奥曲肽注射液治疗食管-胃底静脉曲张破裂出血的有效性和安全性

目的比较国产与进口醋酸奥曲肽注射液治疗肝硬化食管胃底静脉曲张破裂出血的有效性和安全性。方法采用多中心、随机、单盲、平行对照实验。入选131例患者,实验组68例,用国产醋酸奥曲肽;对照组63例,用进口奥曲肽(善宁)。2组用药方法和药量相同,给予首剂0.1 mg静脉推注,随后以0.6 mg溶于5%葡萄糖500 mL中,通过静脉输液泵以42 mL/h(50μg/h)的速度持续静脉滴注,1次/12 h。24 h内有效者,再连续使用4 d。用药过程中详细观察记录血压、脉搏、输血量;定期抽吸胃液,记录胃液量及颜色;进行实验室及心电图检查;严密观察记录不良反应。结果2组治疗前基线资料差异无统计学意义(P>0.05),具有可比性。6、122、4 h止血率、再出血率、平均输血量、不良事件发生率2组差异均无统计学意义(P>0.05)。结论国产醋酸奥曲肽注射液治疗食管胃底静脉曲张出血的疗效与安全性和进口奥曲肽相当,是治疗食管胃底静脉曲张出血有效、安全的药物。

Efficacy and Safety Octreotide in the Treatment of Acute Variceal Bleeding in Cirrhotic Patients

Objective To investigate the efficacy and safety of octreotide acetate and sandostatin in controlling esophageal variceal bleeding,and make comparison between domastic and imported products.Methods One hundred and thirty-one cirrhotic patients with esophageal and gastric variceal bleeding were divided into two groups randomly.68 cases in Group A were treated with octreotide acetate infusion.63 cases in Group B were treated with sandostatin infusion.Group A received octreotide acetate infusion of 50 μg/h intravenously for 120 h after a bolus of 100 μg.Group B same dose sandostatin in same way.The blood pressure,arterial pulse and blood transfusion volume were monitored and recorded in the course of the investigation.Results The base-line data in the two groups were similar.The efficacy of octreotide in hemostasis,the blood transfusion volume and mortality have no significant difference between two groups in statistically(P>0.05).Conclusion Both octreotide and sandostatin present a high initial and final control of esophageal and gastric variceal bleeding.