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Safety and efficacy of ciprofloxacin in paediatric patients — Review

Sicherheit und Wirksamkeit von Ciprofloxacin bei pädiatrischen Patienten — Eine Durchsicht der Literatur

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Summary

Like all fluoroquinolones, ciprofloxacin causes articular damage in juvenile animals. Consequently, this drug was not recommended for children or pregnant women. However, due to its antibacterial effectiveness and convenience of oral administration, ciprofloxacin is now increasingly used for the treatment of certain infectious conditions in children and adolescents aged less than 18 years. In this paper the published literature on this subject is reviewed. Up to now, data are available on more than 1,500 paediatric patients who were given ciprofloxacin, two-thirds of whom were suffering from acute infectious bronchopulmonary exacerbations of cystic fibrosis, mainly due toPseudomonas aeruginosa. The effectiveness of oral ciprofloxacin for this indication compared well to that of standard intravenous combination regimens. The majority of the remaining published trials was conducted in children with multiresistant typhoid fever; the administration of ciprofloxacin was successful in up to 100% of the cases. The safety profile of ciprofloxacin in children and adolescents was very similar to that observed in adult patients. Adverse events were noted in 5–15%, with gastrointestinal, skin and central nervous system reactions being the most common. Reversible arthralgia occurred in 36 out of 1,113 patients with cystic fibrosis, and in no case could cartilage damage be demonstrated by radiographic procedures. Thus, publication data clearly suggest that the administration of ciprofloxacin to children is effective and safe, but there is a need for further prospective, well-controlled clinical trials.

Zusammenfassung

Wie alle Fluorochinolone verursacht auch Ciprofloxacin Gelenkschäden bei heranwachsenden Tieren und wurde aus diesem Grund nicht zum Einsatz bei Kindern und schwangeren Frauen empfohlen. Wegen seiner antibakteriellen Wirksamkeit und der Möglichkeit einer peroralen Gabe wird die Substanz allerdings mittlerweile in steigendem Maße für die Behandlung bestimmter Infektionen bei Kindern und Jugendlichen eingesetzt. In dieser Publikation wird ein Überblick über die bisher zu diesem Thema veröffentlichte Literatur gegeben, die Daten zu mehr als 1500 pädiatrischen Patienten enthält. Zwei Drittel dieser Patienten litt an akuten infektiösen bronchopulmonalen Exazerbationen einer zystischen Fibrose, meist hervorgerufen durchPseudomonas aeruginosa. Die Wirksamkeit von Ciprofloxacin in dieser Indikation war vergleichbar mit der von etablierten intravenösen Kombinationstherapien. Die Mehrzahl der restlichen Studien wurde bei Kindern mit multiresistentem Typhus durchgeführt, bei denen eine Heilungsrate von bis zu 100% erreicht wurde. Das Sicherheitsprofil von Ciprofloxacin entsprach dem bei Erwachsenen. In 5–15% kam es zu unerwünschten Wirkungen, wobei gastrointestinale, dermale und zentralnervöse Reaktionen am häufigsten waren. Reversible Arthralgien fanden sich bei 36 von 1113 Patienten mit zystischer Fibrose; in keinem Fall zeigte sich in radiologischen Untersuchungen ein morphologisches Korrelat. Die publizierten Daten sprechen für die Wirksamkeit und Sicherheit von Ciprofloxacin auch bei pädiatrischen Patienten und belegen die Notwendigkeit weiterer, prospektiver, kontrollierter klinischer Studien.

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Kubin, R. Safety and efficacy of ciprofloxacin in paediatric patients — Review. Infection 21, 413–421 (1993). https://doi.org/10.1007/BF01728929

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