加替沙星注射液安全性随访研究  

Follow-up study for gatifloxacin injections safety

作　　者：张俊[1] 周冰[1] 裴振峨[1] 林鑫[2] 张黎明[1] 

机构地区：[1]北京市药品评价中心,北京100024 [2]北京大学公共卫生学院,北京100083

出　　处：《临床药物治疗杂志》2009年第5期42-45,62,共5页Clinical Medication Journal

摘　　要：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 observe the safety of gatifloxacin with levofloxacin as the control. Methods 1963 inpatients receiving gatifloxacin and 1954 inpatients receiving levofloxacin from 13 hospitals between May 2007 and October 2007 were enrolled in the follow - up study. The liver function （ALT, AST）, kidney function （BUN, Cr） and blood glucose levels were measured before drug administration or after drug discontinuation. Results The incidence of ADR between gatifloxacin and levofloxacin is 1.07% and 1.28%, （P 〉 0.05）, respectively,the difference is not statistically significant. There is no effece on liver and kidney functions of both drugs. The incidence of high blood glucose in gatifloxacin group is higher than in levofloxacin group , they are 13. 92%and 6. 53% （ P 〈0. 05）, respectively, the difference is statistically significant. Conclusion Gatifloxacin can affect glucose metabolism and the blood glucose should be monitored carefully when using it.

关 键 词：加替沙星:左氧氟沙星 安全性 随访研究 

分 类 号：R978[医药卫生—药品] R969.3[医药卫生—药学]