| ObjectiveTo investigate the clinical efficacy and safety of two different dose of rituximab when used in adult patients with immune thrombocytopenia.Materials and MethodsCase selection:We collected cases of ITP patients who were given rituxmab in Qilu hospital during January 2010-September 2014. Then we selected out 66 adult patients according to the inclusion criteria. The inclusion criteria:aged 14 or older; diagnosed as primary ITP; platelet count less than 30×109/L or bleeding; more than one previous treatment for ITP including steroids didn’t work; use low-dose rituximab. Patients with Hepatitis B, C virus or HIV were not included. Women during pregnancy and loctation were excluded, too.Methods:Adult patients with ITP were divided into two groups:group A and B, according to the dosage of rituximab they had used. The dosage of rituximab given to patients in group A was 100m g qw×4 weeks, while for patients in group B the dosage was 375mg/m2 BSA only once. There were 37 patients in group A, and 29 patients in group B. The observation time of the efficacy and adverse effects was at least 6 months since the first infusion of rituximab.Observation index:Complete response(CR) was defined as a platelet count≥ 100×109/L,and the partial response(R) was defined as a platelet count>30×109/L, with at least a doubling of the initial value. All patients whose platelet count was less than 30×109/L, or still bleeding should be defined as no response (NR). CR+R was the total response cases. The adverse reactions were defined according to the rituximab instructions.Statistical methods:The analysis were performed using SPSS software V22. Measurement data was expressed as mean±tandard deviation (x±s), used t test, or expressed by median(M), used nonparametric test. And the categorical data used X2 test. A p-value of< 0.05 was considered statistically significant.ResultsThere were no differences between two groups considering fundermental conditions of patients.Effective rate:Among the total 66 patients,21 cases received the CR(31.82%),17 cases was PR, the total response rate is 57.58%(38/66).12 out of 37 patients in the group A was CR(32.43%),10 got PR(27.03%),15 was NR(40.54%), the total response rate of group A was 59.46%(22/37). While for the group B, CR was 31.03%(9/29), PR was 24.14%(7/29), NR was 44.83%(13/29), the total response rate was 55.17%(16/29). There were no significant differences between the two groups considering the CR rate(P=0.904) and the total response rate(P=0.727).Time to response:For the group A, the time used to get responses was (34.86±19.84) days, and the time to response in group B was (41.13±28.54) d, P=0.43>0.05 so that there was no significant difference between the two groups.Adverse reactions:12 (32.43%) patients in group A and 11(37.93%) patients in group B experienced the adverse effects. But all patients didn’t need to withdraw the rituximab treatment. Most adverse reactions could relieve in 2 weeks spontaneously or after giving simple drugs. The difference was not significant between the adeverse reaction rates of the two groups (P=0.642). But there are two serious adverse reactions happened. One patient in group A was deleyed to leave hospital due to myocarditis. And one patient of group B needed hospitalization because of the pulmonary infection 3 months after using rituximab. The rates of serious adverse reactions were 2.70%(group A) and 3.45%(group B), P=.1000>0.05.ConclusionsRituximab is efficacious for ITP patients who have experienced steroids treatment failure. The two small dose of rituximab appear no differences in efficacy or safty when using in adult ITP patients. |
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