METHODS: A post hoc analysis of data collected during the phase 2b LACTIN-V randomized control trial (L. crispatus CTV-05) explored the impact of clinical BV cure defined as Amsel criteria 0 of 3 (excluding pH, per 2019 Food and Drug Administration guidance) 2 days after completion of treatment with vaginal metronidazole gel on the effectiveness of an 11-week LACTIN-V dosing regimen to prevent BV recurrence by 12 and 24 weeks.
RESULTS: At enrollment, 88% of participants had achieved postantibiotic clinical BV cure. The effect of LACTIN-V on BV recurrence compared with placebo differed by initial clinical BV cure status. The LACTIN-V to placebo risk ratio of BV recurrence by 12 weeks was 0.56 (95% confidence interval, 0.35-0.77) among participants with initial clinical BV cure after metronidazole treatment and 1.34 (95% confidence interval, 0.47-2.23) among participants without postantibiotic clinical BV cure. Among women receiving LACTIN-V, those who had achieved postantibiotic clinical BV cure at enrollment reached higher levels of detectable L. crispatus CTV-05 compared with women failing to achieve postantibiotic clinical BV cure.
CONCLUSIONS: LACTIN-V seems to only decrease BV recurrence in women with clinical cure of BV after initial antibiotic treatment. Future trials of LBPs should consider limiting enrollment to these women.
方法:对2b期LACTIN-V随机对照试验期间收集的数据进行事后分析(L.crispatusCTV-05)探讨了临床BV治愈的影响,定义为Amsel标准0/3(不包括pH,根据2019年食品药品监督管理局指南)在完成阴道甲硝唑凝胶治疗后2天,对11周LACTIN-V给药方案预防BV复发的有效性进行了12周和24周。
结果:在注册时,88%的参与者实现了抗生素后临床BV治愈。与安慰剂相比,LACTIN-V对BV复发的影响因初始临床BV治愈状态而异。12周时LACTIN-V与安慰剂组BV复发的风险比为0.56(95%置信区间,0.35-0.77)在甲硝唑治疗后初始临床BV治愈的参与者和1.34(95%置信区间,0.47-2.23)在没有抗生素后临床BV治愈的参与者中。在接受Lactin-V的女性中,与未能实现抗生素后临床BV治愈的女性相比,在纳入研究时已实现抗生素后临床BV治愈的女性达到了更高的可检测的crispatusCTV-05水平.
结论:LACTIN-V似乎仅在初始抗生素治疗后临床治愈BV的女性中减少BV复发。未来的LBP试验应考虑限制这些女性的入学。