Downtown Women's Health Care, Denver, CO, United States of America.
Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham, AL, United States of America.
PLoS One. 2020 May 4;15(5):e0232394. doi: 10.1371/journal.pone.0232394. eCollection 2020.
Astodrimer Gel contains a novel dendrimer intended to treat and prevent bacterial vaginosis. We assessed the efficacy and safety of Astodrimer Gel for treatment of bacterial vaginosis.
132 women with bacterial vaginosis were randomized 1:1:1:1 to Astodrimer 0.5% (N = 34), 1% (N = 33), or 3% (N = 32) Gel or hydroxyethyl cellulose placebo gel (N = 33) at a dose of 5 g vaginally once daily for 7 days at 6 centers in the United States. The primary endpoint was clinical cure (no bacterial vaginosis vaginal discharge and no more than one of 1) vaginal pH ≥4.5; 2) ≥20% clue cells; or 3) positive whiff test) at study days 21-30. Secondary analyses included clinical cure at study days 9-12, patient-reported symptoms, acceptability and adverse events.
The Astodrimer 1% Gel dose was superior to placebo for the primary and selected secondary efficacy measures in the modified intent-to-treat population. Clinical cure rates at day 9-12 were superior to placebo for the Astodrimer 3%, 1% and 0.5% Gel groups (62.5% [15/24; P = .002], 74.1% [20/27; P < .001], and 55.2% [16/29; P = .001], respectively, vs. 22.2% [6/27]). At day 21-30, clinical cure rates were 46.2% (12/26) for the 1% dose vs. 11.5% for placebo (3/26; P = .006). A greater proportion of patients reported absence of vaginal discharge and vaginal odor at day 9-12 and day 21-30 for Astodrimer Gel groups compared with placebo. Adverse events considered potentially treatment-related occurred in only 25% of Astodrimer Gel-treated patients vs. 22% of placebo patients.
Astodrimer Gel once daily for 7 days was superior to placebo for treatment of bacterial vaginosis and was well-tolerated. The 1% dose consistently showed the strongest efficacy across endpoints. These results support a role for Astodrimer Gel, 1%, as an effective treatment for bacterial vaginosis.
阿司多明凝胶含有一种新型树状聚合物，旨在治疗和预防细菌性阴道病。我们评估了阿司多明凝胶治疗细菌性阴道病的疗效和安全性。
132 名细菌性阴道病患者按 1:1:1:1 随机分为阿司多明 0.5%（N=34）、1%（N=33）或 3%（N=32）凝胶或羟乙基纤维素安慰剂凝胶（N=33）组，剂量为 5 g 阴道单次给药，每日 1 次，共 7 天，在美国 6 个中心进行。主要终点为临床治愈（无细菌性阴道病阴道分泌物和以下 1）阴道 pH 值≥4.5；2）≥20%线索细胞；或 3）阳性气味试验）在研究第 21-30 天。次要分析包括研究第 9-12 天的临床治愈率、患者报告的症状、可接受性和不良事件。
在改良意向治疗人群中，阿司多明 1%凝胶剂量优于安慰剂，主要和选择的次要疗效指标。在第 9-12 天，阿司多明 3%、1%和 0.5%凝胶组的临床治愈率均优于安慰剂（62.5%[15/24；P=0.002]，74.1%[20/27；P<0.001]，55.2%[16/29；P=0.001]，分别为 22.2%[6/27]）。在第 21-30 天，1%剂量的临床治愈率为 46.2%（12/26），安慰剂组为 11.5%（3/26；P=0.006）。与安慰剂组相比，更多的患者在第 9-12 天和第 21-30 天报告无阴道分泌物和阴道异味。仅有 25%的阿司多明凝胶治疗患者发生认为可能与治疗相关的不良事件，安慰剂组为 22%。
阿司多明凝胶每日 1 次，连用 7 天，治疗细菌性阴道病优于安慰剂，且耐受性良好。1%剂量在各终点均表现出最强的疗效。这些结果支持阿司多明凝胶 1%作为治疗细菌性阴道病的有效药物。
