Efficacy And Related Factors Of High-dose Dexamethasone Combined With Low-dose Rituximab In The Treatment Of Immune Thrombocytopenia

BackgroundImmune thrombocytopenia(ITP),formerly known as idiopathic thrombocytopenic purpura,is an acquired immune disorder characterized by solitary thrombocytopenia with a peripheral blood platelet count of less than 100 × 109 / L There are no obvious or potential causes of thrombocytopenia.ITP usually has a clinical manifestation of bleeding from the skin and mucous membranes or gastrointestinal bleeding,visceral hemorrhage and even intracranial hemorrhage.The light can be self-healing,and the severe one can be life-threatening.Studies have found that the severity of thrombocytopenia has a certain correlation with the risk of bleeding,but it is not completely related.High-dose dexamethasone(DXM)is the first-line treatment for ITP with a low sustained response rate of 36%-75%.Rituximab(Rituximab,RTX),as a second-line treatment for ITP,has an average onset time of 5.5 weeks and an average maintenance time of 10.5 months.Only 25%-40% of patients can achieve a sustained response rate of more than 1 year.Is there a treatment that can shorten the onset time and extend the maintenance time? Can high-dose DXM combined with low-dose RTX be an option? ObjectiveTo evaluate the safety and therapeutic effect of high-dose DXM combined with low-dose RTX.Whether high-dose DXM combined with low-dose RTX has different therapeutic effects on newly diagnosed ITP than non-newly diagnosed ITP,and whether there are risk factors affecting the efficacy of ITP.Objectives and methodsThe study included 34 patients with ITP who underwent high-dose DXM combined with low-dose RTX in the Affiliated Tumor Hospital of Zhengzhou University from January 2017 to January 2019.Treatment: DXM 40 mg intravenous infusion,once a day,from day 1 to day 4,RTX 100 mg micro pump was pumped once a week for 4 weeks,7th,14 th,21st,28 th.Effective criteria: total effective rate(ORR),complete response(CR),effective(R),ineffective(NR),relapse,onset time,adverse reactions.Statistical methods: Statistical analysis was performed with SPSS 21.0.The measurement data were analyzed by T test or non-parametric test.The count data were analyzed by chi-square test.Logistic regression was used to analyze the related factors affecting the curative effect.All p values were two-sided test,P< 0.05 was statistically significant.Outcome1.After high-dose DXM combined with low-dose RTX,the initial ORR was 94.1%(32/34),CR was 52.9%(18/34),R was 41.2%(14/34),and initial reaction time was 8.5d.(6.0,11.0);1 year ORR is 65.4%(17/26),CR is 42.3%(11/26),R is 23.1%(6/26),and NR is 34.6%(9/26),of which Six patients had recurrence and the recurrence rate was 30%(6/20).2.After treatment,the ORR rate of newly diagnosed ITP was 100%,66.7%,CR was 54.2%,50%,R was 45.8%,22.2%;the ORR of non-newly diagnosed ITP was 80%,50%.The CR change is 50%,25%.3.The incidence of adverse reactions was 17.6%(6/34).Among them,3 cases had gastrointestinal reactions,1 case had fever,1 case had pulmonary infection on the 28 th day of treatment,and 1 case had elevated transaminase after treatment.There was no serious adverse reaction and safety was good..4.Univariate analysis showed that the anti-platelet antibody-negative group(?2=5.736,P=0.017<0.05)was statistically different.Multivariate analysis showed that platelet antibodies(P=0.022<0.05,OR=0.017,95% CI 0.001-0.564)were risk factors for efficacy.Conclusion1.High-dose DXM combined with low-dose RTX has a good therapeutic effect,and no serious adverse reactions occur;2.High-dose DXM combined with low-dose RTX has no statistical difference in efficacy between newly diagnosed and non-newly diagnosed ITP;3.Platelet antibodies are risk factors for the efficacy of ITP.Further large-center randomized controlled trials are needed to further assess the role of this therapy in the treatment of patients with ITP.