两种剂量奥曲肽治疗食管、胃静脉曲张大出血多中心随机对照临床疗效观察

Efficacy of octreotide in the treatment of acute variceal bleeding in cirrhotic patients:A prospective, multicentric and randomized clinical trial

目的 观察两种剂量奥曲肽治疗食管胃静脉曲张破裂出血的疗效和安全性。方法 采用多中心、随机、对照、开放试验。共入选 249例患者,分为两组,其中奥曲肽 50μg/h剂量组 121例,奥曲肽 25μg/h剂量组 128例。每日奥曲肽用量: 50μg/h组为 1200mg, 25μg/h组为 600mg。结果 两组治疗前基本资料相似,具可比性。止血时间 50μg/h组为 ( 12. 1±12. 5 )h,明显快于 25μg/h组的(19. 3±19. 6)h(P<0. 05); 6、12、24、48和 72h止血率在 50μg/h组为53. 7%、77. 7%、88. 4%、90. 1%和 91. 7%;明显高于 25μg/h组的 37. 5%、53. 9%、71. 1%、75. 8%和 78. 1% (P<0. 05和 0. 01)。平均输血量: 50μg/h组为(296±396)ml,少于 25μg/h组的(413±525)ml(P=0. 048),差异有统计学意义。治疗总有效率: 50μg/h组为 91. 7%,明显高于 25μg/h组的 78. 1% (P<0. 01)。再出血率: 50μg/h组为 9. 9%,明显低于 25μg/h组的 24% (P<0. 05)。死亡率: 50μg/h组为 0. 83% (1 /121), 25μg/h组为2. 34% (3 /128),两组差异无统计学意义。两组均未发生明显不良反应。结论 两种剂量奥曲肽对食管胃静脉曲张均有效, 50μg/h组疗效优于 25μg/h组,且止血时间快、再出血率低,无不良反应。

Objective To investigate the efficacy and safety of octreotide in controlling esophageal variceal bleeding. Methods Two hundreds and forty-nine cirrhotic patients with esophageal variceal bleeding were randomized to receive either octreotide infusion of 50 μg/h (n=121) or 25 μg/h(n=128) intravenously for 96 h after a bolus of 200 μg. The two groups were similar in base-line data. Results The mean time of control bleeding was shorter in patients treating with octreotide of 50 μg/h [(12.1±12.5) h] than that in patients treating with octreotide of 25 μg/h [(19.3±19.6) h](P<0.05). The rate of control of bleeding in 50 μg/h group in 6h,12h,24h,48h and 72h were 53.7%、77.7%、88.4%、90.1% and 91.7% respectively, which was higher than that in 25 μg/h group (37.5%,53.9%,71.1%,75.8% and 78.1% respectively). The efficacy of octreotide in 50 μg/h group was 91.7%, which was higher than that in 25 μg/h group ((78.1%),P<0.01). The rate of rebleeding was lower in group of octreotide of 50 μg/h (9.9% vs 24%) (P<(0.05)). No significant difference in mortality was observed between two groups (one died in 50 μg/h group and three in 25 μg/h group). Conclusions These results show that both dosages present a high initial and final control of esophageal variceal bleeding. The efficacy was higher in the patients receiving octreotide of 50 μg/h.