拉氧头孢与头孢哌酮随机对照治疗细菌性感染202例多中心临床试验  

A RANDOMIZED CONTROLLED MULTI-CENTRE CLINICAL TRIAL ON LATAMOXEF COMPARED WITH CEFOPERAZONE IN THE TREATMENT OF 202 CASES OF BACTERIAL INFECTIONS

作　　者：李家泰[1] 陈尔章[1] 孙永华[1] 尹非[1] 高磊[1] 陈亦芳[1] 丁东杰[1] 赵德恒[1] 阎汝蕴[1] 张雅莲[1] 

机构地区：[1]北京医科大学临床药理研究所抗感染科,北京医科大学人民医院内科,北京市积水潭医院烧伤科

出　　处：《中国临床药理学杂志》1994年第2期70-81,共12页The Chinese Journal of Clinical Pharmacology

摘　　要：本项随机对照多中心临床试验旨在对拉氧头孢（ＬＭＯＸ）与头孢哌酮（ＣＰＺ）治疗细菌性感染２０２例的安全性与有效性进行比较评价，其中下呼吸道感染１３３例，外科感染６０例，尿路感染９例，二组各试验１０１例。试验药与对照药均静脉给药，剂量每次１－２ｇ，Ｑ１２ｈ，每日剂量不超过４ｇ，疗程１０－１４ｄ。结果表明拉氧头孢组痊愈率为７０．３％，显著高于头孢哌酮组５７．４％（Ｐ＜０．０５）。二组有效率分别为９１．１％与８１．９％（Ｐ＞０．０５），细菌清除率分别为８６．８％与７７．３％（Ｐ＞０，０５），均无统计学显著差异。从病人中分离的２２４株致病菌９３．３％对拉氧头孢敏感。拉氧头孢对大肠杆菌，克雷白肺炎杆菌。阴沟肠杆菌。不动杆菌、脆弱拟杆菌的ＭＩＣ９０为０．１２５－２ｍｇ／ｌ。拉氧头孢不良反应发生率为５．９％，显著低于头孢哌酮的反应率１０．９％（Ｐ＜０．０５）。二组出、凝血时间与血小板计数均无异常改变，治疗期间与治疗后无一例发生出血反应。以上结果说明氧头孢烯类拉氧头孢按本治疗方案应用于需氧菌与厌氧菌感染高效、安全。A randomized controlled multi-centre clinical trial was conducted for evaluating the efficacy and safety of latamoxef(LMOX)compared with cefoperazone(CPZ)in the treatment of 202 cases of bacterial infections including 133 cases of lower respiratory tract infections,60 cases of surgical infections and 9 cases of UTI.Each group involved in 101 cases,Both the test compound and the control were given intravenously,the dosage was1-2 g every 12 hours for10-14 days.The daily dosage should not exceed 4 g.The results showed that LMOX with cure rate 70.3% was more effective than that of CPZ(cure rate 57.4%)(P<0.05).The overall efficacy rate of LMOX and CPZ were 91.1% and 81 9% rexpectively(P>0.05).The clearance rate were 86.8% and 77.3% respectively(P>0.05)without statistical significant difference.93.7% of the total 224 strains isolated from patients were sensitive to LMOX.The MIC50 of LMOX against E. coli,Kl.pneumoniae,Ent.cloacae,Acinetobacter spp.and B fragilis was 0.125一2mg/l.The incidence of adverse reaction of LMOX was 5.9% significantly lower than that of CPZ 10.9%,(P<0.05).There were no abnormal changes of CT,BT,and platelet count of both group.No bleeding reaction was found during and after the therapy,The above results indicated that the oxacephem LMOX was safe and highly effective against aerobic and anaerobic bacterial infections when applied according to this thertqoeutic regimen.

关 键 词：拉氧头孢 头孢哌酮 治疗应用 

分 类 号：R978.11[医药卫生—药品]