国产注射用阿莫西林/舒巴坦治疗细菌性感染的临床研究  

A randomized controlled clinical studies of domestic amoxicillin/sulbactam for injection in the treatment of bacterial infections

作　　者：胡鹏[1] 段明纲[1] 肖永红[1] 李崇智[1] 刘鸿渝[1] 吕晓菊[2] 王文雅[2] 陈勇川[3] 胡建林[3] 肖光夏[3] 

机构地区：[1]重庆医科大学附属第一医院,重庆400016 [2]四川大学华西医院,成都610041 [3]第三军医大学西南医院,重庆400038

出　　处：《中国抗生素杂志》2002年第7期408-412,共5页Chinese Journal of Antibiotics

摘　　要：目的 :评价国产注射用阿莫西林 /舒巴坦治疗细菌性感染的有效性与安全性。方法 :采用多中心随机对照方法 ,并选用氨苄西林 /舒巴坦为对照 ,共治疗细菌感染性疾病 130例 ,试验组 6 8例 ,对照组 6 2例。阿莫西林 /舒巴坦每次 1.5～ 3.0 g,q8h疗程 7～ 14 d。氨苄西林 /舒巴坦给药方法、剂量和疗程与阿莫西林 /舒巴坦相同。结果 :阿莫西林 /舒巴坦组和氨苄西林 /舒巴坦组的有效率分别为 87.9%、83.3% ,痊愈率分别为72 .7%、6 3.3% ,细菌清除率分别为 90 .9%、90 .0 % ,不良反应发生率分别为 10 .3%、11.3% ,经统计学处理 ,差异无显著性 (P>0 .0 5 )。阿莫西林 /舒巴坦等 6种抗菌药物的体外活性表明阿莫西林 /舒巴坦对金葡球菌、化脓性链球菌、肺炎链球菌有较强的抗菌活性 ,明显强于阿莫西林、头孢拉定 ,与头孢呋辛、氨苄西林 /舒巴坦相似。舒巴坦增强了阿莫西林对产酶肺炎克雷伯氏菌、大肠埃希氏菌、葡萄球菌、不动杆菌等的抗菌活性。结论 :国产阿莫西林 /舒巴坦治疗细菌性感染安全、有效。Object To evaluate the efficacy and safety of domestic amoxicillin/sulbactam for injection in the treatment of bacterial infections. Methods A randomized controlled multicentre clinical trial was conducted, amoxicillin/sulbactam was served as the control drug. A total of 130 patients were enrolled in the study, 68 in the amoxicillin/sulbactam group and the other 62 in the ampicillin/sulbactam group. Results The cure rates of amoxicillin/sulbactam and ampicillin/sulbactam were 72.7% and 63.3%, and the overall efficacy rates were 87.9% and 83.3% respectively. The bacterial clearance rates were 90.9% in amoxicillin/sulbactam group νs 90.0% in ampicillin/sulbactam group. The adverse drug reaction rates of amoxicillin/sulbactam and ampicillin/sulbactam were 10.3% and 11.3% respectively. There was no statistical significant difference between the two groups. The results of in vitro activities of amoxicillin/sulbactam and other 5 antibacterial agents showed that amoxicillin/sulbactam had good activities against Staphylococcus aureus, Streptococcus pyogene, Streptococcus pneumoniae and more potent than those of amoxicillin, cefradine and similar to those of cefuroxime, ampicillin/sulbactam. Sulbactam could improve the antimicrobial activities of amoxicillin against β lactamases producing Klebsiella pneumoniae, Escherichia coli, Staphylococcus and Acinetobacter . Conclusion Amoxicillin/sulbactam is an effective and safe broad spectrum antibacterial agent for the treatment of bacterial infections.

关 键 词：治疗 阿莫西林 舒巴坦 氨苄西林 细菌性感染 

分 类 号：R978.11[医药卫生—药品] R969.4[医药卫生—药学]