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Renal tolerance of cefpirome (HR 810), a new cephalosporin antibiotic

Nierenverträglichkeit von Cefpirom (HR 810), einem neuen Cephalosporin-Antibiotikum

  • Addendum “Cefpirome (HR 810)”
  • Studies In Phase I
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Summary

An open study was carried out in ten healthy, male volunteers in order to investigate the renal tolerance of cefpirome (HR 810), a new cephalosporin antibiotic. Subjects received a single dose of 1.0 g of cefpirome and then repeated doses of 1.0 g of cefpirome twice daily for five days. Urine was collected in several fractions during the study and the urine excretion, excretions of creatinine, N-acetyl-β-D-glucosaminidase, gamma glutamyltransferase, alanine aminopeptidase and lactate dehydrogenase were calculated in 12-hour fractions. Serum creatinine (using an enzymatic method), β2-microglobulin concentrations and creatinine clearance were also determined. Based on the findings of these renal enzymes, renal tolerance was good. This was also confirmed by creatinine clearance calculations and follow-up of serum β2-microglobulin levels. Cefpirome showed good renal tolerance without any signs of nephrotoxicity in this study with the methods used.

Zusammenfassung

Die Nierenverträglichkeit von Cefpirom (HR 810), einem neuen Cephalosporin-Antibiotikum, wurde in einer offenen Studie mit zehn gesunden männlichen Probanden geprüft. Die Probanden erhielten zuerst eine Einzeldosis von 1,0 g Cefpirom und danach 1,0 g Cefpirom zweimal täglich für fünf Tage. Harn wurde in mehreren Fraktionen während der Studie gesammelt, und die Urinausscheidung, Ausscheidungen von Kreatinin, N-azetyl-β-D-Glukosaminidase, Gamma-Glutamyltransferase, Alanin-Aminopeptidase und Laktatdehydrogenase wurden in 12-Stunden Fraktionen berechnet. Die Konzentrationen von Serum-Kreatinin (bestimmt mit einer enzymatischen Methode) und β2-Mikroglobulin sowie Kreatinin-Clearance wurden ebenso bestimmt. Die gute Nierenverträglichkeit wurde durch die Nierenenzyme, Kreatinin-Clearance-Bestimmungen und die β2-Mikroglobulin-Spiegel im Serum bestätigt. Cefpirom zeigte in dieser Studie mit den verwendeten Methoden eine gute renale Verträglichkeit ohne irgendwelche Hinweise auf Nephrotoxizität.

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Verho, M., Maaß, L., Malerczyk, V. et al. Renal tolerance of cefpirome (HR 810), a new cephalosporin antibiotic. Infection 15, 215–219 (1987). https://doi.org/10.1007/BF01646054

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