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The serum binding of methotrexate was determined by equilibrium dialysis using radiolabelled methotrexate. Methotrexate was only albumin-bound in serum. The binding was 46% in controls versus 42% in rheumatoid arthritis and 44% in cancer. Serum binding was significantly decreased by salicylate and high concentration of naproxen. Hypoalbuminemia and concomitant administration of salicylate or naproxen may influence methotrexate toxicity.
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Inflammation is a complex process involving numerous mediators. Because prostaglandins (PG) have been implicated as mediators in all stages of inflammation, inhibition of their synthesis provides the basis for the therapeutic effects of nonsteroidal antiinflammatory drugs (NSAID). Treatment with NSAID is usually accompanied by gastric side effects, attributed to interference with the formation of cytoprotective PG in gastric mucosa. An ideal NSAID should inhibit PG synthesis at the site(s) of inflammation but not in gastric mucosa. Experimental and clinical data support the view that this criterion has been met by etodolac, a structurally distinct NSAID. Thus, in rats and humans with rheumatoid arthritis, longterm daily administration of etodolac at effective antiinflammatory dosages (3 mg/kg in rats; 600 mg in humans) had no effect on PGF2 and prostacyclin levels in gastric mucosa. In contrast, significant decreases in gastric PG levels occurred with antiinflammatory doses of aspirin, naproxen, and piroxicam. Cyclooxygenase (COX), the pivotal enzyme in PG biosynthesis, exists in 2 isoforms: constitutive COX-1, which produces the PG required for maintenance of normal cell activity (e.g., gastric cytoprotection), and COX-2, which is induced in restricted tissue-specific fashion (e.g., by inflammatory stimuli). The antiinflammatory action of NSAID may result from inhibition of COX-2, whereas their gastric side effects may result in large part from inhibition of COX-1; thus, a preferred NSAID should inhibit COX-2 but not COX-1. Results show that etodolac has 10-fold selectivity for COX-2 and indicate that etodolac's pharmacotherapeutic efficacy can be explained by its demonstrably selective inhibition of COX-2, amplified by its favorable tissular pharmacokinetics. The sparing of COX-1 activity in gastric mucosa gives rise to etodolac's noted gastric tolerance.
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Conscious sedation, GA and some nonpharmacological interventions decreased procedural and postoperative pain, while being safe and satisfactory to patients. Data on the widely used PCB are inadequate to support its use, and it needs to be further studied to determine any benefit.
Anirolac, a new nonsteroidal anti-inflammatory drug, was evaluated for relative efficacy, safety, and time course of analgesia. In a stratified, randomized, parallel, double-blind trial, 120 hospitalized women with moderate or severe postpartum uterine pain were treated with single oral doses of anirolac, 50 or 100 mg, naproxen sodium, 550 mg, or placebo. Using verbal scales, patients rated pain intensity, pain relief, and side effects at regular intervals for 6 hours. Highest summed analgesic ratings over placebo were induced by anirolac, 100 mg (P less than or equal to 0.001), and naproxen (P less than or equal to 0.001), followed by anirolac, 50 mg (P less than or equal to 0.005). At each assessment after the first hour, anirolac, 50 and 100 mg, and naproxen induced significantly stronger analgesia than did placebo. Statistically significantly more drowsiness was reported with all three active agents than with placebo. Our results suggest that, for postpartum uterine pain, analgesia with anirolac, 50 or 100 mg, is equivalent to that with naproxen, 550 mg.
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To examine the prevalence of potentially inappropriate medicines (PIMs) in older New Zealanders at a population level.
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Over a period of 4 months, 648 patients who underwent day-case surgery were included in our study. Data were collected with interviews and questionnaires. Pain intensity was measured using a visual analog scale (VAS) during 4 days after surgery. Side effects of anesthesia and analgesia techniques were also recorded.
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Most drugs are bound to serum proteins to a various degree. Only unbound or free drug is pharmacologically active. Usually total drug is measured for therapeutic monitoring because there is equilibrium between bound and free drugs, and concentration of free drug can be predicted from total drug concentration. However, under certain conditions this equilibrium is disturbed and the measured free drug concentration can be significantly higher than expected from total drug concentrations, especially for strongly protein-bound drugs. In such case a patient may experience drug toxicity even if the total drug concentration is within the therapeutic range. Conditions like uremia, liver disease and hypoalbuminemia can lead to significant increases in free drug concentration. Therefore, monitoring free phenytoin and free valproic acid is recommended in these patients. Drug-drug interactions can also lead to a disproportionate increase in free drug concentration. One strongly protein-bound drug can significantly displace another strongly protein-bound drug if both drugs share the same binding site. Several over-the-counter pain medications such as salicylate, naproxen, and ibuprofen can cause significant displacement of both phenytoin and valproic acid from albumin binding site. Interestingly, such interactions are absent in uremic patients. Elderly patients may have increased free phenytoin or valproic acid due to hypoalbuminemia. Elevated free phenytoin concentrations have also been reported in patients with AIDS. Although digoxin is 25% bound to protein, monitoring free digoxin is useful in patients with elevated endogenous digoxin-like immunoreactive substances or in patients overdosed with digoxin and being treated with digibind. Monitoring free digoxin can also eliminate interference of Chinese medicines Chan Su and Danshen in serum digoxin measurement by certain immunoassays. However, free drug monitoring is not a routine procedure in clinical laboratories due to technical difficulties and lack of established reference ranges for free drugs.
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Haemorrhagic cystitis was reported to be associated with tiaprofenic acid (n = 3) and indomethacin (n = 3). In addition 11 other reports of haematuria (not associated with any coagulopathy and/or hepatic disorders) in relation to other nonsteroidal antiinflammatory drugs, such as diclofenac, ketoprofen, naproxen and piroxicam were received. Five patients who were rechallenged with the suspect drug, suffered from recurrence of cystitis/haematuria.
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A 7-year-old girl with 18q deletion syndrome developed chronic progressive polyarticular inflammatory arthropathy. Atypical features of her arthritis included lack of morning stiffness, absence of pain and discomfort, normal acute-phase reactants, and the presence of clinodactyly, low-set thumbs, metatarsus adductus of her feet, and overriding nontender swollen toes. She had a positive antinuclear antibody test, negative rheumatoid factor and anti-cyclic citrullinated peptide, and undetectable immunoglobulin A level. Magnetic resonance imaging of the right knee and the result of the synovial biopsy were consistent with synovitis. She was treated with naproxen, short course of prednisone, and methotrexate with good clinical response that plateaued over time. We analyzed the scarce reports of inflammatory arthropathy in 18q deletion syndrome and proposed an outline for investigating arthropathies in patients with chromosomal aberrations.
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The effect of paracetamol against ulcerogenic agent, naprosyn on the gastric mucosa of albino rat was observed under dissecting as well as laboratory microscope. Paracetamol in a dose of 250 mg/kg body weight provided protection against the ulcerogenic effect of naprosyn under dissecting microscope. Under laboratory microscope, a significant increase in the mucosal thickness with the administration of paracetamol followed by naprosyn was observed, while the flattening of the surface epithelium with slight exfoliation may be attributed to relative increase of pepsin from the chief cell. The increased secretory activity of the mucous neck cells in animals treated with paracetamol followed by naprosyn may be due to the increased bio-synthesis of prostaglandin from these cells which might have produced protective influence against the damaging effect of naprosyn.
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Of 125 patients identified with early membranous nephropathy, 29 were taking NSAIDs at the time symptoms of nephrotic syndrome developed. Thirteen of these patients met the criteria for NSAID-associated membranous nephropathy. None of these patients had any evidence of renal insufficiency or significant proteinuria after follow-up periods ranging from 5 months to 13 years. In addition to diclofenac and fenoprofen, which have previously been implicated, ibuprofen, nabumetone, naproxen, and tolmetin were found to be associated.
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Auranofin (AF, Ridaura) was administered to 23 children with juvenile rheumatoid arthritis during a prospective, open labelled, noncontrolled trial designed to establish longterm safety and preliminary efficacy. Dosages of AF were up to 0.2 mg/kg/day, with either aspirin (60-80 mg/kg/day), naproxen (400-600 mg/m2/day), or tolmetin sodium (20-40 mg/kg/day) serving as the concurrent nonsteroidal antiinflammatory drug. Nearly all patients showed an initial favorable response, however tachyphylaxis occurred in one-third (mean duration of therapy prior to the development of inefficacy = 22.6 mo). Clinical remission was observed in 6 patients an average of 15 months after enrollment. The drug appears to be safe for extended periods; 7 children are continuing AF at the present time with a mean duration of therapy of 4.25 years (maximum followup = 4.6 years).
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The efficacy and tolerability of nimesulide and naproxen were compared in a randomised double-blind study of patients with pain and inflammation after haemorrhoidectomy. Both drugs appeared similarly effective in reducing pain and oedema and no adverse reaction was detected. These data extend the information on the anti-inflammatory and analgesic efficacy of nimesulide in the postoperative setting.
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We identified 8973 manuscripts from our search, of which 74 randomised trials with a total of 58,556 patients were included in this analysis. 23 nodes concerning seven different NSAIDs or paracetamol with specific daily dose of administration or placebo were considered. All preparations, irrespective of dose, improved point estimates of pain symptoms when compared with placebo. For six interventions (diclofenac 150 mg/day, etoricoxib 30 mg/day, 60 mg/day, and 90 mg/day, and rofecoxib 25 mg/day and 50 mg/day), the probability that the difference to placebo is at or below a prespecified minimum clinically important effect for pain reduction (effect size [ES] -0·37) was at least 95%. Among maximally approved daily doses, diclofenac 150 mg/day (ES -0·57, 95% credibility interval [CrI] -0·69 to -0·46) and etoricoxib 60 mg/day (ES -0·58, -0·73 to -0·43) had the highest probability to be the best intervention, both with 100% probability to reach the minimum clinically important difference. Treatment effects increased as drug dose increased, but corresponding tests for a linear dose effect were significant only for celecoxib (p=0·030), diclofenac (p=0·031), and naproxen (p=0·026). We found no evidence that treatment effects varied over the duration of treatment. Model fit was good, and between-trial heterogeneity and inconsistency were low in all analyses. All trials were deemed to have a low risk of bias for blinding of patients. Effect estimates did not change in sensitivity analyses with two additional statistical models and accounting for methodological quality criteria in meta-regression analysis.
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Sucralfate gel reduces both the incidence of acute gastroduodenal mucosal lesions and symptoms in patients with arthritis receiving short-term nonsteroidal anti-inflammatory drugs.
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Determination of lipophilicity as a tool for predicting pharmacokinetic molecular behavior is limited by the predictive power of available experimental models of the biomembrane. There is current interest, therefore, in models that accurately simulate the biomembrane structure and function. A novel bio-device; a lipid thin film, was engineered as an alternative approach to the previous use of hydrocarbon thin films in biomembrane modeling.
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In a double-blind, randomized study, patients received a single rectal dose of one of the three drugs 30 min before undergoing ERCP: diclofenac (100 mg), indomethacin (100 mg), or naproxen (500 mg). The primary outcome measured was the development of pancreatitis. The levels of serum amylase, lipase, lipoxin A4, and resolvin E1 were measured before ERCP, and at 24 h after the procedure.
A canine experimental model of osteoarthritis (OA), generated by arthroscopic transection of the anterior cruciate ligament (ACL) of the knee, was used to investigate the in vivo effects of the NSAID naproxen on the course of cartilage degeneration. The drug was given at the time of surgery, or from before surgery, and for 16 weeks after surgery. Analysis of the articular cartilage showed the naproxen was able to significantly suppress the decrease in proteoglycan content and metalloproteinase activities. The results indicate that pharmaceutical agents have the potential to modulate the progression of degenerative joint disease.
Evaluar y comparar la eficacia y seguridad de dos combinaciones, en dosis fija y oral para el alivio de los síntomas de la dismenorrea primaria en mujeres mexicanas. Basados en la fisiopatología de la dismenorrea primaria, se utilizó una combinación comercializada en México de paracetamol, pirilamina y pamabrom. El comparador seleccionado fue un medicamento que contiene naproxeno sódico, paracetamol y pamabrom.
The efficacy and safety of flurbiprofen (Ansaid, Upjohn), 100 mg twice daily, were compared with those of naproxen, 250 mg twice daily, in a six-week, double-blind, randomized study involving 133 patients with rheumatoid arthritis. Patients completing the six-week treatment phase were then treated with flurbiprofen, 100 mg twice daily, during a six-week open-label phase. In the double-blind phase, both treatment groups showed improvement from baseline and, in general, the arthritic condition of all patients was significantly less severe while receiving treatment. In the open-label phase, the patients in whom therapy was switched from naproxen to flurbiprofen reported greater improvement compared with baseline than they did at the end of the double-blind phase. Statistically significant differences between medication groups were few. At weeks four and six, grip strength for the naproxen group increased from baseline by a marginal amount compared with the flurbiprofen group. Global evaluations of disease improvement by patients and physicians and proximal interphalangeal joint size showed trends in favor of flurbiprofen. In the double-blind phase, 29.4 percent of flurbiprofen-treated patients (n = 20) and 23.1 percent of naproxen-treated patients (n = 15) experienced side effects, most of which were gastrointestinal in origin. In the open-label phase, 81.0 percent of the patients (n = 87) satisfactorily completed the six weeks of flurbiprofen treatment. Based on this study, 100 mg of flurbiprofen administered twice daily was as effective as 250 mg of naproxen twice daily in the treatment of rheumatoid arthritis.
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Twenty-three patients, mean age 69 years, with osteoarthritis requiring NSAID treatment, received treatment with diclofenac 100 mg/day, naproxen 750 mg/day and piroxicam 20 mg/day, representing a short, medium and long half-life NSAID respectively, in a double-blind, randomised, three way, cross-over block design. In each case, a three week washout control phase was followed by active treatment phases of two weeks each with three week washout between treatment phases.
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1 Two multicentre, parallel group, randomised, double-blind, double-dummy comparison studies were conducted between isoxicam in the usual dose of 200 mg once daily and naproxen 500 mg twice daily. 2 The drugs were administered for 4 weeks to 230 patients suffering from osteoarthritis of the hip and/or knee in the first trial and to 249 patients suffering from rheumatoid arthritis in the second. 3 The studies compared treatments for both safety and overall effectiveness in the relief of pain. 4 In the osteoarthritis trial, overall pain was reduced by both drugs after 2 weeks of therapy but only isoxicam produced further improvement after 4 weeks. 5 Isoxicam produced reductions comparable to those produced by naproxen in pain on standing from the sitting position, pain on walking, and pain on movement of the affected joint, after 2 and 4 weeks. 6 After 4 weeks, isoxicam given once daily in the morning was significantly more effective than naproxen given in the morning and the evening in relieving not only total pain as assessed by a visual analogue scale but, as importantly, night pain. 7 Compared to naproxen therapy, isoxicam therapy was associated with significantly more patients whose disease state was improved at 2 weeks, as assessed by physicians. 8 In the rheumatoid arthritis trial, isoxicam was equally as effective as naproxen in reducing joint tenderness, joint swelling, and pain; at 4 weeks there was a trend in favour of isoxicam in reduction of joint swelling and pain. 9 Isoxicam reduced morning stiffness significantly more than naproxen after 4 weeks; this trend was apparent at 2 weeks.(ABSTRACT TRUNCATED AT 250 WORDS)
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Study subjects (N = 853) were predominantly female (78.8%) and white (80.4%), and had a mean age of 78 years; 65.1% were prescribed a coxib and 34.9% were prescribed a nonselective NSAID. In bivariate analyses, coxib users were more likely than nonselective NSAID users to be white (83.2% vs 75.3%, respectively; P < 0.05), to be prescribed chronic rather than acute therapy (81.8% vs 58.7%; P < 0.001), and to have a concomitant prescription for warfarin (11.2% vs 5.7%; P < 0.05). Multivariate analyses indicated significance for the same predictors of coxib use: chronic versus acute therapy (Dominick model: adjusted odds ratio [AOR] = 3.39; 95% CI, 2.43-4.74; Shaya model: AOR = 3.39; 95% CI, 2.43-4.74); concomitant anticoagulant therapy (Dominick model: AOR = 2.16; 95% CI, 1.18-3.97; Shaya model: AOR = 2.31; 95% CI, 0.28-0.83); and black race (Dominick model: AOR = 0.48; 95% CI, 0.28-0.83; Shaya model: AOR = 0.49; 95% CI, 0.28-0.84). The most commonly prescribed nonselective NSAIDs were ibuprofen (14.3% of all subjects) and naproxen (6.6% of all subjects); the most commonly prescribed coxibs were rofecoxib (36.5%) and celecoxib (28.5%).
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The results of this trial will be helpful to supply the efficacy of acupuncture for menstrual-related migraine prophylaxis.
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2-Arylpropionic acid (profen) drugs are associated with severe hepatotoxicity; however, risk factors are still poorly understood. Acyl-coenzyme A (acyl-CoA) thioesters of profen drugs play a more important role in the covalent binding to rat hepatocyte proteins than the respective acyl-glucuronides. Therefore, we examined whether acyl-glucuronides, acyl-CoA thioesters and oxidative metabolites of profen drugs stereoselectively participated in liver damage.