Randomized trial of low-volume PEG solution versus standard PEG plus electrolytes for bowel cleansing before colonoscopy
Randomized trial of low-volume PEG solution versus standard PEG plus electrolytes for bowel cleansing before colonoscopy
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DOI：
10.1111/j.1572-0241.2007.01708.x
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发表时间：
2008-04-01
影响因子：
9.8
通讯作者：
Gruss, Hans-Juergen
中科院分区：
文献类型：
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作者：
Ell, Christian;Fischbach, Wolfgang;Gruss, Hans-Juergen
预防措施：基于聚乙二醇（PEG）的肠道灌洗液安全有效，但需要消耗大量液体。我们比较了一种新的2 L溶液的PEG加抗坏血酸（PEG + Asc）与标准的4 L PEG与电解质（PEG + E）的肠道清洗前结肠镜检查，以确定疗效，安全性和患者的可接受性。方法：安排进行结肠镜检查的成年住院患者随机接受2 L PEG + Asc或4 L PEG + E。在结肠镜检查前一天晚上和第二天早上分次服用制剂。PEG + Asc组在每次给药时取1L（即，总剂量2 L）。PEG + E组在每次给药时服用2L（即，总剂量为4 L）。肠道清洁的成功率由独立的、不知情的评估者通过录像带进行评估。统计学非劣效性预先定义为治疗差异的97.5%置信区间下限差异<15%。患者对准备工作的看法。结果：PEG + Asc组153例中有136例（88.9%）和4 L PEG + E组155例中有147例（94.8%）成功实现了肠道清洁（平均差异为-5.9 [-12.0-无穷大]）。差异在预定义的非劣效性限度内。临床和实验室参数显示安全性特征无差异。PEG + Asc组患者的可接受性和口味评分优于PEG + E组（P <0.025）。结论：抗坏血酸和PEG基肠道准备的组合减少了患者必须饮用的量而不影响疗效或安全性。低容量PEG + Asc制剂更容易被患者接受，因此应提高常规实践中的有效性。
OBJECTIVES: Polyethylene glycol (PEG)-based gut lavage solutions are safe and effective, but require consumption of large volumes of fluid. We compared a new 2 L solution of PEG plus ascorbic acid (PEG + Asc) with standard 4 L PEG with electrolytes (PEG + E) for bowel cleansing before colonoscopy to determine efficacy, safety, and patient acceptability.METHODS: Consenting adult inpatients scheduled to undergo colonoscopy were randomized to receive either 2 L PEG + Asc or 4 L PEG + E. Preparations were taken as split doses the evening before colonoscopy and the following morning. The PEG + Asc group took 1 L at each administration (i.e., total dose of 2 L). The PEG + E group took 2 L at each administration (i.e., total dose of 4 L). Bowel cleansing success was assessed via videotapes by independent, blinded raters. Statistical noninferiority was predefined as a difference of < 15% in the lower limit of the 97.5% confidence interval for treatment difference. Patient views on the preparations were elicited. Adverse events were noted.RESULTS: Successful gut cleansing was achieved in 136 of 153 (88.9%) cases of the PEG + Asc group and 147 of 155 (94.8%) cases of the 4 L PEG + E group (mean difference -5.9 [-12.0-infinity]). The difference fell within the predefined limit for noninferiority. Clinical and laboratory parameters showed no difference in safety profile. Patient ratings of acceptability and taste were better for the PEG + Asc group than for the PEG + E group (P < 0.025).CONCLUSIONS: The combination of ascorbic acid and PEG-based bowel preparation reduces the volume patients have to drink without compromising efficacy or safety. The low-volume PEG + Asc preparation was more acceptable to patients, and should, therefore, improve effectiveness in routine practice.