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primary studies published RCT

Modification of pediatric lung function measurement by antibacterial filters.

  • Year: 1992
  • Date: 1997
  • Author: Gruper W
Source

Pneumologie YR: 1992 VL: 46 DE: RCT NO: 11

Study design (if review, criteria of inclusion for studies)

RCT

Participants

30 CF patients (age > 5 years) with biochemical cholestasis and compensated liver disease. Baseline clinical variables were comparable. low-dose (n = 17) or high-dose (n = 13) UDCA.

Interventions

low-dose (10 mg/kg/day) and high-dose (20 mg/kg/day) UDCA treatment for 3 and 12 months.

Outcome measures

liver biochemistry

Main results

After 1 year one patient had died of liver failure (low dose), and three had dropped out because of pruritus (one in each group) or personal choice (low dose). In the high-dose group improvement in gamma-glutamyl transferase values was more pronounced after 3 months and 1 year (P < 0.004), and improvement of alanine aminotransferase was better after 1 yer (P < 0.02). Improvement of alkaline phosphatase and aspartate aminotransferase was comparable. Complete normalization of liver enzymes and bilirubin occurred more often in the high-dose group.

Authors' conclusions

High-dose UDCA induces a better response of liver biochemistry values than low-dose UDCA in CF patients with cholestatic liver disease.

Keywords: Adolescent; Adult; Child; Cholagogues and Choleretics; Cholestasis; Gastrointestinal Diseases; High-Dose; Liver Diseases; Low-Dose; pharmacological_intervention; UDCA; Gastrointestinal Agents;