ABSTRACT
PURPOSE: Although clinically driven low-dose (CDLD) treatment with direct oral anticoagulants (DOACs) is frequently administered to Asian patients with atrial fibrillation, clinical evidence confirming its efficacy remains insufficient. We evaluated the clinical efficacy and safety of CDLD treatment with DOACs compared to on-label dose treatment in Asian patients with atrial fibrillation and assessed the differences in the baseline characteristics between patients receiving these treatments. METHODS: We searched the MEDLINE, CENTRAL, EMBASE, Web of Science, and Scopus databases for articles from inception through July 2020. RESULTS: Thirteen studies were included in this meta-analysis. The baseline characteristics of the CDLD group were significantly different from those of the standard dose (STD) and standard low-dose (SLD) groups. The incidences of thromboembolic events (risk ratio [RR] 0.46, 95% confidence interval [CI] 0.29-0.73, p < 0.001) and major bleeding (RR 0.55, 95% CI 0.35-0.87, p = 0.01) in the CDLD group were lower than those in the SLD group; however, they were comparable with those in the STD group. The incidence of a composite endpoint in the CDLD group was not significantly different from that in the STD group but was significantly lower than that in the SLD group (RR 0.50, 95% CI 0.38-0.65, p < 0.001). CONCLUSION: The clinical outcomes of CDLD treatment showed no difference compared to those of the STD treatment despite the vulnerable baseline characteristics of the CDLD group for thromboembolic and major bleeding events.
Subject(s)
Atrial Fibrillation , Sexually Transmitted Diseases , Stroke , Thromboembolism , Administration, Oral , Anticoagulants , Asian People , Atrial Fibrillation/diagnosis , Atrial Fibrillation/drug therapy , Hemorrhage/chemically induced , Hemorrhage/epidemiology , Humans , Sexually Transmitted Diseases/chemically induced , Sexually Transmitted Diseases/drug therapy , Stroke/diagnosis , Stroke/epidemiology , Stroke/prevention & control , Thromboembolism/diagnosis , Thromboembolism/epidemiology , Thromboembolism/prevention & controlABSTRACT
The U.S. Public Health Service's sexually transmitted disease (STD) experiments in Guatemala are an important case study not only in human subjects research transgressions but also in the response to serious lapses in research ethics. This case study describes how individuals in the STD experiments were tested, exposed to STDs, and exploited as the source of biological specimens-all without informed consent and often with active deceit. It also explores and evaluates governmental and professional responses that followed the public revelation of these experiments, including by academic institutions, professional organizations, and the U.S. federal government, pushing us to reconsider both how we prevent such lapses in the future and how we respond when they are first revealed.
Subject(s)
Ethics, Research/history , Nontherapeutic Human Experimentation/ethics , Nontherapeutic Human Experimentation/history , Research Subjects , Sexually Transmitted Diseases/chemically induced , Sexually Transmitted Diseases/history , United States Public Health Service/ethics , Adult , Child , Coercion , Deception , Female , Guatemala , History, 20th Century , Humans , Informed Consent/ethics , Male , Specimen Handling/ethics , Specimen Handling/history , United States , Vulnerable Populations/ethnologyABSTRACT
We present a case of a possible amoxicillin-induced anaphylaxis in a sensitive woman triggered by an instance of oral sexual contact with a man who was taking amoxicillin-clavulanic acid treatment.To our knowledge, this is the first case reported of a suspicion of amoxicillin-induced anaphylaxis in a woman after a sexual contact with a man who was taking the drug, we hypothesised an oral drug transfer through semen.Studies about amoxicillin concentrations achieved in semen after a drug intake are scarce. There are few cases reported of hypersensitivity reactions induced by drugs transported in semen but we have found some concern in sensitive patients about the possibility of transference of allergens via sexual intercourse. As clinicians, we consider that it is important to be aware of the existence of this possibility both in the diagnosis and in the prevention of anaphylactic reactions.
