| Popis: |
Background Beta interferons, are produced by fibroblasts and are used in the treatment of relapsing-remitting multiple sclerosis (MS). Animal studies and human case reports have suggested that interferons are unlikely to be teratogenic. Objective of this study is to determine whether interferon therapy during human pregnancy increases reproductive risks in women with MS. Methods This prospective, observational, cohort study consists of three groups of women: an exposed group, a disease matched unexposed group, and a healthy comparative group. Subjects were selected by contacting the Motherisk Program regarding maternal beta interferon or Copaxone® exposure during pregnancy, from 1997 and 2004. After delivery all of the women were re-contacted for a follow-up interview regarding maternal health, pregnancy outcome, and neonatal health. Results The study group (n=16, pregnancy outcome 23) were exposed to interferon beta at doses ranging from 25–132 mcg/week There was a decrease in mean birth weight in the exposed group (3.2± 0.42 kg) as compare to controls (3.5± 0.5, 3.8 ±0.4, P=0.003). There were 9 spontaneous abortions and one fetal death in exposed group, yielding significantly higher rate of pregnancy loss (P=0.03). There were 2 major malformations (abnormality in the X chromosome, Down's Syndrome) among exposed fetuses. Conclusions Beta interferon therapy in first trimester of pregnancy appears to be associated with an increase risk for miscarriages. Clinical Pharmacology & Therapeutics (2005) 77, P29–P29; doi: 10.1016/j.clpt.2004.12.004 |
Plný text