利那洛肽联合复方聚乙二醇电解质散肠道准备改良方案的随机对照研究

A randomized controlled study on enhanced regimens of bowel preparation of linaclotide combined with compound polyethylene glycol electrolyte powder

摘要:

目的 探讨利那洛肽联合复方聚乙二醇电解质散（polyethylene glycol，PEG）在肠道准备中的效果，并与单独应用PEG 3 L方案及应用复方硫酸镁钠钾方案进行对比。方法 连续纳入2023年1—6月于黑龙江省医院消化病院行结肠镜检查的18~70岁患者进行随机对照研究，使用随机数字表法随机分为3组，按各组方案行肠道准备。A组：3 L PEG；B组：3 L硫酸镁钠钾口服浓溶液；C组：利那洛肽290 μg+2 L PEG。比较肠道准备效果、不良反应、满意度及再次肠道准备意愿。结果 纳入分析360例患者，每组各120例。3组患者各肠段波士顿肠道准备中位评分及总分差异均无统计学意义（左半结肠：3分、2分、3分，H=0.371，P=0.831；横结肠：3分、3分、3分，H=0.487，P=0.784；右半结肠：2分、2分、2分，H=1.088，P=0.580；总分：8分、8分、8分，H=0.017，P=0.991）。不良反应中，恶心呕吐发生率B组［3.33%（4/120）］低于A组［12.50%（15/120）］，差异有统计学意义（χ2=8.042，P=0.018），3组间其他不良反应分类比较差异无统计学意义（P>0.05）。满意度3组比较差异无统计学意义（χ2=11.840，P=0.158）。再次肠道准备意愿方面，C组［95.83%（115/120）］及B组［96.67%（116/120）］再次肠道准备愿意率均高于A组［85.00%（102/120）］（C组比A组：χ2=8.127，P=0.004；B组比A组：χ2=9.808，P=0.002），C组与B组比较差异无统计学意义（χ2=0.000，P=1.000）。结论 利那洛肽联合2 L PEG的肠道清洁效果和安全性与3 L PEG或3 L硫酸镁钠钾口服浓溶液相当，且可减少饮水量，提高患者依从性，可作为肠道准备改良方案。

Abstract:

Objective To explore the efficacy of linaclotide combined with compound polyethylene glycol (PEG) on bowel preparation, and compare it with traditional PEG 3 L and oral sulfate solution (OSS) 3 L methods. Methods Patients aged 18-70 years who underwent colonoscopy at the Digestive Diseases Hospital, Heilongjiang Provincial Hospital from January to June 2023 were continuously enrolled in the randomized controlled trial and randomly divided into 3 groups using the random number table. Intestinal preparation was conducted according to the protocols of each group, Group A: 3 L PEG; Group B: 3 L OSS; Group C: 290 μg of linaclotide + 2 L PEG. The effects of bowel preparation, adverse reactions, satisfaction, and willingness for repeated bowel preparation were compared. Results A total of 360 patients were included in the analysis, with 120 patients in each group. There were no statistically significant differences in the median Boston bowel preparation score for each intestinal segment or the total score among the 3 groups (left colon: 3 VS 2 VS 3, H=0.371, P=0.831; transverse colon: 3 VS 3 VS 3, H=0.487, P=0.784; right colon: 2 VS 2 VS 2, H=1.088, P=0.580; total score: 8 VS 8 VS 8, H=0.017, P=0.991). Among the adverse reactions, the incidence of nausea and vomiting in Group B [3.33% (4/120)] was lower than that in Group A [12.50% (15/120), χ2=8.042, P=0.018], and there were no statistically significant differences in other adverse reactions among the 3 groups (P>0.05). There was no significant difference in the satisfaction level among the 3 groups (χ2=11.840, P=0.158). The willingness to undergo bowel preparation again in Group C [95.83% (115/120)] and Group B [96.67% (116/120)] was higher than that in Group A [85.00% (102/120)] (Group C VS Group A: χ2=8.127, P=0.004; Group B VS Group A: χ2=9.808, P=0.002), and there was no significant difference between Group C and B (χ2=0.000, P=1.000). Conclusion Linaclotide combined with 2 L PEG offers comparable bowel preparation efficacy and safety to 3 L PEG or 3 L OSS, with improved patient compliance due to reduced water intake, suggesting its potential as an enhanced bowel preparation regimen.