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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、有效
OBJECTIVE: To evaluate the safety and efficacy of domestic clarithromycin by means of randomized controlled trials and open trials. Methods: Randomized controlled trials of imported clarithromycin were used as the control group. Each group consisted of 20 patients, each treated with 250 mg q12h for 7-14 days. Results: The clinical effective rate was 85.0% in domestic clarithromycin group, the bacterial clearance rate was 88.2% and the incidence of adverse reactions was 8.3%. The imported clarithromycin in control group was 90.0% and 88.2% respectively 8.6%. The above results were not statistically significant (P> 0.05). Fifteen cases of acute urinary tract infection were treated with open clarithromycin. The clinical effective rate was 73.3%, bacterial clearance rate was 73.3% and adverse reaction rate was 6.7%. Conclusion: Domestic clarithromycin and imported clarithromycin are equally safe and effective in the treatment of acute bacterial infections