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用于治疗中性粒细胞减少患者发热性发作的新型抗感染药物评估。美国传染病学会和美国食品药品监督管理局。

Evaluation of new anti-infective drugs for the treatment of febrile episodes in neutropenic patients. Infectious Diseases Society of America and the Food and Drug Administration.

作者信息

Hughes W T, Pizzo P A, Wade J C, Armstrong D, Webb C D, Young L S

机构信息

Division of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, Tennessee 38105.

出版信息

Clin Infect Dis. 1992 Nov;15 Suppl 1:S206-15. doi: 10.1093/clind/15.supplement_1.s206.

DOI:10.1093/clind/15.supplement_1.s206
PMID:1477232
Abstract

The use of empirical antimicrobial therapy has significantly reduced the morbidity and mortality associated with untreated infections in febrile neutropenic patients. This guideline describes clinical trials of the safety and efficacy of new antimicrobial drugs in this population of patients. Fever and neutropenia should be precisely defined in each protocol. Patients should be randomized to treatment with a new or active-control drug regimen, stratified on the basis of type of cancer and age, and treated until resolution--as defined in the protocol--is attained. Outcome should be assessed both for cases with a defined microbial etiology and for those without. Final microbiological outcome is important for cases with identified pathogens, but clinical outcome is paramount.

摘要

经验性抗菌治疗的应用显著降低了发热性中性粒细胞减少患者因未治疗感染而导致的发病率和死亡率。本指南描述了新抗菌药物在这类患者群体中的安全性和有效性的临床试验。每种方案都应精确界定发热和中性粒细胞减少的定义。患者应随机接受新的或活性对照药物方案治疗,根据癌症类型和年龄进行分层,并治疗至方案中定义的缓解状态。应对有明确微生物病因的病例和无明确微生物病因的病例进行结果评估。对于已识别病原体的病例,最终微生物学结果很重要,但临床结果至关重要。

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