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.
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。