Hauser Goran, Blažević Ivana, Salkić Nermin, Poropat Goran, Giljača Vanja, Bulić Zlatko, Štimac Davor
Department of Gastroenterology, Clinical Hospital Centre Rijeka, Krešimirova 42, Rijeka, 51000, Croatia.
Faculty of Medicine Rijeka, University of Rijeka, Rijeka, Croatia.
Surg Endosc. 2017 Feb;31(2):602-610. doi: 10.1007/s00464-016-5004-9. Epub 2016 Jun 17.
We aimed to compare the efficacy of prophylactic, parenterally administered ceftazidime and rectally applied diclofenac sodium for the prophylaxis of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP).
We prospectively enrolled patients who underwent ERCP. In a double-blind, randomized, controlled trial, patients received a suppository containing diclofenac sodium rectally (100 mg) and placebo intravenously (group A) or ceftazidime intravenously (1 g) and placebo rectally (group B) immediately before the procedure. The serum and urine amylase levels were recorded and the patients were clinically evaluated after ERCP.
Of the 272 patients enrolled (group A: 129; group B: 143), 32 developed pancreatitis (group A: 11 [8.5 %]; group B: 21 [14.7 %]; P = 0.17; relative risk = 1.72; 95 % confidence interval [CI] = 0.86-3.43). The severity of the pancreatitis or complications did not significantly differ between the groups. A serum amylase level of ≥560 U/L and urine amylase level of ≥1150 U/L indicated a positive likelihood ratio for post-ERCP pancreatitis of ≥10. Moreover, the threshold visual analog scale score of ≤5 for abdominal pain after ERCP had excellent diagnostic potential for predicting the presence or absence of post-ERCP pancreatitis.
The PEP incidence did not differ between the ceftazidime and diclofenac sodium groups. In patients with nonsteroidal anti-inflammatory drug contraindications, antibiotics can be considered a safe alternative to diclofenac sodium for PEP prevention. Moreover, the visual analog scale for abdominal pain has excellent diagnostic value for predicting PEP. CLINICAL TRIALS.
NCT 01784445.
我们旨在比较预防性经胃肠外途径给予头孢他啶和经直肠应用双氯芬酸钠预防内镜逆行胰胆管造影术（ERCP）后胰腺炎（PEP）的疗效。
我们前瞻性纳入了接受ERCP的患者。在一项双盲、随机对照试验中，患者在操作前即刻经直肠接受含双氯芬酸钠的栓剂（100毫克）和静脉注射安慰剂（A组），或静脉注射头孢他啶（1克）和经直肠接受安慰剂（B组）。记录血清和尿淀粉酶水平，并在ERCP后对患者进行临床评估。
在纳入的272例患者中（A组：129例；B组：143例），32例发生胰腺炎（A组：11例[8.5%]；B组：21例[14.7%]；P = 0.17；相对风险= 1.72；95%置信区间[CI]= 0.86 - 3.43）。两组间胰腺炎的严重程度或并发症无显著差异。血清淀粉酶水平≥560 U/L和尿淀粉酶水平≥1150 U/L表明ERCP后胰腺炎的阳性似然比≥10。此外，ERCP后腹痛视觉模拟量表评分≤5对于预测ERCP后胰腺炎的有无具有良好的诊断潜力。
头孢他啶组和双氯芬酸钠组的PEP发生率无差异。对于有非甾体抗炎药禁忌证的患者，抗生素可被视为预防PEP的双氯芬酸钠的安全替代药物。此外，腹痛视觉模拟量表对预测PEP具有良好的诊断价值。临床试验。
NCT 01784445。
