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T Hanslik

Publications and source records attributed to T Hanslik.

At least 37 records · Page 2Linked to original sources

Postdischarge adverse drug reactions in primary care originating from hospital care in France: a nationwide prospective study.

OBJECTIVE: To describe and estimate the incidence and preventability of postdischarge adverse drug reactions (ADRs) detected in primary care in France. DESIGN: Prospective study of patients referred to hospital by participating general practitioners (GPs). These GPs reported all cases of an adverse reaction to a drug instituted in hospital among patients who consulted them within 30 days of discharge. SETTING: 305 general practices from all French regions. PATIENTS: 7540 patients referred by GPs to private or public hospitals. MAIN OUTCOME MEASURES: The incidence for postdischarge ADRs in primary care, and their preventability. RESULTS: 30 cases of postdischarge ADR were detected in 29 re-consulting patients, yielding a minimal incidence for France of 0.4 per 100 admissions (95% confidence interval 0.3 to 0.6). The ADRs were assessed as serious in 60% of cases. The main drug classes implicated were cardiovascular drugs (8 ADRs), oral anticoagulants (6), psychoactive drugs (4), antidiabetics (3), and opioid analgesics (3). Patients experiencing a postdischarge ADR were older than patients not experiencing one (median age: 77 vs 68 years; p = 0.004). Detected ADRs were considered preventable in 59% of cases. CONCLUSIONS: Physicians and patients should be aware of the possible occurrence of postdischarge ADRs. Patient information in hospital, close postdischarge follow-up of patients at risk, and appropriate transmission of information between hospital physicians and GPs can help to prevent them.

Adolescent↗

Sentinel monitoring of general community health during the 1998 World Football Cup.

BACKGROUND: Present knowledge of the consequences of mass gatherings for the health of the community is scant. Our objective was to determine the impact of the 1998 World Football Cup on general community health. METHODS: We set up an electronic sentinel disease surveillance, before, during and after the World Football Cup tournament held in France from June 10 to July 12, 1998. Medical activity, and the daily number of cases of communicable, environmental, and societal diseases relating to mass gatherings were surveyed. The incidence of the pathologies surveyed in real time during and after the World Cup versus the pre-Cup reference period was the main outcome measure. Five sentinel networks participated, comprising 553 general practitioners, 60 hospital adult emergency departments, 19 private emergency community services, 4 community health centres, and the medical centre of the Paris airports. RESULTS: Throughout the 66-day study period, physicians reported 558,829 medical encounters via 21,532 connections to the computer. Compared to the reference period, the level of medical activity reflected by the pathological items surveyed remained stable during the study period. CONCLUSION: The 1998 World Football Cup had no epidemiological impact on general community health, as observed by sentinel networks located downstream of the specific health services provided by the French authorities to ensure high standards of safety.

Adult↗

A survey of physicians' vaccine risk perception and immunization practices for subjects with immunological diseases.

Various publications have caused concern by implying that immunization may be linked to new cases or flare-ups of immunological diseases (IDs). In view of the resulting uncertainty, we studied physicians' vaccine risk perception and immunization practices for adults with IDs. A questionnaire was mailed to three groups of physicians in France: internal medicine specialists, general practitioners, and travel clinic physicians. Thirteen vaccines currently used for adults in France were studied. Risk perception was rated on a 10 cm visual analog scale (VAS). The distribution of the answers was compared between and within groups of physicians. Potential associations between risk perception and reported practices were investigated by multivariate analysis. In the three groups of physicians (n=762), the tetanus and Salk poliomyelitis vaccines had the lowest risk perception. The yellow fever, BCG and Sabin poliomyelitis vaccines were the least well perceived. The distribution of risk perception for these three live vaccines and the hepatitis B vaccine was uniform according to VAS grading. For the other vaccines studied, the distribution was skewed to the low-risk perception side of the VAS. Risk perception was greater for physicians who stated: (1) that certain IDs carried a high risk of adverse events following immunization; (2) that they sought the advice of the referent physician before immunization; (3) warned their patients of the risk of an ID flare-up after vaccination; (4) sought information about recent immunization in patients with a flare-up; and (5) had experience of the side effects of immunization in adults with ID. Risk perception was lower for physicians who said they updated immunizations, and for the internists. The worse the vaccine risk perception by physicians, the more uniform the distribution of perception, thus reflecting the disagreement of the scientific community about the risk of using such vaccines for adults with an ID. Risk perception and immunization practices were related in adults with ID. Understanding of decisions concerning immunization may help to improve immunization updating and prevent risk amplification when evidence is lacking.

Adult↗

[Systemic lupus erythematosus and risk of hepatitis B vaccination: from level of evidence to prescription].

INTRODUCTION: Case reports focusing on immunological diseases occurring subsequently to vaccination are often described in the literature. Reporting of such cases may influence physicians' perception of risks related to immunization, and thereby immunization practices. The decision to vaccinate a patient with an immunological disease should not rely on such case reports, but on the level of evidence of a causal relationship between vaccination and the occurrence of an adverse event. This article describes the search for available data supporting such causality before taking the decision to introduce vaccination against hepatitis B in a female patient with systemic lupus erythematosus (SLE). CURRENT KNOWLEDGE AND KEY POINTS: Data extracted from Medline and surveillance system showed that: 1) biologic plausibility of a relationship between the HBs antigen and SLE was unlikely; 2) case reports or case series were seldom and not convincing regarding potential causality; and 3) there were neither controlled observational studies nor controlled clinical trials. The only available clinical study was of poor quality and did not show any adverse event. The level of evidence of a causal relationship between vaccination against hepatitis B and the occurrence of an adverse event in patients with SLE was low, in-between levels 4 and 5 as defined by the Center for evidence-based medicine. The risk-benefit ratio may therefore rely on these results and guide the decision whether or not vaccination should be introduced. FUTURE PROSPECTS AND PROJECTS: The type of reasoning reported in this paper can be used for other vaccines or other immunological diseases, and have wider applicability in terms of therapeutic risk management when data and evaluation are lacking that could guide decisions.

Adverse Drug Reaction Reporting Systems↗

Focal segmental glomerulosclerosis associated with mitochondrial cytopathy.

BACKGROUND: The nonspecific lesion of focal segmental glomerulosclerosis (FSGS) can occur as a primary disease or in a variety of secondary settings. In mitochondrial cytopathies (MCs), the phenotypic expression of the disease depends on the degree of cellular dysfunction, and this correlates with the proportion of abnormal mitochondrial DNA in the cells and the dependence of tissues on oxidative metabolism. The most common renal manifestation in MCs is tubular dysfunction; little has been reported about glomerular diseases. METHODS: Cases of four adult patients with FSGS and MC are reported. Routine histology and mitochondrial DNA analysis were carried out on renal biopsies. RESULTS: Family history and clinical manifestations in the four patients with FSGS suggested a diagnosis of MC. An A3243G transition in the mitochondrial DNA tRNA(leu(UUR)) was found in lymphocytes and kidney. Glomerular lesions of FSGS were associated with unusual hyaline lesions, which appeared to represent individual myocyte necrosis in afferent arterioles and small arteries. CONCLUSION: FSGS is a renal manifestation of MCs. The renal lesion can precede other manifestations of the genetic disease by many years. The striking arteriolar lesions in these cases may have resulted in glomerular hypertension and hyperperfusion, leading to secondary epithelial cell abnormalities and, ultimately, FSGS. However, primary epithelial cell dysfunction caused by mitochondrial defects could not be ruled out on morphological grounds. MCs should be considered in cases of so-called primary FSGS, particularly if there is a familial history of diabetes, neuromuscular disorders, or deafness.

Adolescent↗

Factors associated with inadequate blood pressure control in hypertensive hemodialysis patients.

Hypertension is common in hemodialysis patients and increases cardiovascular morbidity and mortality. We determined the prevalence of inadequate control of hypertension in 489 patients receiving hemodialysis and identified factors associated with uncontrolled hypertension. We interviewed the patients and abstracted demographic and clinical information from a computerized database. The prevalence of uncontrolled hypertension (average predialysis blood pressure, > or =160/90 mm Hg) was 62%. Ninety-one percent of patients with uncontrolled hypertension were receiving submaximal antihypertensive drug therapy, and 59% withheld their medications before dialysis. Uncontrolled hypertensives had a greater interdialytic weight gain (3.8% v 3.5%, P = 0.07) and a greater excess weight gain (3.1 +/- 1.6 kg v 2.5 +/- 1.4 kg; P < 0.05) compared with controlled hypertensives. Patients with uncontrolled hypertension showed higher interdialytic weight gain (2.7 +/- 0.06 kg v 2.2 +/- 0.13 kg; P < 0.05), were more likely to be black (94% v 81%; P < 0.05), were more likely to have hypertension as the cause of their end-stage renal disease (ESRD) (42% v 24%; P < 0.05), and had been receiving hemodialysis for a shorter time (4.3 +/- 2 yr v 6.1 +/- 0.9 yr; P < 0.05) compared with normotensive patients. There was significant correlation between diastolic blood pressure and both interdialytic weight gain (r = 0.31, P < 0.05) and percent weight gain (r = 0.34, P < 0.05) in the hypertensive but not in the normotensive patients (r = -0.21). Interdialytic weight gain and hypertension as a cause of ESRD were independent predictors of predialysis systolic blood pressure. We conclude that hypertension is uncontrolled in most patients undergoing hemodialysis. Submaximal antihypertensive therapy, excessive interdialytic weight gain, and withholding antihypertensive medication before dialysis are correctable factors potentially contributing to uncontrolled hypertension.

Algorithms↗

Acquired hemophilia due to factor VIII inhibitors in 34 patients.

BACKGROUND: Acquired hemophilia is a rare disease caused by the development of auto-antibodies against factor VIII. SUBJECTS AND METHODS: We studied the characteristics and outcomes of 34 patients (19 women and 15 men) with acquired hemophilia from 1980 to 1997. RESULTS: The mean age of the patients was 61 years (range, 22-93 years). An underlying disease was observed in 18 (53%) patients: 5 patients had cancer, 4 an autoimmune disorder, 2 a dermatologic disorder, 3 asthma, 3 were postpartum, and 1 had an adverse reaction to ampicillin. Factor VIII level was <5% in 30 (90%) patients; factor VIII antibodies were elevated (>10 Bethesda units) in 23 (69%) patients. Bleeding requiring transfusions was reported in 25 (75%) patients. Human factor VIII was given to 14 patients and porcine factor VIII to 5. Six patients received prothrombin complex concentrates and one desmopressin. Several immunosuppressive treatments were used, mainly corticosteroids, cyclophosphamide, and intravenous immunoglobulin. Bleeding stopped in all but one patient within 2 weeks. Most patients achieved complete remission, although two relapses were observed subsequently. CONCLUSION: This large study helps to clarify the presentation and clinical course of acquired hemophilia. Prospective studies are needed to determine the efficacy of treatment.

Adult↗

Severe valvular heart disease in patients on chronic dialysis. A five-year multicenter French survey.

A retrospective multicenter survey of the 230 chronic dialysis centers in metropolitan France, conducted between January 1 1998 and December 31 1992, to assess the incidence, causes and features of severe valvular heart disease among chronic dialysis patients, identified 98 patients. The annual incidence was estimated to be 15 to 19 cases per 10,000 dialysed patients. The most common etiologies were calcific valvular disease (69%) and endocarditis (19%). Calcific valvular disease led mostly to aortic stenosis, whereas endocarditis primarily caused mitral insufficiency. Two valves were damaged in 32% of the endocarditis patients versus 9% of those with calcific valvular disease. Sixty-one patients underwent surgery. Median overall survival after surgery was 25 +/- 3.0 months. Patients who underwent surgery for calcific valvulopathy, aortic stenosis or only aortic valve replacement had a median survival of 36 months. Patients who underwent surgery for endocarditis or replacement of 2 valves had a median survival of < 12 months. Actuarial survival of surgical patients differed significantly between: i) the patients for whom presurgical evaluation showed a single valvular lesion and those with multiple valvular lesions (p = 0.002), ii) the patients who had surgery to replace a single heart valve and those who had another type of surgery (p = 0.001), and iii) the patients who had surgery to insert a single aortic prosthetic heart valve and those who had another type of surgery (p = 0.004). Multivariate analysis (including etiologies, number of valvular lesions and type of surgery) showed that survival was significantly dependent only on the number of severe valvular lesions (p = 0.002). Five patients with severe calcific aortic stenosis died before scheduled surgery could be performed. These data suggest that, for patients on chronic dialysis, calcific aortic stenosis is the most frequent form of severe valvular disease. Because aortic stenosis progresses rapidly in these patients and thus quickly leads to irreversible cardiac failure, the operative risk, although high in this population, seems acceptable when only one valve is affected.

Calcinosis↗

Bioequivalence study of alpha-dihydroergocryptine: utility of metabolite evaluation.

Metabolite assessment is an open question in bioequivalence studies. In situations of low absorption, high first-pass metabolism, and intrasubject variability, metabolites may reflect absorption more adequately than the parent drug, and their determination may help decision-making in bioequivalence issues. Treating alpha-dihydroergocryptine (DHECT) as a model, we used both unchanged DHECT and a pool of DHECT metabolites to evaluate the bioequivalence of 2 oral DHECT formulations (reference-R and test-T) in 12 subjects. DHECT and its metabolites were immunoassayed. There was no difference between the 2 formulations in terms of the AUC0-infinity (area under the curve) values determined from unchanged DHECT or DHECT with metabolites profiles: 572 +/- 490 pg/ml.h (R) and 442 +/- 276 pg/ml.h (T) for unchanged DHECT, and 7,141 +/- 2,936 pg/ml.h (R) and 6,941 +/- 1,462 pg/ml.h (R) for DHECT with metabolites. Confidence intervals were within the ranges 0.8-1.25 (AUC0-infinity) and 0.7-1.43 (Cmax) for DHECT with metabolites but not for unchanged DHECT. This study describes a particular case where only measurements on the basis of the metabolites can justify the assumption of bioequivalence.

Adrenergic alpha-Antagonists↗