Methods and findings in experimental and clinical pharmacology
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Methods Find Exp Clin Pharmacol · Oct 2006
Randomized Controlled Trial Multicenter StudyImpact of ibuprofen administration on renal drug clearance in the first weeks of life.
The administration of ibuprofen or any other nonselective cyclooxygenase (COX) inhibitor drug in early neonatal life is associated with a reduction of glomerular filtration, which reduces the elimination of drugs dependent on renal function for clearance. However, the relationship between COX inhibitor drug indication (prophylactic or therapeutic) and the magnitude of this effect remains unclear. ⋯ A significant and clinically relevant reduction in drug clearance is observed when ibuprofen is coadministered independent of indication, postmenstrual or postnatal age. Population modeling with covariate analyses can provide us with the tools to further disentangle the impact of nonselective COX-inhibitors on renal drug clearance.
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Methods Find Exp Clin Pharmacol · Oct 2003
Multicenter Study Clinical TrialIrinotecan (CPT-11) in metastatic colorectal cancer patients resistant to 5-fluorouracil (5-FU): a phase II study.
The efficacy and toxicity of irinotecan (CPT-11) 350 mg/m(2) i.v. once every 3 weeks was assessed in 60 patients with advanced colorectal cancer (CRC) showing failure to 5-fluorouracil (5-FU) treatment. The overall objective response rate was 13.6% (1 complete response and 4 partial responses) and 25 patients (42.4%) showed stable disease; the median time to disease progression was 4.4 months and the median survival was 10.5 months. ⋯ Grade 3 or 4 diarrhea appeared in 21 of 131 cycles (16.1%), whereas grade 3 or 4 neutropenia appeared in 78 cycles (25.0%). In conclusion, the present phase II study confirms that CPT-11 350 mg/m(2) every 3 weeks is active and well tolerated as second-line chemotherapy for CRC in 5-FU resistant patients.
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Methods Find Exp Clin Pharmacol · Sep 1993
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialEfficacy of two different intramuscular doses of dipyrone in acute renal colic. Cooperative Study Group.
A randomized multicenter clinical trial was designed to compare the efficacy and tolerance of two different intramuscular doses of dipyrone (1 g and 2 g) with those of the reference drug, diclofenac sodium (75 mg), in the treatment of acute renal colic. A total of 129 patients were included; 43 patients were alloted to receive dipyrone 1 g, 45 to dipyrone 2 g, and 41 to diclofenac. ⋯ There were no significant differences between the three groups in terms of pain relief in the first 60 min, but dipyrone 2 g provided significantly more pain relief than diclofenac and dipyrone 1 g from 60 min to 6 h after drug injection. It is concluded that dipyrone 2 g produced a longer lasting analgesic response than dipyrone 1 g in the treatment of renal colic.