title: A randomized clinical trial of the efficacy and safety of terconazole vaginal suppository versus oral fluconazole for treating severe vulvovaginal candidiasis.
abstract: Terconazole is a new, broad-spectrum, triazole antifungal agent. The aim of this study was to compare the efficacy and safety of a 6-day course of a terconazole vaginal suppository (80 mg) with two doses of oral fluconazole (150 mg) for the treatment of severe vulvovaginal candidiasis (SVVC). In this prospective, randomized case-control study, 140 consecutive patients with SVVC were enrolled at the Department of Obstetrics and Gynecology of Peking University Shenzhen Hospital from July 1, 2013, through June 31, 2014. Patients with SVVC, initially at a 1:1 ratio, were randomly assigned to receive treatment with either the terconazole vaginal suppository or oral fluconazole. The patients had follow-up visits at 7-14 days and 30-35 days following the last dose of therapy. The clinical cure rates in the terconazole group and the fluconazole group were, respectively, 81.0% (47/58) and 75.8% (50/66) at follow-up day 7-14 and 60.3% (35/58) and 56.1% (37/66) at day 30-35. The mycological cure rates in the two groups were, respectively, 79.3% (46/58) and 71.2% (47/66) at follow-up day 7-14 and 62.1% (36/58) and 53.0% (35/66) at day 30-35 (P > .05 for all). Local irritation was the primary adverse event associated with terconazole, whereas systemic side effects were associated with fluconazole; however, these effects were minimal. This study demonstrated that a terconazole vaginal suppository (80 mg daily for 6 days) was as effective as two dose of oral fluconazole (150 mg) in the treatment of patients with SVVC; as such, terconazole could be a choice for therapy of this disorder.
authors: Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital, Shenzhen, 518036 China Shantou University Medical College, Shantou, Guangdong, 515041 China.
authors: Ting
authors: T
authors: Li
authors: Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital, Shenzhen, 518036 China Shantou University Medical College, Shantou, Guangdong, 515041 China.
authors: Yuxia
authors: Y
authors: Zhu
authors: Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital, Shenzhen, 518036 China Shenzhen Key Laboratory of Gynecological Diagnostic Technology Research, Shenzhen, 518036 China fanshangrong@163.com.
authors: Shangrong
authors: S
authors: Fan
authors: Department of Laboratory Science, Peking University Shenzhen Hospital, Shenzhen 518036, China.
authors: Xiaoping
authors: X
authors: Liu
authors: Department of Laboratory Science, Peking University Shenzhen Hospital, Shenzhen 518036, China.
authors: Huicong
authors: H
authors: Xu
authors: Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital, Shenzhen, 518036 China.
authors: Yiheng
authors: Y
authors: Liang
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000935:Antifungal Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002181:Candidiasis, Vulvovaginal / Q000188:drug therapy*; D016022:Case-Control Studies; D002681:China; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D015725:Fluconazole / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008875:Middle Aged; D011446:Prospective Studies; D013488:Suppositories / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D014230:Triazoles / Q000008:administration & dosage* / Q000009:adverse effects; D055815:Young Adult
chemical_list: D000935:Antifungal Agents; D013488:Suppositories; D014230:Triazoles; C037815:terconazole; D015725:Fluconazole
keywords: fluconazole; terconazole; vulvovaginal candidiasis