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High‐dose nifuratel for simple and mixed aerobic vaginitis: A single‐center prospective open‐label cohort study
Author(s) -
Liang Qian,
Li Nan,
Song Shurong,
Zhang Aihua,
Li Ni,
Duan Ying
Publication year - 2016
Publication title -
journal of obstetrics and gynaecology research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.597
H-Index - 50
eISSN - 1447-0756
pISSN - 1341-8076
DOI - 10.1111/jog.13052
Subject(s) - medicine , prospective cohort study , vaginitis , dose , gastroenterology , gynecology
Aim The efficacy and safety of two nifuratel dosages for the treatment of aerobic vaginitis (AV) were compared. Methods This was a prospective open‐label cohort study of patients diagnosed and treated at the Tianjin Third Central Hospital between January 2012 and December 2013. The co‐presence of bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), or/and trichomonal vaginitis (TV; mixed AV) was determined. Patients were randomized to nifuratel‐500 (500 mg nifuratel, intravaginal, 10 days) or nifuratel‐250 (250 mg nifuratel, intravaginal, 10 days), and followed‐up for three to seven days after treatment completion. Primary and secondary outcomes were recovery rate and adverse events, respectively. Results The study included 142 patients with AV. Age was not significantly different between the groups ( n = 71 each), and disease distribution was identical: 29 (40.85%) simple AV and 42 (59.15%) mixed AV (AV + BV, 42.86 %; AV + VVC, 30.95%; AV + TV, 26.19%). In patients with simple AV, the recovery rate did not differ significantly between the nifuratel‐500 (26/29, 89.66%) and nifuratel‐250 (22/29, 75.86%) groups. In patients with mixed AV, recovery rates were significantly higher in the nifuratel‐500 than in the nifuratel‐250 group (AV + BV, 88.89% vs 50.00 %; AV + VVC, 76.92 % vs 30.77 %; AV + TV, 90.91 % vs 36.36%; all P < 0.05). Only one patient (nifuratel‐500) reported an adverse event (mild anaphylactic reaction). Conclusion Nifuratel 500 mg showed good clinical efficacy for the treatment of AV, particularly mixed AV, and is superior to the 250 mg dosage in the treatment of mixed AV.