盐酸仑氨西林片与阿莫西林胶囊随机双盲双模拟对照治疗急性细菌性感染临床评价

A randomized double-blind, double dummies controlled study to compare lenampicillin hydrochloride tablet and amoxicillin capsule in the treatment of acute bacterial infections

目的评价盐酸仑氨西林片治疗急性细菌性感染的疗效和安全性.方法以阿莫西林胶囊为对照药,观察49例受试者,其中盐酸仑氨西林片治疗25例,阿莫西林胶囊治疗24例.2种药物均以500 mg,每日3次给药,疗程7～14d.结果盐酸仑氨西林片与阿莫西林胶囊两组痊愈率分别为68.0%和70.8%,有效率分别为90.2%和100%.细菌清除率分别为93.3%和100%.不良反应发生率分别为12.0%和4.2%.经统计学检验两组结果差异无显著性.分离出的29株致病菌对盐酸仑氨西林的敏感率为89.7%,与阿莫西林、头孢呋辛、环丙沙星和头孢拉定比较敏感率差异无显著性.结论盐酸仑氨西林片治疗急性细菌性感染是安全和有效的.

Objective This study was designed to evaluate the efficacy and safety of lenampicillin hydrochloride tablet in the treatment of acute bacterial infections. Methods Amoxicillin capsule was used as control treatment. Forty nine patients were evaluated including 25 in lenampicillin group and 24 in amoxicillin group. The dosage regimen for the two agents was 500 mg, 3 times a day for 7-14 days. Results The cure rate was 68.0% in lenampicillin group and 70.8% in amoxicillin group. The response rate was 90.2% in lenampicillin group and 100% in amoxicillin group. Bacterial eradication rate was 93.3% in lenampicillin group and 70.8% in amoxicillin group. The incidence of adverse reaction was 12.0% in lenampicillin group and 4.2% in amoxicillin group. The difference of all these parameters between the two groups was not statistically significant. Of the 29 pathogenic isolates collected, 89.7% were susceptible to lenampicillin, not significantly different from the susceptibility to amoxicillin, cefuroxime, ciprofloxacin and cefradine. Conclusions Lenampicillin hydrochloride tablet is safe and effective in the treatment of acute bacterial infections.