联合应用质子泵抑制剂、生长抑素和加贝酯预防ERCP术后胰腺炎和高淀粉酶血症的临床研究

Clinical Study of Prophylactic Effect of Proton Pump Inhibitor Combined with Somatostatin and Gabexate on Post-ERCP Pancreatitis and Hyperamylasemia

背景:急性胰腺炎和高淀粉酶血症是内镜逆行胰胆管造影术(ERCP)的主要并发症,术前用药对预防和减轻并发症的作用尚存争议。目的:探讨联合应用质子泵抑制剂、生长抑素和加贝酯对ERCP术后胰腺炎(PEP)和高淀粉酶血症的预防作用。方法:共纳入510例行ERCP的患者,随机分为加贝酯组、生长抑素组、联合治疗组(质子泵抑制剂+生长抑素+加贝酯)和安慰剂组。观察术后2 h、12 h和24 h血清淀粉酶水平,评估PEP和高淀粉酶血症的发生率,并分析PEP和高淀粉酶血症的危险因素。结果:ERCP术后2 h、12 h、24 h,联合治疗组、生长抑素组和加贝酯组血清淀粉酶水平显著低于安慰剂组(P<0.05或P<0.01),联合治疗组血清淀粉酶水平亦显著低于生长抑素组或加贝酯组(P<0.05)。ERCP胰管显影者的PEP和高淀粉酶血症发生率显著高于胆管显影者(P<0.05)。单变量分析显示ERCP操作过程中胰管多次显影、导丝多次插入胰管、导丝辅助、反复插管以及操作中发生上腹疼痛为PEP和高淀粉酶血症的技术相关性高危因素。结论:ERCP术前后联合应用质子泵抑制剂、生长抑素和加贝酯可改善PEP和高淀粉酶血症的发生。

Background： Acute pancreatitis and hyperamylasemia are main complications of endoscopic retrograde cholangiopancreatography （ERCP）. The role of drugs to prevent and reduce the serverity of post-ERCP pancreatitis （PEP） and hyperamylasemia is still in debate. Aims： To investigate the prophylactic effect of proton pump inhibitor （PPI） combined with somatostatin and gabexate on PEP and hyperamylasemia. Methods： A total of 510 patients underwent ERCP were enrolled, and were randomly divided into 4 groups： gabexate group, somatostatin group, combination group （PPI＋somatostatin＋gabexate） and placebo group. Levels of serum amylase at the 2nd, 12th and 24th hour after ERCP were determined, the incidence rates of PEP and hyperamylasemia were evaluated, and the risk factors of PEP and hyperamylasemia were analyzed. Results： At the 2nd, 12th and 24th hour after ERCP, serum amylase in combination group, somatostatin group and gabexate group was significantly lower than that in placebo group （P〈0.01 or P〈0.05）. Compared with gabexate group or somatostatin group, serum amylase in combination group was markedly decreased （P〈 0.05）. The incidence rates of PEP and hyperamylasemia were significantly higher in patients with pancreatic duct visualization than those in patients with bile duct visualization. Univariate analysis revealed that multiple pancreatic duct visualization, multiple guide wire insertion to pancreatic duct, guide wire assistance, multiple cannulation and upper abdominal pain during ERCP were the technology-associated high risk factors of PEP and hyperamylasemia. Conclusions： PPI combined with somatostatin and gabexate administered before and after ERCP may effectively prevent the occurrence of PEP and hyperamylasemia.