他唑巴坦/哌拉西林与泰能随机对照治疗细菌性感染

Prospective Randomized Comparison of Piperacillin-tazobactam Versus Imipenem-cilastatin in the Treatment of Acute Bacterial Infections

目的 :以他唑巴坦 /哌拉西林为试验药 ,泰能为对照药 ,通过随机对照及开放试验 ,评价前者的安全性和有效性。方法 :他唑巴坦 /哌拉西林 4 5g/次 ,静滴 ,q12h～q8h ,泰能 1 0g/次 ,静滴 ,q12h～q8h,疗程 7～14天 ,重症者适当延长。以中、重度急性细菌性感染者为试验对象。结果 :试验组完成 2 8例 (包括开放组 10例 ) ,对照组 2 0例。试验组临床有效率 89 2 9% ,对照组 95 0 0 % ;不同细菌感染患者试验组有效率为 91 67% ,对照组者为 94 4 4% ,无显著性差异 (P >0 0 5 )。试验组与对照组细菌阳性率为 85 71%与 90 0 0 % ,细菌清除率和阴转率为 88 0 0 %与 94 4 4% (P >0 0 5 ) ,细菌产酶率均在 70 %以上。 4 2株致病菌中革兰阴性菌 3 0株 ,革兰阳性菌 12株 ,4株耐哌拉西林者对他唑巴坦 /哌拉西林敏感 ,其中 3株产酶 ,且他唑巴坦 /哌拉西林联合后 ,使哌拉西林敏感菌更为敏感。细菌对他唑巴坦 /哌拉西林的敏感率与对哌拉西林及阿莫西林 /克拉维酸者有显著性差异(P <0 0 5 ) ,且它对革兰阳性球菌及大部分革兰阴性菌的MIC值较其他四种抗生素低 ,试验组 2 8例未出现不良反应 ,对照组 1例出现恶心头晕 ,自行缓解 ,不良反应发生率为 5 0 0 % (1/ 2 0 )。结论 :他唑巴坦 /哌拉西林抗菌谱广 。

Objective:Evaluation of efficacy and safety for piperacillin-tazobactam versus imipenem-cilastatin through randomized controlled clinical trial.Method:piperacillin-tazobactam 4 5g q8h,imipenem-cilastatin 1 0g q8h,for 7～14days.Result:Fourty eight patients with moderate and severe acute bacterial infections were enrolled(28 in trial group,20 in control group).The clinical effective response for trial and contral group were 89 79% and 95 00% respectively;causative pathogen positive rate was 85 71% and 90 00% respectively;bacterium eradication rate was 88 00% and 94 44% respectively;β-lactamase positive rate was both above 70%(p>0 05).The results of disk diffusion test demonstated that causative bacteria were more susceptible to piperacillin-tazobactam than to piperacillin and amoxcillin-clavanic acid(p<0 05).The MIC value of piperacillin-tazobactam on most causative bacteria was lower than the other four antibiotics.Tolerance was comparable,with the exception of nausea and dizziness,which in imipenem-cilastatin group.Conclusion:piperacillin-tazobactam seems to be a safe and effective antibiotics for moderate and severe bacterial infections,including respiratory,urinary tract,skin and soft tissue infections.