Methods and findings in experimental and clinical pharmacology
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Methods Find Exp Clin Pharmacol · Sep 2005
Randomized Controlled TrialEffects of granisetron with droperidol or dexamethasone on prevention of postoperative nausea and vomiting after general anesthesia for cesarean section.
This prospective, placebo-controlled, double-blinded, and randomized study was undertaken to compare the efficacy of granisetron, droperidol, and combinations of granisetron with droperidol or dexamethasone on postoperative nausea and vomiting in patients undergoing general anesthesia for cesarean section. Patients (n = 150) who were scheduled for cesarean section under general anesthesia were randomly assigned to one of the five groups: physiological saline 5 ml in Group A, granisetron 40 microg/kg + dexamethasone 8 mg in Group B, granisetron 40 microg/kg + droperidol 1.25 mg in Group C, droperidol 1.25 mg in Group D, and granisetron 40 microg/kg in Group E were administered intravenously after clamping of the fetal umbilical cord. Postoperative nausea and vomiting was observed for 024 h after the anesthesia. ⋯ All granisetron groups were more effective than placebo and droperidol groups during the postoperative 3-24 h (p < 0.01). Although this trial lacks statistical power, granisetron alone and combinations with droperidol or dexamethasone were effective similarly. All treatment groups, except droperidol during the postoperative 3-24 h, were effective for prevention of postoperative nausea and vomiting during the postoperative 0-24 h.
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Methods Find Exp Clin Pharmacol · Sep 2005
ReviewSpecification of laboratory animal use in scientific articles: current low detail in the journals' instructions for authors and some proposals.
The scientific article communicates results of research to other investigators; therefore, it must contain a complete description of the experiment to help other researchers when designing their future investigations. However, poorly detailed data on laboratory animal use is given in published articles. Despite the well-known and important contribution of the International Committee of Medical Journal Editors (ICMJE) to standardize scientific writing and submission of manuscripts to biomedical journals, no specific instructions on the reporting of animal use are given in the ICMJE Uniform Requirements and, therefore, most journals do not detail this to the authors. ⋯ The present article relates some proposals for helping authors when reporting animal use in scientific articles. These proposals are not only based on previous guidelines for animal specifications, but also on Instructions for Authors from journals specialized in Laboratory Animal Science. These proposals are classified into major and minor issues, and they are located in the corresponding parts of the article, as defined by the Introduction, Methods, Results, and Discussion (IMRAD) method.
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Methods Find Exp Clin Pharmacol · Jul 2005
Randomized Controlled Trial Comparative StudyPharmacodynamic study of procaterol hydrochloride dry powder inhaler: evaluation of pharmacodynamic equivalence between procaterol hydrochloride dry powder inhaler and procaterol hydrochloride metered-dose inhaler in asthma patients in a randomized, double-dummy, double-blind crossover manner.
Therapeutic equivalence between procaterol hydrochloride dry powder inhaler (Meptin DPI) and procaterol hydrochloride metered-dose inhaler (Meptin MDI), the currently marketed formulation, was assessed in 16 patients with bronchial asthma. The study was conducted in a randomized, double-dummy, double-blind crossover manner, using forced expiratory volume in the first second (FEV1) as an index of bronchodilatory effect. In Period I, the patients received 20 mcg of either Meptin DPI or Meptin MDI, and then crossed over in Period II after a washout interval of 3--28 days. ⋯ Factors used for the analysis were the treatment group and/or carryover effect, patients within each group, period, and treatment. The 90% confidence intervals for the differences between the two treatments were --0.0995 to --0.0204 (L) for mean AUC (FEV1)/h and --0.102 to --0.022 (L) for mean peak FEV1, both within the acceptance criteria of --0.15 to 0.15 (L). Meptin DPI was therefore assessed as being equivalent to the current Meptin MDI.
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Methods Find Exp Clin Pharmacol · May 2005
Clinical TrialPolymorphic variants of the beta2-adrenergic receptor (ADRB2) gene and ADRB2-related propanolol-induced dyslipidemia in the Colombian population.
Different polymorphisms of the ADRB2 gene encoding the beta-adrenergic receptor (ADRB2) are associated with changes in a variety of responses of the sympathetic nervous system (SNS). In this study, we have investigated the distribution of frequencies of ADRB2-related allelic variants (Arg16Gly, Gln27Glu, Thr164Ile) in the Colombian population, as well as the influence of the Gln27Glu polymorphism as a risk factor for the development of dyslipidemia following propranolol administration. Genotyping was performed in unrelated Colombian volunteers, using PCR-RFLP methods. ⋯ T-CHO levels and serum fibrinogen levels remained unaltered in both subgroups. The evidence that subjects homozygous for Gln27 in the ADRB2 gene show a significant reduction of HDL-CHO levels, as well as the increased TG levels in subjects homozygous for Glu27 after propranolol administration, suggest that the Gln27Glu polymorphism represents a risk factor for dyslipidemia induced by propranolol. These results may contribute to a better understanding of the mechanisms underlying dyslipidemia induced by ADRB2 antagonists.
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Methods Find Exp Clin Pharmacol · Jan 2005
Randomized Controlled Trial Clinical TrialPharmacodynamic effects of 3-day intravenous treatment with pantoprazole or ranitidine after 10 days of oral ranitidine.
Tachyphylaxis (drug tolerance) is an undesirable condition in drug therapy with histamine-2-receptor antagonists (H2RAs). The concept of overcoming tachyphylaxsis via intravenous (i.v.) administration of proton-pump inhibitors (PPIs) or H2RAs is of significant interest to physicians. In the present study, 32 healthy Helicobacter pylori negative male volunteers were evaluated for the ability of i.v. pantoprazole or i.v. ranitidine to overcome oral ranitidine tachyphylaxis. ⋯ After 10 days of oral ranitidine treatment, tachyphylaxis was present in all volunteers. Within 1 day of continuous i.v. pantoprazole or i.v. ranitidine administration, 24-h median gastric pH increased from pH 1.45 to pH 3.50 (241%) and from pH 1.50 to pH 2.35 (157%), respectively. I.v. pantoprazole was found to be significantly more effective (p<0.05) than i.v. ranitidine in increasing the 24-h gastric pH after oral ranitidine tachyphylaxis.