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造血生长因子的评估:确定生长因子试验中的相关临床终点

Evaluation of haematopoietic growth factors: defining relevant clinical endpoints in growth factor trials.

作者信息

Linch D C

机构信息

Department of Haematology, University College London Medical School, U.K.

出版信息

Eur J Cancer. 1994;30A Suppl 3:S40-3.

PMID:7695958
Abstract

Initial evaluation of the therapeutic efficacy of haemopoietic growth factors involves assessment of their effects on the blood count, in various clinical situations. However, hard clinical data are also needed. Microbiologically documented infection is the ideal parameter but is difficult to measure. Consequently, the surrogate parameters of duration of fever and antibiotic usage are used instead. Febrile neutropenia is not a clinical endpoint, but merely a useful indicator to begin antibiotic therapy. To date, cost evaluations of growth factor use have relied on retrospective analyses of relevant clinical data including antibiotic usage, parenteral nutrition requirements, and duration of hospitalisation. Growth factors can reduce all these parameters in selected situations. Clinical data also suggest that growth factors facilitate chemotherapy dose optimisation and intensification, although the degree of intensification appears limited (20-40%). Currently, it is unclear whether such therapy confers benefit in terms of remission rates and survival.

摘要

造血生长因子治疗效果的初步评估包括在各种临床情况下评估其对血细胞计数的影响。然而,还需要确凿的临床数据。微生物学确诊的感染是理想的参数,但难以测量。因此,转而使用发热持续时间和抗生素使用等替代参数。发热性中性粒细胞减少不是一个临床终点,而仅仅是开始抗生素治疗的一个有用指标。迄今为止,生长因子使用的成本评估依赖于对包括抗生素使用、肠外营养需求和住院时间等相关临床数据的回顾性分析。在特定情况下,生长因子可以降低所有这些参数。临床数据还表明,生长因子有助于化疗剂量的优化和强化,尽管强化程度似乎有限(20%-40%)。目前,尚不清楚这种治疗在缓解率和生存率方面是否带来益处。

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