Efficacies Of Dexamethasone In Combination With Recombinant Human Thrombopoietin And Cyclosporine A In The Treatment Of Primary Immune Thrombocytopenia

Objective To observe the short-term, long-term efficacies and side effects of high-dose dexamethasone in combination with recombinant human thrombopoietin(rh TPO) and cyclosporine A(Cs A) in the treatment of primary immune thrombocytopenia.Methods 55 patients with primary immune thrombocytopenia were randomly divided into the control and observation group. In the control group dexamethasone and rh TPO were used as follows: intravenous dexamethasone 40 mg, 1 times / d, for 4 consecutive days; subcutaneous rh TPO 1ug(300U)/kg/d, for 1-14 consecutive days(rh TPO would be canceled when platelet counts were ≥ 100 × 109/L or adverse reactions reached grade 3 or more WHO standards at any time; rh TPO would be used for no more than 14 days in case of invalidity). In the observation group dexamethasone and rh TPO were used same as the control group, oral Cs A was administered in term of 2-4mg/kg/d. The short-term, long-term efficacies and side effects in two groups would be compared. The invalid patients in two groups on day 14 would be departed from relevant group, and would receive other treatments such as splenectomy, rituximab, danazol, vincristine, combination of immunosuppressive agents. The patients who lost response during oral Cs A medication in the observation group would also be departed and receive other treatments. The patients who lost response in the control group could be transferred into the observation group in case of their consents, or receive other treatment options. The complete responders in the observation group in first 3 months would receive descending dosage of Cs A afterwards, and maintain an appropriate dosage of Cs A based on the monitoring of platelet counts. The partial responders within first 3 months would maintain the present dosage of oral Cs A. The invalid patients in first 3 months would be departed from the observation group and accept other treatment options. After the beginning of medication platelet counts on day 4, 7 and 14 were monitored to evaluate the short-term efficacies, platelet counts at M 1, 2, 3 and 6 were monitored to evaluate the long-term efficacies. Blood pressure, blood glucose, liver and kidney functions were regularly monitored after the start of treatment. Adverse reactions were observed for all enrolled patients. Blood Cs A concentrations were checked at least once a month for patients in the observation group.Results There were no significant differences in age, gender, ratio of newly diagnosed cases, pre-treatment platelet counts and the short-term efficacies(day 4, 7 and 14 post-medication) between two groups. The long-term efficacies(M1, 2, 3 and 6 post-medication) in the observation group were better than that in the control group(p<0.05). For responders on day 14 the long-term efficacies at M1 were not statistically different between the two groups(p=0.314), but that at M2, 3 and 6 in the observation group were superior to that in the control group(p<0.05). For newly diagnosed cases the response rates on D4, 7, 14 and M1 were not significantly different in both groups(p > 0.05), but the response rates at M2, 3 and 6 in the observation group were superior to that in the control group(p<0.05). For relapsed cases the response rates on day 4, 7, 14 and M1 and 6 in both groups were not different statistically(p>0.05), but that at M2 and 3 in the observation group were better than that in the control group(p<0.05). Dexamethasone were used for merely two days in one patient in the control group due to the increase of blood glucose induced by dexamethasone(>33.3mmol/L for several times), and in one patient in observation group due to severe insomnia caused by dexamethasone. The monitoring of blood glucose, blood pressure, liver and kidney functions showed no obvious abnormalities during treatment and follow-up in the remaining patients. All patients did not stop the administrations of Cs A and rh TPO due to their side effects.Conclusion The addition of Cs A would increase the long-term efficacies in responders on day 14 receiving the combination therapy of dexamethasone and rh TPO for ITP patients. This three-drug combination therapy would achieve a higher long-term response rate in newly diagnosed ITP patients.