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目的:评价注射用盐酸多西环素国产品治疗细菌性感染的疗效和安全性。方法:采用多中心随机双盲对照临床观察,以阿奇霉素为对照药,共246例患呼吸道或泌尿道感染的病人入组,纳入疗效分析240例,安全性分析246例。结果:注射用多西环素和阿奇霉素的痊愈率分别为63.33%(76/120)、75%(90/120),有效率分别为94.17%(113/120)、96.67%(116/120),细菌清除率分别为81.70%(67/82)和84.10%(69/82),不良反应发生率分别为23.58%(29/123)和25.20%(31/123)。经统计学分析均无显著差异(P>0.05)。结论:国产注射用盐酸多西环素治疗呼吸道感染和泌尿道感染的疗效和安全性与注射用阿奇霉素相仿。
Objective: To evaluate the efficacy and safety of Doxycycline Hydrochloride Injection in the treatment of bacterial infections in China. METHODS: A multicenter, randomized, double-blind, controlled clinical trial was conducted in which azithromycin was used as a reference drug. A total of 246 patients with respiratory tract or urinary tract infection were enrolled. 240 cases were included in the analysis of efficacy and 246 were analyzed for safety. Results: The cure rates of doxycycline injection and azithromycin injection were 63.33% (76/120) and 75% (90/120) respectively, the effective rates were respectively 94.17% (113/120) and 96.67% (116/120) The bacterial clearance rates were 81.70% (67/82) and 84.10% (69/82), respectively. The incidences of adverse reactions were 23.58% (29/123) and 25.20% (31/123) respectively. The statistical analysis showed no significant difference (P> 0.05). Conclusion: The efficacy and safety of domestic injection of doxycycline hyclate for the treatment of respiratory tract infection and urinary tract infection are similar to azithromycin for injection.