Clinical therapeutics
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Clinical therapeutics · Nov 2010
Randomized Controlled TrialEfficacy and tolerability of first-line triple therapy with levofloxacin and amoxicillin plus esomeprazole or rabeprazole for the eradication of Helicobacter pylori infection and the effect of CYP2C19 genotype: a 1-week, randomized, open-label study in Chinese adults.
First-line triple therapy with levofloxa- cin and amoxicillin plus a proton pump inhibitor has been reported to be effective and well tolerated in the eradication of Helicobacter pylori infection. Studies have reported that cytochrome P450 (CYP) 2C19 genotypes may affect the clinical efficacy of clarithromycinbased triple therapies, although there is only one report of such an effect with levofloxacin-based triple therapies. ⋯ One week of first-line triple therapy with levofloxacin and amoxicillin plus esomeprazole 20 or 40 mg BID or rabeprazole 10 mg BID was associated with H pylori eradication rates of 85.2%, 87.1%, and 75.4%, respectively, with no significant differences between treatment groups. There were no significant differences in eradication of H pylori by CYP2C19 genotype in this small population of Chinese adults.
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Clinical therapeutics · Nov 2010
Review Meta AnalysisTransdermal scopolamine for the prevention of postoperative nausea and vomiting: a systematic review and meta-analysis.
Transdermal scopolamine (TDS) is a potential long-acting prophylactic antiemetic initially developed to prevent motion sickness. TDS is a centrally acting anticholinergic agent that was approved in 2001 by the US Food and Drug Administration for the prevention of postoperative nausea and vomiting (PONV). Although TDS has been reported to be clinically efficacious in the prevention of PONV, several adverse events (AEs), such as sedation, dry mouth, blurred vision, central cholinergic syndrome, and confusion (particularly in elderly patients with mild cognitive impairment), are potential concerns. ⋯ In this systematic review and metaanalysis, TDS was associated with significant reductions in PONV with both early and late patch application during the first 24 hours after the start of anesthesia. TDS was associated with a higher prevalence of visual disturbances at 24 to 48 hours after surgery, but no other AEs, compared with placebo.
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Clinical therapeutics · Oct 2010
Randomized Controlled Trial Comparative StudyComparative bioavailability and tolerability of a single 20-mg dose of two fluoxetine hydrochloride dispersible tablet formulations in fasting, healthy Chinese male volunteers: an open-label, randomized-sequence, two-period crossover study.
The proprietary formulation of fluoxetine hydrochloride is an antidepressant of the selective serotonin reuptake inhibitor class. Pharmacokinetic studies investigating the bioequivalence of generic and branded formulations are needed to market generic fluoxetine in China. ⋯ This single-dose study found that the test and reference formulations of fluoxetine hydro- chloride met the regulatory criteria for bioequivalence in these fasting, healthy Chinese male volunteers. Both formulations appeared to be well tolerated.
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Clinical therapeutics · Sep 2010
Case ReportsAllergic shock and death associated with protamine administration in a diabetic patient.
Insulin is used to treat patients with both type 1 and type 2 diabetes mellitus. Allergic reactions to insulin might be triggered by insulin itself or inactive ingredients in the insulin formulation, including proteins such as protamine in neutral protamine Hagedorn (NPH) insulin. The use of highly purified animal insulin and human recombinant insulin has reduced the incidence of anaphylactic reactions to insulin from ~30% to <1%. ⋯ This case report highlights a preventable fatal allergic reaction possibly associated with protamine administration in a patient with a history of allergy to a protamine-containing insulin.
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Clinical therapeutics · Sep 2010
ReviewEfficacy and tolerability of enteral formulations of ibuprofen in the treatment of patent ductus arteriosus in preterm infants.
The persistence of a patent ductus arteriosus (PDA) in preterm infants complicates their clinical course and may contribute to increased morbidity. Intravenous preparations of ibuprofen constitute one of the standard therapies for closure of a PDA. However, the unavailability of intravenous ibuprofen in certain regions of the world and the availability of inexpensive oral preparations has led to off-label nasogastric administration of oral ibuprofen in preterm infants with PDA. ⋯ The evidence supporting the off-label use of enteral ibuprofen for PDA in preterm infants is weak. Well-designed, appropriately powered pharmacologic and controlled clinical studies are needed before use of enteral ibuprofen can be recommended. In countries where an intravenous formulation of racemic ibuprofen is approved, off-label use of enteral racemic ibuprofen cannot be supported.