Muñoz Reyes José Rodolfo, Villanueva Reynoso Carlos, Ramos César Julio, Menéndez Vázquez Jorge, Bailón Uriza René, Vargas Antonio José
Hospital de Gineco-Obstetricia Núm, 4 Luis Castelazo Ayala, Instituto Mexicano del Seguro Social, México D.F.
Ginecol Obstet Mex. 2002 Feb;70:59-65.
Fenticonazole is an imidazole derivative with a broad-spectrum antifungal activity mainly against Candida albicans. Fenticonazole nitrate was compared to myconazole vs. test efficacy, tolerance and treatment compliance in-patients with mycotic vulvovaginitis.
Eighty outpatients with mycotic vulvovaginitis were included and randomly placed in two groups of forty patients each one. Each group was either given 200 mg of fenticonazole nitrate intravaginal ovules or 400 mg of myconazole vaginal ovules on a daily basis for three days. Before the pharmacological treatment, each patient was evaluated clinically and microbiologically, as well as at the end of treatment (day 7-10) and one-month (28 days) after treatment. All patients gave informed consent to participate in the trial.
No statistical differences were found between either treatment group during the anthropometric and demographic evaluation, neither in the signs and clinical symptoms of infection. Both treatment groups were considered as comparable. At after treatment evaluation (7-10 days) it was observed disappearance of almost all symptoms. At the final evaluation this fact was even more evident (day 21-28). At the study's completion, clinical efficacy (symptoms relief) was considered satisfactory in 100% (40/40) of the cases in the fenticonazole group and 97.5% (39/40) of myconazole group (one way ANOVA [GLM] analysis). The microorganisms more frequently isolated as the causing agents of infection in both groups were Candida albicans, 93% in the fenticonazole group and 85% in the myconazole group. Upon the study's completion, the microbiological efficacy was considered as successful in 97.5% of the cases in both groups (chi square [x2] analysis). The patient's compliance to the treatment was considered satisfactory in 100% in the fenticonazole group and 97.5% in the myconazole group. Tolerance was considered excellent in 100% (40/40) of the fenticonazole cases and in 95% (38/40) of the myconazole cases. Nevertheless, 5% (2/40) of the patients in the myconazole group had minor adverse events that did not require treatment suspension. No adverse events were reported in the fenticonazole group.
The results showed that both drugs are equally efficient in treating signs and symptoms of the infection as well as equally effective in the microbiological elimination of the causing agents of the mycotic vulvovaginitis.
芬替康唑是一种咪唑衍生物，具有广谱抗真菌活性，主要针对白色念珠菌。将硝酸芬替康唑与咪康唑在霉菌性外阴阴道炎患者中的治疗效果、耐受性和治疗依从性方面进行比较。
纳入80例霉菌性外阴阴道炎门诊患者，随机分为两组，每组40例。每组患者每日分别给予200mg硝酸芬替康唑阴道栓剂或400mg咪康唑阴道栓剂，持续三天。在药物治疗前、治疗结束时（第7 - 10天）以及治疗后1个月（28天）对每位患者进行临床和微生物学评估。所有患者均签署知情同意书参与试验。
在人体测量和人口统计学评估中，两个治疗组之间未发现统计学差异，在感染的体征和临床症状方面也无差异。两个治疗组被认为具有可比性。在治疗后评估（7 - 10天）时，几乎所有症状均消失。在最终评估时（第21 - 28天），这一情况更为明显。在研究结束时，芬替康唑组100%（40/40）的病例和咪康唑组97.5%（39/40）的病例临床疗效（症状缓解）被认为满意（单因素方差分析[GLM]）。两组中最常分离出的作为感染病原体的微生物均为白色念珠菌，芬替康唑组为93%，咪康唑组为85%。在研究结束时，两组中97.5%的病例微生物学疗效被认为成功（卡方[x²]分析）。芬替康唑组患者对治疗的依从性被认为满意的为100%，咪康唑组为97.5%。芬替康唑组100%（40/40）的病例和咪康唑组95%（38/40）的病例耐受性被认为极佳。然而，咪康唑组有5%（2/40）的患者出现轻微不良事件，但无需暂停治疗。芬替康唑组未报告不良事件。
结果表明，两种药物在治疗感染的体征和症状方面同样有效，在微生物学上消除霉菌性外阴阴道炎病原体方面也同样有效。
