Summary
In a prospective randomized study we evaluated the efficacy and safety of oral ofloxacin (dosage: 200 mg three times daily) versus trimethoprim-sulfamethoxazole (dosage: 960 mg three times daily) as antibacterial prophylaxis in 128 patients with acute leukemia who received aggressive cytotoxic chemotherapy and were granulocytopenic for a median duration of 30 days. Fewer patients receiving ofloxacin were colonized byEnterobacteriaceae (13% versus 90%, p<0.001) andPseudomonas aeruginosa (3% versus 14%, p=0.025), and developed gram-negative bacterial infection (4% versus 26%, p=0.002), whereas the incidence of gram-positive bacterial (19% versus 22%) and fungal (7% versus 14%) infections was similar in both groups. Ofloxacin was significantly better tolerated than trimethoprim-sulfamethoxazole, and shortened the duration of fever (p=0.02) and of parenteral antimicrobial therapy for presumed or documented acquired infection (p=0.01). Ofloxacin appears to be a safe, effective, well-tolerated alternative to trimethoprim-sulfamethoxazole for preventing gram-negative infection in acute leukemia, but more effective prophylaxis of gram-positive infections is still needed.
Zusammenfassung
In einer prospektiven, randomisierten Studie wurden die Wirksamkeit und Verträglichkeit von Ofloxacin (dreimal 200 mg täglich) im Vergleich mit Trimethoprim-Sulfamethoxazol (dreimal 960 mg täglich) als antibakterielle Prophylaxe bei Patienten mit akuter Leukämie geprüft. Beurteilbar waren 128 Patienten, die eine aggressive cytostatische Chemotherapie erhielten, mit einer medianen Granulozytopeniedauer von 30 Tagen. In der Ofloxacin-Gruppe wurde eine Kolonisierung mitEnterobacteriaceae (13% gegenüber 90%, p<0.001) undPseudomonas aeruginosa (3% gegenüber 14%, p=0.025) wesentlich seltener beobachtet als in der Trimethoprim-Sulfamethoxazol-Gruppe. Patienten, die Ofloxacin erhielten, entwickelten auch weniger gram-negative Infektionen (4% gegenüber 26%, p=0.002), während die Inzidenz von gram-positiven bakteriellen (19% gegenüber 22%) und von Pilzinfektionen (7% gegenüber 14%) in beiden Gruppen vergleichbar war. Ofloxacin war besser verträglich und verkürzte die Feiberdauer (p=0.02) sowie die Dauer der parenteralen antimikrobiellen Behandlung von vermuteten oder dokumentierten erworbenen Infektionen (p=0.01). In der Prophylaxe gramnegativer Infektionen bei Patienten mit akuter Leukämie erscheint Ofloxacin daher eine wirksamere und besser verträgliche Alternative zu Trimethoprim-Sulfamethoxazol zu sein. Möglichkeiten einer gezielten Prophylaxe gegen grampositive Infektionen sollten jedoch weiterhin überprüft werden.
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Kern, W., Kurrle, E. Ofloxacin versus trimethoprim-sulfamethoxazole for prevention of infection in patients with acute leukemia and granulocytopenia. Infection 19, 73–80 (1991). https://doi.org/10.1007/BF01645571
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DOI: https://doi.org/10.1007/BF01645571