含呋喃唑酮四联方案初次根除幽门螺杆菌的疗效及效价比评估  

Efficacy and cost-effectiveness ratio of Furazolidone-based quadruple therapy as the initial treatment for Helicobacter pylori infection

作　　者：弋东敏 周炳喜[1] 丁松泽[1] 黄宇博[1] 郭琼雅[1] 张海辉[1] 张延瑞[1] 李修岭[1] 李健[1] 

机构地区：[1]郑州大学人民医院河南省人民医院消化内科,河南郑州450003

出　　处：《胃肠病学和肝病学杂志》2017年第6期673-677,共5页Chinese Journal of Gastroenterology and Hepatology

基　　金：河南省医学科技攻关计划项目(201602269)

摘　　要：目的评价含呋喃唑酮四联方案初次治疗幽门螺杆菌(Helicobacter pylori,H.pylori)感染的疗效、安全性和效价比,探讨河南地区根除H.pylori的最佳治疗方案。方法选取2015年10月-2017年2月因上消化道症状在河南省人民医院行电子胃镜病理或13C、14C-尿素呼气试验确诊为H.pylori感染的患者为研究对象,将符合入选标准的111例初治患者随机分为两组:试验组54例,给予艾司奥美拉唑(20 mg)+枸橼酸铋钾(220 mg)+阿莫西林(1 000 mg)+呋喃唑酮(100 mg),bid×14 d;对照组57例,给予艾司奥美拉唑(20 mg)+枸橼酸铋钾(220 mg)+阿莫西林(1 000 mg)+克拉霉素(500 mg),bid×14 d。所有患者疗程结束4周后,复查13C-尿素呼气试验,结果阴性为H.pylori根除成功。观察指标:(1)H.pylori的根除率;(2)随访并记录治疗期间患者发生的药物不良反应和临床症状改善情况;(3)计算并比较两种方案的成本-效果比和增量成本-效果比。结果 111例H.pylori感染患者中,每组各有2例因不能耐受药物不良反应而未完成本次试验。试验组和对照组的H.pylori根除率按意向性(intention-to-treat,ITT)分析分别为87.0%(47/54)、80.7%(46/57),按符合方案(per protocol analysis,PP)分析分别为90.4%(47/52)、83.6%(46/55),两组比较,差异均无统计学意义(P>0.05)。不良反应包括恶心、腹泻、腹痛、皮疹、口腔异味,其中以恶心最常见。试验组和对照组不良反应的发生率分别为18.5%(10/54)、19.3%(11/57),差异无统计学意义(P=0.917)。两组临床症状缓解情况比较,差异无统计学意义(P>0.05)。两组的成本-效果比分别为5.45、7.37,试验组相对于对照组的增量成本-效果比为-18.31。结论含呋喃唑酮与含克拉霉素四联方案治疗H.pylori感染均可达到良好的根除效果,且安全性高,但前者成本低,更符合理想的H.pylori根除治疗方案。由于河南省人口基数大、经济较落后,含呋喃唑酮四联疗法更易被患者接受,可作为�Objective To evaluate the efficacy,safety and cost-effectiveness ratio of Furazolidone-based quadruple therapy as the initial treatment for Helicobacter pylori（ H. pylori） infection,and to investigate the best treatment for eradicating H. pylori in Henan province. Methods From Oct. 2015 to Feb. 2017,patients with H. pylori infection eliagnosed with upper gastrointestinal symptoms were collected,these patients were examined by endoscopic pathology or 13C,14C-urea breath test in the Henan Provincial People＇s Hospital. Among these patients,111 cases with newly diagnosed criteria were randomly allocated into two groups： 54 cases in the test group with Esomeprazole（ 20 mg） ＋ Bismuth potassium citrate（ 220 mg） ＋ Amoxicillin（ 1 000 mg） ＋ Furazolidone（ 100 mg）,bid × 14 days; 57 cases in the control group with Esomeprazole（ 20 mg） ＋ Bismuth potassium citrate（ 220 mg） ＋ Amoxicillin（ 1 000 mg） ＋ Clarithromycin（ 500 mg）,bid × 14 days. All patients reviewed the13C-urea breath test after 4 weeks of discontinuation. Negative results suggested that H. pylori had been eradicated. Observe indicators：（ 1） eradication rate of H. pylori;（ 2） the adverse drug reactions and clinical symptoms improvement during the treatment was followed-up and recorded;（ 3） the cost-effectiveness ratio and incremental cost-effectiveness ratio were calculated and compared. Results Two patients in each group withdrew from the test because of unable to tolerate adverse drug reactions. On ITT analysis,the eradication rates were 87. 0%（ 47/54）,80. 7%（ 46/57）,respectively. On PP analysis,the eradication rates in two groups were90. 4%（ 47/52）,83. 6%（ 46/55）,respectively. There were no significant differences in the eradication rates of ITT analysis and PP analysis（ P〈0. 05）. Adverse reactions included nausea,diarrhea,abdominal pain,rash and oral odor,and with nausea the most common. The rates of adverse reactions in two groups were 18. 5%（ 10/54）,19. 3%（ 11/57）,r

关 键 词：幽门螺杆菌 四联疗法 呋喃唑酮 根除率 

分 类 号：R378[医药卫生—病原生物学]