摘要
目的比较以艾普拉唑或埃索美拉唑为基础的四联7d疗法作为一线治疗对幽门螺杆菌（Hp）感染的根除率，并对根除失败患者进行Hp菌株耐药基因检测分析。方法采用前瞻性随机平行对照多中心临床研究，2010年10月至2011年7月，以因上胃肠道症状而接受胃镜检查确诊为Hp感染阳性的十二指肠溃疡或慢性胃炎患者为研究对象，在全国10个中心对440例初治患者进行Hp感染的根除治疗。220例十二指肠溃疡和220例慢性胃炎患者采用分段随机法各分为两组，分别接受埃索美拉唑或艾普拉唑＋阿莫西林＋克拉霉素＋枸橼酸铋钾的四联7d疗法（每亚组110例）。慢性胃炎组患者7d后停药，十二指肠溃疡组患者继续服用埃索美拉唑或艾普拉唑14d后停药，两组患者均在停药28d后进行”C尿素呼气试验检测Hp情况，检测结果阳性者再次行胃镜检查，获取其胃黏膜标本进行Hp培养和耐药基因检测。结果慢性胃炎组患者：艾普拉唑组和埃索美拉唑组的Hp根除率符合方案数据分析（PP分析）分别为78．2％（79／101）及82．O％（82／100）（P=0．50），意向性分析（ITT分析）分别为71．8％（79／110）及74．5％（82／110）（P=0．65）；十二指肠溃疡组艾普拉唑组和埃索美拉唑组的Hp根除率PP分析为92．1％（93／101）及91．4％（96／105）（P=0．86），1ITT分析分别为84．5％（93／110）及87．3％（96／110）（P=0．56）。慢性胃炎组患者总体根除率为80．1％（161／201，PP分析）及73．2％（161／220，ITT分析），十二指肠溃疡组患者总体根除率为91．7％（189／206，PP分析）及85．9％（189／220，ITT分析）。两组药物对疼痛、烧灼感、反酸、嗳气、恶心呕吐等症状改善程度近似，均无严重不良反应发生。对其中53例根除失败患者进行Hp菌株的耐药基因检测，克拉霉素耐药基因点突变发生率为100％（53／53）。结论四联7d方案作为一线疗法对慢性胃炎和十二指肠溃疡患者的Hp感染均能获得较好的根除效果；含艾普拉唑与含埃索美拉唑的四联疗法的根除率无明显差异。Hp对克拉霉素耐药可能是导致失败的主要原因。
Objective To explore the effects of 7-day quadruple regimen as the first-line therapystrategy for Helicobacter pylori （H. pylori） infection and compare the eradication rate of ilaprazole versus esoprazole-based regimen. Methods A total of 440 patients with H. pylori infection, who had never received H. pylori eradication treatment, were enrolled from 10 domestic hospitals from October 2010 to July2011. Diagnosed as chronic gastritis or duodenal ulcer according to their endoscopic examination results, they were randomized into ilaprazole and （or） esoprazole-based bismuth-containing quadruple regimen group with amoxicillin and clarithromycin （n = 110 each）. After a 7-day eradication treatment, all patients with duodenal ulcer received PPI （ilaprazole and （or） esoprazole） treatment for ld days and 13C urea breath test was performed at least 28 days after the end of therapy. The patients with failed eradication treatment underwent endoscopy examination and biopsy. H. pylori culture and detection of antibiotic-resistant genes were also performed. Results In gastritis patients, the eradication rate （per-protocol, PP value） were 78.2% （79/101） and 82. 0% （82/100） in ilaprazole and esoprazole groups （ P = 0. 50 ） while the （ intention- to-treat） ITF value of eradication rate were 71.8% （79/110）and 74. 5% （82/110）in ilaprazole and esoprazole groups respectively（P = 0. 65）. And there was no statistical difference （P 〉 0. 05）. In duodenal patients, the eradication rate （PP） were 92. 1% （93/101） and 91.4% （ 96/105 ） in ilaprazole and esoprazole group （P =0. 86）while the ITT value of eradication rate were 84. 5% （93/110）and 87. 3% （96/110）in ilaprazole and esoprazole groups respectively （ P = 0. 56）. And no significant difference existed between two groups in gastritis and duodenal ulcer patients （ P 〉 0. 05 ）. In total, the eradication rate was 80. 1% （161/201） （PP） and 73.2% （161/220） （ITT）, 91.7% （189/206） （PP） and 85.9% （189/220） （ITF） in chronic gastritis and duodenal ulcer patients respectively. The symptomatic improvements of stomachache, burning, belching and nausea remained almost unchanged. No severe side effect was observed. The point mutations for clarithromyein resistance were detected in all 53 H. pylori strains （ 100% ） isolated from the patients with failed eradication treatment. Coneluslons The eradication rate of PPI based bismuthcontaining quadruple regimen as the first-line treatment is satisfactory in chronic gastritis and duodenal ulcer patients. No significant difference exists between the effects of ilaprazole and esoprazole-based groups. And the treatment failure may be attributed mainly to the clarithromycin resistance of H. pylori.
出处
《中华医学杂志》
CAS
CSCD
北大核心
2012年第30期2108-2112,共5页
National Medical Journal of China
基金
中华医学会北京分会科研资金课题（2010-002）
关键词
螺杆菌
幽门
奥美拉唑
药物疗法
联合
艾普拉唑
Helicobacter pylori
Omeprazole
Drug therapy, combination
Ilaprazole
