Effects of polyethylene glycol-conjugated recombinant human megakaryocyte growth and development factor on platelet counts after chemotherapy for lung cancer
Effects of polyethylene glycol-conjugated recombinant human megakaryocyte growth and development factor on platelet counts after chemotherapy for lung cancer
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DOI：
10.1056/nejm199702063360603
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发表时间：
1997-02-06
影响因子：
158.5
通讯作者：
Harker, L
中科院分区：
文献类型：
--
作者：
Fanucchi, M;Glaspy, J;Harker, L
背景聚乙二醇结合的重组人巨核细胞生长发育因子（MGDF，也称为PEG-rHuMGDF），一种与血小板生成素相关的重组分子，特异性地刺激巨核细胞生成和血小板生成，并降低接受骨髓抑制化疗的动物中血小板减少症的严重程度。MGDF在53例接受卡铂和紫杉醇治疗的肺癌患者中的安慰剂对照剂量递增研究。患者以1：3的比例随机分为4组，接受安慰剂或MGDF（每天每公斤体重0.03、0.1、0.3、1.0、3.0或5.0 μ g）皮下注射。结果化疗后接受MGDF治疗的38例患者中，血小板计数最低值中位数为188，000/mm 3（范围68，000 ~ 373，000），而接受安慰剂治疗的12例患者中，血小板计数最低值中位数为111，000/mm 3（范围21，000 ~ 307，000）（P=0.013）。治疗组血小板计数在14天内恢复到基线水平，而安慰剂组超过21天（P
Background Polyethylene glycol (PEG)-conjugated recombinant human megakaryocyte growth and development factor (MGDF, also known as PEG-rHuMGDF), a recombinant molecule related to thrombopoietin, specifically stimulates megakaryopoiesis and platelet production and reduces the severity of thrombocytopenia in animals receiving myelosuppressive chemotherapy.Methods We conducted a randomized, double-blind, placebo-controlled dose-escalation study of MGDF in 53 patients with lung cancer who were treated with carboplatin and paclitaxel. The patients were randomly assigned in blocks of 4 in a 1:3 ratio to receive either placebo or MGDF (0.03, 0.1, 0.3, 1.0, 3.0, or 5.0 mu g per kilogram of body weight per day), injected subcutaneously. No other marrow-active cytokines were given.Results In the 38 patients who received MGDF after chemotherapy, the median nadir platelet count was 188,000 per cubic millimeter (range, 68,000 to 373,000), as compared with 111,000 per cubic millimeter (range, 21,000 to 307,000) in 12 patients receiving placebo (P=0.013). The platelet count recovered to base-line levels in 14 days in the treated patients as compared with more than 21 days in those receiving placebo (P