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1.
BMJ ; 368: l7078, 2020 Feb 05.
Artigo em Inglês | MEDLINE | ID: mdl-32024657

RESUMO

OBJECTIVES: To conduct a systematic review and meta-analysis of the effects of rosiglitazone treatment on cardiovascular risk and mortality using multiple data sources and varying analytical approaches with three aims in mind: to clarify uncertainties about the cardiovascular risk of rosiglitazone; to determine whether different analytical approaches are likely to alter the conclusions of adverse event meta-analyses; and to inform efforts to promote clinical trial transparency and data sharing. DESIGN: Systematic review and meta-analysis of randomized controlled trials. DATA SOURCES: GlaxoSmithKline's (GSK's) ClinicalStudyDataRequest.com for individual patient level data (IPD) and GSK's Study Register platforms, MEDLINE, PubMed, Embase, Web of Science, Cochrane Central Registry of Controlled Trials, Scopus, and ClinicalTrials.gov from inception to January 2019 for summary level data. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Randomized, controlled, phase II-IV clinical trials that compared rosiglitazone with any control for at least 24 weeks in adults. DATA EXTRACTION AND SYNTHESIS: For analyses of trials for which IPD were available, a composite outcome of acute myocardial infarction, heart failure, cardiovascular related death, and non-cardiovascular related death was examined. These four events were examined independently as secondary analyses. For analyses including trials for which IPD were not available, myocardial infarction and cardiovascular related death were examined, which were determined from summary level data. Multiple meta-analyses were conducted that accounted for trials with zero events in one or both arms with two different continuity corrections (0.5 constant and treatment arm) to calculate odds ratios and risk ratios with 95% confidence intervals. RESULTS: 33 eligible trials were identified from ClinicalStudyDataRequest.com for which IPD were available (21 156 patients). Additionally, 103 trials for which IPD were not available were included in the meta-analyses for myocardial infarction (23 683 patients), and 103 trials for which IPD were not available contributed to the meta-analyses for cardiovascular related death (22 772 patients). Among 29 trials for which IPD were available and that were included in previous meta-analyses using GSK's summary level data, more myocardial infarction events were identified by using IPD instead of summary level data for 26 trials, and fewer cardiovascular related deaths for five trials. When analyses were limited to trials for which IPD were available, and a constant continuity correction of 0.5 and a random effects model were used to account for trials with zero events in only one arm, patients treated with rosiglitazone had a 33% increased risk of a composite event compared with controls (odds ratio 1.33, 95% confidence interval 1.09 to 1.61; rosiglitazone population: 274 events among 11 837 patients; control population: 219 events among 9319 patients). The odds ratios for myocardial infarction, heart failure, cardiovascular related death, and non-cardiovascular related death were 1.17 (0.92 to 1.51), 1.54 (1.14 to 2.09), 1.15 (0.55 to 2.41), and 1.18 (0.60 to 2.30), respectively. For analyses including trials for which IPD were not available, odds ratios for myocardial infarction and cardiovascular related death were attenuated (1.09, 0.88 to 1.35, and 1.12, 0.72 to 1.74, respectively). Results were broadly consistent when analyses were repeated using trials with zero events across both arms and either of the two continuity corrections was used. CONCLUSIONS: The results suggest that rosiglitazone is associated with an increased cardiovascular risk, especially for heart failure events. Although increased risk of myocardial infarction was observed across analyses, the strength of the evidence varied and effect estimates were attenuated when summary level data were used in addition to IPD. Because more myocardial infarctions and fewer cardiovascular related deaths were reported in the IPD than in the summary level data, sharing IPD might be necessary when performing meta-analyses focused on safety. SYSTEMATIC REVIEW REGISTRATION: OSF Home https://osf.io/4yvp2/.


Assuntos
Doenças Cardiovasculares/induzido quimicamente , Hipoglicemiantes/efeitos adversos , Rosiglitazona/efeitos adversos , Doenças Cardiovasculares/mortalidade , Humanos , Hipoglicemiantes/farmacologia , Disseminação de Informação , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Risco , Rosiglitazona/farmacologia
2.
Contemp Clin Trials Commun ; 16: 100477, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31799472

RESUMO

Introduction: Many clinical trials terminate early due to safety and efficacy concerns, and less often due to unexpected "positive" findings. However, early termination of post-approval (Phase IV) pragmatic randomized trials for commercial reasons is less frequent, may be more complex, and may require added flexibility in closure methods, including short term follow-up. VOLUME was a randomized, open-label, post-approval pragmatic clinical trial (PCT) or large simple trial that terminated early due to product withdrawal. The aim of this paper is to describe circumstances unique to post-approval PCTs that may require a closure amendment rather than immediate study termination, and our recommendations for operational study closure in these circumstances. We use the VOLUME case study throughout to provide a practical example. Methods: Study closeout considerations at the study level include: notifying external governance bodies, e.g., data monitoring committees (DMC), and scientific steering committees (SSC); executing a study closure amendment; notifying and training of study physicians; and institutional review board (IRB)/ethics committee (EC) approvals. Study closure considerations at the patient level focus on patient safety and include: patient notification, efficient transition to alternative treatments, the need for re-consenting; and drug supply shortages. Conclusions: Early study closeout logistics require careful analysis, detailed planning, and close coordination, and are ideally considered at the study planning phase. Lessons learned from the VOLUME closeout should help other researchers devise contingencies when terminating post approval pragmatic trials that utilize a marketed product.ClinicalTrials.gov: NCT00359801.

3.
Am J Obstet Gynecol ; 2019 Nov 15.
Artigo em Inglês | MEDLINE | ID: mdl-31738897

RESUMO

BACKGROUND: Studies investigating the effects of pain-relieving medication use on conceiving a pregnancy have shown conflicting results. Furthermore, no previous study has examined medication use around ovulation or implantation and the associations with the probability of conception, fecundability. OBJECTIVE: The objective of the study was to explore the association between fecundability and analgesic use in 3 different menstrual cycle windows (preovulation, periovulation, and implantation) as well as across the entire menstrual cycle. STUDY DESIGN: We analyzed data from a prospective cohort study of women between 30 and 44 years of age who were trying to conceive naturally from 2008 through 2015. Using daily diaries, medication usage was classified as acetaminophen, aspirin, or nonaspirin nonsteroidal antiinflammatory drug during 4 time periods of interest (preovulatory, periovulatory, and implantation) as well as the overall nonmenstrual bleeding days of the cycle. Menstrual cycles during the prospective attempt to become pregnant were enumerated using daily diary menstrual bleeding information. Conception was defined as a positive home pregnancy test. Discrete time fecundability models were used to estimate the fecundability ratio and 95% confidence interval in each of the 4 time windows of interest and for each pain reliever (aspirin use, nonaspirin nonsteroidal antiinflammatory drug use, acetaminophen) compared with no medication use after adjustment for several covariates including age, race, education, body mass index, alcohol and caffeine use, frequency of intercourse, and a history of migraines or uterine fibroids. RESULTS: Medication use was infrequent in the 858 women and 2366 cycles in this analysis. Use of nonaspirin nonsteroidal antiinflammatory drugs or acetaminophen was not associated with fecundability in any of the time windows of interest. Although the sample size was small, aspirin use during the implantation window was associated with increased fecundability (adjusted fecundability ratio [confidence interval]: 2.05 [1.23-3.41]). This association remained when limiting the analysis to cycles with minimal missing data or when adjusting for gravidity. None of the other medications were associated with fecundability. CONCLUSION: Aspirin use around implantation was associated with increased fecundability. These results expand previous literature to suggest the following: (1) implantation may be an important target for the effects of aspirin on conception and (2) aspirin may be beneficial, regardless of pregnancy loss history. These observations should be tested with a clinical trial.

5.
JAMA ; 322(1): 81, 2019 07 02.
Artigo em Inglês | MEDLINE | ID: mdl-31265092
6.
Diabetes Care ; 42(9): 1708-1715, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31331907

RESUMO

OBJECTIVE: The Follow-Up Study of patients previously enrolled in Exubera controlled clinical trials (FUSE) was designed to evaluate whether patients previously treated with Exubera (EXU; insulin human [rDNA origin], inhaled powder) in controlled clinical trials died because of incident primary lung cancer at a substantially higher rate than patients treated with a comparator. RESEARCH DESIGN AND METHODS: FUSE is a hybrid, randomized, controlled trial/cohort study including participants of 17 prior EXU clinical trials. Pooled patient data from these trials were used, and the subset of patients enrolled in the follow-up cohort study was followed prospectively for 2 years in order to evaluate the incidence of fatal and nonfatal primary lung cancers and all-cause mortality. RESULTS: There were 24,409 person-years (PY) of observation among 7,439 trial patients, with 4,017 PY (16.5%) from the period after the trials but before the prospective follow-up and 5,299 PY (21.7%) from the prospective follow-up. Just over half of the 2,631 patients (51.6%) in the prospective follow-up were randomized to EXU in the original trial. The incidence density ratio was 2.8 (95% CI 0.5, 28.5) for lung cancer-related mortality and 3.7 (95% CI 1.0, 20.7) for incident primary lung cancer. The hazard ratio for all-cause mortality was 0.81 (95% CI 0.60, 1.10). CONCLUSIONS: These data cannot exclude an increased risk of lung cancer-related mortality associated with EXU use. If real, the absolute increased risk of lung cancer-related mortality was small (0.48 cases per 1,000 PY). For all-cause mortality-the most reliably measured end point with the clearest interpretation-EXU users did not experience an excess all-cause death rate (relative or absolute) compared with users of other diabetes treatments over the study period.

8.
J Am Coll Cardiol ; 70(13): 1587-1597, 2017 Sep 26.
Artigo em Inglês | MEDLINE | ID: mdl-28935036

RESUMO

BACKGROUND: Inferior vena cava (IVC) filters are widely used for prevention of pulmonary embolism (PE). However, uncertainty persists about their efficacy and safety. OBJECTIVES: The authors conducted a systematic review and meta-analysis of the published reports on the efficacy and safety of IVC filters. METHODS: The authors searched PubMed, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov through October 3, 2016, for randomized controlled trials (RCTs) or prospective controlled observational studies of IVC filters versus none in patients at risk of PE. Inverse variance fixed-effects models with odds ratio (OR) as the effect measure were used for primary analyses. Main outcomes included subsequent PE, PE-related mortality, all-cause mortality, and subsequent deep vein thrombosis (DVT). RESULTS: The authors' search retrieved 1,986 studies, of which 11 met criteria for inclusion (6 RCTs and 5 prospective observational studies). Quality of evidence for RCTs was low to moderate. Overall, patients receiving IVC filters had lower risk for subsequent PE (OR: 0.50; 95% confidence interval [CI]: 0.33 to 0.75); increased risk for DVT (OR: 1.70; 95% CI: 1.17 to 2.48); nonsignificantly lower PE-related mortality (OR: 0.51; 95% CI: 0.25 to 1.05); and no change in all-cause mortality (OR: 0.91; 95% CI: 0.70 to 1.19). Limiting the results to RCTs showed similar results. Findings were substantively similar across a wide range of sensitivity analyses. CONCLUSIONS: Very few prospective controlled studies, with limited quality of evidence, exist regarding the efficacy and safety of IVC filters. Overall, filters appear to reduce the risk of subsequent PE, increase the risk for DVT, and have no significant effect on overall mortality.


Assuntos
Embolia Pulmonar/prevenção & controle , Filtros de Veia Cava , Tromboembolia Venosa/complicações , Humanos , Embolia Pulmonar/etiologia , Veia Cava Inferior
9.
Am J Epidemiol ; 185(3): 212-223, 2017 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-28108470

RESUMO

Vitamin B12 (hereafter referred to as B12) deficiency in pregnancy is prevalent and has been associated with both lower birth weight (birth weight <2,500 g) and preterm birth (length of gestation <37 weeks). Nevertheless, current evidence is contradictory. We performed a systematic review and a meta-analysis of individual participant data to evaluate the associations of maternal serum or plasma B12 concentrations in pregnancy with offspring birth weight and length of gestation. Twenty-two eligible studies were identified (11,993 observations). Eighteen studies were included in the meta-analysis (11,216 observations). No linear association was observed between maternal B12 levels in pregnancy and birth weight, but B12 deficiency (<148 pmol/L) was associated with a higher risk of low birth weight in newborns (adjusted risk ratio = 1.15, 95% confidence interval (CI): 1.01, 1.31). There was a linear association between maternal levels of B12 and preterm birth (per each 1-standard-deviation increase in B12, adjusted risk ratio = 0.89, 95% CI: 0.82, 0.97). Accordingly, B12 deficiency was associated with a higher risk of preterm birth (adjusted risk ratio = 1.21, 95% CI: 0.99, 1.49). This finding supports the need for randomized controlled trials of vitamin B12 supplementation in pregnancy.


Assuntos
Recém-Nascido de Baixo Peso , Complicações na Gravidez , Gravidez/sangue , Nascimento Prematuro/etiologia , Deficiência de Vitamina B 12/complicações , Vitamina B 12/sangue , Peso ao Nascer , Feminino , Humanos , Recém-Nascido , Fatores de Risco
10.
J Expo Sci Environ Epidemiol ; 27(1): 90-99, 2017 01.
Artigo em Inglês | MEDLINE | ID: mdl-26732376

RESUMO

Hydraulic-fracturing fluids and wastewater from unconventional oil and natural gas development contain hundreds of substances with the potential to contaminate drinking water. Challenges to conducting well-designed human exposure and health studies include limited information about likely etiologic agents. We systematically evaluated 1021 chemicals identified in hydraulic-fracturing fluids (n=925), wastewater (n=132), or both (n=36) for potential reproductive and developmental toxicity to triage those with potential for human health impact. We searched the REPROTOX database using Chemical Abstract Service registry numbers for chemicals with available data and evaluated the evidence for adverse reproductive and developmental effects. Next, we determined which chemicals linked to reproductive or developmental toxicity had water quality standards or guidelines. Toxicity information was lacking for 781 (76%) chemicals. Of the remaining 240 substances, evidence suggested reproductive toxicity for 103 (43%), developmental toxicity for 95 (40%), and both for 41 (17%). Of these 157 chemicals, 67 had or were proposed for a federal water quality standard or guideline. Our systematic screening approach identified a list of 67 hydraulic fracturing-related candidate analytes based on known or suspected toxicity. Incorporation of data on potency, physicochemical properties, and environmental concentrations could further prioritize these substances for future drinking water exposure assessments or reproductive and developmental health studies.


Assuntos
Deficiências do Desenvolvimento/induzido quimicamente , Água Potável/efeitos adversos , Doenças Urogenitais Femininas/induzido quimicamente , Fraturamento Hidráulico , Águas Residuárias/toxicidade , Bases de Dados Factuais , Água Potável/análise , Água Potável/normas , Feminino , Humanos , Masculino , Doenças Urogenitais Masculinas/induzido quimicamente , Estados Unidos , United States Environmental Protection Agency , Qualidade da Água/normas
11.
PLoS One ; 11(11): e0165051, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27820819

RESUMO

BACKGROUND: Close to one in ten individuals worldwide is born preterm, and it is important to understand patterns of long-term health and mortality in this group. This study assesses the relationship between gestational age at birth and early adult mortality both in a nationwide population and within sibships. The study adds to existing knowledge by addressing selected causes of death and by assessing the role of genetic and environmental factors shared by siblings. METHODS: Study population was all Norwegian men and women born from 1967 to 1997 followed using nation-wide registry linkage for mortality through 2011 when they were between 15 and 45 years of age. Analyses were performed within maternal sibships to reduce variation in unobserved genetic and environmental factors shared by siblings. Specific outcomes were all-cause mortality and mortality from cardiovascular diseases, cancer and external causes including accidents, suicides and drug abuse/overdoses. RESULTS: Compared with a sibling born in week 37-41, preterm siblings born before 34 weeks gestation had 50% increased mortality from all causes (adjusted Hazard Ratio (aHR) 1.54, 95% confidence interval (CI) 1.17, 2.03). The corresponding estimate for the entire population was 1.27 (95% CI 1.09, 1.47). The majority of deaths (65%) were from external causes and the corresponding risk estimates for these deaths were 1.52 (95% CI 1.08, 2.14) in the sibships and 1.20 (95% CI 1.01, 1.43) in the population. CONCLUSION: Preterm birth before week 34 was associated with increased mortality between 15 and 45 years of age. The results suggest that increased premature adult mortality in this group is related to external causes of death and that the increased risks are unlikely to be explained by factors shared by siblings.


Assuntos
Mortalidade Prematura , Nascimento Prematuro , Irmãos , Adolescente , Estudos de Coortes , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Adulto Jovem
12.
Open Forum Infect Dis ; 3(2): ofw048, 2016 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-27047985

RESUMO

Staphylococcus aureus is a common cause of severe bloodstream infection. We performed a systematic review to assess whether consultation with infectious disease specialists decreased all-cause mortality or rate of complications of S aureus bloodstream infections. The review also assessed parameters associated with the quality of management of the infection. We searched for eligible studies in PubMed, Embase, Scopus, and clinical trials.gov as well as the references of included studies. We identified 22 observational studies and 1 study protocol for a randomized trial. A meta-analysis was not performed because of the high risk of bias in the included studies. The outcomes are reported in a narrative review. Most included studies reported survival benefit, in the adjusted analysis. Recommended management strategies were carried out significantly more often among patients seen by an infectious disease specialist. Trials, such as cluster-randomized controlled trials, can more validly assess the studies at low risk of bias.

14.
Environ Res ; 147: 269-74, 2016 May.
Artigo em Inglês | MEDLINE | ID: mdl-26918840

RESUMO

BACKGROUND: It remains unclear as to whether neglecting residential mobility during pregnancy introduces bias in studies investigating air pollution and adverse perinatal outcomes, as most studies assess exposure based on residence at birth. The aim of this study was to ascertain whether such bias can be observed in a study on the effects of PM10 on risk of preterm birth and fetal growth restriction. METHODS: This was a retrospective study using four pregnancy cohorts of women recruited in Connecticut, USA (N=10,025). We ascertained associations with PM10 exposure calculated using first recorded maternal address, last recorded address, and full address histories. We used a discrete time-to-event model for preterm birth, and logistic regression to investigate associations with small for gestational age (SGA) and term low birth weight (LBW). RESULTS: Pregnant women tended to move to areas with lower levels of PM10. For all outcomes, there was negligible difference between effect sizes corresponding to exposures calculated with first, last and full address histories. For LBW, associations were observed for exposure in second trimester (OR 1.09; 95% CI: 1.04-1.14 per 1µg/m(3) PM10) and whole pregnancy (OR 1.08; 95% CI: 1.02-1.14). For SGA, associations were observed for elevated exposure in second trimester (OR 1.02; 95% CI: 1.00-1.04) and whole pregnancy (OR 1.03; 95% CI: 1.01-1.05). There was insufficient evidence for association with preterm birth. CONCLUSION: PM10 was associated with both SGA and term LBW. However, there was negligible benefit in accounting for residential mobility in pregnancy in this study.


Assuntos
Poluentes Atmosféricos/efeitos adversos , Desenvolvimento Fetal/efeitos dos fármacos , Recém-Nascido de Baixo Peso , Material Particulado/efeitos adversos , Dinâmica Populacional , Poluentes Atmosféricos/análise , Connecticut , Feminino , Idade Gestacional , Humanos , Recém-Nascido , Recém-Nascido Pequeno para a Idade Gestacional , Modelos Logísticos , Tamanho da Partícula , Material Particulado/administração & dosagem , Dinâmica Populacional/estatística & dados numéricos , Gravidez , Estudos Retrospectivos
16.
Epidemiology ; 27(1): 66-73, 2016 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-26247489

RESUMO

BACKGROUND: It remains unclear whether fine particulate (PM2.5) exposure affects risk of preterm birth and prelabor rupture of membranes. Unmeasured, poorly measured, and undiscovered individual-level confounders might have introduced bias into past studies that relied on between-women comparisons. METHODS: This was a longitudinal study of preterm birth and prelabor rupture of membranes in Rochester, NY, 2004-2012 (N = 3,264 women, N = 7,121 singleton births). We used conditional logistic regression to match pregnancies to the same woman and estimate the odds of each outcome associated with average PM2.5 concentrations during each trimester and whole pregnancy. RESULTS: For preterm birth, adjusted odds ratios (95% confidence interval) for 1 µg/m increase in PM2.5 in the first trimester, second trimester, third trimester, and whole pregnancy were 1.11 (1.04, 1.18), 1.09 (1.02, 1.16), 1.06 (1.00, 1.13), and 1.17 (1.07, 1.28), respectively. For prelabor rupture of membranes, corresponding odds ratios were 1.00 (0.97, 1.04), 0.99 (0.96, 1.02), 0.99 (0.96, 1.03), and 0.99 (0.94, 1.04), respectively. CONCLUSION: Risk of preterm birth was greater for pregnancies with elevated PM2.5 exposure than other pregnancies to the same women at lower exposure. We did not observe an association between PM2.5 concentrations and prelabor rupture of membranes.


Assuntos
Poluentes Atmosféricos/toxicidade , Poluição do Ar/efeitos adversos , Exposição Ambiental/efeitos adversos , Ruptura Prematura de Membranas Fetais/etiologia , Material Particulado/toxicidade , Nascimento Prematuro/etiologia , Adulto , Poluentes Atmosféricos/análise , Poluição do Ar/análise , Poluição do Ar/estatística & dados numéricos , Exposição Ambiental/análise , Exposição Ambiental/estatística & dados numéricos , Feminino , Humanos , Modelos Logísticos , Estudos Longitudinais , New York , Razão de Chances , Material Particulado/análise , Gravidez , Trimestres da Gravidez , Fatores de Risco
18.
J Natl Cancer Inst ; 107(12): djv275, 2015 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-26424778

RESUMO

BACKGROUND: Overweight and obesity are associated with breast cancer mortality. However, the relationship between postdiagnosis weight gain and mortality is unclear. We conducted a systematic review and meta-analysis of weight gain after breast cancer diagnosis and breast cancer-specific, all-cause mortality and recurrence outcomes. METHODS: Electronic databases identified articles up through December 2014, including: PubMed (1966-present), EMBASE (1974-present), CINAHL (1982-present), and Web of Science. Language and publication status were unrestricted. Cohort studies and clinical trials measuring weight change after diagnosis and all-cause/breast cancer-specific mortality or recurrence were considered. Participants were women age 18 years or older with stage I-IIIC breast cancer. Fixed effects analysis summarized the association between weight gain (≥5.0% body weight) and all-cause mortality; all tests were two-sided. RESULTS: Twelve studies (n = 23 832) were included. Weight gain (≥5.0%) compared with maintenance (<±5.0%) was associated with increased all-cause mortality (hazard ratio [HR] = 1.12, 95% confidence interval [CI] = 1.03 to 1.22, P = .01, I(2) = 55.0%). Higher risk of mortality was apparent for weight gain ≥10.0% (HR = 1.23, 95% CI = 1.09 to 1.39, P < .001); 5% to 10.0% weight gain was not associated with all-cause mortality (P = .40). The association was not statistically significant for those with a prediagnosis body mass index (BMI) of less than 25 kg/m(2) (HR = 1.14, 95% CI = 0.99 to 1.31, P = .07) or with a BMI of 25 kg/m(2) or higher (HR = 1.00, 95% CI = 0.86 to 1.16, P = .19). Weight gain of 10.0% or more was not associated with hazard of breast cancer-specific mortality (HR = 1.17, 95% CI = 1.00 to 1.38, P = .05). CONCLUSIONS: Weight gain after diagnosis of breast cancer is associated with higher all-cause mortality rates compared with maintaining body weight. Adverse effects are greater for weight gains of 10.0% or higher.


Assuntos
Índice de Massa Corporal , Neoplasias da Mama/diagnóstico , Neoplasias da Mama/mortalidade , Causas de Morte , Ganho de Peso , Adulto , Idoso , Neoplasias da Mama/patologia , Feminino , Humanos , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Obesidade/complicações , Obesidade/mortalidade , Razão de Chances , Sobrepeso/complicações , Sobrepeso/mortalidade , Prognóstico , Fatores de Risco
19.
Eur J Obstet Gynecol Reprod Biol ; 195: 94-9, 2015 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-26500184

RESUMO

OBJECTIVE: To assess whether folic acid intake during the first trimester of pregnancy is related to pregnancy outcomes preeclampsia, low birth weight or preterm birth. STUDY DESIGN: Prospective cohort study of 3647 women who were followed from the first trimester of pregnancy. Detailed information on quantity of folic acid intake before and during the first three months of pregnancy was recorded. Pregnancy outcome data were abstracted from obstetric records. RESULTS: Lean mothers who used folic acid supplementation the month before pregnancy had a 40% reduced risk of developing preeclampsia. The adjusted odds ratio (OR) with 95% confidence intervals (95%CI) for preeclampsia in lean mothers (BMI<25) who used folic acid supplements the month before pregnancy was 0.6 (95% CI 0.4-1.0). Obese mothers who used folic acid supplementation in the first trimester had an increased, but not statistically significant risk for preterm birth (adjusted OR 1.9 with 95% CI 0.9-4.0). There were no significant associations between folic acid supplementation and low birth weight. CONCLUSION: Our study supports a possible protective effect of folate intake in early pregnancy on preeclampsia in lean mothers. There was no support for any beneficial effect of folic acid use on preterm birth or low birth weight, and we found no evidence of any harmful effects of folate use for the outcomes included in our study.


Assuntos
Ácido Fólico/uso terapêutico , Obesidade/epidemiologia , Pré-Eclâmpsia/epidemiologia , Nascimento Prematuro/epidemiologia , Complexo Vitamínico B/uso terapêutico , Adulto , Estudos de Coortes , Feminino , Humanos , Recém-Nascido de Baixo Peso , Recém-Nascido , Recém-Nascido Pequeno para a Idade Gestacional , Razão de Chances , Gravidez , Complicações na Gravidez/epidemiologia , Primeiro Trimestre da Gravidez , Estudos Prospectivos , Fatores de Proteção , Fatores de Risco , Adulto Jovem
20.
Blood ; 126(3): 346-53, 2015 Jul 16.
Artigo em Inglês | MEDLINE | ID: mdl-26048910

RESUMO

Therapy for childhood acute lymphoblastic leukemia (ALL) is associated with 5-year survival rates of ∼90% even after largely eliminating cranial radiation. This meta-analysis assesses the long-term neurocognitive functioning after chemotherapy-only regimens among survivors of childhood ALL. We conducted a systematic review to identify studies that evaluated long-term neurocognitive functioning following treatment of ALL by searching MEDLINE/PubMed, Database of Abstracts of Reviews of Effects, and secondary sources. Studies were included if ALL survivors were in continuous first remission, did not receive any radiation, were at least ≥2 years off therapy or ≥5 years since diagnosis, and were compared with a healthy control group. Weighted mean differences with 95% confidence intervals (CIs) were calculated. Ten nonexperimental studies met all eligibility criteria and included 509 patients and 555 controls. Meta-analysis demonstrated statistically significant moderate impairment across multiple neurocognitive domains evaluated, with intelligence most affected. Significant differences in standard deviation (SD) scores were found for Full Scale intelligence quotient (IQ) (-0.52 SD; 95% CI, -0.68 to -0.37), Verbal IQ (-0.54 SD; 95% CI, -0.69 to -0.40), and Performance IQ (-0.41 SD; 95% CI, -0.56 to -0.27); these SD scores correspond to changes in IQ of 6 to 8 points. Working memory, information processing speed, and fine motor domains were moderately, but statistically significantly, impaired. Meta-analysis of ALL survivors treated without cranial radiation demonstrated significant impairment in IQ and other neurocognitive domains. Patients and their families should be informed about these potential negative effects to encourage surveillance and educational planning. Both preventive and intervention strategies are needed.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Neoplasias Encefálicas/induzido quimicamente , Transtornos Cognitivos/induzido quimicamente , Leucemia-Linfoma Linfoblástico de Células Precursoras/tratamento farmacológico , Criança , Humanos , Taxa de Sobrevida , Sobreviventes
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