Ursodeoxycholic acid in the treatment of cholestasis of pregnancy: a randomized, double-blind study controlled with placebo
| Autor: | Lorena Sandoval, Juris Liepins, Humberto Reyes, Fernando Lira, Joaquín Palma, Ramón Almuna V, Ismael Hernandez, Jose Ribalta, Manuel Sedano, Octavio Silva, Juan Silva, Dolores Tohá |
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| Rok vydání: | 1998 |
| Předmět: |
Adult
medicine.medical_specialty Cholestasis Intrahepatic Placebo Gastroenterology law.invention Fetus Randomized controlled trial Cholestasis Double-Blind Method law Pregnancy Internal medicine medicine Humans Hepatology business.industry Ursodeoxycholic Acid Pregnancy Outcome Gestational age medicine.disease Ursodeoxycholic acid Surgery Pregnancy Complications Gestation Female business Cholestasis of pregnancy medicine.drug |
| Zdroj: | Journal of hepatology. 27(6) |
| ISSN: | 0168-8278 |
| Popis: | Intense pruritus and the risk of stillbirths and premature deliveries justify the search for an effective pharmacologic treatment of intrahepatic cholestasis of pregnancy. This study was designed to test the efficacy of ursodeoxycholic acid in maternal pruritus, the biochemical abnormalities and the outcome of pregnancy, in patients with intrahepatic cholestasis of pregnancy of early onset.Pregnant patients hospitalized in a secondary case-referral center with intense pruritus and abnormal serum levels of bile salts and aminotransferases, detected before week 33 of pregnancy, were randomly assigned to receive ursodeoxycholic acid, 1 g per day orally, or an identical placebo, until delivery, in a double-blind study. A 3-week trial period was chosen to compare drug and placebo effects. The follow-up was extended for 3 months after delivery.Twenty-four patients entered the trial; eight had deliveries before 2 weeks of treatment and one dropped out. The study was then completed in 15 patients: eight received ursodeoxycholic acid and seven placebo. No adverse effects were detected in the mothers or in their babies. After 3 weeks of treatment, patients receiving ursodeoxycholic acid (mean daily dose 16 mg/kg body weight) had a significant improvement in pruritus (p0.02), in serum bilirubin (0.36+/-0.19 mg/dl (mean+/-SD) versus 0.95+/-0.48 in patients receiving placebo, p0.01), in aspartate aminotransferase (52+/-42 IU/l vs 98+/-44, p0.05) and in alanine aminotransferase (54+/-50 IU/l vs 229+/-154, p0.01); serum total bile salts also tended to be lower in patients receiving ursodeoxycholic acid (26.3+/-33.7 micromol/l vs 55.0+/-44.8, p N.S.). Deliveries occurred at or near term in all mothers who received ursodeoxycholic acid (mean week of pregnancy: 38), while they occurred before week 36 of pregnancy in five patients who received placebo, including one stillbirth. All babies born alive had birth weights adequate for gestational age and they were thriving normally 3 months after delivery.Ursodeoxycholic acid is effective and safe in patients with intrahepatic cholestasis of pregnancy of early onset, attenuating pruritus and correcting some biochemical abnormalities in the mothers. Relevant aspects of fetal outcome were also improved in patients receiving ursodeoxycholic acid compared to placebo. |
| Databáze: | OpenAIRE |
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