| Primary immune thrombocytopenia(ITP)is an autoimmune hemorrhagic disease mediated by humoral immunity and cellular immune-mediated platelet excessive destruction and suppressed platelet generation,characterized by thrombocytopenia,with or without skin mucosal bleeding-Conventional first-line therapy is glucocorticoid,immunoglobulin,and second-line therapy is splenic resection and use of immunosuppressive agents.For some refractory thrombocytopenia,first-line and second-line treatment regimens are ineffective.Rituximab is a monoclonal antibody against CD20.In recent 10 years,it has been used more and more in the treatment of primary immune thrombocytopenia.Many studies have confirmed its safety and efficacy.ObjectiveTo compare the efficacy,safety and response duration of different dose of rituximab in primary immune thrombocytopenia in adults with steroid failure or relapse.MethodsCollected from January 2010 to December 2016 at the Department of Hematology,Qilu Hospital,Shandong University,diagnosed as primary immune thrombocytopenia,67 patients with pITP who had failed to respond to glucocorticosteroids or have relapsed after obtaining CR were randomly divided into 2 groups:group A(n = 32)and group B(n = 35)..In group A,Rituximab was given with a fixed dose of 100 mg administered as an intravenous infusion weekly(on day 1,8,15 and 22).In group B,Rituximab was given with a single dose of 375mg/m2.The patients in both groups were followed up for at least 6 months.The clinical effect,onset time,duration of efficacy and adverse reactions were observed.Results(1)Research data:There was no statistical significance between the two groups in age,sex,initial platelet value before treatment,the course of ITP,previous treatmenta nti-platelet antibody,bleeding score and other data.The data of the two groups were comparable;(2)clinical effect:The totle response rate(CR+R)between the two groups has no statistical significant difference;(3)Onset time:The shortest onset time of the two groups both was 7 days,the median onset time both was 30 days.The results showed that there was no statistical difference in onset time between the two groups;(4)Efficacy Maintenance Time:Patients in both groups were followed up for 1 year,record the duration of CR acquisition and maintenance in both groups.Group A has a minimum duration of 6 months,and there are 18 patients(18/24,75%)who have maintained the curative effect for more than one year,In group B,the minimum duration of curative effect was 3 months,and 16 patients(16/25,64%)maintained the curative effect for more than one year.Chi-square test was performed on the duration of drug efficacy between the two groups(P =0.426),and there was no statistical difference between the two groups;(5)Adverse effect:Group A:five patients with fatigue(15.63%),two patients complained of deficiency sweat during injection(6.25%),one patient had alopecia(3.13%),one patient complained of joint pain(3.13%),one patient complained of leukocytosis(3.13%),a case with rash(3.13%),improve after treatment or does not affect daily life without giving special treatment.Group B had fore cases of fatigue(11.43%),three cases of hair loss(8.57%),three patients complained of joint pain(8.57%),two patients complained of leukocytopenia(5.71%),improve after treatment or does not affect daily life without giving special treatment.The incidence of adverse reactions and the incidence rate in the two groups was similar.There was no statistical difference between the two groups by chi-square test.ConclusionThere were no statistically significant differences in clinical efficacy,onset time,efficacy maintenance time and adverse reactions between the two groups.The single dose of rituximab 375 mg/m2 is effective and safe in the treatment of pITP.It not only reduce the frequency of hospitalization but also shorten the hospital stay thus is a potential therapeutic regime in pITP.It can replace 100 mg/time once a week,for 4 weeks,in the treatment of primary immune thrombocytopenia with glucocorticoid failure or relapse. |
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