Ray Debarti, Goswami Ravinder, Banerjee Uma, Dadhwal Vatsla, Goswami Deepti, Mandal Piyali, Sreenivas Vishnubhatla, Kochupillai Narayana
Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, New Delhi 110029, India.
Diabetes Care. 2007 Feb;30(2):312-7. doi: 10.2337/dc06-1469.
A large proportion of vulvovaginal candidiasis (VVC) in diabetes is due to non-albicans Candida species such as C. glabrata and C. tropicalis. Observational studies indicate that diabetic patients with C. glabrata VVC respond poorly to azole drugs. We evaluated the response to oral fluconazole and boric acid vaginal suppositories in diabetic patients with VVC.
A total of 112 consecutive diabetic patients with VVC were block randomized to receive either single-dose oral 150-mg fluconazole or boric acid vaginal suppositories (600 mg/day for 14 days). The primary efficacy outcome was the mycological cure in patients with C. glabrata VVC in the two treatment arms. The secondary outcomes were the mycological cure in C. albicans VVC, overall mycological cure irrespective of the type of Candida species, frequencies of yeast on direct microscopy, and clinical symptoms and signs of VVC on the 15th day of treatment. Intention-to-treat (ITT; n = 111) and per-protocol (PP; n = 99) analyses were performed.
C. glabrata was isolated in 68 (61.3%) and C. albicans in 32 (28.8%) of 111 subjects. Patients with C. glabrata VVC showed higher mycological cure with boric acid compared with fluconazole in the ITT (21 of 33, 63.6% vs. 10 of 35, 28.6%; P = 0.01) and PP analyses (21 of 29, 72.4% vs. 10 of 30, 33.3%; P = 0.01). The secondary efficacy outcomes were not significantly different in the two treatment arms in the ITT and PP analyses.
Diabetic women with C. glabrata VVC show higher mycological cure with boric acid vaginal suppositories given for 14 days in comparison with single-dose oral 150-mg fluconazole.
糖尿病患者中很大一部分外阴阴道念珠菌病(VVC)是由非白色念珠菌引起的,如光滑念珠菌和热带念珠菌。观察性研究表明,患有光滑念珠菌性VVC的糖尿病患者对唑类药物反应不佳。我们评估了口服氟康唑和硼酸阴道栓剂对糖尿病VVC患者的疗效。
总共112例连续的糖尿病VVC患者被整群随机分组,分别接受单剂量口服150毫克氟康唑或硼酸阴道栓剂(600毫克/天,共14天)。主要疗效指标是两个治疗组中光滑念珠菌性VVC患者的真菌学治愈情况。次要指标是白色念珠菌性VVC的真菌学治愈情况、无论念珠菌种类如何的总体真菌学治愈情况、直接显微镜检查下酵母菌的频率以及治疗第15天时VVC的临床症状和体征。进行了意向性治疗(ITT;n = 111)和符合方案(PP;n = 99)分析。
111名受试者中,68例(61.3%)分离出光滑念珠菌,32例(28.8%)分离出白色念珠菌。在ITT分析(33例中的21例,63.6%对35例中的10例,28.6%;P = 0.01)和PP分析(29例中的21例,72.4%对30例中的10例,33.3%;P = 0.01)中,与氟康唑相比,使用硼酸治疗光滑念珠菌性VVC的患者真菌学治愈率更高。在ITT和PP分析中,两个治疗组的次要疗效指标没有显著差异。
与单剂量口服150毫克氟康唑相比,糖尿病合并光滑念珠菌性VVC的女性使用硼酸阴道栓剂治疗14天的真菌学治愈率更高。