Uemura Kenichiro, Murakami Yoshiaki, Hayashidani Yasuo, Sudo Takeshi, Hashimoto Yasushi, Ohge Hiroki, Sueda Taijiro
Department of Surgery, Graduate School of Biochemical Sciences, Hiroshima University, Hiroshima, Japan.
J Surg Oncol. 2008 Oct 1;98(5):309-13. doi: 10.1002/jso.21098.
Ulinastatin, an intrinsic trypsin inhibitor, has proved to be effective for the prevention of acute pancreatitis after endoscopic retrograde cholangiopancreatography. The aim of this study was to assess the efficacy of ulinastatin for postoperative pancreatitis following pancreaticoduodenectomy in a randomized clinical trial.
Patients undergoing pancreaticoduodenectomy were randomized to receive perioperative ulinastatin or placebo. Levels of serum amylase, drain amylase, and urine trypsinogen-2 were measured.
A total of 42 patients were enrolled (20 in the ulinastatin group, 20 in the placebo group, 2 excluded). Two patients in the ulinastatin group and nine patients in the placebo group developed hyperamylasemia (P = 0.013) No patient in the ulinastatin group and five patients in the placebo group developed pancreatitis (P = 0.016). One patient in the ulinastatin group and two patients in the placebo group developed grade A pancreatic fistula (P = 0.548). Serum amylase levels at 4 hr and postoperative days 1, 2, and 3, and drain amylase levels on days 2 and 3 were significantly lower in the ulinastatin group than in the placebo group.
Prophylactic administration of ulinastatin reduced the levels of serum and drain amylase and the incidence of postoperative pancreatitis following pancreaticoduodenectomy.
乌司他丁是一种内源性胰蛋白酶抑制剂，已被证明对预防内镜逆行胰胆管造影术后急性胰腺炎有效。本研究的目的是在一项随机临床试验中评估乌司他丁对胰十二指肠切除术后胰腺炎的疗效。
接受胰十二指肠切除术的患者被随机分为接受围手术期乌司他丁或安慰剂治疗。测量血清淀粉酶、引流液淀粉酶和尿胰蛋白酶原-2水平。
共纳入42例患者（乌司他丁组20例，安慰剂组20例，2例排除）。乌司他丁组2例患者和安慰剂组9例患者出现高淀粉酶血症（P = 0.013）。乌司他丁组无患者发生胰腺炎，安慰剂组5例患者发生胰腺炎（P = 0.016）。乌司他丁组1例患者和安慰剂组2例患者发生A级胰瘘（P = 0.548）。乌司他丁组术后4小时、第1、2和3天的血清淀粉酶水平以及第2和3天的引流液淀粉酶水平均显著低于安慰剂组。
预防性给予乌司他丁可降低胰十二指肠切除术后血清和引流液淀粉酶水平以及术后胰腺炎的发生率。
