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一项评估口服硫酸盐溶液和 2-L 抗坏血酸加聚乙二醇疗效和顺应性的前瞻性随机临床研究。

A prospective randomized clinical study evaluating the efficacy and compliance of oral sulfate solution and 2-L ascorbic acid plus polyethylene glycol.

机构信息

Department of Internal Medicine, Dongguk University Ilsan Hospital, Goyang, Korea.

Department of Internal Medicine, Korea University Guro Hospital, Seoul, Korea.

出版信息

Korean J Intern Med. 2020 Jul;35(4):873-880. doi: 10.3904/kjim.2017.275. Epub 2019 Jan 30.

Abstract

BACKGROUND/AIMS: Oral sulfate solution (OSS) is an emerging cleansing agent for bowel preparation. However, data comparing OSS to other conventional bowel preparations in Asian patients are limited. Therefore, the objective of this study was to compare the efficacy and tolerability of OSS to ascorbic acid plus polyethylene glycol (AA + PEG) in Asian patients.

METHODS

This was a prospective, randomized, parallel, investigator-blind study performed in two university hospitals in Korea. Bowel preparation efficacy was evaluated using both the Ottawa Bowel Preparation Scale (OBPS) and Boston Bowel Preparation Scale (BBPS).

RESULTS

Among 173 patients, 86 received OSS while 87 received AA + PEG for bowel preparation. Total OBPS score was 2.80 ± 2.48 in the OSS group and 4.49 ± 3.08 in the AA + PEG group, indicating significantly (p < 0.001) better efficacy with OSS. Total BBPS was higher in the OSS group (7.43 ± 1.49 vs. 6.51 ± 1.76, p < 0.001), indicating superior bowel preparation quality with OSS. Preparation-related adverse events were generally acceptable. Patients receiving OSS had more nausea (1.92 ± 0.94 vs. 1.54 ± 0.76, p = 0.004) and abdominal cramping (1.45 ± 0.78 vs. 1.17 ± 0.51, p = 0.006) than those receiving AA + PEG. However, overall satisfaction and taste were similar between the two groups.

CONCLUSION

OSS had a non-inferior bowel cleansing efficacy than AA + PEG regardless of colon segment.

摘要

背景/目的:口服硫酸盐溶液(OSS)是一种新兴的肠道清洁剂。然而,在亚洲患者中,OSS 与其他传统肠道准备方法的数据比较有限。因此,本研究的目的是比较 OSS 与抗坏血酸加聚乙二醇(AA + PEG)在亚洲患者中的疗效和耐受性。

方法

这是一项在韩国的两家大学医院进行的前瞻性、随机、平行、研究者盲法研究。采用渥太华肠道准备量表(OBPS)和波士顿肠道准备量表(BBPS)评估肠道准备效果。

结果

在 173 名患者中,86 名接受 OSS 肠道准备,87 名接受 AA + PEG 肠道准备。OSS 组的总 OBPS 评分为 2.80 ± 2.48,AA + PEG 组为 4.49 ± 3.08,OSS 组的效果明显(p < 0.001)更好。OSS 组的总 BBPS 更高(7.43 ± 1.49 vs. 6.51 ± 1.76,p < 0.001),表明 OSS 具有更好的肠道准备质量。与 AA + PEG 组相比,OSS 组患者的恶心(1.92 ± 0.94 vs. 1.54 ± 0.76,p = 0.004)和腹痛(1.45 ± 0.78 vs. 1.17 ± 0.51,p = 0.006)更为常见,但两组的不良反应总体上均可以接受。然而,两组的总体满意度和口感相似。

结论

OSS 与 AA + PEG 相比,在肠道各段的清洁效果均非劣效。

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