张莉莉, 胡赛男, 吴剑秋, 潘良熹, 冯继锋. 重组人白细胞介素-11治疗实体瘤化疗所致的血小板减少症的随机对照研究[J]. 中国肿瘤临床, 2005, 32(17): 976-978,983.
引用本文: 张莉莉, 胡赛男, 吴剑秋, 潘良熹, 冯继锋. 重组人白细胞介素-11治疗实体瘤化疗所致的血小板减少症的随机对照研究[J]. 中国肿瘤临床, 2005, 32(17): 976-978,983.
Zhang Lili, Hu Sainan, Wu Jianqiu, . The Studies of a Randomized and Controlled Clinical Trial for Curative Effects of the Recombinant Human Interleukin-11(IL-11) on Chemotherapy-induced Thrombocytopenia[J]. CHINESE JOURNAL OF CLINICAL ONCOLOGY, 2005, 32(17): 976-978,983.
Citation: Zhang Lili, Hu Sainan, Wu Jianqiu, . The Studies of a Randomized and Controlled Clinical Trial for Curative Effects of the Recombinant Human Interleukin-11(IL-11) on Chemotherapy-induced Thrombocytopenia[J]. CHINESE JOURNAL OF CLINICAL ONCOLOGY, 2005, 32(17): 976-978,983.

重组人白细胞介素-11治疗实体瘤化疗所致的血小板减少症的随机对照研究

The Studies of a Randomized and Controlled Clinical Trial for Curative Effects of the Recombinant Human Interleukin-11(IL-11) on Chemotherapy-induced Thrombocytopenia

  • 摘要: 目的:观察重组人白细胞介素-11(rhIL-11)治疗实体瘤化疗所致的血小板减少症的客观疗效;观察rhIL-11在人体的不良反应及其安全性。方法:本研究采用随机对照试验,55例化疗后血小板低于50×109/L的患者,随机分为A组和B组,A组接受rhIL-11,B组不接受rhIL-11治疗。主要观察IL-11能否治疗化疗引起的血小板减少症。结果:A组血小板值在第2~21d均高于B组,第4~21天差别具有显著的统计学意义;A组Ⅱ、Ⅲ及Ⅳ血小板减少的持续天数分别为3.0d、3.2d及0.4d,B组分别为5.1d、5.8d及2.2d,A组血小板减少持续天数短于B组,但无统计学差异。IL-11的不良反应主要包括:心悸、心律失常、水肿、发热、关节肌肉疼痛、注射局部疼痛、皮疹、头痛头晕、乏力等。大多较轻,可以耐受。结论:rhIL-11能刺激血小板增生,治疗化疗引起的血小板降低,是一种有效、安全的治疗血小板减少的药物,值得进一步研究。

     

    Abstract: Objective: To observe the efficacy of rhIL-11 for the chemotherapy-induced thrombocytopenia and to evaluate adverse events and safety of rhIL-11 in vivo. Methods: A total of 55 patients with blood platelet count 50×109/L after chemotherapy were randomly assigned to 2 treatment groups. rhIL-11 was given in group A and was not given in group B. Results: The platelet counts of group A on day 2 to day 21 was significantly higher than that in group B on day 4 to day 21. The durations of Ⅱ, Ⅲ and Ⅳ grade thrombocytopenia were 3.0, 3.2 and 0.4 days in group A, meanwhile the durations were 5.1, 5.8 and 2.2 days in group B. The toxicity and side effects of rhIL-11 included: palpitation, cardiac arrhythmia, edema, fever, joint and muscle pain, skin eruption, Headache, dizzy and inertia. No serious adverse event occurred. Conclusions: rhIL-11 is a safe and effective drug for patients with chemotherapy-induced thrombocytopenia via stimulation of the thrombocyte proliferation.

     

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