Graduate Institute of Acupuncture Science, China Medical University, Taichung 40402, Taiwan.
Division of Colorectal Surgery, Department of Surgery, China Medical University Hospital, Taichung 40447, Taiwan.
World J Gastroenterol. 2021 Feb 7;27(5):428-441. doi: 10.3748/wjg.v27.i5.428.
Efficient bowel cleansing is essential for a successful colonoscopy, but the ideal cleansing agent, volume, and pharmaceutical dosage form have yet to be determined. Small-volume cleansers enhance patient compliance.
To compare the bowel cleansing efficacy of 32-tablet sodium phosphate (Quiklean) with 2-L polyethylene glycol (PEG)/bisacodyl (Klean-Prep/ Dulcolax) under identical dietary recommendations.
This multicenter, randomized, parallel-group, noninferiority clinical trial enrolled 472 outpatients, randomized 456 subjects, and scheduled 442 subjects to undergo colonoscopy (Quiklean = 222 and Klean-Prep/Dulcolax = 220). After bowel preparation, a colonoscopist performed the colonoscopy with video recorded for rating. The primary efficacy endpoint was the bowel cleansing quality using the Aronchick Scale. The secondary endpoints were the bowel cleansing efficacy of three colon segments, tolerability and acceptability, safety using the Ottawa bowel preparation scale, questionnaires by subjects, and monitoring of adverse events.
Success rates (Excellent + Good) of the bowel cleansing quality by Aronchick Scale were 98.6% ( = 205) and 97.6% ( = 204) in the Quiklean and Klean-Prep/Dulcolax groups, respectively. Quiklean demonstrated noninferiority over Klean-Prep/Dulcolax in colon cleansing efficacy. Quicken showed better tolerability and acceptability in the overall experience (was rated as excellent; 24.0% 17.2%; = 0.0016) and the taste of the study preparation (was rated as excellent, 23.1% 13.4%; < 0.0001) than Klean-Prep/Dulcolax. Safety profiles did not differ between the two groups. Our data indicate that Quiklean is an adequate, well-tolerated bowel cleansing preparation compared with the standard comparator Klean-Prep/Dulcolax.
Quiklean is sodium phosphate tablets available on Taiwan's market for bowel preparation; it potentially offers patients an alternative to standard large-volume bowel preparation regimens and may, therefore, increase positive attitudes toward colonoscopies and participation rates.
高效的肠道清洁对于成功进行结肠镜检查至关重要，但理想的清洁剂、容量和药物剂型尚未确定。小容量清洁剂可提高患者的依从性。
比较 32 片装磷酸钠（Quiklean）与 2 升聚乙二醇/比沙可啶（Klean-Prep/Dulcolax）在相同饮食建议下的肠道清洁效果。
这是一项多中心、随机、平行组、非劣效性临床试验，共纳入 472 名门诊患者，随机分组 456 例，计划 442 例接受结肠镜检查（Quiklean = 222 例，Klean-Prep/Dulcolax = 220 例）。肠道准备后，由结肠镜检查医师进行视频记录评分的结肠镜检查。主要疗效终点是使用 Aronchick 量表评估的肠道清洁质量。次要终点是三个结肠段的肠道清洁效果、耐受性和可接受性、使用渥太华肠道准备量表评估的安全性、患者问卷和不良事件监测。
Aronchick 量表评估的肠道清洁质量成功率（优秀+良好）分别为 Quiklean 组 98.6%（=205 例）和 Klean-Prep/Dulcolax 组 97.6%（=204 例）。Quiklean 在结肠清洁效果方面表现出非劣效性优于 Klean-Prep/Dulcolax。Quiklean 在整体体验（评为优秀；24.0% 17.2%；=0.0016）和研究准备的口感（评为优秀；23.1% 13.4%；<0.0001）方面表现出更好的耐受性和可接受性，优于 Klean-Prep/Dulcolax。两组安全性特征无差异。我们的数据表明，与标准对照 Klean-Prep/Dulcolax 相比，Quiklean 是一种充分、耐受良好的肠道清洁准备药物。
Quiklean 是台湾市场上可用于肠道准备的磷酸钠片剂，它为患者提供了一种替代标准大容量肠道准备方案的选择，因此可能会提高对结肠镜检查的积极态度和参与率。
