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.

Ambroxol↗

PubMedDate not supplied

[The importance of betamimetics and magnesium for the outcome of pregnancy: I. Reduction of intrauterine growth retardation, premature rupture of membranes and premature birth after supplemental magnesium therapy].

Of 4 905 single pregnancies recorded within a 4 year period (1979-1982) 882 (18%) were risk pregnancies managed with Betamimetics (B); of these 348 (7,1%) had tocolysis (T) and 534 (10,9%) tocolysis and cerclage (T/C). Since the end of 1979 the patients received in addition to the Betamimetic a K-Mg-Vitamin drug (Feto-Longoral) aimed at "Cardioprotection", and since the beginning of 1981 30-40 mval oral Mg daily in the form of Magnesium aspartate (Mg 5-Longoral) to "support tocolysis". The mean age, parity, percentage with Magnesium therapy, the pregnancy outcome using a gestational age limit less than or equal to 36 weeks, the frequency of premature ruptured membranes (PROM) in premature and mature infants as well as the number of intrauterine growth retarded infants (IUR) (less than 10th percentile BPE) were yearly evaluated and compared for both risk collectives T and T/C as well as for the normal collectives (N). While only 2% of the normal collectives had a pregnancy duration of less than or equal to 36 weeks (completed) the figure was five fold in both T and T/C groups, and however was yearly reduced in the T/C group from 11,0% (1979) to 4,9% (1982). The frequency of PROM with premature infants in the T and T/C groups is about 6% (N-collectives about 1%). It is however reduced in the T/C group in 1981 to 2,2% and in 1982 to 1,6%. For mature infants it is N: 17-12% (fluctuating) and B (T + T/C): 22-11% (yearly decreasing). The rate of IUR (less than 10th percentile BPE) in the T and T/C groups in 1979 was 22,2 and 20,5% respectively and in 1980 12,6 and 17,5% respectively. It is further reduced in 1981 to 11,6 and 8,8% respectively and in 1982 to 9,7 and 10,6% respectively (N-collectives between 8,3 and 11,5%). The "weight gain" exceeds the 25th percentile (Hohenauer): 1979 and 1980 for B: 33,1 and 30,2% respectively, and 1981 and 1982 for B: 25,4 and 24,2% respectively (N between 26,5 and 19,5%). The results show that patients with tocolysis--with or without cerclage--have more premature and growth-retarded infants than normal collectives (a sign of more placenta insufficiencies). In the two years where Magnesium was supplemented at 30-40 mval daily, short term pregnancies, the PROM frequency and the IUR rate decreased (statistically evaluated). It could thus be concluded that a relative Magnesium deficiency might have been responsible for a certain percentage of premature births and hypotrophic infants and that better results were obtained after Magnesium substitution.

Adrenergic beta-Agonists↗

PubMedDate not supplied

[The significance of betamimetics and magnesium for the outcome of pregnancy: II. The role of magnesium in the development of gestosis and fetal hypotrophy].

Of 4905 single pregnancies between 1979 and 1982 the 882 (18.0%) risk pregnancies managed tocolytically with Betamimetics and Magnesium were retrospectively compared with the remaining collective (R) of 4023 (82.0%) patients without management. The tocolysed patients (B/Mg) received Magnesium in addition to Betamimetics: since 1979/1980 a low dose Mg containing drug (Feto-Longoral) aimed at "cardioprotection" (3-6 mval Mg++ daily), and since 1981 to "support tocolysis" 30-40 mval Mg++ daily per os in the form of Mg-aspartate (Mg 5-Longoral). All cases of gestosis (G) in both collectives B/Mg and R were investigated. A normal collective (N) is obtained by subtracting G from R. For all collectives N, G, and B/Mg the following data were compared: mean age, parity, percentage with supplement Mg medication (only the B/Mg collective), the pregnancy outcome with respect to pregnancy duration and the number of intrauterine retarded infants (IUR: less than 10th percentile of the Bavarian Perinatal Evaluation (BPE), less than 25th percentile according to Hohenauer). The number of gestosis in the 882 B/Mg cases is zero. It is 97 (2.0%) in the remaining 4023 patients. The IUR rate (less than 10th perc. BPE) is 9.4% in the 3926 N patients, and is 45.4% in the 97 gestosis patients. The IUR rate is 17.8% in the 398 B/Mg patients of 1979 and 1980 who had received less adjuvant Mg (B/Mg [1]), and it is 10.1% in the 484 B/Mg patients of 1981 and 1982 who had received much higher Magnesium (B/Mg [2]).(ABSTRACT TRUNCATED AT 250 WORDS)

Adrenergic beta-Agonists↗

PubMedDate not supplied

[Induction of osmiophilic lamellar bodies by corticosteroids, Fenoterol and Ambroxol in lung tissue cultures from human fetuses].

Organ cultures were set up from human fetal lung originating from the first trimester of gestation (8-12 weeks) and followed their morphological differentiation in the absence and in the presence of Dexamethasone, Betamethasone, Ambroxol and Dexamethasone + Fenoterol. We were especially interested in studying whether multilamellar bodies and tubular myelin structures which are characteristic of the human surfactant, could be demonstrated in the cells after different treatment. Dexamethasone and Betamethasone promoted directly the development of the multilamellar bodies and the tubular myelin structures in the type II cells. - Furthermore, Ambroxol (Bromhexin-metabolite VIII) produced a prominent stimulatory effect in the synthesis of the surfactant in a concentration of 12 ng/ml. Fenoterol has probably no stimulatory effect on the surfactant production. In cultures treated with 10 ng/ml Fenoterol + 10 ng/ml Dexamethasone the benefit effect of Dexamethasone in stimulation of the multilamellar bodies was impaired. Our investigation shows that the human fetal lung is able to respond to the action of glucocorticoids and Ambroxol as early as in the first trimester of gestation by accumulating phospholipids.

Ambroxol↗