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头孢哌酮的全球临床经验。

Worldwide clinical experience with cefoperazone.

作者信息

Gerber A U, Craig W A

出版信息

Drugs. 1981;22 Suppl 1:108-18. doi: 10.2165/00003495-198100221-00022.

Abstract

The safety and clinical efficacy of cefoperazone 1 to 2g 12-hourly was evaluated in clinical trials conducted in the United States, Europe, South and Latin America, and Japan. 1046 patients were treated in 4 comparative and 9 non-comparative studies. An overall satisfactory clinical response for cefoperazone therapy was achieved in 540 (88%) of the 615 evaluable patients. Cefoperazone was effective in 92% of lower respiratory tract infections, 81% of urinary tract infections, 98% of gynaecological infections and 90% of a mixture of intra-abdominal, wound and soft tissue infections. A satisfactory clinical response was obtained in over 90% of patients infected with organisms normally susceptible to cephalosporins, such as staphylococci, streptococci, Escherichia coli, Klebsiella and Proteus species. 50 to 90% of infections caused by organisms resistant to presently available cephalosporins, such as Enterobacter species, Proteus vulgaris, Providencia species, Morganella morganii, Serratia species, Pseudomonas aeruginosa, and Bacteroides fragilis responded satisfactorily to cefoperazone. In the 4 clinical trials comparing cefoperazone with cefamandole, cephazolin or carbenicillin, cefoperazone therapy resulted in a similar or higher rate of satisfactory clinical response. Adverse reactions related to cefoperazone occurred in 8% of patients and were mainly diarrhoea (4%), skin reactions (3%) and phlebitis (1%). Twice daily dosing with cefoperazone appears to be effective against numerous Gram-positive and Gram-negative bacteria in a variety of clinical infections.

摘要

在美国、欧洲、南美洲、拉丁美洲和日本进行的临床试验中,评估了每12小时使用1至2克头孢哌酮的安全性和临床疗效。在4项对照研究和9项非对照研究中,对1046例患者进行了治疗。在615例可评估患者中,有540例(88%)的头孢哌酮治疗获得了总体满意的临床反应。头孢哌酮对92%的下呼吸道感染、81%的尿路感染、98%的妇科感染以及90%的腹腔内、伤口和软组织混合感染有效。在超过90%感染通常对头孢菌素敏感的微生物(如葡萄球菌、链球菌、大肠杆菌、克雷伯菌和变形杆菌属)的患者中,获得了满意的临床反应。由对现有头孢菌素耐药的微生物(如肠杆菌属、普通变形杆菌、普罗威登斯菌属、摩根摩根菌、沙雷菌属、铜绿假单胞菌和脆弱拟杆菌)引起的感染,50%至90%对头孢哌酮反应良好。在4项将头孢哌酮与头孢孟多、头孢唑林或羧苄西林进行比较的临床试验中,头孢哌酮治疗产生了相似或更高的满意临床反应率。8%的患者出现了与头孢哌酮相关的不良反应,主要是腹泻(4%)、皮肤反应(3%)和静脉炎(1%)。每日两次使用头孢哌酮似乎对多种临床感染中的众多革兰氏阳性和革兰氏阴性细菌有效。

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