注射用兰索拉唑治疗十二指肠溃疡出血临床试验研究  

Clinical experiment report of treating duodenal ulcer and hemorrhage with Lansoprazole for injection

作　　者：孙士其[1] 张振玉[1] 李晓昕[2] 张宜山[2] 唐国都[3] 朱萱[4] 朱人敏[5] 王青[6] 张方信[7] 

机构地区：[1]南京医科大学附属南京第一医院消化内科,江苏南京211100 [2]江苏奥赛康药业有限公司,江苏南京211000 [3]广西医科大学第一附属医院消化内科 [4]江西医学院第一附属医院消化内科 [5]南京军区南京总医院消化内科 [6]青岛市立医院消化内科 [7]兰州军区兰州总医院消化内科

出　　处：《安徽医药》2008年第10期955-957,共3页Anhui Medical and Pharmaceutical Journal

摘　　要：目的注射用兰索拉唑治疗十二指肠溃疡出血疗效及安全性。方法采用随机、盲法、阳性药物、平行对照、多中心的临床试验。试验组:注射用兰索拉唑;对照组:注射用奥美拉唑钠(洛赛克)。结果从2005年4月至2005年11月共有216例患者入组,剔除4例,其余均完成试验。经过治疗后,两组治疗十二指肠溃疡出血有效率相比无统计学意义(P>0.05);两组止血时间相比无统计学意义(P>0.05);两组上腹痛消失天数和消失率相比无统计学意义(P>0.05)。试验组与对照组的不良反应比较,不良反应主要为白细胞减少、转氨酶轻度升高和皮疹等,但两组比较无统计学意义(P>0.05)。结论注射用兰索拉唑治疗十二指肠溃疡出血是有效而安全的,有较高的临床应用的价值。Aim To use Lansoprazole for injection in the treatment of patients with duodenal ulcer and hemorrhage, and to evaluate its efficacy and safety. Method A multi-center, parallel-controlled, blind, randomized, and positive-drug clinical trial was conducted, with testing group receiving Lansoprazole for injection and control group given Omeprazole sodium for injection （ Losec ）. Results From April 2005 to November 2005, a total of 216 patients enrolled, only 4 removed during this period, had completed the trial. There is no significant statistic difference in response rate and haemostatic time of patients with duodenal ulcer and hemorrhage between two groups （ P 〉 0. 05 ） , and there is also no significant statistic difference in response rate and its needed days of upper-stomachache in patients between two groups（ P 〉 0.05 ）. The major adverse effects, such as leucopenia, slight escalation of transaminase, and rash ,have no significant statistic difference between two groups （P 〉 0.05 ）. Conclusion Lansoprazole for injection is effective and safe in treatment of patients with duodenal ulcer and hemorrhage, and better worthy of clinical application.

关 键 词：兰索拉唑 十二指肠溃疡 出血 

分 类 号：R573.1[医药卫生—消化系统]