[Intra-articular radioactive substances in rheumatic diseases].
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Biomedical subjects
Publications and source records attributed to G Bouvenot.
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COMMONLY PRESCRIBED DRUGS: The official French regulatory indication for quinine salts simply states that they can be used as supplementary therapy for nighttime muscle cramps. This type of statement does not indicate a high level of proof of efficacy. Quinine salts are widely prescribed in developed countries. SECONDARY EFFECTS: Drug monitoring surveys have recorded severe adverse effects, particularly sometimes fatal thrombocytopenia. EFFICACITY REVISITED: In this context, we present a critical review of 10 comparative randomized double-blind clinical trials conducted since 1983 and of a meta-analysis published in 1995. The results of these studies are rather difficult to interpret and sometimes contradictory. When an effect is evidenced, it is incomplete and only concerns the number of cramps experienced with no effect on severity or duration. In addition, no precise information is available concerning dose, optimal treatment duration and relapse. Consequently, an irrefutable demonstration of the efficacy of this type of product is still lacking.
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An investigation of prescription and consumption of hypnotic and anxiolytic drugs in hospital was carried out and has associated a transverse prescription study and a prospective consumption study. The prescription study was undertaken on one day in several medical departments of Sainte-Marguerite Hospital in Marseille in February 1999. Of the 91 hospitalized patients included, 42 (46 per cent) had been prescribed a hypnotic or anxiolytic. Furthermore, the quantities of drugs taken out of the pharmacy during the month of February were 1.54 time more than those prescribed. This discrepancy was even more obvious in the case of certain benzodiazepines such as bromazepam (ratio from 1 to 4) and lorazepam (ratio from 1 to 8). Self-prescription and patients being supplied without a prescription are the hypotheses advanced to explain this phenomenon.
Authors have studied the antimutagenic power of alphahederin (a saponin extracted from Hedera helix) versus a clastogenic agent, doxorubicin and an aneugenic agent, carbendazim. We have applied a protocol of incorporation of alphahederin (pretreatment, simultaneous treatment and post treatment) to determine a mechanism of action. According to this protocol, alphahederin induces a significant diminution of the rate of micronuclei wathever the phases of the protocol. These results demonstrate the antimutagenic activity of alphahederin with a mechanism of action, both desmutagenic and bioantimutagenic.
Innovation should not be likened to progress and cost, true innovation should be clearly distinguished from false, novelty for novelty's sake should be avoided, and medicoeconomic evaluations should be interpreted with caution as they are often too precocious and overfavourable. It seems preferable (taking into account examples of statins, anti-Cox 2 NSAIDs, antiTNFs, recombinants...) that therapeutic innovation, as concerns both the prescriber and the evaluator, should give rise to critical reflection rather than to blind enthusiasm and scientistic belief. Delayed use, focusing on real or potential dangers, can be as deleterious for our patients' health as precipitate or generalized use while only considering increased efficacy. Innovation is extremely desirable, particularly when it seems to correspond to a health requirement of prior concern. However, it should be evaluated with a cool head, without prejudice, and even with a hint of scepticism to act as a counterbalance. It should be used with discernment, without improper extrapolation to patients for whom it is not necessary. Careful assessment of the sanitary and economic consequences of therapeutic innovation--which constitute a source of expenditure or economy--should be a permanent concern of health authorities. They must be evaluated using reliable and partly independent data from firms and paying agencies.
In this paper we propose guidelines for clinical trials aimed at assessing the efficacy of drugs for acute non-specific low back pain (LBP) with or without radicular pain, preliminary to their approval and registration. To this end, consensus statements were obtained from a group of experts in the fields of rheumatology, clinical medicine, public health and epidemiology. EBM resources were systematically used as references. Four diagnostic categories were defined: type 1--LBP with no radiation; type 2--LBP radiating no further than the knee; type 3--LBP radiating beyond the knee, but with no neurologic signs; and type 4--LBP radiating to a specific and entire leg dermatome, with or without neurologic signs. Studies should be designed on the basis of the claimed indications for the drug, but must be double-blinded whatever the indication. The duration of the study may be shorter for LBP type 1 or 2 (one week) than for LBP types 3 and 4 (up to one month), depending on the aim of the study and the indications for the drug. The comparator may be inactive (placebo) or active (for a superiority trial, e.g., versus paracetamol). Specific inclusion and exclusion criteria have been defined here for each category. An appropriate wash-out period for any drugs that could affect the pain status should be planned. Paracetamol may be allowed as rescue medication. The primary endpoint should be based on a validated pain assessment tool that may be either generic (type 1 or 2) or oriented (back and knee for types 3 and 4). Secondary endpoints could include the assessment of functional performance; the duration of any period of bed-rest; work limitation; a global assessment comprising pain at rest, standing and walking; the time elapsed before epidural injection, the prescription of other therapeutic agents, or surgery; and the use of rescue medication. Adverse events (AE) should be monitored systematically using a methodology that reflects the mode of action of the tested drug. With the application of these guidelines, LBP could serve as an appropriate disease for testing analgesic drugs. Rigorous evaluation may also help to improve the management of acute LBP.
Data from efficacy trials can provide evidence for the Improvement in Medical Service provided by a drug. A critical analysis of protocols already carried out with a drug enables: a) an evaluation of the limiting characteristics of patients suited to the drug and b) its possible side effects which can be extrapolated to its use in the general population where its use will be much less supervised. An analysis of trial results gives relevant information on the future use and usefulness of the drug.
The choice of dosing of osteoporosis drugs should lie upon appropriate studies, indicating particularly the minimal efficient dosing which is, in this area, of a particular importance. Because of technical difficulties in the realisation, very few studies have been reported at the present time. From a practical point of view, the good choice of dosing of anti osteoporotic drugs must be studied from dose-response relationship curvus at the beginning of phase III clinical studies. From literature, it appears that the supposed optimal dosing of anti osteoporotic drugs have frequently been assessed empirically or from studies with patent methodological errors. Such studies should be on the contrary, prospective in parallel groups, randomized, double-blinded, using a pertinent, validated and more sensitive criteria of response.
This paper is relating the study of 164 patients with primary and proved bronchial carcinoma. A thrombocytosis superior to 400,000/mm3 was observed in 36.6 p. cent of cases. But no statistic relation was found between the histological type of tumor, a biological inflammatory state, the existence of metastasis and thrombocytosis. However thrombocytosis was more frequently observed among anaemic and hyposideremic patients. No significantly changes of paO2 and paCO2 were noted in patients with thrombocytosis. The systematic platelet count could be of an interest in the interpretation of some thoracic radiography.
During a period of five years, fifteen thousand platelet counts has been systematically realised at the Hôtel-Dieu Hospital in Marseilles. A thrombocytosis superior to 400 000/mm3 has been observed in 1,2% of cases, in such various etiological cases as mainly cancer (30%), infectious diseases (28%) and post-hemorragic anaemias (11%).
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The authors found a significant statistical correlation (linear and Spearman) between erythrocyte sedimentation rate (ESR), plasma fibrinogen level, alpha-2-globulins level, platelets count, anemia and age, in 1 000 patients admitted to the Hôtel-Dieu of Marseille. The high degree of partial correlations obtained, confirmed that a direct and independent relationship exists between ESR-fibrinogen, ESR - alpha-2-globulin, fibrinogen - alpha-2-globulin. Determinations of plasma fibrinogen and alpha-2-globulin levels are they still useful in the survey of inflammatory diseases when ESR can be easily determined?
Distribution and correlations of serum uric-acid, cholesterol, triglycerides and lipoproteins were sought in this paper. Blood triglycerides and blood cholesterol in males were found significantly higher in patients with hyperuricaemia than in normo-uricaemic subjects. This elevation was reflected in the electrophoresis by a significant elevation of the bêta and pre-bêta lipoproteins correlated with hyperuricaemia. Partial correlations between age and serum uric-acid have been also demonstrated.
The frequency and nature of abnormalities of serum lipids have been studied in 1 511 patients in correlation with the localizations of atherosclerosis. The mean cholesterol concentration was significantly increased in coronary heart disease and mean triglyceride concentration was significantly increased in peripheral vascular disease. Mean values of R1 and B3 were higher in coronary heart disease, lower in cerebrovascular disease than in healthy subjects.
Changes in blood-level of cadmium, zinc, pseudocholinesterase and aldolase were studied in 44 normal subjects, 40 hypertensive patients and 40 alcoholic ones. The highest serum concentration of cadmium and pseudocholinesterase, the lowest serum and blood concentrations of zinc, the lowest serum concentrations of aldolase were found in the two groups of patients, with still lower levels in alcoholic patients than in hypertensive ones. There was a negative correlation between zinc and cadmium levels in the three groups of subjects. There was a high correlation between systolic and diastolic blood pressure value and cadmium, and negative correlation between blood pressure and zinc blood and serum levels.