PDF(Pubmed)
Abstract：
OBJECTIVE: Recurrent bacterial vaginosis (RBV) after antibiotic treatment has relapse rates of 35% within 3 months and 60% within 12 months. A medical device containing polycarbophil, lauryl glucoside, and glycerides (PLGG) inhibits bacterial growth and has mucoadhesive properties. This study examined the efficacy of the device in women with RBV.
METHODS: This post-market clinical follow-up study comprised two phases. The first phase was an interventional, open-label, non-controlled, multicenter study enrolling 56 women. The second phase was an observational 10-month follow-up without treatment.
RESULTS: After three cycles of PLGG treatment, recurrence was identified in 8 of 54 evaluable patients (14.81%). A positive effect on lactobacilli in the vaginal secretions was observed in 26 of 39 patients (66.67%). Among 35 patients observed after stopping PLGG treatment, one case of RBV (2.86%) was observed after 4 months, and an additional six cases (17.14%) were observed after 10 ± 2 months. Therefore, no recurrence was evidenced in 12 subjects (34.28%) at the end of the study.
CONCLUSIONS: The use of PLGG vaginal ovules in the treatment of BV reduces the rate of recurrence and apparently produces a positive effect on the vaginal microbiota.
METHODS: This post-market clinical follow-up study comprised two phases. The first phase was an interventional, open-label, non-controlled, multicenter study enrolling 56 women. The second phase was an observational 10-month follow-up without treatment.
RESULTS: After three cycles of PLGG treatment, recurrence was identified in 8 of 54 evaluable patients (14.81%). A positive effect on lactobacilli in the vaginal secretions was observed in 26 of 39 patients (66.67%). Among 35 patients observed after stopping PLGG treatment, one case of RBV (2.86%) was observed after 4 months, and an additional six cases (17.14%) were observed after 10 ± 2 months. Therefore, no recurrence was evidenced in 12 subjects (34.28%) at the end of the study.
CONCLUSIONS: The use of PLGG vaginal ovules in the treatment of BV reduces the rate of recurrence and apparently produces a positive effect on the vaginal microbiota.
摘要：
目的：抗生素治疗后复发性细菌性阴道病（RBV）3个月内复发率为35％，12个月内复发率为60％。一种含有聚卡波非的医疗器械，月桂基葡萄糖苷，和甘油酯（PLGG）抑制细菌生长并具有粘膜粘附特性。这项研究检查了该装置在RBV女性中的功效。
方法：本上市后临床随访研究包括两个阶段。第一阶段是介入，开放标签，非受控,多中心研究招募56名女性。第二阶段是观察性的10个月随访，没有治疗。
结果：经过三个周期的PLGG治疗，54例可评估患者中有8例(14.81%)出现复发.39例患者中有26例（66.67％）对阴道分泌物中的乳酸杆菌有积极作用。在停止PLGG治疗后观察到的35例患者中，4个月后观察到1例RBV（2.86%），10±2个月后观察到另外6例(17.14%)。因此,在研究结束时,12名受试者(34.28%)未发现复发.
结论：使用PLGG阴道胚珠治疗BV可降低复发率，并对阴道菌群产生积极影响。
方法：本上市后临床随访研究包括两个阶段。第一阶段是介入，开放标签，非受控,多中心研究招募56名女性。第二阶段是观察性的10个月随访，没有治疗。
结果：经过三个周期的PLGG治疗，54例可评估患者中有8例(14.81%)出现复发.39例患者中有26例（66.67％）对阴道分泌物中的乳酸杆菌有积极作用。在停止PLGG治疗后观察到的35例患者中，4个月后观察到1例RBV（2.86%），10±2个月后观察到另外6例(17.14%)。因此,在研究结束时,12名受试者(34.28%)未发现复发.
结论：使用PLGG阴道胚珠治疗BV可降低复发率，并对阴道菌群产生积极影响。
