Therapie
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We describe the case of a woman who developed a cutaneous leukocytoclastic vasculitis following a treatment with gabapentine.
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Medical devices are characterized notably by a wide heterogeneity (from tongue depressors to hip prostheses, and from non-implantable to invasive devices), a short life cycle with recurrent incremental innovations (from 18 months to 5 years), and an operator-dependent nature. The objective of the current round table was to develop proposals and recommendations concerning the prerequisites needed in order to meet the French health authorities expectations concerning requests for post-approval studies for medical devices, required in cases where short and long-term consequences are unknown. These studies, which are the responsibility of the manufacturer or the distributor of the medical device, are designed to confirm the role of the medical device in the therapeutic management strategy in a real-life setting. ⋯ In light of this, the round table endeavored to clearly identify the conditions for implementation of post-approval studies specific to the characteristics of medical devices. Various areas of progress have been envisaged to improve the performance of these studies, and by consequence, the efficiency of reimbursement of medical devices by the national health insurance. These include providing manufacturers with the opportunity to better anticipate post-approval requirements, defining a study-specific primary objective, integrating a phase allowing dialogue between the manufacturer, the health authorities and the scientific committee, and increasing awareness and training of health professionals on the impact of post-approval clinical studies in terms of the reimbursement of medical devices by the national insurance.
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Letter Case Reports
[Bradykinin mediated angioedema with ACE inhibitor in combination with immunosupressive agents].
We present a serious case of bradykinin mediated angioedema with upper airway disorders resulting from drug interaction between angiotensin-converting enzyme inhibitors and immunosuppressant agents.
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Because of its teratogenicity, isotretinoin is contraindicated in pregnant women and also among women of childbearing age in the absence of effective contraception. The objective of this work is to summarize the results of studies assessing the effects of regulatory measures successively implemented in France since 1996 to prevent foetal exposure to isotretinoin. ⋯ However, these pregnancies are almost preventable, because most of them are explained by the non-compliance with the conditions of prescribing and dispensing. Then it seems mandatory to not deliver oral isotretinoin if it is not prescribed in accordance with the prescription laid down by the authorities.
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The prescription of opioids for the treatment of chronic non-cancer pain (CNCP) is not recommended for all of them, and can expose the patients to a benefit/risk ratio unfavorable. The objective of this study was to evaluate the management of patients hospitalized at the centre for evaluation and treatment of pain for opioid withdrawal, their outcome during hospitalization. ⋯ In this study, 57% of patients received, at admission to hospital, an opioid other than morphine in the treatment of CNCP. The management of pain offered by the pain clinic led to a total or partial opioid withdrawal in 94% of patients.