[Non-inferiority trial used in venous thromboembolic disease. A warily interpretation is necessary!]. / Essais de non-infériorité dans la maladie thromboembolique veineuse. Une lecture critique est nécessaire!

INTRODUCTION: Equivalence trials are actually frequently used to prove non-inferiority in anticoagulant therapy. Equivalence trials consist to demonstrate that two treatments are not too much different. This difference has to be under a margin previously determined. The margin corresponds to an efficacy loss that is defined to be acceptable, in accordance to the advantages due to the new treatment. The aim of this work is to explore the equivalence trial published in the thromboembolic disease by focus on the non-inferiority margin used. METHODS: We identified published equivalence trials in the venous thromboembolic disease, by a systematic search in Medline. We calculated the efficacy loss by reference with the value of the smallest effect size of the standard treatment compared to placebo. RESULTS: We found 9 equivalence trials used in venous thromboembolic disease. The mean value of the efficacy loss was 434%, and the median value was 357%. Eighty-five percent of the values of the efficacy loss were above 100%. DISCUSSION: Eighty-five percent of the equivalence trials conclude to equivalence despite a complete efficacy loss of the effect of the standard treatment compared to placebo. The results of equivalence trials should be interpreted warily. The corresponding non-inferiority margin should be chosen more rigorously and by reference with the value of the smallest effect size of the standard treatment compared to placebo.

[Internal medicine DES 10 years after creation. Results of the survey realized by the Association of young internists]. / Le DES de médecine interne 10 ans après sa création. Résultats de l'enquêt réalisée par l'Association des jeunes internistes.

The internal medicine young practitioners association (AJI) did set, during 93 spring, a survey among the registered internal medicine interns since 1984, regarding their training and future. 88 did answer, showing a certain homegeneous training but a deep care in their future. Most would wish a dual activity in general hospitals : internal medicine and an other speciality acquired during their training.

[Value of the protein profile in unexplained inflammatory syndromes]. / Intérêt du profil protéique dans les syndromes inflammatoires inexpliqués.

UNLABELLED: The diagnosis of unexplained inflammatory syndromes requires many investigations which are commonly expensive, often invasive and must be repeated several times. A means for physicians to improve the diagnosis procedure would be to have new tests available to select the best diagnosis procedures. In order to test the value of the protein profile (PP) in the case of unexplained inflammatory syndromes, we prospectively studied 95 among 650 patients admitted in our unit for an inflammatory syndrome defined by a C Reactive Protein level > 2 mg/dL and a sedimentation rate > 30 mm, which remained unexplained after a 5 day hospitalization (49 men, 46 women; mean age: 62.9 +/- 12.3 years). PP has been considered as a useful test for the diagnosis in 21 cases (22%) having been definitively established by pathologic examination (42%), radiologic procedures (24%), endoscopy (19%), immunological tests (19%), and serological test (9.5%). The definitive diagnosis was a systemic disease in 12 cases, infection (four cases), malignancy (three cases), amyloidosis (one case) and occult intestinal bleeding (one case). CONCLUSION: Our data indicate that PP is a useful test for the diagnosis of unexplained inflammatory syndromes; its main utility is the disclosure of some specific biochemical syndromes available for better selecting the definitive diagnosis procedures.

[New medical treatments of systemic idiopathic fibrosis]. / Les nouveaux traitements médicaux des fibroses systémiques idiopathiques.

Medical treatment of systemic idiopathic fibrosis is first based on steroid therapy, of which efficacy is well known for nearly 75% of cases of retroperitoneal fibrosis, but les certain for the other localisations of the disease. Studies on the immuno-pathological mechanism of systemic fibrosis have led to immunosuppressive drug use, such as azathioprin, cyclophosphamide and methotrexate. Tamoxifen has been tried because of its efficacy on desmoid tumors and seems to be of great interest. Attention is focused on fibrosing cervicitis which may also be treated with immunosuppressive drugs.

[Autoimmunity: a concept to be revisited?]. / L'auto-immunité: un concept à réviser?

Autoimmunity is thought to be a defect in immunologic tolerance, resulting in the activation and expansion of self antigen-specific T and B lymphocyte clones and the production of circulating antibodies, and a myriad of cytokines and other inflammatory mediators. This hypothesis, which speculates on an aberrant response of the immune system to normal self antigens has exerced a powerful influence on clinical investigations and therapeutic researches. Although much information has accumulated, the mechanism of autoimmune disease remains poorly understood and little attention has been paid to the hypothesis that autoimmune diseases might be caused by a conventional immunological response against self antigens for which tolerance has never been established. Clinical practice would undoubtedly get a lot out of it, as well as new therapeutic measures.

[Stauffer's syndrome disclosing kidney cancer: another cause of inflammatory syndrome with anicteric cholestasis]. / Syndrome de Stauffer révélateur d'un cancer du rein: une autre cause de syndrome inflammatoire avec cholestase anicterique.

Stauffer's syndrome is characterized by a cholestasis without biliary obstruction or hepatic metastasis and a renal tumor. We report a case of Stauffer's syndrome in a 73 year-old woman. Cholestasis and inflammatory syndrome regressed with corticosteroid. Giant cell arteritis with negative temporal artery biopsy was wrongly suspected.

[Does a particular risk associated with papillomavirus infections exist in women with lupus?]. / Existe-t-il un risque particulier lié aux infections à papillomavirus chez les femmes lupiques?

PURPOSE: There is strong evidence that papillomavirus infections (HPV), especially infections with HPV 16/18, are involved in the development of dysplasia and cancers. Cervical cancer is thought to be increased in women with systemic lupus erythematosus (SLE). METHODS: To assess this risk we studied cervical smears from 11 women with SLE and determined the prevalence of HPV infection by in situ hybridization. RESULTS: Dysplasia was found in 9% of women with SLE and in 0.03% of control subjects (non significant difference). Dysplasia was found to be six times more frequent in women with SLE (18% versus 3%, P < 0.01). HPV prevalence in normal smears was 37.5% in women with SLE versus 14.7% in control subjects (non-significant difference). Identified HPV genotypes were those for which intermediate or high risk is well established. No correlation was found between infection or dysplasia risk and the lymphocyte count or a previous treatment with cyclophosphamide. CONCLUSION: We conclude that women with SLE would be at increased risk of HPV infection, dysplasia and cervical cancer. We suggest that women with SLE should be regularly tested for cervical cancer by colposcopy, especially in case of HPV 16 infection.

[Silent exercise-induced enzymatic myopathies at rest in adults. A cause of confusion with fibromyalgia]. / Myopathies enzymatiques d'effort silencieuses au repos chez l'adulte. Une cause de confusion avec la fibromyalgie.

Exercise-induced enzymatic myopathies include carnitine palmityl transferase deficiency and, among muscular glycogenoses, Mac Ardle's and Tarui diseases. These diseases are usually recognized when exercise-induced myalgias, myoglobinuria and raised creatinine kinase (CK) levels are present. However, myoglobinuria may be absent in 10 to 50 percent of the cases, and CK levels are often normal at rest; thus, the diagnosis is often delayed for several years, with a risk of acute renal failure in 10 to 30 percent of the patients. We report 6 cases of exercise-induced enzymatic myopathies with normal CK levels and with electromyographic studies at rest. The main clinical features of these cases and those of similar conditions reported in the literature are male sex, onset of the disease before the age of 15 years, episodes of severe exercise-induced myalgias, cramps and muscle weakness and myogenic hyperuricaemia at rest in muscular glycogenosis.