泮托拉唑四联5d疗法与7d疗法随机对照研究

A randomized controlled study of 5-and 7-d pantoprazole quadruple regimens for Helicobacter pylori eradication

目的:比较泮妥拉唑四联5d疗法和7d疗法的Hpylori根除率和症状缓解率.方法:H pylori阳性的胃炎、胃溃疡或十二指肠患者70例随机接受5d(34例)或7d(36例)泮妥拉唑四联疗法:泮妥拉唑40mg、克拉霉素250mg、阿莫西林1.0g和胶体枸橼酸铋钾220 mg,均为2次/d.根除治疗后第4周复查H pylori是否根除,了解症状缓解情况.结果:5d组H pylori根除率为84.8%(PP)和82.4%(ITT),7d组H pylori根除率为88.2%(PP)和83.3%(ITT),5d组疼痛缓解率为72.0%(PP)和69.2%(ITT),7d组疼痛缓解率为83.9%(ITT)和89.7%(PP).按PP及ITT组群分析,两组方案H pylori根除率及疼痛缓解率无明显差异,两组患者均未出现严重不良反应.结论:泮妥拉唑四联5d疗法可以获得较高的H pylori根除率和疼痛缓解率,可以作为H pylori根除治疗的一线治疗方案.

AIM： To compare the efficacy and tolerability of 5- and 7-days therapy with a new pantoprazole quadruple regimen for eradicating Helicobacter pylori infection and relieving symptoms. METHODS： A total of 70 patients were recruited, 34 in the 5-days and 36 group in the 7-days group. Patients with H pylori-positive peptic ulcer disease, as well as gastritis were randomized to receive pantoprazole 40 mg, clarithromycin 250 mg, amoxicillin 1.0 g, and bismuth potassium citrate 220 mg twice daily for 5 or 7 days. H pylori status was determined by urease test, histology, culture and ^13C-urea breath test. Eradication of H pylori and symptomatic relief were determined at week 4. RESULTS： Thirty-three patients in the 5-days and 34 in the 7-days group finished treatment. Intention-to-treat eradication rate was 82.4% and 83.3% （P = 0.91）, and per protocol eradication rate was 84.8% and 88.2% （P = 0.68） in the 5- and7-days group, respectively. Intention-to-treat pain relief rate was 69.2% and 83.9% （P = 0.18） and per protocol rate was 72.0% and 89.7% （P = 0.10） in the 5- and 7-days group, respectively. No severe side-effects were found in either group. CONCLUSION： The 5-days quadruple regimen with pantoprazole, clarithromycin, amoxicillin and bismuth potassium citrate achieved a high H pylori eradication and a high pain relief rate, and may be used as first-line therapy for H pylori eradication.