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: Ting Li, Yuxia Zhu, Shangrong Fan, Xiaoping Liu, Huicong Xu, Yiheng Liang
• Journal: Medical mycology (Med Mycol) Vol. 53 Issue 5 Pg. 455-61 (Jun 2015) ISSN: 1460-2709 [Electronic] England
• PMID: 25877666 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © The Author 2015. Published by Oxford University Press on behalf of The International Society for Human and Animal Mycology.

Chemical References

• Antifungal Agents
• Suppositories
• Triazoles
• terconazole
• Fluconazole

Topics

• Administration, Oral
• Adolescent
• Adult
• Antifungal Agents (administration & dosage, adverse effects)
• Candidiasis, Vulvovaginal (drug therapy)
• Case-Control Studies
• China
• Drug-Related Side Effects and Adverse Reactions (epidemiology, pathology)
• Female
• Fluconazole (administration & dosage, adverse effects)
• Humans
• Middle Aged
• Prospective Studies
• Suppositories (administration & dosage, adverse effects)
• Treatment Outcome
• Triazoles (administration & dosage, adverse effects)
• Young Adult