摘要
目的 探讨盐酸克林霉素棕榈酸酯分散片对治疗细菌性阴道病(bacterial vaginosis,BV)的临床意义。方法采用前瞻性、随机、双盲双模拟、阳性药物平行对照临床试验,将2017年3月至2021年12月北京大学第一医院收治的39例BV患者,分为盐酸克林霉素棕榈酸酯分散片治疗组(试验组)20例和甲硝唑治疗组(对照组)19例,分析两组患者在停药第(7±3)天(第1次随访)和第(28±5)天(第2次随访)时的症状改善及实验室检查等方面的变化。临床疗效由症状体征评分改善率确定,改善率=(治疗前指标积分-治疗后指标积分)/治疗前指标积分×100%。采用Nugent评分进行BV诊断及微生物疗效评价。结果 两组患者治疗前、第1次随访、第2次随访时的阴道分泌物pH值差异均无统计学意义(P>0.05)。第1次随访时,试验组Nugent评分与对照组差异无统计学意义[(5.26±2.88)分vs.(4.88±3.18)分,P>0.05];第2次随访时,试验组Nugent评分与对照组差异亦无统计学意义[(5.65±2.96)分vs.(4.71±2.92)分,P>0.05]。患者的症状体征评分改善率试验组与对照组第1次随访时分别为63.12%和47.06%,第2次随访时分别为64.71%和50.00%,差异均无统计学意义(P>0.05)。治疗前乳杆菌分级两组均为Ⅱb/Ⅲ,第1次随访时两组总计有30.6%的患者阴道乳杆菌恢复至Ⅰ级及Ⅱa级(26.5%vs. 35.3%);第2次随访两组总计有32.3%的患者阴道乳杆菌恢复至Ⅰ级及Ⅱa级(29.4%vs. 35.7%),两组间差异无统计学意义(P>0.05)。结论 盐酸克林霉素棕榈酸酯分散片能够有效治疗BV,临床疗效与对照组相当。抗生素治疗后阴道乳杆菌恢复不令人满意,可考虑辅助恢复阴道菌群的治疗措施。
Objective To study the clinical significance of clindamycin palmitate hydrochloride dispersible tablets in the treatment of bacterial vaginosis(BV).Methods A prospective,randomized,double-blind,double-dummy,positive drug parallel controlled clinical trial was conducted.Totally 39 patients with bacterial vaginosis,who recevied treatment in Beijing University First Hospital from Mar.2017 to Dec.2021,were divided into the clindamycin palmitate hydrochloride dispersible tablets group(n=20)and the metronidazole group(n=19).The changes in symptoms improvement and laboratory tests of the two groups of patients on the(7±3)th day(the first follow-up)and the(28±5)th day(the second follow-up)after drug withdrawal were analyzed.The clinical efficacy was determined by improvement rate of symptom and sign scores:improvement rate=(index score before treatment-index score after treatment)/index score before treatment×100%.The Nugent score was used for BV diagnosis and efficacy evaluation.Results There were no significant differences in pH values of vaginal secretions between the two groups of patients before treatment,at the first follow-up,and at the second follow-up(P>0.05).At the first follow-up,there was no significant difference in the Nugent score between the clindamycin palmitate hydrochloride dispersible tablets group(5.26±2.88)and the metronidazole group(4.88±3.18)(P>0.05).At the second follow-up,there was no significant difference in the Nugent score between the clindamycin palmitate hydrochloride dispersible tablets group(5.65±2.96)and the metronidazole group(4.71±2.92)(P>0.05).The improvement rates of symptom and sign scores of patients was 63.12%in the clindamycin palmitate hydrochloride dispersible tablets group and 47.06%in the metronidazole group at the first follow-up,and at the second follow-up,it was 64.71%and 50.00%,respectively;there was no significant difference(P>0.05).Before treatment,the lactobacillus grading of both groups wasⅡb/Ⅲ.At the first follow-up,a total of 30.6%of the patients in the two groups had their vaginal lactobacilli restored to gradeⅠandⅡa(26.5%vs 35.3%);at the second follow-up,a total of 32.3%of the patients in the two groups had their vaginal lactobacilli restored to gradeⅠandⅡa(29.4%vs 35.7%);there was no significant difference between the two groups(P>0.05).Conclusions Clindamycin palmitate hydrochloride dispersible tablets are effective in the treatment of bacterial vaginosis,and the clinical efficacy is comparable to that of the metronidazole group.The recovery of vaginal lactobacilli after antibiotic treatment is not satisfactory,and therapeutic measures to assist the recovery of vaginal flora can be considered.
作者
张岱
刘朝晖
ZHANG Dai;LIU Zhao-hui(Department of Obstetrics and Gynecology,Peking University First Hospital,Beijing 100034,China;Beijing Obstetrics and Gynecology Hospital,Capital Medical University,Beijing 100026,China)
出处
《中国实用妇科与产科杂志》
北大核心
2025年第5期553-556,共4页
Chinese Journal of Practical Gynecology and Obstetrics
基金
国家自然科学基金面上项目(81771530)。
