PDF(Pubmed)
Abstract：
BACKGROUND: Acceptability and tolerance of bowel preparation is critical to overcome patient hesitancy in undergoing colon cancer screening and surveillance colonoscopy. To improve patient experience, a new sports drink-flavored bowel preparation containing polyethylene glycol (PEG) and sulfate salts (FPSS) was developed to provide a similar experience to a commonly used but not United States Food and Drug Administration (FDA) approved PEG and sports drink bowel preparation (PEG-SD), while also achieving improved cleansing efficacy.
METHODS: This FPSS preparation, approved by the FDA in June 2023, was evaluated in a non-randomized Phase 2 study in which 40 patients requiring colonoscopy were prepared with FPSS and 20 with PEG-SD.
RESULTS: Overall cleansing success was high with FPSS based on unblinded local endoscopist assessment (93%) and blinded central reading (97%), exceeding PEG-SD which achieved success rates of 84% (local read), 74% and 68% (blinded central reads). Similar differences favoring FPSS were seen for excellent preparations and cleansing success by colon segment as rated by local endoscopists. Both preparations were well-tolerated, with 93% of FPSS patients rating their preparation as Tolerable to Very Easy to consume, compared to 100% of PEG-SD. Patients who had previously taken a preparation for colonoscopy found FPSS and PEG-SD better than their prior preparation (73% and 70%, respectively) and nearly all would request their assigned study preparation again in the future. About two thirds of FPSS patients agreed that the preparation tasted similar to a sports drink.
CONCLUSIONS: The new sports drink-like flavored preparation compares favorably to PEG-SD for bowel cleansing efficacy while achieving similar patient satisfaction. The study was registered at www.
RESULTS: gov (NCT03328507) on 01/11/2017.
METHODS: This FPSS preparation, approved by the FDA in June 2023, was evaluated in a non-randomized Phase 2 study in which 40 patients requiring colonoscopy were prepared with FPSS and 20 with PEG-SD.
RESULTS: Overall cleansing success was high with FPSS based on unblinded local endoscopist assessment (93%) and blinded central reading (97%), exceeding PEG-SD which achieved success rates of 84% (local read), 74% and 68% (blinded central reads). Similar differences favoring FPSS were seen for excellent preparations and cleansing success by colon segment as rated by local endoscopists. Both preparations were well-tolerated, with 93% of FPSS patients rating their preparation as Tolerable to Very Easy to consume, compared to 100% of PEG-SD. Patients who had previously taken a preparation for colonoscopy found FPSS and PEG-SD better than their prior preparation (73% and 70%, respectively) and nearly all would request their assigned study preparation again in the future. About two thirds of FPSS patients agreed that the preparation tasted similar to a sports drink.
CONCLUSIONS: The new sports drink-like flavored preparation compares favorably to PEG-SD for bowel cleansing efficacy while achieving similar patient satisfaction. The study was registered at www.
RESULTS: gov (NCT03328507) on 01/11/2017.
摘要：
背景：肠道准备的可接受性和耐受性对于克服患者在接受结肠癌筛查和结肠镜检查时的犹豫至关重要。为了改善患者体验，开发了一种含有聚乙二醇（PEG）和硫酸盐（FPSS）的新型运动饮料风味肠道制剂，以提供与通常使用但未获得美国食品和药物管理局（FDA）批准的PEG和运动饮料肠道制剂（PEG-SD）相似的体验。同时也达到改善清洁功效。
方法：此FPSS准备，2023年6月获得FDA批准,在一项非随机2期研究中进行了评估,其中40例需要结肠镜检查的患者使用FPSS准备,20例使用PEG-SD准备.
结果：基于非盲局部内窥镜评估（93％）和盲中心读数（97％），FPSS的总体清洁成功率很高，超过PEG-SD，成功率为84%(本地阅读)，74%和68%(盲化中央读段)。如局部内窥镜医师所评估的，对于结肠段的出色准备和清洁成功，也看到了有利于FPSS的类似差异。两种制剂的耐受性都很好，93％的FPSS患者将他们的制剂评为可耐受非常容易食用，与100%的PEG-SD相比。先前进行结肠镜检查准备的患者发现FPSS和PEG-SD优于先前的准备（73％和70％，分别），几乎所有人都会在将来再次要求他们分配的研究准备。大约三分之二的FPSS患者同意该制剂的味道类似于运动饮料。
结论：新型运动饮料风味制剂与PEG-SD相比，在肠道清洁功效方面具有优势，同时达到相似的患者满意度。该研究已在www上注册。
结果：gov（NCT03328507）于2017年01月11日。
方法：此FPSS准备，2023年6月获得FDA批准,在一项非随机2期研究中进行了评估,其中40例需要结肠镜检查的患者使用FPSS准备,20例使用PEG-SD准备.
结果：基于非盲局部内窥镜评估（93％）和盲中心读数（97％），FPSS的总体清洁成功率很高，超过PEG-SD，成功率为84%(本地阅读)，74%和68%(盲化中央读段)。如局部内窥镜医师所评估的，对于结肠段的出色准备和清洁成功，也看到了有利于FPSS的类似差异。两种制剂的耐受性都很好，93％的FPSS患者将他们的制剂评为可耐受非常容易食用，与100%的PEG-SD相比。先前进行结肠镜检查准备的患者发现FPSS和PEG-SD优于先前的准备（73％和70％，分别），几乎所有人都会在将来再次要求他们分配的研究准备。大约三分之二的FPSS患者同意该制剂的味道类似于运动饮料。
结论：新型运动饮料风味制剂与PEG-SD相比，在肠道清洁功效方面具有优势，同时达到相似的患者满意度。该研究已在www上注册。
结果：gov（NCT03328507）于2017年01月11日。
