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1.
J Intern Med ; 271(2): 193-203, 2012 Feb.
Article in English | MEDLINE | ID: mdl-21973261

ABSTRACT

OBJECTIVE: An observational safety study of the quadrivalent human papillomavirus vaccine (HPV4) in women was conducted. This report presents findings from autoimmune surveillance. Design. Subjects were followed for 180days after each HPV4 dose for new diagnoses of 16 prespecified autoimmune conditions. SETTING: Two managed care organizations in California. Subjects. Number of 189,629 women who received ≥1 dose of HPV4 between 08/2006 and 03/2008. OUTCOME: Potential new-onset autoimmune condition cases amongst HPV4 recipients were identified by electronic medical records. Medical records of those with ≥12-month health plan membership prior to vaccination were reviewed by clinicians to confirm the diagnosis and determine the date of disease onset. The incidence of each autoimmune condition was estimated for unvaccinated women at one study site using multiple imputations and compared with that observed in vaccinated women. Incidence rate ratios (IRR) were calculated. Findings were reviewed by an independent Safety Review Committee (SRC). RESULTS: Overall, 1014 potential new-onset cases were electronically identified; 719 were eligible for case review; 31-40% were confirmed as new onset. Of these, no cluster of disease onset in relation to vaccination timing, dose sequence or age was found for any autoimmune condition. None of the estimated IRR was significantly elevated except Hashimoto's disease [IRR=1.29, 95% confidence interval: 1.08-1.56]. Further investigation of temporal relationship and biological plausibility revealed no consistent evidence for a safety signal for autoimmune thyroid conditions. The SRC and the investigators identified no autoimmune safety concerns in this study. CONCLUSIONS: No autoimmune safety signal was found in women vaccinated with HPV4.


Subject(s)
Autoimmune Diseases/etiology , Papillomavirus Vaccines/adverse effects , Adolescent , Adult , Adverse Drug Reaction Reporting Systems , Autoimmune Diseases/epidemiology , California/epidemiology , Child , Female , Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 , Humans , Incidence , Papillomavirus Infections/prevention & control , Uterine Cervical Neoplasms/prevention & control , Young Adult
2.
Toxicol Ind Health ; 24(10): 683-92, 2008 Nov.
Article in English | MEDLINE | ID: mdl-19141572

ABSTRACT

This report examines the prevalence rate of Hodgkin's disease in an American mid-west town located directly south of a non-operational oil refinery. The refinery has a history of benzene-containing gasoline leaks dating back to the early 1900s. Exposure data were assessed through the Toxic Release Inventory (TRI) data as published by the Environmental Protection Agency (EPA) and supplemented by exposure simulations using variations of residential exposure times and odour levels and the benzene content of the gasoline. Prevalence rates depended on the size of the population in question. The population size varied greatly between sources, with the more conservative and consistent estimates being reported by the local government and United States Census Bureau and the highest population figure being reported by the Agency for Toxic Substances Disease Registry. The prevalence of Hodgkin's disease for the residents within 1 mile from the refinery was found to be elevated for every population figure, ranging from 72.11 cases per 100,000 using the ATSDR's population to 182.34 per 100,000, whereas the prevalence for Hodgkin's disease in all the United States is only 22 cases of Hodgkin's disease per 100,000 people. The prevalence value reported in this report should be given greater weight than what would have been calculated using data from the ATSDR. Because of its significantly increased value compared with the rest of the United States, it provides evidence of benzene's role as a causative agent in the etiology of Hodgkin's disease.


Subject(s)
Benzene/toxicity , Hodgkin Disease/epidemiology , Inhalation Exposure , Carcinogens, Environmental/toxicity , Cluster Analysis , Data Interpretation, Statistical , Extraction and Processing Industry , Humans , Missouri/epidemiology , Monte Carlo Method , Petroleum , Prevalence
3.
J Toxicol Clin Toxicol ; 42(5): 579-91, 2004.
Article in English | MEDLINE | ID: mdl-15462149

ABSTRACT

There is increasing evidence of permanent sequalae from acute organophosphate poisoning. We report on accidental diazinon overexposure with acute organophosphate poisoning through cutaneous absorption and inhalation followed by persistent neurological effects. In addition, we observed skeletal and endocrine effects likely attributable to the diazinon poisoning. A family of seven was exposed to diazinon in June 1999 over a two-day period. The pesticide company mistakenly used diazinon to heavily spray the inside of the home instead of permethrin. The applicator applied the pesticide over the entire surface of the floor, carpeting, furniture, and clothing in closets to eradicate an infestation of fleas. Acute symptoms in the family members included headaches, nausea, skin irritation, runny nose, and vomiting. The family was first evaluated at 3 months and then 3 years after the acute poisoning. There were persisting neurological symptoms of memory loss, decreased concentration, irritability, and personality changes of varying degrees in all family members. Objective neurological findings of impaired balance, reaction time, color vision, slotted pegboards and trials making were present in the three older children who could be tested. Neuropsychological evaluation revealed evidence of organic brain dysfunction in all seven family members. Bone growth difficulties are present in four of five children. One child has delayed menarche.


Subject(s)
Diazinon/poisoning , Insecticides/poisoning , Neurotoxicity Syndromes/etiology , Adult , Air/analysis , Child , Child, Preschool , Diazinon/analysis , Diazinon/pharmacokinetics , Environmental Exposure/adverse effects , Environmental Exposure/analysis , Female , Headache/chemically induced , Humans , Infant , Inhalation Exposure/adverse effects , Inhalation Exposure/analysis , Insecticides/analysis , Insecticides/pharmacokinetics , Irritants , Male , Neuropsychological Tests , Neurotoxicity Syndromes/psychology , Pregnancy , Rhinitis/chemically induced , Skin Absorption , Vomiting/chemically induced
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