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1.
Int J Obes (Lond) ; 41(10): 1531-1538, 2017 10.
Artículo en Inglés | MEDLINE | ID: mdl-28634363

RESUMEN

BACKGROUND: Prader-Willi syndrome (PWS) is a rare congenital disease that affects growth, sexual development, cognitive function and behavior. Individuals exhibit food preoccupation and hyperphagia, which may lead to obesity with premature morbidity and mortality. The aim of this work was to evaluate the risk of venous thromboembolisms (VTEs), myocardial infarction, pulmonary hypertension, sleep apnea, depression, anxiety and all-cause mortality among persons with PWS as compared with an age- and sex-matched general-population cohort. METHODS: All persons diagnosed with PWS (n=155) were identified in the Danish Health Registries; an age- and sex-matched comparison group was selected from the general population of Denmark (n=15 500); diseases of interest were identified through the health registry and cause of death register. Follow-up began on date of birth or first medical record availability through to first occurrence of an outcome of interest; follow-up ceased at emigration from Denmark or end of study. Incidence rates (IRs) were calculated and Cox's proportional hazards models were used to understand the relative risk (RR) of disease. RESULTS: The IRs for VTE among patients with PWS was 144 (60-347) per 100 000 person-years. Risks for VTE events and all-cause mortality were 9.4 times (95% confidence interval (CI): 3.7-23.5) and 11.0 times (95% CI: 5.7-21.1) higher, respectively, for patients with PWS versus the general population. Increased risks were also found individually for deep venous thromboses (DVTs) (RR: 9.1; 95% CI: 3.2-25.2), pulmonary embolisms (RR: 11.0; 95% CI: 1.4-86.9), myocardial infarction (RR: 7.2; 95% CI: 1.7-30.2) and anxiety (RR: 2.8; 95% CI: 1.0-7.5). No cases of pulmonary hypertension, sleep apnea or depressive disorders were identified within this PWS cohort. CONCLUSIONS: Multiple cardiovascular and behavioral illnesses are more likely to occur among patients with PWS than within the general population. These increased risks may provide an impetus for enhanced disease prevention, screening, diagnosis and treatment.


Asunto(s)
Síndrome de Prader-Willi/epidemiología , Síndrome de Prader-Willi/fisiopatología , Adolescente , Adulto , Ansiedad/epidemiología , Ansiedad/etiología , Niño , Comorbilidad , Dinamarca/epidemiología , Depresión/epidemiología , Depresión/etiología , Femenino , Humanos , Hiperfagia/epidemiología , Hiperfagia/etiología , Hipertensión Pulmonar/epidemiología , Hipertensión Pulmonar/etiología , Lactante , Masculino , Persona de Mediana Edad , Infarto del Miocardio/epidemiología , Infarto del Miocardio/etiología , Obesidad/epidemiología , Obesidad/etiología , Obesidad/fisiopatología , Evaluación del Resultado de la Atención al Paciente , Síndrome de Prader-Willi/complicaciones , Prevalencia , Modelos de Riesgos Proporcionales , Apnea Obstructiva del Sueño/epidemiología , Apnea Obstructiva del Sueño/etiología , Tromboembolia Venosa/epidemiología , Tromboembolia Venosa/etiología , Adulto Joven
2.
Arch Intern Med ; 150(9): 1913-6, 1990 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-2393321

RESUMEN

Of 48,712 acquired immunodeficiency syndrome (AIDS) cases reported to the Centers for Disease Control from October 1987 through March 1989, 1239 (2.5%) were diagnosed with extrapulmonary tuberculosis. Extrapulmonary tuberculosis was diagnosed in 1013 (2.3%) of the US-born persons with AIDS, compared with 26 (8%) of the Mexican-born, 82 (13%) of the Haitian-born, and 4 (1%) of the Cuban-born. Patients with AIDS with and without extrapulmonary tuberculosis were similar in age, except that extrapulmonary tuberculosis was relatively rare in patients with AIDS under the age 10. Compared with white homosexual/bisexual men, black race (odds ratio, 2.7), intravenous drug use (odds ratio, 2.0), heterosexual AIDS transmission category (odds ratio, 1.9), and Hispanic ethnicity (odds ratio, 1.6) were independently associated with extrapulmonary tuberculosis. In 1988, extrapulmonary tuberculosis in persons known to be human immunodeficiency virus seropositive represented 21% of national extrapulmonary tuberculosis morbidity.


Asunto(s)
Síndrome de Inmunodeficiencia Adquirida/complicaciones , Tuberculosis/complicaciones , Síndrome de Inmunodeficiencia Adquirida/epidemiología , Síndrome de Inmunodeficiencia Adquirida/transmisión , Cuba/etnología , Femenino , Haití/etnología , Hispánicos o Latinos , Humanos , Masculino , México/etnología , Análisis Multivariante , Oportunidad Relativa , Factores de Riesgo , Tuberculosis/epidemiología , Estados Unidos/epidemiología
3.
AIDS ; 6(11): 1327-30, 1992 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-1335274

RESUMEN

OBJECTIVE: To determine the prevalence of Mycobacterium tuberculosis resistance to antituberculosis drugs, and to relate this resistance to HIV serologic status. DESIGN: Cross-sectional prevalence study. SETTING: The two major outpatient tuberculosis clinics in Abidjan, Côte d'Ivoire, West Africa. PATIENTS: Sixty individuals with newly diagnosed pulmonary tuberculosis and sputum smears positive for acid-fast bacilli. MAIN OUTCOME MEASURES: HIV serologic status and in vitro testing for susceptibility of M. tuberculosis isolates to antituberculosis drugs. RESULTS: M. tuberculosis was isolated from 82% (49 out of 60) of sputum specimens. Thirty-five per cent (17 out of 49) were obtained from HIV-seropositive and 65% (32 out of 49) from HIV-seronegative patients. There was no statistically significant difference in the proportion of resistant isolates from HIV-seropositive versus HIV-seronegative patients, although the relatively small sample size limited power. Of the total number of isolates, 17% were resistant to isoniazid; resistance was less to streptomycin (7%), rifampin (2%), pyrazinamide (0%), and ethambutol (0%). Eighteen and 21% of mycobacterial isolates from HIV-seropositive and HIV-seronegative individuals, respectively, were resistant to one or more of these drugs. CONCLUSIONS: Surveys of this type are useful in planning and evaluating tuberculosis preventive therapy in individuals with dual infection.


Asunto(s)
Infecciones Oportunistas Relacionadas con el SIDA/complicaciones , Infecciones Oportunistas Relacionadas con el SIDA/tratamiento farmacológico , Antituberculosos/uso terapéutico , Infecciones por VIH/complicaciones , Tuberculosis Pulmonar/complicaciones , Tuberculosis Pulmonar/tratamiento farmacológico , Infecciones Oportunistas Relacionadas con el SIDA/epidemiología , Côte d'Ivoire/epidemiología , Estudios Transversales , Farmacorresistencia Microbiana , VIH-1 , VIH-2 , Humanos , Mycobacterium tuberculosis/efectos de los fármacos , Tuberculosis Pulmonar/epidemiología
4.
Artículo en Inglés | MEDLINE | ID: mdl-1313865

RESUMEN

We conducted a study of 1,003 well and hospitalized children, birth to 5 years old, in Abidjan, Côte d'Ivoire, to determine the prevalence of HIV-1 and HIV-2 infection, evaluate risk factors for infection, and describe associated clinical characteristics. The overall seroprevalence was significantly higher for children in the hospital (10.8%) than for those attending the clinic (3.6%). HIV-1 was the predominant virus in both populations, comprising 87% (hospital) and 77% (clinic) of the seroreactive blood specimens. Ninety-two percent of seroreactive children of all ages had a mother who was HIV positive; 77% of seroreactive children greater than or equal to 15 months old had an HIV-infected mother. The remaining seropositive children had a history of receiving blood transfusions. Hospitalized children who were HIV-1 positive or dually seroreactive were more likely to have HIV-related clinical signs and symptoms than HIV-negative children. These findings suggest that HIV infection is an important cause of morbidity for children in Abidjan and that maternal infection is the primary risk factor for both HIV-1 and HIV-2 infection in children. Further evaluation and attention should be given to transmission, clinical characteristics, and the impact of HIV infection in children in West Africa, where both HIV-1 and HIV-2 are present.


Asunto(s)
Infecciones por VIH/epidemiología , VIH-1 , VIH-2 , Preescolar , Centros Comunitarios de Salud , Côte d'Ivoire/epidemiología , Femenino , Infecciones por VIH/complicaciones , Infecciones por VIH/transmisión , Seroprevalencia de VIH , Humanos , Lactante , Recién Nacido , Masculino , Factores de Riesgo , Organización Mundial de la Salud
5.
Artículo en Inglés | MEDLINE | ID: mdl-7549801

RESUMEN

Given the current explosion of knowledge of the genetics and molecular biology of cancer, the possibility of widespread testing for inherited predisposition to cancer has been raised. The main objective of this study was to assess the effect of inherited predisposition on cancer mortality among the National Academy of Sciences-National Research Council Twin Registry. The twins were white male United States veterans of World War II, who were born during the period 1917-1927. The follow-up period was from 1946 to 1990, and some cause of death was determined with the use of death certificates. We compared concordance for death from cancer among 5690 monozygotic twin pairs to that among 7248 dizygotic pairs. A possible effect of inherited predisposition to death from cancer was considered present if concordance for cancer mortality among monozygotic twin pairs was greater than it was among dizygotic twin pairs. Among monozygotic and dizygotic twins, a total of 1918 cancer deaths was observed. Concordance for death from cancer at all sites among monozygotic twins was higher than it was among dizygotic twins (overall rate ratio, 1.4; 95% confidence interval, 1.0-2.0). For each zygosity group, two or fewer pairs were observed to be concordant for death from cancer of a specific site, with the exception of lung cancer.(ABSTRACT TRUNCATED AT 250 WORDS)


Asunto(s)
Enfermedades en Gemelos/epidemiología , Neoplasias/mortalidad , Estudios de Cohortes , Interpretación Estadística de Datos , Enfermedades en Gemelos/genética , Predisposición Genética a la Enfermedad , Humanos , Masculino , Persona de Mediana Edad , Neoplasias/genética , Estudios Retrospectivos , Análisis de Supervivencia , Gemelos Dicigóticos , Gemelos Monocigóticos , Estados Unidos/epidemiología
6.
Pediatr Infect Dis J ; 20(2): 219-23, 2001 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-11224848

RESUMEN

We conducted a telephone survey of reports of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) to the Vaccine Adverse Event Reporting System. We identified six cases of SJS or TEN after vaccination without other obvious triggers, suggesting that SJS and TEN might very rarely be caused by vaccination. Confirmation of this hypothesis will likely require controlled studies.


Asunto(s)
Sistemas de Registro de Reacción Adversa a Medicamentos/estadística & datos numéricos , Síndrome de Stevens-Johnson/etiología , Vacunación/efectos adversos , Adulto , Preescolar , Femenino , Estudios de Seguimiento , Humanos , Lactante , Masculino , Teléfono
7.
Arch Pediatr Adolesc Med ; 151(3): 255-9, 1997 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-9080932

RESUMEN

OBJECTIVE: To describe the individual characteristics, clinical features, and morbidity associated with syncope following immunization. DESIGN: Large case series. SETTING: United States, 1990 through 1995. SUBJECTS: Reports to the national Vaccine Adverse Event Reporting System (VAERS), a passive surveillance system. An additional 3 reports of head injury (documented by medical records) were obtained through the National Vaccine Injury Compensation Program. MAIN OUTCOME MEASURES: Syncope, syncope and hospitalization, or syncope and head injury within 12 hours of vaccination. RESULTS: A total of 697 cases of syncope after vaccination was reported. Age younger than 20 years was reported for 77.4%; 57.5% were female. Hospitalization was reported in 9.6%. Of the 571 syncope events with known time, 511 occurred 1 hour or less after vaccination. Of these, 323 (63.2%) occurred 5 minutes or less, 454 (88.8%) occurred 15 minutes or less, and 500 (97.8%) occurred 30 minutes or less after vaccination. Tonic or clonic movements, which have been associated with the anoxia of vasovagal syncope, were reported in 30.4% of syncopal episodes occurring 15 minutes or less after and in 12.8% of those occurring 15 minutes or longer after vaccination (P < .001). Six patients suffered skull fracture, cerebral bleeding, or cerebral contusion after falls; 3 of these patients required neurosurgery. Falls occurred 15 minutes or less after vaccination, in or near the clinic or office. Ages ranged from 12 to 28 years; 5 of 6 were male. Follow-up revealed substantial residual impairment in 2 patients. CONCLUSIONS: Prevention of injury from syncope after vaccination and of syncope itself may be possible in many cases. Vaccinators should be aware that patients exhibiting presyncopal signs and symptoms around the time of immunization need to be evaluated carefully and may need to be assisted to sit or lie down after immunization until free of symptoms.


Asunto(s)
Síncope/etiología , Vacunación/efectos adversos , Accidentes por Caídas/estadística & datos numéricos , Adolescente , Adulto , Niño , Traumatismos Craneocerebrales/epidemiología , Traumatismos Craneocerebrales/etiología , Femenino , Hospitalización/estadística & datos numéricos , Humanos , Masculino , Factores Sexuales , Síncope/complicaciones , Síncope/epidemiología , Síncope Vasovagal/epidemiología , Síncope Vasovagal/etiología , Factores de Tiempo , Estados Unidos/epidemiología
8.
Melanoma Res ; 4(4): 235-41, 1994 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-7950359

RESUMEN

Incident cases of in situ and invasive cutaneous malignant melanoma diagnosed during 1975-90 were identified through the National Cancer Institute's Surveillance, Epidemiology, and End Results program. We studied the 32,868 white subjects diagnosed with melanoma, who were living in nine cancer registry areas covering approximately 10% of the population of the USA. The summer-to-winter ratio, defined as the ratio of the number of melanomas diagnosed during June to August (summer), to the number of melanomas diagnosed during December to February (winter), was determined according to gender, stage, histologic type and anatomic site. Summer-to-winter ratios were 1.47 (95% confidence interval (CI) 1.37-1.58) for in situ; 1.43 (95% CI 1.38-1.48) for local stage; 1.24 (95% CI 1.12-1.38) for regional stage; and 0.95 (95% CI 0.82-1.11) for distant stage melanoma. For the melanomas staged as local at diagnosis (86% of the invasive melanomas staged), a July peak was observed. For each of the major histological types of local stage melanoma, summer-to-winter ratios were significantly elevated in men (range 1.24-1.41) and women (range 1.44-1.90). For the major anatomic sites (including the head and neck, which are exposed throughout the year) of local stage melanoma, summer-to-winter ratios were elevated for men (range 1.28-1.45) and for women (range 1.31-1.75).(ABSTRACT TRUNCATED AT 250 WORDS)


Asunto(s)
Melanoma/epidemiología , Estaciones del Año , Neoplasias Cutáneas/epidemiología , Femenino , Humanos , Masculino , Melanoma/patología , Estadificación de Neoplasias , Factores de Riesgo , Programa de VERF , Neoplasias Cutáneas/patología , Estados Unidos/epidemiología
9.
Public Health Rep ; 109(2): 259-65, 1994.
Artículo en Inglés | MEDLINE | ID: mdl-8153278

RESUMEN

Knowing the reasons some physicians do not adhere to the disease prevention and treatment recommendations of expert committees can assist in the development of future recommendations more likely to be adopted by physicians. The authors describe the attitudes and practices of physicians relative to tuberculosis prevention in DeKalb County, GA. Tuberculosis is an important problem in the county, which includes part of the City of Atlanta, as well as suburban areas. Questionnaires for anonymous reply were mailed to 1,621 physicians in the county in 1991, and 848 (53 percent) were completed and returned. The final sample was 793 physicians, who were grouped into 5 specialty areas. Primary care physicians were the group most commonly involved in specific tuberculosis screening and prevention activities. Medical and pediatric specialists, surgeons, obstetricians-gynecologists, and other physicians were significantly less likely to be involved in such activities. Given that primary care physicians constitute a decreasing proportion of physicians in the United States, the findings suggest the importance of ensuring that future strategies for tuberculosis prevention take into account the increasingly specialized nature of the medical practice environment.


Asunto(s)
Conocimientos, Actitudes y Práctica en Salud , Isoniazida/uso terapéutico , Medicina/estadística & datos numéricos , Especialización , Tuberculosis Pulmonar/prevención & control , Medicina Familiar y Comunitaria/estadística & datos numéricos , Georgia , Humanos , Prueba de Tuberculina/estadística & datos numéricos , Tuberculosis Pulmonar/diagnóstico
10.
Med Hypotheses ; 48(4): 351-4, 1997 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-9160291

RESUMEN

Several clinical and epidemiological aspects of cutaneous melanoma seem anomalous because they contrast with other sunlight-associated skin cancers. For example, persons with the greatest risk of melanoma are not those with the greatest cumulative solar exposure, the anatomic areas that receive the most solar exposure are not preferentially affected, and the incidence of the disease is seasonal, with more cases reported in summer than winter. This article discusses the synthesis and biologic effects of vitamin D photoproducts and suggests that sun-related local skin effects, mediated by vitamin D photoproducts, on melanocytes previously damaged by excessive solar exposure may help explain the seemingly anomalous aspects of melanoma.


Asunto(s)
Melanoma/etiología , Modelos Biológicos , Neoplasias Cutáneas/etiología , Luz Solar/efectos adversos , Rayos Ultravioleta , Vitamina D/efectos de la radiación , Humanos , Melanocitos/patología , Melanocitos/efectos de la radiación , Melanoma/epidemiología , Melanoma/fisiopatología , Estaciones del Año , Neoplasias Cutáneas/epidemiología , Neoplasias Cutáneas/fisiopatología , Vitamina D/metabolismo
11.
Mil Med ; 160(7): 351-5, 1995 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-7659242

RESUMEN

Veterans now make up nearly two-thirds of U.S. males aged 65 and older, and thus medical research in the male geriatric population is largely concerned with veterans, whose mortality experience assumes greater importance as they age. Department of Veterans Affairs (VA) records provide an effective and efficient means of gathering information on mortality of veterans, but are useful only if they provide relatively complete ascertainment. We investigated the completeness of VA death reporting (via the Beneficiary Identification and Records Locator Subsystem [BIRLS]) in a large cohort of nearly 32,000 World War II veteran twins followed from 1946 through 1990, comparing VA and Social Security Administration (SSA) mortality ascertainment. The small number of additional deaths found using SSA records--roughly 3% of total deaths--provides evidence that VA death reporting was nearly complete. A further capture-recapture analysis, assuming independence of BIRLS and SSA mortality ascertainment, indicated that BIRLS ascertainment was 95.4% complete.


Asunto(s)
Mortalidad , Veteranos/estadística & datos numéricos , Anciano , Humanos , Masculino , Gemelos , Estados Unidos
12.
BMJ ; 302(6775): 496-9, 1991 Mar 02.
Artículo en Inglés | MEDLINE | ID: mdl-1849431

RESUMEN

OBJECTIVE: To examine the association between HIV-II infection and tuberculosis. DESIGN: Cross sectional study comparing the prevalence of HIV-I and HIV-II infections in patients with tuberculosis and in blood donors. SETTING: Abidjan, Ivory Coast, west Africa. PATIENTS: 2043 consecutive ambulant patients with tuberculosis (confirmed pulmonary, presumed pulmonary, or extrapulmonary) and 2127 volunteer blood donors. MAIN OUTCOME MEASURE: Prevalence of HIV-I and HIV-II infections as assessed by presence of serum antibodies. RESULTS: Overall rates of HIV infection were 40.2% in patients with tuberculosis (26.4% positive for HIV-I, 4.7% for HIV-II, and 9.0% for both); and 10.4% in blood donors (7.2% positive for HIV-I, 1.9% for HIV-II, and 1.3% for both). HIV-II infection was significantly more common in patients with all types of tuberculosis than in blood donors (97/2043, 4.7% v 40/2127, 1.9%; odds ratio 3.8%, 95% confidence interval 2.6 to 5.6). CONCLUSION: Both HIV-I and HIV-II infections are associated with tuberculosis in Abidjan. 35% of adult tuberculosis in Abidjan is attributable to HIV infection and 4% specifically to HIV-II.


Asunto(s)
Infecciones por VIH/complicaciones , VIH-1 , VIH-2 , Tuberculosis/complicaciones , Adulto , Donantes de Sangre , Côte d'Ivoire , Estudios Transversales , Femenino , Infecciones por VIH/epidemiología , Humanos , Masculino , Persona de Mediana Edad , Oportunidad Relativa , Prevalencia , Factores de Riesgo , Tuberculosis Pulmonar/complicaciones
15.
Vaccine ; 26(3): 427-9, 2008 Jan 17.
Artículo en Inglés | MEDLINE | ID: mdl-18093701

RESUMEN

Thimerosal as a preservative (in all but trace amounts) was removed from vaccines used in infants starting in the late 1990s, though the preservative-including inactivated influenza vaccine is still available for use in individuals >or=6 months of age. We compared the proportion of injection site reactions, rash, and infections reported to the Vaccine Adverse Event Reporting System (VAERS) after preservative-free (PFV), preservative-including (PIV), and preservative unknown (PUV) vaccines in reports from 7/1/2004 to 1/4/2006. There were 145, 175, and 216 reports after vaccination with PFV, PIV, and PUV, respectively. The most frequently reported coding terms (fever, rash, and urticaria) were seen in similar proportions in the PFV, PIV, and PUV groups. No difference was detected in the proportion of injection site reactions (ISR), rash, or infections in the PIV, PFV, and PUV reports. Keeping in mind the inherent limitations of VAERS, including underreporting and potential reporting biases, we conclude that there were no substantial differences in the proportion of rash, ISR, and infection reports in the PIV, PFV and PUV reports in infants.


Asunto(s)
Vacunas contra la Influenza/efectos adversos , Conservadores Farmacéuticos/efectos adversos , Timerosal/efectos adversos , Vacunas de Productos Inactivados/efectos adversos , Sistemas de Registro de Reacción Adversa a Medicamentos , Preescolar , Bases de Datos Factuales , Exantema/etiología , Fiebre/etiología , Humanos , Lactante , Recién Nacido , Vacunas contra la Influenza/administración & dosificación , Conservadores Farmacéuticos/administración & dosificación , Timerosal/administración & dosificación , Urticaria/etiología , Vacunación , Vacunas de Productos Inactivados/administración & dosificación
16.
Pharmacoepidemiol Drug Saf ; 16(6): 597-604, 2007 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-17154344

RESUMEN

INTRODUCTION: US smallpox vaccination (SMA) started most recently in December 2002. Military and civilian personnel report adverse events (AEs) to the Vaccine Adverse Event Reporting System (VAERS), a surveillance system that relies on spontaneous reports. Although reported rates of probable myo/pericarditis after SMA in the literature are similar between military personnel and civilian healthcare workers, some civilian AE reporting rates after SMA appeared higher than those in the military. OBJECTIVE: Determine if SMA-associated reporting rates are different in civilians than in the military, considering age, sex, seriousness, and expectedness of the AE, as well as self-reporting. METHODS: Numerators were SMA reports in VAERS from 12/12/02 to 3/1/04. Limitations of VAERS include underreporting and lack of diagnostic confirmation. Denominators were number of military and civilian vaccinees. RESULTS: Reporting rates stratified by age and sex of serious and non-serious AEs were significantly higher in civilian than military personnel ages <55 years (rate ratios 4-27). These rate ratios decreased with increasing age. CONCLUSIONS: Reporting rates in VAERS differed significantly and substantially in civilians compared to military personnel <55 years of age. Differences in stimulated passive surveillance systems, and AE reporting practices, including the 'threshold' for reporting most likely explain these findings. These results suggest that in the case of smallpox vaccine AEs, there may be systematic differences in reporting completeness between the civilian and military sectors, and that passive surveillance data should be interpreted with caution.


Asunto(s)
Personal Militar , Vacuna contra Viruela/efectos adversos , Adulto , Sistemas de Registro de Reacción Adversa a Medicamentos , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Vacunación
17.
Rheumatology (Oxford) ; 46(11): 1688-93, 2007 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-17938138

RESUMEN

OBJECTIVES: New onset heart failure (HF) has been associated with the use of TNF-alpha antagonists etanercept and infliximab based upon spontaneous adverse event reports. HF clinical trials of these agents were stopped early due to futility or worsening of existing HF. A potential association between etanercept and infliximab and new onset HF has been studied minimally at a population level. METHODS: Using administrative claims from a large U.S. health care organization, we identified rheumatoid arthritis (RA) and Crohn's disease (CD) patients receiving infliximab or etanercept (exposed), and comparator cohorts of RA and CD patients receiving non-biologic immunosuppressives (unexposed). We studied adults < 50 years to reduce potential confounding related to common age-related comorbidities. Based on abstracted medical records of suspected HF cases, a physician panel adjudicated cases as definite, possible or no HF. RESULTS: Among 4018 RA and CD patients with mean duration follow-up of 18 months, 9 of 33 suspected HF cases (identified using claims data) were adjudicated as definite (n = 5) or possible (n = 4) HF. The relative risk of HF among TNF-alpha antagonist-treated RA and CD patients was 4.3 and 1.2, respectively (P = NS for both). The absolute difference in cumulative incidence of HF among infliximab or etanercept-exposed compared to unexposed patients was 3.4 and 0.3 cases per 1000 persons for RA and CD (P = NS), respectively, yielding a number needed to harm of 294 for RA and 3333 for CD. CONCLUSION: We found only a small number of presumed HF cases (n = 9, or 0.2%) in a large population of relatively young RA and CD patients. Although there was an increased relative risk of incident, HF that was not statistically significant among those exposed to TNF-alpha antagonists compared to those unexposed, larger cohorts are needed to provide more precise risk estimates and permit adjustment for potential confounding.


Asunto(s)
Antirreumáticos/efectos adversos , Artritis Reumatoide/tratamiento farmacológico , Enfermedad de Crohn/tratamiento farmacológico , Insuficiencia Cardíaca/inducido químicamente , Factor de Necrosis Tumoral alfa/antagonistas & inhibidores , Adulto , Anticuerpos Monoclonales/efectos adversos , Anticuerpos Monoclonales/uso terapéutico , Antirreumáticos/uso terapéutico , Estudios de Cohortes , Etanercept , Femenino , Insuficiencia Cardíaca/epidemiología , Humanos , Inmunoglobulina G/efectos adversos , Inmunoglobulina G/uso terapéutico , Infliximab , Masculino , Persona de Mediana Edad , Receptores del Factor de Necrosis Tumoral/uso terapéutico , Estados Unidos/epidemiología
18.
Pediatrics ; 106(4): E52, 2000 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-11015547

RESUMEN

BACKGROUND: A hypotonic-hyporesponsive episode (HHE) is the sudden onset of hypotonia, hyporesponsiveness, and pallor or cyanosis that occurs within 48 hours after childhood immunizations. This syndrome has been primarily associated with pertussis-containing vaccines administered to children <2 years of age, and has been estimated to occur once every 1750 diphtheria-tetanus-pertussis (DTwP) vaccinations. Previous studies of HHE were limited by small numbers of cases and, sometimes, by limited details of the event. OBJECTIVES: To characterize a large number of HHE cases reported to the Vaccine Adverse Event Reporting System (VAERS), to assist clinicians in identifying HHE, and to assist researchers in investigating the risk factors, cause, and pathogenesis of this syndrome. METHODS: More than 40,000 VAERS reports received between 1996 and 1998 were screened for HHE by a computer algorithm and reviewed, and a telephone follow-up questionnaire was administered to the witness of HHE. RESULTS: There were 215 HHE cases, all nonfatal. The median age of onset of HHE was 4.0 months (range: 1.1-107 months). Over half of the reports (53%) concerned females. The median birth weight was 3. 36 kg (range: 1.27-4.96 kg); 4.7% had a birth weight <2500 g. The median interval between vaccination and HHE was 210 minutes (range: 1 minute-2 days). Among children with HHE who were <24 months of age, the episode occurred within 5 minutes in only 8.5%, compared with 66.7% of children with HHE >24 months of age. There were no relevant findings regarding family medical history or the mothers' gestational history. Nearly all of the children (98.6%) returned to their prevaccination state according to the telephone questionnaire; median time to return was 6 hours (range: 1 minute- 4 months). The 3 children reported as not returning to their prevaccination state all had VAERS reports submitted after they developed conditions (autism, complex partial epilepsy, and developmental delays with infantile spasms) that are not known to be causally associated with immunization. The vast majority of children (93%) with HHE received a pertussis-containing vaccine, either diphtheria-tetanus-acellular pertussis (DTaP, 28%), DTwP (11%), or diphtheria-tetanus-pertussis-Haemophilus influenzae type b (DTwP-HIB, 61%). During the HHE episode, 90.1% of the children had pallor and 49% had cyanosis. Because of the HHE event, 6.8% of children had had all vaccines withheld as of the date of the interview. Of the remainder, 66.5% of children have had 1 or more subsequent vaccinations or vaccine components withheld, and 26.7% have not had any subsequent vaccinations withheld. Only 1 child was reported to have had a repeat episode of HHE, occurring after hepatitis B vaccination. From 1996 to 1998, the number of HHE reports decreased from 99 to 38, when the predominant pertussis vaccine administered to infants changed from whole-cell to acellular. CONCLUSION: This study represents the largest published case series of children with HHE and supports the generally benign, self-limited, nonrecurrent nature of this syndrome. Although HHE has been less frequently reported to VAERS after increased use of DTaP, HHE does occur after the administration of DTaP and other nonpertussis-containing vaccines. Although most parents and pediatricians withheld the pertussis component of subsequent vaccinations, many did not, with no reported adverse events occurring in the children after the subsequent immunizations. Restricting the definition of HHE to a more narrow age range (eg, <2 years of age) is also proposed because most of the older children probably experienced vasovagal syncope rather than HHE within 5 minutes of immunization.


Asunto(s)
Hipotonía Muscular/inducido químicamente , Vacuna contra la Tos Ferina/efectos adversos , Vacunas Virales/efectos adversos , Sistemas de Registro de Reacción Adversa a Medicamentos , Niño , Preescolar , Cianosis/inducido químicamente , Femenino , Humanos , Lactante , Masculino , Encuestas y Cuestionarios , Estados Unidos , Vacunas Acelulares/efectos adversos , Vacunas Combinadas/efectos adversos
19.
J Pediatr ; 131(4): 529-35, 1997 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-9386653

RESUMEN

OBJECTIVE: To provide an overview of the data, function, and performance of the Vaccine Adverse Event Reporting System. DESIGN: Descriptive and correlational analyses. SETTING: United States, 1991 through 1994. SUBJECTS: Reports to the Vaccine Adverse Event Reporting System, a passive national surveillance system, that represents temporal (but not necessarily causal) relationships between vaccinations and adverse events. MAIN OUTCOME MEASURES: Demographic variables, birth weight, vaccine type, severity of adverse event after immunization. RESULTS: A total of 38,787 adverse events was reported during the study period without a clearly increasing or decreasing trend in the annual number of total reports or deaths. Of the deaths with known age, 72.4% were reported in the first year of life, and 63.7% of these were male. The peak age for death reports was 1 to 3 months, with a gradual decline through age 9 months, after which death was relatively rare. Adverse events with onset of symptoms the day of vaccination accounted for 45.5% of total reports; 20.4% had onset of symptoms the following day. Onset within 2 weeks after vaccination was noted for 92.5% of all reports. Simultaneous administration of multiple vaccines was noted in 75.7% of reports for immunizations at ages younger than 20 years. In contrast, among those 20 years or older, only 6.0% of reports named multiple vaccines. Wide geographic variations were noted in adverse event reporting rates for children younger than 2 years, and the states with the lowest reporting rates of less serious events included the most populous states. CONCLUSIONS: The peak age of deaths at ages 1 to 3 months could be expected on the basis of prior studies showing that sudden infant death syndrome deaths peak at that age, that most deaths in the Vaccine Adverse Event Reporting System are attributed to sudden infant death syndrome, and that sudden infant death syndrome has not been associated with vaccination. The large number of reports and national coverage of the Vaccine Adverse Events Reporting System make it useful for monitoring the safety of vaccine lots and for accumulating case series to detect or better understand adverse events that may occur too rarely to be assessed in clinical trials or in the larger studies that are sometimes carried out by manufacturers after vaccine licensure (phase IV studies).


Asunto(s)
Muerte Súbita del Lactante/epidemiología , Muerte Súbita del Lactante/etiología , Vacunación/efectos adversos , Adolescente , Adulto , Anciano , Peso al Nacer , Femenino , Humanos , Lactante , Recién Nacido , Masculino , Persona de Mediana Edad , Mortalidad
20.
JAMA ; 269(22): 2865-8, 1993 Jun 09.
Artículo en Inglés | MEDLINE | ID: mdl-8497090

RESUMEN

OBJECTIVE: To describe and analyze recent changes in tuberculosis mortality in the United States during the acquired immunodeficiency syndrome (AIDS) epidemic. DESIGN: We used National Center for Health Statistics multiple-cause mortality data and analyzed deaths with tuberculosis (1980 through 1990) and/or AIDS (1987 through 1990) as an underlying or associated cause. We also categorized the 50 states and the District of Columbia into high (five states), medium (23 states), and low (23 states) AIDS incidence groups and then compared the groups' rates of death with tuberculosis during the period 1980 through 1990. STUDY POPULATION: Residents of the United States who died in the period 1980 through 1990. MAIN OUTCOME MEASURES: Death certificates indicating AIDS and/or tuberculosis. RESULTS: A bimodal age distribution of persons dying with tuberculosis has emerged concurrent with the AIDS epidemic. A new peak spanning the ages 20 to 49 years accompanies the preexisting peak in the elderly. In 1990, 54.2% (729/1344) of the deaths with tuberculosis in persons 20 to 49 years of age occurred in persons who also had AIDS listed on their death certificates. During the period 1987 through 1990, there was an increasing trend in the proportion of AIDS deaths that also had tuberculosis: 2.3% (353/15,075) in 1987, 2.5% (460/18,649) in 1988, 3.0% (738/24,607) in 1989, and 3.0% (836/27,975) in 1990 (P < .001). Of AIDS deaths in 1990, 1.6% (253/15,565) of whites died with tuberculosis, compared with 4.7% (400/8533) of blacks (P < .001) and 4.7% (172/3666) of Hispanics (P < .001). In the high AIDS incidence states, the rate of death with tuberculosis in persons aged 20 to 49 years rose from 0.61 to 2.82 per 100,000 population in the period 1982 through 1990, an increase of 362%. For this age group in the states with medium and low AIDS incidence, the rates of death with tuberculosis during this period rose 52% and 47% (from 0.44 to 0.67 and from 0.19 to 0.28 per 100,000 population), respectively. The increases in the rate of death with tuberculosis within all three groups and the differences among the groups were all highly statistically significant (P < .001). CONCLUSION: The AIDS epidemic has significantly increased the number and rate of tuberculosis deaths in younger adults through 1990, although in this study discrimination of deaths due to tuberculosis from deaths with tuberculosis was not possible. Vigorous efforts to prevent and treat tuberculosis and AIDS are indicated to reverse the trends we have described.


Asunto(s)
Síndrome de Inmunodeficiencia Adquirida/mortalidad , Tuberculosis/mortalidad , Síndrome de Inmunodeficiencia Adquirida/complicaciones , Síndrome de Inmunodeficiencia Adquirida/etnología , Adolescente , Adulto , Factores de Edad , Anciano , Anciano de 80 o más Años , Niño , Preescolar , Humanos , Lactante , Persona de Mediana Edad , Mortalidad/tendencias , Tuberculosis/complicaciones , Tuberculosis/etnología , Estados Unidos/epidemiología
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