阿莫西林／舒巴坦治疗感染性疾病的临床研究

Clinical study on amoxicillin/sulbactam in treatment of infectious diseases

目的评价阿莫西林/舒巴坦治疗急性细菌感染性疾病的安全性、有效性与药物不良反应及其体外抗菌活性,为临床合理选择抗菌药物提供理论依据。方法 121株临床分离菌株采用琼脂平板两倍稀释法测定最低抑菌浓度(MIC);110例急性感染性疾病患者予以注射用阿莫西林/舒巴坦治疗后观察疗效。结果阿莫西林/舒巴坦对革兰阳性球菌的敏感率为90.0%,明显高于阿莫西林与头孢噻肟;对革兰阴性杆菌中大肠埃希菌、肺炎克雷伯菌的敏感率分别为82.0%、83.0%,与氨苄西林/舒巴坦、阿莫西林/克拉维酸、头孢呱酮相近,明显高于阿莫西林;不动杆菌属敏感率为83.0%,显著高于阿莫西林,略强于其他两种酶抑制剂复合制剂和头孢噻肟;阿莫西林/舒巴坦治疗呼吸系统、泌尿系统、腹腔感染及败血症患者110例,痊愈84例,显效25例,有效1例,总有效率为99.0%,细菌清除率91.0%;不良反应发生率4.6%。结论加入酶抑制剂提高了阿莫西林对临床常见病原菌的抗菌活性,治疗感染性疾病临床疗效好、不良反应发生率低。

OBJECTIVE To evaluate the clinical effectiveness, safety, adverse reactions, and the in vitro antibacterial activity of amoxicillin/sulbactam in the treatment of acute bacterial infections so as to provide theoretical basis for the clinical reasonable use of antibiotics. METHODS The minimal inhibitory concentration （MIC） of amoxicillin/ sulbactam against clinical isolated strains were determined by using agar dilution method. A randomized multicentre clinical trial on effect and safety of domestic amoxicillin/sulbactan for treatment of acute bacterial infections was conducted. RESULTS The susceptible rate of amoxiciilin/sulbaetam against the gram-positive strains was 90.0%, significantly higher than that of amoxicillin and cefotaxime. The susceptible rates of amoxicillin/ sulbactam against Escherichia coli and Klebsiella pneumoniae were 82.0 % and 83.0%, respectively, which were similar to amoxicillin/clavulanic acid, ampicillin/sulbactam and eefotaxime and significantly higher than amoxicillin. The susceptible rate of amoxicillin/sulbactam against Acinetobacter was 83.0%, significantly higher than that of amoxicillin, and slightly higher than that of two agents containing β-1actamases inhibitors and cefotaxime. Of 110 patients who used amoxicillin/sulbactam for the treatment of respiratory system infection, urinary system infections, abdominal infections, and septicemia, 84 cases were cured, 25 cases were markedly improved, and 1 case was improved. The total effective rate was 99.9%, the bacterial clearance rate was 91.0%, and the incidence rate of adverse reactions was 4. 6%. CONCLUSION The adding of enzyme inhibitors has improved the antibacterial activity of amoxicillin against the clinical common pathogens. It suggested that amoxicillin/sulbactam is an effective and safe drug to treat infectious disease.