Sobel J D, Brooker D, Stein G E, Thomason J L, Wermeling D P, Bradley B, Weinstein L
Division of Infectious Diseases, Wayne State University, Detroit, MI 48201, USA.
Am J Obstet Gynecol. 1995 Apr;172(4 Pt 1):1263-8. doi: 10.1016/0002-9378(95)91490-0.
Candida vaginitis is currently treated with a wide range of intravaginal preparations usually prescribed over several days. Fluconazole with its marked activity against Candida species and favorable pharmacokinetics offered a safe, effective, and convenient alternative to topical therapy in a single-dose regimen.
We conducted a multicenter, randomized, prospective, single-blinded study of 429 patients with acute Candida vaginitis, comparing the efficacy and safety of a single oral 150 mg dose of fluconazole with 7-day clotrimazole 100 mg vaginal treatment. Posttherapy evaluations and mycologic eradication rates were conducted.
No statistically significant differences were seen between fluconazole and clotrimazole in the clinical, mycologic, or therapeutic responses. At the 14-day evaluation clinical cure or improvement was seen in 94% of fluconazole-treated patients and 97% of clotrimazole-treated patients. Mycologic and therapeutic cures were seen in 77% and 76% of the fluconazole and 72% of the clotrimazole groups, respectively. At the 35-day evaluation 75% of both groups remained clinically cured, and 56% of the fluconazole and 52% of the clotrimazole group were considered therapeutic cures. In both treatment groups patients with a history of recurrent vaginitis (33/84) compared with those without a history of recurrent vaginitis (177/266) were significantly less likely to respond clinically and mycologically (p < 0.001). Twenty-seven percent of the fluconazole-treated patients and 17% of the clotrimazole-treated patients reported mild side effects only.
Fluconazole administered as a single 150 mg oral dose proved to be as safe and effective as 7 days of intravaginal clotrimazole therapy for Candida vaginitis. Therapy of vaginitis should be individualized, taking into consideration severity of disease, history of recurrent vaginitis, and patient preference.
目前念珠菌性阴道炎的治疗采用多种阴道内制剂，通常需连续使用数天。氟康唑对念珠菌属具有显著活性且药代动力学良好，在单剂量方案中为局部治疗提供了一种安全、有效且便捷的替代方法。
我们对429例急性念珠菌性阴道炎患者进行了一项多中心、随机、前瞻性、单盲研究，比较单次口服150mg氟康唑与7天使用100mg克霉唑阴道给药的疗效和安全性。进行了治疗后评估和真菌清除率测定。
在临床、真菌学或治疗反应方面，氟康唑和克霉唑之间未观察到统计学上的显著差异。在14天评估时，94%接受氟康唑治疗的患者和97%接受克霉唑治疗的患者临床治愈或病情改善。氟康唑组和克霉唑组的真菌学和治疗治愈率分别为77%、76%和72%。在35天评估时，两组均有75%的患者临床治愈，氟康唑组和克霉唑组分别有56%和52%的患者被认为达到治疗治愈。在两个治疗组中，有复发性阴道炎病史的患者（33/84）与无复发性阴道炎病史的患者（177/266）相比，临床和真菌学反应的可能性显著降低（p<0.001）。仅27%接受氟康唑治疗的患者和17%接受克霉唑治疗的患者报告有轻微副作用。
单次口服150mg氟康唑治疗念珠菌性阴道炎与7天阴道内使用克霉唑治疗一样安全有效。阴道炎的治疗应个体化，考虑疾病严重程度、复发性阴道炎病史和患者偏好。
