SummaryIn a prospective, randomized, double‐blind, multicentre trial the effect of antenatal treatment with betamethasone phosphate was compared with placebo in the prevention of the respiratory distress syndrome (RDS) in preterm infants. The dose of betamethasone was 4 mg every 8 h for six doses, unless delivery occurred. The 251 women who were enrolled gave birth to 262 liveborn infants, 130 in the betamethasone and 132 in the placebo group; the two groups were evenly matched in most respects. The diagnosis of RDS in the newborn was confirmed by two independent assessors. Seven of the 130 infants in the betamethasone group and 16 of the 132 in the placebo group developed RDS. In infants whose mothers had received at least three injections, RDS was also less frequent in the steroid group than in the placebo group (3/104 and 10/104 respectively; P<0·05). There was a significant reduction of RDS in those born between 24 h and 6 days after entry into the trial (0/30 and 8/45 respectively; P<0·05). The largest difference in frequency of RDS occurred in the subgroup of infants born before 34 weeks gestation, within 8 days of trial entry, and whose mothers had received at least three injections (0/27 steroid group and 7/32 placebo group; P=0·03), and there were also significantly fewer neonatal deaths (2/27 and 13/32, respectively; P<0·01) in this subgroup. Betamethasone did not provoke earlier delivery. Premature rupture of the membranes and maternal hypertension did not seem to contraindicate the use of steroids: there was no increase in maternal or neonatal sepsis nor in stillbirth in hypertensive pregnancies in the steroid group. Neonatal jaundice was significantly less frequent in the steroid (55/129) than in the placebo group (81/127; P<0·01) but not in the subgroups born before 34 completed weeks gestation.
. Serum levels, half‐lives and urine concentrations of cephalexin, an oral cephalosporin antibiotic which is unique in its absorption and excretion, are reported in human volunteers, fasting, non‐fasting and non‐fasting plus probenecid. Accumulation does not seem to occur.
. Cephalexin clearance was 376 ml./min and the ratio of cephalexin/creatinine clearances was 2·6 in one volunteer.
. Cephalexin had no effect on the urinary excretion of leucocytes, red cells or protein.
. The very high rate of absorption giving high serum levels and urine concentrations suggest cephalexin will be a useful antibiotic in susceptible bacterial infections in man.
Cefuroxime, a new cephalosporin antibiotic which is stable to most beta-lactamases produced by gram-negative bacteria, was given by bolus intravenous injection to six volunteers in doses of 500 mg and 750 mg. The concentrations of cefuroxime in serum and urine were measured at pre-determined times after injection and the data analysed by a two-compartment open system model. A serum concentration of 8 microgram/ml was exceeded for 100.3 min (+/- 18.3) after a 500 mg dose and for 144.5 min (+/- 19.8) after 750 mg. The ultimate serum half-life was 1.1 h. Excretion of cefuroxime in the urine was almost complete in 24 h, the clearance being 150 ml/min/1.73m2. About 45% was excreted through the renal tubules. The injections were well tolerated and no changes in haematological or biochemical values were seen. The resulting data are compared with those published for some other cephalosporins. It is concluded that the favourable pharmacokinetics, especially the high concentrations of unbound cefuroxime in the serum, are likely to aid effective therapy of human infection caused by sensitive bacteria.
Healthy volunteers were given a single intramuscular (i.m.) injection of a solution of 1 g, 500 or 250 mg sodium cephalexin or an intravenous (i.v.) injection of 1 g. Following i.m. injection, mean peak serum levels were estimated by computer analysis to be 18.3, 17.9 and 8.2 pg ml-l respectively. The mean serum level 15 min after i.v. injection was 52.5 pg ml-l. The rate of recovery of cephalexin in the urine after i.m. injection was slower than after both i.v. injection and oral administration. Concentrations of cephalexin in the urine reached a higher maximum after i.v. than after i.m. injection, but were maintained for a shorter time. Analysis of the data after i.m. injection suggests the occurrence of a depot-like effect.
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