Pui C H, Boyett J M, Hughes W T, Rivera G K, Hancock M L, Sandlund J T, Synold T, Relling M V, Ribeiro R C, Crist W M, Evans W E
St. Jude Children's Research Hospital and the University of Tennessee, Memphis, Colleges of Medicine, 38105-0318, USA.
N Engl J Med. 1997 Jun 19;336(25):1781-7. doi: 10.1056/NEJM199706193362503.
Recombinant human granulocyte colony-stimulating factor PO1 CA-20180ilgrastim) hastens the recovery from neutropenia after P30 CA-21765emotherapy, but its role in the management of childhood leukemia is unclear.
We randomly assigned 164 patients with acute lymphoblastic leukemia (age range, 2 months to 17 years) to receive placebo or G-CSF (10 microg per kilogram of body weight per day subcutaneously), beginning one day after the completion of remission-induction therapy and continuing until the neutrophil count was greater than or equal to 1000 per cubic millimeter for two days. The clinical and laboratory effects of this therapy were documented for 21 days. The area under the plasma G-CSF concentration-time curve was measured on days 1 and 7 in both groups.
Responses to the growth factor could be assessed in 148 patients (73 in the G-CSF group and 75 in the placebo group). G-CSF treatment did not significantly lower the rate of hospitalization for febrile neutropenia (58 percent in the G-CSF group vs. 68 percent in the placebo group; relative risk, 0.85; 95 percent confidence interval, 0.59 to 1.16), increase the likelihood of event-free survival at three years (83 percent in both groups), or decrease the number of severe infections (five in the G-CSF group vs. six in the placebo group). Patients treated with G-CSF had shorter median hospital stays (6 days vs. 10 days, P=0.011) and fewer documented infections (12 vs. 27, P=0.009). The median total costs of supportive care were similar in the G-CSF and placebo groups ($8,768 and $8,616, respectively). Among patients who did not have febrile neutropenia during the first week of G-CSF or placebo injections, higher systemic exposure to the growth factor on day 7 was significantly related to a lower probability of subsequent hospitalization (P=0.049).
G-CSF treatment had some clinical benefit in children who received induction chemotherapy for acute lymphoblastic leukemia, but it did not reduce the rate of hospitalization for febrile neutropenia, prolong survival, or reduce the cost of supportive care.
重组人粒细胞集落刺激因子（PO1 CA - 20180，即伊莫拉司亭）可加速化疗后中性粒细胞减少的恢复，但它在儿童白血病治疗中的作用尚不清楚。
我们将164例急性淋巴细胞白血病患者（年龄范围为2个月至17岁）随机分组，在缓解诱导治疗结束后一天开始，一组接受安慰剂，另一组接受G - CSF（每天每千克体重皮下注射10微克），持续至中性粒细胞计数连续两天大于或等于每立方毫米1000个。记录该治疗21天的临床和实验室效果。两组在第1天和第7天测量血浆G - CSF浓度 - 时间曲线下面积。
148例患者（G - CSF组73例，安慰剂组75例）可评估对生长因子的反应。G - CSF治疗并未显著降低发热性中性粒细胞减少症的住院率（G - CSF组为58%，安慰剂组为68%；相对风险为0.85；95%置信区间为0.59至1.16），未增加三年无事件生存的可能性（两组均为83%），也未减少严重感染的数量（G - CSF组5例，安慰剂组6例）。接受G - CSF治疗的患者住院中位天数较短（6天对10天，P = 0.011），记录到的感染较少（12例对27例，P = 0.009）。G - CSF组和安慰剂组支持治疗的中位总成本相似（分别为8768美元和8616美元）。在G - CSF或安慰剂注射第一周未发生发热性中性粒细胞减少症的患者中，第7天生长因子的全身暴露量较高与随后住院的可能性较低显著相关（P = 0.049）。
G - CSF治疗对接受急性淋巴细胞白血病诱导化疗的儿童有一定临床益处，但未降低发热性中性粒细胞减少症的住院率，未延长生存期，也未降低支持治疗成本。
