Routine database registration of biological therapy increases the reporting of adverse events twentyfold in clinical practice. First results from the Danish Database (DANBIO).

OBJECTIVE: To present from the Danish Database for Biological Therapies in Rheumatology (DANBIO) the frequencies and types of adverse events as well as risk factors during treatment with biological agents in clinical practice. METHODS: Adverse events during the first 2 years of clinical use of biological agents in Denmark were reported to the nationwide DANBIO and compared to the mandatory reports to the Danish Medicines Agency. RESULTS: Almost 90% of the patients treated with biological agents were registered in the DANBIO, and the database picked up 20 times as many adverse events as the Danish Medicines Agency. Infections and hypersensitivity reactions were the most prevalent adverse events. Age, disease duration, and previous number of disease-modifying anti-rheumatic drugs (DMARDS) were found to be risk factors for bacterial infections. CONCLUSION: A routine-based Danish database for biological therapies covers approximately 90% of patients and improves the reporting of adverse events.

Body composition in hemodialysis patients measured by dual-energy X-ray absorptiometry.

Dual-energy X-ray absorptiometry (DXA) measures three of the principal components of the body: fat mass, lean soft-tissue mass (comprising muscle, inner organs, and the body water), and the bone mineral content. The purpose of this study was to test the estimation capacity of DXA when it is applied to patients with end-stage renal failure. Twenty dialysis patients were examined by DXA before and after one hemodialysis session. A highly significant positive correlation between weight measurements performed by conventional scales and DXA was found. A positive correlation between fluid loss during dialysis and reduction in fat-free mass (lean soft-tissue mass plus bone mineral content) was observed by DXA. The estimation of the fat-free mass was independent of the amount of fluid loss. No significant differences in variance between the data obtained before and after the dialysis were observed. We conclude that DXA is a useful tool for estimating the magnitude of body compartments in patients with end-stage renal failure.

[Erythropoietin treatment of dialysis patients]. / Erytropoietinbehandling af dialysepatienter.

The effect of recombinant human erythropoietin therapy on correction of renal anaemia was evaluated. A total of 100 patients with endstage renal disease and anaemia (level of haemoglobin < 9.6 g/dl) received erythropoietin for 125 patient years. In 81 patients the level of haemoglobin increased to the intended range (10.5-12.0 g/dl) within three to four months. In 16 of the patients acute infections were followed by a temporary reduction in the haemoglobin level. In 11 patients a previous transfusion requirement was reduced, or, in most cases, abolished. In the remaining eight patients the transfusion requirement was unchanged. The patients with either a sub-optimal or no response suffered from chronic infections, malignant diseases or recurrent bleeding episodes. In 28 patients the level of haemoglobin exceeded the intended target for a period of four months (average). Serious side effects were not observed. Six patients had 'flu-like symptoms after the first injections. Three cases of thrombosis of the arterio-venous fistula were observed in two patients. The frequency of thrombosis of the vascular access did not exceed what we expected to find.

Computer-assisted diagnosis of acute azotaemia: diagnostic strategy and diagnostic criteria.

This report describes the diagnostic strategy, cost-effectiveness and diagnostic accuracy of a rule-based, backward chaining diagnostic expert system designed to assist in diagnosing the cause(s) of acute azotaemia. The diagnostic strategy of the expert system seems to be cost-effective compared with that of a renal unit and the diagnostic criteria of the expert system accurately imitate the diagnoses of the renal unit. It is suggested that the expert system is diagnostically reliable and may reduce cost in the diagnostic work-up of patients with acute azotaemia.