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[目的]通过治疗敏感菌所致的急性呼吸系统细菌性感染,评价罗红霉素缓释片的安全性及有效性。[方法]采用多中心、区组随机化、双盲双模拟、随机平行对照实验设计。实验组和对照组各10 2例,实验药罗红霉素缓释片30 0mg ,1次/d ,口服;对照药罗红霉素片15 0mg ,2次/d ,口服,疗程7～10d。[结果]有效率:实验组及对照组分别为90 .2 %、89.2 % (Ρ>0 .0 5 )。细菌清除率:实验组97.5 5 % ,对照组97.6 7% (Ρ>0 .0 5 ) ;与药物有关的不良事件:实验组和对照组分别为12 .75 %和9.8% (Ρ>0 .0 5 )。[结论]罗红霉素缓释片治疗急性呼吸系统感染安全、有效,临床耐受性好。
[Objective] To evaluate the safety and effectiveness of roxithromycin sustained-release tablets by treating bacterial infections of acute respiratory system caused by sensitive bacteria. [Methods] A multicentre, block randomized, double-blind, double-dummy, randomized parallel controlled trial design was used. The experimental group and the control group each 10 2 cases, the experimental drug roxithromycin sustained-release tablets 300mg, 1 / d, oral; control drug roxithromycin tablets 150mg, 2 times / d, oral, treatment 7 ~ 10d . [Result] The effective rate was 90.2% in the experimental group and 89.2% in the control group (Ρ> 0.05). The bacterial clearance rate was 97.5% in the experimental group and 97.6% in the control group (Ρ0.05). The drug-related adverse events were 12.7% in the experimental group and 9.8% in the control group (P> 0.05). 0 5). [Conclusion] Roxithromycin sustained-release tablets in the treatment of acute respiratory infections are safe, effective and have good clinical tolerance.