阿莫西林/舒巴坦新戊酰氧甲酯与阿莫西林/克拉维酸钾随机对照治疗急性细菌性感染的临床试验

A Randomized Controlled Clinical Trial on the Effect of Amoxicillin/Sulbactam and Amoxicillin /Clavulanate Potassium in the Treatment of Acute Bacterial Infections

目的评价阿莫西林／舒巴坦新戊酰氧甲酯治疗急性呼吸系及泌尿系细菌性感染的有效性和安全性。方法采用随机双盲双模拟平行对照方法，比较阿莫西林／舒巴坦新戊酰氧甲酯与阿莫西林／克拉维酸钾的临床疗效。急性细菌感染性疾病患者41例（其中急性呼吸系感染21例，急性泌尿系感染20例），随机分为两组。治疗组19例，给予阿莫西林／舒巴坦新戊酰氧甲酯，每次0．5g，po，q8h，共7～14d。对照组22例，给予阿莫西林／克拉维酸钾，每次0．75g，po，q8h，共7—14d。结果治疗组与对照组临床有效率分别为94．7％（18／19）和90．9％（20／22），细菌清除率分别为91．7％和93，3％。经统计学处理，上述指标差异均无显著性（均P〉0．05）。不良反应发生分别为4例和2例。结论阿莫西林／舒巴坦新戊酰氧甲酯对于由敏感菌引起的轻中度急性细菌性感染是一种安全有效的抗菌药物，其临床治疗效果与阿莫西林／克拉维酸钾相近。

Objective To assess the therapeutic effect and safeness of amoxicillin/sulbactam in the treatment of acute respiratory tract and urinary tract bacterial infections. Methods A double blind randomized controlled study was carried out for comparing the clinical therapeutic effects of amoxicillin/sulbactam and amoxicillin/clavulanate potassium in the treatment of acute bacterial infections. 41 patients with acute bacterial infections were randomly divided into 2 groups： the trial group （n = 19） and control group（n =22）. In the patients of the trial group, 10 suffered from respiratory tract infection and 9 from urinary tract infection. 11 of the patients of the control group had respiratory tract infection and 11 others had urinary tract infection. Patients of the trial group were given each 0.5 g of amoxicillin/sulbactam PO ,q. 8. h. for 7 - 14 consecutive days. Patients of the control group were given each 0.75 g of amoxicillin/clavulanate potassium q. 8. h. for 7 - 14 consecutive days. Results The overall clinical effective rates were 94. 7% （ 18/19 ） and 90. 9% （ 20/22 ） in patients of the trial group and control group, respectively. The rates of pathogen eradication rates were 91.7% and 93.3% in patients of the trial group and control group, respectively. The differences between patients of the 2 groups with respect to the effective rate and pathogen eradication rate were insignificant （P 〉0.05 ）. Four patients in the trial group manifested mild gastrointestinal side effects. One patient of the control group showed elevation of serum alkaline phosphatase activity and another patient had hyperbilinlinemia. Conclusion Amoxicillin/sulbactam was shown to be effective and safe in the treatment of mild to moderate infections caused by bacteria sensitive to the drug. Its clinical therapeutic effect was similar to that of amoxicillin/clavulanate potassium.