Unit of Lower Genital Tract Disease, Vittore Buzzi Hospital, University of Milan, Milan, Italy -
Clinica Medicală, Timisoara, Romania.
Minerva Ginecol. 2020 Oct;72(5):292-298. doi: 10.23736/S0026-4784.20.04661-4.
The effectiveness of a new vaginal medical device, which contains polycarbophil, 0.04% lauryl glucoside and glycerides (Polybactum, Effik Italia Spa, Cinisello Balsamo, Milan, Italy), in reducing BV recurrence rate was investigated.
This was a multicenter, open label, not comparative study. Women over 18 years old affected by recurrent BV were included. The latest episode was diagnosed by Amsel criteria 6-9 days before the start of the study and treated with vaginal metronidazole (gel 0.75% mg for 5 days or ovules 500 mg for 7 days). The recurrence was defined by at least 2 episodes in the previous 12 months. Polybactum vaginal ovules, day 1-4-7, were started within the 12 and the 24 hour after the end of metronidazole therapy and repeated monthly for 3 cycles.
The first 41 patients enrolled were evaluated for an interim analysis 6 months after the study started; 2 patients interrupted the trial, leaving 39 evaluable subjects. The recurrence rate was significantly reduced compared to previous published data (10.26% vs. 40% P<0.001). In 35 patients without recurrence, the assessment of Lactobacillus vaginal flora performed by phase contrast microscopy evidenced a significant improvement form baseline (P=0.022) The investigator global assessment of tolerability was excellent in 38 out of 39 cases.
Our research showed that 3 monthly cycles of Polybactum ovules administered after one course of metronidazole vaginal therapy can reduce the rate of Bacterial vaginosis recurrence and improve the vaginal milieu, favoring the growth of vaginal lactobacillus species.
研究了一种含有聚卡波非、0.04%月桂基葡糖苷和甘油酯的新型阴道医学装置（Polybactum，Effik Italia Spa，Cinisello Balsamo，米兰，意大利）在降低细菌性阴道病复发率方面的效果。
这是一项多中心、开放标签、非对照研究。纳入年龄在 18 岁以上、患有复发性细菌性阴道病的女性。最新的发作是在研究开始前 6-9 天通过 Amsel 标准诊断的，并使用阴道甲硝唑（凝胶 0.75%mg 治疗 5 天或阴道栓剂 500mg 治疗 7 天）进行治疗。复发定义为在过去 12 个月内至少发生 2 次。Polybactum 阴道栓剂，第 1-4-7 天，在甲硝唑治疗结束后 12 小时内开始，并在接下来的 24 小时内重复使用，每月重复 3 个周期。
研究开始后 6 个月对最初纳入的 41 例患者进行了中期分析；2 例患者中断了试验，留下 39 例可评估的受试者。与以前发表的数据相比，复发率显著降低（10.26%比 40%，P<0.001）。在 35 例无复发的患者中，通过相差显微镜对阴道乳杆菌菌群的评估显示，从基线开始有显著改善（P=0.022）。39 例患者中，38 例研究者对耐受性的总体评估为优秀。
我们的研究表明，在一疗程甲硝唑阴道治疗后，每月使用 3 个周期的 Polybactum 阴道栓剂可降低细菌性阴道病的复发率，并改善阴道环境，有利于阴道乳杆菌属的生长。
