A Clinical Study Of Using Low-dose Rituximab,dexamethasone And Cyclosporine A To Treat Refractory ITP In Children

Objective(s):The purposes of this study is describing the clinical efficacy and safety of using low-dose rituximab,cyclosporine A and dexamethasone to treat refractory ITP in children[1],and exploring the clinical application value of platelet parameters in refractory ITP.Methods:A total number of 142 cases with ITP were admitted to the hematology department of kunming children's hospital from February 2017 to February 2019.Twenty-three of them were diagnosed as refractory ITP,And all of them had no response for Conventional treatments.With permission of parents,to give intravenous dexamethasone 0.6 mg/kg daily for day 1 to 4,and to use intravenous low-dose rituximab 100 mg once a week(for days 7,14,21 and 28).the rituximab was diluted with 0.9%sodium chloride solution or 5%glucose solution to a concentration of 1mg/ml,then seting up a separate channel for infusion at a speed of 5ml/kg.h(upper limit of 100ml/h).Before the rituximab,we should give methylprednisolone 1 to 2 mg/kg to avoid allergic reactions.At the same time,they need to take oral cyclosporine A 2.5 mg/kg daily for day 1 to 28.We should take the blood cell analysis every other day to monitor the tendency of platelet counts during the treatment,then once every 2 weeks until 6 months,then once a month.Take blood biochemistry before and after treatment,and observe the bleeding and adverse reactions.200 children who had a physical examination at department of Children Healthcare in kunming children's hospital were randomly selected as the control group.There was no significant difference in age and gender between the treatment group and control group.To compare platelet parameters(PLT?MPV,PCT?PDW,L-PCR)change before and after treatment.SPSS 22.0 statistical software was used for date analysis.P<0.05 was considered to statistically significant.Results:1.Clinical efficacy:After 6 weeks,the total effective rate was 60.86%.Among the 23 cases,7 cases(30.43%)showed complete response,and 7 cases showed partial response(30.43%).there was 9 cases(39.14%)showed no response,of which 6 cases showed transient responsed.At the end of follow-up,the total effective rate was 56.52%(13/23),the complete response rate was 30.43%(7/23),the partial response rate was 26.09%(6/23),and the ineffective rate was 43.48%(10/23).2.Clinical bleeding:there were no bleeding symptoms in the 13 effective cases(complete response add partial response).one of the ten ineffective patients died at the seventh week due to intracranial hemorrhage.There were 4 cases with platelet counts between 23?30 109/L without bleeding symptoms.Another 5 cases had platelets counts between 3?20 109/L,accompanied bleeding symptoms,and repeated hospitalization.3.Safety:During the infusion of low-dose rituximab,there were no adverse events,such as wheezing,shortness of breath,dyspnea,hypoxemia and so on.Among the 23 cases,Only 5 cases had adverse reactions.3 of them(13.04%)appeared erythra with pruritus,2 cases(8.70%)had a headache,vomiting,and high blood pressure.4 cases(17.39%)got infection,Three quarters of them(13.04%)were upper respiratory tract infection,and a quarter of them(4.35%)had serious infection,including soft tissue inflammation,sepsis,and herpes.All above the adverse reactions disappeared after symptomatic treatment.Having analyzed AST,ALT and AST/ALT of all cases before and after treatment,we found that only one patient had liver function damage,and The symptoms disappeared after the drug treatmen.4.It's statistically significant to compare platelet parameters between ITP group and healthy control group(P<0.05).The result is that PLT and PCT of ITP group were lower than healthy control group.On the contrary,PDW,P-LCR and MPV were higher than healthy control group.5.Comparison of platelet parameters between different therapeutic groups at the first week and sixth week,the results as followed.1).Complete response group and partial effective group:the differences of all parameters were statistically significant(P<0.05).After treatment,PCT and PLT increased,while MPV,PDW and P-LCR decreased.2).Ineffective group:there was no statistically significant difference(P>0.05),and no significant change in platelet parameters before and after treatment.Conclusion(s):1.The combination therapy of low-dose rituximab,cyclosporine A and dexamethasone can be a good choice for refractory ITP in children.The adverse reactions were tolerable well,and it has a weak effect on liver function.The total effective rate and the complete reaction rate were acceptable.2.Platelet parameters play a significant role in observation of the therapeutic effect in refractory ITP patients.PLT and PCT were positively correlated with curative effect,while MPV,PDW and P-LCR were negatively correlated with curative effect.