盐酸小檗碱、阿莫西林、兰索拉唑、铋剂四联疗法根除幽门螺杆菌283例的临床研究

Clinical study on berberine, amoxicillin, lansoprazole, bismuth quadruple therapy for Helicobacter pylori eradication in 283 patients

目的评价盐酸小檗碱、阿莫西林、兰索拉唑、铋剂新四联疗法根除H.pylori的有效性和安全性。方法前瞻性纳入2015年12月至2016年4月在门诊就诊的H.pylori感染初治患者566例，分为观察组（盐酸小檗碱＋阿莫西林＋兰索拉唑＋胶体酒石酸铋）和对照组（克拉霉素＋阿莫西林＋兰索拉唑＋胶体酒石酸铋）各283例，两组疗程均为14 d。治疗结束后4周，比较两组患者的H.pylori根除率和不良反应发生率。统计学方法采用t检验和卡方检验。结果两组患者基线特征包括性别、年龄、BMI、症状评分等差异均无统计学意义（P均〉0.05）。治疗结束后4周，观察组和对照组H.pylori根除率根据符合方案分析（PP）分别为87.5%（244/279）和87.1%（242/278），根据意向性分析（ITT）分别为86.2%（244/283）和85.5%（242/283），差异均无统计学意义（χ^2=0.021、0.058，P均〉0.05），两组整体不良反应发生率分别为12.5%（35/279）和16.5%（46/278），差异无统计学意义（χ^2=1.795, P=0.180）。结论盐酸小檗碱联合阿莫西林的含铋剂新四联方案与克拉霉素联合阿莫西林的含铋剂标准四联方案均能有效根除H.pylori感染，新方案可作为西安地区或克拉霉素高耐药地区的一线根除方案。

ObjectiveTo assess the efficacy and safety of berberine, amoxicillin, lansoprazole, bismuth quadruple therapy for Helicobacter pylori （H.pylori）eradication.MethodsFrom December 2015 to April 2016, 566 patients with initial treatment of H. pylori infection were prospectively enrolled. Patients were divided into observation group （berberine, amoxicillin, lansoprazole, bismuth） and control group （clarithromycin, amoxicillin, lansoprazole, bismuth）, 283 cases in each group, and the treatment courses in two groups were both 14 days. Four weeks after completion of the treatment, the eradication rate of H. pylori and adverse effect rate of the two groups were compared. Student t test and Chi square test were performed for comparison between the two groups.ResultsThere was no statistically significant difference in the baseline demographic data including gender, age, body mass index （BMI）, symptom score between patients of the two groups （all P〉0.05）. Four weeks after completion of the treatment, the eradication rates of observation group and control group were 87.5%（244/279） and 87.1%（242/278） according to per-protocol analysis, and which were 86.2%（244/283） and 85.5 %（242/283） according to intention-to-treat analysis. There was no statistically significant difference between the two groups （χ^2=0.021, 0.058; both P〉0.05）. The adverse effect rates of the two groups were 12.5%（35/279） and 16.5%（46/278）, and there was no statistically significant difference （χ^2=1.795, P=0.180）.ConclusionsBoth the new quadruple regimen containing berberine, amoxicillin and bismuth, and the standard quadruple regimen containing clarithromycin, amoxicillin and bismuth both can effectively eradicate H. pylori infection. The new regimen might be recommended as first-line eradication regimen in Xi′an district or area with high clarithromycin resistance.