陰道用乳桿菌活菌膠囊臨床應(yīng)用的價(jià)值
發(fā)布時(shí)間：2018-09-14 20:44
【摘要】：細(xì)菌性陰道病（bacterial vaginosis，BV)是婦科常見多發(fā)病，為陰道內(nèi)正常菌群失調(diào)所致的一種內(nèi)源性混合感染，是以陰道內(nèi)能產(chǎn)生過氧化氫的優(yōu)勢乳桿菌減少、厭氧菌和陰道加德納菌過盛生長而致的陰道分泌物紊亂綜合癥。細(xì)菌性陰道病除導(dǎo)致陰道炎癥外，還可引起其他不良結(jié)局，如妊娠期細(xì)菌性陰道病可導(dǎo)致絨毛膜羊膜炎、胎膜早破、早產(chǎn)，非孕婦女可引起子宮內(nèi)膜炎、盆腔炎、子宮切除術(shù)后陰道斷端感染等。 傳統(tǒng)治療細(xì)菌性陰道病是選用抗厭氧菌藥物，主要有甲硝唑、替硝唑、克林霉素。不論是口服藥物或局部陰道給藥療效相似，治愈率在80%左右。甲硝唑是目前治療細(xì)菌性陰道病公認(rèn)有效的藥物，但許多致病菌被殺滅的同時(shí)大量的優(yōu)勢菌也被殺滅，所以約有30-40%的婦女在3個(gè)月內(nèi)復(fù)發(fā)，治療后9個(gè)月內(nèi)復(fù)發(fā)率可達(dá)到80%。細(xì)菌性陰道病復(fù)發(fā)較常見，影響患者的生活質(zhì)量甚至情緒，因此有效的治療該疾病，減少其復(fù)發(fā)率成為臨床研究的熱點(diǎn)。 細(xì)菌性陰道病是陰道內(nèi)正常菌群失調(diào)所致，引發(fā)陰道微生態(tài)平衡失調(diào)的原因是多方面的，如抗生素的廣泛應(yīng)用、灌洗不當(dāng)、全身性疾病、性激素變化等。微生態(tài)治療著眼點(diǎn)是促進(jìn)陰道內(nèi)生理性正常菌群的發(fā)育，通過生物拮抗，間接地控制并消滅病原菌，目前已經(jīng)成為治療細(xì)菌性陰道病研究熱點(diǎn)。 陰道用乳桿菌活菌膠囊(定君生)是我國唯一的陰道乳桿菌活菌制劑，用于由菌群紊亂引起的細(xì)菌性陰道病的治療,由康白教授主持歷時(shí)20年完成，于2003年上市，現(xiàn)已在臨床得到廣泛應(yīng)用，其II期臨床試驗(yàn)結(jié)果表明，定君生治療細(xì)菌性陰道病臨床總有效率達(dá)87%-93.3%，而甲硝唑栓總有效率達(dá)85.4%-87.3%。 為進(jìn)一步確認(rèn)陰道用乳桿菌活菌膠囊治療細(xì)菌性陰道病的療效、檢測用藥前后陰道菌群的變化情況及德氏乳桿菌在陰道內(nèi)的定植情況，本課題進(jìn)行乳桿菌活菌膠囊在細(xì)菌性陰道病的臨床應(yīng)用研究。本研究對(duì)象是年齡18-65周歲的非妊娠、非計(jì)劃妊娠、非哺乳期及月經(jīng)期，和非長期使用抗菌藥物及避孕藥物、非過敏體質(zhì)或?qū)Ρ狙芯克幬镆阎煞葸^敏者等。本研究通過Amsel標(biāo)準(zhǔn)診斷細(xì)菌性陰道病，且研究對(duì)象的陰道分泌物涂片革蘭染色顯微鏡檢查Nugent評(píng)分≥7分。采用平行對(duì)照的研究方式將試驗(yàn)分成三組，分別為試驗(yàn)組A、試驗(yàn)組B和試驗(yàn)組C，每組各20例，共60例。試驗(yàn)組A每晚睡前甲硝唑栓1枚放入陰道深部，連用7天；試驗(yàn)組B每晚睡前陰道用乳桿菌活菌膠囊1粒放入陰道深部，連用10天；試驗(yàn)組C每晚睡前甲硝唑栓1枚放入陰道深部，連用7天，之后每晚將陰道用乳桿菌活菌膠囊1粒放入陰道深部，連用10天，停藥后3-5天非月經(jīng)期隨訪復(fù)查。 經(jīng)過安全性指標(biāo)檢查，，通過Amsel標(biāo)準(zhǔn)和革蘭氏染色Nugent評(píng)分來確認(rèn)陰道用乳桿菌活菌膠囊治療細(xì)菌性陰道病療效及安全性。試驗(yàn)組B進(jìn)一步確認(rèn)陰道乳桿菌活菌膠囊單獨(dú)用藥治療細(xì)菌性陰道病的有效性，試驗(yàn)組C用于觀察陰道乳桿菌活菌膠囊在甲硝唑針對(duì)細(xì)菌性陰道病治療后調(diào)節(jié)陰道微生態(tài)的聯(lián)合療效。并用PCR-PGGE技術(shù)檢測用藥一個(gè)療程前后陰道菌群的變化情況及德氏乳桿菌在陰道的定植情況。
[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.
【學(xué)位授予單位】：大連醫(yī)科大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2014
【分類號(hào)】：R711.31
本文編號(hào)：2243817
[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.
【學(xué)位授予單位】：大連醫(yī)科大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2014
【分類號(hào)】：R711.31
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