[Analysis of high-dose dexamethasone in different cycles on efficacy and safety of newly diagnosed ITP].

OBJECTIVE

To compare the efficacy and safety of high-dose dexamethasone in treating new-diagnosed primary immune thrombocytopenia (ITP) in monocycle, di-cycle, tri-cycle.

METHODS

Divided by the ratio of 1:1:1, 93 newly diagnosed patients were randomly accepted monocycle (Group A:dexamethasone 40 mg once a day, from day1 to day4), dicycle (Group B:dexamethasone 40 mg once a day, from day 1 to day 4, day 15 to day 18), tri-cycle (Group C:dexamethasone 40 mg once a day, from day 1 to day 4, day 15 to day 18, day 29 to day 32) of high-dose dexamethasone treatment. Its efficacy and safety on the patients in three groups were compared.

RESULTS

Ninety-three newly patients with new-diagnosed ITP were divided into Group A, B, and C, 31 patients in each group. In terms of short-term benefits, there was no statistically significant difference among the 7th and 14th day complete response rate after end of treatment. However, there was statistically significant difference after the end of treatment on the 7th day response rate (41.9% 70.0% 90.0%, <0.01) and the 14th day response rate (16.1% 36.70% 63.3%, < 0.01); in terms of long-term benefits, there was no statistically significant difference among the 120-day response rate, the complete response rate within the treatment on the 60th, 90th and 120th day and the relapse rate at 90th and 120th day; however, there was statistically significant difference among the 60- day response rate (10.0% 26.6% 53.3%, <0.01), 90-day(0.0% 13.3% 30.0%, <0.01) and 60-day relapse rate(88.9% 73.3% 46.7%, <0.01). Mostly of the treatment-related adverse reactions in the three groups were mild, and most patients are tolerable.

CONCLUSIONS

Although the complete response rate of ITP patients did not improved by increasing the cycle of high-dose dexamethasone, but improved response rate in three months, and adverse reactions were tolerable, which could be used as a reference for clinical use.