注射用右旋雷贝拉唑钠治疗消化性溃疡合并上消化道出血的疗效和安全性分析  

Efficacy and safety of intravenous dexrabeprazole sodium in the treatment of peptic ulcer bleeding

作　　者：周艳华[1] 宗晔[1] 张澍田[1] 孟凡冬[1] 吴咏冬[1] ZHOU Yan-hua;ZONG Ye;ZHANG Shu-tian(National Clinical Research Center for Digestive Diseases,Department of Gastroenterology,Beijing Friendship Hospital,Capital Medical University,Beijing 100050,China)

机构地区：[1]国家消化系统疾病临床医学研究中心消化分中心首都医科大学附属北京友谊医院消化内科,北京100050

出　　处：《临床和实验医学杂志》2020年第14期1495-1499,共5页Journal of Clinical and Experimental Medicine

基　　金：消化道肿瘤诊疗生物标志物验证及应用研究(编号:2016YFC1303200)。

摘　　要：目的探讨注射用右旋雷贝拉唑钠治疗消化性溃疡合并上消化道出血的疗效和安全性。方法采用随机、双盲双模拟、阳性药物平行对照的多中心临床研究方法,选取2016年8月至2018年4月之间首都医科大学附属北京友谊医院等25家医院收治的252例消化性溃疡合并上消化道出血患者为研究对象,将患者随机分为试验组和对照组,试验组共入组127例,采用注射用右旋雷贝拉唑钠10 mg每12小时1次连续治疗共5 d,对照组共入组125例,采用注射用雷贝拉唑钠20 mg每12小时1次连续治疗5 d。以72 h有效止血率为主要疗效指标,以24 h、48 h、120 h有效止血率、5 d内因消化道出血导致的再次内镜诊治率、72 h和5 d内的平均输血量为次要观察指标,比较两组患者注射后治疗效果,同时行安全性分析。结果试验组与对照组患者的72 h有效止血率分别为96.85%、94.35%,两组比较差异无统计学意义(P=0.372);试验组与对照组患者的24 h有效止血率分别为51.97%、60.48%(P=0.203),48 h有效止血率分别为89.76%和89.52%(P=1.000),120 h有效止血率分别为97.64%、95.97%(P=0.496),两组比较差异均无统计学意义。5 d内因消化道出血再次内镜治疗者,试验组2例,对照组3例(P=1.000)。用药前输血试验组与对照组分别为2例和1例(P=1.000);用药后输血试验组与对照组均为4例(P=1.000),两组比较差异均无统计学意义。安全性方面,在整个试验中没有非预期不良反应发生。试验组与对照组用药后不良事件发生例数分别为62例(48.82%)和53例(42.74%)(P=0.376),不良反应发生例数分别为21例(16.54%)和19例(15.32%)(P=0.864),差异均无统计学意义。试验组主要的不良反应为轻度白细胞计数下降9例(7.09%)、血甘油三酯升高3例(2.36%)、高胆固醇血症3例(2.36%)。两组均无严重不良事件发生。结论注射用右旋雷贝拉唑钠用于消化性溃疡合并出血的治疗是有效且安全的。Objective To investigate the efficacy and safety of intravenous dexrabeprazole sodium in the treatment of peptic ulcer bleeding.Methods A randomized,double-blind,double-simulated,parallel-controlled multicenter clinical trial was conducted.252 patients with peptic ulcer bleeding were treated with either intravenous dexrabeprazole sodium 10 mg Q12 h(trial group,127 patients)or intravenous rabeprazole sodium 20 mg Q12 h(control group,125 patients)for 5 days in 25 hospitals including Beijing Friendship Hospital from August 2016 to April 2018.The primary outcome was the successful hemostasis rate in 72 h.The secondary outcomes included the successful hemostasis rate at 24 h,48 h and 120 h,a second endoscopy rate because of rebleeding within 5 days,the average amount of blood transfusion within 72 h and 5 d.And safety was also analyzed.Results The successful hemostasis rates of the trial group and the control group in 72 h were 96.85%and 94.35%,respectively,and there was no significant difference between the two groups(P=0.372).The 24 h successful hemostasis rates of the trial group and the control group were 51.97%and 60.48%(P=0.203),the 48 h effective hemostatic rates were 89.76%and 89.52%(P=1.000),and the 120-hour effective hemostatic rates were 97.64%and 95.97%(P=0.496),respectively,which all had no statistically significant differences.There were 2 cases in the trial group and 3 cases in the control group who underwent a second endoscopic treatment because of rebleeding within 5 days(P=1.000).There were 2 cases of transfusion in the trial group and 1 in the control group before treatment(P=1.000),and both 4 cases in the two groups after treatment(P=1.000).There were no significant differences in transfusion between the two groups.In terms of safety,there were no unexpected adverse reactions in the trial.The number of adverse events in the two group were 62(48.82%)and 53(42.74%)(P=0.376),and the number of adverse reactions were 21(16.54%)and 19(15.32%)(P=0.864),respectively,both of the differences were not statist

关 键 词：消化性溃疡 上消化道出血 右旋雷贝拉唑钠 雷贝拉唑钠 疗效 安全性 

分 类 号：R573.1[医药卫生—消化系统] R573.2[医药卫生—内科学]