国产克拉霉素治疗急性细菌性感染临床研究

A clinical study on home made clarithromycin in the treatment of acute bacterial infections

目的：通过随机对照和开放试验的方法评价国产克拉霉素的安全、有效性。方法：随机对照选用进口克拉霉素作对照组，每组各２０例，均按２５０ｍｇ，ｑ１２ｈ给药，疗程７～１４ｄ。结果：国产克拉霉素组临床有效率８５．０％，细菌清除率８８．２％，不良反应发生率８．３％；对照组进口克拉霉素分别为９０．０％，８８．２％和８．６％，以上结果经统计学处理差异无显著性（Ｐ＞０．０５）。开放试验国产克拉霉素治疗急性泌尿道感染１５例，临床有效率７３．３％，细菌清除率７３．３％，不良反应发生率６．７％。结论：国产克拉霉素与进口克拉霉素治疗急性细菌感染同样安全。

larithromycin is a new macrolide antibiotic. The aim of the study was to evaluate the efficacy and safety of home made clarithromycin by randomized and opened clinical trials. Imported clarithromycin was chosen as a control drug. Each group included twenty cases, both drugs were administered 250 mg Q12 h for seven to forteen days. The clinical efficacy rate of home made clarithromycin group was 85.0% , the bacterial clearence rate was 88.2% , the incidence of adverse drug reaction was 8.3% . Imported clarithromycin group was 90.0% , 88.2% and 8.6% respectively. There were no significantly statistical differences betweent them ( P > 0.05 ). The opened group included fifteen cases urinary tract infections. The clinical efficacy rates was 73.3% ; the bacterial clearence rate was 73.3% ; the incidence of adverse drug reaction was 6.7% . The above results indicated that home made clarithromycin was as safe and effective as imported clarithromycin in the treatment of acute bacterial infections.