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We developed a decision model to estimate the costs and effectiveness of 3 treatment strategies: 250 mg naproxen 3 times daily for 26 weeks, 100 mg celecoxib twice daily for 26 weeks, and 25 mg hyaluronan by intraarticular injection once per week for 5 weeks followed by conventional treatment for 21 weeks. The probabilities and utility data were obtained by surveying the literature and consulting experts. Cost data were obtained from insurance reimbursement data of National Taiwan University Hospital and were converted to 2002 US dollars. The timeframe of the decision tree was 26 weeks. Outcomes were expressed in aggregated costs, quality-adjusted life-years (QALY), and the incremental cost-effectiveness ratio (ICER). Sensitivity analyses were performed on most variables.
Numbers of opioid users were small. Information collected on reason for use of pain medications was not specific to each type of pain medication. Therefore, we cannot rule out confounding by indication as an explanation of these results.
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One hundred fifty patients (108 women, 42 men; mean [SE] age, 26.8 [0.6] years; 30 patients per group) had data available for analysis. Demographic data were similar between the 5 groups. No significant differences in mean VAS scores were found between the 5 groups at any time point. All mean VAS scores indicated minor pain. The rate of additional postoperative analgesics required was significantly lower in the diflunisal group compared with groups receiving naproxen sodium, meloxicam, acetaminophen, and rofecoxib (3 [10%] patients vs 11 [37%], 15 [50%], 15 [50%], and 14 [47%] patients, respectively; all, P < 0.05). Bleeding at the surgical site was reported in 2 patients each in the diflunisal, naproxen sodium, meloxicam, and acetaminophen groups, and in 1 patient in the rofecoxib group; the between-group differences were not significant. No significant differences in the prevalences of other adverse effects (eg, nausea, vomiting, allergy, gastrointestinal symptoms) were found between the 5 treatment groups.
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Out of 2869 articles only one single arm open trial was identified that fulfilled our inclusion criteria. This trial assessed the safety and efficacy of naproxen (dosage not specified) in 58 patients with active rheumatoid arthritis and gastrointestinal comorbidities for up to 52 weeks. Thirteen participants (22%) remained on gold therapy, four participants (10%) remained on hydroxychloroquine, 27 (47%) remained on corticosteroids, 12 (21%) remained on salicylates and all participants continued on antacids and bland diet. The presence of faecal occult blood was reported in 1/58 participants tested between weeks 1 to 26 and 2/32 participants tested between weeks 27 to 52. Over the course of the study, seven participants (12.1%) withdrew due to adverse events but of these, only two participants withdrew due to gastrointestinal side effects (abdominal pain n=1, nausea n=1) and no serious adverse events were reported. Noteable, out of 14 studies excluded due to inclusion of mixed population (osteoarthritis or other rheumatic conditions) or intervention already withdrawn, five trials reported higher risk of developing gastrointestinal events in patients with prior gastrointestinal events when treated with NSAIDs.
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In continuation of our efforts to discover novel nitric oxide-releasing non-steroidal anti-inflammatory drugs (NO-NSAIDs) as potentially "Safe NSAIDs," we report herein the design, synthesis and evaluation of 21 new NO-NSAIDs of commonly used NSAIDs such as aspirin, diclofenac, naproxen, flurbiprofen, ketoprofen, sulindac, ibuprofen and indomethacin. These prodrugs have NO-releasing disulfide linker attached to a parent NSAID via linkages such as an ester (compounds 9-16), a double ester (compounds 17-24), an imide (compounds 25-30) or an amide (compounds 31-33). Among these NO-NSAIDs, the ester-containing NO-aspirin (9), NO-diclofenac (10), NO-naproxen (11), and the imide-containing NO-aspirin (25), NO-flurbiprofen (27) and NO-ketoprofen (28) have shown promising oral absorption, anti-inflammatory activity and NO-releasing property, and also protected rats from NSAID-induced gastric damage. NO-aspirin compound 25, on further co-evaluation with aspirin at equimolar doses, exhibited comparable dose-dependent pharmacokinetics, inhibition of gastric mucosal prostaglandin E(2) (PGE(2)) synthesis and analgesic properties to those of aspirin, but retained its gastric-sparing properties even after doubling its oral dose. These promising NO-NSAIDs could therefore represent a new class of potentially "Safe NSAIDs" for the treatment of arthritic pain and inflammation.
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BACKGROUND: Individual patient meta-analysis to determine the analgesic efficacy and adverse effects of single-dose rofecoxib in primary dysmenorrhoea. METHODS: Individual patient information was available from three randomised, double blind, placebo and active controlled trials of rofecoxib. Data were combined through meta-analysis. Number-needed-to-treat (NNT) for at least 50% pain relief and the proportion of patients who had taken rescue medication over 12 hours were calculated. Information was collected on adverse effects. RESULTS: For single-dose rofecoxib 50 mg compared with placebo, the NNTs (with 95% CI) for at least 50% pain relief were 3.2 (2.4 to 4.5) at six, 3.1 (2.4 to 9.0) at eight, and 3.7 (2.8 to 5.6) at 12 hours. For naproxen sodium 550 mg they were 3.1 (2.4 to 4.4) at six, 3.0 (2.3 to 4.2) at eight, and 3.8 (2.7 to 6.1) at 12 hours. The proportion of patients who needed rescue medication within 12 hours was 27% with rofecoxib 50 mg, 29% with naproxen sodium 550 mg, and 50% with placebo. In the single-dose trial, the proportion of patients reporting any adverse effect was 8% (4/49) with rofecoxib 50 mg, 12% (6/49) with ibuprofen 400 mg, and 6% (3/49) with placebo. In the other two multiple dose trials, the proportion of patients reporting any adverse effect was 23% (42/179) with rofecoxib 50 mg, 24% (45/181) with naproxen sodium 550 mg, and 18% (33/178) with placebo. CONCLUSIONS: Single dose rofecoxib 50 mg provided similar pain relief to naproxen sodium 550 mg over 12 hours. The duration of analgesia with rofecoxib 50 mg was similar to that of naproxen sodium 550 mg. Adverse effects were uncommon suggesting safety in short-term use of rofecoxib and naproxen sodium. Future research should include restriction on daily life and absence from work or school as outcomes.
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A defined mixture of rho iso-alpha-acids (RIAA), a modified hop extract, was evaluated for anti-inflammatory efficacy and safety. RIAA inhibited LPS-stimulated PGE(2) formation with >200-fold selectivity of COX-2 (IC(50)=1.3 microg/ml) over COX-1 (IC(50)>289 microg/ml). This occurred only when RIAA was added prior to, but not post, LPS stimulation. Consistent with this observation, RIAA produced no physiologically relevant, direct inhibition of COX-1 or COX-2 peroxidase activity. This suggests that RIAA inhibits inducible but not constitutive COX-2. In support, we found RIAA showed minimal PGE(2) inhibition (IC(50)=21mug/ml) relative to celecoxib (IC(50)=0.024 microg/ml), aspirin (IC(50)=0.52 microg/ml) or ibuprofen (IC(50)=0.57 microg/ml) in the AGS gastric mucosal model, where COX-1 and -2 are expressed constitutively. Taken together these results predict RIAA may have lower potential for gastrointestinal and cardiovascular toxicity observed with COX enzyme inhibitors. Following confirmation of bioavailable RIAA administered orally, gastrointestinal safety was assessed using the fecal calprotectin biomarker in a 14-day human clinical study; RIAA (900 mg/day) produced no change compared to naproxen (1000 mg/day), which increased fecal calprotectin 200%. Cardiovascular safety was addressed by PGI-M measurements where RIAA (1000 mg) did not reduce PGI-M or affect the urinary PGI-M/TXB(2) ratio. Drug interaction potential was evaluated against six major CYPs; of relevance, RIAA inhibited CYP2C9. Toxicity was assessed in a 21-day oral, mouse subchronic toxicity study where no dose dependent histopathological effects were noted. Clinically, RIAA (1000 mg/day) produced a 54% reduction in WOMAC Global scores in a 6-week, open-label trial of human subjects exhibiting knee osteoarthritis.
Numerous studies in humans have demonstrated increases in intestinal permeability resulting from the administration of non-steroidal anti-inflammatory drugs (NSAIDs). The increased permeability correlates well with ulceration. The time course of the changes in intestinal permeability, however, has not been studied, which makes comparative studies between different NSAIDs or different formulations of the same drug difficult. In the present study we have administered single doses of indomethacin to examine both the time course and pharmacokinetic/pharmacodynamic relationships of intestinal permeability in rats estimated by following the urinary excretion of [51Cr]-EDTA. The change in intestinal permeability was both time- and dose-dependent. Following both 10 mg kg-1 and 20 mg kg-1 oral doses of indomethacin, there was a rapid rise in intestinal permeability to a maximum level, after at least 12 h post-dose, which is longer than those previously observed for ibuprofen, ketoprofen, flurbiprofen and naproxen. The maximal effect lasted 12 and 36 h following 10 and 20 mg kg-1 doses, respectively. The side-effect-plasma concentration relationship demonstrated a counter-clockwise hysteresis. The relationship between the observed side-effect and the estimated deep effect compartment concentration was, on the other hand, linear. In comparative permeability studies of NSAIDs the time of administration, concentration and drug dependencies should be considered.
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The purpose of this study was to determine the efficacy of naproxen, a nonsteroidal anti-inflammatory drug, on the MG-63 human osteosarcoma cell line. MG-63 cells were exposed to naproxen in a wide range of concentrations of 0.03, 0.05, 0.1, 0.42, 0.83, and 1.67 mg/ml for 72 h. The activity of naproxen was assessed by the following assays: cell morphology; 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide (MTT) method; terminal deoxynucleotidyl transferase-mediated dUTP nick end labeling (TUNEL) assay; comet assay; and acridine orange and monodansylcadaverine (MDC) staining. Naproxen exerted a significant inhibitory effect on MG-63 cell proliferation, in a concentration-dependent manner, in all treatment groups compared with untreated cells. An increase in frequency of DNA damage, apoptotic bodies, apoptotic cells, and autophagic vacuoles was observed in MG-63-treated cells. Although future studies are needed, these findings suggest that naproxen may lead to improvements in treatment of patients with osteosarcoma.
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The metal-organic framework MIL-101 was fabricated in a polyetheretherketone (PEEK) tube as micro-trapping device, and applied to sorptive extraction of naproxen and its metabolite in urine samples. The remarkable water stability of the MIL-101 characterizes the material as being different from other moisture sensitive metal-organic framework. It is therefore suitable for extraction of pharmaceuticals from biological fluids. The adsorption isotherms in aqueous solution showed that the adsorption of naproxen on MIL-101 is endothermic. Additionally, MIL-101 exhibited higher extraction capacity to naproxen than that of C18-bonded silica and multi-walled nanotube. A specially designed in-tube sorptive extraction (ITSE) device endows the extraction process with the characteristic of rapidness, convenience, and easy of conjunction with high performance liquid chromatography (HPLC). Finally the MIL-101 based ITSE method coupled with HPLC and fluorescence detection was applied to analysis of naproxen and 6-O-desmethylnaproxen in urine samples. Parameters that influence the online extraction procedure, including pH of the sample solution, flow rate of extraction, sample volume, desorption solvents and time were investigated. The method is proved to be highly sensitive with the linear range of 0.05-6.0μgL(-1) and the limits of detection of 0.034 and 0.011μgL(-1) for naproxen and 6-O-desmethylnaproxen, respectively. The recoveries in urine samples were 85.3-98.3% for naproxen and 94.0-97.3% for 6-O-desmethylnaproxen with intra- and inter-day RSDs of 2.7-5.2% and 7.1-8.1%, respectively. Urine samples could be directly subjected to analysis without any additional sample pretreatment. The proposed method was demonstrated an efficient, flexible and versatile extraction tool which is ideally suitable for online conjunction with chromatographic methods.
Natural water treatment systems such as bank filtration have been recognized as providing effective barriers in the multi-barrier approach for attenuation of organic micropollutants for safe drinking water supply. In this study, the role of biodegradation in the removal of selected pharmaceutically active compounds (PhACs) during soil passage was investigated. Batch studies were conducted to investigate the removal of 13 selected PhACs from different water sources with respect to different sources of biodegradable organic matter. Neutral PhACs (phenacetine, paracetamol, and caffeine) and acidic PhACs (ibuprofen, fenoprofen, bezafibrate, and naproxen) were removed with efficiencies greater than 88% from different organic matter water matrices during batch studies (hydraulic retention time (HRT): 60 days). Column experiments were then performed to differentiate between biodegradation and sorption with regard to the removal of selected PhACs. In column studies, removal efficiencies of acidic PhACs (e.g., analgesics) decreased under conditions of limited biodegradable carbon. The removal efficiencies of acidic PhACs were found to be less than 21% under abiotic conditions. These observations were attributed to sorption under abiotic conditions established by a biocide (20 mM sodium azide), which suppresses microbial activity/biodegradation. However, under biotic conditions, the removal efficiencies of these acidic PhACs were found to be greater than 59%. This is mainly attributed to biodegradation. Moreover, the average removal efficiencies of hydrophilic (polar) neutral PhACs (paracetamol, pentoxifylline, and caffeine) with low octanol/water partition coefficients (log Kow less than 1) were low (11%) under abiotic conditions. However, under biotic conditions, removal efficiencies of the neutral PhACs were greater than 98%. In contrast, carbamazepine persisted and was not easily removed under either biotic or abiotic conditions. This study indicates that biodegradation represents an important mechanism for the removal of PhACs during soil passage.
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The elimination kinetics of inorganic blood sulfate in mice was followed for four hours after a single, oral administration of an antirheumatic drug. Sodium salicylate, aspirin, diflunisal and benorylate, all in a dose of 1.25 mmol/kg, reduced the sulfate level to the less than half that of control. This phenomenon was also demonstrated by phenylbutazone, oxyphenbutazone (both 1 mmol/kg), chloroquine diphosphate (0.6 mmol/kg) and tiaprofenic acid (0.02-0.35 mmol/kg). Niflumic acid (1.08 mmol/kg), piroxicam (0.03 mmol/kg), indomethacin (6.10(-3) mmol/kg), diclofenac (5.10(-3) mmol/kg), ketoprofen (0.2 mmol/kg), naproxen (0.08 mmol/kg) and ibuprofen (0.24 mmol/kg) possessed no sulfate lowering properties. The potential relevance of the use of sulfate lowering drugs for articular cartilage integrity is discussed in the light of what is already known about this subject.
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Cystitis, a rare adverse effect of systematically administered drugs, was first reported to be associated with a nonsteroidal antiinflammatory drug, tiaprofenic acid, in 1991. Similar reports of adverse effect of tiaprofenic acid were received by a number of national drug monitoring centres. It was therefore decided to investigate the frequency of cystitis associated with tiaprofenic acid and to see whether this association is typical of tiaprofenic acid or also occurs with other nonsteroidal antiinflammatory drugs.
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ANTIINFLAMMATORY DRUGS: Non-steroidal antiinflammatory drugs (NSAID) constitute one of the most widely prescribed drug classes. Selective inhibitors of cyclooxygenase type 2 (Cox-2) can have antiinflammatory and antialgesic activities without affecting prostaglandin synthesis at sites where classical NSAID have known toxicity. This fact has led to the development of celebrex and rofecoxib, the leading selective inhibitors of Cox-2. We review here the renal effects of steroidal antiinflammatory drugs. RENAL EFFECTS OF NSAID: The renal effects of NSAID are, in decreasing order: electrolyte imbalance (hyperkaliemia, edema, hypertension), acute renal failure, nephrotic syndrome associated with interstitial nephropathy, papillary necrosis. Electrolyte disorders and acute renal failure are observed more frequently in patients with risk factors. INTRARENAL LOCALIZATION OF CYCLOOXYGENASE: Cox-1 is present in endothelial and smooth muscle cells of pre- and postglomerular vessels as well as in the cortex, the medullary tubes and in interstitial cells. Cox-2 expression has been identified in the interstitium, medullary tubes and intercalate cells, and in the deep medulla. The regulatory role of Cox-2 on renin production has been demonstrated in the macula densa. RENAL EFFECTS OF COX-2 INHIBITORS: Several studies have demonstrated that Cox-2 inhibitors inhibit prostaglandin synthesis much like conventional NSAID. The long-term effects of selective inhibitors of Cox-2 on blood pressure, edema, kaliemia and renal function have also been described. All these studies point to the strictly identical renal effects of these new drugs and conventional NSAID.
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To assess whether prostaglandins contribute to the control of basal retinal and choroidal hemodynamics, retinal (RBF) and choroidal blood flow (ChBF) were measured by a microsphere technique in 1- to 4-day-old pigs before and after (at 20 and 60 min) administration of indomethacin (0.3 mg/kg, n = 6 or 10 mg/kg, n = 5), ibuprofen (40 mg/kg, n = 7), naproxen (20 mg/kg, n = 5) or vehicle (n = 8). In 40 other animals, PGF2 alpha, PGE2, and 6-keto-PGF1 alpha were measured in the retina and choroid at times corresponding to blood flow measurements. Mean arterial blood pressure and blood gases and pH were not altered by any of the agents. Except for the lower dose of indomethacin (0.3 mg/kg), which did not change retinal and choroidal prostaglandin concentrations, the prostaglandin levels were decreased similarly (P < 0.01) by the three drugs. However, RBF and ChBF were not changed by ibuprofen and naproxen, but decreased to the same extent after low and high doses of indomethacin. The data suggest that the effects of indomethacin on RBF and ChBF cannot be simply attributed to prostaglandin synthesis inhibition, and that prostaglandins may not play a significant role in controlling basal blood flow to the retina and choroid.
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Solvent-free optical resolution of N-methylamphetamine was developed by distillation after partial diastereoisomeric salt formation. From the 18 chiral acids tested by this method, five provide by this method resolution: O,O'-dibenzoyltartaric acid, O,O'-di-p-toluoyltartaric acid, 6-methoxy-alpha-methyl-2-naphthaleneacetic acid (Naproxen), the cis-permetrinic acid, and the 2-phenoxypropionic acid. Among them the O,O'-dibenzoyltartaric acid in water-free form provided the more effective resolution. The efficiency of this resolution S = 0.74 is in the range of the industrial-scale resolutions and not worse than the efficiency achieved by optical resolution via fractional crystallization.
I present a technique that permits evaluation of the permeability to water of the luminal membrane of the toad urinary bladder, independently of constraints to water flow imposed by the remainder of the tissue. This technique essentially depends on fixation of the luminal membrane with 1% glutaraldehyde for 5 min, and subsequent elimination of cytosolic constraints by decreasing the tonicity of the serosal bath to 1/2 normal strength. The increased hydraulic conductivity found with serosal hypotonicity is readily reversible, as the bladder returns to an isotonic serosal bath. By evaluating water flow in luminally fixed bladders during bathing in normal and hypotonic bath, one may identify the relative contribution of the luminal membrane and the "cytosol" on water flow. Using this technique, I found that the effect of the prostaglandin inhibitor Naproxen to increase vasopressin-stimulated water flow is due to increased luminal membrane permeability. The effect of histidine to increase vasopressin-stimulated water flow, however, depends on increased permeability of both the luminal membrane as well as the underlying structures. The action of serosal hypertonicity to induce water flow is due to an increased luminal permeability. However, serosal hypertonicity decreases "cytosolic" permeability, so that its overall function is a composite effect of its action at the luminal membrane and the "cytosolic" level.
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Endotoxin exposure may be followed by visceral hypersensitvity but potential mechanisms are not fully explored. We aimed to test the hypothesis that mast cells and the cyclooxygenase pathway (COX) mediate modulation of afferent nerve sensitivity following systemic endotoxin.
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The results are consistent with data that suggest that regular, but not intermittent, ibuprofen may abrogate the benefits of aspirin when used for the secondary prevention of AMI. There may be differences in the risk of heart disease with various NSAID.
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Arachidonic Acid (AA) injected into a hindpaw of Lewis rats produces high levels of tissue myeloperoxidase (MPO), a biochemical marker for PMN leukocytes. Treatment with a corticosteroid (prednisolone) or dual 5-LO/CO inhibitors of AA metabolism (phenidone, SKF 86002) produced dose-related inhibition of AA-induced elevations in paw tissue MPO levels. In contrast, administration of high pharmacologic doses of selective cyclooxygenase inhibitors (indomethacin, ibuprofen, naproxen), anti-histamine/serotonin agents (cyproheptadine, chlorpheniramine) or an anti-arthritic gold compound (auranofin) produced only slight or moderate effects. Thus, AA-induced hindpaw inflammation is a useful method for determining pharmacologic effects of 5-LO/CO inhibitors on PMN leukocyte infiltration in vivo.
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NSAIDs and triptans are the mainstays of acute migraine therapy, and antiemetic drugs can be added as necessary. Opioids and combination analgesics containing opioids should not be used routinely. Patient-specific clinical features should help guide the selection of an acute medication for an individual patient. Acute medications can be organized into four treatment strategies for use in various clinical settings. The acetaminophen-NSAID strategy is suitable for patients with attacks of mild to moderate severity. The triptan strategy is suitable for patients with severe attacks and for those with attacks of moderate severity who do not respond well to NSAIDs. The refractory migraine strategies may be useful for patients who do not respond well to the NSAIDs or triptans alone and include using triptans and NSAIDs simultaneously in combination, DHE, and rescue medications (eg, dopamine antagonists, combination analgesics, and corticosteroids) when the patient's usual medications fail. Strategies for patients with contraindications to vasoconstricting drugs include use of NSAIDs, combination analgesics, and dopamine antagonists.Acetaminophen is the safest acute migraine drug during pregnancy, and acetaminophen with codeine is also an option. Sumatriptan may be an option during pregnancy for selected patients and is compatible with breast-feeding.
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Isolated monoarthritis caused by Mycobacterium tuberculosis in the absence of clinical pulmonary disease is extremely rare in North America. After decades of consistent declines in incidence, a remarkable resurgence of tuberculosis (TB) is occurring in North America. It must always be considered in the differential diagnosis of chronic monoarthritis if devastating sequelae are to be avoided. We describe 2 cases of tuberculous arthritis in young children presenting with monoarthritis of the knee. The presumptive diagnosis in each case was oligoarticular onset juvenile rheumatoid arthritis (JRA). Each had an atypical course for JRA, with lack of response to intraarticular corticosteroid. The diagnosis of TB arthritis was made only with synovial biopsy.
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Two series of 1,2,4-triazoles and 1,2,4-triazolo[3,4-b]-1,3,4-thiadiazoles derived from three selected arylpropionic acids namely, ibuprofen, flurbiprofen and naproxen, were synthesized and evaluated for anti-inflammatory activity and ulcerogenic potential. All the tested compounds exhibited anti-inflammatory activity comparable to that of hydrocortisone. Compared to ibuprofen, however, all the tested compounds displayed more potent anti-inflammatory activity. Compounds tested for ulcerogenicity showed no or minimal ulcerogenic effect compared to indomethacin.
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This is a retrospective chart review with convenience sampling of patients on NSAIDs (at least five tablets a week, for at least 3 months prior to the study), attending the Rheumatology clinic of a tertiary care institution in south India between June 2004 and November 2004. Those with pre-existing heart disease, hypertension, thrombo-embolic disease, peptic ulcer and patients on corticosteroids were excluded. All the recorded adverse events were noted and compared between the Celecoxib and non-selective NSAID users. Univariate analysis using Chi-square test was performed.
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The method's reproducibility and stability were satisfactory. Indomethacin and naproxen increased the faecal calprotectin significantly from a base line of 4.7 mg/l to 9.0 mg/l and 8.0 mg/l, respectively. Lornoxicam failed to increase the faecal calprotectin. Shedding after 7 days of naproxen treatment was positively correlated to gastroduodenal mucosal inflammation assessed by endoscopy.
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Many women report an increased frequency of headaches around the time of menses. For some women, these headaches are more severe, of longer duration, and lead to greater disability than those occurring at other times in the menstrual cycle. A headache diary is critical to properly diagnose menstrual migraine (MM) by prospectively documenting headache days, severity of headache, and the headaches' relationship to menses. In women with diagnosed MM, acute treatment has been proven to be effective in randomized clinical trials. For those women who have predictable periods and may require preventive therapy, short-term prevention is a reasonable approach due to the predictability of MM. Although several agents (eg, naproxen sodium, magnesium, triptans) have been evaluated for prevention of MM, all but triptans have been assessed in small trials of between 20 and 35 women. Naratriptan, frovatriptan, and, most recently, zolmitriptan have been proven effective in preventing MM. Triptans are generally well tolerated, and the long-term safety of these agents is currently being evaluated. The flexibility of using acute and preventive therapy allows physicians to tailor treatment of MM and meet the needs of individual patients.