多西环素与阿奇霉素随机双盲对照治疗呼吸系统感染

目的:评价国产多西环素治疗呼吸系统感染的有效性和安全性。方法:采用多中心随机对照双盲试验。选用132例呼吸系统感染病人,随机分为2组,每组均66例。试验组予国产多西环素200 mg静脉滴注,对照组予国产阿奇霉素500 mg静脉滴注,均为每日1次,疗程5-12 d。结果:试验组完成65例,对照组完成64例。试验组痊愈率68％,有效率95％,细菌清除率90％;对照组分别为63％,94％, 87％,差异均无显著意义(P>0．05)。不良反应发生率试验组、对照组分别为9％和8％(P> 0．05)。共分离出致病菌98株,革兰阳性菌和革兰阴性菌对多西环素的敏感率分别为100％和98％。结论:国产多西环素对敏感菌引起的呼吸系统感染疗效确切,安全性好。

A multicenter randomized contorlled clinical trial of doxycycline versus azithromycin in treatment of respiratory tract infections

AIM: To evaluate the safety and efficacy of domestic doxycycline in the treatment of respiratory tract infections. METHODS: A multicenter, double-blind, randomized controlled clinical trial of doxycycline vs azithromycin was conducted among 132 patients with respiratory tract infections. The patients were divided into two groups randomly, with 66 in each. The patients in the trial group were treated with doxycycline, 200 mg, iv, gtt, qd, and other patients in the control group were treated with azithromycin, 500 mg, iv, gtt, qd, individually for both groups with a same course of 5-12 d. RESULTS: Sixty-five and 64 patients completed the treatment in the trial and control group, respectively; and ready to be analyzed. The overall cure rates, efficacy rates and bacterial clearance rates in trial group were 68 %, 95 %, and 90 %, vs 63 %, 94 %, and 87 % in trial group and control group, respectively. The adverse reaction rates were 9 % and 8 % in trial and control groups respectively. There were no statistical significant differences of the above results between the two groups (P > 0.05). All together 98 species of pathogen were isolated including Gram-positive and Gram-negative bacteria with sensitivity rates to doxycycline as 100 % and 98 % respectively. CONCLUSION: The demostic doxycycline injection is effective and safe in treatment of acute respiratory tract infections caused by the sensitive bacterium.