Deding Ulrik, Kaalby Lasse, Baatrup Gunnar, Kobaek-Larsen Morten, Thygesen Marianne Kirstine, Epstein Owen, Bjørsum-Meyer Thomas
Department of Surgery, Odense University Hospital, Svendborg, Denmark.
Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
Clin Epidemiol. 2022 Apr 2;14:437-444. doi: 10.2147/CLEP.S353527. eCollection 2022.
To investigate whether the prokinetic prucalopride increases the completion rate of colon capsule endoscopy (CCE). Secondary outcomes included demographic distribution, polyp detection rate (PDR), distribution of Leighton-Rex grade, and adverse events.
In a nested cohort within the CareForColon2015 trial, a subgroup of 406 individuals underwent CCE in 2021. The first half (control) received the standard bowel preparation and the second half (prucalopride) was supplemented with 2 mg of prucalopride. Transit times and bowel preparations were analyzed and completion rates calculated as those having timely transit and acceptable bowel cleanliness. Major adverse events were recorded continuously and minor adverse events were quantified from questionnaires.
The group demographics were homogenous. The prevalence ratio for complete CCE was 1.32 (CI 95% 1.15; 1.53) in the prucalopride group compared to the control group. Completion rate was 74.9% in the prucalopride group and 56.7% in the control group. The proportions of acceptable bowel preparation and complete transits were higher in the prucalopride group. The mean CCE transit time was 2 hours and 8 minutes faster in the prucalopride group. The PDR was higher in the intervention group with 55.7% compared to 36.0% in the control group for polyps greater than 9 mm, whereas the groups' PDRs were similar for small and diminutive polyps. In all, 589 polyps (mean 2.9) were found in the prucalopride group compared to 522 polyps (mean 2.6) in the control group.
Prucalopride led to an increase in CCE completion rates. The proportions of complete transits and acceptable bowel preparations were higher in the prucalopride group. The PDR was higher in the prucalopride group compared to the control group. No major adverse events were identified. Nausea, diarrhea, headache and fatigue were more commonly reported in the prucalopride group.
研究促动力药普芦卡必利是否能提高结肠胶囊内镜检查（CCE）的完成率。次要结果包括人口统计学分布、息肉检出率（PDR）、Leighton-Rex分级分布及不良事件。
在CareForColon2015试验的一个嵌套队列中，2021年有406名个体的亚组接受了CCE检查。前半部分（对照组）接受标准肠道准备，后半部分（普芦卡必利组）补充2mg普芦卡必利。分析转运时间和肠道准备情况，并将完成率计算为具有适时转运和可接受肠道清洁度的患者的完成率。持续记录严重不良事件，并通过问卷调查对轻微不良事件进行量化。
两组人群在人口统计学上具有同质性。与对照组相比，普芦卡必利组CCE完成率的患病率比值为1.32（95%置信区间1.15；1.53）。普芦卡必利组的完成率为74.9%，对照组为56.7%。普芦卡必利组可接受肠道准备和完全转运的比例更高。普芦卡必利组的平均CCE转运时间快2小时8分钟。干预组的PDR更高，对于大于9mm的息肉，干预组为55.7%，对照组为36.0%，而两组对于小息肉和微小息肉的PDR相似。普芦卡必利组共发现589个息肉（平均2.9个），对照组为522个息肉（平均2.6个）。
普芦卡必利可提高CCE完成率。普芦卡必利组完全转运和可接受肠道准备的比例更高。与对照组相比，普芦卡必利组的PDR更高。未发现严重不良事件。普芦卡必利组更常报告恶心、腹泻、头痛和疲劳。
