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目的 :本研究对阿莫西林钠 /舒巴坦钠与氨苄西林钠 /舒巴坦钠随机单盲对照治疗中、重度急性细菌性感染 ,评价阿莫西林钠 /舒巴坦钠的有效性与安全性。方法 :采用区组随机单盲对照试验设计 ,完成试验药 2 0例及对照药 19例感染患者的临床试验。结果 :两组病例的一般项目基本相似 ,阿莫西林钠 /舒巴坦钠和氨苄西林 /舒巴坦钠治疗各种细菌感染的临床有效率分别为 85 0 0 %与 89 4 7% ,细菌学有效率为分别为 80 0 0 %和 86 6 7% ,细菌清除率为 93 33%与 10 0 % ,临床分离细菌的产酶率均为 6 6 6 7%。两组病例的不良反应发生率分别为 10 0 0 %和 10 5 3% ,不良反应轻微 ,不需特殊处理 ,停药后可自行恢复正常。结论 :阿莫西林钠 /舒巴坦钠是一种安全有效治疗细菌感染的药物 ,对β -内酰胺酶产生菌也同样有较好疗效 ,可用于治疗多种细菌引起的各种感染
OBJECTIVE: To evaluate the efficacy and safety of amoxicillin / sulbactam sodium in combination with ampicillin / sulbactam sodium in the treatment of moderate and severe acute bacterial infections safety. Methods: The block randomized single-blind controlled trial design, the completion of the trial drug 20 cases and 19 cases of control drug in patients with clinical trials. Results: The general items of the two groups were similar. The clinical efficacies of amoxicillin sodium / sulbactam and ampicillin / sulbactam sodium in treating various bacterial infections were 85 0% and 89 4 7%, respectively. Bacteria The effective rates were 80 0% and 86 6 7% respectively, the bacterial clearance rates were 93 33% and 10 0%, and the clinical isolates were 6 6 6 7% respectively. The incidence of adverse reactions in both groups was 100% and 105.3%, respectively. The adverse reactions were mild and no special treatment was required. After discontinuation, the patients could resume normal on their own. Conclusion: Amoxicillin / sulbactam sodium is a safe and effective drug for the treatment of bacterial infections. It also has a good effect on β - lactamases producing bacteria and can be used to treat various infections caused by various bacteria