重组人白细胞介素-11治疗化疗所致血小板减少症的有效性与安全性

[Effectiveness and safety of recombinant human interleukin-11 in the treatment of chemotherapy-induced thrombocytopenia].

作者信息

Lei Wei, Liang Jun, Chen Wei-Gang, Ma Xue-Zhen, Xu Mei, Du Li-Li

机构信息

Department of Medical Oncology , Medical School Hospital, Qingdao University, Qingdao 266003, China.

出版信息

Zhonghua Zhong Liu Za Zhi. 2006 Jul;28(7):542-4.

PMID:17147124

Abstract

OBJECTIVE

To investigate the effectiveness and safety of domestically produced recombinant human interleukin 11 (rhIL-11) for the treatment of chemotherapy- induced thrombocytopenia.

METHODS

A total of 32 solid cancer patients who developed chemotherapy-induced thrombocytopenia ( _70 x 10(9)/L) after the first cycle of chemotherapy was studied by self-cross control. The patients were given subcutaneous injection of rhIL-11 (25 microg x kg(-1) x d(-1)) for 7 to 14 consecutive days or until platelet count > or = 100 x 10(9)/L during the second cycle of chemotherapy using the identical regimen as in the first cycle.

RESULTS

The mean platelet count of the patients after rhIL-11 treatment was higher at different time points during the second cycle of chemotherapy than that during the first cycle of chemotherapy with the mean platelet count of (110.2 +/- 53.5) x 10(9)/L in the first cycle of chemotherapy versus (55.6 +/- 46.8) x 10(9)/L in the second cycle of chemotherapy (P < 0. 01). Patients with platelet count < or = 50 x 10(9)/L was 4/32 (12.5%) in the first cycle of chemotherapy and 12/32 (37.5%) in the second cycle of chemotherapy (P < 0.01). The time recovery to the normal platelet count was 2 - 18 days (median 5 days) in the first cycle of chemotherapy versus 5 - 27 days (median 12 days) in the second cycle of chemotherapy (P < 0.01). The case/frequency of the platelet transfusion was 2/2 in the first cycle of chemotherapy, while it was 7/9 in the second cycle of chemotherapy (P < 0.01). The major adverse reactions relative to rhIL-11 treatment were fatigue, myalgia/arthralgia, ache, headache, palpitation, edema and fever, most of which could be relieved automatically without any specific treament. However, some 3 grade side effects such as fatigue, myalgia/arthralgia and headache needed proper medication.

CONCLUSION

rhIL-11 is safe and effective for chemotherapy-induced thrombocytopenia with mild and manageable side effects.

摘要

目的

探讨国产重组人白细胞介素11（rhIL-11）治疗化疗所致血小板减少症的有效性和安全性。

方法

采用自身交叉对照研究32例实体癌患者，这些患者在第1周期化疗后发生化疗所致血小板减少症（<70×10⁹/L）。在第2周期化疗期间，患者皮下注射rhIL-11（25μg·kg⁻¹·d⁻¹），连续7至14天，或直至血小板计数≥100×10⁹/L，化疗方案与第1周期相同。

结果

rhIL-11治疗后患者在第2周期化疗不同时间点的平均血小板计数高于第1周期化疗，第1周期化疗平均血小板计数为（110.2±53.5）×10⁹/L，第2周期化疗为（55.6±46.8）×10⁹/L（P<0.01）。血小板计数≤50×10⁹/L的患者在第1周期化疗时为4/32（12.5%），第2周期化疗时为12/32（37.5%）（P<0.01）。血小板计数恢复正常的时间在第1周期化疗时为2至18天（中位数5天），第2周期化疗时为5至27天（中位数12天）（P<0.01）。血小板输注的例数/次数在第1周期化疗时为2/2，第2周期化疗时为7/9（P<0.01）。与rhIL-11治疗相关的主要不良反应为乏力、肌痛/关节痛、疼痛、头痛、心悸、水肿和发热，大多数无需特殊治疗可自行缓解。然而，一些3级副作用如乏力、肌痛/关节痛和头痛需要适当用药。