【摘要】 目的 :观察国产重组人白介素— 11衍生物 (rhIL— 11Ala10 )对恶性肿瘤患者化疗所致血小板减少的疗效及其不良反应。方法 :采用自身对照试验的方法 ,对 11例曾因化疗引起血小板减少的恶性肿瘤患者 (外周血Plt<75× 10 9/L) ,给予rhIL— 11Ala10 预防性治疗。第 1周期单用化疗 ,第 2周期化疗联合rhIL— 11Ala10 。rhIL— 11Ala10 按 4 0ug/kg·d剂量每日皮下注射 ,连续 10天。结果 :对照周期 :化疗后血小板最低均值 4 4 6± 12 2× 10 9/L ,血小板低于 10 0× 10 9/L平均天数 9 8±3 4天 ,2例需输注血小板。研究周期 :化疗后血小板最低均值 10 1 3± 2 0 6× 10 9/L(P <0 0 5 ) ,血小板低于 10 0 /L平均天数2 4± 1 9天 (P <0 0 5 ) ,无l例输注血小板。主要不良反应 :谷丙转氨酶升高 (9 0 % ) ,尿素氮升高 (9 0 % ) ,头痛 (9 0 % ) ,乏力 (2 7 3% ) ,肌肉、关节痛 (2 7 3% ) ,结膜充血 (9 0 % )。结论 :国产重组人白介素 1l衍生物 (rhIL 11Ala10 )具有提升化疗后血小板的作用 ,预防性用药可减轻血小板下降的幅度及缩短血小板低下的持续时间 ;不良反应可耐受。更多还原

【Abstract】 Objective:The current study was designed to observe the efficacy and toxicity of domestic rhIL-11Ala 10 in prevention of chemotherapy-induced thrombocytopenia in patients with malignant tumor.Methods:A total of 11 malignant tumor patients with chemotherapy-induced thrombocytopenia(<75×10 9/L) were involved into auto-control clinical trial and every patient received 2 cycles of chemotherapy. Patients only received chemotherapy in the first cycle,In the second cycle,beside of chemotherapy, rhlL-11Ala 10 was administered subcutaneously(40μg /kg.d), beginning 24 hours after completion of chemotherapy for 10 consecutive days or continuing until platelet count was > 400×10 9/L.Results:Efficacy could be evaluated in 11 cases. In the control cycle (the first cycle): the mean minimum platelet count was 44.6±12.2×109/L. Mean days of the platelet counts lower than 100×10 9/L were 9.8±3.4 days. Total 2 cases accepted infusion of platelet. Study cycle (the second cycle): The mean minimum platelet count was 101.3±20.6×10 9/L(P<0.05). Mean days of the platelet counts lower than 100×10 9/L were 2.4±1.9 days(P<0.05). No patients accepted infusion of platelet. Major side effects: The cases of elevation of glutamic-pyruvic transaminase(GPT), elevation of blood uria nitrogen(BUN), headache, fatigue, arthralgia/ muscle pain and conjunctival congestion were 1 (9%), 1 (9%), 1 (9%), 3 (27.3%), 3 (27.3%) and 1 (9 %), respectively. Conclusion:Domestic rhIL-11Ala 10 can elevate blood platelet count, prevent the reduction of blood platelet and shorten the duration of thrombocytopenia induced by chemotherapy. It’s side effects is tolerable and it may be a safe and effective drug for treatment of thrombocytopenia.更多还原