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本项临床试验旨在评价罗红霉素的安全性与有效性。试验方法为两组随机化双盲平行对照多中心试验设计，并选用进口罗力得作为对照药。本次试验共治疗细菌性感染或支原体、衣原体感染１５０例，其中罗红霉素组１００例（呼吸道感染５０例与罗力得组５０例配对观察，另外呼吸道感染２０例，皮肤感染１０例和非淋病性尿道炎２０例开放观察），罗力得组５０例作为对照组。罗红霉素组临床痊愈率为６９％，有效率为９０％，细菌清除率为８６％，罗力得组相应为６９％，９０％，９０％，经统计学处理两组无明显差异。罗红霉素不良反应发生率为８％，对照组为６％。表明罗红霉素在药效和不良反应率方面与进口罗力得一致，是一种新的安全有效的口服抗生素。
This clinical trial aims to evaluate the safety and efficacy of roxithromycin. The test method for the two randomized double-blind parallel control multicenter trial design, and the selection of imported Luo Lide as a reference drug. The trial treated a total of 150 cases of bacterial infection or mycoplasma and chlamydia infection, including roxithromycin group of 100 cases (50 cases of respiratory tract infection and 50 cases of Luo Li group observation, and another respiratory tract infection in 20 cases, 10 cases of skin infections and 20 cases of non-gonococcal urethritis open observation), Luo Li group 50 cases as a control group. In the roxithromycin group, the clinical cure rate was 69%, the effective rate was 90%, the bacterial clearance rate was 86%, and the Luo Li De group was 69%, 90% and 90% respectively. There was no significant difference between the two groups. Roxithromycin adverse reaction rate was 8% in the control group was 6%. Show that roxithromycin in the efficacy and adverse reaction rates with imported Luo Li was consistent, is a new safe and effective oral antibiotics.