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Additionally, we have evidence that circulating maternal activin A concentrations are not suppressed after glucocortocoid treatment Coleman et al., submitted ; . We also failed to find a significant increase in activin A or inhibin A concentrations in the membranes of the pregnancies with evidence of infection. This was unexpected since we have recently established that inflammatory cytokines stimulate activin production by amnion, decidual and placental cells in vitro Keelan et al. 1998 ; . However, interpretation of these data are compromised by our ability to accurately diagnose those pregnancies with intrauterine infection. Our categorisation of these pregnancies was based on the presence of two or more of several clinical indicators of intrauterine infection, and histological examination was available only on a small number of these placentae. Hence, further studies are required to assess the effects of intrauterine infection on placental activin inhibin expression in vivo. In conclusion, we have measured activin A, inhibin A and follistatin concentrations in gestational tissues and observed an increase in placental activin A and inhibin A concentrations with term labour. Inhibin A concentrations in the extra placental membranes appeared to decline with term labour, and the resulting increase in the ratio of activin to inhibin may be reflected in a local increase in activin A bioactivity with labour. Concentrations of activin A, inhibin A and follistatin were not elevated in the tissues from preterm deliveries compared with term deliveries, and the data do not support an association between increased activin A production and preterm labour and delivery. Acknowledgements The assistance of the nursing and theatre staff at the National Women's Hospital with the collection of the placental tissues is gratefully acknowledged. The authors are extremely grateful to Dr Malcom Battin for reviewing the neonatal records. This study was supported by the Auckland University Research Committee, New Zealand Lottery Health Grants Board, and the Health Research Council of New Zealand. References.
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Length of coma is usually measured by the time to follow commands GCS motor 6 ; , time to initiate willful movements GCS motor 5 ; , or attempt to verbalize GCS verbal 3 ; . Length of coma correlates with survival, length of posttramatic amnesia PTA ; , and many functional outcomes. See Table 1. Spontaneous eye opening may indicate emergence from coma to a vegetative state and will occur within 3-4 weeks of injury. Unless eye signals can be reliably correlated with yes no responses, they are difficult to correlate with meaningful interaction with the environment. Those who do not emerge from coma by "following commands" may remain in a vegetative state for variable periods of time. Length of posttraumatic confusion or posttraumatic amnesia PTA ; is the next important recovery point. Prospectively, it can be measured when the person is consistently oriented or by the Galveston Orientation and Amnesia Test GOAT, see insert ; , with two consecutive scores greater than 75 100 within 24 hours and
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Logarithmic value of the mean diameter and the drug concentration was obtained. The correlation coefficient ranged from 0.998 to 0.9996. Little difference in coefficient value was observed between the plasma standard solution Consera Nissui as a control serum; Nissui Seiyaku Co. Ltd., Tokyo, Japan ; and the urine standard solution pH 7.0 phosphate buffer ; , being more than 0.998. The quantitation limit was 0.1 , ug ml. The precision was evaluated by five replicate measurements with the solutions of 0.1, 0.8, and 3.1 , ug ml. The within-day coefficients of variation were 1.3, 1.4, and 1.5% in the plasma standard and 2.7, 1.3, and 1.1% in the urine standard for both, n 5 ; . The between-day coefficients of variation 5 days ; for the above concentrations of each standard solution were 6.1, 5.2, and 2.9% and 1.6, 0.9, and 1.6%, respectively. The band-culture method 7 ; used for the investigation of metal ion effect was assessed by assaying aqueous solutions of LFLX 0.5 to 8 , ug coli 7437 as the test organism and trypto-soy agar pH 7.0; Eiken Chemical Co. Ltd., Tokyo, Japan ; as the assay medium were used. The quantitation limit was 0.5 jig ml. Very little deviation was found between the observed value and the predicted value from the standard curve, with the coefficient of variation being greater than 0.998. The precision was evaluated by four replicate measurements with 0.5- and 8.0-, ug ml solutions. The withinday coefficients of variation for the two solutions were 1.3 and 2.1%, respectively. The between-day coefficients of variation for the two solutions were 2.1% and 3.0%, respectively. According to our data for the method validation, both the HPLC and the bioassay method determined LFLX in biological samples accurately, with the same level of precision and reproducibility, and were sufficient to be used for pharmacokinetic study. Measurement of the stability constant. A potentiometric method was used for measurement of the stability constant of the chelates. Drugs 0.1 to 0.3 mmol ; were dissolved in water 40 ml ; , and the pH of each solution was adjusted to a pH close to that of the metal solutions by adding trace amounts of 0.1 M HCl and NaOH. Then, 1 M NaCl 5 ml ; was added to each solution and the solutions were diluted to 50 ml with water. Forty milliliters each of the drug solutions was pipetted into a thermostated cell equipped with a jacket and titrated at 25C with the metal solutions 15 mM ; in 0.1 M NaCl by using a Comtite-101 titrator Hiranuma Sangyo Co. Ltd. ; equipped with a glass-Ag AgCl electrode. Measurement of 13C-NMR spectra of the chelates. 13CNMR spectral data were recorded with a Varian XL-400 spectrometer at 100.577 MHz. The spectrum of LFLX hydrochloride was measured in D20 2.0-6.5 x 10-2 M ; . An equimolar amount of AlC13. 6H20 or MgCl2. 6H20 and one-half the LFLX concentration was added to the LFLX solution and measured. Typical measurement conditions were as follows: spectral width, 21008.4 Hz; acquisition time, 0.679 s; pulse flip angle, 300; pulse delay time, 0.250 s; transient number of acquisition pulse, 52, 224. 13C-chemical shifts 8c ; were obtained from acetonitrile as an internal standard CH3CN; bc, 1.71 ppm.
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Dosing a arting dose is 20 mg kg q 8 h. increase in 20 mg kg increments q 2 wk. c.Therapeutic range is listed at 5-45 g mL. d.Has been used in cats at same dose; but small numbers and no long term studies. * Side effects a.Few side effects reported: ataxia. * Pharmacokinetics Short half life ~3 to 4 Undergoes minimal hepatic metabolism; mostly excreted in urine and imovane.
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N 28 ; at dose of 10 mg, back pain was reported as a limiting adverse event in patients with moderate renal impairment. At a dose of 5 mg, the incidence and severity of back pain was not significantly different than in the general population. In patients on hemodialysis taking 10- or 20-mg avafynetyme HCl, there were no reported cases of back pain. The dose of avafynetyme HCl should be limited to 5 mg not more than once daily in patients with severe renal insufficiency or end-stage renal disease. A starting dose of 5 mg not more than once daily is recommended for patients with moderate renal insufficiency; the maximum recommended dose is 20 mg not more than once every 24 hours. No dose adjustment is required in patients with mild renal insufficiency see DOSAGE AND ADMINISTRATION ; . Patients with Diabetes Mellitus -- In patients with diabetes mellitus after a 10 mg avafynetyme HCl dose, exposure AUC ; was reduced approximately 19% and Cmax was 5% lower than that observed in healthy subjects. No dose adjustment is warranted. Pharmacodynamics Effects on Blood Pressure -- avafynetyme HCl 20 mg administered to healthy subjects produced no significant difference compared to placebo in supine systolic and diastolic blood pressure difference in the mean maximal decrease of 1.6 0.8 mm Hg, respectively ; and in standing systolic and diastolic blood pressure difference in the mean maximal decrease of 0.2 4.6 mm Hg, respectively ; . In addition, there was no significant effect on heart rate. Effects on Blood Pressure when HAVIDOL is Administered with Nitrates -- In clinical pharmacology studies, avafynetyme HCl 5 to 20 mg ; was shown to potentiate the hypotensive effect of nitrates. Therefore, the use of HAVIDOL in patients taking any form of nitrates is contraindicated see CONTRAINDICATIONS ; . A study was conducted to assess the degree of interaction between nitroglycerin and avafynetyme HCl, should nitroglycerin be required in an emergency situation after avafynetyme HCl was taken. This was a double-blind, placebo-controlled, crossover study in 150 subjects receiving daily doses of avafynetyme HCl 20 mg or matching placebo for 7 days. Subjects were administered a single dose of 0.4 mg sublingual nitroglycerin NTG ; at pre-specified timepoints, following their last dose of avafynetyme HCl 2, 4, 8, and 96 hours after avafynetyme HCl ; . The objective of the study was to determine when, after avafynetyme HCl dosing, no apparent blood pressure interaction was observed. In this study, a significant interaction between avafynetyme HCl and NTG was observed at each timepoint up to and including 24 hours. At 48 hours, by most hemodynamic measures, the interaction between avafynetyme HCl and NTG was not observed, although a few more avafynetyme HCl subjects compared to placebo experienced greater blood-pressure lowering at this timepoint. After 48 hours, the interaction was not detectable see Figure 2.
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