摘要
目的评估高剂量双联方案与含铋剂四联方案治疗军人幽门螺杆菌(H.pylori)感染的有效性、性价比等。方法随机对照研究。纳入2022年3至5月就诊于解放军总医院第一医学中心的共160例H.pylori感染、首次接受治疗的军人患者,其中男性74例、女性86例,年龄20~74(43±13)岁。患者随机分配到高剂量双联组和含铋剂四联组,疗程均为14 d。比较两组H.pylori根除率、不良反应、依从性和治疗费用。连续变量用t检验,分类变量进行χ^(2)检验。结果按意向治疗(ITT)、按改良意向治疗(mITT)以及按方案(PP)分析,高剂量双联组根除率与四联组相比,两组根除率差异无统计学意义。ITT:90.0%(95%CI 81.2%~95.6%)比87.5%(95%CI 78.2%~93.8%),χ^(2)=0.25,P=0.617;mITT:93.5%(95%CI 85.5%~97.9%)比93.3%(95%CI 85.1%~97.8%),χ^(2)<0.01,P=1.000;PP:93.5%(95%CI 85.5%~97.9%)比94.5%(95%CI 86.6%~98.5%),χ^(2)<0.01,P=1.000。高剂量双联组不良事件发生率低于四联组[21.8%(17/78)比38.5%(30/78),χ^(2)=5.15,P=0.023]。高剂量双联组依从性为98.7%(77/78),四联组为94.9%(74/78),两组差异无统计学意义(χ^(2)=0.83,P=0.363)。高剂量双联方案每个疗程药费(人民币472.10元)比四联方案(人民币693.94元)减少32.0%。结论高剂量双联方案对军人H.pylori感染根除率高,根除效果达B级。高剂量双联方案不良反应发生率低、依从性好、成本显著降低,有望成为军人H.pylori感染首次根除治疗的新选择,值得进一步临床验证和推广研究。
Objective To assess the efficacy and cost-effectiveness of high-dose dual therapy compared with bismuth-containing quadruple therapy for treating Helicobacter pylori(H.pylori)infection in servicemen patients.Methods A total of 160 H.pylori-infected,treatment-naive servicemen,including 74 men and 86 women,aged from 20 years to 74 years,with a mean(SD)age of 43(13)years,tested in the First Center of Chinese PLA General Hospital from March 2022 to May 2022 were enrolled in this open-label,randomized controlled clinical trial.Patients were randomly allocated into 2 groups:the 14-day high-dose dual therapy group and the bismuth-containing quadruple therapy group.Eradication rates,adverse events,patient compliance,and drug costs were compared between the two groups.The t-test was used for continuous variables,and the Chi-square test for categorical variables.Results No significant difference in H.pylori eradication rates were found between high-dose dual therapy and bismuth-containing quadruple therapy by ITT,mITT and PP analysis[ITT:90.0%(95%CI 81.2%-95.6%)vs.87.5%(95%CI 78.2%-93.8%),χ^(2)=0.25,P=0.617;mITT:93.5%(95%CI 85.5%-97.9%)vs.93.3%(95%CI 85.1%-97.8%),χ^(2)<0.01,P=1.000;PP:93.5%(95%CI 85.5%-97.9%)vs.94.5%(95%CI 86.6%-98.5%),χ^(2)<0.01,P=1.000].The dual therapy group exhibited significantly less overall side effects compared with the quadruple therapy group[21.8%(17/78)vs.38.5%(30/78),χ^(2)=5.15,P=0.023].There were no significant differences in the compliance rates between the two groups[98.7%(77/78)vs.94.9%(74/78),χ^(2)=0.83,P=0.363].The cost of medications in the dual therapy was 32.0%lower compared with that in the quadruple therapy(472.10 RMB vs.693.94 RMB).Conclusions The dual regimen has a favorable effect on the eradication of H.pylori infection in servicemen patients.Based on the ITT analysis,the eradication rate of the dual regimen is grade B(90%,good).Additionally,it exhibited a lower incidence of adverse events,better compliance and significantly reduced cost.The dual regimen is expected to be a
作者
张晓梅
闵汉琛
陈静
支俊丽
董红霞
孔金艳
孟江云
孙刚
王子恺
潘飞
彭丽华
杨云生
Zhang Xiaomei;Min Hanchen;Chen Jing;Zhi Junli;Dong Hongxia;Kong Jinyan;Meng Jiangyun;Sun Gang;Wang Zikai;Pan Fei;Peng Lihua;Yang Yunsheng(Department of Gastroenterology and Hepatology,the First Medical Center,Chinese PLA General Hospital,Beijing 100853,China;Medical School of Chinese PLA,Beijing 100853,China)
出处
《中华内科杂志》
CAS
CSCD
北大核心
2023年第5期520-525,共6页
Chinese Journal of Internal Medicine
基金
“十三五”军队重点学科专业建设项目(A350109)。
关键词
螺杆菌
幽门
质子泵抑制剂
阿莫西林
军事人员
Helicobacter pylori
Proton pump inhibitors
Amoxicillin
Military personnel
