重组人白细胞介素-11预防和治疗化疗所致血小板减少症的临床研究

[Clinical study of rhIL-11 for prevention and treatment of chemotherapy-induced thrombocytopenia].

作者信息

Sun Xiao-fei, Guan Zhong-zhen, Huang He, Zhou Qing-hua, Yi Cheng, Zhang Li-jian, Zhu Jun, Li Rong, Zhou Juan, Zhang Mei, Guo Yin

机构信息

Cancer Center, Sun Yat-sen University, Guangzhou 510060, P. R. China.

出版信息

Ai Zheng. 2002 Aug;21(8):892-5.

PMID:12478901

Abstract

BACKGROUND AND OBJECTIVE

Cancer chemotherapy can induce thrombocytopenia. It is necessory to develop drugs that can prevent and treat thrombocytopenia. The current study was designed to evaluate the efficacy and toxicity of rhIL-11 in prevention and treatment of chemotherapy-induced thrombocytopenia.

METHOD

A total of 109 cancer patients were involved randomly into AB or BA group and every patient received 2 cycles of chemotherapy. IL-11 was administered subcutaneously(50 micrograms/kg/d), beginning 24 hours after completion of chemotherapy for 14 consecutive days or continuing until platelet count was > 400 x 10(9)/L during cycle A. Patients did not received IL-11 during cycle B. Another 41 cases of cancer patients whose platelet were less than 50 x 10(9)/L after chemotherapy entered into open study group. IL-11 administration was the same as above.

RESULTS

Efficacy can be evaluated in 107 cases in controlled study group. Mean platelet count of cycle A was (246.49 +/- 88.64) x 10(9)/L and cycle B was (180.24 +/- 83.34) x 10(9)/L(P = 0.000). Grade III/IV thrombocytopenia in cycle A and cycle B were 7/107(6.5%) and 15/107(14%), respectively (P = 0.04). The minimum platelet counts were (136.46 +/- 74.64) x 10(9)/L and (107.77 +/- 61.33) x 10(9)/L, respectively (P = 0.000). The maximum platelet counts were (381.28 +/- 150.39) x 10(9)/L and (207.44 +/- 113.32) x 10(9)/L, respectively (P = 0.000). For open study group, 32 patients could be evaluated. The platelet count increased from(30.1875 +/- 12.13) x 10(9)/L to (226.25 +/- 163.91) x 10(9)/L after IL-11 administration. Major adverse effects were edema, dizziness, palpitation, etc.

CONCLUSION

rhIL-11 can reduce thrombocytopenia induced by chemotherapy and is a safe and effective drug for treatment of thrombocytopenia.

摘要

背景与目的

癌症化疗可导致血小板减少。开发能够预防和治疗血小板减少的药物很有必要。本研究旨在评估重组人白细胞介素-11（rhIL-11）预防和治疗化疗所致血小板减少的疗效及毒性。

方法

109例癌症患者随机分为AB组或BA组，每位患者接受2个周期的化疗。在A周期化疗结束24小时后开始皮下注射IL-11（50微克/千克/天），连续注射14天，或持续至血小板计数>400×10⁹/L。B周期患者不接受IL-11治疗。另外41例化疗后血小板计数低于50×10⁹/L的癌症患者进入开放研究组。IL-11给药方式同上。

结果

对照研究组107例患者可进行疗效评估。A周期平均血小板计数为（246.49±88.64）×10⁹/L，B周期为（180.24±83.34）×10⁹/L（P = 0.000）。A周期和B周期Ⅲ/Ⅳ级血小板减少分别为7/107（6.5%）和15/107（14%）（P = 0.04）。最低血小板计数分别为（136.46±74.64）×10⁹/L和（107.77±61.33）×10⁹/L（P = 0.000）。最高血小板计数分别为（381.28±150.39）×10⁹/L和（207.44±113.32）×10⁹/L（P = 0.000）。开放研究组32例患者可进行评估。注射IL-11后血小板计数从（30.1875±12.13）×10⁹/L升至（226.25±163.91）×10⁹/L。主要不良反应为水肿、头晕、心悸等。