国产clarithromycin治疗急性细菌性感染多中心临床研究

A multicentre clinical study on domestic clarithromycin in the treatment of acute bacterial infections

本项多中心临床研究旨在评价国产ｃｌａｒｉｔｈｒｏｍｙｃｉｎ（ＣＲＭ）的安全性和有效性。１２４例被确诊为急性呼吸道感染、皮肤软组织感染的成年患者入选随机对照试验。进口ＣＲＭ作对照药。患者被随机地分入国产或进口ＣＲＭ组。两药均按２５０ｍｇ，ｑ１２ｈ给药，疗程７～１４ｄ。国产ＣＲＭ组临床总有效率为９１．９％，细菌清除率９２．６％，不良反应发生率７．５％；对照组进口ＣＲＭ分别为９１．９％、９１．１％和７．６９％。以上结果经统计学处理，无显著性差异（Ｐ＞０．０５）。开放试验包括４５例急性细菌性感染病例，临床有效率为８６．７％，细菌清除率８７．８％，不良反应发生率６．７％。由以上结果可见，国产与进口ＣＲＭ治疗急性细菌性感染同样安全。

The efficacy and safety of domestic clarithromycin were evaluated in the multicentre study. One hundred and twentyfour adult patients with acute respiratory tract infections; acute skin and soft tissue infections were enrolled in randomized controlled clinical trial. Imported clarithromycin was chosen as a control drug. The patients were randomly assigned to receive either domestic clarithromycin or imported one, both drugs were administered 250mg q12h for seven to forteen days. Overall, the clinical efficacy rate of domestic clarithromycin group was 91.9%, the bacterial clearence rate was 92.6%, the incidental rate of adverse drug reaction was 7.57%. Imported clarithromycin group was 91.9%, 91.1% and 7.69% respectively. There was no significant statistical differences between them (P>0.05). The open group included 45 cases acute bacterial infections. The clinical efficacy rate was 86.7%; the bacterial clearence rate was 87.8%; the incidence of adverse drug reaction was 6.7%. It was concluded that domestic clarithromycin is as effective and well tolerated as imported clarithromycin with acute bacterial infections.