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Biomedical subjects

Y Juillet

Publications and source records attributed to Y Juillet.

At least 19 recordsLinked to original sources

[Optimization of good use of medicinal products].

Optimization of good use of medicinal products is aimed at allowing the patient to benefit fully from the efficacy of the prescribed treatment while limiting the negative impact of adverse effects. The prescriber and the dispensing pharmacist have an important complementary role crucial for the good use of medicinal products. This potential must be developed and improved. Patients' awareness should be reinforced, particularly be encouraging their dialogue with healthcare professionals. Improvement of the current situation can be based on self-appropriation of suitable information by each of the participants, leading to changing behavior. Common elaboration and diffusion of recommendations by the French National Academies of Medicine and Pharmacology would allow significant progress in good use of medicines.

Drug Therapy↗

Internationalization of regulatory requirements.

The aim of harmonisation of medicines regulatory requirements is to allow the patient quicker access to new drugs and to avoid animal and human duplications. Harmonisation in the European Union (EU) is now completed, and has led to the submission of one dossier in one language study leading to European marketing authorizations, thanks in particular to efficacy guidelines published at the European level. With the benefit of the European experience since 1989, more than 40 guidelines have been harmonised amongst the EU, Japan and the USA through the International Conference on Harmonisation (ICH). ICH is a unique process gathering regulators and industry experts from the three regions. Its activity is built on expertise and trust. The Common Technical Document (CTD), an agreed common format for application in the three regions, is a logical follow-up to the ICH first phase harmonising the content of the dossier. The CTD final implementation in July 2003 will have considerable influence on the review process and on the exchange of information in the three regions.

Drug Industry↗

[Objectives and organization of the International Conference on Harmonization].

The objective of the International Conference on Harmonization established since 1989 is to allow marketing of new drugs as soon as possible for patient benefit. At the same time harmonization decreases development time by harmonizing the content and the format of the registration file in the three regions: European Union, United States and Japan. ICH is a unique process involving health authorities and industry representatives of the three regions. The Conference which took place in July 1997 was the end of the first step of the process. At the meeting it was decided to pursue this harmonization activity, particularly in initiating a project devoted to the file format (Common Technical Document). The current period will be essentially focused on implementation of the common Guidelines and on their update in relation to scientific progress, the major part of the file now being harmonized in its content.

Drug Industry↗

The arterial wall: a new pharmacological and therapeutic target.

In recent years, two key concepts having numerous interrelationships were advanced for the understanding of various cardiovascular diseases: the "endothelial dysfunction" and the "arterial remodelling". Both endothelial dysfunction and arterial remodelling occur in various pathologies including essential hypertension, heart failure, atherosclerosis, restenosis after angioplasty, and pulmonary hypertension, and have modified the therapeutic approach by offering new pharmacological targets: specific receptors not only at the site of the vascular smooth muscle cells but also on the endothelial cells, growth factors that stimulate proliferation of smooth muscle, and receptors and enzymes of the extra-cellular matrix. Among the various substances under research, the present review will discuss angiotensin II receptor antagonists, endothelin receptor antagonists, nitrates-NO donors, potassium channel activators, and substances interfering with proteoglycans and other components of the extra-cellular matrix.

Angiotensin Receptor Antagonists↗

Hypothenar hammer syndrome: seventeen cases with long-term follow-up.

Hypothenar hammer syndrome is a rare and often incorrectly diagnosed form of secondary Raynaud's phenomenon in workers who use their hand as a hammer. We report 17 documented cases with long-term follow-up after diagnosis made on the basis of arteriography. Clinical findings include male sex, unilaterality, sudden onset, and severe Raynaud's phenomenon. Angiography indicated that the 17 patients had either ulnar thrombosis or ulnar aneurysm; most of them also had embolic occlusions of the digital arteries. Main pathologic findings were thrombosis on the intima and fibrosis in the media. We adopted a surgical procedure consisting of resection with end-to-end reconstruction for patent aneurysms to avoid downstream emboli and more conservative treatment when the ulnar artery was thrombosed. No patient required digital amputation and all except one improved and were able to live and work normally with only a moderate disability, consisting of Raynaud's phenomenon during the cold season only.

Adult↗

[How to determine the optimal dosage of a drug].

Determining the optimal dosage is an important step in the development of any drug, as it will provide a basis to demonstrate the effectiveness of that drug at different dosage levels. This determination is mainly attempted in phase II, notably by means of dose-response studies, but it is obvious that data obtained at every stage in the life of the drug will provide a better approach to dosage recommendations. Several examples are discussed.

Clinical Trials as Topic↗

[Industrial drug-surveillance].

Drug surveillance is a fundamental stake for the pharmaceutical industry. Drug manufacturers are responsible, both legally and morally, for the marketing of new products, and this represents very important investments. It is the duty and to the benefit of the pharmaceutical industry to set up a structure devised to collect and evaluate undesirable side-effects. In addition, drug surveillance may give rise to fruitful exchanges between scientific, teaching and industrial communities.

Drug Industry↗

Effect of local urokinase on arterial occlusion of lower limbs.

Sixty nine patients were treated with local intra-arterial urokinase (37,500 U/CTA. hr-1) for recent severe ischemia of lower limbs: 27 (40%) ultimately required amputation. The difference of amputation rate between the groups with and without thrombolysis was not significant (33% v. 42%). A biological study in 6 patients showed that local arterial plasminemia occurred in only 1 patient. Local urokinase does not strongly stimulate "endogenous" thrombolysis and enhances "exogenous" thrombolysis only very inconstantly. A better adaptation of urokinase dosage or the use of an agent with higher affinity for fibrin might improve the efficiency of local thrombolytic therapy.

Aged↗

[Clinical presentations of Cockett's syndrome. 16 cases].

Cockett's syndrome (iliac compression syndrome) results from compression of the common iliac vein by the aortic bifurcation. The anatomical abnormality is frequent (15-20% of the population), but symptoms only appear when compression is pronounced. In a study of 16 patients, predominantly female, the following clinical presentations were observed: venous oedema of the left lower limb in 4 cases; symptoms suggesting iliac phlebitis in 3 cases; pulmonary embolism as first sign of peripheral venous thrombosis in 6 cases; and deterioration of angiodyplasia in 3 cases. In all patients, the diagnosis of Cockett's syndrome was confirmed by cavography. Surgical treatment, successfully performed in 13 patients, consists of uncrossing the artery and vein and placing a clip on the vena cava in case of pulmonary embolism

Adolescent↗