注射用阿莫西林钠-舒巴坦钠治疗细菌性感染的临床随机对照试验

Clinical randomized controlled trial of Amoxycillin-sulbactam injection in the treatment of bacterial infection

目的 :通过以阿莫西林钠 克拉维酸钾 (安灭菌 )为对照药进行临床研究 ,评价阿莫西林钠 舒巴坦钠治疗常见致病菌引起的细菌感染性疾病的临床疗效和安全性。 方法 :采用随机对照盲法平行试验设计 ,入选病例 4 8例 ,脱落 1例 ,完成 4 7例。其中呼吸道感染 2 3例 ,泌尿系统感染 2 4例。试验组 (2 4例 )应用注射用阿莫西林钠 舒巴坦钠 1.5g/次 ,每 12h或 8h一次静滴 ;对照组 (2 3例 )应用安灭菌 1.2 g/次 ,每 12h或 8h一次静滴。疗程均为7～ 14天。 结果 :阿莫西林钠 舒巴坦钠治疗呼吸道感染、泌尿系统感染的痊愈率和有效率分别为 91.6 6 %和10 0 %、83.33%和 91.6 7% ,总痊愈率和有效率为 87.5 0 %和 95 .83% ,与安灭菌对照组比较无显著差异。阿莫西林钠 舒巴坦钠对分离细菌的清除率为 10 0 %。应用注射用阿莫西林钠 舒巴坦钠未见严重不良反应 ,仅发生皮疹 1例、恶心 3例 ,总发生率为 16 .6 7% (4 / 2 4 ) ,与安灭菌对照组比较无显著差异。 结论 :四类新药阿莫西林钠 舒巴坦钠对临床常见致病菌引起的呼吸道、泌尿系统感染 ,尤其是产酶菌引起的严重感染 ,临床疗效较好 ,使用安全 。

Objectives: To evaluate the efficacy and safety of Amoxycillin sulbactam injection compared with Amoxycillin clavulanic acid injection in the treatment of acute bacterial infections. Methods:A total of 47 patients (23 with respiratory tract infections and 24 with urinary tract infections)were included in this study, 24 cases treated with Amoxycillin sulbactam were compared with 23 cases treated with Amoxycillin clavulanic acid. Drugs were administered intravenously at a dose of 1.5 g of Amoxycillin sulbactam or 1.2 g of Amoxycillin clavulanic acid, q 12 h or q 8 h for 7～14 days. Results:The overall clinical efficacious rates of Amoxycillin sulbactam was 95.83%. There was no significant difference( P >0.05) between Amoxycillin sulbactam and Amoxycillin clavulanic acid in the clinical efficacy and bacterial clearance rates. The incidence of adverse drug reactions(16.67%) for Amoxycillin sulbactam was low, and no severe adverse drug reactions were found. Conclusions:Amoxycillin sulbactam injection is an effective and safe antibiotics for the treatment of acute bacterial infection.