ABSTRACT
ABLöSUNG DER IN-VITRO-DIAGNOSTIKA-RICHTLINIE AUF DIE IN-VITRO-DIAGNOSTIKA-VERORDNUNG (IVDR) 05/2022 (CHRISTOPH SUCKER, GüNTHER KAPPERT): Planmäßig soll am 26.05.2022 die bisher geltende In-Vitro-Diagnostika-Richtlinie durch die In-Vitro-Diagnostika-Verordnung (IVDR) ersetzt werden und würde dann an diesem Tag unmittelbar rechtlich wirksam.
ABSTRACT
We analyzed data for women who received fondaparinux for ≥7 days during pregnancy. The study retrospectively included women who received fondaparinux pre-, peri- and/or postpartum for ≥7 days for prophylaxis/venous thromboembolism (VTE) treatment at German specialist centers (2004-2010). Data on pregnancy, VTE risk factors, anticoagulant treatment, pregnancy outcome and adverse events were extracted from medical records. 120 women (mean age 31.5 years) were included. Among 84 women with prior pregnancies, 41.0% had ≥1 abortion. Anticoagulation was indicated for prophylaxis in 92.5% cases, including 82.5% women with an elevated VTE risk (82.8% thrombophilia, 34.2% VTE history). All women received low-molecular-weight heparin (LMWH) as first-line therapy; 3 also unfractionated heparin. Treatment changed to fondaparinux, due to heparin allergy (41.7%) or heparin-induced thrombocytopenia (10.0%). Fondaparinux was generally well tolerated. Adverse events included bleeding events (n = 5), abortion (n = 2), premature births (n = 2), stillbirth (n = 1), arrested labors (n = 2), injection site erythema (n = 4) and unspecified drug hypersensitivity (n = 6). No VTE events or increased liver enzymes occurred during treatment. In this retrospective study, fondaparinux was effective and well tolerated. Trial registration: ClinicalTrials.gov NCT01004939.
Subject(s)
Fondaparinux/therapeutic use , Venous Thromboembolism/drug therapy , Adult , Cohort Studies , Female , Fondaparinux/pharmacology , Humans , Male , Postpartum Period , Pregnancy , Retrospective Studies , Risk FactorsSubject(s)
Contracts/ethics , Digital Technology/economics , Drug Industry/legislation & jurisprudence , Health Care Sector/legislation & jurisprudence , Societies, Medical/organization & administration , Blood Coagulation Disorders/drug therapy , Blood Coagulation Disorders/economics , Contracts/statistics & numerical data , Cost-Benefit Analysis , Digital Technology/instrumentation , Electronic Prescribing , Germany , Health Care Sector/statistics & numerical data , Humans , Prescription Drugs , SafetyABSTRACT
BACKGROUND: Inhalation of high concentrations of zinc oxide particles (ZnO) may cause metal fume fever. In an earlier human inhalation study, no effects were observed after exposure to ZnO concentrations of 0.5 mg/m3. Further data from experimental studies with pure ZnO in the concentration range between 0.5 and 2.5 mg/m3 are not available. It was the aim of this experimental study to establish the concentration-response relationship of pure nano-sized ZnO particles. METHODS: Sixteen healthy subjects were exposed to filtered air and ZnO particles (0.5, 1.0 and 2.0 mg/m3) for 4 h on 4 different days, including 2 h of cycling with a low workload. The effects were assessed before, immediately after, and about 24 h after each exposure. Effect parameters were symptoms, body temperature, inflammatory markers and clotting factors in blood, and lung function. RESULTS: Concentration-dependent increases in symptoms, body temperature, acute phase proteins and neutrophils in blood were detected after ZnO inhalation. Significant effects were detected with ZnO concentrations of 1.0 mg/m3 or higher, with the most sensitive parameters being inflammatory markers in blood. CONCLUSION: A concentration-response relationship with nano-sized ZnO particles in a low concentration range was demonstrated. Systemic inflammatory effects of inhaled nano-sized ZnO particles were observed at concentrations well below the occpational exposure limit for ZnO in many countries. It is recommended to reassess the exposure limit for ZnO at workplaces.