Wiest W, Ruffmann R
Frauenklinik, Vinzenz Krankenhaus, Mainz, FRG.
J Int Med Res. 1987 Sep-Oct;15(5):319-25. doi: 10.1177/030006058701500508.
In an unblinded, randomized parallel group trial three different therapeutic dose schedules of fenticonazole (vaginal ovules) were compared in the treatment of vaginal candidiasis. A total of 60 patients, aged 17-71 years, affected by mycologically confirmed symptomatic vaginal candidiasis were included and randomly allocated to three treatment groups: 200 mg daily, for 3 days; 600 mg in a single administration; and 1000 mg in a single administration. Therapeutic efficacy was assessed by microbiological and clinical criteria 7 days after the end of the treatment. All mycologically cured patients were re-checked, microbiologically and clinically, 2 weeks after the end of treatment to identify and evaluate possible relapses. The results obtained indicate that vaginal application of fenticonazole ovules is highly effective in producing both symptomatic relief and mycological sterilization of vaginal swabs in 75-85% of treated patients. No relapses were noted at the time of re-check. The three administration schedules tested appear to be equally effective and well tolerated. In one case only of the group given 200 mg and two cases of those given 1000 mg, a local burning sensation was noted. These results show that short-term treatment of vaginal candidiasis with fenticonazole ovules is effective and well tolerated.
在一项非盲法、随机平行组试验中,比较了芬替康唑(阴道栓剂)三种不同治疗剂量方案治疗阴道念珠菌病的效果。共有60例年龄在17至71岁之间、经真菌学确诊为有症状的阴道念珠菌病患者被纳入研究,并随机分为三个治疗组:每日200毫克,连用3天;单次给药600毫克;单次给药1000毫克。在治疗结束7天后,通过微生物学和临床标准评估治疗效果。所有经真菌学治愈的患者在治疗结束后2周进行微生物学和临床复查,以确定和评估可能的复发情况。获得的结果表明,阴道应用芬替康唑栓剂对75%至85%的治疗患者在缓解症状和使阴道拭子真菌学除菌方面非常有效。复查时未发现复发情况。所测试的三种给药方案似乎同样有效且耐受性良好。仅在200毫克组中有1例、1000毫克组中有2例出现局部烧灼感。这些结果表明,用芬替康唑栓剂短期治疗阴道念珠菌病有效且耐受性良好。