Treatment of Faecal Impaction with Polyethelene Glycol Plus Electrolytes (PGE + E) Followed by a Double‐blind Comparison of PEG + E Versus Lactulose as Maintenance Therapy
Лечение калового завала полиэтиленгликолем с электролитами (PEG + E) с последующим двойным слепым сравнением PEG + E и лактулозы в качестве поддерживающей терапии
2006-07-01
SCID: 54.1/spv4qcyz
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childhood constipationfaecal impactionlactulosemaintenance therapypolyethylene glycol plus electrolytes
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Abstract (AI)
OBJECTIVES: To assess the efficacy of polyethylene glycol 3350 plus electrolytes (PEG + E; Movicol) as oral monotherapy in the treatment of faecal impaction in children, and to compare PEG + E with lactulose as maintenance therapy in a randomised trial. PATIENTS AND METHODS: An initial open-label study of PEG + E in the inpatient treatment of faecal impaction (phase 1), followed by a randomised, double-blind comparison between PEG + E and lactulose for maintenance treatment of constipation over a 3-month period (phase 2) in children aged 2 to 11 years with a clinical diagnosis of faecal impaction. RESULTS: Disimpaction on PEG + E was achieved in 58 (92%) of 63 of children (89% of 2-4 year olds and 94% of 5-11 year olds) without additional interventions. A maximum dose of 4 sachets (for 2-4 year olds) or 6 sachets (for 5-11 year olds) was required; median time to disimpaction was 6 days (range, 3-7 days). Seven children (23%) reimpacted whilst taking lactulose, whereas no children reimpacted while taking PEG + E (P = 0.011). The total incidence rate of adverse events seen was higher in the lactulose group (83%) than in the PEG + E group (64%). CONCLUSIONS: PEG + E is safe and highly effective in the management of childhood constipation. It allows a single orally administered laxative to be used for disimpaction without recourse to invasive interventions. It is significantly more effective than lactulose as maintenance therapy, both in efficacy in treating constipation and efficacy in preventing the recurrence of faecal impaction.
Key Findings
1
Adverse events were less frequent with PEG plus electrolytes than with lactulose (64% versus 83%).
2
Disimpaction required up to four sachets daily in 2–4-year-olds or six sachets in 5–11-year-olds, with a median duration of six days.
3
During three-month maintenance therapy, faecal reimpaction occurred in 23% of children receiving lactulose versus none receiving PEG plus electrolytes (P = 0.011).
4
Oral PEG 3350 plus electrolytes achieved faecal disimpaction without additional interventions in 58 of 63 children (92%).
5
PEG plus electrolytes was concluded to be a safe, effective oral monotherapy for disimpaction and more effective than lactulose for maintenance treatment.
Research Object
Children aged 2–11 years with faecal impaction and constipation treated with polyethylene glycol 3350 plus electrolytes (PEG + E) or lactulose
Research Subject
The efficacy, safety, disimpaction success, and prevention of recurrent faecal impaction of PEG + E versus lactulose during treatment and 3-month maintenance therapy
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2006-07-01
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