A Randomized Controlled Clinical Trial of Piperacillin/Tazobactam Versus Imipenem/Cilastatin in the Treatment of Bacterial Infections

OBJECTIVE: To evaluate the efficacy and safety of piperacillin/tazobactam in the treatment of moderate and severe bacterial infections .METHODS: An open and randomized controlled multicenter clinical trial was conducted, and imipenem/ cilastatin was used as control agent.RESULTS:A total of 145 patients were enrolled in the study,in which 54 patiants were included in each groups of comparative study and another 37 patients were treated with piperacillin/tazobactam in the open group.In comparative study,the clinical efficacy rate,cure rate and bacterial eradication rate in the treatment of respiratory, uro-genital, intra-abdominal, skin and soft tissue,and other infections were 92.59%, 79.63% and 91.49% for piperacillin/ tazobactam, and 92.59%, 81 .48% and 90.39% for imipeneln/cilastatin. No statistical significant difference between the two groups was found. The clinical efficacy rate,cure rate and bactarial eradicated rate in the open group were 86.49%,75.68% and 84.83%,respectively. The adverse drug reactions occurred in 4.40% and 5.56% patients treated with piperacillin/tazobactam and imipenem/cilastatin,respectively. One patient treated with piperacillin/tazobactam had skin rash. The in vitro antibacterial activities of piperacillin/tazobactam were much more potent than those of piperacillin and a little less than those of imipenem.The activities of piperacillin/tazobactam against Gram positive and negative bacteria were comparable to those of amoxicillin/clavulanic acid or ceftazidime,respectively. CONCLUSION: These results showed that piperacillin/tazobactam is a highly effective, safe and broad-spectrum antibacterial agent,whose clinical and antibacterial efficacies are comparable to those of imipenem/cilastatin.