The use of ACV in pregnancy is not yet recommended for two main reasons : its safety has not been established and the,lack of studies on pharmacokinetics. In this paper, we have.reviewed data concerning nine pregnant women who was iven ACV in the perinatal period. Route of administration ani doses were as following : orally (0) 350 mg/8 hours (5), lntravenousl (IV) 5-10 mg/kg/8 hours ( 4 ) . Plasm? trough (T) and eak (P) fevels of ACV was deteroinated by radio~mmuno assay. At girth, plasma ACV levels were achieved in the mother and her offspring. P and T after IV were effective to inhiblt viral replication (17-41 pmol/l 1 22-1 36 umol/l) and hi her than in vitro ID 50 for Herpes'vi;adea'viruses (0.1-4 pmoY/l) ; whereas T and P ranged from 0.32 to 0, 59 pmol/l and from 1.79 to 3.78 pmol/l after 10 doses given orally. Furthermore steady state plasma level was not achieved even after 10 doses 0. The maternal foetal ratio of ACV level was approximately 1. No side effects were noted in newborns. Conclnsion : If this drug is felt,to be used in a pregnant.voman, IV administration seems to be advisable regarding it's efficacy. 0 administration requires more data about recommended dosage. Transplacental passa e of ACV occurs. Plasma ACV levels in the mother reflect probagly foetal ACV level. Fifteen very low birth weight I1tLBY1 children, nine appropriate for qeitati;i;al age in6A. aean birth weight 1302tIb4 g, gestational age 30t_1.5 neeksl, and six jrall for gestaticaa! aqe ISSR, aean birth neigih I:b3t117 g, qestatlonal age 35.35.5 weeks), xere studied at the age of 7-12 years, and coapared to trentysix age-, sex-, and height-latched healthy children, who were born at term (lean birth weight 3?2b+ib7 51. !lox of :Ce YLRY rhildren had developed chronic broncopullonary disease, The hab~tua! !ere1 of physical act~vity was not different in the YLBY and control Grcup. Pulronary function tests and progresirre exercise tests on treadlill were perforled. Forced v!tal caoacity, forced expiraiory ?oliiae at one second and forced expiratory flow between 251 and 751 of vital capaclty were in tb: norral range for all the subjects. No difference; were founo in aaxiwda oxyeen con'.um~tion (YO2 aaxl, anaerobic threshold IATI and #axiral heart rate between :he ASR !'lo2 lax - Lidoca~rcis either a convulsant or an anticonvulwnt drug, according to the plasmatic levels. W e used its anticonvulwnt effect in scizures of various etiology. Lidocairtinfusion (L.I.) was efficient in 19/29 full term (FT) and in 10/13 prcmaturc babies (PT) with seizures (confirmed by EEG) resisting to Phenobarbital and Diazepam therapy. L.1. was given at decreasing dosage (4 mg/kg/h, day 1; 3 mg/kg/h, day 2; 2 mg/kg/h,day 3; 1 mg/kg/h,day 4). After L.I. beginning : -seizures were controlled within 30 min. in 23 cases, aftcr 3 to 13 hours in 4 cases; -background EEG changed in some casts, immediatly or after a delay (up to 24 hours) into a very discontinuous pattern. In 2 cases L.I. alone did not control seizures, but an additional bolus (2 mg/Kg) was efficient ...
In an international multicenter trial infants with clinical and radiological signs of severe RDS (age 2-15 h, birthweight 700-2,000 g, mechanical ventilation, FiO2 ≧ 0.6, no complicating disease) were randomized to receive either a single dose (n = 176) or up to three subsequent doses (n = 167) of a natural porcine surfactant (Curosurf). Using a logistic regression model, the effects of therapy, birthweight, sex, hospital and other clinical factors on survival and various outcome parameters were evaluated. Mortality (13 vs. 21 %, p < 0.05) and the incidence of pneumothorax (9 vs. 18%, p < 0.01) were significantly lower in the multiple-dose group. Low birthweight, hospital allocation, low Apgar score and initial disease severity were associated with an increased mortality. Low birthweight, hypothermia (admission temperature < 36°C) and acidosis (pH < 7.25) prior to surfactant treatment could be identified as risk factors for the development of intracranial hemorrhage.
In an exploratory study the 24-h urinary excretion pattern of caffeine and 14 of its major metabolites was studied in 32 volunteers (adults, adolescents and children), 14 patients either with end stage renal disease or liver cirrhosis, 7 heavy smokers and 27 patients on therapy with cimetidine, allopurinol, theophylline or phenytoin. Caffeine and its metabolites were quantified by UV-absorption after liquid/liquid-extraction and HPLC-separation, which ensured proper analysis of 1-methyluric acid. In adults the renal excretion of caffeine derivatives corresponded to an intake of 509 mg caffeine/day, with 1-methyluric acid as the predominant metabolite. About 69% of caffeine was degraded by the paraxanthine pathway, and theobromine- (19%) and the theophylline pathway (14%) were less important. The ratio of paraxanthine formation to urinary caffeine concentration (= clearance equivalent) was about 2.2 ml.min-1.kg-1 in adults, and the corresponding ratios for theophylline and theobromine were 0.43 ml.min-1.kg-1 and 0.59 ml.min-1.kg-1, respectively. As expected, caffeine degradation was impaired in patients with cirrhosis and was increased in persons who smoked heavily or who were on phenytoin therapy. The results document the possibility of noninvasively investigating gross differences in caffeine disposition by analysis of the urinary pattern of its metabolites.
Aims To investigate the dose‐response relationship and contribution of verapamil SR and trandolapril given in combination once a day for the treatment of essential hypertension. Methods A randomized, double‐blind, placebo controlled, factorial, 12 arm parallel group comparison with placebo, verapamil SR (120, 180 mg), trandolapril (0.5, 1.0, 2.0 mg) covering all combinations of both drugs. A 4 week placebo run‐in period followed by 6 weeks of treatment. Four hundred and fifty‐six patients from office practice (22 centres) with mild to moderate hypertension enrolled and 426 with diastolic pressure ≥100 mm Hg at the end of run‐in period were randomized. Main outcome measures were reduction in sitting systolic (SBP) and sitting diastolic (DBP) blood pressure. Results The combination of verapamil SR and trandolapril, particularly verapamil SR 180 mg and trandolapril 0.5 or 1.0 mg was significantly superior to both monocomponents at the same dose (P<0.05). For these combinations, the adjusted mean reductions in DBP from baseline to last visit were 14.1 and 16.0 mm Hg, respectively. Response surface analysis provided further evidence that these combinations were optimal for antihypertensive efficacy. All treatments were well tolerated. The incidence of adverse events did not differ significantly between treatment groups; the profile of adverse events on combination therapy was mild and consistent with that of each monocomponent. Conclusions All dosage combinations of verapamil SR and trandolapril produced significantly greater reduction of blood pressure than the monotherapy at the same dosage. However, verapamil SR 180 mg in combination with trandolapril 1.0 mg was the dosage with the greatest blood pressure reduction and had the greatest effects compared with the monocomponents.
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