中国临床医学2025，Vol.32Issue(5)：743-747,5.DOI:10.12025/j.issn.1008-6358.2025.20250401
TCIC-001用于结肠镜前肠道准备的有效性和耐受性:一项探索性随机对照临床试验
Evaluation of efficacy and tolerability of TCIC-001 for bowel preparation prior to colonoscopy:an exploratory randomized controlled clinical trial
摘要
Abstract
Objective To compare the efficacy and tolerability of the novel bowel-cleansing agent TCIC-001 and the traditional polyethylene glycol(PEG)regimen for bowel preparation prior to colonoscopy.Methods Prospective inclusion of 62 patients who were scheduled to undergo colonoscopy at Zhongshan Hospital,Fudan University from July 2021 to July 2022.They were randomly divided into TCIC-001 group(n=31)and PEG group(n=31)using a random number table method.The TCIC-001 group took TCIC-001 orally,drinking water in stages,with a total liquid intake of 1 500 mL;the PEG group took PEG orally,taking it in 4 doses,with a total liquid intake of 3 000 mL.The primary endpoint indicator is the quality of intestinal hygiene evaluated by the Boston Bowel Preparation Scale(BBPS),the secondary endpoint indicators were medication adherence,medication duration,frequency of bowel movements,duration of bowel movements,and incidence of adverse events between two groups.Results No significant differences were observed in sex,age,or defecation frequency between the two groups.For efficacy,both groups achieved equivalent bowel cleanliness,with a"good preparation"rate of 93.55%and comparable BBPS score of each intestinal segment and total scores.For tolerability,the TCIC-001 group had a shorter medication duration compared to the PEG group([48.8±25.9]min vs[82.8±28.4]min,P<0.001),a longer defecation duration([288.6±74.0]min vs[236.5±74.3]min,P<0.001),and a lower incidence of first defecation before medication completion(9.68%vs 41.94%,P=0.004).Regarding safety,no significant differences were observed between the TCIC-001 group and the PEG group in incidences of chloride disturbances(0%vs 9.68%)and calcium disturbances(3.23%vs 6.45%),and no other adverse events.Conclusions TCIC-001 demonstrated comparable bowel-cleansing efficacy to PEG while significantly improving tolerability(reduced medication time and lower risk of premature defecation)and maintaining favorable safety.关键词
TCIC-001/肠道准备/结肠镜/耐受性/有效性/安全性Key words
TCIC-001/bowel preparation/colonoscopy/tolerability/efficacy/safety分类
医药卫生引用本文复制引用
宋宝回,庄小龙,加沙尔·巴合提努尔,徐晓玥,徐佳昕,张丹枫,钟芸诗,周平红,蔡明琰..TCIC-001用于结肠镜前肠道准备的有效性和耐受性:一项探索性随机对照临床试验[J].中国临床医学,2025,32(5):743-747,5.基金项目
上海市卫生健康委员会卫生行业临床研究专项(202340178),2023年度复旦大学附属中山医院临床研究专项基金(ZSLCYJ202350).Supported by Shanghai Municipal Health Commission Specialized Clinical Research Project(202340178),Clinical Research Special Project of Zhongshan Hospital,Fudan University(ZSLCYJ202350). （202340178）
