罗红霉素缓释片与罗红霉素片治疗急性呼吸系感染的临床研究

Randomized controlled clinical trial on Roxithromycin Retard versus Roxithromycin in treatment of acute bacterial infections of respiratory system

关键词:  罗红霉素缓释片  呼吸系统  细菌感染

Key words:  Roxithromycin retard  respiratory system  bacterial infection

摘要:

［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102例，实验药罗红霉素缓释片300　mg，1次/d，口服；对照药罗红霉素片150　mg，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％（P＞0.05）。细菌清除率：实验组97.55％，对照组97.67％（P＞0.05）；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％（P＞0.05）。［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。

Abstract:

［Objective］In order to evaluate the efficacy and safety of Roxithromycin Retard in the treatment of acute bacterial infections of respiratory system.［Methods］A randomized double-blind labeled controlled clinical trial was conducted for the treatment of 204 patients with respiratory tract infections. In the study,102 patients were enrolled in Roxithromycin Retard group while 102 patients were enrolled in Roxithromycin group. The dosage of Roxithromycin Retard was 300 mg,once daily orally while the dosage of Roxithromycin was 150 mg twice daily orally. The duration of treatment was 7～10 days in both groups.［Results］The results showed that the efficacy rates were 90.2% for Roxithromycin Retard group and 89.2% for Roxithromycin group, the bacterial clearance rates were 97.55% and 97.67%,respectively. The incidence of adverse reaction was 12.75% and 9.8%,respectively.［Conclusion］Roxithromycin Retard is effective and safe drug for acute bacterial infections of respiratory system.