注射用雷贝拉唑钠治疗十二指肠球部溃疡出血多中心、随机、双盲、阳性药物平行对照临床研究

Intravenous Rabeprazole Sodium for Treatment of Duodenobulbar Ulcer Bleeding:A Multicenter,Randomized,Double-blind,Positive Drug Parallel-group Controlled Clinical Study

迄今未有注射用雷贝拉唑钠治疗十二指肠球部溃疡出血的临床研究。目的:评价不同剂量和用法注射用雷贝拉唑钠治疗十二指肠球部溃疡出血的有效性和安全性。方法:采用多中心、随机、双盲、阳性药物平行对照试验设计。纳入105例经胃镜检查确诊的十二指肠球部溃疡出血患者,随机分为四组。A、B、C组分别给予静脉滴注注射用雷贝拉唑钠20 mg qd、40 mg qd和20 mg bid,对照组给予静脉滴注奥美拉唑钠40 mg bid,疗程均为5 d。以止血成功率作为主要疗效指标,以止血时间、输血量作为次要疗效指标。结果:A、B、C组和对照组止血成功率分别为96.2%(25/26)、92.6%(25/27)、100.0%(26/26)和100.0%(26/26),四组间差异无统计学意义(P>0.05)。A、B、C组和对照组中位止血时间分别为24(24,72)h、24(24,72)h、24(24,48)h和24(24,48)h,四组间差异无统计学意义(P>0.05)。疗程中四组患者均未输血。仅C组1例患者发生不良反应,表现为疗程结束后白细胞数量轻度减少。结论:三种剂量和用法的注射用雷贝拉唑钠治疗十二指肠球部溃疡轻中度出血均安全、有效,以20 mg bid疗效更佳。

Background：To date,clinical studies on intravenous rabeprazole sodium for treatment of duodenobulbar ulcer bleeding are still lacking.Aims：To evaluate the efficacy and safety of intravenous rabeprazole sodium with different doses and times of administration in treating patients with duodenobulbar ulcer bleeding.Methods：A multicenter,randomized, double-blind,positive drug parallel-group controlled trial was performed.One hundred and five patients with duodenobulbar ulcer bleeding proved by gastroscopy were randomly divided into four groups.Patients in group A,B and C were treated with intravenous rabeprazole sodium 20 mg qd,40 mg qd and 20 mg bid for 5 days,respectively.Patients in control group received intravenous omeprazole sodium 40 mg bid for 5 days.Hemostatic rate was the primary endpoint,hemostatic time and amount of blood transfusion were the secondary endpoints.Results：Hemostatic rates in group A,B,C and control group were 96.2% （25 /26）,92.6% （25 /27）,100.0% （26 /26）and 100.0% （26 /26）,respectively,no significant difference was seen between the four groups （P 〉0.05）.Median hemostatic time in group A,B,C and control group were 24 （24,72）h,24 （24,72）h,24 （24,48）h and 24 （24,48）h,respectively,no significant difference was seen between the four groups （P 〉0.05）.No patient need blood transfusion during the treatment course.Slight leucopenia was the exclusive adverse effect seen in one case in group C after accomplishment of treatment.Conclusions：Three intravenous rabeprazole sodium regimens with different doses and times of administration were all effective and safe for treatment of mild to moderate duodenobulbar ulcer bleeding.Administration with 20 mg bid seems more effective among the three regimens.