安奈拉唑钠肠溶片治疗反流性食管炎有效性和安全性的多中心、随机双盲Ⅱ期临床研究  

Efficacy and safety of anaprazole in the treatment of reflux esophagitis:a multicenter,randomized,double-blinded phaseⅡclinical study

作　　者：朱惠云 范惠珍 潘忠威 黄才斌 吴昊[5] 阮继刚[6] 吕农华[7] 李兆申 杜奕奇 Zhu Huiyun;Fan Huizhen;Pan Zhongwei;Huang Caibin;Wu Hao;Ruan Jigang;Lyu Nonghua;Li Zhaoshen;Du Yiqi(Department of Gastroenterology,the First Affiliated Hospital of Naval Medical University(Shanghai Changhai Hospital),Shanghai 200433,China;Department of Gastroenterology,Yichun People's Hospital,Yichun 336028,China;Department of Gastroenterology,Meihekou Central Hospital,Meihekou 135099,China;Department of Gastroenterology,the First Affiliated Hospital of Gannan Medical University,Ganzhou 341001,China;Department of Gastroenterology,the Second Affiliated Hospital of Wenzhou Medical University,Wenzhou 325088,China;Department of Gastroenterology,General Hospital of Ningxia Medical University,Yinchuan 750003,China;Department of Gastroenterology,the First Affiliated Hospital of Nanchang University,Nanchang 330006,China)

机构地区：[1]海军军医大学第一附属医院(上海长海医院)消化内科,上海200433 [2]宜春市人民医院消化内科,宜春336028 [3]梅河口市中心医院消化内科,梅河口135099 [4]赣南医科大学第一附属医院消化内科,赣州341001 [5]温州医科大学附属第二医院消化内科,温州325088 [6]宁夏医科大学总医院消化内科,银川750003 [7]南昌大学第一附属医院消化内科,南昌330006

出　　处：《中华消化杂志》2024年第9期590-597,共8页Chinese Journal of Digestion

摘　　要：目的评估安奈拉唑钠40、60 mg对比雷贝拉唑钠20 mg治疗反流性食管炎(RE)的有效性和安全性。方法本项Ⅱ期临床研究采用多中心、随机、双盲和阳性药物平行对照设计。由海军军医大学第一附属医院(上海长海医院)牵头,南昌大学第一附属医院、宜春市人民医院、梅河口市中心医院、赣南医科大学第一附属医院、金华市中心医院等24家国内临床试验机构参与研究。经筛选入组156例RE(洛杉矶分级A~D级)患者,根据随机数字表法按照1∶1∶1比例随机分为安奈拉唑钠40 mg组、安奈拉唑钠60 mg组和雷贝拉唑钠20 mg组。以上3组患者服用相应的试验用药(1次/d),连续治疗4周或8周,采用盲态独立中心阅片与研究者阅片的方法评估各组患者的内镜下治愈率。此外,各单项症状(日间反流、日间烧心、夜间反流、夜间烧心)严重程度评分的改善情况和药物安全性也作为评价指标。按组别计算治疗8周和4周后的内镜下治愈率及其95%置信区间(95%CI),以及试验组与对照组间治愈率差值及其95%CI。采用卡方检验进行统计学分析。结果共153例受试者进入全分析集,144例进入符合方案集(PPS),151例进入安全性分析集(SS)。全分析集中,治疗8周后,安奈拉唑钠40 mg组、安奈拉唑钠60 mg组和雷贝拉唑钠20 mg组盲态独立中心阅片评估的内镜下治愈率分别为86.0%(43/50)、86.5%(45/52)和86.3%(44/51),95%CI分别为76.4%~95.6%、77.3%~95.8%、76.8%~95.7%;研究者阅片评估的治愈率分别为88.0%(44/50)、90.4%(47/52)和86.3%(44/51),95%CI分别为79.0%~97.0%、82.4%~98.4%、76.8%~95.7%;各组治愈率相当。全分析集中,盲态独立中心阅片和研究者评估的安奈拉唑钠40 mg组、安奈拉唑钠60 mg组与雷贝拉唑钠20 mg组治愈率差值(95%CI)分别为-0.3%(-13.7%~13.2%)、0.6%(-12.3%~13.6%)和1.7%(-11.3%~14.8%)、3.9%(-8.5%~16.3%)。PPS结果与全分析集结果趋势一致。治疗8周后,各组单项症状(�Objective To evaluate the efficacy and safety of anaprazole(40 mg and 60 mg)and compared with rabeprazole(20 mg)in the treatment of reflux esophagitis(RE).Methods This multicenter,randomized,double-blinded,positive drug parallel controlled study was led by the First Affiliated Hospital of Naval Medical University(Shanghai Changhai Hospital)and a total of 24 clinical trial institutions nationwide including the First Affiliated Hospital of Nanchang University,Yichun People's Hospital,Meihekou Central Hospital,the First Affiliated Hospital of Gannan Medical University,and Jinhua Central Hospital,participated in this research.A total of 156 patients with RE(Los Angeles grade A to D)were enrolled and randomly divided into 3 groups,anaprazole 40 mg group,anaprazole 60 mg group and rabeprazole 20 mg group,using a random number table in a ratio of 1∶1∶1.Patients in the above 3 groups were treated with the appropriate trial medication once per day for 4 or 8 weeks.The endoscopic healing rates were evaluated by Blinded Independent Central Review(BICR)and investigators.In addition,the improvement in the severity of individual symptoms(daytime reflux,daytime heartburn,nighttime reflux,nighttime heartburn)and medication safety were also evaluated.The endoscopic healing rates and 95%confidence intervals(95%CI)at week-8 and-4 were calculated by groups,as well as the difference in the healing rates and their 95%CI among groups.The chi-square test was used for statistical analysis.Results A total of 153 subjects were included in the full analysis set(FAS),144 in the per-protocol analysis set(PPS)and 151 in the safety set(SS).In the FAS,after 8 weeks of treatment,the endoscopic healing rates of anaprazole 40 mg group,anaprazde 60 mg group and raberazole 20 mg group blindly assessed by BICR were 86.0%(43/50),86.5%(45/52)and 86.3%(44/51),respectively,and the 95%CI were 76.4%to 95.6%,77.3%to 95.8%and 76.8%to 95.7%,respectively.The endoscopic healing rates of anaprazole 40 mg group,anaprazde 60 mg group and raberazole 20 mg group

关 键 词：安奈拉唑 反流性食管炎 内镜下治愈率 反流 烧心 

分 类 号：R571[医药卫生—消化系统]