| Objective:To evaluate the efficacy and safety of recombinant human thrombopoietin(rh TPO)in the treatment of immune thrombocytopenia(ITP)secondary to autoimmune diseases.Methods:The patients with ITP secondary to autoimmune diseases admitted to the Second hospital of Hebei Medical University from January 2016 to December2020 were retrospectively analyzed.All enrolled patients were treated with stable dose of glucocorticoid or(and)immunosuppressant for autoimmune diseases,and the baseline platelet counts were less than 30×10~9/L at the time of enrollment.Patients who were treated with rh TPO for thrombocytopenia based on the therapies of primary autoimmune diseases were included in the experimental group,and patients who received only basic therapies for primary autoimmune diseases were included in the control group.Usage of rh TPO:15000U,once a day,subcutaneously injection for 14 days.If the platelet count has increased to≥100×10~9/L after less than 14 days,rh TPO should be stopped.The main end points were complete response(CR)rate and total response rate(ORR)of the two groups on the 14th day after the first treatment.The secondary end points were:(1)the highest platelet count and onset time(i.e.the time required for patients to achieve response)after treatment in the two groups.(2)The influence of gender,age,platelet baseline value and primary autoimmune disease type on the efficacy of rh TPO in the experimental group.(3)Changes in bleeding scores of the two groups of patients before and after treatment.(4)The laboratory examination results of patients in the experimental group before and after treatment were compared to help evaluate the efficacy and safety of rh TPO in the treatment of ITP secondary to autoimmune diseases,and the types and frequency of adverse events during the treatment.Results:A total of 60 patients with ITP secondary to autoimmune diseases were enrolled in this study.There were 30 patients in the experimental group and 30 patients in the control group.There was no significant difference in clinical data between the two groups,including age,gender,type of primary autoimmune disease,course of disease,white blood cell count,hemoglobin level,baseline value of platelet count and bleeding score before treatment.Clinical efficacy:In the experimental group:Complete response(CR)was 76.7%(23/30),Response(R)was 13.3%(4/30),Total response rate(ORR)was 90%(27/30),and No response(NR)was 10%(3/30).In the control group:CR was 10%(3/30),R was 53.3%(16/30),ORR was63.3%(19/30),NR was 36.7%(11/30).The CR rate(76.7%vs 10%,P=0.000)and ORR(90%vs 63.3%,P=0.015)of the experimental group were significantly higher than those of the control group.After treatment,the median of the highest platelet count in the test group was 147.5(103.5～208.3)×10~9/L,which was higher than the control group 55.5(32～76.3)×10~9/L(P=0.000).The median onset time of the experimental group was 4.5(3-7)days,which was shorter than 7(3-14)days in the control group(P=0.043).There was no significant difference between the age,gender,baseline value of platelet count and the type of primary autoimmune disease and the clinical efficacy of rh TPO in the experimental group(P>0.05).The bleeding score of the experimental group was 1(0～2)points,and the bleeding score of the control group was 1(0～2.25)points after treatment,there was no statistical difference(P=0.573).There were no significant differences in WBC count,hemoglobin,liver function,renal function and coagulation function before and after rh TPO treatment(P>0.05).During the course of rh TPO treatment,only 4(13.3%)patients developed dizziness and fatigue,which could be relieved without special treatment.No thrombosis occurred.Conclusions:Recombinant human thrombopoietin(rh TPO)has a high effective rate(90%)for the treatment of immune thrombocytopenia secondary to autoimmune diseases,with a fast onset(median onset time is 4.5 days),and few adverse events. |
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