不同疗程含呋喃唑酮三联疗法根除幽门螺杆菌的临床研究

Clinical study of Helicobacter pylori eradication in different course of furazolidone-containing triple therapy

目的探讨埃索美拉唑、阿莫西林、呋喃唑酮三联疗法应用7、10、14天根除幽门螺杆菌(Helicobacter pylori,H.pylori)的疗效及安全性。方法将270例经14 C尿素酶呼气试验(14 C-UBT)或电子胃镜检查快速尿素酶试验为阳性的患者随机分为3组,每组90例;A组:埃索美拉唑20mg+阿莫西林1 000mg+呋喃唑酮100mg,口服每日2次,疗程7天;B组和C组:治疗方案同A组,疗程分别为10天和14天。治疗期间观察患者不良反应发生情况,疗程结束至少4周后复查14 C-UBT,观察H.pylori根除率。结果按完成治疗分析,A、B、C 3组H.pylori根除率分别为71.6%(63/88)、81.8%(72/88)、86.2%(75/87),3组间差异有统计学意义(P<0.05)。按意向性分析,A、B、C3组H.pylori根除率分别为70.0%(63/90)、80.0%(72/90)、83.3%(75/90)(P>0.05)。A、B、C 3组不良反应发生率为9.1%,8.0%,10.3%(P>0.05)。主要不良事件是胃肠道反应及尿色发黄。结论 14天含呋喃唑酮的三联疗法H.pylori根除率明显高于7天疗法,而不良反应无明显增加。14天含呋喃唑酮的三联疗法根除率达86.2%。

Objective To study the efficacy and safety of 7-, 10-and 14-day triple therapy including esomeprazole,amoxicillin and furazolidone for Helicobacter pylori （H. pylori） eradication. Methods A total of 270 patients with H. pylori positive （14 C-urea breath test [-14 C-UBT] or rapid urease test positive） were randomly divided into three groups,90 cases for each group. Group A received esomeprazole （20 rag,bid） ＋ amoxicillin （1 000 mg,hid）＋ furazolidone （100 mg,bid） ,for 7-day. Group B and group C received the same medication and daily dosage as group A, but respectively for 10 days and 14 days. During the therapy, the adverse reactions in patients were observed. The H. pylori eradication rates were assessed by 14 C-UBT at lease 4 weeks after the therapy. Results According to per- protocol analysis, the H. pylori eradication rates of group A, B and C were 71.6% （63/88）, 81.8% （72/88） and 86.2 % （75/87） ,respectively. There were statistical differences among three groups （ P = 0. 047）. According to intention-to- treatment analysis, the H. pylori eradication rdtes of group A, B and C were 70.0% （63/90）, 80.0 % （72/90） and 83.3 % （75/90） ,respectively（ P〉0.05）. And the adverse reactions rates of group A, B and C were 9.1%, 8.0%, 10.3%, respectively（ P 〉0.05）. The main adverse reactions were gastrointestinal reactions and orange-color urine. Conclusion The 14-day triple therapy is more effective than the 7-day therapy for H pytori eradication, and the adverse reactions are not significantly increased. The H. pylori eradication rate of 14-day containing furazolidone triple therapy is up to 86.2 %.