[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.\nMETHOD: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.\nRESULTS: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.\nCONCLUSION:rhIL-11 can reduce thrombocytopenia induced by chemotherapy and is a safe and effective drug for treatment of thrombocytopenia.