Noninferiority clinical trial comparing the bowel cleansing efficacy of sodium phosphate tablets(Quiklean®)with a polyethylene glycol/bisacodyl kit

作     者：Shih-Ya Hung Hung-Chang Chen Tao-Wei Ke Jiann-Hwa Chen Koung-Hung Hsiao Hwei-Ming Wang Hua-Che Chiang Sheng-Chi Chang Yi-Chang Chen Ming-Hao Hsieh Yuan-Yao Tsai Yo-Wen Hsieh William Tzu-Liang Chen 

作者机构：Graduate Institute of Acupuncture ScienceChina Medical UniversityTaichung 40402Taiwan Department of Medical ResearchChina Medical University HospitalTaichung 40447Taiwan Division of Colorectal SurgeryDepartment of SurgeryChina Medical University HospitalTaichung 40447Taiwan Division of GastroenterologyTaipei Tzu Chi HospitalTaipei 23142Taiwan Division of Colorectal SurgeryTaipei Tzu Chi HospitalTaipei 23142Taiwan Department of PharmacyChina Medical University HospitalTaichung 40447Taiwan Department of Colorectal SurgeryChina Medical University Hsinchu HospitalZhubei 30272Taiwan School of MedicineChina Medical UniversityTaichung 40402Taiwan 

出 版 物：《World Journal of Gastroenterology》 (世界胃肠病学杂志（英文版）)

年 卷 期：2021年第27卷第5期

页      面：428-441页

核心收录：

学科分类：1002[医学-临床医学] 100201[医学-内科学(含：心血管病、血液病、呼吸系病、消化系病、内分泌与代谢病、肾病、风湿病、传染病)] 10[医学] 

基　　金：The China Medical University Hospital No.DMR-108-125 

主　　题：Bowel preparation Clinical trial Colonoscopy Polyethylene glycol Sodium phosphate 

摘      要：BACKGROUND Efficient bowel cleansing is essential for a successful colonoscopy,but the ideal cleansing agent,volume,and pharmaceutical dosage form have yet to be ***-volume cleansers enhance patient *** To compare the bowel cleansing efficacy of 32-tablet sodium phosphate(Quiklean®)with 2-L polyethylene glycol(PEG)/bisacodyl(Klean-Prep/Dulcolax®)under identical dietary *** This multicenter,randomized,parallel-group,noninferiority clinical trial enrolled 472 outpatients,randomized 456 subjects,and scheduled 442 subjects to undergo colonoscopy(Quiklean®=222 and Klean-Prep/Dulcolax®=220).After bowel preparation,a colonoscopist performed the colonoscopy with video recorded for *** primary efficacy endpoint was the bowel cleansing quality using the Aronchick *** secondary endpoints were the bowel cleansing efficacy of three colon segments,tolerability and acceptability,safety using the Ottawa bowel preparation scale,questionnaires by subjects,and monitoring of adverse *** Success rates(Excellent+Good)of the bowel cleansing quality by Aronchick Scale were 98.6%(n=205)and 97.6%(n=204)in the Quiklean®and Klean-Prep/Dulcolax®groups,***®demonstrated noninferiority over Klean-Prep/Dulcolax®in colon cleansing *** showed better tolerability and acceptability in the overall experience(was rated as excellent;24.0%vs 17.2%;P=0.0016)and the taste of the study preparation(was rated as excellent,23.1%vs 13.4%;P0.0001)than Klean-Prep/Dulcolax®.Safety profiles did not differ between the two *** data indicate that Quiklean®is an adequate,well-tolerated bowel cleansing preparation compared with the standard comparator Klean-Prep/Dulcolax®.CONCLUSION Quiklean®is sodium phosphate tablets available on Taiwan’s market for bowel preparation;it potentially offers patients an alternative to standard large-volume bowel preparation regimens and may,therefore,increase positive attitudes toward