bluuebunny/crossref_metadata_2025_split huggingface dataset:
Prenatal diagnosis of de novo deletions of 8p23.1 or 15q26.1 in two fetuses with diaphragmatic hernia and congenital heart defects
Authors: López Isabel , Bafalliu Juan A. , Bernabé M. Carmen , García Francisco , Costa Miguel , Guillén‐Navarro Encarna 
Published: May 2006

AbstractObjectiveTo show the importance of using high‐resolution chromosome analysis and FISH‐technique for finding subtle chromosomal lesions in prenatal diagnosis specially when there are abnormal ultrasound findings.MethodsEcographic examination of the fetus. GTG banded chromosome and FISH analysis using subtelomeric probes on amniocytes.ResultsWe report two prenatal cases with congenital diaphragmatic hernia (CDH) and congenital heart defects (CHDs) with different deletions confirmed by FISH: del(8)(p23.1p23.1) and del(15)(q26.1).ConclusionThese cases support the evidence that the regions 15q26.1 and 8p23.1 may play an important role in the development of the diaphragm. A deletion 8p23.1 or 15q26.1 should be considered whenever a CDH and/or a cardiac abnormality are detected on ultrasound. Copyright © 2006 John Wiley & Sons, Ltd.
National patterns of medication use during pregnancy
Authors: Lee Euni , Maneno Mary K. , Smith Leah , Weiss Sheila R. , Zuckerman Ilene H. , Wutoh Anthony K. , Xue Zhenyi 
Published: May 2006

AbstractPurposeTo describe patterns of medication use during pregnancy in ambulatory care settings according to the U.S. Food and Drug Administration (FDA) pregnancy risk classification.MethodsA cross‐sectional study of two national ambulatory care surveys, sampling all office visits made by pregnant women in 1999 and 2000, was conducted. Using the FDA pregnancy risk classification, patterns of medication use and predictive factors for FDA pregnancy risk D or X (D/X) medications were evaluated.ResultsIn 1999 and 2000, about half of all pregnant visits had one or more medications. Among the total visits, FDA Class A was the majority (private = 65.7%; hospital = 79.5%; p < 0.05) followed by Class C (private = 26.5%; hospital = 36.4%; p < 0.05). Class D/X medications accounted for 6.4% and 2.9% of visits in private and hospital, respectively (p < 0.05). Medications with unknown pregnancy categories were predominant in the private setting (12.0% and 3.9%; p < 0.05). Age, insurance type, region, physician specialty, and number of medications were associated with a category D/X prescription. Among hospital visits, those from the West region and with private insurance were more likely to receive category D/X prescriptions. Number of medications was strongly associated with high‐risk drugs in both settings.ConclusionsThis study shows considerable medication use among pregnant women. The prevalence of visits with FDA pregnancy category D/X drugs was moderate, but still indicates exposure to high‐risk medications. Copyright © 2006 John Wiley & Sons, Ltd.
Antibiotic use in ambulatory care in Europe (ESAC data 1997–2002): trends, regional differences and seasonal fluctuations
Authors: Elseviers Monique M. , Ferech Matus , Vander Stichele Robert H. , Goossens Herman ,   the ESAC project group
Published: May 2006

AbstractPurposeThe ESAC project (European Study on Antibiotic Consumption) aims to collect antibiotic‐use data through a European network of national surveillance systems. This paper reports on the retrospective data collection in ambulatory care for the period 1997–2002.MethodsValid data of antibiotic consumption of 24 European countries for 2002 and of 18 countries for the entire 6‐year period was classified according to the Anatomical Therapeutic Chemical Classification (ATC) and expressed in defined daily dose (DDD) per 1000 inhabitants per day (DID). Overall and subgroup comparison of antibiotic consumption over time as well as between geographical clusters was performed.ResultsTotal use of antibiotics in Europe remained at a median level of 20 DID in the period 1997–2002 with a wide variation between countries ranging from 9.8 DID in The Netherlands to 32.2 DID in France. A substantial increase in subclass consumption of co‐amoxiclav and fluoroquinolones was noted while the use of narrow‐spectrum penicillins, erythromycin, quinolones and sulfonamides decreased. Total consumption as well as seasonal fluctuations showed remarkable geographical clustering with low consumption and low variation between summer and winter in the North, high consumption patterns in the South and a mixed model in the East.ConclusionsWithin the ESAC project, valid time series of antibiotic‐use data are publicly available now, enabling to improve the study of determinants of use, the evaluation of governmental antibiotic consumption policies and the investigation of the associated emergence of antibiotic resistance. Copyright © 2006 John Wiley & Sons, Ltd.
Developments of the incidence of osteoporosis in The Netherlands: a PHARMO study
Authors: Goettsch Wim G. , de Jong Romy B. , Kramarz Piotr , Herings Ron M.C. 
Published: May 2006

AbstractPurposeTo assess recent and to predict future time trends in the incidence of osteoporosis using routine databases in The Netherlands in the period 1993–2015 and to compare estimations based on hip fractures versus a proxy based on pharmacy and hospitalisation data.MethodsThe incidence of hip fractures was estimated over the period 1986–2002 using information from the Dutch Medical Registry, covering more than 99% of all Dutch hospitalisations. Additionally, a proxy (hospitalisation for osteoporosis or osteoporotic fractures, treatment with glucocorticosteroids or treatment with anti‐osteoporosis drugs) was constructed in order to identify osteoporotic patients in the PHARMO database. Age and gender specific incidences of hip fractures and osteoporosis were calculated and extrapolated to The Netherlands. Results of both studies were extrapolated till 2015 using a power function.ResultsThe incidence of hip fractures decreased slightly (270 per 100 000 in 1993, 260 per 100 000 in 2002). The incidence of osteoporosis using the constructed proxy decreased from 870 per 100 000 in 1993 to 700 per 100 000 in 2002.The incidence of hip fractures and osteoporosis remained fairly constant when modelled till 2015. Both studies showed the same time trends.ConclusionBoth the estimations based on the hospitalisations for hip fracture and on our proxy for osteoporosis showed that the increase in the incidence of osteoporosis as observed in the 1990s is levelling off. Due to ageing of the population the absolute number of hip fractures will however increase. Our definition of osteoporosis resulted in a higher estimation of the incidence of osteoporosis and may be used in future studies to follow developments in osteoporosis prevalence and incidence. Copyright © 2006 John Wiley & Sons, Ltd.
Co‐dispensing of contraindicated medications in patients using cisapride in Italy
Authors: Staniscia Tommaso , Romano Ferdinando , Festi Davide , Bilker Warren B. , Macones George A. , Strom Brian L. 
Published: May 2006

AbstractPurposeTo investigate the co‐dispensing of contraindicated medications in patients using cisapride in an Italian population.MethodsThe study included patients who had at least one cisapride prescription dispensed between 1 April 1997 and 30 September 2000. The proportion of cisapride users with concomitant medications, the proportion of prescriptions of cisapride with an overlapping dispensing of a contraindicated medication and the proportion of person‐days of cisapride use concomitant with contraindicated medications, were calculated.ResultsIn the 4‐year study period, 249 740 total cisapride prescriptions, which corresponded to 382 835 packages, were dispensed to 91 204 users (52 442 female, 57.5%). Concomitant use of contraindicated drugs was identified in 4403 cisapride users (4.83%). Throughout the study period, there was an increase in the proportion of cisapride users with contraindicated co‐prescriptions: 4.29% in 1997, 4.99% in 1998, 5.15% in 1999, but a decline to 3.34% in 2000. In each year, this figure was higher in males, with the highest proportion reported in 1999 (5.50%). A total of 7215 cisapride prescriptions (2.85%) were concomitant with contraindicated drugs, ranging from 2.27% in September 1998 to 3.55% in January 1999. Cisapride prescriptions were most frequently associated with macrolide antibiotics (1.14%) and class III antiarrhythmics (1.03%).ConclusionsIn the period 1997–2000, a substantial proportion of cisapride prescriptions were concomitant with contraindicated medications. In Italy in 1998, the National Health Authority issued a bulletin warning about the risk of serious arrhythmias after concomitant use of contraindicated drugs. Despite this warning, there was no reduction in contraindicated drug uses. Copyright © 2006 John Wiley & Sons, Ltd.
Measuring change in prescription drug utilization in Australia
Authors: Mandryk John A. , Mackson Judith M. , Horn Fiona E. , Wutzke Sonia E. , Badcock Caro‐Anne , Hyndman Rob J. , Weekes Lynn M. 
Published: May 2006

AbstractPurposeThe National Prescribing Service Ltd (NPS) aims to improve prescribing and use of medicines consistent with evidence‐based best practice. This report compares two statistical methods used to determine whether multiple educational interventions influenced antibiotic prescription in Australia.MethodsMonthly data (July 1996 to June 2003) were obtained from a national claims database. The outcome measures were the median number of antibiotic prescriptions per 1000 consultations for each general practitioner (GP) each month, and the mean proportion (across GPs) of each subgroup of antibiotics (e.g. roxithromycin) out of nine antibiotics having primary use for upper respiratory tract infection. Two approaches were used to investigate shifts in prescribing: augmented regression, which included seasonality, autocorrelation and one intervention; and seasonally adjusted piecewise linear dynamic regression, which removed seasonality prior to modelling, included several interventions, GP participation and autocorrelated errors. Both methods are variations of piecewise linear regression modelling.ResultsBoth approaches described a similar decrease in rates, with a non‐significant change after the first intervention. The inclusion of more interventions and GP participation made no difference. Using roxithromycin as an example of the analyses of proportions, both approaches implied that after the first intervention the proportion decreased significantly. The statistical significance of this intervention disappears when other interventions are included.ConclusionsThe two analyses provide results which agree regarding the possible impact of the NPS interventions, but raise questions about what is the best way to model drug utilization, particularly regarding whether to include all intervention terms when they belong to an extended roll‐out of related interventions. Copyright © 2006 John Wiley & Sons, Ltd.
The nature of the scientific evidence leading to drug withdrawals for pharmacovigilance reasons in France
Authors: Olivier Pascale , Montastruc Jean‐Louis 
Published: May 2006

AbstractIntroductionBecause of design, objectives and number of included subjects, clinical studies are insufficient to assess the safety of new drugs. Sometimes, serious adverse drug reactions (ADRs) led to withdrawal of the drug from the market after their approval. The objective of our study was to determine the scientific evidences leading to drug withdrawal for pharmacovigilance reasons in France.MethodsData coming from French Health Products Safety Agency, literature and Toulouse Pharmacovigilance Center allowed to identify all drugs withdrawn from the French market for pharmacovigilance reasons from 1998 to 2004. We classified data according to their study design (Randomized Clinical Trial [RCT], case serie or case report, case‐control study, cohort study, observational study, animal study), the organ/system affected and the type of ADR.ResultsA total of 21 drugs were withdrawn for safety reasons between 1998 and 2004 in France. The most frequent ADRs were hepatic (n = 7), cardiovascular (n = 4) or neurological (n = 3) ones. Eleven withdrawals were due to type‐B (‘unexpected’) reactions (52%). For 19 out of 21 drugs, scientific evidence leading to drug withdrawal came from spontaneous case reports (or case series). Among these, case reports were the sole evidence in 12 cases. Withdrawals were based on evidence from case reports in combination with case‐control or cohort study in four cases, in combination with observational study in two cases or in combination with animal study in two other cases. In only one case, a RCT supported the decision.ConclusionsThis study underlines the importance of spontaneous case reports in detecting signals and supporting withdrawal of drug for pharmacovigilance reasons in France. Health authorities suffer from lack of comparative data resource. In this perspective, a pharmaco‐epidemiological population‐based database could represent a helpful tool to both generate and test safety hypotheses. Copyright © 2006 John Wiley & Sons, Ltd.
Quality of manufacturer provided information on safety and efficacy claims for dietary supplements for colonic health
Authors: Hass David J. , Lewis James D. 
Published: May 2006

AbstractPurposeFood and Drug Administration (FDA) approval of dietary supplements is not required. However, manufacturers must ensure that data exist to support safety and efficacy claims of their product. This study was designed to evaluate accessibility and quality of such data from manufacturers of dietary supplements for ‘colonic health.’MethodsSupplements promoting ‘colonic health’ were identified at area stores. A physician contacted the manufacturers by mail and telephone requesting data to substantiate claims of efficacy and safety. MEDLINE was searched to identify reports of adverse events or medication interactions.ResultsTwelve manufacturers of 23 products were surveyed. Eight manufacturers responded, of whom four provided no clinical data to substantiate claims of efficacy or safety. No manufacturer provided data that directly evaluated their product. Our literature review identified a wide range of potential adverse events and drug‐supplement interactions, albeit mostly as case reports, animal studies, or in vitro experiments.ConclusionsThere is a need to increase availability of supplement safety data to physicians and the general public. Consideration should be given to various responses, including legislative actions that address this issue. Copyright © 2006 John Wiley & Sons, Ltd.
How is leflunomide prescribed and used in Australia? Analysis of prescribing and adverse effect reporting
Authors: Chan Vivien , Tett Susan E. 
Published: May 2006

AbstractPurposeTo evaluate the use of leflunomide in the Australian community since introduction in 2000. Trends in adverse drug reaction (ADR) reporting were also studied.MethodsAnnual Australian prescription and dispensing statistics were analysed. Drug utilisation was estimated as defined daily doses (DDD)/1000 inhabitants/day. ADR data from the Therapeutic Goods Administration's Adverse Drug Reactions Advisory Committee (ADRAC) national monitoring system were compared with the World Health Organisation (WHO) Vigibase records.ResultsLeflunomide use in Australia (dispensing data) increased from 0.2 in 2000 to 0.4 DDD/1000 inhabitants/day in 2002. The same overall pattern was observed in the ‘authority to prescribe’ data. From 2000–2002, prescribing of the starter pack (3 × 100 mg loading dose plus 30 × 20 mg tablets) declined (down 74%); likewise for the 20 mg (30 tablets) pack. Gradual increases were noted for the 10 mg (30 tablets) pack (up 40%). Approximately 135 reports, detailing about 370 individual ADR, were generated annually. Gastro‐intestinal disorders predominated, accounting for 24% of reactions reported to ADRAC. Skin and appendages disorders constituted 14% of reported reactions. Deaths in leflunomide users were attributed to a combination of haematological and gastro‐intestinal complications, but it was not possible to ascertain other medication usage or contributing factors. Trends observed with the ADRAC reports were consistent with the WHO database.ConclusionsLeflunomide was the first registered DMARD in Australia in over a decade and its use has increased within the community. The ADR reports might have contributed to Australian rheumatologists gradually abandoning loading patients with high doses of leflunomide in favour of starting therapy at lower doses. Copyright © 2006 John Wiley & Sons, Ltd.
Systemic lupus erythematosus prevalence in the U.K.: methodological issues when using the General Practice Research Database to estimate frequency of chronic relapsing‐remitting disease
Authors: Nightingale A. L. , Farmer R. D. T. , de Vries C. S. 
Published: May 2006

AbstractPurposeThe purpose of this study was to calculate the prevalence of systemic lupus erythematosus (SLE) between 1992 and 1998 using the General Practice Research Database (GPRD)MethodsWe identified all individuals who had contributed at least 3 years of data to the GPRD and who had a diagnosis of SLE with supporting evidence of their diagnosis. We calculated the annual age‐ and sex‐specific prevalence of SLE. Additionally, we stratified the prevalence by years of data contributed to the GRPD.ResultsIn males the point estimate of the prevalence of SLE increased from 7.5/100 000 (CI95 6.3, 8.8) to 10.1/100 000 (CI95 7.8, 12.2) but this rise was not statistically significant. However, prevalence appeared to increase significantly amongst females from 42.6/100 000 (CI95 39.6, 45.6) in 1992 to 70.8/100 000 (CI95 65.1, 76.6) in 1998. This increase was mainly amongst women aged 50–79 and in those contributing more than 5 years of data and could not be explained by increasing incidence of SLE or decreasing mortality during the study period.ConclusionsWe found an increasing prevalence of SLE that could not be explained by increasing incidence or decreasing mortality. This is almost certainly an artefact caused by the increased likelihood of detecting or confirming cases of chronic relapsing‐remitting diseases with increasing time contributed to the GPRD. Copyright © 2006 John Wiley & Sons, Ltd.
Changes in use of disease‐modifying anti‐rheumatic drugs in Australia over the period 1992–2004
Authors: Chan Vivien , Tett Susan E. 
Published: May 2006

AbstractPurposeEvidence is growing that early use of disease‐modifying anti‐rheumatic drugs (DMARDs) and combinations of these drugs provide optimal care for people with rheumatoid arthirits. The aim of this study was to describe objectively the pattern of consumption of DMARDs in the Australian community (community‐based prescribing, specialist and general practitioner) 1992–2004, and to compare this with prescribing patterns reported in other countries.MethodDispensing statistics from the Pharmaceutical Benefit Scheme (PBS—Australia's universal prescription subsidy scheme) were analysed and temporal trends evaluated. Drug consumption was calculated as the number of dispensed defined daily doses (DDD)/1000 inhabitants/day (WHO ATC/DDD classification 2005).ResultsThe consumption of DMARDs in the Australian community increased steadily from 2.6 DDD/1000 inhabitants/day in 1992 to 5.5 DDD/1000 inhabitants/day. Over the period 1992–2004, methotrexate (MTX) was the most commonly used DMARD (from 0.6 to 3.0 DDD/1000 inhabitants/day). Consumption of gold (parenteral and oral) and penicillamine declined during this time. The inclusion of leflunomide on the PBS in 2000 contributed to the increase in DMARD usage.ConclusionUse of DMARDs within the Australian community has increased in recent years, coinciding with the change in guidelines for therapy for rheumatoid arthritis (RA) to earlier use of DMARDs and the more common use of combinations. This study used DDD methodology to quantify trends for DMARD consumption and these trends are broadly consistent with international prescribing patterns assessed using different methodologies. Copyright © 2006 John Wiley & Sons, Ltd.
Anxiolytics, hypnotics, and antidepressants dispensed to adolescents in a French region in 2002
Authors: Mancini Julien , Thirion Xavier , Masut Alain , Saillard Carine , Pradel Vincent , Romain Fanny , Pastor Marie‐Joseph Jean , Coudert Christine , Micallef Joëlle 
Published: May 2006

AbstractPurposeThis study proposes to complete declarative studies by describing the prescriptions of anxiolytics, hypnotics, and antidepressants dispensed to adolescents in a French region in 2002.MethodsThis cross‐sectional study analyzes all the hypnotic, anxiolytic, and antidepressant prescriptions (ATC codes beginning with N05B, N05C, and N06A, respectively) sent by adolescents (aged 13–17 years) to the French Health Insurance system of the study region for reimbursement during one year (2002). It was performed in a southern France area with 120 908 adolescents covered by this insurance scheme. Adverse drug reactions (ADRs) recorded in the Pharmacovigilance database were also studied.ResultsThree thousand two hundred and eighty‐six adolescents (2.7% of adolescent population) had at least one prescription of the studied drugs. This prevalence increased with age and female sex, leading to a maximum of 6.3% for the 17‐year‐old girls. Two thousand four hundred and thirty‐one of adolescents were dispensed anxiolytics, 935 antidepressants, and 548 hypnotics. The most dispensed drugs were zolpidem, zopiclone, and niaprazine for hypnotics; hydroxyzine, etifoxine, and bromazepam for anxiolytics; and paroxetine, sertraline, and fluoxetine for antidepressants. Zolpidem, hydroxyzine, and paroxetine accounted, respectively, for 82.9%, 57.1%, and 59.8% of the prescriptions. 75.5% of hypnotics users had only one prescription, 77.4% for anxiolytics, and 57.4% for antidepressants. Three ADRs were reported.ConclusionsThis study confirms the large use of psychotropics in French adolescents and the influence of age and sex. Also, the results underline treatment for most adolescents is short, which may be beneficial for hypnotics and anxiolytics but not for antidepressants. Copyright © 2006 John Wiley & Sons, Ltd.
Six‐minute walk test in children and adolescents with cystic fibrosis
Authors: Cunha Maristela Trevisan , Rozov Tatiana , de Oliveira Rosangela Caitano , Jardim José R. 
Published: May 2006

AbstractThe 6‐min walk test is a simple, rapid, and low‐cost method that determines tolerance to exercise. We examined the reproducibility of the 6‐min walk test in 16 children with cystic fibrosis (11 female, 5 male; age range, 11.0 ± 1.9 years). We related the distance walked and the work performed (distance walked × body weight) with nutritional (body mass index and respiratory muscle strength) and clinical (degree of bronchial obstruction and Shwachman score) status. Patients were asked to walk as far as possible upon verbal command on two occasions. There was no statistical difference between distances walked (582.3 ± 60 and 598.2 ± 56.8 m, P = 0.31), heart rate, respiratory rate, pulse oxygen saturation, arterial blood pressure, dyspnea, and percentage of maximal heart rate for age in the two tests. Distance walked correlated (Pearson) with maximal expiratory pressure (98.6 ± 28.1 cmH2O, r = 0.60, P < 0.01), maximal heart rate (157.9 ± 10.1 bpm, r = 0.59, P < 0.02), Borg dyspnea scale (1.7 ± 2.4, r = 0.55, P < 0.03), and double product (blood pressure × heart rate; r = 0.59, P < 0.02). The product of distance walked and body weight (work) correlated (Pearson) with height (r = 0.83, P = 0.000), maximal expiratory pressure (r = 0.64, P < 0.01), systolic blood pressure (r = 0.56, P < 0.02), and diastolic blood pressure (r = 0.55, P < 0.03). We conclude that the 6‐min walk test is reproducible and easy to perform in children and adolescents with cystic fibrosis. The distance walked was related to the clinical variables studied. Work in the 6‐min walk test may be an additional parameter in the determination of physical capacity. Pediatr Pulmonol. 2006; 41: 618–622. © 2006 Wiley‐Liss, Inc.