重组人白细胞介素11预防和治疗血小板降低的临床研究报告

背景与目的:肿瘤化疗可引起血小板下降,有必要研制预防和治疗血小板减少的药物。本文主要观察重组人白细胞介素11(rhIL-11)预防和治疗化疗引起的血小板减少的疗效和毒性。方法:研究分两部分,第一部分主要观察rhIL-11能否预防化疗引起的血小板下降。109例癌症患者进入对照研究组,随机分AB和BA两组,每例患者均化疗2个疗程。A疗程化疗后加rhIL-11,B疗程化疗后不用rhIL-11治疗。rhIL-11剂量为:50μg·(kg·d)-1于化疗结束后24h开始,臀部皮下注射,连用14天或直到血小板从最低点恢复至>400×109/L。第二部分主要观察rhIL-11能否治疗化疗引起的血小板下降。41例化疗后血小板<50×109/L的患者直接进入开放研究组,IL-1150μg·(kg·d)-1,连用14天或至血小板>400×109/L。结果:对照研究组107例患者可评价疗效,A疗程化疗后全组血小板平均数量为(246.49±88.64)×109/L;B疗程化疗后全组血小板平均数量为(180.24±83.34)×109/L(P=0.000)。A疗程Ⅲ/Ⅳ级血小板减少发生率为6.5%(7/107),B疗程Ⅲ/Ⅳ级血小板减少发生率为14%(15/107)(P=0.04)。A疗程化疗后血小板最低值:(136.46±74.64)×109/L,B疗程化疗后血小板最低值为(107.77±61.33)×109/L(P=0.000)。A疗程化疗后血小板最高值(381.28±150.39)×109/L,B疗程化疗后血

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

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.