国产和进口注射用奥曲肽治疗食管胃静脉曲张破裂出血的疗效.pdfVIP

· 752· Chin J Gastroenteml，2007，Vo1．12，No．12 国产和进口注射用奥曲肽治疗食管胃 静脉曲张破裂出血的疗效 奥曲肽协作组 背景：目前生长抑素及其类似物已广泛应用于肝硬化食管胃静脉曲张破裂出血的治疗。目的：评价国产注射用 奥曲肽治疗肝硬化食管胃静脉曲张破裂出血的临床疗效和安全性。方法：采用随机、单盲、平行对照多中心临床研 究。试验组和对照组分别使用国产和进ISl醋酸奥曲肽注射液，用法为0．1 mg静脉推注，随后以0．6 mg溶于5％葡萄 糖注射液500 ml中静脉滴注，1次／12 h，24 h内出血停止者再连续应用2 d。结果：共99例患者入选，试验组67例， 对照组32例。按意向治疗(nT)分析，试验组24 h止血率为80．6％，治疗期间再出血率为6．0％；对照组分别为84．4％ 和0％，组问差异均无统计学意义(P0．05)。试验组输血例数29例，平均输血量280．6 ml；对照组输血例数 l0例，平 均输血量 190．0 ml，组问差异无统计学意义(P0．05)。试验过程中两组均未发生与试验药物有关的严重不良事件。结 论：国产醋酸奥曲肽注射液治疗肝硬化食管胃静脉曲张破裂出血安全有效。 关键词 奥曲肽； 肝硬化； 高血压，门静脉； 食管和胃静脉曲张； 出血 Efficacy of Domestic and Imported Octreotide Injection for Esophagogastric VarIceal Bleeding Cooperation Group r the Sumey ofOctreotide． Correspondence to：CHENG Liufang，Department of Gastroenterology，China PLA General Hospital，Beijing(100853)， Emaih liufangchengC~ahoo．com．cn _ Background： Somatostatin and its analogues are widely used for esophagogastric variceal bleeding in cirrhotic patients． Aims： To evaluate the efficacy and safety of domestic octreotide injection in the treatment of cirrhotic esophagogastric variceal bleeding．Methods：A randomized，single·blind，parallel·controlled muhicenter clinical trial was conducted．Patients were randomly allocated to experimental group and control group，and received domestic and imported octreotide acetate injection．respectively．The medication was given as follows：intravenous injection with 0．1 mg at first and subsequent infusion with 0．6 mg in 500 ml of 5％glucose solution was given every 12 hours for 3 days．Patients were withdrawn from the study if the hemorrhage tendency still persisted 24 hours after starting the treatment．Results：Ninety- nin