(30/117)比39.8%(47/118)],且患者满意度高于单纯聚乙二醇组[93.2%(109/117)比76.3%(90/118)],差异均有统计学意义(χ^(2)=0.24、0.64,P=0.018、0.031)。结论与3 L聚乙二醇方案相比,580μg利那洛肽联合2 L聚乙二醇方案能够取得同等的肠道准备效果,且安全性和患者满意度更高,值得临床推广。

Objective To evaluate the efficacy and safety of linaclotide with polyethylene glycol in bowel preparation.Methods From September 2021 to February 2022,240 patients who visited the Department of Gastroenterology,Third People's Hospital of Hubei Province,Jianghan University and underwent colonoscopy were selected.According to the random number table,in the ratio of 1 to 1,the patients were divided into the linaclotide with polyethylene glycol group and the simple polyethylene glycol group,with 120 cases in each group.The patients in the linaclotide with polyethylene glycol group took 580μg linaclotide and 2 L polyethylene glycol electrolyte powder solution,and the patients in the simple polyethylene glycol group took 3 L polyethylene glycol electrolyte powder solution.The Boston bowel preparation scale(BBPS)score,the detection rate of polyps or adenomas,the insertion time of colonoscopy,the withdrawal time of colonoscopy,the time of the first defecation,the frequency of defecations,the success rate of cecal intubation,the occurrence of adverse effects and the satisfaction rate of patients were compared between the 2 groups.Independent sample t test and chi-square test were used for statistical analysis.Results A total of 235 patients completed bowel preparation and accepted colonoscopy.There were no statistically significant differences in the BBPS score,the detection rate of polyps or adenomas,the insertion time of colonoscopy,the withdrawal time of colonoscopy,the success rate of cecal intubation and the frequency of defecations between the linaclotide with polyethylene glycol group and simple polyethylene glycol group(7.3±1.1 vs.7.0±1.2;58.1%,68/117 vs.60.2%,71/118;38.5%,45/117 vs.39.8%,47/118;(4.2±1.9)min vs.(4.3±1.6)min;(5.9±2.7)min vs.(6.2±2.4)min;100.0%,117/117 vs.100.0%,118/118;5.3±2.3 vs.5.1±2.7;all P>0.05).The rate of adverse effects of the linaclotide with polyethylene glycol group was lower than that of simple polyethylene glycol group(25.6%,30/117 vs.39.8%,47/118),the satisfaction rate of patients was higher than that of the simple polyethylene glycol group(93.2%,109/117 vs.76.3%,90/118),and the differences were statistically significant(χ^(2)=0.24 and 0.64,P=0.018 and 0.031).Conclusion Compared with the 3 L polyethylene glycol regimen,580 g linaclotide with 2 L polyethylene glycol regimen can achieve the same bowel preparation effect with higher safety and patient satisfaction,which is worthy of clinical application.