[Regulatory guidelines and drug safety]. / Regulative Vorschriften und Arzneimittelsicherheit.

Regulatory prescriptions are essentially safety-oriented. On one hand, they consist of the documentation required for registration, on the other hand, they imply the duty to inform the authorities on side effects, interactions and adverse drug events in the context of postmarketing drug surveillance. Directly addressed to the firms, they are a challenge for every user in the perception of a new drug risk.

[Primary hyperparathyroidism of the aged female: effect of estrogens on calcium metabolism]. / Hyperparathyroïdie primaire de la femme âgée: effet des oestrogènes sur le métabolisme calcique.

Serum calcium, urinary calcium and a calcium loading test were evaluated twice in 5 elderly women with primary hyperparathyroidism, once not under and once under estrogen therapy. The treatment produced a significant lowering of blood calcium and normalization of urinary calcium excretion in the fasting state, per 24 h and after calcium load. Estrogen therapy might be useful in conservative treatment of asymptomatic hyperparathyroidism and in symptomatic cases where surgery is impossible.

[Malignant non-Hodgkin's lymphoma with visual disorders and nephrotic syndrome]. / Malignes Non-Hodgkin-Lymphom mit Visusstörungen und nephrotischem Syndrom.

A favourable outcome is reported in a 65-year-old patient with malignant non-Hodgkin lymphoma, in whom early manifestations were papillitis and nephrotic syndrome due to membranoproliferative glomerulonephritis. The pathogenesis of the ophthalmologic and renal disease may be associated with the malignant lymphoma. Under cytostatic treatment (prednisone, chlorambucil, vincristine) the malignant lymphoma went into still-lasting remission accompanied by a normalization of the ophthalmologic and renal functions.

[Therapy with vitamin D and D-metabolites]. / Therapie mit Vitamin D und D-Metaboliten.

Elucidation of the vitamin D endocrine system and the availability of potent metabolites have led to new approaches to vitamin D therapy. The traditional management of exogenous (sunlight) or endogenous (malabsorption) vitamin D deficiency without evidence of disordered vitamin D metabolism has not changed, since it consists of treatment with vitamin D itself--a therapy which preserves the normal intrinsic mechanisms for regulating the rate of production of 1,25-dihydroxycholecalciferol. 1,25-DHCC and the analogue compound 1 alpha-CC should be reserved for treatment of hypocalcemia consequent on chronic renal failure or hypoparathyroidism, where 1-hydroxylation is lacking or impaired. Hypophosphatemic rickets has been treated with 1-hydroxylated compounds, with promising results; this use of the latter metabolites warrants further investigation. The use of vitamin D metabolites and of pharmacological doses of vitamin D itself must be regarded as substitution of a hormone or hormone precursors. Therefore, careful monitoring of serum and urine calcium is required in every patient receiving these compounds, in order to avoid excessive dosage. Special attention must be paid to patients with sarcoidosis since they often develop hypercalcemia after vitamin D or UV-light exposure, as a result of an intrinsic regulation defect in 1,25-DHCC synthesis.

[Disturbances of the calcium-phosphorus metabolism and skeletal diseases following kidney transplantation]. / Störungen des Calcium-Phosphor-Stoffwechsels und Erkrankungen des Skeletts nach Nierentransplantation.

53 patients were followed up for an average of 3 years after renal transplantation for evaluation of disturbances in calcium-phosphorus metabolism and skeletal diseases. Postoperative hypercalcemia and hypophosphatemia can be related to persistence of hyperparathyroidism when kidney function is restored. Hypercalcemia was observed in 43% of the patients and lasted less than one year in 80% of cases. Transient hypophosphatemia was present in 15%. These abnormalities did not cause clinical symptoms or deterioration of renal function. However, the skeletal diseases are more impressive and in the first place osteopenia. Bone densitometry revealed decreased bone mineral content in two thirds of the females and one fifth of the males. In females the bone density decreased 3.3% during an average observation period of 7 months, but remained constant in males. Renal osteodystrophy is the main cause of the initial osteopenia. The absence of remineralization or the progression of bone losses is related to the initial persistence of hyperparathyroidism and to corticosteroid treatment. According, 12.5% of the patients presented pathological fractures (spine, hip). In 3 patients (5.7%) with reduced transplant function, osteomalacia without hypophosphatemia was observed. 4 patients (7.5%) had osteonecrosis of the femoral head. There was little progression and surgery was not necessary.

[Isolated erythroid aplasia during immunosuppressive therapy with azathioprine after kidney transplantation]. / Isolierte erythroide Aplasie unter immunsuppressiver Therapie mit Azathioprin nach Nierentransplantation.

The case is presented of a 40-year-old man with pure red cell aplasia which developed 4 years after institution of azathioprine therapy for renal transplantation. The patient recovered 5 1/2 months after substitution of cyclophosphamide for azathioprine.

Comparison of plasma creatinine determined with the Greiner Selective Analyser GSA II and the glomerular filtration rate.

1. Reference values for the plasma creatinine were established using the alkaline picrate method with the Greiner Selective Analyzer GSA II in relation to the Cr 51-EDTA Clearance. Individuals with normal GFR between 93 to 159 ml/min/1.73 m2 had creatinine values in men (n = 65) from 53.7 to 119.5 mumol/l (0.61 to 1.35 mg/100 ml) and in women (n = 59) from 37.7 to 107 mumol/l (0.42 to 121 mg/100 ml). 2. The creatine determinations with the GSA II were compared to those on the Technicon Analyzer, the Beckman Creatinine Analyzer, the Gemsaec-Fast Analyzer and to the enzymatic creatinine method. A good correlation (r = 0.9780-0.984) was observed. 3. With the GSA II and the enzymatic method, bilirubin showed a minor interference which was more marked with the Beckman analyzer.

[The variation of 16 serum protein fractions following renal transplantation (author's transl)]. / Das Verhalten von 16 Serumeiweissfraktionen nach Nierentranspplantation.

We have investigated 16 serum proteins in 20 patients with stable renal function after renal transplantation. Our investigations have shown the following substantial findings: a regular increase of prealbumin, alpha1-glycoprotein, haptoglobin, hemopexin and beta2-glycoprotein, as well as a rather frequent increase of alpha 2-macroglobulin. As far as variations of the serum protein levels are concerned there was no correlation with kidney disease, accompanying illnesses, therapy or interval since transplantation.

[Piperazine intoxication in long-term hemodialysis]. / Piperazinintoxikation bei Langzeithämodialyse.

A 35-year-old patient with terminal renal failure who had received 30 mg piperazine hexahydrate/kg body weight daily for 10 days for oxyuriasis was subsequently admitted to hospital in precoma with severe clinical symptoms not unlike those observed in so-called dialysis dementia: loss of consciousness, dysarthria, apraxia, clonic spasms, tremor, muscular weakness, dropping of objects, inability to think clearly and/or hallucinations. The EEG showed disturbances with diffuse, multifocal delta waves. Under maintenance hemodialysis the patient became asymptomatic one week after discontinuation of the piperazine therapy. Piperazine is contraindicated in patients with renal failure.

[Clinical importance of disorders of vitamin D metabolism]. / Klinische Bedeutung von Störungen des Vitamin-D-Stoffwechsels.

Some aspects of disordered vitamin D metabolism are reviewed. The causes and consequences of diminished blood levels of 25-OH-D3 are discussed. The role of 1,25(OH)2D3 in calcium and phosphorus homeostasis is presented and the diseases associated with alterations of this hormone are described.

Selective deficiency of hepatic triglyceride lipase in uremic patients.

To investigate the pathogenesis of hypertriglyceridemia in patients with renal disease we measured plasma lipoprotein composition as well as hepatic triglyceride lipase and lipoprotein lipase in post-heparin plasma. Three groups with renal disease were studied: conservatively treated chronic uremia; patients undergoing maintenance hemodialysis; and renal-allograft recipients. A selective decrease of hepatic triglyceride lipase with normal lipoprotein lipase was found in conservatively treated uremia and in patients undergoing hemodialysis. Elevated levels of very-low-density lipoproteins and increased triglycerides in low-density lipoproteins occurred in these patients. In contrast, hepatic triglyceride lipase and lipoprotein lipase were both normal in patients after renal transplantation who had Type II hyperlipoproteinemia as a common lipoprotein pattern with increased low-density-lipoprotein cholesterol and decreased high-density-lipoprotein cholesterol concentrations. The accumulation of a triglyceride-rich low-density lipoprotein in the majority of patients with renal disease may be the consequence of low hepatic triglyceride lipase.

[Mineral content of the skeleton in chronic kidney insufficiency treated with dialysis and after kidney transplantation. Results of isotope densitometry]. / Mineralgehalt des Skeletts bei chronischer Niereninsuffizienz, unter Dialysebehandlung sowie nach Nierentransplantation. Resultate der Isotopendensitometrie.

By means of a photon densitometer utilizing a 125I-source, bone mineral content was measured in 15 chronic renal failure patients on conservative management, 46 patients on maintenance hemodialysis and 20 patients after renal transplantation. The determinations were made at 4 sites in both radius and tibia. In patients with chronic renal failure on conservative treatment the bone mineral content did not differ significantly from that in normals. Patients on hemodialysis showed a low bone mineral content in 61 percent of females and 53 percent of males. Especially low values were obtained from 5 females who had undergone bilateral nephrectomy. After renal transplantation all female patients showed low values, whereas 50 percent of male patients showed decreased values. No correlations were found between bone mineral content and serum parameters (calcium, phosphate, alkaline phosphatase, creatinine), duration of renal failure, hemodialysis treatment or steroid medication.