Abstract：
OBJECTIVE: In this study, we tested the efficacy, safety, and tolerability of vaginal ovules and a vaginal douche containing tyndallized ferments in women affected by nonspecific vulvovaginitis, with or without the human papillomavirus (HPV).
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.
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.
摘要：
目的：在本研究中，我们测试了疗效，安全,受非特异性外阴阴道炎影响的女性的阴道胚珠和阴道冲洗液的耐受性，有或没有人乳头瘤病毒（HPV）。
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。
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。
