国产注射用醋酸奥曲肽治疗食管胃底静脉曲张破裂出血的多中心随机对照临床研究

背景：生长抑素及其类似物可降低门静脉压力，减少奇静脉血流，临床上广泛应用于门静脉高压所致食管胃底静脉曲张破裂出血的治疗。目的：评价国产注射用醋酸奥曲肽治疗急性食管胃底静脉曲张破裂出血的疗效和安全性。方法：采用多中心、随机、单盲、阳性药物平行对照试验设计，以善宁醋酸奥曲肽注射液作为对照．疗程5天。首剂0．1mg加入5％葡萄糖20ml静脉推注，随后以0．025mg／h的速度连续静脉滴注72h．如出血停止，则继续皮下注射0．1mg1次／8h，连续2天。疗效评价指标包括呕血量和便血量，安全性评价指标包括实验室检查结果、患者生命体征以及治疗中的不良反应。结果：共129例患者人组，其中试验组64例，对照组65例。按全分析集（FAS）评价，试验组临床显效率为78．1％．总有效率为93．8％，对照组临床显效率为83．1％．总有效率为96．9％，两组相比差异无统计学意义（P〉0．05）。试验组2例（3．1％）患者出现发热的不良事件，对照组无不良事件和不良反应发生。两组均未发生严重不良事件。结论：国产注射用醋酸奥曲肽用于治疗食管胃底静脉曲张破裂出血安全、有效，与同剂量善宁醋酸奥曲肽注射液疗效相近。

Domestic-made Octreotide Acetate Injection in the Treatment of Esophagogastric Variceal Bleeding: a Multicenter, Randomized, Controlled Clinical Trial

Background: Somatostatin and its analogues can reduce portal pressure, decrease azygous venous blood flow, and have been extensively used in the treatment of esophagogastric variceal bleeding due to portal hypertension. Aims: To evaluate the efficacy and safety of domestic-made octreotide acetate injection in the treatment of acute esophagogastric variceal bleeding. Methods: A multicenter, randomized, single-blind, positive-controlled parallel-group clinical trial was conducted. Sandostatin octreotide acetate injection was taken as control. The course of treatment was 5 days (0.1 mg+20 ml 5% glucose iv, followed by 0.025 mg/h iv gtt for 72 hours, and then 0.1 mg q8h hypodermically for 2 days). The criteria of efficacy included volume of hematemesis and hemafecia, the safety evaluation indexes included laboratory data, vital sign and adverse reactions. Results: 129 patients were recruited, 64 in the treatment group and 65 in the control group. Using full analysis set (FAS), the clinical excellence rate and efficacy rate of the treatment group were 78.1% and 93.8%, respectively; and those of the control group were 83.1% and 96.9%, respectively, there was no remarkable difference between the two groups (P>0.05). Two patients (3.1%) in the treatment group had some fever. No adverse event and adverse reaction were found in the control group. No serious adverse event was observed in both groups. Conclusions: Domestic-made octreotide acetate injection is effective and safe in the treatment of esophagogastric variceal bleeding. Its efficacy is similar as Sandostatin octreotide acetate injection.