注射用硫酸依替米Ⅲ星期临床试验

为进一步了解注射用氨基糖苷类新品种硫酸依替米星治疗急性细菌性感染的安全性和有效性 ,采用多中心开放临床试验治疗呼吸系统、泌尿系统及其它系统感染 2 2 12例。给药方法分单一用药和联合用药 ,前者每次 10 0 mg,q12 h或每次 2 0 0 mg,qd;后者将硫酸依替米星与已获批准文号的抗菌药物合用 ,疗程 5～ 10 d,结果显示 :单一用药总痊愈率为 6 1.2 % ,总有效率为 91.8% ,细菌清除率为 91.7% ,不良反应发生率为 4.3% ;联合用药总痊愈率为 48.5 % ,总有效率为 85 .1% ,细菌清除率为 88.6 % ,不良反应发生率为 4.4%。一般反应轻微 ,患者可耐受 ,其中听力平衡功能异常 14例 ,发生率 0 .73% ,肝肾功能异常 7例 ,发生率0 .37%。注射用硫酸依替米星是氨基糖苷类抗生素中毒性较低 ,安全有效的新产品。临床疗效及安全性与 期临床结论相似 ,对重度感染患者联合用药有助于提高疗效。

The multi-center clinical study of etimicin injection against acute bacterial infections

To evaluate the efficacy and safety of etimicin injection, 2212 patients with acute bacterial infections in respiratory tract, urinary tract, digestive tract, and other infections were treated with the drug in an opened trial. Etimicin were administered single (100mg, q12h or 200mg, qd) or association (combinated with other antimicrobial agents sanctioned by government) for 5~10 days. The results showed that the total cure rate, effective rate, bacterial clearance rate and adverse reaction rate were 61.2%, 91.8%, 91.7%, 4.33% respectively for single administered and 48.5%, 85.1%, 88.6%, 4.4% respectively for association administered. The mostly adverse reactions were generally mild and well tolerated. Only 14 patients occur hypoacusis (0.73%); 7 patients occur hepatic or renal function disorders (0.37%). The results indicated that etimicin injection is an effective and safe drug with lower toxity, and may contribute to treat the patients with serious bacterial infections combinated with other antibiotics.