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盐酸克林霉素棕榈酸酯分散片治疗细菌性阴道病临床试验研究
Clinical trial study on clindamycin palmitate hydrochloride dispersible tablets in the treatment of bacterial vaginosis
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 was Ⅱb/Ⅲ. At the first follow-up，a total of 30.6% of the patients in the two groups had their vaginal lactobacilli restored to grade Ⅰ and Ⅱa （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 grade Ⅰ and Ⅱa （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.
bacterial vaginosis / clindamycin palmitate / vaginal microecology
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Bacterial vaginosis (BV) affects women of reproductive age and can either be symptomatic or asymptomatic. Approximately 50 % of women are symptomatic and experience vaginal malodor, discharge, itching and increased vaginal pH. BV can increase the risk of contracting many sexually transmitted infections (STIs) such as human immunodeficiency virus (HIV), Neisseria gonorrhea (NG), Chlamydia trachomatis (CT), Trichomonas vaginalis (TV) and herpes simplex virus-2 (HSV-2). Though effective treatment options do exist, metronidazole or clindamycin, these methods have proven not to be effective long term. The purpose of this review is to summarize current literature on the epidemiology of BV and highlight areas of deficiency in current clinical practice with respect to BV. BV recurrence rates are high, approximately 80 % three months after effective treatment. Furthermore, in some instances treatment is ineffective and BV persists. Literature also documents the relationship between BV and human papillomavirus (HPV). HPV is the most common sexually transmitted infection among young adult women while BV is the most common cause of vaginal symptoms among women of reproductive age. BV is associated with high levels of anaerobic organisms which can damage the vaginal epithelium and increase the risk of HPV infection. Recent research also highlights the role of the vaginal microbiome in BV. The results of this review warrant further exploration into the etiology of BV as well as exploration of more long-term effective treatment and the investigation of prognostic indicators. Additionally, the need for a standard definition of recurrent and persistent BV is recognized.Copyright © 2020 Elsevier B.V. All rights reserved.
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董子洵, 韩晟, 林丽开, 等, 盐酸克林霉素棕榈酸酯分散片药学特性综合评价[J]. 药物评价研究, 2022, 45(6):1092-1098. DOI:10.7501/j.issn.1674-6376.2022.06.011.
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赵兴坤, 李敏, 闫倩倩, 等. 阴道微生态异常与生殖道高危型人乳头瘤病毒感染相关性研究[J]. 中国实用妇科与产科杂志, 2024, 40(12):1245-1248.DOI:10.19538/j.fk2024120118.
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中华医学会妇产科分会感染性疾病协作组. 阴道微生态评价的临床应用专家共识[J]. 中华妇产科杂志, 2016, 51(10):721-723. DOI:10.3760/cma.j.issn.0529-567x.2016.10.001.
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These guidelines for the treatment of persons who have or are at risk for sexually transmitted infections (STIs) were updated by CDC after consultation with professionals knowledgeable in the field of STIs who met in Atlanta, Georgia, June 11-14, 2019. The information in this report updates the 2015 guidelines. These guidelines discuss 1) updated recommendations for treatment of Neisseria gonorrhoeae, Chlamydia trachomatis, and Trichomonas vaginalis; 2) addition of metronidazole to the recommended treatment regimen for pelvic inflammatory disease; 3) alternative treatment options for bacterial vaginosis; 4) management of Mycoplasma genitalium; 5) human papillomavirus vaccine recommendations and counseling messages; 6) expanded risk factors for syphilis testing among pregnant women; 7) one-time testing for hepatitis C infection; 8) evaluation of men who have sex with men after sexual assault; and 9) two-step testing for serologic diagnosis of genital herpes simplex virus. Physicians and other health care providers can use these guidelines to assist in prevention and treatment of STIs.
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Bacterial vaginosis (BV) is a condition in which the vaginal microbiome presents an overgrowth of obligate and facultative anaerobes, which disturbs the vaginal microbiome balance. BV is a common and recurring vaginal infection among women of reproductive age and is associated with adverse health outcomes and a decreased quality of life. The current recommended first-line treatment for BV is antibiotics, despite the high recurrence rate. Live biopharmaceutical products/probiotics and vaginal microbiome transplantation (VMT) have also been tested in clinical trials for BV. In this review, we discuss the advantages and challenges of current BV treatments and interventions. Furthermore, we provide our understanding of why current clinical trials with probiotics have had mixed results, which is mainly due to not administering the correct bacteria to the correct body site. Here, we propose a great opportunity for large clinical trials with probiotic strains isolated from the vaginal tract (e.g., Lactobacillus crispatus) and administered directly into the vagina after pretreatment.
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Bacterial vaginosis (BV) is the most common cause of vaginal discharge and is often associated with other health consequences mainly in pregnant women. BV is described by an imbalance in the vaginal microbiota where strictly and facultative anaerobic bacteria outgrow the lactic acid- and hydrogen peroxide-producing Lactobacillus species. The species involved in BV are capable to grow and form a polymicrobial biofilm in the vaginal epithelium. The treatment of BV is usually performed using broad-spectrum antibiotics, including metronidazole and clindamycin. However, these conventional treatments are associated with high recurrence rates. The BV polymicrobial biofilm may have an important role on the treatment outcome and is accounted as one of the factors for treatment failure. Other possible reasons for treatment failure include the presence of species resistant to antibiotics or the chance of reinfection after treatment. Therefore, novel strategies to increase the rates of treatment have been studied namely the use of probiotics and prebiotics, acidifying agents, antiseptics, plant-based products, vaginal microbiota transplantation, and phage endolysins. Although some of them are still in an initial phase of development with very preliminary results, they show great perspectives for application. In this review, we aimed to study the role of the polymicrobial nature of BV in treatment failure and explore a few alternatives for treatment.© 2023 The Authors. Microbial Biotechnology published by Applied Microbiology International and John Wiley & Sons Ltd.
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