泮托拉唑四联4d与7d疗法随机对照研究  

A randomized controlled study of 4-day and 7-day pantoprazole quadruple regimens for Helicobacter pylori eradication

作　　者：李晓宇[1] 魏虹[1] 胡伏莲[2] 

机构地区：[1]航天中心医院消化内科,北京100039 [2]北京大学第一医院消化内科,北京100034

出　　处：《中国新药杂志》2004年第5期448-451,共4页Chinese Journal of New Drugs

摘　　要：目的:比较泮托拉唑四联4d疗法和7d疗法的幽门螺杆菌(Hp)根除率和症状缓解率。方法:Hp阳性的胃炎、胃溃疡或十二指肠溃疡患者随机接受4d或7d泮托拉唑四联疗法:泮托拉唑40mg、克拉霉素250mg、阿莫西林1.0g和胶体枸橼酸铋钾220mg,均为bid。根除治疗4周后复查Hp是否根除,了解症状缓解情况。结果:共有73例患者纳入本试验,其中4d组37例,7d组36例。4d组Hp根除率为62.2%[意向治疗(ITT)群组分析和符合方案(PP)群组分析],7d组Hp根除率为83.3%(ITT)和88.2%(PP);4d组疼痛缓解率为78.8%(ITT,PP),7d组疼痛缓解率为83.9%(ITT)和89.7%(PP)。按PP群组分析4d组Hp根除率明显低于7d组,按ITT群组分析,2组方案Hp根除率无明显差异。2组方案疼痛缓解率无明显差异,2组患者均未出现严重不良反应。结论:泮托拉唑四联4d疗法可以获得较高的疼痛缓解率,但是其Hp根除率低于7d疗法,不宜作为Hp根除治疗的一线治疗方案。Objective:To compare the efficacy and tolerability of a 4-day therapy with a 7-day therapy of a new pantoprazole quadruple regimen in eradicating Helicobacter pylori (Hp) infection and relieving symptoms. Methods: Patients with Hp-positive peptic ulcer disease as well as gastritis were randomized to receive pantoprazole 40mg, clarithromycin 250mg, amoxicillin 1.0g, and bismuth potas-sium citrate 220mg twice daily for either 4 days or 7 days. Hp status was determined by urease test, histology, culture and 13C-urea breath test. Eradication of Hp and symptomatic relief was determined at week 4. Results:A total of 73 patients were recruited,37 patients in the 4-day group and 36 patients in the 7-day group. All patients in the 4-days group and 34 patients in 7-day group finished the treat-ment. Intention-to-treat Hp eradication rates were 62.2% and 83.3% (P=0. 078) and per protocol Hp eradication rates were 62.2% and 88.2% (P = 0.024) in the 4-day and 7-day groups, respective-ly. Intention-to-treat pain relief rates were 78. 8% and 83. 9% (P = 0. 841) and per protocol pain relief rates were 78. 8% and 89. 7% (P = 0. 312) in 4-day and 7-day groups, respectively. No severe side-effects were found in both groups. Conclusion: The 4-day pantoprazole quadruple regimen shows a higher pain relief rate but a lower Hp eradication rate than the 7-day quadruple regimen,and the 4-day regimen shoud not be used as a first-line therapy in Hp eradication.

关 键 词：幽门螺杆菌 四联疗法 泮托拉唑 

分 类 号：R969.4[医药卫生—药理学] R574.1[医药卫生—药学]