Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, CA 94105, USA.
Sex Transm Dis. 2010 Dec;37(12):745-50. doi: 10.1097/OLQ.0b013e3181e50026.
Bacterial vaginosis (BV) is a common vaginal infection caused by a lack of endogenous lactobacilli and overgrowth of pathogens that frequently recurs following antibiotic treatment.
A phase 2a study assessed colonization efficiency, safety, tolerability, and acceptability of Lactobacillus crispatus CTV-05 (LACTIN-V) administered by a vaginal applicator. Twenty-four women with BV were randomized in a 3:1 ratio of active product to placebo. Participants used LACTIN-V at 2 × 10 colony-forming units (cfu)/dose or placebo for 5 initial consecutive days, followed by a weekly application over 2 weeks. They returned for follow-up on Days 10 and 28.
Sixty-one percent of the 18 women randomized to the LACTIN-V group were colonized with L. crispatus CTV-05 at Day 10 or Day 28. Among LACTIN-V users with complete adherence to the study regimen, 78% were colonized at Day 10 or Day 28. Of the 120 adverse events (AEs) that occurred, 108 (90%) and 12 (10%) were of mild and moderate severity, respectively. AEs were evenly distributed between the LACTIN-V and placebo group. Of the total AEs, 93 (78%) were genitourinary in origin. The most common genitourinary AEs included vaginal discharge (46%), abdominal pain (46%), dysuria (21%), pollakiuria (21%), vaginal odor (21%), and genital pruritus (17%). No grade 3 or 4 AEs or serious AEs occurred and no deep epithelial disruption was seen during colposcopic evaluation. The product was well tolerated and accepted.
LACTIN-V colonized well, and was safe and acceptable in women treated for BV.
细菌性阴道病（BV）是一种常见的阴道感染，由内源性乳杆菌缺乏和病原体过度生长引起，抗生素治疗后常复发。
一项 2a 期研究评估了阴道应用器给予的卷曲乳杆菌 CTV-05（LACTIN-V）的定植效率、安全性、耐受性和可接受性。24 名 BV 女性按 3:1 的比例随机分为活性产品组和安慰剂组。参与者使用 LACTIN-V 每次 2×10 菌落形成单位（cfu）/剂量或安慰剂，连续 5 天，然后每周使用一次，持续 2 周。她们在第 10 天和第 28 天返回进行随访。
18 名随机分配至 LACTIN-V 组的女性中，有 61%在第 10 天或第 28 天定植卷曲乳杆菌 CTV-05。在完全遵守研究方案的 LACTIN-V 使用者中，78%在第 10 天或第 28 天定植。发生的 120 次不良事件（AE）中，108 次（90%）和 12 次（10%）分别为轻度和中度严重程度。AE 在 LACTIN-V 组和安慰剂组之间均匀分布。在所有 AEs 中，93 次（78%）起源于泌尿生殖系统。最常见的泌尿生殖系统 AEs 包括阴道分泌物（46%）、腹痛（46%）、尿痛（21%）、尿频（21%）、阴道异味（21%）和生殖器瘙痒（17%）。未发生 3 级或 4 级 AEs 或严重 AEs，阴道镜检查评估未见深部上皮破坏。该产品耐受性良好，可接受。
LACTIN-V 定植良好，在治疗 BV 的女性中安全且可接受。
