Edson Zangiacomi Martinez

C-Peptide Levels and Insulin Independence Following Autologous Nonmyeloablative Hematopoietic Stem Cell Transplantation in Newly Diagnosed Type 1 Diabetes Mellitus

CONTEXT In 2007, the effects of the autologous nonmyeloablative hematopoietic stem cell transplantation (HSCT) in 15 patients with type 1 diabetes mellitus (DM) were reported. Most patients became insulin free with normal levels of glycated hemoglobin A(1c) (HbA(1c)) during a mean 18.8-month follow-up. To investigate if this effect was due to preservation of beta-cell mass, continued monitoring was performed of C-peptide levels after stem cell transplantation in the 15 original and 8 additional patients. OBJECTIVE To determine C-peptide levels after autologous nonmyeloablative HSCT in patients with newly diagnosed type 1 DM during a longer follow-up. DESIGN, SETTING, AND PARTICIPANTS A prospective phase 1/2 study of 23 patients with type 1 DM (aged 13-31 years) diagnosed in the previous 6 weeks by clinical findings with hyperglycemia and confirmed by measurement of serum levels of anti-glutamic acid decarboxylase antibodies. Enrollment was November 2003-April 2008, with follow-up until December 2008 at the Bone Marrow Transplantation Unit of the School of Medicine of Ribeirão Preto, Ribeirão Preto, Brazil. Hematopoietic stem cells were mobilized via the 2007 protocol. MAIN OUTCOME MEASURES C-peptide levels measured during the mixed-meal tolerance test, before, and at different times following HSCT. Secondary end points included morbidity and mortality from transplantation, temporal changes in exogenous insulin requirements, and serum levels of HbA(1c). RESULTS During a 7- to 58-month follow-up (mean, 29.8 months; median, 30 months), 20 patients without previous ketoacidosis and not receiving corticosteroids during the preparative regimen became insulin free. Twelve patients maintained this status for a mean 31 months (range, 14-52 months) and 8 patients relapsed and resumed insulin use at low dose (0.1-0.3 IU/kg). In the continuous insulin-independent group, HbA(1c) levels were less than 7.0% and mean (SE) area under the curve (AUC) of C-peptide levels increased significantly from 225.0 (75.2) ng/mL per 2 hours pretransplantation to 785.4 (90.3) ng/mL per 2 hours at 24 months posttransplantation (P < .001) and to 728.1 (144.4) ng/mL per 2 hours at 36 months (P = .001). In the transient insulin-independent group, mean (SE) AUC of C-peptide levels also increased from 148.9 (75.2) ng/mL per 2 hours pretransplantation to 546.8 (96.9) ng/mL per 2 hours at 36 months (P = .001), which was sustained at 48 months. In this group, 2 patients regained insulin independence after treatment with sitagliptin, which was associated with increase in C-peptide levels. Two patients developed bilateral nosocomial pneumonia, 3 patients developed late endocrine dysfunction, and 9 patients developed oligospermia. There was no mortality. CONCLUSION After a mean follow-up of 29.8 months following autologous nonmyeloablative HSCT in patients with newly diagnosed type 1 DM, C-peptide levels increased significantly and the majority of patients achieved insulin independence with good glycemic control. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00315133.

Effectiveness of Oral Rinse with Chlorhexidine in Preventing Nosocomial Respiratory Tract Infections among Intensive Care Unit Patients

OBJECTIVE To evaluate the effectiveness of the oral application of a 0.12% solution of chlorhexidine for prevention of respiratory tract infections among intensive care unit (ICU) patients. DESIGN The study design was a double-blind, randomized, placebo-controlled trial. SETTING The study was performed in an ICU in a tertiary care hospital at a public university. PATIENTS. Study participants comprised 194 patients admitted to the ICU with a prospective length of stay greater than 48 hours, randomized into 2 groups: those who received chlorhexidine (n = 98) and those who received a placebo (n = 96). INTERVENTION Oral rinses with chlorhexidine or a placebo were performed 3 times a day throughout the duration of the patients stay in the ICU. Clinical data were collected prospectively. RESULTS Both groups displayed similar baseline clinical features. The overall incidence of respiratory tract infections (RR, 1.0 [95% confidence interval [CI], 0.63-1.60]) and the rates of ventilator-associated pneumonia per 1,000 ventilator-days were similar in both experimental and control groups (22.6 vs 22.3; P = .95). Respiratory tract infection-free survival time (7.8 vs 6.9 days; P = .61), duration of mechanical ventilation (11.1 vs 11.0 days; P = .61), and length of stay (9.7 vs 10.4 days; P = .67) did not differ between the chlorhexidine and placebo groups. However, patients in the chlorhexidine group exhibited a larger interval between ICU admission and onset of the first respiratory tract infection (11.3 vs 7.6 days; P = .05). The chances of surviving the ICU stay were similar (RR, 1.08 [95% CI, 0.72-1.63]). CONCLUSION Oral application of a 0.12% solution of chlorhexidine does not prevent respiratory tract infections among ICU patients, although it may retard their onset.

Menopause symptoms and quality of life in women aged 45 to 65 years with and without breast cancer.

Objective:To compare the prevalence of menopause symptoms, sexual activity, and quality of life in women with and without breast cancer. Design:A cross-sectional study using one group for comparison was conducted on women aged 45 to 65 years who had not received hormone therapy or tamoxifen during the last 6 months. Participants were recruited from the Menopause and Breast Cancer Outpatient Facilities. One hundred eighty-two women were included, 97 with breast cancer and 85 without breast cancer. Sociodemographic and clinical features and prevalence of menopause symptoms were assessed. The quality of life was assessed by the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) questionnaire. To compare sociodemographic and clinical features between groups, the Students t test or Fisher exact test was used. Multiple logistic regression and linear regression models were used to control for potential confounding variables. Results:The mean age of participants with breast cancer was 53.2 ± 6.2 years, and the mean age of those without cancer was 57.8 ± 4.9 years (P < 0.01). Age at menopause was 47.2 ± 5.1 years and 47.4 ± 4.9 years for women with and without breast cancer (P = 0.76), respectively. Approximately one-fourth of women with breast cancer and 4.7% of women without cancer were premenopausal (P < 0.01). The prevalence of menopause symptoms was similar between the groups. Women with breast cancer reported less sexual activity (51.5%) than women without cancer (62.4%) (P < 0.01). Quality of life scores were good in both groups. There was a significant difference regarding physical functioning, with a median score of 90 for the cancer group and 75 for the group without cancer (P < 0.01). Conclusion:The prevalence of menopause symptoms was similar in women with and without breast cancer. Sexual activity was less frequent in women with breast cancer. Quality of life was good in women from both groups, although women with breast cancer had the highest level of physical functioning.

Quality of Life in Brazilian Breast Cancer Survivors Age 45–65 Years: Associated Factors

Abstract:  The objectives of this study were to evaluate quality of life (QOL) and identify its associated factors in climacteric women with a history of breast cancer. A cross‐sectional study was performed including 75 breast cancer survivors age 45–65 years who had undergone complete oncologic treatment and nonusers of hormone therapy or tamoxifen in the last 6 months. Sociodemographic and clinical characteristics in addition to the prevalence of climacteric symptoms were evaluated. QOL was evaluated by the Medical Outcomes Study 36‐item Short‐Form Health Survey (SF‐36) questionnaire, including eight components that can be condensed into two summaries: a physical component summary (physical functioning, role‐physical, body pain, general health) and a mental component summary (vitality, social functioning, role‐emotional, and mental health). Generalized linear models were used to analyze the data, allowing the identification of factors affecting QOL, adjusting for confounding variables. The mean age of the participants was 53.1 ± 5.9 years. Breast cancer survivors reported good QOL. The most prevalent symptoms were nervousness (69%) and hot flashes (56%). Factors associated with poorer QOL were dizziness, postmenopausal status, and breast‐conserving therapy (physical component), as well as insomnia and being married (mental component). In conclusion, participants demonstrated good QOL. We identified factors that may influence QOL in women with breast cancer, highlighting being married, climacteric symptoms, postmenopausal status, and breast‐conserving therapy. Given the impact of these factors, health professionals and patients must discuss choices for alleviating climacteric symptoms and explanations for the potential repercussions of breast cancer treatment.

Late-night Salivary Cortisol Has a Better Performance Than Urinary Free Cortisol in the Diagnosis of Cushing's Syndrome

CONTEXT The comparison of variability, reproducibility, and diagnostic performance of late-night salivary cortisol (LNSF) and urinary free cortisol (UFC) using concurrent and consecutive samples in Cushings syndrome (CS) is lacking. Objectives, Patients, and Methods: In a prospective study, we evaluated 3 simultaneous and consecutive samples of LNSF by RIA and UFC by liquid chromatography associated with tandem mass spectrometry in Cushings disease (CD) patients (n = 43), adrenal CS patients (n = 9), and obese subjects (n = 18) to compare their diagnostic performances. In CS patients, we also performed a modified CS severity index. RESULTS There was no difference in the coefficient of variation (percentage) between LNSF and UFC among the 3 samples obtained for each patient with Cushings disease (35 ± 26 vs 31 ± 24), adrenal CS (28 ± 14 vs 22 ± 14), and obesity (39 ± 37 vs 48 ± 20). LNSF confirmed the diagnosis of hypercortisolism even in the presence of normal UFC in 17.3% of CS, whereas the inverse situation was not observed for UFC. The area under the receiver-operating characteristic curves for LNSF was 0.999 (95% credible interval [CI] 0.990-1.00) and for UFC was 0.928 (95% CI 0.809-0.987). The ratio between areas under the curve was 0.928 (95% CI 0.810-0.988), indicating better performance of LNSF than UFC in diagnosing CS. There was no association between the CS severity index and the degree of biochemical hypercortisolism. CONCLUSION Our data show that despite similar variability between both methods, LNSF has a superior diagnostic performance than UFC and should be used as the primary biochemical diagnostic test for CS diagnosis.

Efficacy of brief alcohol screening intervention for college students (basics): a meta-analysis of randomized controlled trials

BackgroundMany studies reported that brief interventions are effective in reducing excessive drinking. This study aimed to assess the efficacy of a protocol of brief intervention for college students (BASICS), delivered face-to-face, to reduce risky alcohol consumption and negative consequences.MethodsA systematic review with meta-analysis was performed by searching for randomized controlled trials (RCTs) in Medline, PsycInfo, Web of Science and Cochrane Library databases. A quality assessment of RCTs was made by using a validated scale. Combined mean effect sizes, using meta-analysis random-effects models, were calculated.Results18 studies were included in the review. The sample sizes ranged from 54 to 1275 (median = 212). All studies presented a good evaluation of methodological quality and four were found to have excellent quality. After approximately 12 months of follow-up, students receiving BASICS showed a significant reduction in alcohol consumption (difference between means = −1.50 drinks per week, 95% CI: -3.24 to −0.29) and alcohol-related problems (difference between means = −0.87, 95% CI: -1.58 to −0.20) compared to controls.ConclusionsOverall, BASICS lowered both alcohol consumption and negative consequences in college students. Gender and peer factors seem to play an important role as moderators of behavior change in college drinking. Characteristics of BASICS procedure have been evaluated as more favorable and acceptable by students in comparison with others interventions or control conditions. Considerations for future researches were discussed.

Factors associated with quality of life in a cohort of postmenopausal women

Objective. To evaluate quality of life (QOL) and identify its associated factors in a cohort of postmenopausal women who had not received hormone therapy. Methods. A cross-sectional study was conducted among 81 postmenopausal women who had not used hormone therapy in the last six months. Sociodemographic and clinical characteristics, in addition to the prevalence of menopausal symptoms, were evaluated. QOL was assessed by the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) questionnaire, which may be condensed into two summaries: Physical Component Summary and Mental Component Summary. Generalized linear models were used to analyze the data, allowing the identification of factors affecting QOL, adjusting for confounding variables. Results. The mean (±standard deviation) age of the participants was 58.1 ± 4.7 years. The most prevalent symptoms were nervousness (67%) and hot flushes and sweating (51%). Factors associated with poorer QOL were sweating, palpitations, nervousness (physical component), and dizziness, nervousness, depression, insomnia and dyspareunia (mental component). Conclusion. We observed that menopausal symptoms negatively affected the physical and mental components of QOL in postmenopausal women.

Comparison of quality of life, satisfaction with surgery and shoulder-arm morbidity in breast cancer survivors submitted to breast-conserving therapy or mastectomy followed by immediate breast reconstruction

OBJECTIVES This study was designed to compare the prevalence of shoulder-arm morbidity, patient satisfaction with surgery and the quality of life of women submitted to breast-conserving therapy or modified radical mastectomy and immediate breast reconstruction . METHODS This study was a cross-sectional study of women who underwent breast-conserving therapy (n = 44) or modified radical mastectomy and immediate breast reconstruction (n = 26). Quality of life was evaluated with the SF-36 Health Survey Questionnaire. RESULTS No differences were found in the prevalence of lymphedema. The movements that were most commonly affected by these procedures were abduction, flexion and external rotation. When the two groups were compared, however, we only found a statistically significant difference for the prevalence of restricted internal rotation, which occurred in 32% of women in the breast-conserving therapy group and 12% of those in the modified radical mastectomy and immediate breast reconstruction group (OR: 7.23; p = 0.03 following adjustment for potential confounding factors). No difference in quality of life or satisfaction with surgery was found between the two groups. CONCLUSIONS These data suggest that the type of surgery did not affect the occurrence of lymphedema. Breast-conserving therapy, however, increased the risk of shoulder movement limitation. No differences were found between the two surgical techniques with respect to quality of life or satisfaction with surgery.

Risk-of-Malignancy Index in preoperative evaluation of clinically restricted ovarian cancer

CONTEXT There is no adequate preoperative method for differentiating between benign and malignant pelvic masses. Evaluations of CA 125 serum levels, ultrasonography findings and menstrual state have been tested in isolation as diagnostic methods. The evaluation of these three methods in association with each other could improve diagnostic performance. OBJECTIVE To evaluate the risk-of-malignancy index by combining serum CA 125 levels, ultrasound score and menopausal status in preoperative diagnoses for women with pelvic masses clinically restricted to the ovaries and without clear evidence of malignancy. DESIGN Cross-sectional study. SETTING Centro de Atenção Integral à Saúde da Mulher, Universidade Estadual de Campinas, Campinas, São Paulo, Brazil. PARTICIPANTS 158 women admitted between January 1996 and March 1998 for surgical exploration of pelvic masses. PROCEDURES The risk-of-malignancy index was calculated as US x M x CA 125, performed preoperatively. Ultrasound findings were classified according to the shape, size, multiplicity, presence of wall expansion involvement or ascites, using a score system (US). Menopausal status was considered as 1 for premenopausal and 3 for postmenopausal (M), and CA 125 serum levels were considered in absolute values. STATISTICAL ANALYSIS Most relevant variables were included in a logistic multiple regression model, fitted using the ultrasound score, the serum CA 125 level and the menopausal status. The model was used for evaluating the performance of each individual predictor in determining the malignancy of these tumors and identifying the risk-of-malignancy index. RESULTS The best individual performance was found in CA 125 levels (sensitivity of 78%, specificity of 75%), followed by ultrasound score (sensitivity of 75%, specificity of 73%) and menopausal status (sensitivity of 73%, specificity of 69%). The performance obtained for the risk-of-malignancy index at the cut-off point of 150 was a sensitivity and specificity of 79%. The area under the ROC curve for the risk-of-malignancy index was 0.90, which was greater than the area for CA 125 levels (0.83) or ultrasound score (0.79). CONCLUSION The risk-of-malignancy index using ultrasound morphological score, serum CA 125 levels and menopausal status might be of value in the preoperative assessment of ovarian carcinomas.

A SARIMA forecasting model to predict the number of cases of dengue in Campinas, State of São Paulo, Brazil

INTRODUCTION Forecasting dengue cases in a population by using time-series models can provide useful information that can be used to facilitate the planning of public health interventions. The objective of this article was to develop a forecasting model for dengue incidence in Campinas, southeast Brazil, considering the Box-Jenkins modeling approach. METHODS The forecasting model for dengue incidence was performed with R software using the seasonal autoregressive integrated moving average (SARIMA) model. We fitted a model based on the reported monthly incidence of dengue from 1998 to 2008, and we validated the model using the data collected between January and December of 2009. RESULTS SARIMA (2,1,2) (1,1,1)12 was the model with the best fit for data. This model indicated that the number of dengue cases in a given month can be estimated by the number of dengue cases occurring one, two and twelve months prior. The predicted values for 2009 are relatively close to the observed values. CONCLUSIONS The results of this article indicate that SARIMA models are useful tools for monitoring dengue incidence. We also observe that the SARIMA model is capable of representing with relative precision the number of cases in a next year.