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1.
Ann Clin Psychiatry ; 34(3): 197-206, 2022 08.
Artigo em Inglês | MEDLINE | ID: mdl-35849771

RESUMO

BACKGROUND: Systematic data regarding long-term neurobehavioral effects of maternal antidepressant use during pregnancy are sparse. The aim of this study was to evaluate the impact of gestational exposure to antidepressants on later neurodevelopmental function. METHODS: This study describes a cohort of mother-child dyads (44 mothers, 54 children) in which maternal depressive symptoms and medication exposures were prospectively collected across pregnancy and the postpartum period. Children age 6 to 17 were assessed using validated instruments across domains of childhood behavior and executive memory and functioning. RESULTS: No associations were found between maternal use of selective serotonin reuptake inhibitors (SSRIs) during pregnancy and atypical neurodevelopment of children. Borderline clinical or clinical ranges of internalizing symptoms were associated with exposure to a higher maternal depressive symptom burden during pregnancy compared with those in the normal range. Compared with age- and sex-matched controls, the SSRI-exposed group showed superior performance on executive function tasks; findings did not demonstrate elevated risk for abnormal neurodevelopment in children age 6 to 17 exposed to SSRIs in utero. Deviations from the norm were instead associated with higher in utero exposure to maternal depression burden. CONCLUSIONS: This study highlights the need for rigorous studies of long-term outcomes after fetal antidepressant exposure.


Assuntos
Complicações na Gravidez , Efeitos Tardios da Exposição Pré-Natal , Adolescente , Antidepressivos/efeitos adversos , Criança , Feminino , Seguimentos , Humanos , Gravidez , Complicações na Gravidez/tratamento farmacológico , Efeitos Tardios da Exposição Pré-Natal/tratamento farmacológico , Inibidores Seletivos de Recaptação de Serotonina/uso terapêutico
2.
Arch Womens Ment Health ; 24(4): 659-667, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-33710399

RESUMO

Aripiprazole has become one of the most commonly prescribed psychotropics, making a more comprehensive understanding of its reproductive safety profile a priority. The goal of the current analysis was to determine the risk of major malformations in infants exposed during the first trimester of pregnancy to aripiprazole compared to infants whose mothers had psychiatric diagnoses but did not use an atypical antipsychotic during pregnancy. The National Pregnancy Registry for Atypical Antipsychotics is a prospective pharmacovigilance program in which pregnant women are enrolled and interviewed during pregnancy and the postpartum period. Medical records are assessed to confirm presence or absence of major malformations. Pregnant women ages 18-45 with psychiatric diagnoses are enrolled. As of April 2020, N = 848 women who had delivered infants were eligible for analyses. A total of 158 women with first trimester exposure to aripiprazole were compared to 690 controls. For 163 infants born to women in the exposed group, seven major malformations were confirmed (4.29%), compared to fourteen of the 690 unexposed infants (1.99%). The unadjusted odds ratio for major malformations between aripiprazole-exposed and unexposed infants was 2.21 (95% confidence interval [CI] = (0.88, 5.57) The adjusted odds ratio for major malformations was 1.35 (95% confidence interval [CI] = (0.43, 4.20). After adjustment for confounding variables, the risk of major malformations after first trimester exposure to aripiprazole was not significant compared to controls. While these results are reassuring, they are limited by relatively small numbers of participants. Future analyses with larger numbers are expected to provide more of a complete and precise reproductive safety profile regarding aripiprazole use during pregnancy. Trial registration: clinicaltrials.gov NCT01246765.


Assuntos
Antipsicóticos , Adolescente , Adulto , Antipsicóticos/efeitos adversos , Aripiprazol/efeitos adversos , Feminino , Hospitais Gerais , Humanos , Lactente , Massachusetts , Pessoa de Meia-Idade , Gravidez , Estudos Prospectivos , Sistema de Registros , Adulto Jovem
3.
J Pediatr ; 204: 162-171.e3, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30318371

RESUMO

OBJECTIVE: To assess whether treatment with biologic response modifying agents during clinical trial study periods increases the risk of serious infections in children with juvenile idiopathic arthritis (JIA). STUDY DESIGN: A systematic literature review using Medline, Embase, Cochrane library, and the clinical trial registry was performed up to July 2017. Random effects meta-analyses were used to compare rates of serious infections in children with JIA given biologic agents compared with controls, and the pooled relative risk calculated. Subanalyses were performed for different biologic agent classes. RESULTS: In total, 19 trials accounting for 21 individual studies were included (11 for tumor necrosis factor-alpha inhibitors [n = 814 patients], 3 for interleukin-6 inhibitors [n = 318], 6 for interleukin-1 inhibitors [n = 353], and 1 for selective T-lymphocyte costimulation modulators [n = 122]). Patients (68% female) had a mean age of 10.8 years. Seventeen serious infections were reported among 810 children receiving biologic agents and 15 among 797 controls. The most frequent infections were bronchopulmonary and varicella. No statistically significant difference in risk of serious infections was found between children receiving biologic agents compared with control groups (pooled relative risk = 1.13; 95% CI [0.63, 2.03]) during the trial study periods. The risk remained nonsignificant when evaluating the different classes of biologic agents separately. However, the analyses were underpowered to detect differences in the risk of serious infections overall or differences between classes of biologic agents. CONCLUSIONS: In this systematic review and meta-analyses, serious infections were uncommon and not significantly increased among patients with JIA receiving biologic agents compared with controls. However, the analyses were underpowered and study periods were relatively short. Ongoing careful monitoring for serious infections remains necessary for all patients with JIA, and particularly those receiving biologic agents.


Assuntos
Antirreumáticos/efeitos adversos , Artrite Juvenil/tratamento farmacológico , Produtos Biológicos/efeitos adversos , Infecções/induzido quimicamente , Adolescente , Antirreumáticos/uso terapêutico , Produtos Biológicos/uso terapêutico , Criança , Feminino , Humanos , Incidência , Infecções/epidemiologia , Masculino , Fatores de Risco
4.
Ann Clin Psychiatry ; 31(1): 4-16, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30699214

RESUMO

BACKGROUND: Women often seek antidepressant alternatives for major depressive disorder (MDD) in anticipation of or during pregnancy. In this preliminary study, EnBrace HR, a prenatal supplement containing methylfolate, was investigated for depressive relapse prevention and for acute treatment of MDD in women planning pregnancy or during pregnancy. METHODS: This 12-week open-label study included women with histories of MDD who were planning pregnancy or pregnant < 28 weeks. At enrollment, Group 1 participants were well (not depressed) and planned to discontinue antidepressants for pregnancy. Group 2 participants were depressed. Primary outcome variables by group included MDD relapse and depressive symptoms, verified with the Mini-International Neuropsychiatric Interview and the Montgomery-Åsberg Depression Rating Scale (MADRS), respectively. Biomarkers of inflammation and the folate cycle were collected. RESULTS: Group 1 participants (N = 11) experienced lower rates of depressive relapse (27.3% P = .005) than expected from a historical comparison group and no significant changes in MADRS scores. Group 2 participants (N = 6) experienced significant improvements in MADRS scores (P = .001), with 5 (83.3%) improving >50% and 1 improving 33.3%. One adverse event occurred, a hospitalization for depression. CONCLUSIONS: Results suggest EnBrace HR is a well-tolerated intervention with potential efficacy for prevention and treatment of perinatal depression. Larger controlled trials are necessary.


Assuntos
Transtorno Depressivo Maior/tratamento farmacológico , Transtorno Depressivo Maior/prevenção & controle , Suplementos Nutricionais , Cuidado Pré-Natal , Tetra-Hidrofolatos/administração & dosagem , Adulto , Feminino , Humanos , Gravidez , Escalas de Graduação Psiquiátrica , Prevenção Secundária/estatística & dados numéricos
5.
BMC Emerg Med ; 19(1): 27, 2019 04 17.
Artigo em Inglês | MEDLINE | ID: mdl-30995927

RESUMO

BACKGROUND: In low- and middle-income countries emergency surgery represents a higher proportion of the total number of surgeries and is associated with greater morbidity/mortality. Study aims were to determine if emergency department length of stay (ED-LOS) was associated with adverse perioperative outcomes and if such association varied across patient's risk categories. METHODS: A retrospective cohort study was conducted of adult patients who underwent orthopedic or abdominal emergency surgery at two Colombian University hospitals. The population comprised a mix of a representative sample of eligible cases, with unselected patients (2/3), enriched with a high-risk subset (1/3). ED-LOS was defined as the interval between emergency department arrival and surgery start time. Our primary outcome was an adverse perioperative outcome during hospitalization, which was a composite of in-hospital mortality or severe complications such as major cardiovascular adverse events, infection, renal failure and bleeding. RESULTS: Among 1487 patients analyzed, there were 519 adverse perioperative outcomes including 150 deaths. In the unselected sample (n = 998) 17.9% of patients presented an adverse perioperative outcome with a mortality of 4.9%. The median ED-LOS was 24.6 (IQR 12.5-53.2) hours. ED-LOS was associated with age, comorbidities and known risk factors for 30-day mortality. Patients developing an adverse perioperative outcome started surgery 27.1 h later than their counterparts. Prolonged ED-LOS increased the risk of an adverse perioperative outcome in patients without risk factors (covariate-adjusted OR = 2.52), while having 1-2 or 3+ risk factors was negatively associated (OR = 0.87 and 0.72, respectively, p < 0.001 for the interaction). CONCLUSION: Prolonged ED-LOS is associated with increased adverse perioperative outcome for patients without risk factors for mortality, but seems protective and medically justified for more complex cases.


Assuntos
Serviço Hospitalar de Emergência/estatística & dados numéricos , Mortalidade Hospitalar , Tempo de Internação/estatística & dados numéricos , Período Perioperatório/estatística & dados numéricos , Idoso , Colômbia/epidemiologia , Procedimentos Cirúrgicos do Sistema Digestório , Tratamento de Emergência , Feminino , Hospitais Universitários , Humanos , Masculino , Pessoa de Meia-Idade , Procedimentos Ortopédicos , Estudos Retrospectivos , Fatores de Risco
6.
Psychosomatics ; 59(2): 125-134, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29078988

RESUMO

BACKGROUND: Obesity during pregnancy is the most common high-risk obstetric condition, resulting in increased rates of adverse maternal and neonatal outcomes. Individuals with psychiatric disorders have a higher risk of obesity than the general population, but data regarding implications of obesity in women with psychiatric disorders are sparse. OBJECTIVE: The objective of this study was to assess pre-pregnancy weights and gestational weight gain in women who were exposed to second-generation antipsychotics (SGAs) during pregnancy compared to controls. METHODS: We assessed pre-pregnancy weights and gestational weight gain from the Massachusetts General Hospital National Pregnancy Registry for Atypical Antipsychotics for patients exposed to SGAs and controls unexposed to these medicines during pregnancy. Both groups experienced similar psychiatric morbidity. RESULTS: A total of 403 participants had evaluable data for these analyses (N = 279 exposed to SGAs; N = 124 controls). The mean pre-pregnancy weight, body mass index (BMI), and likelihood to begin pregnancy with an obese BMI were significantly higher in the exposed group compared to controls (p = 0.0003, p < 0.0001, and p < 0.0001 respectively), as were the mean weight and BMI at delivery (p < 0.0001). The mean weight gain did not differ significantly between groups. Across pre-pregnancy BMI categories, both groups gained more than the recommended amount of weight during pregnancy. CONCLUSION: We found that women exposed to SGAs began pregnancy with higher BMIs than controls. Both exposed and unexposed groups experienced similar weight gain during pregnancy. Strategies are needed to prevent excessive gestational weight gain and to reduce pre-pregnancy obesity in women with psychiatric disorders, especially those treated with SGAs.


Assuntos
Antipsicóticos/efeitos adversos , Ganho de Peso na Gestação/efeitos dos fármacos , Complicações na Gravidez/tratamento farmacológico , Adolescente , Adulto , Antipsicóticos/uso terapêutico , Índice de Massa Corporal , Estudos de Casos e Controles , Feminino , Humanos , Transtornos Mentais/complicações , Transtornos Mentais/tratamento farmacológico , Pessoa de Meia-Idade , Gravidez , Adulto Jovem
8.
BMJ Open Respir Res ; 11(1)2024 Apr 05.
Artigo em Inglês | MEDLINE | ID: mdl-38580440

RESUMO

PURPOSE: This study examines the financial impact of the COVID-19 pandemic on the Colombian Health System, focusing on the adequacy of reimbursement rates for inpatient stays. The study, based on a cost of illness analysis, aims to evaluate the effectiveness of the reimbursement scheme and identify potential economic losses within the health system. PATIENTS AND METHODS: The study protocol outlines the inclusion criteria for patients >18 years with confirmed COVID-19 infection and moderate to critical disease. Patients hospitalised between June 2020 and June 2021 for at least 24 hours were included. Exclusion criteria involved pregnant patients and those initially hospitalised for non-COVID-19. RESULTS: The study included 781 patients contributing to 790 hospitalisations. Demographic and clinical characteristics were analysed, with critical illness being the most prevalent category (61%). The overall mortality rate was 20.3%, primarily observed in critically ill patients. In the general ward for moderate cases, the reimbursement rate saw a substantial increase from US$3237 in 2020 to US$6760 in 2021, surpassing median resource utilisation. However, for severe cases in the intermediate care unit, reimbursement rates decreased, indicating potential insufficiency in covering costs. In the intensive care unit for critical cases, despite improved reimbursement rates, median resource utilisation still exceeds the 2021 rate, suggesting financial insufficiency in reimbursement rates. CONCLUSION: Our study underscores the inadequacies of the previous reimbursement system in addressing the varying resource utilisation and costs associated with COVID-19 inpatient care. Our analysis reveals substantial discrepancies between estimated costs and actual resource utilisation, particularly for severe and critical cases. We advocate for government flexibility in revising reimbursement baskets, supported by pilot studies to assess effectiveness. The use of real-world evidence forms a crucial basis for informed adjustments to reimbursement levels in preparation for future pandemics. This proactive approach ensures alignment between reimbursement policies and the actual costs associated.


Assuntos
COVID-19 , Humanos , Colômbia/epidemiologia , Pandemias , Hospitalização , Unidades de Terapia Intensiva
9.
J Clin Psychiatry ; 84(1)2023 01 04.
Artigo em Inglês | MEDLINE | ID: mdl-36602927

RESUMO

Objective: While poor neonatal adaptation syndrome (PNAS) has been particularly well described among infants exposed to antidepressants, specifically selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), this is not the case for second-generation antipsychotics (SGAs). In 2011, the US Food and Drug Administration (FDA) issued a drug safety warning regarding fetal antipsychotic exposure and risk for PNAS and extrapyramidal symptoms (EPS). The primary objective of this study was to examine the risk for PNAS among infants exposed to SGAs compared to SSRI/SNRI-exposed infants, leveraging the prospective, longitudinal design of the National Pregnancy Registry for Psychiatric Medications (NPRPM).Methods: The NPRPM is a prospective pharmacovigilance program in which pregnant women, aged 18-45 years, are enrolled and followed prospectively. Medical records were systematically reviewed and data abstracted using a checklist of PNAS and EPS symptoms specifically outlined in the FDA drug safety warning. The two study groups included infants exposed to an SGA during pregnancy and infants exposed to an SSRI/SNRI during pregnancy. The primary outcome was the presence of at least one or more PNAS symptoms during the first month of life. Other neonatal outcomes following exposure to the medication of interest, including preterm birth, neonatal intensive care unit (NICU) admission, rates of EPS, and whether infants were discharged home with their mothers, are also reported.Results: Of the 2,145 women enrolled in this study as of December 16, 2020, a total of 373 women and their infants (n = 384) were eligible for inclusion (n = 193 SGA-exposed infants and 191 SSRI/SNRI-exposed infants). Among SGA-exposed infants, 32.6% (63/193) experienced at least 1 PNAS sign compared to 34.6% of infants (66/191) in the SSRI/SNRI-exposed group. The majority of infants in each group showed no symptoms of PNAS. No differences were observed between the two groups with respect to rates of preterm birth, NICU admission, prevalence of EPS, and timing of infants being discharged home with their mothers.Conclusions: PNAS symptomatology was comparable among infants exposed prenatally to an SGA or to an SSRI/SNRI. These preliminary findings provide an estimated risk of PNAS among infants exposed to SGAs of roughly 30%. Interestingly, these findings are also consistent with estimates in the literature of PNAS in SSRI/SNRI-exposed infants, suggesting a possible common pathway underlying this phenomenon.Trial Registration: ClinicalTrials.gov identifier: NCT01246765.


Assuntos
Antidepressivos , Antipsicóticos , Nascimento Prematuro , Feminino , Humanos , Recém-Nascido , Gravidez , Antidepressivos/efeitos adversos , Antipsicóticos/efeitos adversos , Nascimento Prematuro/epidemiologia , Estudos Prospectivos , Sistema de Registros , Inibidores Seletivos de Recaptação de Serotonina/efeitos adversos , Inibidores da Recaptação de Serotonina e Norepinefrina/efeitos adversos
10.
J Clin Psychiatry ; 82(4)2021 08 03.
Artigo em Inglês | MEDLINE | ID: mdl-34352165

RESUMO

Objective: Second-generation antipsychotics (SGAs) are prescribed for a wide range of indications in women of reproductive age. The National Pregnancy Registry for Atypical Antipsychotics (NPRAA) was established to determine the risk of major malformations among infants exposed to these medications during the first trimester relative to a comparison group of unexposed infants of mothers with histories of psychiatric morbidity.Methods: Women, aged 18-45 years, with histories of psychiatric illness were prospectively followed through pregnancy and during the postpartum period. Pediatric and maternal medical records were obtained and screened for evidence of major malformations. Potential cases were adjudicated by a dysmorphologist who was blinded to drug exposure.. Recruitment to the Registry, which is based at the Ammon-Pinizzotto Center for Women's Mental Health at Massachusetts General Hospital (MGH), includes nationwide provider referral, self-referral, and advertisement through the MGH Center for Women's Mental Health website.Results: As of April 9, 2020, 1,906 women had enrolled, including 889 in the exposure group and 1,017 controls. A total of 1,311 women completed the study and were eligible for inclusion in the analysis. Medical records were obtained for 81.3% of participants. Among 640 live births in the exposure group, 16 (2.50%) had confirmed major malformations reported, and among 704 live births in the control group, 14 (1.99%) had confirmed major malformations reported. The estimated odds ratio for major malformations comparing exposed and unexposed infants was 1.48 (95% CI, 0.625-3.517).Conclusions: Data from the Registry assessing SGAs as a class indicate that they are unlikely to have a major teratogenic effect. These findings provide pertinent information for women and their health care providers regarding decisions about atypical antipsychotic use during pregnancy.Trial Registration: ClinicalTrails.gov identifier: NCT01246765.


Assuntos
Anormalidades Induzidas por Medicamentos/epidemiologia , Antipsicóticos/efeitos adversos , Adulto , Estudos de Casos e Controles , Feminino , Humanos , Lactente , Recém-Nascido , Massachusetts/epidemiologia , Transtornos Mentais/tratamento farmacológico , Transtornos Mentais/epidemiologia , Gravidez , Complicações na Gravidez/tratamento farmacológico , Complicações na Gravidez/epidemiologia , Estudos Prospectivos , Sistema de Registros , Método Simples-Cego
12.
J Psychosom Res ; 123: 109735, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-31376871

RESUMO

OBJECTIVE: Obesity is associated with an increased risk of adverse pregnancy outcomes. As individuals with psychiatric disorders are at a higher risk of obesity than the general population, we aimed to examine the effect of obesity on neonatal and maternal outcomes in this population. METHODS: Pregnant women with psychiatric disorders were enrolled in the Massachusetts General Hospital National Pregnancy Registry for Psychiatric Medications (NCT01246765) and followed prospectively until 6 months postpartum. Pre-pregnancy body mass index was used to categorize participants as normal-weight, overweight, and obese to assess comparative risk of adverse outcomes. RESULTS: Within our sample of 584 participants (N = 252 normal-weight; N = 170 overweight; N = 162 obese), obesity was not significantly associated with higher risk for birth defects (OR: 3.19; 95% CI:0.79,12.95; p = 0.10; unadjusted due to the rarity of this outcome in the sample). After adjustment, women with obesity were at higher risk for gestational diabetes (p = 0.011; OR:3.23; 95% CI:1.30,7.98), as were women in the overweight BMI category (p = 0.003; OR:3.77; 95% CI:1.58,9.00). Among women with obesity, there was a tendency for a higher C-section rate (p = 0.07) compared to women in the normal-weight BMI category. Other outcomes were not significantly different among groups. CONCLUSIONS: Peripartum complications associated with obesity are common among women with psychiatric illness; thus, it is important to develop antenatal weight management interventions for this population.


Assuntos
Obesidade/complicações , Complicações na Gravidez/etiologia , Resultado da Gravidez/epidemiologia , Transtornos Psicóticos/etiologia , Adolescente , Adulto , Feminino , Humanos , Pessoa de Meia-Idade , Gravidez , Complicações na Gravidez/psicologia , Estudos Prospectivos , Transtornos Psicóticos/psicologia , Sistema de Registros , Adulto Jovem
13.
J Clin Neurosci ; 70: 183-188, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31416730

RESUMO

OBJECTIVE: To describe patient characteristics, radiological findings and the clinical course of adults with fatal reversible cerebral vasoconstriction syndrome (RCVS). METHODS: A systematic literature search from January 1, 2000, until December 31, 2018, was performed using PubMed, EMBASE, Scopus, Cochrane reviews, LILACS and Scielo. Studies reporting RCVS in adult patients with fatal outcomes were included. RESULTS: 430 studies were initially identified, 179 full-text articles were reviewed, and 9 publications describing 12 subjects were included. The vast majority of the reports were from the U.S. Most of the female cases occurred during postpartum. All patients had a headache on initial presentation, although only 42% had thunderclap headache. A CT scan was performed on 67% of the patients. Imaging results were diverse, with a tendency toward cerebral hemorrhage followed by mixed cases. The main course of treatment included steroids (58% of the patients), with only 42% receiving nimodipine. The time to death ranged from 4 to 14 days, with a median of 9.2 days (SD ±â€¯3.2). CONCLUSION: We found that the majority of fatal cases reported in the literature are most likely related to postpartum angiopathy. We established a tendency in the onset of brain hemorrhage and the combination of infarction and brain hemorrhage. We described various markers for poor prognosis, including focal signs, the presence of hemorrhage and infarct in the first diagnostic image obtained and the need for invasive interventions. The majority of fatal cases in our report occurred in women, with over half of those cases during the puerperium period.


Assuntos
Vasoespasmo Intracraniano , Adulto , Feminino , Humanos , Masculino , Vasoespasmo Intracraniano/etiologia , Vasoespasmo Intracraniano/patologia , Vasoespasmo Intracraniano/fisiopatologia
14.
Am J Psychiatry ; 175(12): 1225-1231, 2018 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-30111186

RESUMO

OBJECTIVE: Second-generation antipsychotics are commonly prescribed to reproductive-age women for the treatment of a spectrum of psychiatric disorders. Quetiapine is the most commonly prescribed medication in this class, and therefore a better understanding of its reproductive safety profile is critical. The goal of this study was to determine the risk of major malformations among infants exposed to quetiapine during pregnancy compared with a group of infants whose mothers had a history of psychiatric morbidity but who did not use a second-generation antipsychotic during pregnancy. METHOD: The National Pregnancy Registry for Atypical Antipsychotics interviews pregnant women ages 18-45 during pregnancy and the postpartum period. Obstetric, labor, and delivery medical records and pediatric medical records from the first 6 months of life were screened for evidence of major malformations, followed by adjudication by a blinded dysmorphologist. Women with first-trimester exposure to quetiapine were compared with control subjects without exposure to second-generation antipsychotics. RESULTS: As of March 2017, 888 women had enrolled prospectively and 357 were eligible for analysis. Of these, 152 women with first-trimester exposure to quetiapine were compared with 205 control subjects without any second-generation antipsychotic exposure. For the 155 infants born to women in the exposed group (including three sets of twins), two major malformations were confirmed (1.3%), compared with three major malformations among the 210 infants born in the unexposed group (including five sets of twins) (1.4%). The unadjusted odds ratio for major malformations between infants with and without quetiapine exposure was 0.90 (95% CI=0.15, 5.46), which is consistent with the pooled estimate of the available controlled data on fetal exposure to quetiapine. CONCLUSIONS: These data regarding the safety of fetal exposure to quetiapine in a small sample of well-characterized participants are reassuring given that the confidence interval does not exceed a fivefold increased risk of major malformations relative to psychiatric control subjects. Future analyses based on ongoing data collection will produce more precise estimates.


Assuntos
Anormalidades Induzidas por Medicamentos/etiologia , Antipsicóticos/toxicidade , Fumarato de Quetiapina/toxicidade , Adolescente , Adulto , Estudos de Casos e Controles , Feminino , Humanos , Pessoa de Meia-Idade , Gravidez , Primeiro Trimestre da Gravidez , Sistema de Registros , Fatores de Risco , Adulto Jovem
15.
Gen Hosp Psychiatry ; 53: 73-79, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29958100

RESUMO

OBJECTIVE: The goal of this analysis was to examine the effect of benzodiazepine use during pregnancy on maternal and neonatal outcomes in a cohort of women with psychiatric disorders. METHODS: 794 evaluable women from the Massachusetts General Hospital National Pregnancy Registry for Psychiatric Medications were followed across pregnancy (N = 144 exposed to benzodiazepines and N = 650 unexposed). Data obtained through maternal report and medical records included maternal outcomes (cesarean section, preeclampsia) and neonatal outcomes (birth weight, breathing difficulty, feeding difficulty, head circumference, 5-minute Apgar score, muscular and/or extrapyramidal symptoms, NICU admission, prematurity). RESULTS: In adjusted analyses, infants exposed to benzodiazepines in utero were more likely to be admitted to the NICU (OR: 2.02, 95% CI: 1.11, 3.66) and to have small head circumferences (OR: 3.89, 95% CI: 1.25, 12.03) compared to unexposed infants. Other neonatal adverse effects such as respiratory distress or muscular symptoms including hypotonia were not observed. There were no significant differences in adverse obstetrical outcomes. CONCLUSIONS: Infants exposed to benzodiazepines during pregnancy had an increased risk of NICU admissions and small head circumferences. Confounding from psychiatric symptoms and other variables cannot be ruled out as contributors to these findings.


Assuntos
Benzodiazepinas/efeitos adversos , Cesárea , Doenças do Recém-Nascido/induzido quimicamente , Transtornos Mentais/tratamento farmacológico , Pré-Eclâmpsia/etiologia , Complicações na Gravidez/tratamento farmacológico , Sistema de Registros/estatística & dados numéricos , Adulto , Cesárea/estatística & dados numéricos , Feminino , Humanos , Recém-Nascido , Transtornos Mentais/epidemiologia , Pré-Eclâmpsia/epidemiologia , Gravidez , Complicações na Gravidez/epidemiologia
16.
Med. UIS ; 30(3): 21-30, sep.-dic. 2017. tab, graf
Artigo em Inglês | LILACS | ID: biblio-894214

RESUMO

Abstract Background: We depict the experience with the use of thrombolysis for acute ischemic stroke in a tertiary center in South America. Objective: To describe the main outcomes in our population of patients aged less and older than 80 years treated with recombinant tissue plasminogen activator. Materials and Methods: Retrospective observational study. We described the main variables and the difference in outcome accounting for age. Results: 70 patients were included. 51.4% of the patients were women, 22.8% were older than 80 years. The average window time was 70 minutes and the average door-to-needle time was 90 minutes. Hypertension, dyslipidemia and previous stroke were the most common risk factors. Favorable outcome Modified Rankin Scale ≤2 was present in 25% of the patients older than 80 years and 53.7% in the population younger than 80 years (p=0.009). Mortality was present in 31.2% of the patients older than 80 years and in 5.5% of the patients younger than 80 years (p=0.005). Symptomatic intra-cerebral hemorrhage was found in 6.25% of the patients older than 80 years (p=0.65), compared to 3.7% in the younger than 80 years. Conclusions: We found that intravenous thrombolysis still had benefit in people older than 80 years. Significant differences in symptomatic intra-cerebral hemorrhage were not found, however, a greater mortality in patients older than 80 years was. These findings of our experience of recombinant tissue plasminogen activator use in real life are consistent with other latinamerican publications. MÉD.UIS. 2017;30(3):21-30.


Resumen Introducción: Describimos la experiencia con el uso de trombólisis para el infarto cerebral isquémico agudo en un centro terciario en América del Sur. Objetivos: Describir los principales resultados en nuestra población de pacientes menores y mayores de 80 años tratados con activador recombinante de plasminógeno tisular. Materiales y Métodos: Estudio observacional retrospectivo. Se describieron las principales variables y se determinaron los resultados según la edad. Resultados: Se incluyeron 70 pacientes. Se encontró que 51,4% eran mujeres y 22,8% eran mayores de 80 años. El tiempo de ventana promedio estuvo en 70 minutos, así como el de puerta-aguja de 90 minutos. La hipertensión, dislipidemia y accidente cerebrovascular previo fueron los factores de riesgo más comunes. En el 25% de los pacientes mayores de 80 años y el 53,7% de los menores de 80 años, tuvieron un resultado favorable en la Escala Modificada de Rankin ≤ 2 (p = 0,009). La mortalidad estuvo presente en el 31,2% de los pacientes mayores de 80 años y en el 5,5% de los pacientes menores de 80 años (p = 0,005). La hemorragia intracerebral sintomática fue de 6,25% en los pacientes mayores de 80 años, frente a los menores de 80 años 3,7% (p = 0,65). Conclusiones: Se encontró que la trombólisis todavía presenta beneficio en personas mayores de 80 años. No se encontraron diferencias en cuanto a la hemorragia intra-cerebral sintomática, pero se presentó una mayor mortalidad en los mayores de 80 años. En esta experiencia el uso de rt-PA en la vida real es consistente con otras publicaciones latinoamericanas. MÉD.UIS. 2017;30(3):21-30.


Assuntos
Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Terapia Trombolítica , Acidente Vascular Cerebral , Idoso , Idoso Fragilizado , Ativador de Plasminogênio Tecidual , Dislipidemias , Fibrinolíticos , Hipertensão
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