A clinical comparative study on the efficacy of different dosages of rhIL-11 on chemotherapy-induced thrombocytopenia.

Objective:To investigate the effects of different dosages of recombinant human interleukin-11( rhIL-11) in the management of chemotherapy-induced thrombocytopenia in malignant tumor patients. Methods:46 malignant tumor patients,who developed Grade II or greater thrombocytopenia in response to chemotherapy,were treated with subcutaneous injection of 1.5mg/d rhIL-11 or 3mg/d rhIL-11 for 3 to 20 consecutive days until their platelet count returned to normal level,Patients were naturally divided into two different groups,group A(n=22) and group B(n=23) . Results:Group B had significant shorter duration of thrombocytopenia defined by platelet count 20×109 /L after rhIL-11 treatment compared with group A(p=0.031) ;The time patient recovered to the normal platelet count was 5～25d(median 11d) for group A versus 3～18d(median 8d) for group B,and the difference was statistically significant(p=0.048) ;The minimum level of platelet was higher for in group B,and the duration of PLT 50 ×109 /L,the number of cases suffering from hemorrhage complication and receiving infusion of apheresis platelets in group A were lower than group B,but without significant difference(p0.05) . The major adverse reactions relatived to rhIL-11 treatment were soreness of limb and lumbodorsal muscle complicated with skeleton and joint pain,hypodynamia,and fever,and grade I-II fever with headache and dizziness,these symptoms,however,were relieved when rhIL-11 was withdrawn or oral administration of Bufferin was applied. Conclusions:rhIL-11 is effective and safe in the treatment of chemotherapy-induced thrombocytopenia in malignant tumor patients,and well suited for routine use in clinic. However 3.0mg/daily regimen(approximately 50ug/kg/d) might be superior to 1.5mg/daily regimen(approximately 25ug/kg/d) when efficacy and adverse effects are concerned.