不同剂量抗生素治疗幽门螺杆菌的临床观察

Clinical observation of different doses of antibiotic treatment in Helicobacter pylori

目的通过临床观察,评估标准剂量与小剂量抗生素治疗方案治疗幽门螺杆菌的根治率、不良反应、依从性、成本的影响差异。方法选择我院幽门螺杆菌感染患者108例,将其随机分为两组:A组(标准剂量),兰索拉唑(15mg),阿莫西林(1g),克拉霉素(500mg),每日2次,疗程10天;B组(小剂量),兰索拉唑(15mg)每日2次,阿莫西林(500mg),克拉霉素(250mg),每日3次,疗程10天。停药至少4周后或停用抑酸药至少2周后行尿素呼气试验(UBT)。对整个治疗期间的依从性及不良反应进行评估。结果意向治疗(ITT)分析,A组、B组的根除率分别是83.3%(45/54)vs 81.5%(44/54),差异无统计学意义(P>0.05)。方案(PP)分析,A组、B组的根除率分别是84.9%(45/53)vs 86.3%(44/51),差异无统计学意义(P>0.05)。A组的不良反应发生率62.3%明显高于B组18.2%(P<0.05)。小剂量的治疗费用明显低于标准剂量(327.6元、258.6元)。结论小剂量阿莫西林、克拉霉素联合兰索拉唑为期10天的治疗方案,根治幽门螺杆菌与标准方案相比同样有效,但更经济,耐受性及依从性更好。两种治疗方案与公认的标准根治率相比均不理想。

Objective To evaluate the difference of efficacy and safety between standard-dose and smaller dose triple regimen for the eradication of Helicobacter pylori infection. Methods A total of 108 consecutive patients with documented infection were enrolled in this open-label trial and the patients were randomed into two groups. Group A （standard dose） received lansoprazole（15 rag） ,amoxicillin （1 g） ,and clarithromyclin （500 rag）, all twice daily for l0 days. Group B （small dose） received lansoprazole（ 15 rag）, twice daily, amoxicillin （500 mg） and clarithromycin （250 mg） ,all three times a day for 10 days. Urea breath test（UBT） was performed at least 4 weeks after treatment and at least 2 weeks after any acid-suppressive therapy. Compliance and adverse effects were evaluated throughout the treatment. Results Eradication of Helicobacter pylori in group A and group B was respectively 83.3% （45/54） and 81.5%0 （44/54） ,on an intent-to-treat（ITT） analysis （ P〈0.05）. On a Per protocol analysis（PP） ,the eradication rates were 45 of 53 （84.9%） and 44 of 51 （85.30/00） ,respectively （ P ~〉0.05）. The number of patients reporting any adverse effect was significantly higher in group A （52.8% vs 18.2% ; P 〈0.05）. The cost of treatment was significantly less in patients receiving the small dose regimen （￥327.5 yuan vs ￥258.6 yuan）. Conclusion A small doses of 10-day regimen of lansoprazole, amoxieillin, and clarithromycin is equally effective but cheaper and better tolerated than its standard-dose regimen in the treatment of Helicobacter pylori. Eradication rates of both regimens are, however, suboptimal compared with accepted standards.