幽门螺杆菌感染初治患者1 440例根除治疗方案的对比研究  

Comparative study on eradication therapy of 1 440 newly diagnosed patients with Helicobacter pylori infection

作　　者：阿达克·赛肯 宋志强 周丽雅 

机构地区：[1]北京大学第三临床医学院消化科,100191

出　　处：《中华消化杂志》2017年第7期433-437,共5页Chinese Journal of Digestion

摘　　要：目的评价常规根除治疗方案和个体化治疗方案在H.pylori感染初治患者中的有效性和安全性。方法纳入2008年3月至2010年2月、2013年9月至2014年4月、2015年1月至10月因H.pylori阳性行根除治疗且资料完整的患者1 440例，其中个体化组、含克拉霉素的铋剂四联组和伴同组各350例，标准三联组100例，序贯组90例，含左氧氟沙星的铋剂四联组200例。比较6组的H.pylori根除率、不良反应发生率和依从性。统计学方法采用卡方检验。结果6个治疗组在意向性治疗分析中的H.pylori根除率差异均无统计学意义（χ2＝0.985，P＝0.323）；而在修正的意向性治疗分析和符合方案集分析中，个体化组的H.pylori根除率[92.5%（282/305）和93.3%（278/298）]最高，含左氧氟沙星的铋剂四联组[90.3%（167/185）和91.6%（164/179）]次之，差异均有统计学意义（χ2＝11.285、13.981，P均〈0.01）。6个治疗组患者的不良反应发生率差异有统计学意义（χ2＝5.692，P＝0.018），其中以含左氧氟沙星的铋剂四联组的不良反应发生率[16.2%（30/185）]最低，个体化组[21.0%（64/305）]次之。6个治疗组患者的依从性差异有统计学意义（χ2＝4.712，P＝0.023），其中以标准三联组[100.0%（100/100）]和序贯组[100.0%（90/90）]的依从性最高，个体化组[97.7%（298/305）]次之。结论含左氧氟沙星的铋剂四联方案和个体化治疗方案均能有效根除H.pylori感染，前者可安全有效地用于临床上难以行个体化治疗的患者。Objective To evaluate the efficacy and safety of common therapy and individualized treatment in newly diagnosed patients with Helicobacter pylori （H. pylori） infection. Methods From March 2008 to February 2010, September 2013 to April 2014, January to October 2015, a total of 1 440 patients with H. pylori infection who received eradication therapy and with complete clinical data were retrospectively enrolled. Each was 350 cases in individualized treatment group, clarithromycin and bismuth containing quadruple therapy group and concomitant therapy group. A total of 100 cases were in standard triple therapy group, 90 cases in sequential therapy group, and 200 cases in levofloxacin and bismuth-containing quadruple therapy group. The eradication rate of H. pylori, incidence of adverse events and compliance rate were compared in the six groups. Chi square test was performed for statistical analysis. Results The results of intention-to-treat analysis indicated that there was no statistically significant difference in H. pylori eradication rates among six groups （x^2 =0. 985, P=0. 323）. However, the results of modified intention-to-treat analysis showed that H. pylori eradication rate of individualized treatment group was the highest （92. 5% （282/305） and 93. 3% （278/298））, second was levofloxacin and bismuth-containing quadruple therapy group （90.3% （167/185） and 91.6% （164/179））, and the differences were statistically significant （x^2 = 11. 285 and 13. 981, both P〈0.01）. There was statistically significant difference in indcidence of adverse events among the six groups （x^2 = 5. 692, P = 0. 018）, the incidence of adverse events in levofloxacin and bimuth-containing quadruple therapy group was lowest （16.2 % （30/185））, and second was individualized treatment group （21.0% （64/305））. There was statistically significant difference in compliance rates among the six groups （x^2 = 4.712, P= 0. 023）, the compliance rates of standard triple therapy group and sequent

关 键 词：幽门螺杆菌 根除率 依从性 安全性 个体化 

分 类 号：R57[医药卫生—消化系统]