摘要
目的对比间歇性静脉滴注艾普拉唑钠和大剂量、持续静脉滴注艾司奥美拉唑钠,预防内镜止血成功的消化性溃疡出血患者再出血的疗效和安全性。方法采用多中心、区组随机、双盲、双模拟、平行对照设计,纳入2021年3月3日至6月15日于浙江大学医学院附属第一医院等33家医院成功施行内镜止血治疗的高危消化性溃疡出血患者151例,区组随机分为试验组(74例)和对照组(77例)。试验组患者间歇性静脉滴注艾普拉唑钠,1次/d,首日20 mg滴注60 min,第2、3日10 mg滴注30 min;对照组患者持续性静脉滴注艾司奥美拉唑钠72 h,首剂量80 mg滴注0.5 h,之后以8 mg/h的速度持续滴注71.5 h。静脉滴注治疗结束后,2组患者均予以口服艾普拉唑肠溶片,每次10 mg,1次/d,持续4 d。基于全分析集(试验组72例,对照组75例)分析2组患者治疗72 h后和治疗后7 d内的再出血率,治疗后72 h内因再出血而接受内镜下或手术再治疗的患者比例;基于安全性分析集(试验组74例,对照组76例)观察2组患者的不良反应发生情况。统计学方法采用卡方检验或Fisher确切概率法。结果72例试验组患者治疗72 h后均未发生再出血,治疗后7 d内仅1例(1.39%,1/72)发生再出血;对照组在治疗72 h后和治疗后7 d内分别有1例(1.33%,1/75)和4例(5.33%,4/75)发生再出血。试验组和对照组患者在治疗72 h后和治疗后7 d内的再出血率比较差异均无统计学意义(P均>0.05);2组患者治疗72 h内均无患者因再出血而需接受内镜下或手术再治疗。试验组和对照组中分别有5例(6.8%,5/74)和6例(7.9%,6/76)发生不良反应,未予治疗即自行恢复;2组均无严重不良反应发生。结论在内镜止血成功的高危消化性溃疡出血患者中,间歇性静脉滴注艾普拉唑钠与大剂量、持续静脉滴注艾司奥美拉唑钠的疗效和安全性相似,但间歇性给药方案用量更少,给药方式更简便,值得临床推广。
Objective To explore the efficacy and safety of intermittent infusion of ilaprazole sodium and high-dose continuous infusion of esomeprazole sodium in preventing rebleeding in patients with peptic ulcer bleeding after successful endoscopic hemostasis.Methods This is a multi-center,interval randomized,double-blind,double-dummy,parallel controlled study.From March 3rd to June 15th,2021,151 patients with high risk of peptic ulcer bleeding and successfully underwent endoscopic hemostasis from 33 hospitals including the First Affiliated Hospital of Zhejiang University School of Medicine were enrolled.Patients were interval randomly divided into the trial group(74 cases)and the control group(77 cases).Patients in the trial group received intermittent intravenous infusion of ilaprazole sodium once daily(20 mg administered as a 60 min intravenous infusion on day 1,and 10 mg administered as a 30 min intravenous infusion on day 2 and 3);patients in the control group received continuous intravenous infusion of esomeprazole sodium for 72 h(esomeprazole sodium 80 mg at first dose in half an hour,and 8 mg per hour continuous intravenous infusion for 71.5 h).After intravenous infusion treatment,patients of both groups were given oral ilaprazole enteric-coated tablets,10 mg each time,once a day for 4 d.The rebleeding rate after 72 h and within 7 d after treatment and the proportion of patients who received endoscopic retreatment or surgery due to rebleeding within 72 h after treatment were analysised based on the full analysis set(72 cases in the trial group and 75 cases in the control group);and the incidence rate of adverse reactions was observed in the two groups based on the safety analysis set(74 cases in the trial group and 76 cases in the control group).Chi-square test or Fisher exact probability test was used for statistical analysis.Results There was no rebleeding case in the trial group within 72 h and 1 case of rebleeding within 7 d(1.39%,1/72).In the control group,there was 1 case of rebleeding(1.33%,1/75)within 72 h
作者
季峰
吴国兰
周辛欣
范惠珍
林佐光
陈平湖
黄刚
马许辉
申屠建中
Ji Feng;Wu Guolan;Zhou Xinxin;Fan Huizhen;Lin Zuoguang;Chen Pinghu;Huang Gang;Ma Xuhui;Shentu Jianzhong(Department of Gastroenterology,the First Affiliated Hospital,Medical College of Zhejiang University,Hangzhou 310003,China;Research Center of Clinical Pharmacy,the First Affiliated Hospital,Medical College of Zhejiang University,Hangzhou 310000,China;Department of Gastroenterology,Yichun People’s Hospital,Yichun 336000,China;Department of Gastroenterology,The People’s Hospital of Gaozhou,Gaozhou 525200,China;Department of Gastroenterology,Center People’s Hospital of Zhanjiang,Zhanjiang 524045,China;Department of Gastroenterology,Guangyuan Center Hospital,Guangyuan 628000,China;Department of Gastroenterology,Huaihe Hospital of Henan University,Kaifeng 475000,China)
出处
《中华消化杂志》
CAS
CSCD
北大核心
2021年第8期514-521,共8页
Chinese Journal of Digestion
关键词
消化性溃疡出血
止血
内窥镜
再出血预防
注射用艾普拉唑钠
注射用艾司奥美拉唑钠
Peptic ulcer hemorrhage
Hemostasis,endoscopic
Preventing rebleeding
Ilaprazole sodium for injection
Esomeprazole sodium for injection
