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Clinical study on the dose-effect relationship of a nifuratel-nystatin combination in the treatment of vulvo-vaginal infections.

Author(s): Polatti F, Nappi RE, Brundu B, Fantuzzi M, Frisenda L

Affiliation(s): Department of Obstetrics/Gynaecology, University of Pavia, Policlinico San Matteo, Pavia, Italy. polattif@libero.it

Publication date & source: 2003, Arzneimittelforschung., 53(10):730-7.

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.

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