Clinical therapeutics
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Clinical therapeutics · May 2007
Randomized Controlled Trial Multicenter Study Comparative StudyAssessment of comparative pain relief and tolerability of SKI306X compared with celecoxib in patients with rheumatoid arthritis: a 6-week, multicenter, randomized, double-blind, double-dummy, phase III, noninferiority clinical trial.
SKI306X, which consists of biologically active ingredients from Clematis mandsburica, Tricbosantbes kirilowii, and Prunella vulgaris, was developed and tested in preclinical trials in Korea. Those studies found that SKI306X was associated with an anti-inflammatory and analgesic effect, and that it can delay the destruction of cartilage in rheumatoid arthritis (RA). ⋯ The results of this study suggest that SKI306X was generally well tolerated and not inferior to celecoxib in regard to pain relief in these Korean patients with RA.
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Clinical therapeutics · May 2007
Clinical TrialA disease-specific measure of health-related quality of life in adults with chronic immune thrombocytopenic purpura: psychometric testing in an open-label clinical trial.
The Immune Thrombocytopenic Purpura Patient Assessment Questionnaire (ITP-PAQ) was developed to assess disease-specific quality of life (QoL) in adults with ITP. It is a 44-item questionnaire that includes scales for physical health (symptoms, fatigue/sleep, bother, and activity), emotional health (psychological and fear), overall QoL, social activity, women's reproductive health, and work. A previous study reported preliminary evidence of its reliability and validity. ⋯ The results of this analysis indicate that the ITP-PAQ has acceptable responsiveness, reliability, and validity. Further study of the minimal clinically important difference in ITP-PAQ scale scores is needed.
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Clinical therapeutics · May 2007
Comparative StudyEmpiric therapy for secondary peritonitis: a pharmacodynamic analysis of cefepime, ceftazidime, ceftriaxone, imipenem, levofloxacin, piperacillin/tazobactam, and tigecycline using Monte Carlo simulation.
Inappropriate antibiotic therapy (ie, the selection of an empiric agent without activity against the responsible pathogen) of secondary peritonitis may result in poor patient outcomes. The selection of an appropriate agent can be challenging because of the emerging resistance of target organisms to commonly prescribed antibiotics. ⋯ : MIC distribution and pathogen prevalence strongly influence the likelihood of microbiological success in secondary peritonitis; therefore, decisions regarding empiric therapy should consider local epidemiology. Using current global data, the following regimens are adequate choices if Enterococcus is not targeted: Combination therapy (with metronidazole) using cefepime 1 g or 2 g q12h, or ceftazidime 2 g q8h; or monotherapy with imipenem 500 mg q6h or piperacillin-tazobactam 3.375 g q6h. When Enterococcus is included in the epidemiologic mix, imipenem, piperacillin/tazobactam, and tigecycline all appear to be viable monotherapeutic choices.
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Clinical therapeutics · May 2007
Randomized Controlled Trial Multicenter StudyTwelve-week, randomized, placebo-controlled, multicenter study of the efficacy and tolerability of budesonide and formoterol in one metered-dose inhaler compared with budesonide alone and formoterol alone in adolescents and adults with asthma.
The addition of the long-acting beta(2)-adrenergic agonist formoterol to low- to moderate-dose budesonide has shown clinical efficacy in patients with persistent asthma. Combination therapy with budesonide/formoterol in 1 pressurized metered-dose inhaler (pMDI) has been found to have greater efficacy than its monocomponents in patients with moderate to severe persistent asthma, but it has not been assessed in patients with mild to moderate persistent asthma. ⋯ In this population of adults and adolescents with mild to moderate persistent asthma previously treated with ICSs, twice-daily budesonide/formoterol pMDI was associated with significantly increased pulmonary function versus its monocomponents. All study drugs were generally well tolerated.
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Clinical therapeutics · May 2007
Randomized Controlled TrialPrevention of pain due to injection of propofol with IV administration of lidocaine 40 mg + metoclopramide 2.5, 5, or 10 mg or saline: a randomized, double-blind study in Japanese adult surgical patients.
Pain on injection is a recognized adverse event (AE) with propofol, an agent used to induce general anesthesia in surgical patients. Lidocame (LID) has been found efficacious in reducing pain on injection of propofol; however, this type of pain may not be completely eliminated with LID. Metoclopramide (MET) is a dopamine receptor agonist with antiemetic and prokinetic properties used for the treatment of nausea and facilitation of gastric emptying in patients with gastroparesis. MET also has local anesthetic properties similar to those of LID. ⋯ Among these 240 Japanese patients undergoing elective surgery, N administration of LID/MET 40/5 or 40/10 was associated with lower incidence, but not lower mean pain intensity scores, of pain on injection of propofol than LID/MET 40/2.5 or LID/saline before induction of anesthesia.