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为进一步研究国产硫酸依替米星的安全性和临床疗效 ,在上海市组织 11家医院共 35 0例病例进行了 期临床实验 ,研究采用多中心开放式非对照试验设计 ,硫酸依替米星剂量为 2 0 0～ 30 0 mg/ d,1次或 2次静脉滴注 ,疗程 5～ 14d。研究表明依替米星治疗感染性疾病 ,有效率为 87.7% ,痊愈率为 5 2 .7% ,其中治疗下呼吸道感染的有效率为 88.3% ,痊愈率为 49.0 %。 32 2例病例共分离出菌株 2 73株 ,细菌学清除率为90 .1% ,体外抗菌作用表明依替米星对肠杆菌科的敏感性为 91.2 % ,高于奈替米星和庆大霉素。不良反应率为 3.43% ,且反应轻微 ,停药或对症处理后即恢复正常。说明依替米星是一个高效、安全、具有广泛临床应用价值的抗菌药物 ,值得推广。
In order to further study the safety and clinical efficacy of domestic etimicin sulfate, a total of 35 0 cases were studied in 11 hospitals in Shanghai. The study was conducted in a multicenter, open-label, non-controlled trial design. Etimicin sulfate Dose of 200 ~ 30 0 mg / d, 1 or 2 intravenous infusion, treatment of 5 ~ 14d. Studies have shown that etimicin treatment of infectious diseases, the effective rate was 87.7%, the cure rate was 5.27%, including the treatment of lower respiratory tract infection was 88.3%, the cure rate was 49.0%. 3223 cases were isolated strains of 2 73 strains, the bacteriological clearance rate of 90.1%, in vitro antibacterial activity showed that etimicin on Enterobacteriaceae sensitivity was 91.2%, higher than netilmicin and Qingda Mice. Adverse reaction rate was 3.43%, and the reaction was mild, withdrawal or symptomatic treatment returned to normal. Etimicin is an effective, safe and widely used antimicrobial drug with clinical value, which is worth promoting.