Effectiveness of Fluconazole for Suppressive Maintenance Therapy in Patients with RVVC: a Randomized Placebo-Controlled Study

氟康唑 医学 安慰剂 安慰剂对照研究 内科学 临床试验 随机对照试验 外科 抗真菌 双盲 皮肤病科 病理 替代医学
作者
Forouzan Bolouri,Nasrin Moghadami Tabrizi,Fatemeh Davari Tanha,Nasrin Niroomand,Azra Azmoodeh,Saeed Emami,Mehraban Falahati,Somaye Sharifynia,Maliheh Safavi,Abbas Shafiee,Alireza Foroumadi
出处
期刊:Iranian Journal of Pharmaceutical Research [Shahid Beheshti University]
卷期号:8 (4): 307-313 被引量:14
标识
DOI:10.22037/ijpr.2010.827
摘要

Recurrent vulvovaginal candidiasis (RVVC) is seen in 5% of women with Candida vaginitis. Use of fluconazole as prophylactic treatment has been suggested for RVVC. The aim of the present study was to evaluate the efficacy of fluconazole suppressive therapy in RVVC patients, as a randomized, placebo-controlled, double-blind prophylactic study. Among the 330 women with acute symptomatic vulvovaginal candidiasis referred to Mirza-kouchak Khan gynecology hospital, 64 eligible subjects with RVVC were enrolled. Then, all of them were treated with fluconazole (150 mg orally every 3 days, for three doses). This was followed by microscopical and clinical examination. Next, patients were randomly divided into two groups. In the fluconazole group (n = 32), patients received fluconazole 150 mg, per week for 6 months and in the control group (n = 32) they received placebo. All the patients were revisited on a monthly basis and at the end of treatment, as well as 3 and 6 months after treatment. At the end of treatment, the frequency of positive culture in fluconazole group was significantly lower than the placebo group (25% vs. 62.5%, P = 0.05). Furthermore, the rate of clinical recurrence was significantly lower in the fluconazole group,with respect to the placebo group (18.8% vs. 50%, P = 0.017). However, following band 6 months after treatment, patients who received fluconazole maintenance therapy had a non-significant differences, compared to the placebo group, based on the rate of clinical recurrence or the frequency of positive cultures. Resistance to fluconazole (MIC ≥ 64) was comparable between groups. Despite the fact that fluconazole is well tolerated by the patients, suppressive treatment with fluconazole in RVVC patients had an insufficient effect on prevention from recurrence of clinical signs and the improvement of vaginal mycological status in long term (3-6 months after treatment).
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