Amaya-Guio Jairo, Viveros-Carreño David Andres, Sierra-Barrios Eloisa Mercedes, Martinez-Velasquez Mercy Yolima, Grillo-Ardila Carlos F
Department of Obstetrics and Gynecology, Faculty of Medicine, Universidad Nacional de Colombia, Bogota, Colombia.
Cochrane Database Syst Rev. 2016 Oct 1;10(10):CD011701. doi: 10.1002/14651858.CD011701.pub2.
Bacterial vaginosis (BV) is an infection that has a prevalence between 10% to 50% worlwide. BV results in an imbalance of the normal vaginal flora. Microorganisms associated with BV have been isolated from the normal flora of the male genital tract, and their presence could be related to the recurrence of BV after antibiotic treatment. Therefore, the treatment of sexual partners could decrease the recurrence of infection and possibly the burden of the disease.
To assess the effectiveness in women and the safety in men of concurrent antibiotic treatment for the sexual partners of women treated for BV.
We searched the Cochrane Sexually Transmitted Infections Group Specialized Register (23 July 2016), CENTRAL (1991 to 23 July 2016), MEDLINE (1946 to 23 July 2016), Embase (1974 to 23 July 2016), LILACS (1982 to 23 July 2016), the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (23 July 2016), ClinicalTrials.gov (23 July 2016) and the Web of Science™ (2001 to 23 July 2016). We also handsearched conference proceedings, contacted trial authors and reviewed the reference lists of retrieved studies.
Randomized controlled trials (RCTs) that compared the concurrent use of any antibiotic treatment with placebo, no intervention or any other intervention by the sexual partners of women treated for BV.
Three review authors independently assessed trials for inclusion, extracted data and assessed the risk of bias in the included studies. We resolved any disagreements through consensus. We assessed the quality of the evidence using the GRADE approach.
Seven RCTs (1026 participants) met our inclusion criteria, and pharmaceutical industry funded four of these trials. Five trials (854 patients) compared any antibiotic treatment of sexual partners with placebo. Based on high quality evidence, antibiotic treatment does not increase the rate of clinical or symptomatic improvement in women during the first week (risk ratio (RR) 0.99, 95% confidence interval (CI) 0.96 to 1.03; 712 participants, four studies; RR 1.06, 95% CI 1.00 to 1.12; 577 patients, three studies, respectively), between the first and fourth week (RR 1.02, 95% CI 0.94 to 1.11; 590 participants, three studies; RR 0.93, 95% CI 0.84 to 1.03; 444 participants, two studies; respectively) or after the fourth week (RR 0.98, 95% CI 0.90 to 1.07; 572 participants, four studies; RR 1.03, 95% CI 0.90 to 1.17; 296 participants, two studies; respectively). Antibiotic treatment does not led to a lower recurrence during the first and fourth week (RR 1.28, 95% CI 0.68 to 2.43; 218 participants, one study; low quality evidence) or after the fourth week of treatment (RR 1.00, 95% CI 0.67 to 1.52; 372 participants, three studies; low quality evidence) in women, but increases the frequency of adverse events (most frequently gastrointestinal symptoms) reported by sexual partners (RR 2.55, 95% CI 1.55 to 4.18; 477 participants, three studies; low quality evidence). Two trials (172 participants) compared any antibiotic treatment for sexual partners with no intervention. When we compared it with no intervention, the effects of antibiotic treatment on recurrence rate after the fourth week (RR 1.71, 95% CI 0.65 to 4.55; 51 participants, one study), clinical improvement between the first and fourth week (RR 0.93, 95% CI 0.70 to 1.25; 152 participants, two studies) and symptomatic improvement after the fourth week (RR 0.66, 95% CI 0.39 to 1.11; 70 participants, one study) were imprecise and there were no differences between groups. We downgraded the quality of the evidence to low or very low.
AUTHORS' CONCLUSIONS: High quality evidence shows that antibiotic treatment for sexual partners of women with BV, compared with placebo, does not increase the rate of clinical or symptomatic improvement during the first, between the first and fourth or after the fourth week into the women. Low quality evidence suggests that antibiotic treatment does not led to a lower recurrence rate during the first and fourth or after the fourth week of treatment into the women, but increases the frequency of adverse events reported by sexual partners. Finally, compared with no intervention, antibiotic treatment does not decrease the recurrence rate after the fourth week and does not increase the frequency of clinical or symptomatic improvement between the first and fourth or after the fourth week into the women, respectively.
细菌性阴道病（BV）是一种在全球患病率为10%至50%的感染性疾病。BV会导致正常阴道菌群失衡。与BV相关的微生物已从男性生殖道的正常菌群中分离出来，它们的存在可能与抗生素治疗后BV的复发有关。因此，对性伴侣进行治疗可能会降低感染的复发率，并可能减轻疾病负担。
评估对BV女性患者的性伴侣同时进行抗生素治疗对女性的有效性和对男性的安全性。
我们检索了Cochrane性传播感染小组专业注册库（2016年7月23日）、CENTRAL（1991年至2016年7月23日）、MEDLINE（1946年至2016年7月23日）、Embase（1974年至2016年7月23日）、LILACS（1982年至2016年7月23日）、世界卫生组织（WHO）国际临床试验注册平台（ICTRP）（2016年7月23日）、ClinicalTrials.gov（2016年7月23日）以及Web of Science™（2001年至2016年7月23日）。我们还手工检索了会议论文集，联系了试验作者并查阅了检索到的研究的参考文献列表。
随机对照试验（RCT），比较对BV女性患者的性伴侣同时使用任何抗生素治疗与安慰剂、不干预或任何其他干预措施的效果。
三位综述作者独立评估试验是否纳入、提取数据并评估纳入研究的偏倚风险。我们通过共识解决了任何分歧。我们使用GRADE方法评估证据质量。
七项RCT（1026名参与者）符合我们的纳入标准，其中四项试验由制药行业资助。五项试验（854名患者）比较了对性伴侣进行任何抗生素治疗与安慰剂的效果。基于高质量证据，抗生素治疗在第一周内（风险比（RR）0.99，95%置信区间（CI）0.96至1.03；712名参与者，四项研究；RR 1.06，95%CI 1.00至1.12；577名患者，三项研究）、第一周与第四周之间（RR 1.02，95%CI 0.94至1.11；590名参与者，三项研究；RR 0.93，95%CI 0.84至1.03；444名参与者，两项研究）或第四周后（RR 0.98，95%CI 0.90至1.07；572名参与者，四项研究；RR 1.03，95%CI 0.90至1.17；296名参与者，两项研究）均未提高女性的临床或症状改善率。抗生素治疗在治疗的第一周与第四周之间（RR 1.28，95%CI 0.68至2.43；218名参与者，一项研究；低质量证据）或第四周后（RR 1.00，95%CI 0.67至1.52；372名参与者，三项研究；低质量证据）并未降低女性的复发率，但增加了性伴侣报告的不良事件（最常见的是胃肠道症状）的发生率（RR 2.55，95%CI 1.55至4.18；477名参与者，三项研究；低质量证据）。两项试验（172名参与者）比较了对性伴侣进行任何抗生素治疗与不干预的效果。当与不干预进行比较时，抗生素治疗对第四周后的复发率（RR 1.71，95%CI 0.65至4.55；51名参与者，一项研究）、第一周与第四周之间的临床改善（RR 0.93，95%CI 0.70至1.25；152名参与者，两项研究）以及第四周后的症状改善（RR 0.66，95%CI 0.39至1.11；70名参与者，一项研究）的影响不精确，且两组之间无差异。我们将证据质量降级为低或极低。
高质量证据表明，与安慰剂相比，对BV女性患者的性伴侣进行抗生素治疗在第一周、第一周与第四周之间或第四周后均未提高女性的临床或症状改善率。低质量证据表明，抗生素治疗在治疗的第一周与第四周之间或第四周后并未降低女性的复发率，但增加了性伴侣报告的不良事件的发生率。最后，与不干预相比，抗生素治疗在第四周后并未降低复发率，在第一周与第四周之间或第四周后也未增加女性的临床或症状改善率。
