氧头孢烯类新抗生素氟氧头孢（Flomoxef）随机对照治疗细菌性感染206例临床研究  

A RANDOMIZED CONTROLLED CLINICAL STUDY ON A NEW OXACEPHEM,FLOMOXEF IN THE TREATMENT OF 206 CASES OF BACTERIAL INFECTIONS

作　　者：李家泰[1] 陈尔章[1] 孙永华[1] 刘又宁[1] 崔洪[1] 陈杨[1] 赵德恒[1] 陈欣[1] 王睿[1] 曹照龙[1] 

机构地区：[1]北京医科大学临床药理研究所,北京医科大学人民医院呼吸内科,北京积水潭医院烧伤科,中国人民解放军总医院呼吸科

出　　处：《中国临床药理学杂志》1995年第2期65-77,共13页The Chinese Journal of Clinical Pharmacology

摘　　要：氟氧头孢（ｆｌｏｍｏｘｅｆ，ＦＭＯＸ）是一个新的氧头孢烯类广谱抗生素。本项临床试验采用多中心随机对照方法，评价了氟氧头孢治疗呼吸道感染、尿路感染、妇产科及外科感染的有效性与安全性，并选用头孢美唑（ｃｅｆｍｅｔａｚｏｌｅ，ＣＭＺ）作对照。两组共治疗患者２０６例，其中氟氧头孢组１０５例，头孢美唑组１０１例，均为静脉给药，剂量每次１－２ｇ，每日两次，间隔１２ｈ，疗程：７－１４ｄ。氟氧头孢组与头孢美唑组痊愈率分别为６１．０％和５４．５％，有效率分别为９１．４％与８９．１％。细菌清除率两组分别为９０．８％和８６．７％，不良反应发生率分别为６．６％和８．９％，以上结果经统计学处理均无显著差异（Ｐ＞０．０５）。氟氧头孢组治疗葡萄球菌属感染共２３例，其中ＭＲＳＡ感染６例，有效率１００％。氟氧头孢组共分离到葡萄球菌２６株（其中３株为混合感染），细菌清除率为９６．２％。从２０６例病人中共分离到致病菌２３２株，其中氟氧头孢高度敏感菌占８８．４％，显著高于头孢美唑（７４．１％）、头孢哌酮（６６．８％）、头孢唑啉（４７．４％）、头孢噻肟（７２．４％）。不论阳性或阴性细菌对氟氧头孢的敏感率均高于对头孢美唑的敏感率，具有统计学显著或极显?Flomoxef (FMOX) is a new broad - spectrum oxacephem antibiotic.A randomized controlled multi-centre clinical trial was conducted to evaluate the efficacy and safty of flomoxef in the treatment of RTI,UTI,obstetric and gynecological infections and surgical infections. Cefmetazole (CMZ) was chosen as the control.Total 206 patients entered the study, 105 in flomoxef group and 101 in cefmetazole group. Both compounds were given intravenously. 1 -2g every 12 hours for 7 - 14days. The cure rates of flomoxef and cefmetazole were 61. 0% and 54. 5% respectively, the overall clinical response rates were 91. 4% and 89. 1% respectivly. The bacterial clearance rate was 90. 8%of flomoxef vs, 86. 7 % of cefmetazole.The adverse drug reactions of flomoxef and cefmetazole were 6 .6% and 8.9% respectively.There was no statistical significant difference between the two groups for above results.In the flomoxef group, the overall efficacy rate and the bacterial clearence rate of 23 cases infected by Staphylococcus. spp. including 6 cases of MRSA infections of were 100% and 96. 2% respectively. The results of disc susceptibility test showed that the sensitive rate of the clinical isolates to flomoxef was 88.4% which was significantly higher than that of cefmetazole 74.1 %( P<0.01). The sensitive rates of both gram -positive and gram -negative organisms to flomoxef were higher than that to cefmetazole with significantly statistical differences (P <0. 05, P<0. o1).The above results showed that flomoxef is a highly effective and safe broad - spectrum antibiotic,especially in the treatment of infections caused by staphylococcus aureas and stphylococcus epidermidis.

关 键 词：氟氧头孢 头孢美唑 临床试验 细菌性感染 

分 类 号：R515.05[医药卫生—内科学] R978.11[医药卫生—临床医学]