美国加州大学旧金山分校Craig R. Cohen团队在研究中取得进展。他们探讨了Lactin-V预防细菌性阴道病复发的疗效。2020年5月14日，《新英格兰医学杂志》发表了这一成果。

细菌性阴道病困扰15至50％的育龄妇女，使用抗生素治疗后很容易复发。高复发率表明需要采取新的治疗方法来进行预防。

研究组进行了一项随机、双盲、安慰剂对照的临床2b期试验，以评估卷曲乳杆菌CTV-05（Lactin-V）预防细菌性阴道病复发的能力。研究组招募了228名18-45岁确诊为细菌性阴道病的患者，均已完成阴道甲硝唑凝胶治疗，按2：1随机分组，其中152名接受经阴道给药Lactin-V治疗，76名接受安慰剂治疗，均持续11周，随访持续到第24周。

Lactin-V组中88％和安慰剂组中84％的患者进入最终分析。在意向性治疗人群中，Lactin-V组中有30％的患者在第12周时发生细菌性阴道病复发，安慰剂组中有45％，风险比为0.66，差异显著。到第24周时，复发的风险比为0.73。在12周的随访中，Lactin-V组中有79％的患者检测到了卷曲乳杆菌CTV-05。两组间局部或全身不良事件的发生率无显著差异。

总之，阴道甲硝唑治疗后使用Lactin-V，与安慰剂相比，可显著降低12周后的细菌性阴道病复发率。

附：英文原文

Title: Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis

Author: Craig R. Cohen, M.D.,, Michael R. Wierzbicki, Ph.D.,, Audrey L. French, M.D.,, Sheldon Morris, M.D.,, Sara Newmann, M.D.,, Hilary Reno, M.D.,, Lauri Green, B.S.,, Steve Miller, M.D.,, Jonathan Powell, M.P.H.,, Thomas Parks, Ph.D.,, and Anke Hemmerling, M.D.

Issue&Volume: 2020-05-13

Abstract: Abstract

Background

Bacterial vaginosis affects 15 to 50% of women of reproductive age, and recurrence is common after treatment with an antibiotic agent. The high incidence of recurrence suggests the need for new treatments to prevent recurrent bacterial vaginosis.

Methods

We conducted a randomized, double-blind, placebo-controlled, phase 2b trial to evaluate the ability of Lactobacillus crispatus CTV-05 (Lactin-V) to prevent the recurrence of bacterial vaginosis. Women 18 to 45 years of age who had received a diagnosis of bacterial vaginosis and who had completed a course of vaginal metronidazole gel as part of the eligibility requirements were randomly assigned, in a 2:1 ratio, to receive vaginally administered Lactin-V or placebo for 11 weeks; follow-up occurred through week 24. The primary outcome was the percentage of women who had a recurrence of bacterial vaginosis by week 12.

Results

A total of 228 women underwent randomization: 152 to the Lactin-V group and 76 to the placebo group; of these participants, 88% in the Lactin-V group and 84% in the placebo group could be evaluated for the primary outcome. In the intention-to-treat population, recurrence of bacterial vaginosis by week 12 occurred in 46 participants (30%) in the Lactin-V group and in 34 participants (45%) in the placebo group (risk ratio after multiple imputation for missing responses, 0.66; 95% confidence interval [CI], 0.44 to 0.87; P=0.01). The risk ratio for recurrence by week 24 (also calculated with multiple imputation for missing responses) was 0.73 (95% CI, 0.54 to 0.92). At the 12-week visit, L. crispatus CTV-05 was detected in 79% of participants in the Lactin-V group. The percentage of participants who had at least one adverse event related to Lactin-V or placebo by week 24 did not differ significantly between the groups. The percentage of participants with local or systemic adverse events was similar in the two groups.

Conclusions

The use of Lactin-V after treatment with vaginal metronidazole resulted in a significantly lower incidence of recurrence of bacterial vaginosis than placebo at 12 weeks.

DOI: NJ202005143822010

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1915254