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栎阴道乳膏与甲硝唑阴道凝胶治疗细菌性阴道病的效果:一项双盲随机对照试验。

The effect of Quercus (Oak Gal) vaginal cream versus metronidazole vaginal gel on bacterial vaginosis: A double‑blind randomized controlled trial.

机构信息

Department of Midwifery, Reproductive Health Promotion Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.

Medicinal Plants Research Center and Department of Pharmacognosy, Faculty of Pharmacy, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.

出版信息

Complement Ther Med. 2020 Aug;52:102497. doi: 10.1016/j.ctim.2020.102497. Epub 2020 Jul 3.

Abstract

OBJECTIVE

This study was aimed to compare the effect of an Oak Gall extract‑based cream and a metronidazole Gel on the bacterial vaginosis among women in reproductive age.

MATERIAL AND METHODS

This was a double-blind, randomized controlled trial performed on 84 women with BV in reproductive age. Accordingly, the women were randomly assigned to the Oak Gall (n = 42) or metronidazole (n = 42) groups. Diagnosis of BV was confirmed when at least 3 of the 4 Amsel criteria were met by the participants (whitish-grey or thin homogeneous discharge, pH ≥ 4.5, the release of a fishy odor on the addition of 10 % KOH, and detection of clue cells > 20 % in the microscopic examination). For each group, either a methanol extract of Oak Gall vaginal cream or a metronidazole vaginal gel (5 g) was used as intravaginal for 5 consecutive days, and all the signs or symptoms were assessed by passing 4-7 days from the treatment completion.

RESULTS

At baseline, the two groups were homogenous in terms of the vaginal burning, odor, dysuria, dyspareunia, and itching. Also, all women in both groups were free of symptoms (vaginal itching and burning sensation, bad odor, dysuria, and dyspareunia) by passing one week from the intervention (p < 0.001). The percent of bacterial vaginosis treatment was in 33(82.1 %) patients in terms of Oak Gall group and in 34(87.5 %) patients of Metronidazole group (p=0.56). Notably, Oak Gall was as effective and safe as metronidazole in the treatment of BV in reproductive-aged women.

CONCLUSION

Oak Gall could be recommended for women in reproductive age who are uncomfortable with the potential side effects of synthetic drugs.

摘要

目的

本研究旨在比较栎倍素乳膏和甲硝唑凝胶对育龄期女性细菌性阴道病(BV)的疗效。

材料与方法

这是一项双盲、随机对照试验,共纳入 84 例育龄期 BV 患者。将患者随机分为栎倍素组(n=42)和甲硝唑组(n=42)。当至少 4 项 Amsel 标准中有 3 项被患者满足时(灰白色或稀薄均匀分泌物、pH 值≥4.5、加入 10%KOH 后释放鱼腥臭味、显微镜检查中线索细胞>20%),即可确诊为 BV。每组均使用栎倍素阴道乳膏(甲醇提取物)或甲硝唑阴道凝胶(5g)阴道内给药,连续 5 天。治疗结束后 4-7 天评估所有症状或体征。

结果

基线时,两组患者的阴道烧灼感、异味、尿痛、性交痛和瘙痒症状相似。两组患者在干预结束后 1 周内均无任何症状(阴道瘙痒和烧灼感、异味、尿痛和性交痛)(p<0.001)。栎倍素组和甲硝唑组的细菌性阴道病治疗有效率分别为 33%(82.1%)和 34%(87.5%)(p=0.56)。栎倍素在治疗育龄期女性 BV 方面与甲硝唑一样有效且安全。

结论

栎倍素乳膏可作为一种替代治疗药物,用于对合成药物潜在副作用感到不适的育龄期女性。

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