Isenmann Rainer, Rünzi Michael, Kron Martina, Kahl Stefan, Kraus Dietmar, Jung Norbert, Maier Ludwig, Malfertheiner Peter, Goebell Harald, Beger Hans G
Department of Abdominal and Transplantational Surgery, University of Ulm, Germany.
Gastroenterology. 2004 Apr;126(4):997-1004. doi: 10.1053/j.gastro.2003.12.050.
BACKGROUND & AIMS: Antibiotic prophylaxis in necrotizing pancreatitis remains controversial. Until now, there have been no double-blind studies dealing with this topic.
A total sample size of 200 patients was calculated to demonstrate with a power of 90% that antibiotic prophylaxis reduces the proportion of patients with infected pancreatic necrosis from 40% placebo (PLA) to 20% ciprofloxacin/metronidazole (CIP/MET). One hundred fourteen patients with acute pancreatitis in combination with a serum C-reactive protein exceeding 150 mg/L and/or necrosis on contrast-enhanced CT scan were enrolled and received either intravenous CIP (2 x 400 mg/day) + MET (2 x 500 mg/day) or PLA. Study medication was discontinued and switched to open antibiotic treatment when infectious complications, multiple organ failure sepsis, or systemic inflammatory response syndrome (SIRS) occurred. After half of the planned sample size was recruited, an adaptive interim analysis was performed, and recruitment was stopped.
Fifty-eight patients received CIP/MET and 56 patients PLA. Twenty-eight percent in the CIP/MET group required open antibiotic treatment vs. 46% with PLA. Twelve percent of the CIP/MET group developed infected pancreatic necrosis compared with 9% of the PLA group (P = 0.585). Mortality was 5% in the CIP/MET and 7% in the PLA group. In 76 patients with pancreatic necrosis on contrast-enhanced CT scan, no differences in the rate of infected pancreatic necrosis, systemic complications, or mortality were observed.
This study detected no benefit of antibiotic prophylaxis with respect to the risk of developing infected pancreatic necrosis.
坏死性胰腺炎的抗生素预防仍存在争议。到目前为止，尚无关于该主题的双盲研究。
计算得出总共200名患者的样本量，以90%的检验效能证明抗生素预防可将感染性胰腺坏死患者的比例从40%的安慰剂（PLA）组降至20%的环丙沙星/甲硝唑（CIP/MET）组。纳入114例急性胰腺炎患者，其血清C反应蛋白超过150mg/L和/或增强CT扫描显示有坏死，给予静脉注射CIP（2×400mg/天）+MET（2×500mg/天）或PLA。当发生感染性并发症、多器官功能衰竭败血症或全身炎症反应综合征（SIRS）时，停止研究用药并改为开放抗生素治疗。在招募了计划样本量的一半后，进行了适应性中期分析，并停止了招募。
58例患者接受CIP/MET治疗，56例患者接受PLA治疗。CIP/MET组28%的患者需要开放抗生素治疗，而PLA组为46%。CIP/MET组12%的患者发生感染性胰腺坏死，而PLA组为9%（P = 0.585）。CIP/MET组的死亡率为5%，PLA组为7%。在76例增强CT扫描显示有胰腺坏死的患者中，感染性胰腺坏死率、全身并发症或死亡率均无差异。
本研究未发现抗生素预防在降低感染性胰腺坏死风险方面有任何益处。
