中药联合四联疗法提高慢性胃炎患者幽门螺杆菌根除率的临床试验研究

发布时间：2018-04-06 00:35

本文选题：慢性胃炎　切入点：幽门螺杆菌　出处：《辽宁中医药大学》2017年硕士论文

【摘要】：研究背景:幽门螺杆菌相关性胃炎为临床上的常见病,因其缠绵难愈,并且易反复发作,逐渐成为目前的研究热门。目前学术界共识,幽门螺杆菌是慢性胃炎以及消化性溃疡的重要致病因子,并且是胃癌发生的启动因子之一。目前,西医根除幽门螺杆菌的方法很多,但随着其耐药性的增加,其根除率逐渐下降,且多复发。中医药因其独特的辨证优势,在西药的基础上,结合不同患者的不同症状进行辨证治疗,可以提高Hp的根除率,还能使患者的临床症状减轻,提高病患的生活质量,并减少复发的可能。目的:评价辨证应用中药汤剂、中药固定方剂联合“四联疗法”提高慢性胃炎患者幽门螺杆菌(Hp)根除率的有效性。材料与方法:用随机、对照、单盲临床试验设计方法。应用SPSS16.0软件,计算病例数,以60例作为该实验样本含量。考虑不超过20%的退出率,总的例数确定为75例。采用整体分层区组随机化方法,分试验组B、C,对照组A。试验组为西药四联配合中药固定方剂(抗幽合剂)疗法14天,西药四联配合中药汤剂(辨证方剂)疗法14天;对照组为西药四联疗法14天。试验设计、实施、结局评价分工进行,结局评价者不清楚干预措施的分配,采用不参与治疗的第三方进行结局评价。结果:1、Hp根除率:A组西药四联组为84.0%,B组抗幽合剂联合西药四联组为92.0%,C组中药辨证方剂联合西药四联组为88.0%。2、经Wilcoxon秩和检验(p0.05),三组药物能够明显缓解胃部不适症状(胃胀、胃疼、恶心呕吐、嗳气、反酸烧心)。以B实验组效果最好,A、C实验药物疗效无显著性差异。3、在缓解胃疼症状上,经Kruskal-Wall H秩和检验,P0.05,B实验组效果最好,评分差值的平均秩次明显高于A组、C组。三组药物在恶心呕吐、嗳气、反酸烧心三个症状的表现,p0.05,差异不显著。4、治疗后三组PRO量表评分比较:治疗后B组的排便情况的恢复好于A组(P0.05),与C组比较差异没有统计学意义(P0.05);治疗后B组的消化不良的恢复状态好于A组(P0.05),与C组比较差异没有统计学意义(P0.05);治疗后B组的精神状态好于A组(P0.05),与C组比较差异没有统计学意义(P0.05);治疗后B组的总体状态的恢复好于A组(P0.05),与C组比较差异没有统计学意义(P0.05);治疗后B组的社会功能恢复优于A组和C组(P0.05);治疗后B组的健康满意度好于A组和C组,(P0.05),而A组和C组没有统计学差异。5、B组药物在改善患者排便维度上的效果与A组和C组间差异不明显;B组在社会功能维度、健康满意维度的评分改变上优于A组和C组,而A组与C组间差异不显著。结论:经研究分析,三组试验都能有效提高Hp的根除率,但三者间的差异没有统计学意义,尚不能认为中药抗幽合剂合并四联组优于其他两种疗法。但使用抗幽合剂对于缓解胃痛症状,提高患者生活质量有着明显作用。对未来该领域研究有一定参考价值。
[Abstract]:Background: Helicobacter pylori associated gastritis is a common clinical disease.The current academic consensus is that Helicobacter pylori is an important pathogenic factor of chronic gastritis and peptic ulcer, and is one of the promoters of gastric cancer.At present, there are many methods to eradicate Helicobacter pylori in western medicine, but with the increase of drug resistance, the eradication rate of Helicobacter pylori decreases gradually, and more relapse.Because of its unique advantage of syndrome differentiation, traditional Chinese medicine can improve the eradication rate of HP, alleviate the clinical symptoms and improve the quality of life of patients by combining different symptoms of different patients with syndrome differentiation on the basis of western medicine.And reduce the possibility of recurrence.Objective: to evaluate the effectiveness of TCM decoction and fixed prescription combined with quadruple therapy in improving the eradication rate of Helicobacter pylori (HP) in patients with chronic gastritis.Materials and methods: a randomized, controlled and single blind clinical trial design method was used.SPSS16.0 software was used to calculate the number of cases and 60 cases were used as the sample content of the experiment.Taking into account the exit rate of no more than 20%, the total number of cases is determined to be 75 cases.The whole stratified block randomization method was used to divide the trial group into two groups: BX C and A control group.The experimental group was treated with western medicine combined with traditional Chinese medicine fixed prescription (Kangyou mixture) for 14 days, the western medicine with traditional Chinese medicine decoction for 14 days, and the control group with western medicine for 14 days.Trial design, implementation, outcome evaluation division of labor, outcome evaluators are not clear about the allocation of intervention measures, using non-participation in the treatment of third parties to conduct outcome evaluation.Results the eradication rate of HP was 84.0 in the control group and 84.0 in the fourth group of western medicine, and that in the fourth group was 92.00.The medicine differentiation prescription combined with western medicine in group C was 88.0.2.The Wilcoxon rank sum test showed that the three groups could relieve the symptoms of stomach discomfort (stomach distension, stomachache).Nausea and vomiting, belching, acid regurgitation.There was no significant difference in the effect of drug in group B with the best effect. The effect of Kruskal-Wall H rank sum test was the best in group B, and the average rank of score difference was significantly higher than that in group C.Three groups of drugs in nausea, vomiting, belching,After treatment, the scores of PRO scale in group B were better than those in group A (P0.05), and there was no significant difference between group A and group C (P 0.05), and after treatment in group B, the recovery of defecation in group B was better than that in group A (P 0.05), but there was no significant difference between group A and group C (P 0.05).The recovery of dyspepsia in group A was better than that in group A (P 0.05), but there was no significant difference between group C and group C (P 0.05); after treatment, the mental state of group B was better than that of group A (P 0.05), and there was no significant difference between group A and group C (P 0.05).The recovery of social function in group B was better than that in group A and group C, and the health satisfaction of group B was better than that of group A and group C after treatment.There was no significant difference between group B and group A and group C in improving the defecation dimension of patients.The scores of health satisfaction were better than those of group A and group C, but there was no significant difference between group A and group C.Conclusion: the results show that the three groups can effectively improve the eradication rate of HP, but the difference among the three groups is not statistically significant, so it can not be considered that the anti-you mixture combined with the other two groups is superior to the other two kinds of therapy.But the use of Kangyou mixture can relieve the symptoms of stomach pain and improve the quality of life of patients.It has certain reference value to the future research in this field.
【学位授予单位】：辽宁中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R573.3

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