注射用盐酸多西环素治疗急性细菌性感染随机、双盲、平行对照多中心临床研究_医学论文.docVIP

注射用盐酸多西环素治疗急性细菌性感染随机、双盲、平行对照多中心临床研究_医学论文 注射用盐酸多西环素治疗急性细菌性感染随机、双盲、平行对照多中心临床研究_医学论文 作者：袁吉吉 杨春 黄文祥 贾杰 钟良宝 刘振湘 陈文 【关键词】 多西环素；,,阿奇霉素；,,呼吸系统感染；,,泌尿系统感染 　　摘要： 目的 评价国产注射用盐酸多西环素治疗急性呼吸道及泌尿道感染的有效性与安全性。方法 采用多中心随机双盲对照试验设计，试验药盐酸多西环素注射液静脉滴注，每次200mg，每日1次，疗程5～12d；对照药阿奇霉素每次500mg，每日1次，静脉滴注，疗程5～12d。结果 试验组、对照组的总体临床有效率与痊愈率分别为9764%、7953%与9435%、6774%；两组的细菌清除率分别为9674%和9605%；对革兰阴性菌的清除率试验组为9608%，对照组为9556%；对革兰阳性菌的清除率试验组为9756%，对照组为100%，经统计学分析无显著差异(Pgt005)；对支原体的清除率试验组为9333%，对照组为7778%，统计学分析有显著性差异(005)。纸片药敏结果表明临床分离菌对多西环素敏感率与米诺环素、阿奇霉素、阿米卡星、头孢噻肟、左氧氟沙星比较，均无统计学差异。MIC结果提示多西环素对多种需氧革兰阳性、阴性菌有较强的抗菌活性，对支原体也有良好的抗菌活性。试验组与对照组不良事件发生率分别为1783%与1349%，两组比较无显著性差异(Pgt005)，两组不良事件均以静脉刺激及消化道反应为多见，无严重不良事件发生。结论 盐酸多西环素注射液抗菌谱广、抗菌活性强，治疗各种敏感菌所致的急性轻、中度呼吸道、泌尿道细菌及支原体感染均有很好临床疗效和细菌学疗效，不良反应发生率低。 　　关键词： 多西环素； 阿奇霉素； 呼吸系统感染； 泌尿系统感染 　　A multicenter randomized controlled clinical trial of doxycycline versus　azithromycin for injection in the treatment of acute bacterial infections) STRACT Objective To evaluate the safety and efficacy of domestic intravenous doxycycline for injection in the treatment of acute respiratory tract and urinary tract infections. Method A multicenter, doubleblind, randomized controlled clinical trials of intravenous doxycycline and azithromycin on patients with acute bacterial infections were conducted. The dosage of doxycycline was 02g, once daily, 5～12d and azithromycinwas 05g once daily, 5～12d. Both drugs were given intravenously. Results The overall efficacy rate and　cure rate in trial and control group were 9764% vs 7953% and 9435% vs 6774% respectively. The bacterial clearance rates were 9674% vs 9605% respectively. There were no statistically significant differences of the above results between the two groups. The clearance rates for mycoplasma were 9333% and 7778% respectively. It showed that there was statistical difference between two groups (005). Disk agar diffusion test showed the sensitive rate of clinical isolates to doxycycline was same to the other antibacterial agents. MIC values showed the d