阴道用乳杆菌活菌胶囊临床应用的价值

发布时间：2018-09-14 20:44

【摘要】：细菌性阴道病（bacterial vaginosis，BV)是妇科常见多发病，为阴道内正常菌群失调所致的一种内源性混合感染，是以阴道内能产生过氧化氢的优势乳杆菌减少、厌氧菌和阴道加德纳菌过盛生长而致的阴道分泌物紊乱综合症。细菌性阴道病除导致阴道炎症外，还可引起其他不良结局，如妊娠期细菌性阴道病可导致绒毛膜羊膜炎、胎膜早破、早产，非孕妇女可引起子宫内膜炎、盆腔炎、子宫切除术后阴道断端感染等。传统治疗细菌性阴道病是选用抗厌氧菌药物，主要有甲硝唑、替硝唑、克林霉素。不论是口服药物或局部阴道给药疗效相似，治愈率在80%左右。甲硝唑是目前治疗细菌性阴道病公认有效的药物，但许多致病菌被杀灭的同时大量的优势菌也被杀灭，所以约有30-40%的妇女在3个月内复发，治疗后9个月内复发率可达到80%。细菌性阴道病复发较常见，影响患者的生活质量甚至情绪，因此有效的治疗该疾病，减少其复发率成为临床研究的热点。细菌性阴道病是阴道内正常菌群失调所致，引发阴道微生态平衡失调的原因是多方面的，如抗生素的广泛应用、灌洗不当、全身性疾病、性激素变化等。微生态治疗着眼点是促进阴道内生理性正常菌群的发育，通过生物拮抗，间接地控制并消灭病原菌，目前已经成为治疗细菌性阴道病研究热点。阴道用乳杆菌活菌胶囊(定君生)是我国唯一的阴道乳杆菌活菌制剂，用于由菌群紊乱引起的细菌性阴道病的治疗,由康白教授主持历时20年完成，于2003年上市，现已在临床得到广泛应用，其II期临床试验结果表明，定君生治疗细菌性阴道病临床总有效率达87%-93.3%，而甲硝唑栓总有效率达85.4%-87.3%。为进一步确认阴道用乳杆菌活菌胶囊治疗细菌性阴道病的疗效、检测用药前后阴道菌群的变化情况及德氏乳杆菌在阴道内的定植情况，本课题进行乳杆菌活菌胶囊在细菌性阴道病的临床应用研究。本研究对象是年龄18-65周岁的非妊娠、非计划妊娠、非哺乳期及月经期，和非长期使用抗菌药物及避孕药物、非过敏体质或对本研究药物已知成份过敏者等。本研究通过Amsel标准诊断细菌性阴道病，且研究对象的阴道分泌物涂片革兰染色显微镜检查Nugent评分≥7分。采用平行对照的研究方式将试验分成三组，分别为试验组A、试验组B和试验组C，每组各20例，共60例。试验组A每晚睡前甲硝唑栓1枚放入阴道深部，连用7天；试验组B每晚睡前阴道用乳杆菌活菌胶囊1粒放入阴道深部，连用10天；试验组C每晚睡前甲硝唑栓1枚放入阴道深部，连用7天，之后每晚将阴道用乳杆菌活菌胶囊1粒放入阴道深部，连用10天，停药后3-5天非月经期随访复查。经过安全性指标检查，，通过Amsel标准和革兰氏染色Nugent评分来确认阴道用乳杆菌活菌胶囊治疗细菌性阴道病疗效及安全性。试验组B进一步确认阴道乳杆菌活菌胶囊单独用药治疗细菌性阴道病的有效性，试验组C用于观察阴道乳杆菌活菌胶囊在甲硝唑针对细菌性阴道病治疗后调节阴道微生态的联合疗效。并用PCR-PGGE技术检测用药一个疗程前后阴道菌群的变化情况及德氏乳杆菌在阴道的定植情况。
[Abstract]:Bacterial vaginosis (BV) is a common gynecological disease, caused by the normal vaginal flora disorders caused by an endogenous mixed infection, is the vaginal production of hydrogen peroxide in the dominant Lactobacillus reduction, anaerobic bacteria and vaginal Gardnerella overgrowth caused by vaginal secretion disorders. Bacterial vaginosis elimination In addition to causing vaginal inflammation, it can also cause other adverse outcomes, such as bacterial vaginosis during pregnancy can lead to chorioamnionitis, premature rupture of membranes, premature delivery, non-pregnant women can cause endometritis, pelvic inflammation, vaginal infection after hysterectomy and so on.
The traditional treatment of bacterial vaginosis is the use of anti-anaerobic drugs, mainly metronidazole, tinidazole, clindamycin. Whether oral or local vaginal drug efficacy is similar, the cure rate is about 80%. Metronidazole is currently recognized as an effective drug for the treatment of bacterial vaginosis, but many pathogens are killed at the same time a large number of dominant bacteria are also. As a result, about 30-40% of women relapse within 3 months, and the recurrence rate can reach 80% within 9 months after treatment. Bacterial vaginosis recurrence is common, affecting the quality of life and even mood of patients, so effective treatment of the disease and reducing its recurrence rate has become a hot spot in clinical research.
Bacterial vaginosis is caused by the imbalance of normal vaginal flora. The causes of vaginal microecological imbalance are various, such as the wide use of antibiotics, improper irrigation, systemic diseases, changes in sex hormones and so on. Eradication of pathogenic bacteria has become a research hotspot in the treatment of bacterial vaginosis.
Lactobacillus vaginalis capsule (Dingjunsheng) is the only viable preparation of Lactobacillus vaginalis in China. It is used for the treatment of bacterial vaginosis caused by bacterial flora disorder. It was completed under the chairmanship of Professor Kang Bai for 20 years and was marketed in 2003. The total effective rate of the disease was 87%-93.3%, while the total effective rate of Metronidazole Suppositories was 85.4%-87.3%.
To further confirm the efficacy of Lactobacillus vaginalis capsules in the treatment of bacterial vaginosis, detect the changes of vaginal flora before and after treatment and the colonization of Lactobacillus deltoides in vagina, the clinical application of Lactobacillus vaginalis capsules in bacterial vaginosis was studied. In this study, the Amsel criteria were used to diagnose bacterial vaginosis, and the Nugent score (> 7) was examined under a Gram staining microscope for vaginal secretions. The control study divided the test into three groups, test group A, test group B and test group C, each group of 20 cases, a total of 60 cases.Test group A every night before bedtime metronidazole suppository into the deep vagina, for 7 days; test group B every night before bedtime vaginal Lactobacillus capsule into the deep vagina, for 10 days; test group C every night before bedtime metronidazole suppository. One suppository was placed in the deep vagina for 7 days. Then one capsule of Lactobacillus vaginalis was put into the deep vagina every night for 10 days.
The efficacy and safety of Lactobacillus vaginalis viable capsule in the treatment of bacterial vaginosis were confirmed by Amsel standard and Nugent score of Gram staining. The combined effect of metronidazole Capsule on regulating vaginal microecology after treatment of bacterial vaginosis was studied. The changes of vaginal microflora and the colonization of Lactobacillus deltoides were detected by PCR-PGGE.
【学位授予单位】：大连医科大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R711.31

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