奥曲肽预防ERCP术后胰腺炎及高淀粉酶血症的多中心随机对照临床研究

目的 探讨奥曲肽预防ERCP术后胰腺炎和高淀粉酶血症的临床疗效和安全性。方法 研究在国内12个中心同时进行,拟行ERCP诊断和治疗的患者进入研究,并随机分为2组。奥曲肽组:0.3 mg奥曲肽加入500 ml生理盐水中,于ERCP术前1 h开始静脉滴注并持续6 h,输注停止后6 h和12 h再分别给予奥曲肽0.1 mg皮下注射各1次。对照组则给予安慰剂(生理盐水)行静脉滴注,但不进行皮下注射。结果 共有961例ERCP患者入选,其中129例患者不符合要求而被剔除,最后832例患者纳入统计,其中奥曲肽组414例,对照组418例。急性胰腺炎总的发生率为3.85％,其中奥曲肽组为2.42％(10/414),对照组为5.26％(22/418)(P=0.026)。高淀粉酶血症总发生率为14.9％,奥曲肽组为12.32％(51/414),对照组为17.46％(73/418)(P=0.041);两组基础数据如年龄、操作过程(诊断和治疗)、造影剂的使用量、胰胆管显影次数等基本相似(P>0.05),未发生与奥曲肽相关的不良反应。结论 奥曲肽对ERCP术后胰腺炎和高淀粉酶血症均有预防作用。

Effect of Octreotide on prophylaxis of post ERCP pancreatitis and hyperamylasemia:a multicenter,randomized clinical trial

Objective To study on the efficacy of Octreotide prophylaxis of post ERCP pancreatitis (PEP) and hyperamylasemia. Methods The study was conducted in 12 digestive endoscopic units in China. Patients were randomized into two groups. Octreotide group: Octreotide (0. 3mg) were dissolved in 500 ml of 0.9% saline solution and administrated by continues intravenous infusion, beginning 1 hr before the endoscopic examination and continuing for 6 hr afterward, 0. 1 mg Octreotide were injected subcutaneously at 6h, 12h after the intravenous injection stopped. Control group was given a placebo (saline solution) intravenously without subcutaneous injection. Results A total of 961 patients were accepted in the study, 832 patients were enrolled in the final analysis, Octreotide group 414 cases, and control group 418 cases. The overall incidence of acute pancreatitis was 3.85% (32/832) .which includec 2.42% (10/414) in Octreotide group and 5. 26% (22/418) in control group (P =0. 046). Incidence of hyperamylasemia was 14. 9% (124/ 832) which included 12. 32% (51/414) in Octreotide group and 17. 46% (73/418) in controlled group (P = 0. 041). The two groups were matched in many basic aspects, such as sex, age, contrast agent, indication of ERCP, the times of visualization of pancreatic duct and bile duct, etc. There was no side effect associated with Octreotide found. Conclusion The results of this trial indicate that Octreotide can prevent post ERCP pancreatitis and hyperamylasemia.