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目的以左氧氟沙星注射液为对照,观察加替沙星注射液的安全性。方法对2007年5月至2007年10月期间来自北京市13所医院的1963例使用加替沙星的住院患者和1954例使用左氧氟沙星的住院患者进行随访研究,观察给药前、后肝功能(ALT,AST),肾功能(BUN,Cr)及血糖的变化。结果加替沙星与左氧氟沙星的不良反应发生率分别为1.07%和1.28%,P>0.05,无统计学差异。两药均对肝肾功能无明显影响;加替沙星组用药后高血糖的发生率(13.92%)高于左氧氟沙星组(6.53%),P<0.05,差异有统计学意义。结论加替沙星对肝肾功能的影响较小,对血糖代谢的影响相对较大,应用时,应密切监测血糖的变化。
Objective To levofloxacin injection as a control, observe the safety of gatifloxacin injection. Methods A total of 1963 inpatients with gatifloxacin and 1954 inpatients using levofloxacin from 13 hospitals in Beijing from May 2007 to October 2007 were studied retrospectively to observe the changes of liver function ALT, AST), renal function (BUN, Cr) and blood glucose changes. Results The incidence of adverse reactions of gatifloxacin and levofloxacin were 1.07% and 1.28%, respectively, P> 0.05, with no significant difference. Both drugs had no significant effect on liver and kidney function. The incidence of hyperglycemia in gatifloxacin group (13.92%) was higher than that in levofloxacin group (6.53%), P <0.05, the difference was statistically significant. Conclusion Gatifloxacin has little effect on liver and kidney function, and has a relatively large effect on blood glucose metabolism. When applied, the changes of blood glucose should be closely monitored.