Schwebke Jane R, Carter Belvia A, Waldbaum Arthur S, Agnew Kathy J, Paull Jeremy R A, Price Clare F, Castellarnau Alex, McCloud Philip, Kinghorn George R
Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham, AL, USA.
Women's Physician Group, Memphis, TN, USA.
Eur J Obstet Gynecol Reprod Biol X. 2021 Jan 19;10:100121. doi: 10.1016/j.eurox.2021.100121. eCollection 2021 Apr.
The objective of the study was to confirm the efficacy and safety of Astodrimer 1% Gel to prevent recurrence of bacterial vaginosis.
864 women with a diagnosis of bacterial vaginosis and a history of recurrent bacterial vaginosis were enrolled in North America and first received oral metronidazole (500 mg twice daily for 7 days). Women successfully treated with metronidazole were randomly assigned 1:1 to Astodrimer 1% Gel (N = 295) or placebo (N = 291) at a dose of 5 g vaginally every second day for 16 weeks, and followed for a further 12 weeks off-treatment. The primary endpoint was recurrence of bacterial vaginosis (presence of ≥3 Amsel criteria) at or by Week 16. Secondary endpoints included time to recurrence, and recurrence of subject-reported symptoms. Adverse events were monitored throughout the study.
Astodrimer 1% Gel was superior to placebo for the primary and many secondary efficacy measures. At or by Week 16, bacterial vaginosis recurred in 44.2 % (130/294) of women receiving astodrimer and 54.3 % (158/291) receiving placebo ( = .015). Time to recurrence of bacterial vaginosis was significantly longer for women receiving astodrimer compared with placebo (Kaplan-Meier survival curves, = .007). Recurrence of subject-reported symptoms at or by Week 16 was also significantly lower in the astodrimer arm compared with placebo (vaginal odor and/or discharge, 27.9 % [75/269] vs 40.6 % [108/266], = .002). A significantly lower proportion of patients receiving astodrimer compared with placebo had recurrence of bacterial vaginosis at or by Week 16 by other secondary measures, including individual Amsel criteria (vaginal discharge and clue cells) and Nugent score 7-10. Recurrence of subject-reported vaginal odor and/or discharge was significantly lower in the astodrimer arm compared with placebo up to 8 weeks after cessation of therapy (36.1 % [97/269] vs 45.5 % [121/266], = .027).Adverse events were infrequent, and rates were generally similar between placebo and astodrimer groups. Vulvovaginal candidiasis and urinary tract infection occurred more often in women receiving astodrimer.
Astodrimer 1% Gel, administered every second day for 16 weeks, was effective and superior to placebo for prevention of recurrent bacterial vaginosis in women with a history of recurrent BV, and was well-tolerated.
本研究的目的是确认1%阿斯托地聚物凝胶预防细菌性阴道病复发的有效性和安全性。
864名诊断为细菌性阴道病且有复发性细菌性阴道病史的女性在北美入组，首先接受口服甲硝唑（500mg，每日两次，共7天）治疗。甲硝唑治疗成功的女性被随机1:1分配至1%阿斯托地聚物凝胶组（N = 295）或安慰剂组（N = 291），每两天阴道给药5g，持续16周，并在停药后继续随访12周。主要终点是在第16周或之前细菌性阴道病的复发（存在≥3项阿姆斯勒标准）。次要终点包括复发时间以及受试者报告症状的复发情况。在整个研究过程中监测不良事件。
在主要疗效指标和许多次要疗效指标方面，1%阿斯托地聚物凝胶优于安慰剂。在第16周或之前，接受阿斯托地聚物治疗的女性中有44.2%（130/294）细菌性阴道病复发，接受安慰剂治疗的女性中有54.3%（158/291）复发（P = 0.015）。与安慰剂相比，接受阿斯托地聚物治疗的女性细菌性阴道病复发时间显著更长（Kaplan-Meier生存曲线，P = 0.007）。在第16周或之前，阿斯托地聚物组受试者报告症状的复发率也显著低于安慰剂组（阴道异味和/或分泌物，27.9% [75/269] 对40.6% [108/266]，P = 0.002）。与安慰剂相比，接受阿斯托地聚物治疗的患者在第16周或之前通过其他次要指标（包括单个阿姆斯勒标准（阴道分泌物和线索细胞）以及纽金特评分7 - 10）细菌性阴道病复发的比例显著更低。在治疗停止后长达8周内，阿斯托地聚物组受试者报告的阴道异味和/或分泌物复发率显著低于安慰剂组（36.1% [97/269] 对45.5% [121/266]，P = 0.027）。不良事件不常见，安慰剂组和阿斯托地聚物组的发生率总体相似。接受阿斯托地聚物治疗的女性中，外阴阴道念珠菌病和尿路感染更常发生。
每两天给药一次，持续16周的1%阿斯托地聚物凝胶在预防有复发性细菌性阴道病史女性的细菌性阴道病复发方面有效且优于安慰剂，并且耐受性良好。
