Li Ting, Zhu Yuxia, Fan Shangrong, Liu Xiaoping, Xu Huicong, Liang Yiheng
Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital, Shenzhen, 518036 China Shantou University Medical College, Shantou, Guangdong, 515041 China.
Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital, Shenzhen, 518036 China Shenzhen Key Laboratory of Gynecological Diagnostic Technology Research, Shenzhen, 518036 China
Med Mycol. 2015 Jun;53(5):455-61. doi: 10.1093/mmy/myv017. Epub 2015 Apr 15.
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.
特康唑是一种新型的广谱三唑类抗真菌药物。本研究的目的是比较6天疗程的特康唑阴道栓剂（80毫克）与两剂口服氟康唑（150毫克）治疗重度外阴阴道念珠菌病（SVVC）的疗效和安全性。在这项前瞻性、随机病例对照研究中，2013年7月1日至2014年6月31日期间，北京大学深圳医院妇产科连续纳入了140例SVVC患者。SVVC患者最初按1:1的比例随机分配接受特康唑阴道栓剂或口服氟康唑治疗。患者在最后一剂治疗后的7 - 14天和30 - 35天进行随访。在随访的第7 - 14天，特康唑组和氟康唑组的临床治愈率分别为81.0%（47/58）和75.8%（50/66）；在第30 - 35天，分别为60.3%（35/58）和56.1%（37/66）。两组的真菌学治愈率在随访第7 - 14天分别为79.3%（46/58）和71.2%（47/66）；在第30 - 35天分别为62.1%（36/58）和53.0%（35/66）（所有P值均＞0.05）。局部刺激是与特康唑相关的主要不良事件，而全身副作用与氟康唑相关；然而，这些影响极小。本研究表明，特康唑阴道栓剂（每日80毫克，共6天）在治疗SVVC患者方面与两剂口服氟康唑（150毫克）一样有效；因此，特康唑可作为这种疾病的一种治疗选择。
