[Ambroxol versus betamethasone for stimulating antepartal lung maturity--a multicenter study].
In a multicenter, randomized double-blind study, the effect of Betamethasone and Ambroxol, both used for prenatal prevention of RDS in premature and newborn infants, is compared in a total of 185 patients with premature labour or an induced termination of pregnancy between the 28 and 36th week of gestation. The Ambroxol group of 93 patients is reduced to 77 due to a break up of therapy in 16 patients. The Betamethasone group is likewise reduced from 92 to 85 due to a break up of therapy in 7 patients. The main reason for breaking up therapy in these patients is the impossibility of stopping labour and delivery within 72 hours after admission to the hospital. Both treatment groups show no significant differences with regard to age, weight, history, rate of premature rupture of membranes, gestational age at beginning of therapy and at time of delivery, mode of delivery, rate of tocolytic therapy and prematurity. RDS morbidity, established by a standardized evaluation of the infants considering X-ray, clinical and blood-gas analyses findings, is 9% (7 out of 79 infants) in the Ambroxol group, and 6% (5 out of 86 infants) in the Betamethasone group. Statistically seen, the difference between the two groups is insignificant. Amniotic fluid analyses carried out in a total of 46 patients of both groups show increased surfactant parameters after therapy as compared to initial values before therapy. A significant difference between the two groups is not manifest. The objections against corticosteroids regarding there indications and side effects are generally known. The results of this study indicate that Ambroxol compared to Betamethasone can be considered as an effective drug for prevention of neonatal respiratory distress syndrome.