Department of Gastroenterology and Hepatology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands.
Dis Colon Rectum. 2018 Feb;61(2):239-249. doi: 10.1097/DCR.0000000000000956.
Because of its volume, adequate bowel preparation remains problematic in physically unfit patients.
This study aimed to compare a small-volume sodium picosulfate/magnesium citrate preparation with a 2-L ascorbic acid-enriched polyethylene glycol solution plus bisacodyl.
This study has a noninferiority design, assuming that ascorbic acid-enriched polyethylene glycol solution plus bisacodyl is 70% efficacious in achieving an Ottawa score ≤7 and accepting a difference in success rate of <15% with a target enrollment of 146 patients per group.
This study was conducted in an outpatient department.
Patients referred for diagnostic colonoscopy were randomly assigned. Key exclusion criteria were severe kidney disease, ASA class ≥III, and hospital admission.
Patients were randomly assigned to receive sodium picosulfate/magnesium citrate or ascorbic acid-enriched polyethylene glycol solution plus bisacodyl according to a split-dose regimen. Patients in the sodium picosulfate/magnesium citrate group received advice on the recommended 4-L fluid intake. Patients in the ascorbic acid-enriched polyethylene glycol solution plus bisacodyl group received 2 bisacodyl tablets 2 days before and advice on the additionally recommended 2-L fluid intake.
To assess bowel-cleansing adequacy, the Ottawa, Aronchick, and Boston scores were used. Colonoscopy quality measures were obtained. Safety was assessed for a 30-day follow-up period.
Overall, 341 patients (169 men, mean age 57.0 years; BMI 26.2 kg/m) were included. Comorbidities were present in 76.2% of patients, and 75.4% of patients used medication. An adequate Ottawa score was obtained in 81.4% and 75.8% of patients receiving ascorbic acid-enriched polyethylene glycol solution plus bisacodyl and sodium picosulfate/magnesium citrate (difference of 5.6% (95% CI, -3.5 to -14.6; p = 0.023)), showing noninferiority of the sodium picosulfate/magnesium citrate therapy. Ottawa segmental scores were lower for sodium picosulfate/magnesium citrate in the right and transverse colon. In both groups, successful ileocecal intubation was achieved in 95%. No medication-related adverse events were reported.
These results in a physically disabled ambulant population cannot be extrapolated to immobile, hospitalized patients.
Sodium picosulfate/magnesium citrate proved to be noninferior to ascorbic acid-enriched polyethylene glycol solution plus bisacodyl in efficacy and safety. Timing of the colonoscopy and addition of bisacodyl to sodium picosulfate/magnesium citrate warrants further consideration. See Video Abstract at http://links.lww.com/DCR/A461.
由于体积较大，对于身体不适的患者来说，充分的肠道准备仍然存在问题。
本研究旨在比较小剂量的匹可硫酸钠/柠檬酸镁制剂与 2L 富含抗坏血酸的聚乙二醇溶液加比沙可啶的疗效。
本研究采用非劣效性设计，假设富含抗坏血酸的聚乙二醇溶液加比沙可啶的疗效为 70%，可使渥太华评分≤7，接受成功率差异<15%，目标入组每组 146 例患者。
本研究在门诊进行。
因诊断性结肠镜检查而转介的患者被随机分配。主要排除标准为严重的肾脏疾病、ASA 分级≥3 级和住院。
患者被随机分配接受匹可硫酸钠/柠檬酸镁或富含抗坏血酸的聚乙二醇溶液加比沙可啶，根据分剂量方案给药。匹可硫酸钠/柠檬酸镁组的患者接受了关于推荐的 4L 液体摄入的建议。富含抗坏血酸的聚乙二醇溶液加比沙可啶组的患者在 2 天前服用 2 片比沙可啶，并接受了另外推荐的 2L 液体摄入的建议。
为了评估肠道清洁程度，使用了渥太华、阿龙奇克和波士顿评分。获得了结肠镜检查质量指标。对 30 天随访期间的安全性进行了评估。
总体而言，纳入了 341 名患者（男性 169 名，平均年龄 57.0 岁；BMI 26.2kg/m）。76.2%的患者存在合并症，75.4%的患者使用药物。接受富含抗坏血酸的聚乙二醇溶液加比沙可啶和匹可硫酸钠/柠檬酸镁治疗的患者中，有 81.4%和 75.8%获得了足够的渥太华评分（差异为 5.6%（95%CI，-3.5 至-14.6；p=0.023）），表明匹可硫酸钠/柠檬酸镁治疗具有非劣效性。匹可硫酸钠/柠檬酸镁在右半结肠和横结肠的渥太华节段评分较低。两组患者均成功进行了回盲部插管。未报告与药物相关的不良事件。
这些在身体不适的可走动的门诊患者中的结果不能外推到不能活动的住院患者。
匹可硫酸钠/柠檬酸镁在疗效和安全性方面被证明不劣于富含抗坏血酸的聚乙二醇溶液加比沙可啶。结肠镜检查的时间安排和在匹可硫酸钠/柠檬酸镁中添加比沙可啶值得进一步考虑。详见视频摘要，网址：http://links.lww.com/DCR/A461。
