随机试验表明，Lactin-V 可预防细菌性阴道病复发。
Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis.
机构信息
From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).
出版信息
N Engl J Med. 2020 May 14;382(20):1906-1915. doi: 10.1056/NEJMoa1915254.
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 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, 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. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT02766023.).
背景
细菌性阴道病影响 15%至 50%的育龄妇女，且在接受抗生素治疗后复发常见。高复发率表明需要新的治疗方法来预防复发性细菌性阴道病。
方法
我们进行了一项随机、双盲、安慰剂对照、2b 期试验，以评估 CTV-05（Lactin-V）预防细菌性阴道病复发的能力。18 至 45 岁的女性，曾被诊断为细菌性阴道病，且符合纳入标准，已完成阴道甲硝唑凝胶治疗，按 2:1 的比例随机分配，接受阴道给予 Lactin-V 或安慰剂治疗 11 周；随访至第 24 周。主要结局是第 12 周细菌性阴道病复发的女性百分比。
结果
共有 228 名女性接受随机分组：152 名进入 Lactin-V 组，76 名进入安慰剂组；其中，Lactin-V 组 88%的参与者和安慰剂组 84%的参与者可对主要结局进行评估。在意向治疗人群中，Lactin-V 组 12 周时细菌性阴道病复发 46 例（30%），安慰剂组 34 例（45%）（多重插补缺失反应后的风险比，0.66；95%置信区间 [CI]，0.44 至 0.87；P=0.01）。第 24 周时的复发风险比（同样用多重插补缺失反应计算）为 0.73（95%CI，0.54 至 0.92）。在第 12 周访视时，Lactin-V 组 79%的参与者检测到 CTV-05。Lactin-V 或安慰剂组至第 24 周至少有 1 例与 Lactin-V 或安慰剂相关的不良事件的参与者百分比无显著差异。两组局部或全身不良事件的百分比相似。
结论
与安慰剂相比，在阴道用甲硝唑治疗后使用 Lactin-V 可显著降低细菌性阴道病在 12 周时的复发率。（由美国国立卫生研究院资助；临床试验.gov 编号，NCT02766023。）
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