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Retrospective cohort study.
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A total of 13274 osteoarthritis patients from 39 countries were randomly assigned to double-blind treatment with either celecoxib 100 mg twice daily (BID), celecoxib 200 mg BID, or nonselective NSAID therapy (diclofenac 50 mg BID or naproxen 500 mg BID) for 12 weeks. Standard validated measures were used to assess osteoarthritis efficacy. Serious UGI events were evaluated by 2 blinded, independent, gastrointestinal events committees.
The average time between assessments was 1.2 years (SD = 0.42). Nine medications showed a difference (P < .05) across the four participant groups in mean psychometric change scores from the first to the second assessment. Medications associated with improved psychometric performance were naproxen, calcium-vitamin D, ferrous sulfate, potassium chloride, flax, and sertraline. Medications associated with declining psychometric performance were bupropion, oxybutynin, and furosemide.
Person-years of exposure among non-users of aspirin were: 75,761 to acetaminophen, 42,671 to rofecoxib 65,860 to celecoxib, and 37,495 to NS-NSAIDs. Among users of aspirin, they were: 14,671 to rofecoxib, 22,875 to celecoxib, 9,832 to NS-NSAIDs and 38,048 to acetaminophen. Among non-users of aspirin, the adjusted hazard ratios (95% confidence interval) of hospitalization for AMI/GI vs the acetaminophen (with no aspirin) group were: rofecoxib 1.27 (1.13, 1.42), celecoxib 0.93 (0.83, 1.03), naproxen 1.59 (1.31, 1.93), diclofenac 1.17 (0.99, 1.38) and ibuprofen 1.05 (0.74, 1.51). Among users of aspirin, they were: rofecoxib 1.73 (1.52, 1.98), celecoxib 1.34 (1.19, 1.52), ibuprofen 1.51 (0.95, 2.41), diclofenac 1.69 (1.35, 2.10), naproxen 1.35 (0.97, 1.88) and acetaminophen 1.29 (1.17, 1.42).
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Endocrine disrupting compounds (EDCs) and pharmaceuticals and personal care products (PPCPs) have been acknowledged as emerging pollutants due to widespread contamination in environment. A rapid and reliable analytical method, based on ultrasonic extraction, clean up on Envi-carb cartridge, derivatized with N-tert-butyldimethylsilyl-N-methyltrifluoroacetamide (MTBSTFA), and analyzed by gas chromatography-mass spectrometry (GC-MS), was developed for determination of 4 EDCs (bisphenol A, estrone, nonylphenol and octylphenol) and 10 PPCPs (acetylsalicylic acid, carbamazepine, clofibric acid, diclofenac, gemfibrozil, ibuprofen, ketoprofen, naproxen, paracetamol and triclosan) in sewage sludge. Mean recoveries of the target analytes, at different spike levels (40, 300 and 2000 ng/g), ranged from 57.9% to 103.1%. Relative standard deviations (RSDs) were in the range of 1.3-9.5% at different spiked levels. The limit of quantification (LOQ) ranged from 4.7 to 39 ng/g. The method was applied to sewage sludge samples from sewage treatment plants (STPs) in southern California. High concentrations of PPCPs and EDCs were found in sewage sludge, ranging from 1502 to 5327 ng/g dry weight. Appropriate disposal of sewage sludge was required to avoid secondary contamination.
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Established antigen-induced arthritis was produced in 264 out of 339 sensitized Old English rabbits 4-6 weeks after a single intra-articular injection of ovalbumin into one knee joint. Positive arthritis was diagnosed when the joint swelling at this time was greater than or equal to 2 mm. A positive correlation between established joint swelling and delayed hypersensitivity to ovalbumin injected intradermally 24 h prior to joint challenge was demonstrated. Groups of 5-10 arthritic rabbits were dosed orally with increasing or fixed doses of a range of drugs for a period of 3-7 weeks. Drug activity was measured on joint swelling intermittently during the test and on joint macroscopy, cell content of the synovial fluid and joint histopathology at the end of the experiment. Prednisolone sodium phosphate and ketoprofen were the most active compounds tested. Chloroquine diphosphate, cyclo phosphamide, indomethacin, naproxen, SKF 36914 and sudoxicam had some activity, while aspirin, levamisole, oxisuran and D(-)penicillamine had little or no activity.
The methodological design of each study was scored according to a pre-determined system. The three main outcome measures of pain, physical function and patient global assessment were chosen based on the core set agreed upon by OMERACT (Outcome Measures in Rheumatology Clinical Trials). These were used to determine the power of each trial. The equivalency of NSAID doses was calculated using the percentage of the recommended maximum daily dose. Sample size estimates for the detection of clinically relevant changes in outcome measures used in the assessment of OA knee were used for power calculations. These calculations were performed to determine whether the trials were of a sufficient size to detect clinically relevant differences which were statistically significant. The calculations incorporate estimates of standard deviation, and minimum, median and maximum differences (delta) between drugs which are deemed to be clinically important. The number of "withdrawals due to lack of efficacy" was also selected as an outcome measure for this review. The Peto odds ratio and 95% confidence intervals were calculated where possible. The results of studies which compared the same trial and reference NSAIDs were combined where possible.
The data showed that octanoic acid lowered the 1:1 binding constants for all the drug-HSA interactions investigated. The effect of octanoic acid was greater on the R than on the S forms of the drugs as shown by the differences in free energies of interaction in the presence and absence of octanoic acid.