Dale David C, Crawford Jeffrey, Klippel Zandra, Reiner Maureen, Osslund Timothy, Fan Ellen, Morrow Phuong Khanh, Allcott Kim, Lyman Gary H
Department of Medicine, University of Washington, 1959 NE Pacific St, Seattle, WA, 98195, USA.
Duke Cancer Institute, Duke University Medical Center, 30 Duke Medicine Circle, Duke South 25177 Morris Bldg, Durham, NC, 27710, USA.
Support Care Cancer. 2018 Jan;26(1):7-20. doi: 10.1007/s00520-017-3854-x. Epub 2017 Sep 22.
Filgrastim (NEUPOGEN) is the originator recombinant human granulocyte colony-stimulating factor widely used for preventing neutropenia-related infections and mobilizing hematopoietic stem cells. This report presents findings of a systematic literature review and meta-analysis of efficacy and safety of originator filgrastim to update previous reports.
A literature search of electronic databases, congress abstracts, and bibliographies of recent reviews was conducted to identify English-language reports of clinical trials and observational studies evaluating filgrastim in its US-approved indications up to February 2015. Two independent reviewers assessed titles/abstracts and full texts of publications, and extracted data from studies that compared originator filgrastim vs placebo or no treatment. For outcomes with sufficient homogeneous data reported across studies, meta-analysis was performed and relative risk (RR) determined. Data were summarized descriptively for all other evaluated outcomes.
A total of 1194 unique articles evaluating originator filgrastim were identified, with 25 meeting eligibility criteria for data extraction: 18 randomized controlled trials, 2 nonrandomized clinical trials, and 5 observational studies. In chemotherapy-induced neutropenia (CIN), filgrastim vs placebo or no treatment significantly reduced febrile neutropenia incidence (RR 0.63, 95% CI 0.53-0.75) and grade 3 or 4 neutropenia incidence (RR 0.50, 95% CI 0.37-0.68). The most commonly reported adverse event (AE) with filgrastim was bone pain (RR 2.61, 95% CI 1.29-5.27 in CIN). Additional efficacy and safety outcomes are described within indications.
This systematic literature review and meta-analysis confirms and updates previous reports on the efficacy and safety of originator filgrastim. Bone pain was the commonly reported AE associated with filgrastim use.
非格司亭（NEUPOGEN）是首个重组人粒细胞集落刺激因子，广泛用于预防中性粒细胞减少相关感染及动员造血干细胞。本报告展示了一项关于首个非格司亭疗效和安全性的系统文献综述及荟萃分析结果，以更新既往报告。
检索电子数据库、会议摘要及近期综述的参考文献，以识别截至2015年2月评估非格司亭美国获批适应证的英文临床试验和观察性研究报告。两名独立评审员评估出版物的标题/摘要及全文，并从比较首个非格司亭与安慰剂或未治疗的研究中提取数据。对于各研究报告的具有充分同质性的数据结局，进行荟萃分析并确定相对风险（RR）。对所有其他评估结局进行描述性总结。
共识别出1194篇评估首个非格司亭的独特文章，其中25篇符合数据提取的纳入标准：18项随机对照试验、2项非随机临床试验和5项观察性研究。在化疗引起的中性粒细胞减少（CIN）中，非格司亭与安慰剂或未治疗相比，显著降低了发热性中性粒细胞减少的发生率（RR 0.63，95%CI 0.53 - 0.75）和3级或4级中性粒细胞减少的发生率（RR 0.50，95%CI 0.37 - 0.68）。使用非格司亭最常报告的不良事件（AE）是骨痛（CIN中RR 2.61，95%CI 1.29 - 5.27）。各适应证内描述了其他疗效和安全性结局。
这项系统文献综述和荟萃分析证实并更新了既往关于首个非格司亭疗效和安全性的报告。骨痛是与使用非格司亭相关的常见报告AE。
