Scientific Reports ( IF 3.8 ) Pub Date : 2020-03-27 , DOI: 10.1038/s41598-020-62120-w Shih-Ya Hung , Hong-Chang Chen , William Tzu-Liang Chen
Bowel cleansing is essential for a successful colonoscopy, but the ideal clearing agent and the volume have yet to be determined. A small-volume cleanser is important for patient compliance. This study aimed to compare the bowel cleansing efficacy, safety, tolerability, and acceptability of a 300-mL small-volume sodium picosulfate/magnesium citrate (PSMC) preparation-Bowklean with one 2-L polyethylene glycol (PEG)/bisacodyl-Klean-Prep/Dulcolax preparation under identical dietary recommendations. This multicenter, randomized, parallel-group, pre-specified noninferiority study enrolled 631 outpatients scheduled to undergo colonoscopy (Bowklean = 316 and Klean-Prep/Dulcolax = 315). After bowel preparation, an independent evaluator blinded to the subject’s treatment allocation rated the quality of the colon cleansing. Efficacy was evaluated using the Aronchick Scale and Ottawa Bowel Preparation Scale (OPBS). Safety was assessed by monitoring adverse events. Tolerability and acceptability were measured via a patient questionnaire. Bowklean was non-interior to Klean-Prep/Dulcolax in overall colon cleansing but was associated with significantly better preparation quality. Notably, Bowklean was associated with significantly greater tolerability and acceptability of bowel preparations than Klean-Prep/Dulcolax. Safety profiles did not differ significantly between the groups. Our data indicate that Bowklean is a more effective and better-tolerated bowel cleansing preparation before colonoscopy than Klean-Prep/Dulcolax. Bowklean may therefore increase positive attitudes toward colonoscopies and participation rates.
中文翻译:
一项比较Picosulfate /柠檬酸镁和聚乙二醇/ Bisacodyl的肠清洁功效的随机试验(Bowklean研究)。
肠清洁对于成功的结肠镜检查是必不可少的,但是理想的清洁剂和量尚未确定。小容量清洁剂对于患者依从性很重要。这项研究的目的是比较300mL小体积皮硫酸钠,柠檬酸镁(PSMC)制剂-Bowklean与一种2L聚乙二醇(PEG)/ bisacodyl-Klean-的肠道清洁功效,安全性,耐受性和可接受性。在相同的饮食建议下准备/ Dulcolax。这项多中心,随机,平行分组,预先指定的非劣效性研究招募了631位计划进行结肠镜检查的门诊患者(Bowklean = 316和Klean-Prep / Dulcolax = 315)。肠道准备后,独立评估者对受试者的治疗分配视而不见,对结肠清洁的质量进行了评估。使用Aronchick量表和渥太华肠准备量表(OPBS)评估疗效。通过监测不良事件评估安全性。耐受性和可接受性通过患者问卷进行测量。Bowklean在整体结肠清洗中不位于Klean-Prep / Dulcolax的内部,但与明显更好的制备质量有关。值得注意的是,与Klean-Prep / Dulcolax相比,Bowklean与肠道制剂的耐受性和可接受性明显更高。两组之间的安全性没有显着差异。我们的数据表明,与Klean-Prep / Dulcolax相比,Bowklean在结肠镜检查之前是一种更有效,耐受性更好的肠清洁制剂。因此,鲍克林可能会提高对结肠镜检查和参与率的积极态度。