不同疗程含铋四联疗法一线治疗幽门螺杆菌感染的临床研究

Different Duration of Quadruple Therapy for First-line Helicobacter Pylori Eradication Treatment——A Randomized,Controlled Trial

目的:比较不同疗程含铋四联疗法一线治疗幽门螺杆菌(H.pylori)感染的疗效。方法:研究对象为因上胃肠道症状而接受胃镜检查确诊的H.pylori感染患者,所有患者被随机分为两组,LACB7组:兰索拉唑30mg Bid,阿莫西林1 000mg Bid,克拉霉素500mg Bid,枸橼酸铋钾220mg Bid,疗程7天;LACB10组:治疗药物同LACB7组,疗程10天。疗程结束4周后,采用尿素呼气试验判断根除效果,结果阴性者判断为H.pylori根除。结果:共有125例患者被纳入本研究,平均年龄48.3岁,其中,男性60例。LAC7组和LAC10组患者的H.pylori根除率按符合方案(PP)分析,分别为82.5%(47/57)和86 2%(50/58)(P>0 05);按意向治疗(ITT)分析,分别为78.3%(47/60)和78.2%(50/64)(P>0.05)。结论:含铋剂四联疗法7天和10天方案一线治疗H.pylori感染疗效相近,均无明显不良反应。

Objective：To compare efficacy of different duration of quadruple therapy in first-line treatment for H.pylori infection. Methods：The subjects were the patients with H.pylori infection who received endoscopy examination due to upper gastrointestinal symptoms. All patients were randomly divided into 2 groups,as follows：group LACB7,1ansoprazole 30mg Bid,amoxicillin 1 000mg Bid,clarithromycin 500mg Bid,Bismuth potassium citrate 220mg Bid,for 7 days.Group LACB10：the same regimen of group LACB7 but for I 0 days duration. H.pylori status was rechecked by 3C-urea breath test 4 week ai2er the end oftherapy.Results：A total of 125 patients were enrolled including 60 males.The average of the patients was 48.3 years old ranged from 20 to 75 years old.H.pylori eradication rates with per protocol analyses were 82.5% and 86.2% in group LACB7 and LACBl0,respectively （P〉0.05）.Intention to treat eradication rates were 78.3%,and 78.2% in group LACB7 and LACBl0,respectively （P〉0.05）.Conelusion：7 days and 10 days Bismuth-based quadruple therapy for H.pylori eradication are similar in terms of efficacy, safety and patient compliance.