[Multicenter clinical study of Bi-Profenid in rheumatologic practice].
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Biomedical subjects
Publications and source records attributed to G Ziegler.
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A retrospective study of factors influencing survival in 1,103 patients with systemic lupus erythematosus (SLE) was carried out at 9 university centers diverse in geographic, socioeconomic, and racial characteristics. The mortality and disease characteristics of the patients at study entry varied widely among centers. The survival rates from the time patients with a diagnosis of SLE were first evaluated at the participating center was 90% at 1 year, 77% at 5 years, and 71% at 10 years. Patients with a serum creatinine greater than 3 mg/dl at study entry had the lowest survival rates: 48%, 29%, and 12% at 1, 5, and 10 years, respectively. Survival rate also correlated independently with the entry hematocrit, degree of proteinuria, number of preliminary American Rheumatism Association criteria for SLE satisfied, and source of funding of medical care. When data were corrected for socioeconomic status, race/ethnic origin did not significantly influence survival. Survival rates varied widely at different participating institutions, generally due to differences in disease severity. Place of treatment was independently associated with survival only in the second year after study entry. Disease duration before study entry did not account for the differences in disease severity.
Causes of death were examined for 1,103 systemic lupus erythematosus patients who were followed from 1965 to 1978 at 9 centers that participated in the Lupus Survival Study Group. A total of 222 patients (20%) died. Lupus-related organ system involvement (mainly active nephritis) and infection were the most frequent primary causes of death. Causes of death were similar throughout the followup period. Hemodialysis had little impact on the length of survival for patients with nephritis. Active central nervous system disease and myocardial infarction were infrequent causes of death. There were no deaths from malignancy.
Midazolam kinetics were evaluated in six healthy male subjects after single oral (15 mg)and intravenous (0.075 mg/kg) doses. The three-part randomized crossover study consisted of a morning dose in supine position (part A) and morning (part B) and evening (part C) doses under ambulant (sitting/walking) conditions. While no significant changes could be observed in the absorption and distribution process or the elimination half lives, total plasma clearance was higher during part A (616+/-157 ml/min, P=0.01) and C(463+/-82 ml/min, P=0.02), than in part B (317+/-110 ml/min, +/-SD). Since the intrinsic (oral) clearance was also higher during part A (1656+/-657 ml/min, P=0.003) and C(1310+/-579 ml/min, P=0.024) than during part B(710+/-241 ml/min), bioavailability did not change (range 37 to 44%). These data indicate that posture and circadian rhythm are important variables affecting blood flow-dependent hepatic elimination of midazolam.
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The action of lead on the intermediary metabolism, especially on the synthesis of heme, the red blood cell pigment, is well documented. Therefore biological monitoring of lead exposed persons by means of the urinary metabolites of porphyrin metabolism is very valuable. Biological monitoring through the urinary metabolite - aminolevulinic acid (ALAU) has been put to extensive use for over ten years by the Swiss National Accident Insurance Fund (Suva). At present there are over 3000 workers in 100 factories which are periodically screened for this metabolite. Urinary analyses are carried out at regular intervals of 2, 4 or 6 months according to the lead exposition with additional medical examinations once or twice a year. Due to biological monitoring, technical improvements and personal hygiene there have been no further lead poisoning recently in industrial plants supervised by Suva.
The effect-kinetics of the new benzodiazepine midazolam was evaluated in six subjects after single oral (7.5 and 15 mg) and intravenous (0.075 mg/kg) doses and infusion programs. The drug is bound to plasma proteins by 94%, and less than 0.5% is excreted unchanged in urine. Hepatic elimination is rapid: t1/2 beta is 2.4 +/- 0.8 hr (mean +/- S.D) and total body clearance is 283 +/- 43 ml/min (plasma) or 502 +/- 105 ml/min (blood). This substantial first-pass effect leads to bioavailability of only 44%, despite very rapid absorption (t1/2abs = 0.23 +/- 0.37 hr) after oral dosing. There is good intraindividual linear correlations (r between 0.68 and 0.97) between plasma levels and dynamic effects, as assessed by the d2 letter cancellation test and a sedation index formed from visual analogue scales.
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The authors describe a method of enzymo-immunological estimation of rheumatoid factor. This estimation, of non-competitive type, includes 3 stages : the rheumatoid factor is first extracted from the serum by fixation on the aggregated IgG linked to cellulose powder; then its presence is revealed by fixation of an oxidase IgG glucose conjugate on the solid phase; finally, the enzyme activity linked to the solid phase is measured. This activity is directly related to the concentration of rheumatoid factor present. The estimation, carried out on 2 050 patients including 114 with rheumatoid arthritis, is well correlated with technic of the Rose-Waaler reaction. Furthermore, the greater sensitivity, the better reproducibility and the quantitative character of this method might improve the supervision of patients with rheumatoid arthritis.
The authors describe an enzymo-immunologic method of determination of the class of rheumatoid factors (RF). This technic includes 3 main stages : 1) extraction of RF by fixation on aggregated rabbit IgG previously adsorbed on the walls of a plastic tube; 2) recognition of RF linked to the solid phase by anti-IgG addition, and addition of human IgA and IgM linked to glucose oxidase; 3) revelation of the enzyme activity linked to the solid phase : this enzyme activity directly depends on the levels of RF to be estimated. The results are expressed as a percentage of the fixation of a reference serum obtained from a patient with rheumatoid arthritis (RA). This serum presents an antiglobulin activity in the 3 major classes of immunoglobulins. The coefficients of variation of intra- and intersystem reproductibility lay between 5,6 and 17.8%. The specificity of the estimation was controlled by the localisation of the antiglobulin activity of the sera after chromatography on Sephadex G200 and by estimation of RF after their absorption by an aggregated IgG immunoadsorbant. This technic was applied to the identification of RF in RA (90 cases); in diseases not related to RA and in control subjects : the sensitivity of this method appears greater than that of technics previously described (immuno-fluorescence, Rose-Waaler reaction) in fact, only 12,2% of sera of patients with RA remain negative with this new test. However, this greater sensitivity does not seem to have altered the clinical specificity of the test : in fact, only 8,4% of the sera of patients with diseases unrelated to RA are positive by this method, which, moreover, may be explained by the age of these subjects (average age 71.5 years).
The clinical and laboratory features in five patients with non-excretory myeloma are described including plasma cell immunofluorescence and, in two cases, ultrastructure. Findings are compared with those in similar patients previously reported, and those in excretory disease. Clinical, haematological and biochemical features were similar to those found in excretory myeloma, showing differences only in relation to the absence of serum or urinary monoclonal immunoglobin. Cellular cytological and ultrastructural features allowed no differentiation from excretory cells. Within this non-excretory group distinction between secretory and non-secretory myeloma cells is possible on the basis of immunofluorescence. Differing patterns of intermittent excretion occurred in three of these patients.
In the last years the symptom of unstable bladder behaviour has been interpreted with increasing clinical importance, sometimes being regarded as a diagnosis or as a causative factor for different complaints (1, 3-6, 16, 18, 20). The term 'unstable bladder' is still not precisely defined (17). Few investigations on this topic had been done in children, therefore, the urodynamic findings of 216 children were analysed to look for co-findings of bladder instability and, if possible, to demonstrate some causative factors. The investigations revealed that unstable bladder behaviour seems to be a secondary cystometric phenomenon (directly or indirectly induced). The treatment of unstable bladder should be concentrated on the causative disorder rather than on the cystometric symptom
A sandwich enzyme-immunoassay (EIA) has been applied to the determination of the rheumatoid factor (RF). This non-competeitive assay comprises 3 steps: 1) the RF to be assayed is extracted for the biological medium by an immunosorbent of aggregated IgG linked to cellulose; 2) the solid phase is then incubated with the enzyme-labeled aggregated IgG; 3) the enzymatic activity of the immunosorbent is then measured with a suitable chromogenic reagent. This activity is a direct function of the amount of RF to be assayed. This assay gave reproducible results in the range 0.5-50.0 IU/ml. A good agreement was obtained between the EIA and the Waaler-Rose test but no correlation was obtained with the latex slide-test. This assay permits a quantitation of RF with a good reproducibility (coefficient of variation in the range of 10% for moderately elevated values) and thus allows a closer follow-up of patients. The results do not depend on the interpretation of the technician performing the test, which can be easily automated. Finally, it may detect some RF devoid of agglutinating activity.
Cylinder knee splints afforded significant relief of pain and were not associated with loss of range of motion or muscle strength in 13 of 15 patients. Splints help patients who demonstrate persistent synovitis of the knee, who do not respond to intraarticular injection of steroids, and for whom surgery is not immediately appropriate. The fiberglass polymer used in this study has several advantages over plaster for splints.
The authors studied the radiological manifestations in bone in 111 patients suffering from multiple bone myeloma. The analysis deals mainly with the maxilla, and in particular with the lower maxilla which was the site of myelomatous lesions in 49 cases. The authors describe two different types of image observed and the radiological methods used, and they discuss the principal problems of diagnosis. They emphasize the diagnostic value of systematic study of this site, which may be solitary, without a concomitant lesion of the cranial dome in particular.