1.5 L低容量优化乳果糖方案在结肠镜肠道准备中有效性的单中心随机对照研究

A single-center randomized controlled study of the effectiveness of a 1.5 L low-volume optimized lactulose regimen in bowel preparation for colonoscopy

摘要:

目的 探究1.5 L低容量优化乳果糖方案在肠道准备中的有效性、安全性和耐受性。 方法 采用盲法、单中心、随机、对照的方法将280例患者根据签署知情同意书的先后顺序进行编号，采用预先生成的随机数字表按1∶1比例将受试者分配至1.5 L低容量优化乳果糖(Lactulose，LAC)组和3 L聚乙二醇(Polyethylene Glycol，PEG)组。 LAC组为150 mL LAC原液联合1.5 L LAC稀释液一次口服，PEG组为常规3 L分次口服法。研究的主要观察指标为肠道准备质量合格率，以波士顿肠道准备量表(Boston Bowel Preparation Scale，BBPS)评分评价。次要观察指标包括不良反应发生率、再次肠道准备意愿、睡眠质量、息肉检出率(Polyp Detection Rate，PDR)、腺瘤检出率(Adenoma Detection Rate，ADR)、进镜时间、退镜时间及盲肠插管率，以评估两组肠道准备的有效性、耐受性和安全性。 结果 共纳入LAC组135例，PEG组132例。两组患者年龄、性别等基线数据无统计学差异（P>0.05）。有效性：LAC组肠道准备的合格率和BBPS评分均显著高于PEG组。肠道准备合格率：LAC组91.9% vs. PEG组77.3%，χ2= 10.91，P=0.001；BBPS总评分：LAC组7.73±1.46 vs. PEG组6.88±1.49，t=4.74，P<0.001。 耐受性：再次肠道准备意愿：LAC组65.9% vs. PEG组52.3%，χ2=5.15，P=0.023；服药后腹痛发生率：LAC组3.0% vs. PEG组9.8%，χ2= 5.31，P=0.021；腹胀发生率：LAC组23.0% vs. PEG组29.5%，χ2=1.50，P=0.221；恶心发生率：LAC组38.5% vs. PEG组31.1%，χ2= 1.64，P=0.201；呕吐发生率：LAC组22.2% vs. PEG组14.4%，χ2=2.73，P=0.099；头晕发生率：LAC组6.7% vs. PEG组4.5%，χ2=0.57，P=0.452；口干发生率：LAC组14.8% vs. PEG组3.8%，χ2=9.56，P=0.002； 安全性：两组在肠道准备前后电解质等指标均在正常范围内，均未观察到严重不良反应。 结论 1.5 L低容量优化乳果糖方案可作为一种比较优良的肠道准备方式进行推广。

Abstract:

Objective To explore the efficacy, patient tolerability and safety of 1.5 L low volume optimized lactulose regimen for bowel preparation . Methods This single-center, randomized, controlled, blinded study enrolled 280 patients, who were consecutively numbered according to the order of signing the informed consent. Using a pre-generated random number table, participants were randomly assigned in a 1:1 ratio to either the 1.5 L low-volume optimized lactulose (Lactulose, LAC) group or the 3 L polyethylene glycol (Polyethylene Glycol, PEG) group. Patients in the LAC group received a single oral dose of 150 mL LAC solution combined with 1500 mL diluted LAC, while patients in the PEG group received the conventional 3 L split-dose PEG regimen. The primary outcome was the adequacy of bowel preparation, assessed using the Boston Bowel Preparation Scale (BBPS). Secondary outcomes included incidence of adverse events, willingness to repeat bowel preparation, sleep quality, polyp detection rate (PDR), adenoma detection rate (ADR), insertion and withdrawal times, and cecal intubation rate, in order to evaluate the efficacy, tolerability, and safety of the two regimens. Results A total of 135 patients in the LAC group and 132 patients in the PEG group were included. Baseline characteristics, including age and sex, were comparable between groups. Efficacy: The LAC group showed significantly higher adequate bowel preparation rates and BBPS scores than the PEG group (adequate preparation: 91.9% vs. 77.3%,χ2= 10.91，P=0.001；total BBPS score: 7.73±1.46 vs. 6.88±1.49, t=4.74，P<0.001).Tolerability: Willingness to repeat bowel preparation was higher in the LAC group than in the PEG group (65.9% vs. 52.3%,χ2=5.15，P=0.023). The incidence of abdominal pain was lower in the LAC group (3.0% vs. 9.8%,χ2= 5.31，P=0.021). Other adverse events, including bloating (23.0% vs. 29.5%, χ2=.50，P=0.221), nausea (38.5% vs. 31.1%,χ2= 1.64，P=0.201), vomiting (22.2% vs. 14.4%,χ2=2.73，P=0.099), dizziness (6.7% vs. 4.5%, χ2=0.57，P=0.452), and dry mouth (14.8% vs. 3.8%, χ2=9.56，P=0.002), showed no clinically significant differences except dry mouth. Safety: Electrolyte levels before and after bowel preparation were within the normal range in both groups, and no serious adverse events were observed. Conclusion The 1.5 L low-volume optimized lactulose regimen can be applied in clinical practice.