注射用兰索拉唑治疗十二指肠溃疡出血临床试验研究

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。

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

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.