氟罗沙星治疗急性细菌性感染临床研究  

ACLINICALSTUDYINTHETREATMENTOFACUTEBACTERIALINFECTIONSWITHFLERO┐XACIN

作　　者：侯杰[1] 李家泰[1] 崔洪[1] 郝凤兰[1] 

机构地区：[1]北京医科大学临床药理研究所

出　　处：《中华内科杂志》1996年第10期663-667,共5页Chinese Journal of Internal Medicine

摘　　要：本临床试验目的是对氟罗沙星进行安全性及有效性评价。采用随机对照开放试验方法，选用洛美沙星作对照药，两组治疗泌尿道感染和呼吸道感染各３０例，同时完成氟罗沙星开放试验５０例，共１１０例。氟罗沙星与洛美沙星给药方法均为２００ｍｇ／次，每日２次，或４００ｍｇ，每日１次，疗程７～１４天。随机对照氟罗沙星组细菌培养阳性率８３．３％；有效率９３．３％；细菌清除率９２．３％，不良反应发生率９．４％；洛美沙星对照组分别为８０．０％，９０．０％，８７．５％，６．７％；以上结果经统计学处理差异无显著性（Ｐ＞０．０５）。氟罗沙星随机加开放试验共治疗各种细菌性感染患者８０例，总有效率９０．０％，细菌阳性率８３．８％，细菌清除率８８．２％，不良反应发生率９．６％。表明氟罗沙星为广谱、高效、安全的抗菌药物。Thepurposeofthisclinicaltrialistoevaluatetheefficacyandsafetyoffleroxacinandtocomparewiththoseoflomefloxacin.Arandomizedcontroledstudywascarriedouttotreatsixtypa-tientswithurinarytractandrespiratorytractbacterialinfections,thirtyineachgroupwithoneofthetwodrugs,andfiftycasesweretreatedwithfleroxacininanopentrial.Altogethertherewereonehan-dredandtencases.Bothfleroxacinandlomefloxacinweregivenoraly,thedosagewas200mgevery12hoursor400mgevery24hoursfor7～14days.Theclinicalefficacyratewas93.3%;theculturingrateinthefleroxacingroupwas83.3%;thebacterialclearanceratewas92.3%,theincidenceofadversere-actionswas9.4%,whileinthelomefloxacingrouptheywere90.0%,80.0%,87.5%and6.7%re-spectively,withnostatisticalysignificantdifferencebetweenthetwogroups(P>0.05).Intheopenandrandomizedtrials,flero-xacincuredeightycasesofbacterialinfections,theoveralclinicaleficacyratewas90.0%,theculturingrateintheflero-xacingroupwas83.8%,thebacterialclearanceratewas88.2%andtheincidenceofadversereationswas9.6%.Itisshownthatfleroxacinisanantiboticofbroad-apectrum,higheficacyandsafety.

关 键 词：喹诺酮类 细菌感染 药物疗法 氟罗沙星 

分 类 号：R515.05[医药卫生—内科学]