【作者】 陈伟；

【导师】 张桂英；

【作者基本信息】 中南大学 ， 消化内科， 2012， 硕士

【摘要】 研究目的1.观察和比较含呋喃唑酮的四联7天及10天疗法一线治疗幽门螺杆菌阳性的慢性胃炎及十二指肠球部溃疡的症状缓解率及不良反应率；2.观察含呋喃唑酮的四联7天及10天疗法一线治疗对幽门螺杆菌根除效果,并与克拉霉素四联7天疗法比较根除效果。研究对象及方法研究对象：152例因上胃肠道症状而接受胃镜及幽门螺杆菌检测(快速尿素酶试验、组织病理学检测、尿素呼气试验)检查诊断为Hp阳性的慢性胃炎或十二指肠球部溃疡无并发症的患者。方法：152例患者随机分成对照组、含呋喃唑酮四联7天组及10天组。对照组：埃索美拉唑(20mg)+丽珠得乐(220mg)+阿莫西林(1000mg)+克拉霉素缓释片(500mg),bid*7天；四联7天组：埃索美拉唑(20mg)+丽珠得乐(220mg)+阿莫西林(1000mg)+呋喃唑酮(100mg),bid*7天；四联10天组：埃索美拉唑(20mg)+丽珠得乐(220mg)+阿莫西林(1000mg)+呋喃唑酮(100mg),bid*10天。随诊并记录患者症状缓解情况和药物不良反应,了解患者依从性及耐受性。幽门螺杆菌根除治疗结束后至少4周,停用PPI至少2周后行UBT检测,观察幽门螺杆菌根除率。幽门螺杆菌根除率采用ITT分析和PP分析。应用药物经济学评价法中的成本—效果分析法计算成本—效果比值和增量成本—效果比值评价比较三种方案。统计分析采用SPSS17.0软件完成统计分析。定性资料采用百分数表示,比较采用χ2检验,不符合χ2检验条件的行Fisher确切概率法；定量资料的比较采用多个样本均数比较的方差分析(ANOVA检验),P<0.05将认为所检验的差别有统计学意义。结果1.完成研究的140例患者,症状缓解总有效率为77.86%。对照组总有效率为75%；四联7天组总有效率为77.78%；四联10天组总有效率为80.85%。三组患者症状缓解情况的比较无显著差异(P>0.05)。2.对照组不良反应发生率10.42%；四联7天组不良反应发生率13.33%；四联10天组不良反应发生率6.38%。三组患者不良反应发生率的比较无显著差异(P>0.05)。3.幽门螺杆菌根除率按PP分析,对照组87.50%；四联7天组88.89%；四联10天组93.62%。按ITT分析,对照组79.25%；四联7天组83.33%；四联10天组86.27%。三组间根除率无论是PP分析还是ITT分析均无显著差异(P>0.05)。4.三组间十二指肠球部溃疡患者幽门螺杆菌根除率比较；三组间慢性胃炎患者幽门螺杆菌根除率比较均无统计学意义。三组内十二指肠球部溃疡患者的幽门螺杆菌根除率均较慢性胃炎患者高,但两者无显著差异。5.对照组、四联7天组和四联10天组的成本—效果比分别为3.69、2.48和3.37,四联7天组相对于对照组的增量成本—效果比值为-73.22,四联10天组现对于对照组的增量成本—效果比值为-1.17。结论1.三组患者在症状缓解率及不良反应发生率方面无明显差异；2.三组方案间十二指肠球部溃疡患者幽门螺杆菌根除率比较无显著差异,慢性胃炎患者幽门螺杆菌根除率比较亦无显著差异；3.三组方案内十二指肠球部溃疡患者的幽门螺杆菌根除率均较慢性胃炎患者高,但两者无显著差异。4.含呋喃唑酮的四联7天及10天方案较对照组对幽门螺杆菌的根除率有提高,均具有较高的幽门螺杆菌根除率。不良反应少而轻微,且降低了四联方案的成本,两种方案均为安全、有效、经济的一线治疗方案,符合我国国情,值得临床推广。更多还原

【Abstract】 Objectives1.To view and compare the rate of symptom remission and adverse reactions of furazolidone-based quadruple therapy as first-line treatment for patients with H.pylori,2. To view and compare the H.pylori eradication rate of furazolidone-based quadruple therapy as first-line treatment for patients with H.pylori with clarithromycin quadruple therapy.Subjects and methodsSubjects:152patients with upper gastrointestinal symptoms underwent electronic gastroscope and H.pylori tests(RUT,Histopathology,UBT) and were diagnosed as Hp-positive chronic gastritis or duodenal ulcer.Methods:152patients were randomly divided into three groups:the control group received esomeprazole20mg,bismuth potassium critrate220mg,amoxicillin1000mg and clarithromycin500mg,twice a day for7days;furazolidone-based quadruple7days group received esomeprazole20mg,bismuth potassium critrate220mg,amoxicillin1000mg and furazolidone100mg,twice a day for7days; furazolidone-based quadruple10days group received esomeprazole20mg,bismuth potassium critrate220mg,amoxicillin1000mg and furazolidone100mg,twice a day for10days.Followed up and record the symptom remission and adverse reactions,observed their compliance and tolerance.After at least4weeks of the treatment and2weeks of nonuse of PPI, H.pylori eradication was checked by UBT. H.pylori eradication rate was analyzed by PP and ITT analysis.Used two index of cost-effectiveness analysis(cost-effectiveness ratio and incremental cost-effectiveness ratio) to evaluate the three treatment.Use SPSS17.0 statistical analysis software to analysis.Qualitative data,which was exptessed by percentage, was compared with Chi-square test or Fisher’s exact test.Quantitative date were compared with multiple sample ANOVA test. When P<0.05,it considered statistically significant.Results1.Totally,140cases completed the study,the total efficiency is77.86%.The rates of symptom remission in the three groups were75%,77.78%and80.85%.There was no significant difference(P>0.05).2. The rates of adverse reactions in the three groups were10.42%,13.33%and6.38%.There was no significant difference(P>0.05).3.On PP analysis,the H.pylori eradication rate of the three groups were87.50%,88.89%and93.62%.On ITT analysis, the H.pylori eradication rate of the three groups were79.25%,83.33%and86.27%. There was no significant difference either on PP analysis or on ITT analysis.4. Among the three groups of patients with duodenal ulcer, The H.pylori eradication rate was no significant difference. Among the three groups of patients with chronic gastritis, the H.pylori eradication rate was no significant difference.The H.pylori eradication rate of patients with duodenal ulcer was higher than that of patients with chronic gastritis in the three groups, The eradication rate of patients with duodenal ulcer or chronic gastritis was similar in the three groups.5.The cost-effectiveness ratio of the three groups were3.69,2.48and3.37.the incremental cost-effectiveness ratio of furazolidone-based quadruple7days group was-73.22as against control group; the incremental cost-effectiveness ratio of furazolidone-based quadruple10days group was-1.17as against control group.Conclusions1.0There was no significant difference in the rate of symptom remission and adverse reactions among the three groups. 2.Among the three groups,the eradications rate of patients with duodenal ulcer or chronic gastritis were similar.3.In the three groups,the eradication of patients with duodenal ulcer was higher than that of patients with chronic gastritis,but there was no significant difference between them.4.Both H.pylori eradication rates of furazolidone-based quadruple7days and10days group are higher than that of control group,both of them have high eradication rates,and there is few slightly side effects,whatmore,they can reduce the cost of quadruple treatment,both of the two treatments,which are safe,effective and economical first-line treatment and accord with the situations of our country,can be recommended for clinical practice.更多还原