摘要
目的 :评价阿莫西林钠 舒巴坦钠的有效性和安全性。方法 :多中心随机单盲对照试验设计 ,完成有效病例 1 2 0例 ,其中试验组 (阿莫西林钠 舒巴坦钠 ) 5 9例 ,对照组 (氨苄西林钠 舒巴坦钠 ) 61例。结果 :阿莫西林钠 舒巴坦钠和氨苄西林钠 舒巴坦钠治疗各种细菌感染的有效率 ,分别为 91 .5 3 %和93 .44% ,痊愈率分别为 5 7.63 %和 3 9.3 4%。细菌清除率为 85 .1 1 %和 84.90 % ,临床分离细菌的产酶率为 63 .3 8%和 68.88% ,两组的不良反应发生率分别为 9.3 8%和 8.2 2 % (P >0 .0 5 ) ,不良反应轻微。阿莫西林钠 舒巴坦钠对金葡菌 ,化脓性链球菌 ,肺炎链球菌有较强的抗菌活性 ,明显强于氨苄西林、红霉素、青霉素G、头孢唑啉。舒巴坦增强了对产酶菌的抗菌活性 ,同氨苄西林钠 舒巴坦钠相似。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。
AIM: To evaluate the efficacy and safety of domestic amoxicillin/sulbactam for injection in treatment of patients with bacterial infections. METHODS: A randomized controlled multicentre clinical trial was conducted. Amoxicillin/sulbactam was served as the control drug. A total of 120 patients were enrolled in the study, 59 of them in the amoxicillin/sulbactam group and the other 61 in the ampicillin/sulbactam group. RESULTS: The cure rates of amoxicillin/sulbactam and ampicillin/sulbactam were 57.63 % and 39.34 %, and the overall efficacy rates were 91.53 % and 93.44 %, respectively; the β lactamase producing rates were 63.83 % and 68.88 %. The bacterial clearance rates were 85.11 % in amoxicillin/sulbactam group and 84.90 % in ampicillin/sulbactam group. The adverse drug reaction rates of amoxicillin/sulbactam and ampicillin/sulbactam were 9.38 % and 8.22 %, respectively. There was no statistical significant difference between the two groups. The side effects were mild. The in vitro activities of amoxicillin/sulbactam and other 4 antibacterial agents showed amoxicillin/sulbactam had good activities against staphylococcus aureus, streptococcus pyogene and streptococcus pneumoniae. Sulbactam could improve the antimicrobial activities of amoxicilina againtβ lactamases. CONCLUSION: Amoxicilina/sulbactam is an effective and safe broad spectrum antibacterial agent in treating bacterial infections.
出处
《中国临床药理学与治疗学》
CAS
CSCD
2003年第5期544-547,共4页
Chinese Journal of Clinical Pharmacology and Therapeutics
