摘要:

AbstractIn an earlier issue of Pharmacoepidemiology and Drug Safety, I described an IMBRF/ISPE meeting on proposed European and British regulations on confidential medical data. ISPE members commonly deal in confidential medical data when they evaluate adverse drug reactions, when they make and respond to regulatory requests for population data on drug safety, and when they compare the health and economic consequences of treatment strategies! Here I would like to open a discussion of the first of the research areas that were raised by that meeting. This is the question of when data must be regarded as ‘personally identified

ISSN:1053-8569    

DOI:10.1002/pds.2630040502

出版商:John Wiley&Sons, Ltd.    

年代:1995

数据来源: WILEY

摘要:

AbstractIn 418 patients (median 67 years) with acute myocardial infarction (AMI) we examined if ongoing β‐blocker treatment at the onset of AMI (n= 63) had beneficial effects on infarct size as judged from peak creatine kinase (CKmax) activity. The study had an observational exposed/non‐exposed design where we investigated the possible association between β‐blocker treatment and CKmax. Both crude and adjusted effects were looked for, in the latter adjusting for the effect of confounders such as thrombolytic treatment and age during AMI.Crude effects: β‐blocker treatment significantly (p= 0.003) reduced CKmax, from 1171 U/1 to 790 U/1 (median values). In the 25% of patients with the largest infarcts, β‐blockers reduced the incidence of large infarcts by 61% (odds ratio = 0.39) (p= 0.015). Previous coronary heart disease reduced CKmax(p= 0.0001), whereas thrombolytic treatment significantly increase CKmax(p= 0.0001), probably due to reperfusion.Adjusted effects: β‐blocker treatment significantly reduced CKmax(p= 0.03), and reduced the incidence of large infarcts by 54% (odds ratio = 0.46).Thus, when adjusting for confounders, β‐blocker treatment at the onset of AMI reduced infarct size as well as the incidence of large infarcts. These observational results suggest real

ISSN:1053-8569    

DOI:10.1002/pds.2630040503

出版商:John Wiley&Sons, Ltd.    

年代:1995

数据来源: WILEY

摘要:

AbstractCancer occurrence was determined through 1988 among a cohort of 143,574 Kaiser Permanente Medical Care Program members whose prescription records were computer‐stored between 1969–1973. Age‐ and gender‐adjusted standardized morbidity ratios (SMRs) were determined by dividing the number of cancers observed among one category of drug users by the number expected based on the cancer experience of the cohort as a whole. This hypothesis‐generating screening programme examined 215 drugs and 56 cancer sites. Although a large number of drug‐cancer associations were nominally statistically significant, many of these have been previously reported and the primary focus of this report is on new findings. Among the new findings considered intriguing were associations of indomethacin with stomach cancer (SMR = 1.51,p<0.05), prednisone with myeloid leukemia (SMR = 2.27,p<0.05) and lymphosarcoma (SMR = 2.22,p<0.002), sulfamethoxazole with lymphosarcoma (SMR = 2.90,p<0.01), thiazides (SMR = 1.80,p<0.05) and isoniazid (SMR = 8.46,p<0.05) with gallbladder cancer.Given the long follow‐up of this cohort, drug‐cancer relationships that are manifested only after latencies approaching two decades would have sufficient time to become apparent. However, since these data are based on pharmaceuticals dispensed over a short time period and because limited data on potential confounders were available, more definite investigations should follow

ISSN:1053-8569    

DOI:10.1002/pds.2630040504

出版商:John Wiley&Sons, Ltd.    

年代:1995

数据来源: WILEY

ISSN:1053-8569    

DOI:10.1002/pds.2630040505

出版商:John Wiley&Sons, Ltd.    

年代:1995

数据来源: WILEY

ISSN:1053-8569    

DOI:10.1002/pds.2630040506

出版商:John Wiley&Sons, Ltd.    

年代:1995

数据来源: WILEY

摘要:

AbstractA survey conducted by the Special Interest Group on Adverse Reactions (SIGAR) identified an interest in developing a formal educational programme on pharmacovigilance. The majority of potential delegates had between 1 and 5 years of experience in pharmacovigilance and held higher qualifications. They were prepared to provide up to 6 hours of self‐study per week but only a minority would sponsor themselves.Managers envisaged providing at least one candidate for up to three modules per annum. Preferred modules included regulatory requirements and guidelines, spontaneous reporting, methodologies and company systems. As a result of this favourable response an academic partner has been appointed in the United Kingdom and the course will commence in 199

ISSN:1053-8569    

DOI:10.1002/pds.2630040507

出版商:John Wiley&Sons, Ltd.    

年代:1995

数据来源: WILEY

ISSN:1053-8569    

DOI:10.1002/pds.2630040508

出版商:John Wiley&Sons, Ltd.    

年代:1995

数据来源: WILEY

ISSN:1053-8569    

DOI:10.1002/pds.2630040501

出版商:John Wiley&Sons, Ltd.    

年代:1995

数据来源: WILEY