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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。
Objective To evaluate the efficacy and safety of lansoprazole for the treatment of bleeding of duodenal ulcer. Methods Randomized, blinded, positive drugs, parallel controls, multicenter clinical trials. Test group: Lansoprazole for injection; Control group: Omeprazole sodium for injection (Losec). Results From April 2005 to November 2005, a total of 216 patients were enrolled in the study. Four patients were excluded and the rest were completed. After treatment, the effective rate of hemorrhage in duodenal ulcer between the two groups was no significant difference (P> 0.05); there was no significant difference between the two groups in the bleeding time (P> 0.05) There was no significant difference in the disappearance rate (P> 0.05). There was no significant difference between the two groups (P> 0.05). Adverse reactions were mainly leucopenia, slight increase of transaminase and skin rashes in experimental group and control group. Conclusions Lansoprazole injection for the treatment of duodenal ulcer bleeding is effective and safe, and has a high clinical value.