康妇特栓治疗细菌性阴道病的临床研究

Clinical evaluation of Kangfute for bacterial vaginosis

目的①观察康妇特栓对细菌性阴道病(bacterialvaginosis,BV)的疗效;②了解BV时阴道菌群情况。方法对106‘例BV患者采用多中心、前瞻性、将康妇特与甲硝唑进行随机对照研究,观察患者症状、体征及实验室检查等方面的变化,并在初诊和第1次随访时进行阴道分泌物需氧菌培养。结果①大多数的BV患者有白带增多、白带异常的症状,检查时发现黄色分泌物占60·4%,胺试验阳性者大于80·0%,pH值绝大多数>4·5,线索细胞均阳性。②实验组与对照组比较,在第1次随访时两组患者症状明显改善,症状、体征及实验室检查均无明显差异(P>0·05),总有效率分别为92·0%与86·0%(P>0·05),两组无统计学差异。第2次随访时实验组的分泌物形状及清洁度比对照组有明显改善(P=0·023及0·001),且总有效率明显高于对照组(100·0%vs92·5%,P=0·002),患者满意程度也优于对照组(P=0·002)。③BV患者的阴道内以大肠杆菌为主,其次为甲类溶血链球菌、粪肠球菌、不动杆菌、棒状杆菌、草绿链球菌、表皮葡萄球菌。结论①应提高对BV的认识,积极予以治疗;②康妇特在疗效上明显优于甲硝唑。

Objective ① To observe the effect of Kangfute for bacterial vaginosis （ BV） .②Toexplo the vagina flora of BV. Methods A multcenter, prospective, case control, random clinical study was conducted, in which Kangfute was used in 54 cases with BV as study group, and metronidazole in 52 cases as control group. Symptoms, signs, examination of laboratory and curative effect were compared between the two Stoups. Results ① Increased vaginal discharge and odorous discharge were complained by more than eighty percent of patients with BV. Yellowish vaginal discharge （60.4 % ）, the diamine test positive （ 〉 80.0% ）, pH〉 4.5 （100%）, the clue cells （100%） were presented. ② The efficiency of Kangfute and metronidazole were 92.0% and 86.0% respectively （P〉0.05） after 1 week of treatment, 100.0% and 92.5% （P=0.002） after 4 weeks. ③ Escherichia coli, Streptococcus heanolyticus, Enterococcus faecalis, Corynebacteriaceae, Streptococcus aglacfiae and Staphylococcus epidennidis were the most common bacteria isolated. Conclusions BV needs further investigation, and Kangfute is more effective than metronidazole for bacterial vaginosis.