幽门螺杆菌药敏培养后四联疗法治疗上消化道疾病的临床效果

Clinical effects of quadruple therapy based on antimicrobial susceptibility testing in treatment of Helicobacter pylori associated upper digestive tract diseases

目的:研究本地区幽门螺杆菌(Helicobacter pylori,H.pylori)的体外培养6种抗生素的药敏情况,以两种敏感抗生素的四联个体化方案与的四联经验治疗方案进行疗效对比,为临床用药提供参考依据.方法:选取乐清地区1000例经14C呼气试验及胃镜检查后诊断为上消化道疾病的H.pylori感染的患者,按照随机数字表法分为2组,观察组取胃黏膜标本行H.pylori培养与药敏试验,根据药敏结果选择2种抗生素,加用埃索美拉唑片20 mg 2次/d、枸橼酸铋钾片0.6 g 2次/d;经验组500例选择阿莫西林胶囊1.0 g 2次/d、克拉霉素片0.5 g 2次/d,埃索美拉唑片20 mg 2次/d、枸橼酸铋钾片0.6 g 2次/d,疗程均为2 wk,治疗结束后4 wk复查14C呼气试验,阳性者为根除治疗失败,阴性者为根除治疗成功.结果:观察组总体耐药情况:阿莫西林耐药0例(0.0%),克拉霉素耐药54例(17.3%),左氧氟沙星耐药88例(28.1%),甲硝唑耐药299例(95.5%),呋喃唑酮耐药1例(0.3%),庆大霉素耐药0例(0.0%).观察组313例,8例失访,305例完成治疗,281例根除成功.经验组500例,28例失访,472例完成治疗,405例根除治疗成功.两组对比,观察组方案治疗(per-protocol,PP)根除率92.1%高于经验组根除率85.8%,两组间差异有统计学意义(P<0.05).观察组意向治疗(intention-to-treat,ITT)根除率89.8%高于经验组根除率81.0%,两组间差异有统计学意义(P<0.05).结论:本地区上消化道疾病患者的H.pylori体外培养对阿莫西林、呋喃唑酮、庆大霉素耐药率较低,对克拉霉素、左氧氟沙星、甲硝唑耐药率较高.以H.pylori培养加药敏为基础的个体化四联方案根除率高于经验四联方案根除率,是目前有效的H.pylori根除方案,值得推广.

AIM： To compare the clinical effects of quadruple therapy based on antimicrobial susceptibility tesing vs empirical quadruple therapy in the treatment of Helicobacter pylori（H. pylori）associated upper digestive tract diseases.METHODS： One thousand patients diagnosed with H. pylori infection and upper digestive tractdiseased by ^14 C breath test and endoscopy were randomly and equally divided into two groups： an observation group and a control group. The observation group underwent antimicrobial susceptibility testing, and based on the testing results, two kinds of sensitive antibiotics, plus esomeprazole magnesium tablets 20 mg, twice daily, and bismuth potassium citrate tablets 0.6 g, twice daily, were used. The control group was empirically given penicillin capsules 1.0 g, twice daily, clarithromycin tablets 0.5 g, twice daily, esomeprazole magnesium tablets 20 mg, twice daily, and bismuth potassium citrate tablets 0.6 g, twice daily. The treatment lasted 2 wk. Four weeks after treatment, 14 C breath test was performed again to detect if eradication therapy was successful or failed.RESULTS： In the observation group, no patients were resistant to penicillin or gentamicin, 54（17.3%） were resistant to clarithromycin, 8 8（ 2 8. 1 %） tolevo floxacin, 2 9 9（ 9 5. 5 %） t o metronidazole, and 1（0.3%） to furazolidone. There were 3 1 3 cases in the observationgroup, of whom 8 were lost to follow-up, 305 completed the treatment, and 281 had successful eradication. There were 500 cases in the control group, of whom 28 were lost to follow-up, 472 completed the treatment, and 405 had successful eradication. The eradication rates by both perprotocol and intention to treat analyses were significantly higher in the observation group than in the control group（92.1% vs 85.8%, P 〈0.05; 89.8% vs 81.0%, P 〈0.05）.CONCLUSION： Quadruple therapy based on antimicrobial susceptibility testing is associated with a higher eradication rate in patients with H. pylori associated upper digestive tract diseases.