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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。
To further understand the safety and efficacy of etimicin sulfate, a new aminoglycoside injection, for the treatment of acute bacterial infections, a multicenter open clinical trial was conducted to treat 21 212 cases of respiratory, urinary and other systemic infections. Administered by a single drug and combination therapy, the former each 10 0 mg, q12 h or 200 mg each time, qd; the latter will be etimicin sulfate and the approved number of antimicrobial agents, treatment 5 ~ 10 days. The results showed that the total cure rate was 6 1.2%, the total effective rate was 91.8%, the bacterial clearance rate was 91.7% and the adverse reaction rate was 4.3%. The total cure rate of combination therapy was 48.5% The efficiency was 85.1%, the bacterial clearance rate was 88.6% and the incidence of adverse reactions was 4.4%. General mild reactions, patients can tolerate, including abnormal hearing function in 14 cases, the incidence of 0.73%, liver and kidney dysfunction in 7 cases, the incidence rate of 0.37%. Etimicin sulfate for injection is a less toxic, safe and effective new product of aminoglycoside antibiotics. Clinical efficacy and safety and clinical conclusions similar to the combination of patients with severe infections help to improve the curative effect.