比较蔗糖凝胶与甲硝唑凝胶治疗细菌性阴道病临床症状的效果：一项随机对照试验。
Comparing the effect of sucrose gel and metronidazole gel in treatment of clinical symptoms of bacterial vaginosis: a randomized controlled trial.
作者信息
Khazaeian Somayyeh, Navidian Ali, Navabi-Rigi Shahin-Dokht, Araban Marzieh, Mojab Faraz, Khazaeian Safoura
机构信息
Pregnancy Health Research Center, Department of Midwifery, Zahedan University of Medical Sciences, Zahedan, Iran.
Pregnancy Health Research Center, Department of Counseling, Zahedan University of Medical Sciences, Zahedan, Iran.
出版信息
Trials. 2018 Oct 26;19(1):585. doi: 10.1186/s13063-018-2905-z.
BACKGROUND
Lactobacilli, as normal vaginal flora, have a central role in controlling body environment and preventing the growth of pathogens. Sucrose, by promoting the growth of Lactobacilli, accelerates the suppression of pathogenic bacteria. The aim of this research was to compare the effects of sucrose gel with those of metronidazole gel in treating women with bacterial vaginosis (BV).
METHODS
This triple-blind clinical trial (IRCT2016112631105N1) was conducted with 70 sexually active, premenopausal women diagnosed with bacterial vaginosis through meeting at least three out of four Amsel criteria. The subjects were randomly divided into two groups of 35 patients, one group treated with sucrose vaginal gel, and the other with metronidazole vaginal gel. The treatment period was 14 days for each group. At the end of the treatment period, the status of each woman's improvement was determined by elimination at least three out of four Amsel criteria (homogeneous vaginal discharge, presence of clue cells > 20%, positive whiff test and vaginal pH value > 4.5), and clinical complaints and reported side effects of medication were recorded for the patients. Data were analyzed using the t test, chi-squared test and McNemar's test).
RESULTS
The sucrose vaginal gel and metronidazole vaginal gel were not significantly different in reducing patients' clinical complaints or in elimination at least three out of four of the Amsel criteria that were positive before treatment. With an 85.7% improvement rate with sucrose gel and an 88.5% improvement rate with metronidazole gel, the differences in therapeutic response were not significant, and neither was statistically different in improving the disease (p = 0.389).
CONCLUSION
It seems that sucrose vaginal gel might be considered a possible alternative to metronidazole vaginal gel in the treatment of bacterial vaginosis.
TRIAL REGISTRATION
Iranian Registry of Clinical Trials, IRCT2016112631105N1 . Registered on 27 December 2016.
背景
乳酸杆菌作为正常阴道菌群，在控制机体环境和预防病原体生长方面发挥着核心作用。蔗糖通过促进乳酸杆菌生长，加速对病原菌的抑制。本研究旨在比较蔗糖凝胶与甲硝唑凝胶治疗细菌性阴道病（BV）女性的效果。
方法
本三盲临床试验（IRCT2016112631105N1）纳入了70名性活跃的绝经前女性，她们通过满足四项阿姆斯勒标准中的至少三项被诊断为细菌性阴道病。受试者被随机分为两组，每组35例患者，一组接受蔗糖阴道凝胶治疗，另一组接受甲硝唑阴道凝胶治疗。每组的治疗期为14天。在治疗期结束时，通过消除四项阿姆斯勒标准中的至少三项（均匀的阴道分泌物、线索细胞>20%、阳性嗅试验和阴道pH值>4.5）来确定每位女性的改善状况，并记录患者的临床症状和报告的药物副作用。数据采用t检验、卡方检验和麦克尼马尔检验进行分析。
结果
蔗糖阴道凝胶和甲硝唑阴道凝胶在减轻患者临床症状或消除治疗前四项阿姆斯勒标准中至少三项阳性方面无显著差异。蔗糖凝胶的改善率为85.7%，甲硝唑凝胶的改善率为88.5%，治疗反应差异不显著，在改善疾病方面两者也均无统计学差异（p = 0.389）。
结论
在治疗细菌性阴道病方面，蔗糖阴道凝胶似乎可被视为甲硝唑阴道凝胶的一种可能替代物。
试验注册
伊朗临床试验注册中心，IRCT2016112631105N1。于2016年12月27日注册。
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