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氟罗沙星与氯霉素治疗伤寒的随机对照研究

Randomized comparative study of fleroxacin and chloramphenicol in typhoid fever.

作者信息

Arnold K, Hong C S, Nelwan R, Zavala-Trujillo I, Kadio A, Barros M A, de Garis S

机构信息

Roche Asian Research Foundation, Hong Kong.

出版信息

Am J Med. 1993 Mar 22;94(3A):195S-200S.

PMID:8452180
Abstract

This study compared fleroxacin, 400 mg daily for 7 or 14 days, with chloramphenicol, 50 mg/kg per day for 14 days, for the treatment of patients with typhoid fever in a multicenter study. A total of 184 patients were randomly assigned to the three treatment groups. Efficacy was determined by culture of blood and stool, overall clinical response, and time to defervescence. Safety was assessed by occurrence of adverse events and laboratory abnormalities. A total of 97 patients were evaluable for efficacy, 28 in the fleroxacin 7-day group, 35 in the fleroxacin 14-day group, and 34 in the chloramphenicol group. All showed rapid defervescence with high cure rates. Bacteriologic cure rates were 96% in the fleroxacin 7-day group, 97% in the fleroxacin 14-day group, and 85% in the chloramphenicol group. Clinical cure rates were 83-100% with fleroxacin and 82% with chloramphenicol. The time to defervescence was shorter for patients treated with fleroxacin than for those treated with chloramphenicol. All three treatment regimens were well tolerated. Fleroxacin, 400 mg daily for 7 days, appears to be satisfactory for the treatment of typhoid fever and compares favorably with the standard 14-day therapy with chloramphenicol.

摘要

在一项多中心研究中,本研究比较了每日400毫克氟罗沙星治疗7天或14天与每日50毫克/千克氯霉素治疗14天对伤寒患者的疗效。总共184例患者被随机分配到三个治疗组。通过血液和粪便培养、总体临床反应及退热时间来确定疗效。通过不良事件的发生情况和实验室异常来评估安全性。共有97例患者可进行疗效评估,其中氟罗沙星7天治疗组28例,氟罗沙星14天治疗组35例,氯霉素治疗组34例。所有患者均迅速退热,治愈率高。氟罗沙星7天治疗组的细菌学治愈率为96%,氟罗沙星14天治疗组为97%,氯霉素治疗组为85%。氟罗沙星治疗的临床治愈率为83% - 100%,氯霉素治疗的临床治愈率为82%。氟罗沙星治疗的患者退热时间比氯霉素治疗的患者短。所有三种治疗方案耐受性良好。每日400毫克氟罗沙星治疗7天似乎对伤寒治疗效果令人满意,与标准的14天氯霉素治疗相比具有优势。

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