摘要
目的观察9d疗程的含莫西沙星三联方案对初治和复治幽门螺杆菌（Hp）感染患者的根除效果。方法纳入313例Hp感染初治患者、51例第2次治疗患者、32例第3次治疗患者，均给予莫西沙星400mg1次／d，埃索美拉唑20mg2次／d，替硝唑400mg2次／d，疗程9d。疗程结束4周以后复查呼气试验，阴性者为根除成功，按照意向治疗（ITT）和按符合方案（PP）分析计算Hp根除率及95％可信区间（CI），并观察药物的不良反应和患者的依从性。结果按ITT分析：首次治疗组、第2次治疗组、第3次治疗组的Hp根除率分别是89．8％（86．7％～93．O％）、81．2％（75．3％～90．9％）、81．2％（66．1％～92．6％），差异无统计学意义（χ^2=4．339，P〉0．05）；按PP分析：3组Hp根除率分别是93．9％（90．9％～96．4％）、84．8％（79．1％-93．6％）、81．2％（66．1％～92．6％），差异有统计学意义（χ^2=9．294，P〈0．01），第2次治疗组、第3次治疗组的根除率均低于首次治疗组（χ^2=4．885、P〈0．05，χ^2=7．023、P〈0．01）。在首次治疗组中，不管按ITT还是PP分析，活动期溃疡病和慢性胃炎患者的Hp根除率差异均无统计学意义（χ^2=1．670、0．030，均P〉0．05）。按ITT分析，3组慢性胃炎患者的Hp根除率差异无统计学意义（χ^2=2．950，P〉0．10），而按PP分析则差异有统计学意义（χ^2=8．551，P〈0．05），其中第3次治疗的慢性胃炎患者Hp根除率低于首次治疗（χ^2=8．076，P〈0．01）。比较常见的不良事件是大便次数增多、腹部不适和头晕，多出现在服药的前3d内，一般可以忍受，仅1例（0．3％）因头晕而停药，治疗的依从性为96．0％。结论9d疗程的莫西沙星＋埃索美拉唑＋替硝唑方案对于初治和复治Hp感染患者都有比较高的根除率，依从性高，不良事件相对较少，可以作为一线甚至二线补救治疗的选择方案。
Objective To evaluated the efficacy of 9-clay moxifloxacin-based triple therapy as first- or second-line treatment to eradicate Helicobacter pylori （H. pylori）. Methods Three hundred and thirteen H. pylori-positive patients without previous treatment （Group A） , 51 Hp-positive patients with once-failed treatment （Group B） and 32 with twice-failed treatment （Group C） were recruited to receive moxifloxacin, esomeprazole and tinidazole （MET） for 9 days. H. pylori status was re-assessed 4 weeks after the end of therapy by urea breath test. The eradication rate and its 95% confidence interval （95% CI） were calculated in intention-to-treat （ ITT） and per-protocol （PP） analyses respectively. Results In ITT analysis, the Hperadication rate was 89. 8% （95% CI： 86. 7%--93.0% ） in Group A, 81.2% （75.3%--90. 9%） in Group B and 81.2% （66. 1%--92. 6% ） in Group C,among which no significant difference was observed （ χ^2 = 4. 339, P 〉 0. 05 ）. However, in PP analysis there was a significant difference among them [ 93.9% （90. 9%--96. 4% ） in Group A, 84. 8% （79. 1%---93.6% ） in Group B and 81.2% （66. 1%--92. 6% ） in Group C （χ^2 = 9. 294, P 〈 0. 01 ） ]. The rates were significantly lower respectively in Group B （ χ^2 = 4. 885, P 〈0. 05） and in Group C （χ^2 =7. 023, P 〈0. 01 ） than that observed in Group A according to PP analysis. But there was no significant difference between the patients with first-treated active ulceration and with first-treated gastritis （χ^2 = 1. 670, P 〉 0. 05 in ITT, or χ^2 = 0. 030, P 〉 0. 05 in PP analysis ）.Eradication rate in patients with 3rd-treated gastritis was lower than that in patients with first-treated gastritis according to PP analysis （ χ^2 = 8. 076, P 〈 0. 01 ）. The compliance rate was 95.99% in all patients. Conclusion Nine-day moxifloxacin-based triple therapy provides an optimal eradication rate with a good compliance as first-line or second-line eradication of Hp.
出处
《中华医学杂志》
CAS
CSCD
北大核心
2010年第2期87-91,共5页
National Medical Journal of China
关键词
螺杆菌
幽门
消化性溃疡
胃炎
药物疗法
联合
莫西沙星
Helicobacter pylori
Peptic ulcer
Gastritis
Drug therapy, combination
Moxifioxacin
