亚胺培南西司他丁钠治疗中重度细菌性感染的临床研究

A Randomized Controlled Clinical Trial of Imipenem Cilastatin Sodium in Treatment of Moderate to Severe Bacterial Infections

目的评价国产注射用亚胺培南西司他丁钠(齐佩能)对中重度细菌性感染的临床有效性及安全性。方法采用随机开放、平行对照试验设计,以进口注射用亚胺培南西司他丁钠(泰能)作对照药物。结果齐佩能与泰能的临床有效率分别为86.42%和81.82%,细菌清除率分别为85.71%和87.18%,不良反应发生率为4.94%和3.41%,两组比较均无显著性差异(P>0.05)。结论注射用亚胺培南西司他丁钠(齐佩能)治疗中重度细菌性感染疗效肯定且安全。

Objective To evaluate the efficacy and safety of imipenem eilastatin sodium（Bacqure） in the treatment of moderate to severe bacterial infections. Methods A randomized controlled clinical trial was conducted. Imported imipenem eilastatin sodium（Tienam） was used as the control drug. Results The overall efficacy rate of Bacqure and Tienam was 86. 42% and 81.82% respectively. The bacterial clearance rate was 85.71% and 87.18% respectively. The incidence rate of adverse reaction was 4.94% and 3.41%. There was no statistical significant difference between the two groups for the above results. Conclusion Imipenem eilastatin sodium（Baequre） is a highly effective and safe antibacterial agent for the treatment of moderate to severe bacterial infections.