重症急性坏死性胰腺炎的早期抗生素治疗：一项随机、双盲、安慰剂对照研究

Early antibiotic treatment for severe acute necrotizing pancreatitis： A randomized, double-blind, placebo-controlled study

本研究主要目的是通过预防性静脉应用美罗培南在阻止／延缓胰腺或周围组织感染方面的疗效。此外，还评估了预防性美罗培南用药在手术清创的要求、总体病死率和死亡时间等方面的作用。

Background ＆ Aims In to administer early, broad-spectrum antibiotics, patients with severe, necrotizing pancreatitis, it is common often a carbapenem, in the hope of reducing the incidence of pancreatic and peripancreatic infections, although the benefits of doing so have not been proved. Methods A muhicenter, prospective, double-blind, placebo-controlled randomized study set in 32 centers within North America and Europe. Participants： One hundred patients with clinically severe, confirmed necrotizing pancreatitis： 50 received meropenem and 50 received placebo. Interventions： Meropenem （1 g intravenously every 8 hours） or placebo within 5 days of the onset of symptoms for 7 to 21 days. Main Outcome Measures： Primary endpoint： development of pancreatic or peripancreatic infection within 42 days following randomization. Other endpoints： time between onset of pancreatitis and the development of pancreatic or peripancreatic infection; all-cause mortality; requirement for surgical intervention; development of nonpancreatic infections within 42 days following randomization. Results Pancreatic or peripancreatic infections developed in 18% （9 of 50） of patients in the meropenem group compared with 12% （6 of 50） in the placebo group （P = 0.401）. Overall mortality rate was 20% （10 of 50） in the meropenem group and 18% （9 of 50） in the placebo group （P = 0.799）. Surgical intervention was required in 26% （13 of 50） and 20% （10 of 50） of the meropenem and placebo groups, respectively （P= 0.476）.Conclusions This study demonstrated no statistically significant difference between the treatment groups for pancreatic or peripancreatic infection, mortality, or requirement for surgical intervention, and did not support early prophylactic antimicrobial use in patients with severe acute necrotizing pancreatitis.