Clinical Study on the Dose-Effect Relationship of a Nifuratel-Nystatin Combination in the Treatment of Vulvo-vaginal Infections

Franco Polatti, Rossella Elena Nappi, Benedetta Brundu, Mario Fantuzzi, Linda Frisenda

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Abstract

Objective: The dose-effect relationship of nifuratel (CAS 4936-47-4) + nystatin (CAS 1400-61-9, CAS 34786-70-4) (Macmiror Complex®) in topical treatment of vulvo-vaginitis was studied. Method: Sixty patients with Trichomoniasis and/or Candidiasis were randomized to: 1) nifuratel 125 mg/nystatin 50000 IU, 2) nifuratel 250 mg/nystatin 100000 IU, 3) nifuratel 500 mg/nystatin 200000 IU. Undistinguishable ovules were intravaginally applied qd for 10 days. The dose-effect relationship was assessed by ANCOVA. Result: After 5 days the microbiological cure rate occurred in 10% of patients in the least dose, in 40% in the middle dose and in 85% in the highest dose group (P=0.000). After 10 days of treatment, the microbiological cure rate increased to 45%, 84%, and 95%, respectively (P=0.007). Clinical signs and symptoms gradually disappeared in a dose-and time-dependent manner. No relapse has been observed after 10 day-follow up on 46 patients. Conclusion: The results confirmed a linear relationship between nifuratel + nystatin dose and effect. The least effective dose was nifuratel 250 mg + nystatin 100,000 IU once daily for 5 days and the best dose in terms of risk/benefit ratio was nifuratel 500 mg + nystatin 200,000 IU once daily for 5 days.

Original languageEnglish
Pages (from-to)730-737
Number of pages8
JournalArzneimittel-Forschung/Drug Research
Volume53
Issue number10
Publication statusPublished - 2003

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Keywords

  • CAS 1400-61-9
  • CAS 34786-70-4
  • CAS 4936-47-4
  • Macmiror complex®, effect on vulvo-vaginal infections
  • Nifuratel, combination with nystatin
  • Nystatin, combination with nifuratel
  • Vulvo-vaginal infections

ASJC Scopus subject areas

  • Drug Discovery
  • Organic Chemistry
  • Chemistry(all)
  • Pharmacology

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