A prospective randomized controlled trial of AJG522 versus standard PEG+E as bowel preparation for colonoscopy.

A prospective randomized controlled trial of AJG522 versus standard PEG+E as bowel preparation for colonoscopy.
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DOI:
10.1155/2015/521756
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发表时间:
2015
影响因子:
--
通讯作者:
Yamada M
Yamada M
中科院分区:
生物学3区
文献类型:
--
作者:
Sagawa T;Sato K;Tomizawa T;Mizuide M;Yasuoka H;Shimoyama Y;Kuribayashi S;Kakizaki S;Kawamura O;Kusano M;Yamada M

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用于结肠镜检查的基于聚乙二醇(PEG)的肠道准备通常由于需要大量的液体摄入而耐受性差。我们比较了低容量“改性”PEG +抗坏血酸(AJG522)与标准PEG+电解质(PEG + E)以及刺激性泻药和改善肠道功能的药物在结肠镜检查前进行肠道清洁,以评估其有效性,安全性和可接受性。计划接受结肠镜检查的门诊患者随机接受AJG522或PEG + E。由设盲和独立研究者通过肉眼粪便检查结果评估肠道清洁状况。采用问卷调查的方式,对患者对制剂的反馈进行调查。除PEG + E组中的4例外,所有病例在服用制剂后3小时均成功清洁。在服用每种制剂后2小时,AJG522组的粪便性质比PEG + E组明显更清楚(P = 0.013)。虽然肠道准备的总液体量没有减少,但AJG522制剂可以显著减少所需的准备量(P < 0.0001)。AJG522组患者的可接受性更好(P = 0.010)。两组之间的安全性特征无显著差异(UMIN000013892)。
Polyethylene glycol- (PEG-) based bowel preparations for colonoscopies are often poorly tolerated due to the large volumes of fluid intake required. We compared low-volume “modified” PEG + ascorbic acid (AJG522) with standard PEG with electrolytes (PEG + E) in addition to a stimulant laxative and an agent to improve bowel function for the bowel cleansing before colonoscopy to evaluate its efficacy, safety, and acceptability. Outpatients scheduled to undergo colonoscopy were randomized to receive either AJG522 or PEG + E. Bowel cleansing conditions were assessed via macroscopic fecal findings by blinded and independent investigators. A survey of the patients' feedback regarding the preparation was conducted by questionnaire. Successful cleansing was achieved in all cases, except for 4 cases in the PEG + E group, at 3 hours after taking the preparation. The fecal properties were significantly clearer in the AJG522 group than in the PEG + E group at 2 hours after taking each preparation (P = 0.013). Although the total liquid volume of the bowel preparation was not reduced, the AJG522 preparation could significantly reduce the required volume of the preparation (P < 0.0001). Moreover, the patients in the AJG522 group had better acceptability (P = 0.010). There were no significant differences in the safety profiles between groups (UMIN000013892).
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