硫酸镁钠钾口服液用于成人结肠镜检查前肠道准备有效性和安全性的Ⅲ期临床多中心随机对照研究

Efficacy and safety of oral sodium sulfate solution for bowel preparation before colonoscopy: a phase Ⅲ multi‑center randomized controlled trial

摘要:

目的 评价硫酸镁钠钾口服液（oral sulfate solution，OSS）用于成人结肠镜检查前肠道准备的有效性和安全性。方法 采用多中心、随机、研究者单盲、阳性对照、非劣效性临床研究。受试者随机接受结肠镜检查前分次服用共2瓶OSS（177 mL/瓶）或4 L复方聚乙二醇电解质散（Ⅲ）（polyethylene glycol，PEG）的肠道准备方案。主要疗效指标为肠道准备的有效性。波士顿评分量表（Boston bowel preparation scale，BBPS）各节段（右侧结肠、中段结肠和左侧结肠）评分均≥2分定义为有效。次要疗效指标包括受试者的依从性和结肠镜下肠腔气泡评估，同时包括服药后排便间隔时间、服药后大便呈Ⅶ型（Bristol大便分类法）间隔时间、排便次数、结肠镜检查阳性率（息肉、非息肉性隆起、溃疡等检出率），以及通过不良事件和严重不良事件的发生情况来评估安全性。结果 共4家医院的240名受试者参加研究，其中试验组（OSS组）120例，对照组（PEG组）120例。全分析集（full analysis set，FAS）分析显示OSS组与PEG组的肠道准备成功率分别为92.44%（110/119）和91.60%（109/119）（χ2=0.058，P=0.809）。除FAS分析左侧结肠BBPS评分差异无统计学意义外，FAS和符合方案集（per protocol set，PPS）分析均显示OSS组BBPS总分及各肠段评分均优于PEG组。OSS组的气泡评估满意率高于PEG组（95.80%比89.08%，P=0.025），两组的依从性、结肠镜检查阳性率和安全性相似。结论 OSS方案的肠道准备质量不低于4 L PEG方案，消泡效果好，安全性相当。

Abstract:

Objective To evaluate the efficacy and safety of oral sulfate solution (OSS) for bowel preparation. Methods A multi‑center, randomized, single‑blinded, positive‑controlled and non‑inferiority clinical study was conducted. Participants were randomized to receive two bottles of OSS or 4‑liter polyethylene glycol (Ⅲ) (PEG) regimen. The primary indicator was efficacy for bowel preparation. Boston bowel preparation scale (BBPS) ≥2 scores in each segment was determined as effective. Secondary endpoints included subjects"" compliance, colonoscopy bubble evaluation, time interval of defecation after medication, time interval of defecation type Ⅶ (Bristol stool classification), the number of defecation, and the positive rate of colonoscopy (detection rate of polyps, non‑polyp eminence, ulcers, etc.) were also recorded. The safety was evaluated by the incidence of adverse events and severe adverse events. Results A total of 240 subjects from 4 hospitals were enrolled in the study, with 120 subjects in the experimental group (the OSS group) and 120 subjects in the control group (the PEG group). The full analysis set (FAS) showed that the bowel preparation success rates were 92.44% (110/119) in the OSS group and 91.60% (109/119) in the PEG group (χ2=0.058, P=0.809) . The total BBPS score and the scores of each bowel segment were all higher in the OSS group than those in the PEG group (P<0.05) in both FAS and per protocol set (PPS) except the score of left colon in the FAS. The satisfaction rate of bubble evaluation in the OSS group was higher ( 95.80% VS 89.08%, P=0.025). The compliance, positive rate of colonoscopy and safety of the two groups were comparable. Conclusion Compared with 4‑liter PEG regimen, OSS regimen shows similar bowel preparation quality, superior anti‑foaming effect with acceptable safety.