Faculty of Human Medicine, Zagazig University, Zagazig, Egypt.
J Matern Fetal Neonatal Med. 2021 Jan;34(1):58-65. doi: 10.1080/14767058.2019.1588246. Epub 2019 Mar 18.
To compare between continuous and interrupted use of vaginal probiotic after vaginal clindamycin cream for treatment and prevention of recurrence of bacterial vaginosis. A double-blinded randomized controlled clinical trial, 273 women were randomly allocated to use clindamycin 2% vaginal cream 5 g at bedtime for 7 days followed after 1 week by continuous probiotics vaginal capsule once daily for 6 weeks ( = 129) or clindamycin 2% vaginal cream 5 g at bedtime for 7 days followed by one probiotic vaginal capsule twice a week for 6 weeks ( = 144). The initial evaluation was at 1 week after cessation of probiotics treatment to estimate the cure rates, the follow-up visits were at 1, 3, 6, and 9 months from the initial visit. The primary outcome of this study was cure rate; the secondary outcomes were the frequency of recurrence, the presence of vaginal discharge, pH > 4.5, positive whiff test and detection of clue cells. At the initial visit there was no significant difference in cure rate between continuous probiotics group and interrupted probiotics group (87.4 versus 82.5%; = .81). There was no significant difference between the two groups in the recurrence rate at one, three, six and 9 months follow up visits ( = .16, = .42, = .59, = .66). There was no significant difference between both groups regarding vaginal discharge reduction, pH dropping, the presence of positive whiff test and detection of clue cells at one, three, six and 9 months follow up visits. Except at 9-month visits, the differences in vaginal discharge reduction and positive whiff test were statically significant. After initial treatment of bacterial vaginosis with vaginal clindamycin cream, the continuous use of vaginal probiotics is equally effective to short repetitive courses in terms of cure rates and prevention of relapse.
比较阴道克林霉素乳膏治疗细菌性阴道病后连续和间断使用阴道益生菌预防复发的效果。一项双盲随机对照临床试验,273 例女性随机分为两组,一组在睡前使用 2%克林霉素阴道乳膏 5g,连续使用 7 天,停药 1 周后,每天使用阴道益生菌胶囊 1 次,连续使用 6 周(n=129);另一组在睡前使用 2%克林霉素阴道乳膏 5g,连续使用 7 天,停药 1 周后,每周使用阴道益生菌胶囊 2 次,连续使用 6 周(n=144)。初始评估在停药后 1 周进行,以评估治愈率,随访时间为初始就诊后 1、3、6 和 9 个月。本研究的主要结局为治愈率;次要结局为复发频率、阴道分泌物、pH 值>4.5、阳性气味试验和线索细胞检测。初始就诊时,连续使用益生菌组和间断使用益生菌组的治愈率无显著差异(87.4%与 82.5%, = .81)。两组在 1、3、6 和 9 个月随访时的复发率无显著差异( = .16, = .42, = .59, = .66)。两组在 1、3、6 和 9 个月随访时阴道分泌物减少、pH 值下降、阳性气味试验和线索细胞检测结果无显著差异。除 9 个月随访外,阴道分泌物减少和阳性气味试验的差异具有统计学意义。初始治疗细菌性阴道病后,阴道克林霉素乳膏连续使用阴道益生菌与短程重复疗程相比,在治愈率和预防复发方面效果相当。