糖胶体治疗细菌性阴道病的有效性和安全性的随机对照临床试验

发布时间：2018-04-30 18:53

本文选题：细菌性阴道病 + 糖胶体　；参考：《河北医科大学》2017年硕士论文

【摘要】：目的:细菌性阴道病(Bacterial Vaginosis,BV)是最常见的阴道感染性疾病,并与其它阴道感染性病疾密切相关。BV可借助于标准化的临床诊断或实验室阴道分泌物革兰染色后细菌形态学评分来确诊。即使检测诊断BV的方法目前在临床上还未取得长足发展,但分子生物学学诊断正在兴起。目前,BV依然是难治性疾病,临床医生还缺乏长期治疗BV的有效手段。除了标准的抗生素治疗外,其它替代疗法,如防腐剂、消毒剂、阴道酸化剂、缓冲剂和益生菌在BV长期预防方面也取得了一些令人满意的进展。本研究的目的在于探索一种新的药物治疗细菌性阴道病,与甲硝唑和安慰剂从有效性及安全性方面进行比较分析。方法:通过对长春、北京、石家庄、郑州、南京、西安六个地区共计14822名育龄妇女进行筛查,共计筛选出908名疑似细菌性阴道病患者,从中选取560例在8家医院进行药物治疗。将患者以3:1:1的比例分别纳入糖胶体组、甲硝唑凝胶组和安慰剂组。三组均采取每日早晚阴道内给药5.0g,连续使用5天。在治疗第7-10天和治疗第21-35天进行临床疗效观察及安全性评价。结果:本研究三组患者的年龄、身高、体重、血压、脉搏等进行基线比较,结果无统计学差异(P0.05)。治疗第7-10天,主要疗效安慰剂、甲硝唑凝胶和糖胶体三组CMH卡方检验(Cochran Mantel Haenszel)在FAS人群(Full Analysis Set)和PP人群(Per Protocol)差别均有统计学意义(P0.0001)。在FAS人群安慰剂、甲硝唑凝胶和糖胶体组的治愈率分别为0.90%、70.64%和82.67%。安慰剂组和糖胶体组比较P0.0001,甲硝唑凝胶组和糖胶体组比较P=0.0068。治疗第21-35天,主要疗效安慰剂、甲硝唑凝胶和糖胶体组三组CMH卡方检验在FAS人群和PP人群差别均有统计学意义(P0.0001)。在FAS人群安慰剂、甲硝唑凝胶和糖胶体组的治愈率分别为7.21%、66.06%和61.09%,安慰剂组和糖胶体组比较P0.0001,甲硝唑凝胶组和糖胶体组比较P=0.3543。本研究SS人群(Safety Set)中,未出现严重不良事件。发生频率大于1%的不良事件有:胃肠系统异常、呼吸系统异常、白细胞和网状内皮系异常、泌尿系统异常和女性生殖系统异常。不良反应发生率安慰剂组5.36%;甲硝唑凝胶组12.84%;糖胶体组4.83%。结论:糖胶体治疗细菌性阴道病的近期疗效优于安慰剂和甲硝唑凝胶;远期疗效优于安慰剂,与甲硝唑凝胶相当。不良反应发生率糖胶体组低于安慰剂和甲硝唑凝胶组。
[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.
【学位授予单位】：河北医科大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R711.3

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