注射用头孢匹胺国产品与进口品随机对照单盲治疗急性细菌性感染临床评价

A Randomized, Controlled, Single Blinded Clinical Study on Domestic versus Imported Cefpiramide for Injection in the Treatment of Acute Bacterial Infections

目的:评价国产注射用头孢匹胺治疗中、重度呼吸道细菌性感染的有效性和安全性。方法:本临床试验选用两组药物,采用随机对照方法。试验药(国产注射用头孢匹胺)和对照药(进口注射用头孢匹胺钠)的剂量均为每次2g,Bid,疗程为(7～14)天。结果:试验组与对照组疗效评价例数分别为30例和28例,临床有效率分别为90.0%和89.3%,细菌清除率分别为92.3%和91.6%,药物不良反应发生率分别为3.57%和3.33%,以上结果经统计学处理差异无显著性(P>0.05)。结论:国产注射用头孢匹胺与进口品在临床疗效、细菌学疗效、药物不良反应等方面无明最差异,且对敏感细菌引起的中重度感染疗效确切,药物不良反应少而轻微。

Objective： To evaluate the clinical efficacy and safety of domestic cefpiramide for injection in the treatment of respiratory tract infections, Methods： A randomized controlled, single blinded clinical trial was carried out in our hospital. Domestic eefpiramide for injection was chosen as investigational drug, and imported one for control. Both drags were administered intravenously at a dosage of 2g twice a day for （7-14）days. Results：The efficacy rates were 90.0% and 89.3%, the bacterial clearance rates were 92.3% and 91.6%. The rates of drug side effects were 3,57% and 3.33 %, respectively between domestic cefpiramide and control groups. There was no statistical significant difference between the two groups （P〉0.05）. Conclusion：Domestic cefpiramide for injection was effective and safe for the treatment of acute bacterial infections.