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A randomized clinical study comparing reduced-volume oral sulfate solution with standard 4-liter sulfate-free electrolyte lavage solution as preparation for colonoscopy.

机译:一项随机临床研究,比较了小剂量口服硫酸盐溶液与标准的4升无硫酸盐电解质灌洗液作为结肠镜检查的准备。

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BACKGROUND: Low-volume bowel preparations for colonoscopy improve tolerability. OBJECTIVE: We compared the efficacy, tolerability, and safety of a new low-volume sulfate solution with a standard 4-L polyethylene glycol electrolyte lavage solution as bowel preparation for colonoscopy. DESIGN: Multicenter, single-blind, randomized, noninferiority study. SETTING: Five academic and community endoscopy centers in the United States. PATIENTS: One hundred thirty-six outpatients undergoing colonoscopy. INTERVENTIONS: Patients were randomized to receive 4 L sulfate-free electrolyte lavage solution (SF-ELS) given the night before colonoscopy versus 12 oz oral sulfate solution (OSS) given in equally divided doses the evening before and the morning of colonoscopy. MAIN OUTCOME MEASUREMENTS: Successful (ie, good or excellent) bowel preparation. RESULTS: Successful bowel preparation was more frequent with OSS than with SF-ELS (98.4% vs 89.6%; P = .04). Excellent preparation also was achieved more frequently with OSS (71.4% vs 34.3%; P < .001). Patients receiving OSS had less residual stool in the cecum and ascending colon and less residual fluid in the cecum and ascending, transverse, and descending colon compared with SF-ELS. The percentage of patients with GI side effects and adverse events was not significantly different between the 2 groups. LIMITATIONS: The OSS was administered in split doses, whereas the SF-ELS was administered the evening before (which is its FDA-approved regimen). CONCLUSIONS: Oral sulfate solution is promising as a safe low-volume preparation for colonoscopy. (Clinical trial registration number: NCT00856843.).
机译:背景:用于结肠镜检查的小剂量肠道制剂可提高耐受性。目的:我们比较了新型低容量硫酸盐溶液与标准4-L聚乙二醇电解质灌洗液作为结肠镜检查肠准备的功效,耐受性和安全性。设计:多中心,单盲,随机,非劣效性研究。地点:美国的五个学术和社区内窥镜检查中心。患者:一百三十六名接受结肠镜检查的门诊患者。干预措施:患者被随机分配接受结肠镜检查前一晚给予的4 L无硫酸盐电解质灌洗液(SF-ELS),而结肠镜检查前一晚和早晨按等分剂量给予12 oz口服硫酸盐溶液(OSS)。主要观察指标:成功(即好或好)肠准备。结果:OSS的成功肠道准备比SF-ELS更为频繁(98.4%比89.6%; P = .04)。 OSS的使用频率也更高(71.4%对34.3%; P <.001)。与SF-ELS相比,接受OSS的患者在盲肠和升结肠的粪便残留量较少,在盲肠和升结肠,横结肠和降结肠的残留液较少。两组之间有胃肠道副作用和不良事件的患者百分比无显着差异。局限性:OSS分次给药,而SF-ELS在前一天晚上给药(这是FDA批准的方案)。结论:口服硫酸盐溶液有望作为一种安全的小剂量结肠镜检查制剂。 (临床试验注册号:NCT00856843。)。

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