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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 被引量:2

The Studies of a Randomized and Controlled Clinical Trial for Curative Effects of the Recombinant Human Interleukin-11(IL-11) on Chemotherapy-induced Thrombocytopenia
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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。 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〈50×10^9/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,ⅢandⅣ 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,diaay 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.
出处 《中国肿瘤临床》 CAS CSCD 北大核心 2005年第17期976-978,983,共4页 Chinese Journal of Clinical Oncology
基金 江苏省自然科学基金资助(编号:BK2001167)
关键词 人白细胞介素-11 化疗 血小板减少症 Recombinant human interleukin-11 Chemotherapy Thrombocytopenia
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