METHODS: The study included 91 female patients and had a randomized, controlled sequential design, with parallel groups. Ovules and douche were tested and compared to a control group treated with sterile physiological solution. Total symptom score (TSS), individual signs and symptoms, therapeutic success were evaluated, as well as safety and tolerability.
RESULTS: The tyndallized ferments formulations (ovules and douche) had a safe and tolerable profile, and resulted in a significant decrease in TSS in patients affected by nonspecific vulvovaginitis, both at 5 and 10 days of treatment, when compared to a control group. The treatment was more effective than the control in reducing symptoms such as vulvar erythema, vulvar edema, itching, and burning. Patients affected by vulvovaginitis and HPV-positive received a 30 days treatment either with ovules or ovules + douche, and we observed an improvement at Day 30 compared to Day 0, for both regimens.
CONCLUSIONS: Our study suggests that topical treatment with tyndallized ferments is a safe and effective strategy to reduce symptoms of nonspecific vulvovaginitis.
方法:该研究包括91名女性患者,受控顺序设计,平行组。测试胚珠和冲洗液,并与用无菌生理溶液处理的对照组进行比较。总症状评分(TSS),个别体征和症状,评估治疗成功,以及安全性和耐受性。
结果:发酵发酵制剂(胚珠和冲洗液)具有安全性和耐受性,并导致受非特异性外阴阴道炎影响的患者的TSS显着下降,在治疗的5天和10天,与对照组相比。治疗在减轻外阴红斑等症状方面比对照组更有效,外阴水肿,瘙痒,和燃烧。受外阴阴道炎和HPV阳性影响的患者接受了30天的胚珠或胚珠+冲洗治疗,与第0天相比,我们观察到两种方案在第30天的改善。
结论:我们的研究表明,局部治疗用感染发酵剂是一种安全有效的策略,可以减轻非特异性外阴阴道炎的症状。