【摘要】 目的　评价国产加替沙星氯化钠注射液治疗急性细菌性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 ,以盐酸左氧氟沙星注射液为对照药 ,试验组和对照组剂量均为每次 2 0 0mg ,每日2次 ,静脉滴注 ,疗程 7～ 14d。结果　治疗呼吸系统、泌尿生殖系统、皮肤软组织及其他部位细菌性感染 2 49例 ,其中试验组 12 5例 ,对照组 12 4例。两组的总体临床有效率与痊愈率分别为 95 90 %、81 15 %与 95 0 8%、81 15 % ,细菌清除率分别为 93 5 8%和 91 15 % ,细菌转阴率分别为 93 5 8%和 91 15 % ;试验组和对照组对枝原体、衣原体的清除率为 10 0 % ,无显著性差异 (P >0 0 5 )。纸片药敏结果表明临床分离菌对加替沙星敏感率明显高于环丙沙星、司帕沙星与头孢噻肟。MIC结果提示加替沙星对绝大多数细菌有较强的抗菌活性 ,尤其是抗革兰氏阳性菌的抗菌活性优于其他几种抗生素 ,对革兰氏阴性菌的抗菌活性与其他几种抗生素相近或略优。试验组与对照组不良反应发生率分别为 16 8%与 13 71% ,两组比较无显著性差异 (P >0 0 5 ) ,主要不良反应为头晕、皮疹、转氨酶升高 ,试验中未见光敏反应及其他严重不良反应。结论　国产加替沙星氯化钠注射液抗菌谱广、抗菌活性强 ,治疗各种敏感菌所致的急性中、重度感?更多还原

【Abstract】 Objective To evaluate the safety and efficacy of domestic gatifloxacin for injection in the treatment of acute bacterial infections. Method A multicenter, double blind, randomized controlled clinical trials of gatifloxacin for injection and levofloxacin for injection on patients with acute bacterial infections were conducted. The regimen of the two group were 0 2g, twice daily, 7～14d. Both drugs were given intrave nously. Results A total of 249 patients with respiratory tract, urinary tract, skin acute bacterial infections and other infections were treated. 125 patients enrolled in gatifloxacin group, 124 patients enrolled in levofloxacin group. The overall efficacy rate and cure rate in trial and control group were 95 90%, 81 15% and 95 08%, 81 15% respectively. The bacterial clearance rates were 93 58% and 91 15% respectively. There were no statistical significant differences of the above results between the two groups. The clearance rates for mycoplasma and chlamydia of STD were 100%. Disc agar diffusion test showed the sensitive rate of clinical isolates to gatifloxacin was much higher than that against other antibacterial agents. MIC values showed that the gatifloxacin had a good antibacterial activity to major clinical isolates, especially to the Gram positive bacteria. Antibacterial activity of gatifloxacin against Gram negative bacteria were similar to or better than the other antibacterial agents. The adverse drug reaction rates were 16 8% and 13 71% in gatifloxacin and levofloxacin group respectively. The most common adverse events observed were dizziness, rash and ALT elevation. There were no photosensitivity and other serious adverse effects. Conclusion Results suggested that the demostic gatifloxacin for injection had powerful antibacterial activity and wide spectrum, and was an effective and safe quinolone in treatment of acute bacterial infections.更多还原