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Drugs used in oncology represent more than half of the innovative and costly drugs which are not covered by a Group Homogène de Soins (DRG type classification) within the context of the case-mix based payment system (termed T2A). For these drugs, good practice reference guidelines have been drawn up by scientific societies and registration agencies. Recognised indications, relevant indications and situations where the treatment should not be prescribed are defined by the National Institute of Cancer. The reference guidelines should lead towards the good use of these drugs and allow the sick funds to control prescriptions. They should evolve with time, which means that bibliographic monitoring and independent expert opinion is necessary to update them as science provides new data. Manufacturers are involved in this process which in no case should undermine developmental efforts leading to registration. The objective of this protocolisation is to allow all patients early and legitimate access to drugs representing real therapeutic progress. These reference guidelines should be integrated into the life-cycle of a drug and should give rise to new developments allowing the good use of cancer products in situations which have been properly validated.

Les médicaments utilisés en cancérologie représentent plus de la moitié des médicaments innovants et coûteux pris en charge hors d’un groupe homogène de soins dans le cadre de la tarification à l’activité. Pour ces médicaments, des référentiels de bon usage élaborés par les sociétés savantes, les agences d’enregistrement et l’Institut National du Cancer (INCa) définissent les indications reconnues, les indications pertinentes et les situations où le traitement ne doit pas être prescrit. Ces référentiels devraient tendre à un bon usage de ces médicaments et permettre un contrôle des prescriptions par les organismes payeurs. Ces référentiels se doivent d’être évolutifs, d’où la nécessité d’une veille bibliographique et de l’appel à des experts indépendants pour une actualisation en fonction des données nouvelles de la science. Les industriels sont impliqués dans cette démarche qui ne doit en rien se substituer aux efforts des développements pouvant conduire à un enregistrement. L’objectif de cette protocolisation est de permettre un accès précoce et légitime de tous les patients aux médicaments représentant un réel progrès thérapeutique. Ces référentiels doivent s’intégrer dans la vie du médicament et doivent permettre de nouveaux développements permettant le bon usage des produits de cancérologie dans des situations correctement validées.

Summary The aim of the study was to use a novel combination of two methods for the simultaneous evaluation of two effects of oral cisapride in 10 diabetic patients with autonomic neuropathy; gastric emptying time was measured by following radio-opaque markers and orocaecal transit time by the sulphasalazine-sulphapridine method. The study was of double-blind, randomized, placebo-controlled, cross-over design.

Two hundred and seventy patients over 65 years were included in a placebo-controlled randomized double-blind trial to determine whether a small dose of a low molecular weight (LMW) heparin prevents the occurrence of deep vein leg thrombosis (DVT) diagnosed by 125I fibrinogen scanning. LMW heparin (60 mg daily) significantly reduced the frequency of DVT from 9 to 3 percent (p = 0.03). Adverse drug reactions did not differ significantly between the 2 groups, except for the injection site hematomas that were more frequent in the LMW heparin group. In conclusion, LMW heparin appears of value in preventing the occurrence of DVT in an unselected elderly in-patient population.

The gastric potential difference (PD) was measured in ten healthy volunteers after sodium taurocholate intake. This bile salt was given after treatment with dimethicone or placebo in a cross-over design study.

The effect of the calcium antagonist, diltiazem, on glycoregulation was investigated in 12 healthy volunteers using a standard glucose tolerance test. No significant change was observed in plasma glucose, insulin or glucagon levels after oral treatment for B days with diltiazem 180 mg/day.

Endoscopic lesions of the gastric mucosa were evaluated in 12 healthy volunteers after administration of single doses of ketoprofen (25 mg), ibuprofen (200 mg) and aspirin (500 mg) in a randomized, double-blind, crossover study. The grades of the lesions (according to Lanza's scale) were lower after the administration of ketoprofen than aspirin and were comparable to ibuprofen. An endoscopic score >1 was observed in 3 cases after ibuprofen or ketoprofen, and in 8 cases after aspirin. At a time when low, single doses of NSAIDs are widely used as analgesics, gastroscopy makes it possible directly to assess the local agressivity of these molecules. In this way it was possible to demonstrate that the local toxicity of NSAIDs was lower than that of aspirin.

The effect of omeprazole treatment on theophylline pharmacokinetics was studied in eight, non-smoking healthy male volunteers during repeated administration of a slow release formulation of theophylline. In a randomized double-blind cross-over study, the subjects received theophylline 5 mg·kg-1 per day with omeprazole 20 mg per day or identical placebo during two periods, each of 7 days, separated by a washout period of 7 days.