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机构地区:[1]北京医科大学临床药理研究所
出 处:《中国医院药学杂志》1998年第6期251-252,共2页Chinese Journal of Hospital Pharmacy
摘 要: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.
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