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


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
Polatti
Franco
F
Department of Obstetrics/Gynaecology, University of Pavia, Policlinico San Matteo, Pavia, Italy. polattif@libero.it
Nappi
Rossella Elena
RE
Brundu
Benedetta
B
Fantuzzi
Mario
M
Frisenda
Linda
L
D000293:Adolescent; D000328:Adult; D000935:Antifungal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002181:Candidiasis, Vulvovaginal / Q000188:drug therapy / Q000382:microbiology; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008875:Middle Aged; D009181:Mycoses / Q000188:drug therapy* / Q000382:microbiology; D009545:Nifuratel / Q000009:adverse effects / Q000627:therapeutic use*; D009761:Nystatin / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D014247:Trichomonas Vaginitis / Q000188:drug therapy / Q000382:microbiology; D014623:Vaginal Diseases / Q000188:drug therapy* / Q000382:microbiology
D000935:Antifungal Agents; D004338:Drug Combinations; D009761:Nystatin; D009545:Nifuratel