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1. |
Epidermal Growth Factor Concentrations in Growth Hormone-Deficient ChildrenEffects of Single versus Multiple Injections of Recombinant Human Growth Hormone |
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Drug Investigation,
Volume 8,
Issue 5,
1994,
Page 257-262
J. Paul Frindik,
Stephen F. Kemp,
Gregory L. Kearns,
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摘要:
Urinary epidermal growth factor/creatinine (EGF/Cr) excretion increases after prolonged therapy with 0.09 to 0.1 mg/kg bodyweight/week pituitary-derived growth hormone (GH) given 3 times weekly to GH-deficient children. We studied the short term and 1-month effects of 0.3 mg/kg/week of recombinant human growth hormone (rhGH) administered either daily (n = 12, 0.043 mg/kg/day) or 3 times weekly (n = 7, 0.1 mg/kg/day) on plasma and urinary EGF/Cr excretion in newly diagnosed GH-deficient children (all male, mean age 12.8 ± 3.3 years). Total 24-hour urinary EGF/Cr excretion was greater immediately after a single dose of rhGH 0.1 mg/kg compared with that after a single dose of 0.043 mg/kg (195.6 ± 27.4ng EGF/mg Crvs138.9 ± 10.2 ng/mg, respectively, p = 0.04). After 1 month, total 24-hour urinary EGF/Cr excretion of the daily group increased from 138.9 ± 10.2 ng/mg initially to 225.8 ± 38.8 ng/mg (p = 0.03), and was virtually identical to that of the 1-month 3-times-weekly 24-hour excretion (216.9 ± 38.7 ng/mg). During a 24-hour period, urinary EGF excretion varied with rhGH dose, time and duration of therapy. Plasma EGF concentrations did not change after 1 month of either daily (1.6 ± 0.1 ng/mlvs1.3 ± 0.2 pretreatment) or 3-times-weekly (1.3 ± 0.4 ng/mlvs1.1 ± 0.2 pretreatment) rhGH. We conclude that urinary EGF/Cr but not plasma EGF concentrations increase as a function of both rhGH dosage and duration of treatment in children with GH deficiency.
ISSN:0114-2402
出版商:ADIS
年代:1994
数据来源: ADIS
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2. |
Cefprozil versus Cefaclor in the Treatment of Bronchitis in the Elderly |
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Drug Investigation,
Volume 8,
Issue 5,
1994,
Page 263-270
Lawrence L. Pelletier,
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摘要:
In a prospective, randomised, nonblinded, multi-investigator trial, cefprozil 500mg twice daily was compared with cefaclor 500mg 3 times daily, both administered orally for 10 days for episodes of bronchitis. A total of 247 patients aged 65 years or older with mild to moderate acute bronchitis or exacerbations of chronic bronchitis were treated in 30 in- and outpatient clinical sites in Europe and North America. Of these, 104 patients did not have a defined bacterial pathogen in pretreatment sputum cultures. Among the 143 other patients,Haemophilus influenzae, Streptococcus pneumoniaeandMoraxella (Branhamella) catarrhaliswere the most frequently isolated bacteria. There was a satisfactory clinical response to treatment in 119 of 156 cefprozil-treated patients (84%) and in 63 of 91 (82%) of those treated with cefaclor. Eradication of the presumed bacterial pathogen occurred in 74 of 89 (83%) cefprozil-treated patients and 35 of 42 (83%) cefaclor-treated patients. Both cefprozil and cefaclor were well tolerated, with possible drug-related adverse reactions in only 16 of 156 (10%) cefprozil-treated patients and 10 of 91 (11%) cefaclor-treated patients. Thus, in these clinical trials cefprozil was shown to be a safe, well-tolerated and effective treatment for episodes of bronchitis in elderly patients.
ISSN:0114-2402
出版商:ADIS
年代:1994
数据来源: ADIS
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3. |
Famotidine Pharmacokinetics in Patients Undergoing Cardiac Surgery |
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Drug Investigation,
Volume 8,
Issue 5,
1994,
Page 271-277
Bertil K.J. Wagner,
Louis T. DiFazio,
David W. Amory,
Claudine M. Majcher,
Alan J. Spotnitz,
Gregory E. Scott,
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摘要:
In order to study the pharmacokinetics of famotidine in cardiac surgery patients, we administered famotidine 20mg by intravenous injection at the beginning of surgery and 12 hours after surgery in 8 patients undergoing elective cardiac surgery with cardiopulmonary bypass. Total body clearance, volume of distribution, and elimination half-life were calculated using noncompartmental analysis and compared with published normal parameters (control) using a 2-tailed, 1 -sample t-test. Intra- and postoperative clearances were 2.93 ± 1.06 and 3.18 ± 1.06 ml/min/kg, respectively, which were more than 50% less than the control value (6.07 ml/min/kg; p<0.0005). The volume of distribution (1.0 L/kg) was unaltered during the study and did not differ from the control value (1.19 L/kg; p>0.08). Intra- and postoperative half-lives were 4.52 ± 2.21 hours and 4.27 ± 1.58 hours, respectively, which were more than 50% longer than control (2.92 hours; p<0.03). Famotidine pharmacokinetics are significantly altered during cardiac surgery with cardiopulmonary bypass, and these changes persist for up to 24 hours after surgery.
ISSN:0114-2402
出版商:ADIS
年代:1994
数据来源: ADIS
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4. |
Pharmacokinetics of Epoetin in Dialysis Patients Before and After Correction of the Anaemia |
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Drug Investigation,
Volume 8,
Issue 5,
1994,
Page 278-287
J.D. Jensen,
J.K. Madsen,
L.W. Jensen,
E.B. Pedersen,
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摘要:
The purpose of this study was to investigate the influence of prolonged treatment with recombinant human erythropoietin (epoetin) on the pharmacokinetics of epoetin in dialysis patients. 12 patients (male/female: 6/6, median age 44 years) with end-stage renal failure were investigated. Five were treated with continuous ambulatory peritoneal dialysis and 7 with haemodialysis. The pharmacokinetics were studied in each patient after an intravenous and a subcutaneous dose of epoetin 100 U/kg before regular treatment with epoetin was instituted. The investigation was repeated in the same patients after a median of 8 months of regular epoetin treatment. The haematocrit count increased from 25 to 33% (medians). The intravenous elimination half-life (8.23vs7.96 hours), intravenous mean residence time (11.8vs11.2 hours), clearance (0.31vs0.32 L/h/1.73 m2), subcutaneous maximal concentration (108vs123 U/L) at 19vs12 hours, and bioavailability (20.8vs21.6%) did not change significantly after prolonged epoetin treatment. The volume of distribution was slightly reduced from 3.76 to 3.46 L/1.73m2. The estimated absorption half-life (25.1vs16.7 hours), the mean input time (29.0vs29.9 hours), and the mean residence time (42.5vs40.1 hours) after subcutaneous application did not change significantly. The estimated endogenous epoetin production was unchanged at 144vs155 U/day/1.73m2. The loss of epoetin in the peritoneal dialysis bags was below 2.3% of the dose.In conclusion, except for a small reduction in the volume of distribution, long term treatment with epoetin had no influence on the intravenous or subcutaneous pharmacokinetics of epoetin in dialysis patients. No compensatory adjustment of the native epoetin production was detected.
ISSN:0114-2402
出版商:ADIS
年代:1994
数据来源: ADIS
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5. |
Treatment of Acute Lumbosacral Back Pain with Diclofenac ResinateResults of a Double-Blind Comparative Trial versus Piroxicam |
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Drug Investigation,
Volume 8,
Issue 5,
1994,
Page 288-293
R. Bakshi,
N. Thumb,
H. Bröll,
G. Klein,
F. Mayrhofer,
F. Rainer,
F. Singer,
J. Smolen,
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摘要:
A 2-week multicentre, double-blind, randomised trial was conducted to evaluate the efficacy and tolerability of diclofenac resinate, a new galenic formulation of diclofenac, versus piroxicam, an established analgesic/anti-inflammatory agent, in patients suffering from acute lumbosacral back pain. Adult male or female patients complaining of moderate to severe pain at rest/on movement were treated with either diclofenac resinate 75mg twice daily or piroxicam 20mg once daily for up to 14 days; the latter group received piroxicam 40 mg/day for the first 2 days. In the 132 patients eligible for efficacy analyses (66 in each treatment group), both drugs led to comparable and clinically significant reductions in mean pain scores commencing after 3 days of treatment. Tests for spinal flexion also showed considerable improvement, as did functional capability, with no significant differences being observed between diclofenac and piroxicam. Overall evaluations of efficacy by the investigators and the patients revealed a positive response rate in 78.8 and 81.8%, respectively, in patients treated with diclofenac compared with 83.3 and 87.7%, respectively, for piroxicam. The incidence of adverse effects, most frequently gastrointestinal, was 19.7% for diclofenac resinate and 18.2% for piroxicam. The results of this controlled study show that diclofenac at a daily dosage of 150mg has efficacy similar to piroxicam 20mg with a loading dose regimen of 40mg for the symptomatic management of acute lumbosacral back pain.
ISSN:0114-2402
出版商:ADIS
年代:1994
数据来源: ADIS
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6. |
A Graphical Approach to Aminoglycoside Dosage Regimens in End-Stage Renal Disease Patients Undergoing Haemodialysis |
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Drug Investigation,
Volume 8,
Issue 5,
1994,
Page 294-308
Manuel Valera Mac-Kay,
Inmaculada Pérez Fernández de Liger,
Jesús Sánchez Bursón,
Joaquín Herrera Carranza,
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摘要:
It is common practice in clinical therapy to use the aminoglycoside group of antibiotics to treat infections caused by Gram-negative organisms in end-stage renal disease (ESRD) patients who are undergoing haemodialysis (HD). Tobramycin, amikacin and, to a lesser extent, gentamicin and netilmicin are the drugs most frequently administered. However, as this type of treatment involves complex problems of dosage, partly because of the numerous factors involved in determining the dosage, and partly because of the narrow therapeutic range of these antibiotics, some complex pharmacokinetic adjustments have to be carried out in order to avoid adverse reactions and to maintain the minimum therapeutic levels of these drugs. To solve these problems, a multifactorial study was carried out using the various parameters involved in these processes in order to develop a simple graphical approach. Using this system of graphs, the loading and maintenance doses of these antibiotics can be predicted, obviating the need for complex calculations. The approach was checked by applying it to the analysis of dosage regimens in ESRD patients undergoing HD being treated with tobramycin and amikacin. It was found that after the administration of the loading and maintenance doses calculated using this approach, plasma concentrations correctly situated within the therapeutic range of these antibiotics [maximum and minimum therapeutic drug concentrations (Cmaxand Cmin)] were achieved, in contrast to those obtained when administering the doses recommended in antimicrobial therapy for these cases.
ISSN:0114-2402
出版商:ADIS
年代:1994
数据来源: ADIS
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7. |
Methods Used to Facilitate Sleep in a Hospitalised Elderly Population |
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Drug Investigation,
Volume 8,
Issue 5,
1994,
Page 309-311
Peter N. Gonski,
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ISSN:0114-2402
出版商:ADIS
年代:1994
数据来源: ADIS
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8. |
Effect ofd-Indobufen on Platelet Function in Patients with Cerebrovascular Disease |
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Drug Investigation,
Volume 8,
Issue 5,
1994,
Page 312-315
Masako Yamazaki,
Shinichiro Uchiyama,
Takako Hashiguchi,
Shoichi Maruyama,
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ISSN:0114-2402
出版商:ADIS
年代:1994
数据来源: ADIS
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9. |
Stevens-Johnson Syndrome Due to Carbamazepine Hypersensitivity |
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Drug Investigation,
Volume 8,
Issue 5,
1994,
Page 316-319
Tau Hur,
Yu-Ying Chang,
Jiunn-Min Hsieh,
Chung-Jeih Yang,
Kao-Chen Cheng,
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ISSN:0114-2402
出版商:ADIS
年代:1994
数据来源: ADIS
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