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Abstract：
OBJECTIVE: Live biotherapeutic products (LBPs) containing vaginal Lactobacillus crispatus are promising adjuvant treatments to prevent recurrent bacterial vaginosis (BV) but may depend on the success of initial antibiotic treatment.
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.
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.
摘要：
目的：含有阴道型卷曲乳杆菌的活的生物治疗产品（LBP）是预防复发性细菌性阴道病（BV）的有希望的辅助治疗方法，但可能取决于初始抗生素治疗的成功与否。
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。
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。
