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皮克沙尔与聚乙二醇在儿童结肠镜检查前肠道清洁中的比较:一项随机对照试验。

Pico-Salax versus polyethylene glycol for bowel cleanout before colonoscopy in children: a randomized controlled trial.

机构信息

Division of Gastroenterology, Hepatology and Nutrition, The Hospital for Sick Children, University of Toronto, Toronto, Canada.

出版信息

Endoscopy. 2009 Dec;41(12):1038-45. doi: 10.1055/s-0029-1215333. Epub 2009 Dec 4.

DOI:10.1055/s-0029-1215333
PMID:19967619
Abstract

BACKGROUND AND STUDY AIMS

Comparison of bowel preparation for colonoscopy in children with either Pico-Salax (sodium picosulphate with magnesium citrate) or polyethylene glycol with electrolyte solution (PEG-ELS).

PATIENTS AND METHODS

In this investigator-blinded, randomized controlled trial, 83 children (12.5 +/- 3.1 years) requiring elective colonoscopy at a referral hospital were randomly allocated to Pico-Salax (n = 43) or PEG-ELS (n = 40), and an intention-to treat analysis was applied. Pico-Salax was administered in two doses, one the evening before and one on the morning of the procedure. PEG-ELS was administered over 4 hours. Efficacy was scored using the Ottawa scale and other constructs. Tolerability and toxicity were measured by patient and nursing questionnaires and serum biochemistry.

RESULTS

35 of Pico-Salax patients (81 %) were satisfied or very satisfied with the cleanout, compared with 19 (48 %) in the PEG-ELS group (P = 0.001). No differences were found in bowel cleanout effectiveness, as judged by the Ottawa score (P = 0.24), completion rates (P = 0.69), colonoscopy duration (P = 0.59), need for enemas (P = 0.25), or physician's global impression (P = 0.7). Except for one case of mild dehydration in the Pico-Salax group, no clinically significant adverse events were recorded. Serum biochemistry results were similar between groups except for more hypermagnesemia associated with Pico-Salax and hypokalemia with PEG-ELS; neither was clinically significant.

CONCLUSION

Children tolerate Pico-Salax better than PEG-ELS for bowel cleanout before colonoscopy. This study did not demonstrate superiority of effectiveness or safety for either regimen.

摘要

背景和研究目的

比较儿童用匹克沙洛(含柠檬酸镁的聚卡波非钙)或聚乙二醇电解质溶液(PEG-ELS)行结肠镜检查的肠道准备效果。

患者和方法

这是一项研究者设盲、随机对照试验,83 例(12.5±3.1 岁)在转诊医院行择期结肠镜检查的患儿被随机分配至匹克沙洛组(n=43)或 PEG-ELS 组(n=40),采用意向治疗分析。匹克沙洛分 2 次服用,一次在检查前一晚,一次在检查当天清晨。PEG-ELS 在 4 小时内服用。采用渥太华肠道准备量表及其他指标进行疗效评分。通过患者和护理人员问卷调查及血清生化检查来测量耐受性和毒性。

结果

35 例(81%)匹克沙洛组患儿对肠道清洁效果满意或非常满意,而 PEG-ELS 组仅 19 例(48%)(P=0.001)。渥太华评分(P=0.24)、完成率(P=0.69)、结肠镜检查时间(P=0.59)、需要灌肠(P=0.25)或医师整体印象(P=0.7)等肠道清洁效果指标两组间无差异。除匹克沙洛组 1 例轻度脱水外,两组均无明显不良事件。两组间血清生化结果相似,仅匹克沙洛组更易发生轻度高镁血症和 PEG-ELS 组更易发生低钾血症,但均无临床意义。

结论

与 PEG-ELS 相比,儿童行结肠镜检查前用匹克沙洛肠道准备的耐受性更好。本研究未显示出两种方案在有效性或安全性方面有优势。

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