989 resultados para drug quality


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Toxoplasma gondii causes severe disease both to man and livestock and its detection in meat after slaughtering requires PCR or biological tests. Meat packages contain retained exudate that could be used for serology due to its blood content. Similar studies reported false negative assays in those tests. We standardized an anti-T. gondii IgG ELISA in muscle juices from experimentally infected rabbits, with blood content determination by cyanhemoglobin spectrophotometry. IgG titers and immunoblotting profiles were similar in blood, serum or meat juice, after blood content correction. These assays were adequate regardless of the storage time up to 120 days or freeze-thaw cycles, without false negative results. We also found 1.35% (1/74) positive sample in commercial Brazilian rabbit meat cuts, by this assay. The blood content determination shows ELISA of meat juice may be useful for quality control for toxoplasmosis monitoring. (C) 2011 Elsevier Ltd. All rights reserved.

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Methods. We studied participants with acute and/or early HIV infection and TDR in 2 cohorts (San Francisco, California, and Sao Paulo, Brazil). We followed baseline mutations longitudinally and compared replacement rates between mutation classes with use of a parametric proportional hazards model. Results. Among 75 individuals with 195 TDR mutations, M184V/I became undetectable markedly faster than did nonnucleoside reverse-transcriptase inhibitor (NNRTI) mutations (hazard ratio, 77.5; 95% confidence interval [CI], 14.7-408.2; P < .0001), while protease inhibitor and NNRTI replacement rates were similar. Higher plasma HIV-1 RNA level predicted faster mutation replacement, but this was not statistically significant (hazard ratio, 1.71 log(10) copies/mL; 95% CI, .90-3.25 log(10) copies/mL; P = .11). We found substantial person-to-person variability in mutation replacement rates not accounted for by viral load or mutation class (P < .0001). Conclusions. The rapid replacement of M184V/I mutations is consistent with known fitness costs. The long-term persistence of NNRTI and protease inhibitor mutations suggests a risk for person-to-person propagation. Host and/or viral factors not accounted for by viral load or mutation class are likely influencing mutation replacement and warrant further study.

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Context. Although several studies have evaluated the frequency of adverse drug reactions (ADRs) and drug-drug interactions (DDIs) in general medicine, few studies have looked at the epidemiology of adverse drug events (ADEs) in oncology. Objectives. We sought to investigate how many hospital admissions in oncology are related to a DDI or an ADR. Methods. All cancer patients admitted to an oncology ward during an eight-month period had their charts retrospectively evaluated for reasons of hospitalization, using a 4-point scale (definitely, probably, possibly, or unlikely associated) to classify admissions by their probability of being associated with either a DDI or an ADR. Results. From September 2007 to May 2008, there were 550 hospital admissions and 458 were eligible. Among unplanned admissions (n = 298), 39 (13.0%, 95% confidence interval [CI] 9.4%-17.4%) were considered to be associated with an ADE, 33 (11.0%, 95% CI 7.7%-15.2%) with an ADR, and six (2.0%, 95% CI 0.7%-4.3%) with a DDI. The most common DDIs involved warfarin, captopril, and anti-inflammatory agents, and the most frequent ADR was neutropenic fever post-chemotherapy. Most patients were discharged completely recovered, but two patients died. Conclusion. Approximately one in 10 unplanned hospitalizations of cancer patients is associated with an ADE. Prospective and population-based studies are warranted to evaluate their magnitude in oncology. J Pain Symptom Manage 2011;42:342-353. (C) 2011 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.

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Dizziness is frequent in elderly people. Aims: To evaluate the Quality of Life (QoL) in elderly subjects with dizziness, relate it with gender and age. Material and Method: A prospective study comprising 120 elderly patients with dizziness evaluated with Brazilian versions of the Whoqol-bref and the dizziness handicap inventory (DHI). The factor analysis (FA), the Mann Whitney and Kruskal Wallis tests, and the Spearman correlation were applied to study the results. Results: The most compromised domains were the DHI physical domain and the Whoqol-bref physical and environment domains. FA resulted in 3 factors in the DHI and 5 factors in the Whoqol-bref. There was a moderate correlation (-0.596) in the total scores of both instruments. Males had a better QoL in the ""environment perception and introspectivity"" and ""health perception"" factors of the Whoqol-bref test. Females had a better QoL in the ""functionality perception"" factor of the Whoqol-bref test. There were no significant age differences. Conclusions: Elderly patients with dizziness have a worse QoL. Elderly females with dizziness have worse QoL scores in ""environment perception and introspectivity"" and ""health perception"" and better QoL in the ""functionality perception"" factor compared to elderly males.

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OBJECTIVE. The purpose of the study was to investigate patient characteristics associated with image quality and their impact on the diagnostic accuracy of MDCT for the detection of coronary artery stenosis. MATERIALS AND METHODS. Two hundred ninety-one patients with a coronary artery calcification (CAC) score of <= 600 Agatston units (214 men and 77 women; mean age, 59.3 +/- 10.0 years [SD]) were analyzed. An overall image quality score was derived using an ordinal scale. The accuracy of quantitative MDCT to detect significant (>= 50%) stenoses was assessed using quantitative coronary angiography (QCA) per patient and per vessel using a modified 19-segment model. The effect of CAC, obesity, heart rate, and heart rate variability on image quality and accuracy were evaluated by multiple logistic regression. Image quality and accuracy were further analyzed in subgroups of significant predictor variables. Diagnostic analysis was determined for image quality strata using receiver operating characteristic (ROC) curves. RESULTS. Increasing body mass index (BMI) (odds ratio [OR] = 0.89, p < 0.001), increasing heart rate (OR = 0.90, p < 0.001), and the presence of breathing artifact (OR = 4.97, p = 0.001) were associated with poorer image quality whereas sex, CAC score, and heart rate variability were not. Compared with examinations of white patients, studies of black patients had significantly poorer image quality (OR = 0.58, p = 0.04). At a vessel level, CAC score (10 Agatston units) (OR = 1.03, p = 0.012) and patient age (OR = 1.02, p = 0.04) were significantly associated with the diagnostic accuracy of quantitative MDCT compared with QCA. A trend was observed in differences in the areas under the ROC curves across image quality strata at the vessel level (p = 0.08). CONCLUSION. Image quality is significantly associated with patient ethnicity, BMI, mean scan heart rate, and the presence of breathing artifact but not with CAC score at a patient level. At a vessel level, CAC score and age were associated with reduced diagnostic accuracy.

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The goal of the current study was to compare the quality of esophageal speech and voice to videofluoroscopic features of the esophagus and pharyngoesophageal (PE) segment. The speech and voice characteristics of 30 laryngectomized patients were rated by 5 speech-language pathologists. Based on these ratings, patients were divided into 3 categories: fluent (n = 9), moderately fluent (n = 10) and nonfluent (n = 11). Videofluoroscopy of the PE region was then performed during both swallowing and voice production. An insufflation test and percutaneous pharyngeal plexus block were required in 9 patients to determine the etiology of poor esophageal voice production. The strongest videofluoroscopic indicators of nonfluent speakers were: (1) small or absent air reservoir and (2) lack of a vibrating PE segment. Fluent speakers presented with shorter PE segments (1.17 mm) compared to moderately fluent speakers (17.1-29.9 mm). Perceptually, fluent speakers presented with a predominantly rough vocal quality. In contrast, moderately fluent speakers presented with a tense quality. In addition, stoma blast noise was reduced in fluent speakers. Videofluoroscopic findings highly correlated with the quality of esophageal speech. Copyright (C) 2009 S. Karger AG, Basel

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Objective: The purpose of this study was to evaluate the isolated and associated effects of estrogen therapy (estradiol valerate 1 mg/d orally) and physical exercise (moderate aerobic exercise, 3 h/wk) on health-related quality of life (HRQOL) and menopausal symptoms among women who had undergone hysterectomy. Design: A 6-month, randomized, double-blind, placebo-controlled clinical trial with 44 postmenopausal women who had undergone hysterectomy. The interventions were physical exercise and hormone therapy (n = 9), being sedentary and hormone therapy (n = 14), physical exercise and placebo (n = 11), and being sedentary and placebo (n = 10). HRQOL was assessed by a Brazilian standard version of the Medical Outcome Study Short-Forrn Health Survey and symptoms by Kupperman Index at baseline and after 6 months. Results: There was a decrease in symptoms in all groups, but only groups who performed physical exercise showed an increase in quality of life. Analysis of variance showed that changes in physical functioning (P = 0.001) and bodily pain (P = 0.012) scores over the 6-month period differed significantly between women who exercised and women who were sedentary, regardless of hormone therapy. Hormone therapy had no effect, and there was also no significant association between physical exercise and hormone therapy in HRQOL. Conclusions: Physical exercises can reduce menopausal symptoms and enhance HRQOL, independent of whether hormone therapy is taken.

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Twenty-nine HCV-infected patients were treated with pegylated interferon alpha. Diagnosis was based on serum HCV RNA-PCR positive results and liver biopsy. All patients had elevated serum levels of alanine aminotransferase at the time of the study, but liver disease was compensated. Patients were evaluated at baseline treatment and after 4 and 12 weeks of antiviral treatment with the Medical Outcomes Study 36-item Short-Form Health Survey. The Mini-International Neuropsychiatric Interview was used to exclude previous or current psychiatric diagnoses. Both patients and psychiatrists were blind to the HCV RNA status, and serum HCV RNA test results only became available after the visit at week 12. After antiviral treatment, 16 patients (55.2%) were classified as nonresponders and 13 (44.8%) were classified as responders. When compared to nonresponders, responders had a greater improvement in the HRQOL scores for the mental health domain (P<.019). Differences in other domains were not significant. The present study confirms that active viral infection is one possible reason for the poor Health-Related Quality of Life in this population.

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BACKGROUND: There is scarce literature on assessing surgical results and the impact of upper blepharoplasty on quality of life of patients. OBJECTIVE: To evaluate the impact on quality of life of patients submitted to upper blepharoplasty. METHODS: A prospective study using a standardized questionnaire applied to adult women submitted to upper blepharoplasty and evaluated 90 days later to estimate the surgical impact on quality of life and complications. RESULTS: Forty-one healthy adult females (median age of 53 years) were evaluated from June 2005 to March 2006. The questionnaire showed high internal consistency. The quality of life element with greater impact on the first postoperative week was related to physical appearance perception and that of lesser impact was associated to relationship with relatives and close friends. Hypertrophic scar was the main late complication. Satisfaction levels with the surgery were significantly related with absence of undesirable effects (p<0.01). CONCLUSIONS: The authors suggest a consistent tool to evaluate the impact of this surgical procedure on quality of life of patients. High satisfaction levels with upper blepharoplasty stood out. Keywords: Blepharoplasty; Quality of life; Patient satisfaction