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首页> 外文期刊>Endoscopy International Open >A European, multicentre, observational, post-authorisation safety study of oral sulphate solution: compliance and safety
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A European, multicentre, observational, post-authorisation safety study of oral sulphate solution: compliance and safety

机译：口腔硫酸盐解决方案的欧洲，多期中心，观察，授权后安全性研究：遵守和安全

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Background and study aims?Oral sulphate solution (OSS) is a sulphate-based, low-volume bowel cleansing preparation taken in two doses of 500?mL, each followed by 1000mL of water or clear liquid. The primary objective of this observational study was to document compliance with the recommended hydration guidelines in a representative sample of the European population. Patients and methods?Prospective, non-interventional, multicentre study (NCT02630680, EUPAS9361) in patients prescribed OSS for colonoscopy preparation in routine clinical practice in Europe. Patients were included according to pre-agreed consecutive enrolment rules. Patients recorded the volume of OSS and water or clear liquid intake, and occurrence of adverse events (AEs). Compliance with hydration was calculated as a ratio of actual volume of water/clear liquid taken versus prescribed 2,000?mL, and non-compliance defined as ?75?% intake. Colon cleansing level was assessed on a 4-point scale. Results?Between October 2015 and January 2017, 1,281 patients were recruited in 16 centres in four European countries (safety population n?=?1,206; registry population n?=?1,177). Of patients, 94.5?% were ≥?75?% and 86.8?% 100?% compliant with hydration guidelines. Patients took an average of 96.8?% of the recommended OSS volume; 46 patients (3.9?%) were non-compliant. Colon cleansing levels were good-to-excellent in 87.6?% of patients. Three hundred and twenty-nine patients (27.3?%) experienced 758 treatment-related AEs, mostly gastrointestinal (82.9?%), all were mild-to-moderate. Non-compliant patients had no AEs suggestive of dehydration. Conclusion?In this non-interventional study in a real-life setting, treatment compliance with hydration guidelines was good-to-excellent in 94.5?% of patients receiving OSS.?The safety profile of OSS was similar to the prescribing information..
机译：背景和研究目标？口腔硫酸盐溶液（OSS）是一种基于硫酸盐的，低容量肠清洁制剂以两种剂量为500×ml，每个水或透明液体。该观察学研究的主要目标是向欧洲人口代表性样本中遵守推荐的水合指南。患者和方法？在欧洲常规临床实践中规定患者的患者前瞻性，非介入，多期面研究（NCT02630680，EUPAS9361）在欧洲常规临床实践中的结肠镜检查准备。根据预定的连续入学规则包含患者。患者记录了OSS和水或透明液体摄入量，并发生不良事件（AES）。计算符合水合的依从性的水/透明液体与规定的2,000毫升的比例，并且不合规定义为<α75？％摄入量。在4分尺度上评估结肠清洁水平。结果？2015年10月至2017年1月，1,281名患者在四个欧洲国家的16个中心招募（安全人群N？=？1,206;注册人口N？=？1,177）。患者，94.5〜％≥？75〜75℃，86.8倍符合水合指南。患者平均花费96.8？％推荐的OSS卷; 46名患者（3.9？％）是不符合的。结肠清洁水平在87.6岁的患者中是良好的。三百二十九名患者（27.3？％）经历了758个治疗相关的AES，主要是胃肠道（82.9〜％），所有人都轻度至中等。不合规的患者没有AES暗示脱水。结论？在这个真实环境中的非介入研究中，94.5岁的治疗指南的治疗符合性良好符合优秀的患者。患者患者的百分比，OSS的安全性曲线类似于处方信息..

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