布拉氏酵母菌对补救治疗幽门螺杆菌的影响

发布时间：2018-02-25 17:30

本文关键词： 幽门螺杆菌布拉氏酵母菌慢性胃炎莫西沙星补救治疗　出处：《山西医科大学》2017年硕士论文　论文类型：学位论文

【摘要】：目的:通过临床病例对照研究,探讨布拉氏酵母菌(S.boulardii)治疗方案即其与艾司奥美拉唑、阿莫西林(AMX)、莫西沙星(MXF)联合应用在补救治疗中的有效性和安全性,评价其对H.pylori根除率及不良反应发生率的影响,分析S.boulardii在根除幽门螺杆菌(H.pylori)的辅助作用,旨为今后S.boulardii在H.pylori补救治疗中的辅助作用提供科学依据。方法:收集2014年1月至2016年12月于山西省人民医院及山西省肿瘤医院内镜门诊就诊且通过首次标准治疗除菌失败的慢性胃炎(CG)或消化性溃疡(PU)的受试者447例,所有受试者用药前均被告知可能获得的益处和风险并签署知情同意书,详细记录其姓名、性别、年龄、详细联系方式后,按入选时的胃镜检查结果随机分为对照组224例,以艾司奥美拉唑、AMX、MXF三联疗法治疗;试验组223例,在对照组的基础上加用S.boulardii,两组疗程均为14天;PU受试者加服艾司奥美拉唑2周。治疗期间门诊复诊或电话随访以记录受试者出现的不良反应。记录停药4周后受试者的呼气试验结果,按照统计学方法进行分析,得出数据并进行效果分析。结果:对照组受试者有224例,中断治疗者17例,失访者28例,179例完成研究,复查呼气试验阴性135例,H.pylori根除率按符合方案集分析(Per-protocol analysis,PP分析)为75.42%、按意向性分析(Intention to treat analysis,ITT分析)为60.27%;试验组有223例,中断治疗者17例,失访者34例,176例参与研究,复查呼气试验阴性159例,H.pylori根除率PP分析为90.34%、ITT分析为71.30%;PP分析和ITT分析结果对比显示试验组的H.pylori根除率更高,且差异显著(χ2=13.886,P=0.001a;χ2=6.042,P=0.014a)。对照组受试者有224例,中断治疗者17例,完成研究者179人。17例中断治疗者有10例因出现发生不良反应而退出,179例完成者有35例出现不良反应,发生不良反应率PP分析为19.55%、ITT分析为20.09%;试验组有223例,中断治疗者13例,完成研究者176人。13例中断治疗者有8人因发生不良反应而退出,176例完成者有20例出现不良反应,发生不良反应率PP分析为11.36%、ITT分析为12.56%;PP分析和ITT分析结果对比显示试验组的不良反应发生率更低,且差异显著(χ2=4.546,P=0.033a;χ2=6.670,P=0.010a)。结论:MXF三联方案(艾司奥美拉唑、AMX、MXF)与S.boulardii联合治疗与MXF三联方案相比,前者提高补救治疗H.pylori根除率,减少不良反应事件发生,且优势明显。S.boulardii联合艾司奥美拉唑、AMX、MXF可作为首次或多次根除失败的替代疗法或者首选疗法。
[Abstract]:Objective: to investigate the efficacy and safety of S.boulardii in combination with oxomeprazole, amoxicillin AMXX and moxifloxacin in the treatment of MXF by a clinical case-control study, and to explore the efficacy and safety of the treatment regimen of S.boulardii in combination with oxomeprazole, amoxicillin, and moxifloxacin. To evaluate the effect of S. boulardii on H. pylori eradication rate and adverse reaction rate, and to analyze the role of S. boulardii in H. pylori eradication. Objective: to provide scientific basis for the auxiliary role of S.boulardii in the treatment of H.pylori from January 2014 to December 2016. Methods: from January 2014 to December 2016, S.boulardii was admitted to the endoscopic clinic of Shanxi Provincial people's Hospital and Shanxi Cancer Hospital. There were 447 subjects with failed chronic gastritis (CGG) or peptic ulcer (PUU). All the subjects were informed of the potential benefits and risks and signed an informed consent form. After recording their names, sex, age and contact details, they were randomly divided into control group (224 cases) according to the results of gastroscopy. The treatment group was treated with AMXX MXF triple therapy with oxmeprazole, 223 cases in the trial group, S. boulardii was added to the control group. The course of treatment in both groups was 14 days and the subjects were given esomeprazole for 2 weeks. During the course of treatment, the patients were followed up by telephone or at the outpatient clinic to record the adverse reactions of the subjects. The adverse reactions were recorded after 4 weeks of withdrawal. The results of the breath test, Results: there were 224 subjects in the control group, 17 patients had interrupted treatment, and 179 patients had lost the visit, the results showed that there were 224 cases in the control group, 17 cases in the control group, and 179 cases in the control group. The eradication rate of H.pylori in 135 patients with negative breath test was 75.42 according to Per-protocol analysis (PP) and 60.27 according to intentionality analysis), 223 cases in the trial group, 17 cases in interruption of treatment, and 176 cases in 34 cases of loss of treatment in the study group, the eradication rate of H.pylori was 75.42% and 60.27% according to intentionality analysis, respectively, in the test group, there were 223 cases in the trial group, 17 cases in the interrupted treatment group, and 176 cases in the study group. The eradication rate of H.pylori was 90.34% and 71.30% respectively. The results of PP analysis and ITT analysis showed that the eradication rate of H.pylori in the test group was higher than that in the control group (蠂 ~ 2 / 13.886 / P = 0.001a; 蠂 ~ (2 +) 6.042P = 0.014 a). There were 224 cases in the control group and 17 cases in the control group. Ten out of 179 patients who had completed the treatment, and 35 out of 179 who had completed the treatment. The adverse reaction rate was 19.5555 and ITT analysis was 20.09 in PP analysis, 223 in the trial group, and 13 in the interrupted treatment group, and the rate of adverse reaction was 19.555and ITT in the study group, while in the trial group, there were 223 patients in the trial group and 13 patients in the treatment interruption group. Of the 176 people who completed the study, 8 of the 13 who interrupted the treatment, 8 withdrew from the study because of adverse reactions. 20 of the 176 completed patients had adverse reactions. The incidence of adverse reactions in the test group was lower than that in the test group, compared with the results of the PP analysis and ITT analysis, which were 11.36% and 12.56%, respectively. The difference was significant (蠂 ~ 2 = 4.546P = 0.033a; 蠂 ~ 2 = 6.670 / P = 0.010a). Conclusion compared with MXF regimen, the former can increase the eradication rate of H.pylori and decrease the incidence of adverse events. [conclusion] compared with the combination regimen of S.boulardii and Ameprazole, the former can increase the eradication rate of H.pylori and decrease the incidence of adverse events. S. boulardii combined with omeprazole (AMXX) MXF can be used as the first or first choice therapy for eradication failure.
【学位授予单位】：山西医科大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R573

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