国产注射用头孢美唑钠治疗呼吸系统感染临床试验及其护理

目的]评价国产注射用头孢美唑钠治疗中重度呼吸系统细菌感染的疗效和安全性并探讨其护理。方法]采用随机、双盲临床试验,对照药为进口注射用头孢美唑钠。将48例符合入选标准的病人随机分为实验组和对照组,每组24例,分别静脉输注国产和进口注射用头孢美唑钠,剂量均为2 g,12 h输注1次,疗程5 d~12 d。结果]实验组和对照组意向性疗效及安全性指标分析（ITT分析）总有效率分别为70.83%和75.00%,完成研究的合格病例的疗效分析（PP分析）总有效率分别为72.73%和76.19%;细菌清除率ITT分析及PP分析均分别为87.50%和76.92%;对革兰阴性菌的清除率分别为100.00%和75.00%;对革兰阳性菌的清除率分别为81.82%和80.00%,两组各项指标比较差异均无统计学意义（P〉0.05）,均未发生不良事件。结论]国产注射用头孢美唑钠治疗呼吸系统感染疗效与进口注射用头孢美唑钠相近,安全性高;护理人员参与药物临床试验,保证试验顺利完成起着重要作用。

Clinical trial and nursing care of patients with respiratory tract infection treated with domestic cefmetazole sodium for injection

Objective：To evaluate the clinical efficacy and safety of domestic cefmetazole sodium for injection to treat moderate and severe respiratory tract infection patients and to probe into nursing care of them.Methods：A double-blind randomized clinical trial was adopted.A total of 48 patients met the inclusion criteria were randomly divided into test group（24 cases） and control group（24 cases）.Patients in test and control group were intravenously infused domestic and imported cefazolin sodium for injection at a dose of 2 gram every 12 hrs for 5 to 12 days respectively.Results：By analysis of intention therapeutic effect and safety indexes of both test and control group cases,the total effective rates were 70.83% in test group and 75.00% in control group.And PP analysis on therapeutic effects of eligible patients completed the study showed the total effective rates were 72.73% and 76.19% respectively.The total bacterial eradication rate of the two group cases were 87.50% and 76.92% respectively by ITT and PP analysis;of which were 100.00% and 75.00% for G~-bacteria and 81.82% and 80.00% for G~＋ bacteria respectively.There were no statistical significant differences between the two groups（P0.05）.And no adverse events were reported among all the two groups.Conclusions：Therapeutic effect of the domestic cefmetazole sodium for injection is equivalent to the imported cefazolin sodium for injection in the treatment of patients with respiratory tract infection.And it is important for nursing staff participating drug clinical trials to ensure the successful completion of trials.