含艾司美拉唑、阿莫西林2种方案根除幽门螺旋杆菌相关慢性胃炎患者疗效和安全性评价  

Evaluation of the efficacy and safety of two regimens containing esomeprazole and amoxicillin in eradicating Helicobacter pylori associated chronic gastritis

作　　者：雷晓毅[1] 章金艳[1] 吴婷娜 刘明[1] LEI Xiao-yi;ZHANG Jin-yan;WU Ting-na;LIU Ming(Department of Gastroenterology,the First Affiliated Hospital of Xiamen University,Fujian Xiamen 361003,China)

机构地区：[1]厦门大学附属第一医院消化内科,福建厦门361003

出　　处：《中国医院药学杂志》2020年第4期427-431,共5页Chinese Journal of Hospital Pharmacy

摘　　要：目的:由于对抗生素耐药率的增加,传统三联疗法方案在幽门螺旋杆菌(Hp)的根除率在逐渐下降,但对阿莫西林耐药率仍然比较低。因此我们观察含有艾司美拉唑、阿莫西林为主的两种不同方案在根除Hp相关慢性胃炎患者的临床疗效和安全性评价。方法:纳入2015年1月至2016年12月在厦门大学附属第一医院确诊Hp感染且未接受过根除治疗的慢性胃炎患者200例,随机接受包含艾司美拉唑、阿莫西林的2种根除Hp的方案进行治疗。方案A(大剂量二联疗法):(艾司美拉唑40 mg bid+阿莫西林1.0 g tid)×14 d;方案B(含铋剂标准剂量四联疗法):(艾司美拉唑20 mg bid+枸橼酸铋钾220 mg bid+阿莫西林1.0 g bid+克拉霉素0.5 g bid)×14 d;根除治疗结束停药后4周及8周复查13C-尿素呼气试验。结果:2组患者基线资料差异无显著性(P>0.05)。193例患者最终完成试验。大剂量二联疗法ITT和PP根除率分别为88.0%(88/100)和91.7%(88/96);含铋剂标准剂量四联疗法ITT和PP根除率分别为92.0%(92/100)和94.8%(92/97);大剂量二联疗法、含铋剂标准剂量四联疗法二者相比差异无显著性(P>0.05)。两者的药物不良反应发生率分别为10.4%和13.4%,差异无显著性(P>0.05)。实验室检查方面2组中有个别患者出现一过性的ALT、AST增高,但均未达到正常值2倍上限;1例Cr、1例CK轻度增高;以上实验室异常指标2周后复查均已恢复正常。各组服药依从性较好,2组分别为97.9%和96.9%,差异无显著性(P>0.05)。成本-效果分析显示,大剂量二联疗法成本/效果比值(C/E)低于含铋剂标准剂量四联疗法。结论:大剂量二联疗法和含铋剂标准剂量四联疗法在根除Hp感染的慢性胃炎方面疗效相当,不良反应轻微,根除率高;在达到类似的根除效果情况下,大剂量二联疗法费用略低,可作为经典四联疗法的有效补充。OBJECTIVE Due to the increasing rate of antibiotic resistance,the eradication rate of traditional triple therapy regimen in Helicobacter pylori(Hp)has been gradually decreasing,but the rate of resistance to amoxicillin remains relatively low.Therefore,we observed the clinical efficacy and safety of two different regimens containing esomeprazole and amoxicillin in the eradication of patients with Hp-related chronic gastritis.METHODS A total of 200 patients with chronic gastritis who were diagnosed with Hp infection and had not received eradication therapy in the First Affiliated Hospital of Xiamen University from January 2015 to December 2016 were included and randomly treated with two Hp eradication regimens containing esomeprazole and amoxicillin.Regimen A(high-dose dual therapy):(esomeprazole 40 mg bid+amoxicillin 1.0 g tid)×14 d;Regimen B(standard dose quadruple therapy with bismuth):(esomeprazole 20 mg bid+bismuth potassium citrate 220 mg bid+amoxicillin 1.0 g bid+clarithromycin 0.5 g bid)×14 d;13C-urea breath test was repeated 4 and 8 weeks after discontinuation at the end of eradication therapy.RESULTS The eradication rates of ITT and PP with high-dose dual therapy were 88.0%(88/100)and 91.7%(88/96),respectively.The eradication rates of ITT and PP with standard quadruple therapy containing bismuth were 92.0%(92/100)and 94.8%(92/97),respectively.There was no significant difference between high-dose dual therapy and standard quadruple therapy containing bismuth(P>0.05).The incidence of adverse drug reactions was 10.4%and 13.4%,respectively,and there was no significant difference(P>0.05).In terms of laboratory tests,individual patients in the two groups had transient ALT and AST elevations,but none of them reached the upper limit of 2 times of normal value;1 case of Cr and 1 case of CK slightly elevated;the above laboratory abnormalities had returned to normal after re-examination after 2 weeks.Medication compliance was good in all groups,97.9%and 96.9%in the two groups,respectively,and the difference was no

关 键 词：幽门螺旋杆菌 艾司美拉唑 阿莫西林 大剂量二联疗法 含铋剂四联疗法 根除治疗 

分 类 号：R969[医药卫生—药理学]