Efficacy Analysis Of Eltrombopag And Rituximab In The Treatment Of Primary Immune Thrombocytopenia

Primary immune thrombocytopenia(ITP)is an acquired autoimmune disease involving multiple mechanisms.The main characteristics were solitary thrombocytopenia,normal or increased megakaryocytes in bone marrow and decreased quality of life.Long-term use of glucocorticoids,the first-line treatment of ITP,is associated with more side effects,and most patients do not experience long-term remission from glucocorticoids.Second-line treatment is the main method of long-term treatment for ITP patients,and many ineffective methods of first-line treatment will be transferred to second-line treatment later.Second-line therapies include thrombocytopenin receptor agonists,rituximab,splenectomy surgery,and immunosuppressants.Each of these treatment options has its advantages and disadvantages.In the 2019 American Hematology Annual Meeting,it was pointed out that no second-line treatment plan is optimal for all patients with ITP.Doctors and patients should make joint decisions and make individualized choices.Objective:To compare the clinical efficacy,safety and health-related quality of life(HRQOL)of two second-line drugs,Eltrombopag and Rituximab,in the treatment of primary immune thrombocytopenia that failed the first-line treatment.Provide evidence-based medicine for the rational selection of second-line drugs to treat ITP.Methods:This study is a retrospective study.The clinical data of patients(including outpatient and inpatient department)with failed the first-line treatment ITP treated in the Department of Hematology of Jingzhou First People’s Hospital from July 2018 to March 2020,the data were collected through the hospital electronic medical record system.All patients were given second-line treatment with eltrombopag or rituximab.The initial dose of Eltrombopag was 25 mg/d.If the Platelets count for two consecutive weeks is less than 50×10~9/L,the dose will be increased by 25 mg/d,and the maximum dose will be 75 mg/d,to maintain platelets at(50-150)×10~9/L.If the platelet count>150×10~9/L lasts for more than 2 weeks,the dosage or frequency of administration shall be reduced sequentially.Rituximab is used once a week,100 mg each time,use it continuously for 4 weeks.A total of 59 patients who met the criteria for inclusion were collected and followed up mainly through the inpatient department,outpatient clinic,telephone.The effective rate,onset time,recurrence,efficacy maintenance time,health-related quality of life,adverse reactions,etc.after receiving the above two drugs were statistically analyzed.Result:(1)Patient’s baseline clinical characteristics:Baseline clinical characteristics such as gender,age,duration of ITP,baseline platelet count,previous treatment with corticosteroids,intravenous immunoglobulin,danazol or azathioprine,platelet transfusion,splenectomy and bleeding degree classification were statistically analyzed in the eltrombopag group and the rituximab group.Indicating that the clinical data of the two groups of patients are comparable(P values were all>0.05).The reliability and validity analysis of the ITP-PAQ scale shows that the scale is reliable and effective as a health-related quality of life assessment scale for adult ITP patients.The independent sample t test was used for statistical analysis of the ITP-PAQ scale before treatment for the two drugs,and there was no significant difference in quality of life between the two drugs before treatment(P value>0.05 for both).(2)Clinical efficacy:The sum of CR+R was taken as the standard for clinical evaluation of effectiveness.During the follow-up period,the highest effective rates of receiving eltrombopag and rituximab were 84%(31/37)and 68%(15/22)respectively.And the effective rates at the end of follow-up were 78%(29/37)and 41%(9/22).Chi-square test was used to analyze the effective rate at the end of follow-up.The effective rate of Eltrombopag group was significantly higher than rituximab group(P=0.004).(3)Onset time:Onset time was 12 days(6-26 days)in the eltrombopag group,and 37days(12-86 days)in the rituximab group.Onset time of the two drugs was plotted by Kaplan-Meier method,the onset time of eltrombopag group was significantly better than rituximab group(P<0.01).(4)Recurrence:31 patients who were effective with Eltrombopag,2 were relapsed and29 were not relapsed;15 patients who were effective with rituximab,6 relapsed and no relapse 9 people.The chi-square test was performed on the recurrence.The recurrence rate after treatment with eltrombopag was lower than that of rituximab(P=0.009).(5)Efficacy Maintenance time:By the end of the follow-up,the average maintenance time in the eltrombopag group was(11.38±3.68)months;the average maintenance time in the rituximab group was(9.93±4.56)months.The maintenance time of drug treatment in patients receiving the two drugs was in accordance with the normal distribution,and statistical analysis was performed using independent sample t-test.The results indicated that there was no statistical significance in the efficacy Maintenance time of the two drugs(P=0.204).(6)Health-related quality of life after treatment:The quality of life after 10 months of treatment with the two drugs was compared,and the data was statistically analyzed using independent sample t-test.Patients receiving eltrombopag have better symptoms,fatigue/sleep,bother,fear and work dimensions than patients receiving rituximab(P value were 0.026、0.001、0.049、0.032、0.037 respectively),but patients receiving rituximab have better activity is better than that of patients receiving eltrombopag(P=0.043).There was no statistical difference in psychological Health,quality of life,social quality of life,and female reproductive health scale scores in patients treated with eltrombopag and rituximab,indicating that there was no difference in the above four dimensions(P value were 0.967、0.058、0.792、0.362 respectively).(7)Adverse reactions:The incidence of adverse reactions after treatment with eltrombopag and rituximab was 8.1%and 9.1%respectively.The chi-square test of adverse reactions after treatment with two drugs showed no statistical difference in the incidence of adverse reactions between the two drugs(P=0.623).Conclusion:1.The efficacy of eltrombopag and rituximab in the treatment of ITP with failure of first-line treatment was compared,and the former was better than the latter in terms of post-treatment efficiency,onset time and reduction of recurrence rate,while there was no significant difference in adverse reactions between the two drugs after treatment.2.Using the ITP-PAQ scale to assess the health-related quality of life after treatment with both drugs,patients treated with eltrombopag were superior to those treated with rituximab on symptoms,fatigue/sleep,distress,fear,and work dimensions.However,patients receiving rituximab had a better activity dimension than those receiving eltrombopag.There were no significant differences in mental health,overall quality of life,social activities and reproductive health of women after treatment with two drugs.3.Studies on the related factors affecting the effectiveness of the two drugs showed that the shorter the course of disease,the higher the effectiveness of the two drugs after treatment,while age,baseline platelet count,gender,previous treatment number and bleeding grade had no effect on the effectiveness.