胰管支架和非甾体类抗炎药预防胆总管取石术后胰腺炎的前瞻性随机对照研究

Pancreatic duct stent and NSAIDs for prevention of post ERCP pancreatitis in choledocholithiasis patients： a prospective randomized controlled study

目的探讨放置胰管支架、使用非甾体类抗炎药（NSAIDs）以及两者联合应用对ERCP胆总管取石术后胰腺炎（PEP）的预防作用。方法200例胆总管结石患者按抽取的随机顺序号均分成4组，分别接受单纯放置胰管支架预防PEP（A组）、单纯使用NSAIDs（帕瑞昔布钠）预防PEP（B组）、放置胰管支架联合应用帕瑞昔布钠预防PEP（C组）和常规ERCP无预防PEP措施（D组）。术前及术后4、24、48h，检测血清淀粉酶和C反应蛋白（CRP）水平，采用视觉模拟评分法（VAS评分）对腹痛程度进行评分。统计术后48h高淀粉酶血症和PEP发生率。结果（1）术后48h高淀粉酶血症发生率：A组、B组和C组分别为6％（3／50）、6％（3／50）和4％（2／50），均明显低于D组的22％（11／50）（P〈0．05）。（2）术后48hPEP发生率：A组和C组均为2％（1／50），明显低于D组的10％（5／50）（P〈0．05）；B组为4％（2／50），但与D组差异无统计学意义（P〉0．05）。（3）疼痛程度VAS评分：术后4、24和48h各组均明显高于术前（P〈0．05）；B组术后4、24和48h均明显低于D组（P〈0．05）；A组和c组仅术后4h明显低于D组（P〈0．05），术后24h和48h虽低于D组但差异无统计学意义（P〉0．05）。（4）血清CRP水平：术后4、24和48h各组检测值均明显高于术前水平（P〈0．05）；B组和C组术后4、24和48h均明显低于D组（P〈0．05）；A组术后4h和24h均明显低于D组（P〈0．05），术后48h虽低于D组但差异无统计学意义（P〉0．05）。结论（1）预防性胰管支架和NSAIDs均可明显减少ERCP胆总管取石术后高淀粉酶血症的发生，且单纯预防性放置胰管支架和联合使用NSAIDs均可减少PEP的发生。（2）预防性胰管支架、NSAIDs或二者联合使用均可减轻ERCP胆总管取石术后患者的疼痛和炎症反应，而以单纯使用NSAIDs效果最好。

Objective To evaluate the prophylactic effect of pancreatic duct stentt （ PPDS）, Non- Steroid Anti-Inflammtory Drugs （NSAIDs）, and joint PPDS and NSAIDs on post endoscopic rectrograde cholangiopancreatography（ERCP） Pancreatitis （PEP） in choledocholithiasis patients. Methods A total of 200 choledocholithiasis patients were randomly divided into 4 groups, prophylactic pancreatic duct stent（ PP- DS） group （A）, NSAIDs group （B）, joint PPDS-NSAIDs group （C） and routine ERCP without prevention for PEP（group D）. VAS score, levels of amylase in serum and CRP were measured before and 4 h,24 h, 48 h after ERCP. Incidences of hyperamylasemia and PEP were observed. Results （ 1 ） Incidences of hy- peramylasemia 48 h after ERCP were 6% （3/50）, 6% （3/50） and 4% （2/50） in group A, group B and group C respectively, which were significantly lower than that of group D （11/55 ） （P 〈 0. 05 ）. （2） Inci- dences of PEP 48 h after ERCP were both 2% （1/50） in group A and group C, which were lower than that in group D （10% ,5/50,P 〈 0. 05）. Group B （4% ,2/50） was lower than that of group D but there was no statistical significance（P 〉0. 05）. （3） VAS scores of all groups at 4 h, 24 h and 48 h after the operation were significantly higher than before （ P 〈 0. 05 ）. Group B score was significantly lower than that of group D （P 〈 0. 05）. Scores of group A and C at 4 h were lower than those of group D （P 〈 0. 05 ）, and those at 24 h and 48 h were also lower but with no statistical significance （P 〉0. 05）. （4） Serum CRP levels at 4 h, 24 h and 48 h were significantly higher than those before in each group. Serum CRP levels of group B and C were significantly lower than that of group D at 4 h, 24 h and 48 h. Serum CRP level of group A was significantly lower than group D at 4 h, 24 h. ClIP level at 48 h of group A was lower than that of group D, but there was no statistical significance （ P 〉 0. 05 ）. Conclusion Both prophylactic pancreatic duct stent and NSAIDs （Parecoxib Sodium） can reduce incidence of hyperamylasemia after ERCP common bile duct lithotomy. Single or joint use of prophylactic pancreatic duct stent can prevent PEP. Furthermore, prophylactic pancreatic duct stent and NSAIDs （Parecoxib Sodium） can reduce pain and inflammation after ERCP common bile duct lithotomy. NSAIDs only （ Parecoxib Sodium） is more effective than prophylactic pancreatic duct stem only and joint use of both.