Randomised clinical trial: low-volume bowel preparation for colonoscopy - a comparison between two different PEG-based formulations
Randomised clinical trial: low-volume bowel preparation for colonoscopy - a comparison between two different PEG-based formulations
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DOI：
10.1111/apt.12026
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发表时间：
2012-10-01
影响因子：
7.6
通讯作者：
Hassan, C.
中科院分区：
文献类型：
--
作者：
Repici, A.;Cestari, R.;Hassan, C.
背景：与用于结肠镜检查的标准聚乙二醇（PEG）肠道制剂相比，小体积聚乙二醇（PEG）肠道制剂可提供同等的清洁效果，并且耐受性提高。最近研制出了一种新的等渗透无硫酸盐聚乙二醇-柠檬酸盐-西甲硅氧烷（PEG-CS）与双羟基乙酸乙酯复合配方。目的比较成人门诊结肠镜检查患者使用聚乙二醇-聚乙二醇-双乙酰胆碱与聚乙二醇-抗坏血酸（PEG-ASC）进行肠道清洁的质量。方法对意大利5个中心接受结肠镜检查的成人门诊患者进行随机、观察者盲、平行组研究。这两项准备工作都是在手术前一天晚上进行的。受试者被指示在结肠镜检查前一天的16:00（类似于小时）服用24片5 mg的比沙可，20:00（类似于小时）服用2 mg的PEG-CS，或2 mg的PEG-ASC加1 mg的补充水。根据波士顿肠准备量表评估肠道清洁（=6分被认为是临床成功），并根据3分制评估粘膜可见性。并对耐受性、可接受性和依从性进行了评价。结果48例患者被随机分配到PEG-CS + bisacodyl组（n相似=相似204，男性患者48%，平均年龄59.1相似岁）或PEG-ASC组（n相似=相似204，男性患者51%，平均年龄59.4相似岁）。在计划的方案分析中，采用PEG-CS与比沙代碱的制备成功率为79.1%，采用PEG-ASC的制备成功率为70%
Background Low-volume bowel preparations with polyethylene glycol (PEG) have been shown to provide an equivalent cleansing with improved tolerability as compared with standard PEG bowel preparation for colonoscopy. A new iso-osmotic sulphate-free formulation of PEG-Citrate-Simethicone (PEG-CS) in combination with bisacodyl has been recently developed. Aim To compare the quality of bowel cleansing with PEG-CS with bisacodyl vs. PEG-Ascorbate (PEG-ASC) in adult out-patients undergoing colonoscopy. Methods Randomised, observer-blind, parallel group study in adult out-patients undergoing colonoscopy in five Italian centres. Both preparations were taken the evening before the procedure. Subjects were instructed to take 24 tablets of 5 similar to mg bisacodyl at 16:00 similar to hours and 2 similar to L of PEG-CS at 20:00 similar to hours or 2 similar to L of PEG-ASC plus 1 similar to L of additional water the day before colonoscopy. Bowel cleansing was evaluated according to the Boston Bowel Preparation Scale (=6 scores were considered as clinical success), and mucosal visibility according to a 3-point scale. Tolerability, acceptability and compliance were also evaluated. Results Four hundred and eight patients were randomly allocated to PEG-CS and bisacodyl (n similar to=similar to 204, male patient 48%, mean age 59.1 similar to years) or PEG-ASC (n similar to=similar to 204, male patient 51%, age 59.4 similar to years). In the planned per-protocol analysis, the rate of successful preparation was 79.1% following PEG-CS with bisacodyl, and 70% following PEG-ASC (P similar to