Department of Obstetrics and Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, 10700, Thailand.
Arch Gynecol Obstet. 2021 Jan;303(1):151-160. doi: 10.1007/s00404-020-05784-z. Epub 2020 Sep 17.
To compare the clinical response, microscopic examination and fungal culture between dequalinium chloride (DQC) and clotrimazole (CT) for treating vaginal candidiasis (VC).
The double-blind, randomized study was conducted from September 2014 to September 2016 at Siriraj Hospital, Thailand. Eligible participants were Thai women diagnosed with VC by microscopic examination. The exclusion criteria included immunocompromised conditions, consumption of antifungal drugs, and having recurrent VC. Each participant was randomized with a 1:1 allocation to receive six vaginal tablets of 100 mg CT or 10 mg DQC. Two visits included 10 ± 2 days (C1) and 38 ± 4 days (C2). Outcome measures were improvement of VC symptoms, microscopic examination, culture, satisfaction and tolerability.
Of 155 eligible participants, 150 were randomized and allocated into CT (N = 76) and DQC (N = 74). The average age was 31.1 ± 7.2 years. Comparable improvement of clinical response was demonstrated (OR at C1 0.79, 95% CI 0.56-1.10, p = 0.197; and OR at C2 0.99, 95% CI 0.69-1.43, p = 0.985). Of CT and DQC groups, the microscopic examination was positive at 11/75 (14.9%) vs 18/72 (25.3%) at C1 and 18/74 (24.3%) vs 28/66 (42.4%) at C2. And the culture was positive at 25/75 (33.8%) vs 46/72 (65.7%) at C1 and at 26/74 (36.6%) vs 46/66 (69.7%) at C2. Most participants had high satisfaction and tolerability and none reported any side effects.
DQC and CT show comparable clinical response but CT results in greater improvement of microscopic examination and fungal culture.
The Clinical Trial Registry number was NCT02242695. (September 17, 2014).
比较盐酸双氯苯双胍己烷（DQC）和克霉唑（CT）治疗阴道念珠菌病（VC）的临床疗效、显微镜检查和真菌培养。
本研究为 2014 年 9 月至 2016 年 9 月在泰国诗里拉吉医院进行的一项双盲、随机研究。合格的参与者为经显微镜检查诊断为 VC 的泰国女性。排除标准包括免疫功能低下、使用抗真菌药物以及复发性 VC。每位参与者按 1:1 随机分配接受 6 片 100mg CT 或 10mg DQC 的阴道用药。两次就诊时间分别为 10±2 天（C1）和 38±4 天（C2）。主要结局指标为 VC 症状改善、显微镜检查、培养、满意度和耐受性。
155 名合格参与者中，150 名被随机分为 CT 组（N=76）和 DQC 组（N=74）。平均年龄为 31.1±7.2 岁。在 C1 时，两组的临床反应改善程度相当（OR 值为 0.79，95%CI 为 0.56-1.10，p=0.197；在 C2 时，OR 值为 0.99，95%CI 为 0.69-1.43，p=0.985）。在 CT 组和 DQC 组中，C1 时显微镜检查阳性分别为 11/75（14.9%）和 18/72（25.3%），C2 时分别为 18/74（24.3%）和 28/66（42.4%）。C1 时培养阳性分别为 25/75（33.8%）和 46/72（65.7%），C2 时分别为 26/74（36.6%）和 46/66（69.7%）。大多数参与者对治疗有高度满意度和耐受性，无人报告任何不良反应。
DQC 和 CT 的临床疗效相当，但 CT 可更显著改善显微镜检查和真菌培养。
NCT02242695（2014 年 9 月 17 日）。
