| Objective: To evaluate the efficacy and safety of recombinant human interleukin-11 combined with cyclosporine A in treatment for the patients with idiopathic thrombocytopenic purpura(ITP) who were unresponsive to corticosteroid therapy.Methods: Inclusion criteria was the patients with ITP who unresponsive to corticosteroid therapy and with manifestations of bleeding, platelet counts≤30×109/L; exclusion criteria is patients infected with hepatitis B virus, hepatitis C virus, human immunodeficiency virus, previous malignant disease; patients with severe heart,liver disease, intracranial hemorrhage and pregnant women had to be excluded. During a period from January 2008 to October 2010, twenty-three inpatients, 12 female (52.2%)and 11 male (47.8%) were enrolled. The ages of the patients ranged from 6 to 85 years, with a median age of 42 years. The method of administration consisted of rhIL-11 was given in a daily subcutaneous dose of 3mg/d for 14 days (juvenile patients at half dose), additionally,cyclosporine A was given orally at a dose of 2～3mg/kg per day from day 1, the dosage continued for 2 weeks after the platelet counts rose to normal or near to normal, than the dosage reduced gradually, the course of treatment is about 5 months. Platelet counts were performed before treatment and 3 days, 7 days, 15 days, 1 month, 3 months, 5 months after initiation of the treatment. At the same time, decrease and/or subsidence of bleeding manifestations were recorded. Patients were monitored for side effects like hypertension, hyperglycemia, infections and weight gain. Initial response assessment was scheduled on the day 30th, patients unresponsive to the protocol were excluded, the rest continued the administration, and follow-up evaluation was scheduled 3 months after the whole course. No patient underwent splenectomy before or during the study, no other platelet enhancing treatment during the study period was prescribed.Results:Clinical effect: Platelet counts of the 23 patients before treatment are (15.3±8.3)×10~9/L,the counts rose to (49.3±26.6)×10~9/L on the third day of the treatment, bleeding manifestations subsided in all patients as their platelet counts improved. All the patients break away from platelet transfusions and intravenous immunoglobulin shortly, the counts are(87.4±59.7)×10~9/L,(104.4±60.8)×10~9/L on the 7th,15th day, the counts are(107.0±46.8)×10~9/L on the 30th day, but 3/23 patients whose platelet counts fell again after shortly rising were excluded, the remaining patients continued the treatment. Clinical effects were evaluated 3 months after the whole course, which as follows: Of the 23 patients who could be evaluated, clearly effective was observed in 39.1%(9/23) and good effective in 30.4%(7/23), advancement was observed in 17.4%(4/23), totally effective in 87.0%(20/23),whereas 13.0%(3/23) patients had no response. Tolerance and security: Abdominal distension were reported in 8 of the 23 patients, edema appeared in 4 patients, hepatobiliary laboratory abnormalities were found in 2 patients. All of the adverse effects were mild and reversible, no patient discontinued treatment. Platelet counts of the 3 patients, who were evaluated as ineffective eventually, increased shortly at the beginning of the treatment, and the 3 patients break away from platelet transfusions and intravenous immunoglobulin at the same time. No patient died during the whole study period.Conclusion: RhIL-11 and cyclosporine A regimen is an effective therapy with few side effects and could be considered as ideal second-line treatment in patients who unresponsive to corticosteroid which merits further exploration in a prospective clinical trial. |
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