甲磺酸加替沙星片治疗急性细菌感染性疾病的多中心随机对照临床研究

A randomized controlled multicentre clinical trial on efficacy and safety of gatifloxacin methanesulfonate tablet in the treatment of acute bacterial infections

目的 评价新药甲磺酸加替沙星片治疗常见致病菌引起的呼吸系统、泌尿系统细菌感染性疾病的临床疗效和安全性。方法 以盐酸左氧氟沙星片为对照药 ,采用多中心随机盲法阳性对照平行试验设计方法 ,进行甲磺酸加替沙星片治疗急性细菌性感染疾病安全性和有效性临床研究。结果 试验组甲磺酸加替沙星氯化钠片治疗呼吸道感染、泌尿系统感染的临床痊愈率和有效率分别为 74 .73%和 96 .70 %、90 .91%和10 0 % ;细菌阴转率分别为 97.92 %和 97.96 %。对照组左氧氟沙星片治疗上述感染的临床痊愈率和有效率依次分别为 80 .2 2 %和 97.80 %、86 .6 7%和 96 .6 7% ;细菌阴转率分别为 98.6 1%和 96 .15 %。试验组与对照组不良反应发生率分别为 6 .87%和 6 .0 6 %。两组比较差异无统计学意义。应用甲磺酸加替沙星片未见严重不良反应发生。结论 新药甲磺酸加替沙星片治疗临床常见致病菌引起的呼吸系统、泌尿系统感染临床疗效较好而不良反应发生率较低 。

Objective To compare the efficacy and safety of gatifloxacin methanesulfonate tablet verus levofloxacin hydrochloride tablet in the treatment of acute respiratory and urinary system bacterial infections. Methods Levofloxacin hydrochloride tablet was used as control drug and a randomized controlled multicentre clinical trial was conducted to evaluate the efficacy and safety of gatifloxacin methanesulfonate tablet against acute bacterial infection. Results The cure rates and efficacy rates in the treatments of respiratory and (urinary) system bacterial infections in the gatifloxacin group were 74.73%, 96.70% and 90.91%, 100% respectively, and the bacterial clearance rates were 97.92 % and 97.96% respectively. The cure rate and efficacy rate in treatments of respiratory and urinary system bacterial infections in the levofloxacin group were 80.22%, 97.80% and 86.67%, 96.67%, and the bacterial clearance rates were 98.61% and 96.15%. The adverse drug reaction rates in these two groups were 6.87% and 6.06% respectively. The difference between the two groups was not statistically significant. No serious adverse drug reaction was found during the treatment. Conclusion Gatifloxacin methanesulfonate tablet was effective and safe in the treatment of acute respiratory and urinary system bacterial infections.