發(fā)布時間：2018-02-25 17:30

  本文關鍵詞： 幽門螺桿菌 布拉氏酵母菌 慢性胃炎 莫西沙星 補救治療　出處：《山西醫(yī)科大學》2017年碩士論文　論文類型：學位論文

【摘要】：目的:通過臨床病例對照研究,探討布拉氏酵母菌(S.boulardii)治療方案即其與艾司奧美拉唑、阿莫西林(AMX)、莫西沙星(MXF)聯(lián)合應用在補救治療中的有效性和安全性,評價其對H.pylori根除率及不良反應發(fā)生率的影響,分析S.boulardii在根除幽門螺桿菌(H.pylori)的輔助作用,旨為今后S.boulardii在H.pylori補救治療中的輔助作用提供科學依據(jù)。方法:收集2014年1月至2016年12月于山西省人民醫(yī)院及山西省腫瘤醫(yī)院內(nèi)鏡門診就診且通過首次標準治療除菌失敗的慢性胃炎(CG)或消化性潰瘍(PU)的受試者447例,所有受試者用藥前均被告知可能獲得的益處和風險并簽署知情同意書,詳細記錄其姓名、性別、年齡、詳細聯(lián)系方式后,按入選時的胃鏡檢查結(jié)果隨機分為對照組224例,以艾司奧美拉唑、AMX、MXF三聯(lián)療法治療;試驗組223例,在對照組的基礎上加用S.boulardii,兩組療程均為14天;PU受試者加服艾司奧美拉唑2周。治療期間門診復診或電話隨訪以記錄受試者出現(xiàn)的不良反應。記錄停藥4周后受試者的呼氣試驗結(jié)果,按照統(tǒng)計學方法進行分析,得出數(shù)據(jù)并進行效果分析。結(jié)果:對照組受試者有224例,中斷治療者17例,失訪者28例,179例完成研究,復查呼氣試驗陰性135例,H.pylori根除率按符合方案集分析(Per-protocol analysis,PP分析)為75.42%、按意向性分析(Intention to treat analysis,ITT分析)為60.27%;試驗組有223例,中斷治療者17例,失訪者34例,176例參與研究,復查呼氣試驗陰性159例,H.pylori根除率PP分析為90.34%、ITT分析為71.30%;PP分析和ITT分析結(jié)果對比顯示試驗組的H.pylori根除率更高,且差異顯著(χ2=13.886,P=0.001a;χ2=6.042,P=0.014a)。對照組受試者有224例,中斷治療者17例,完成研究者179人。17例中斷治療者有10例因出現(xiàn)發(fā)生不良反應而退出,179例完成者有35例出現(xiàn)不良反應,發(fā)生不良反應率PP分析為19.55%、ITT分析為20.09%;試驗組有223例,中斷治療者13例,完成研究者176人。13例中斷治療者有8人因發(fā)生不良反應而退出,176例完成者有20例出現(xiàn)不良反應,發(fā)生不良反應率PP分析為11.36%、ITT分析為12.56%;PP分析和ITT分析結(jié)果對比顯示試驗組的不良反應發(fā)生率更低,且差異顯著(χ2=4.546,P=0.033a;χ2=6.670,P=0.010a)。結(jié)論:MXF三聯(lián)方案(艾司奧美拉唑、AMX、MXF)與S.boulardii聯(lián)合治療與MXF三聯(lián)方案相比,前者提高補救治療H.pylori根除率,減少不良反應事件發(fā)生,且優(yōu)勢明顯。S.boulardii聯(lián)合艾司奧美拉唑、AMX、MXF可作為首次或多次根除失敗的替代療法或者首選療法。
[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.
【學位授予單位】：山西醫(yī)科大學
【學位級別】：碩士
【學位授予年份】：2017
【分類號】：R573

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本文編號：1534497