CAJ | 학술논문

背景：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。
배경：흘금미유주사용뢰패랍서납치료십이지장구부궤양출혈적림상연구。목적：평개불동제량화용법주사용뢰패랍서납치료십이지장구부궤양출혈적유효성화안전성。방법：채용다중심、수궤、쌍맹、양성약물평행대조시험설계。납입105례경위경검사학진적십이지장구부궤양출혈환자，수궤분위사조。A、B、C 조분별급여정맥적주주사용뢰패랍서납20 mg qd、40 mg qd 화20 mg bid，대조조급여정맥적주오미랍서납40 mg bid，료정균위5 d。이지혈성공솔작위주요료효지표，이지혈시간、수혈량작위차요료효지표。결과：A、B、C 조화대조조지혈성공솔분별위96．2％（25/26）、92．6％（25/27）、100．0％（26/26）화100．0％（26/26），사조간차이무통계학의의（P ＞0．05）。A、B、C 조화대조조중위지혈시간분별위24（24，72）h、24（24，72）h、24（24，48）h 화24（24，48）h，사조간차이무통계학의의（P ＞0．05）。료정중사조환자균미수혈。부 C 조1례환자발생불량반응，표현위료정결속후백세포수량경도감소。결론：삼충제량화용법적주사용뢰패랍서납치료십이지장구부궤양경중도출혈균안전、유효，이20 mg bid 료효경가。
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.