含利福布汀+呋喃唑酮的三联方案与含米诺环素+呋喃唑酮的四联方案根除难治性幽门螺杆菌感染的疗效和安全性

Efficacy and safety of rifabutin and furazolidone included triple regimen and minocycline plus furazolidone included quadruple regimen in eradicating refractory Helicobacter pylori infection

目的观察含利福布汀+呋喃唑酮的三联方案与含米诺环素+呋喃唑酮的四联方案根除难治性H.pylori感染的疗效和安全性。方法选择经≥2次规范抗H.pylori治疗失败的146例患者,将其分入埃索美拉唑+利福布汀+呋喃唑酮方案治疗组(ERF组74例)和埃索美拉唑+米诺环素+呋喃唑酮+枸橼酸铋钾方案治疗组(EMFB组72例),疗程均为10 d。于疗程结束后3 d内复查肝肾功能,停药1个月后测定13C或14C呼气试验。治疗期间每2周随访1次,详细记录服药情况和不良反应。对比分析两组患者的依从性和不良反应发生率。采用意向性治疗分析(ITT)和符合方案分析(PP)两种方法比较两组间和组内各亚组的H.pylori根除率。采用成本-效果分析(CEA)对两个方案进行成本-效果评价。采用PP方法计算成本效果比(C/E)。采用卡方检验和t检验进行统计学分析。结果ERF组和EMFB组患者依从性(90.5%比90.3%)差异无统计学意义(P>0.05)。采用ITT,ERF组与EMFB组H.pylori根除率(82.4%比84.7%)差异无统计学意义(P>0.05)。采用PP,ERF组与EMFB组组间(91.0%比93.8%),ERF组组内男、女亚组间(87.9%比94.1%)和<60岁、≥60岁亚组间(89.7%比92.9%),以及EMFB组组内男、女亚组间(89.7%比97.2%)和<60岁、≥60岁亚组间(93.6%比94.4%)H.pylori根除率差异均无统计学意义(P均>0.05)。ERF组与EMFB组组间(20.3%比22.2%),ERF组组内男、女亚组间(25.0%比15.8%)和<60岁、≥60岁亚组间(26.2%比12.5%),以及EMFB组组内男、女亚组间(19.4%比24.4%)和<60岁、≥60岁亚组间(24.5%比15.8%)不良反应发生率差异均无统计学意义(P均>0.05)。ERF组的固定每日费用、总费用和C/E值分别为59.0元、590.5元和648.9,根除率为91.0%(61/67)。EMFB组的固定每日费用、总费用和C/E值分别为32.9元、329.1元和350.9,根除率为93.8%(61/65)。结论含利福布汀+呋喃唑酮的三联方案和含米诺环素+呋喃唑酮的四联方案根除难治性H.pylori感染均有良好的疗效、安全性和依从性,综合考虑,后者更优。

Objective To observe the efficacy and safety of rifabutin and furazolidone included triple regimen and minocycline plus furazolidone included quadruple regimen in eradicating refractory H.pylori infection.Methods A total of 146 patients who failed(≥two times)to treat H.pylori with standard anti-H.pylori therapy were selected and divided into esomeprazole,rifabutin and furazolidone treatment group(ERF group,n=74)and esomeprazole,minocycline,furazolidone and bismuth potassium citrate group(EMFB group,n=72).The duration of treatment were both 10 days.Liver and renal functions were examined within three days after therapy.13C or 14C-urease breath test was performed one month after the medication withdrawal.The patients were followed up once every two weeks during the treatment period.The medication and adverse reactions were recorded in detail.The compliance and rates of adverse events in two groups were compared and analyzed.The eradication rates of the two groups and subgroups were compared by intention-to-treat(ITT)and per-protocol(PP)analyses.The cost-effectiveness of the two groups was evaluated with cost effectiveness analysis(CEA).The cost/effectiveness(C/E)ratio was calculated by PP.Chi-square test and t test were used for statistical analysis.Results There was no significant difference in complicance between ERF group and EMFB group(90.5%vs.90.3%,P>0.05).There was no significant difference in H.pylori eradication rate between ERF group and EMFB group analyzed by ITT(82.4%vs.84.7%,P>0.05).Analyzed by PP,there were no significant differences in H.pylori eradication rate between ERF group and EMFB group(91.0%vs.93.8%),between male subgroup and female subgroup of ERF group(87.9%vs.94.1%),between subgroup with age less than 60 years and subgroup with age over 60 years of ERF group(89.7%vs.92.9%),between male subgroup and female subgroup of EMFB group(89.7%vs.97.2%)and between subgroup with age less than 60 years and subgroup with age over 60 years of EMFB group(93.6%vs.94.4%)(all P>0.05).There were no statistically significant differences in the rate of adverse events between ERF group and EMFB group(20.3%vs.22.2%),between male subgroup and female subgroup of ERF group(25.0%vs.15.8%),between subgroup with age less than 60 years and subgroup with age over 60 years of ERF group(26.2%vs.12.5%),between male subgroup and female subgroup of EMFB group(19.4%vs.24.4%)and between subgroup with age less than 60 years and subgroup with age over 60 years of EMFB group(24.5%vs.15.8%)(all P>0.05).Fixed daily cost,total cost and C/E of ERF group was RMB 59.0 yuan,RMB 590.5 yuan and 648.9,respectively;and the eradication rate was 91.0%(61/67).Fixed daily cost,total cost and C/E of EMFB group was RMB 32.9 yuan,RMB 329.1 yuan and 350.9,respectively;and the eradication rate was 93.8%(61/65).Conclusions Rifabutin and furazolidone included triple regimen and minocycline plus furazolidone included quadruple regimen both have good efficacy,safety and compliance in the eradication of refractory H.pylori infection,and the latter is better.