Department of Obstetrics and Gynecology, College of Medicine, Alfaisal University, Riyadh, Saudi Arabia.
College of Graduate Health Sciences, University of Tennessee Health Science Center, Memphis, TN, USA.
Int J Clin Pract. 2021 Jul;75(7):e14165. doi: 10.1111/ijcp.14165. Epub 2021 Apr 1.
Bacterial vaginosis is a frequent source of vaginal infection among reproductive-aged women. Astodrimer gel is a novel drug which demonstrated favourable outcomes for treatment of patients with bacterial vaginosis.
We attempted to conduct a systematic review and meta-analysis of all randomized controlled trials (RCTs) which examined the efficacy and safety of astodrimer gel in patients with bacterial vaginosis.
We searched four databases from inception to August 15, 2020, using relevant keywords. We identified all RCTs which surveyed the efficacy and safety of astodrimer gel in treating patients with bacterial vaginosis. We appraised the quality of the included RCTs using the Cochrane risk of bias assessment tool. We pooled dichotomous outcomes as numbers and totals and reported them as risk ratios (RR) with 95% confidence intervals (95% CI) under random- or fixed-effects meta-analysis models depending on heterogeneity.
Three eligible studies comprising four independent RCTs and 1165 patients were identified (614 and 551 patients received astodrimer gel and placebo, respectively). For efficacy outcomes (n = 320 astodrimer gel versus n = 260 placebo), astodrimer gel was significantly superior to placebo for all pooled efficacy outcomes, including clinical cure rate (at 9-12 and 21-30 days), microbiological Nugent cure rate (at 9-12 and 21-30 days), patient self-reported absence of vaginal odor/discharge (at 9-12 and 21-30 days), resolution of Amsel criteria (at 9-12 days) and percentage of patients who did not receive rescue therapy during study. With respect to safety outcomes (n = 614 astodrimer gel versus n = 551 placebo), astodrimer gel demonstrated equal tolerability to placebo for all pooled safety endpoints, expect unfavourably for vulvovaginal candidiasis and treatment-related vulvovaginal candidiasis.
Astodrimer gel is effective in treating bacterial vaginosis and corroborated by clinical (Amsel criteria) and microbiological (Nugent score) measurements as well as patient-reported symptoms. Moreover, astodrimer gel is largely safe and associated with marginal rate of vulvovaginal candidiasis.
细菌性阴道病是育龄妇女阴道感染的常见病因。阿昔莫司凝胶是一种新型药物，其治疗细菌性阴道病的疗效结果良好。
我们试图对所有评估阿昔莫司凝胶治疗细菌性阴道病患者的疗效和安全性的随机对照试验（RCT）进行系统评价和荟萃分析。
我们从建库到 2020 年 8 月 15 日，在四个数据库中使用相关关键词进行了检索。我们确定了所有评估阿昔莫司凝胶治疗细菌性阴道病患者疗效和安全性的 RCT。我们使用 Cochrane 偏倚风险评估工具评估纳入 RCT 的质量。我们将二分类结局作为数量和总和，并根据异质性，在随机或固定效应荟萃分析模型下，将其报告为风险比（RR）和 95%置信区间（95%CI）。
共纳入 3 项符合条件的研究，包括 4 项独立 RCT 和 1165 例患者（分别有 614 例和 551 例患者接受阿昔莫司凝胶和安慰剂治疗）。对于疗效结局（n=320 例阿昔莫司凝胶与 n=260 例安慰剂），阿昔莫司凝胶在所有汇总的疗效结局方面均显著优于安慰剂，包括临床治愈率（第 9-12 天和第 21-30 天）、微生物学 Nugent 治愈率（第 9-12 天和第 21-30 天）、患者自我报告的阴道异味/分泌物消失（第 9-12 天和第 21-30 天）、Amsel 标准缓解（第 9-12 天）和研究期间未接受补救治疗的患者比例。关于安全性结局（n=614 例阿昔莫司凝胶与 n=551 例安慰剂），阿昔莫司凝胶在所有汇总的安全性结局方面与安慰剂的耐受性相当，除了阴道假丝酵母菌病和治疗相关的阴道假丝酵母菌病发生率较高外。
阿昔莫司凝胶治疗细菌性阴道病有效，临床（Amsel 标准）和微生物学（Nugent 评分）测量以及患者报告的症状均证实了这一点。此外，阿昔莫司凝胶的安全性较好，与阴道假丝酵母菌病的发生率增加有关。
