本文選題：細菌性陰道病 + 糖膠體��； 參考：《河北醫(yī)科大學(xué)》2017年碩士論文

【摘要】：目的:細菌性陰道病(Bacterial Vaginosis,BV)是最常見的陰道感染性疾病,并與其它陰道感染性病疾密切相關(guān)。BV可借助于標準化的臨床診斷或?qū)嶒炇谊幍婪置谖锔锾m染色后細菌形態(tài)學(xué)評分來確診。即使檢測診斷BV的方法目前在臨床上還未取得長足發(fā)展,但分子生物學(xué)學(xué)診斷正在興起。目前,BV依然是難治性疾病,臨床醫(yī)生還缺乏長期治療BV的有效手段。除了標準的抗生素治療外,其它替代療法,如防腐劑、消毒劑、陰道酸化劑、緩沖劑和益生菌在BV長期預(yù)防方面也取得了一些令人滿意的進展。本研究的目的在于探索一種新的藥物治療細菌性陰道病,與甲硝唑和安慰劑從有效性及安全性方面進行比較分析。方法:通過對長春、北京、石家莊、鄭州、南京、西安六個地區(qū)共計14822名育齡婦女進行篩查,共計篩選出908名疑似細菌性陰道病患者,從中選取560例在8家醫(yī)院進行藥物治療。將患者以3:1:1的比例分別納入糖膠體組、甲硝唑凝膠組和安慰劑組。三組均采取每日早晚陰道內(nèi)給藥5.0g,連續(xù)使用5天。在治療第7-10天和治療第21-35天進行臨床療效觀察及安全性評價。結(jié)果:本研究三組患者的年齡、身高、體重、血壓、脈搏等進行基線比較,結(jié)果無統(tǒng)計學(xué)差異(P0.05)。治療第7-10天,主要療效安慰劑、甲硝唑凝膠和糖膠體三組CMH卡方檢驗(Cochran Mantel Haenszel)在FAS人群(Full Analysis Set)和PP人群(Per Protocol)差別均有統(tǒng)計學(xué)意義(P0.0001)。在FAS人群安慰劑、甲硝唑凝膠和糖膠體組的治愈率分別為0.90%、70.64%和82.67%。安慰劑組和糖膠體組比較P0.0001,甲硝唑凝膠組和糖膠體組比較P=0.0068。治療第21-35天,主要療效安慰劑、甲硝唑凝膠和糖膠體組三組CMH卡方檢驗在FAS人群和PP人群差別均有統(tǒng)計學(xué)意義(P0.0001)。在FAS人群安慰劑、甲硝唑凝膠和糖膠體組的治愈率分別為7.21%、66.06%和61.09%,安慰劑組和糖膠體組比較P0.0001,甲硝唑凝膠組和糖膠體組比較P=0.3543。本研究SS人群(Safety Set)中,未出現(xiàn)嚴重不良事件。發(fā)生頻率大于1%的不良事件有:胃腸系統(tǒng)異常、呼吸系統(tǒng)異常、白細胞和網(wǎng)狀內(nèi)皮系異常、泌尿系統(tǒng)異常和女性生殖系統(tǒng)異常。不良反應(yīng)發(fā)生率安慰劑組5.36%;甲硝唑凝膠組12.84%;糖膠體組4.83%。結(jié)論:糖膠體治療細菌性陰道病的近期療效優(yōu)于安慰劑和甲硝唑凝膠;遠期療效優(yōu)于安慰劑,與甲硝唑凝膠相當。不良反應(yīng)發(fā)生率糖膠體組低于安慰劑和甲硝唑凝膠組。
[Abstract]:Objective: Bacterial Vaginosissis (BV) is the most common vaginal infectious disease, and is closely related to other vaginal infections. BV can be diagnosed by means of standardized clinical diagnosis or bacteriological morphological score after vaginal discharge Gram staining. Molecular biology diagnosis is on the rise even though the methods of detecting and diagnosing BV have not made great progress in clinic. At present, BV is still a refractory disease, and clinicians lack the effective means to treat BV for a long time. In addition to the standard antibiotic treatment, other alternative therapies, such as preservatives, disinfectants, vaginal acidifiers, buffers and probiotics, have also made some satisfactory progress in the long-term prevention of BV. The purpose of this study was to explore a new drug for the treatment of bacterial vaginosis and to compare the efficacy and safety with metronidazole and placebo. Methods: 14822 women of childbearing age were screened in Changchun, Beijing, Shijiazhuang, Zhengzhou, Nanjing and Xi'an, and 908 suspected bacterial vaginosis patients were screened out. Among them, 560 patients were selected for drug treatment in 8 hospitals. The patients were divided into sugar colloid group, metronidazole gel group and placebo group at 3:1:1. All the three groups were given intravaginal administration of 5.0 g daily for 5 days. The clinical efficacy and safety were evaluated on day 7-10 and day 21-35. Results: there was no significant difference in age, height, weight, blood pressure and pulse between the three groups. On the 7th to 10th day of treatment, the main therapeutic placebo, metronidazole gel and sugar colloid in three groups of CMH chi-square test (Cochran Mantel Haenszelel) had significant difference between FAS population and PP group (P 0.0001). The cure rates of metronidazole gel group and sugar colloid group were 70.64% and 82.67% respectively in FAS population placebo. Placebo group and sugar colloid group compared P 0.0001, metronidazole gel group and sugar colloid group compared P0. 0068. On the 21-35th day of treatment, the main therapeutic effects were placebo, metronidazole gel and sugar colloid group. The CMH chi-square test of three groups had statistical significance in FAS population and PP population (P 0.0001). The cure rates of metronidazole gel and sugar colloid group were 7.21% and 61.09%, respectively, compared with placebo group and sugar colloid group (P 0.0001), metronidazole gel group and sugar colloid group (P 0.3543). In this study, there were no serious adverse events in SS population Safety Settings. Abnormal gastrointestinal system, respiratory system, white blood cell and reticuloendothelium, urinary system and female reproductive system were more than 1% of the adverse events. The incidence of adverse reactions was 5.36 in placebo group, 12.84 in metronidazole gel group and 4.83 in glucose colloid group. Conclusion: the short-term efficacy of glucose colloid in the treatment of bacterial vaginosis is better than that of placebo and metronidazole gel, and the long-term curative effect is better than placebo and equivalent to metronidazole gel. The incidence of adverse reactions in the colloidal group was lower than that in the placebo and metronidazole gel groups.
【學(xué)位授予單位】：河北醫(yī)科大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：R711.3

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