多中心临床观察铝碳酸镁四联与铋剂四联根除幽门螺杆菌的疗效及安全性  

Multi-center clinical observation on the efficacy and safety of Hydrotalcite quadruple and Bismuth quadruple in the eradication of Helicobacter pylori

作　　者：贾燕 潘元明 盛剑秋 朱云清[2] 刘改芳 郭晓峰[4] 范如英 王萍[2] 吴婧 张丽敏 JIA Yan;PAN Yuanming;SHENG Jianqiu;ZHU Yunqing;LIU Gaifang;GUO Xiaofeng;FAN Ruying;WANG Ping;WU Jing;ZHANG Limin(Department of Gastroenterology,the Seventh Medical Center of PLA General Hospital,Beijing 100700;Department of Gastroenterology,Shaanxi Provincial People's Hospital;Department of Gastroenterology,Hebei Provincial People's Hospital;Department of Gastroenterology,Shanxi Provincial People's Hospital,China)

机构地区：[1]中国人民解放军总医院第七医学中心消化内科,北京100700 [2]陕西省人民医院消化内科 [3]河北省人民医院消化内科 [4]山西省人民医院消化内科

出　　处：《胃肠病学和肝病学杂志》2022年第6期648-655,共8页Chinese Journal of Gastroenterology and Hepatology

摘　　要：目的探讨并比较铝碳酸镁四联与铋剂四联根除幽门螺杆菌(Helicobacter pylori,H.pylori)的疗效及安全性。方法采用前瞻性随机对照多中心临床研究,对象为^(13)C尿素呼气试验阳性者,于2018年3月至2020年1月共入组400例,最终符合统计标准的患者357例(剔除因个人原因和未按要求服药的14例及失访的29例),其中铝碳酸镁四联组179例,铋剂四联组178例。铝碳酸镁四联组:铝碳酸镁1000 mg tid+雷贝拉唑钠10 mg bid+阿莫西林1000 mg bid+克拉霉素500 mg bid;铋剂四联组:胶体果胶铋300 mg bid+雷贝拉唑钠10 mg bid+阿莫西林1000 mg bid+克拉霉素500 mg bid,疗程均为10 d。治疗结束至少28 d后所有患者均接受^(13)C尿素呼气试验检测,评估并比较两组H.pylori根除率、症状缓解情况及安全性(不良反应发生率)。结果(1)H.pylori根除率:铝碳酸镁四联组为77.7%,铋剂四联组为82.0%,两组比较差异无统计学意义(P>0.05)。(2)影响H.pylori根除失败的单因素分析或多因素分析发现,H.pylori根除率在吸烟者中为71.8%,不吸烟者为82.1%,两组比较差异有统计学意义(P<0.05);(3)临床症状好转率:铝碳酸镁四联组为88.8%,铋剂四联组为84.8%,两组比较差异无统计学意义(P>0.05)。透射电镜结果显示铝碳酸镁四联组对保持胃亚细胞器结构(尤其是线粒体结构)的完整性优于铋剂四联组,扫描电镜发现感染H.pylori的胃黏膜组织经根除H.pylori后腺管开口均一,渗出消失,其中铝碳酸镁四联组较铋剂四联组恢复更好(P=0.035)。(4)不良反应发生率:铝碳酸镁四联组为10.6%(19/179),铋剂四联组为27.0%(48/178);单纯因铝碳酸镁四联组治疗方案引起的不良反应占比4.5%(8/179),铋剂四联组治疗方案引起的不良反应为21.3%(38/178),两组比较差异均有统计学意义(P<0.05)。结论吸烟可能影响H.pylori根除疗效;铝碳酸镁四联与铋剂四联根除H.pylori疗效相当,但不良反应率更低,可能与铝碳酸镁保�Objective To compare the efficacy and safety of Hydrotalcite quadruple and Bismuth quadruple in the eradication of Helicobacter pylori(H.pylori).Methods A prospective randomized controlled multicenter clinical study was conducted 400 patients with positive ^(13)C urea breath test were enrolled from Mar.2018 to Jan.2020.Finally,357 patients met the statistical criteria(14 patients were excluded because of personal reasons and did not meet the medication requirements and 29 patients were lost to follow-up).There were 179 cases in Hydrotalcite quadruple group and 178 cases in Bismuth quadruple group.The patients in Hydrotalcite quadruple group were treated with Hydrotalcite 1000 mg tid+Rabeprazole 10 mg bid+Amoxicillin 1000 mg bid+Clarithromycin 500 mg bid;Bismuth quadruple group:Colloidal bismuth pectin 300 mg bid+Rabeprazole 10 mg bid+Amoxicillin 1000 mg bid+Clarithromycin 500 mg bid for 10 days.At least 28 days after the end of therapy,all patients received ^(13)C urea breath test to evaluate and compare the H.pylori eradication rate,symptom relief and safety(incidence of adverse reactions).Results(1)The eradication rate of H.pylori was 77.7% in Hydrotalcite quadruple group and 82.0% in Bismuth quadruple group.There was no significant difference(P>0.05).(2)Univariate or multivariate analysis showed that the rate of H.pylori eradication was 71.8% in smoking patients and 82.1%in non-smoking patients(P<0.05).(3)The improvement rate of clinical symptoms was 88.8% in Hydrotalcite quadruple group and 84.8%in Bismuth quadruple group(P>0.05).The results of transmission electron microscopy showed that the stability of gastric subcellular organelles(especially mitochondria)in Hydrotalcite quadruple group was better than that in Bismuth quadruple group.Scanning electron microscopy showed that glandular ducts of gastric mucosa infected with H.pylori were repaired in two groups,and the protective effect of Hydrotalcite quadruple group was better than that of Bismuth quadruple group(P=0.035).(4)The incidence of adverse reactio

关 键 词：胃黏膜感染 幽门螺杆菌 铝碳酸镁 药物组合疗法 根除率 

分 类 号：R378[医药卫生—病原生物学]