| Objective:To explore the effectiveness of BTK inhibitor therapy and its impact on cellular immune function in patients with chronic lymphocytic leukemia(CLL).Methods: The 51 newly diagnosed CLL patients with complete clinical data from the Second Affiliated Hospital of Anhui Medical University from January 2017 to January 2022 were collected,and 10 healthy patients were selected as the control group.Single-agent BTK inhibitor treatment for 4-6 courses.peripheral CD3 + T cells,CD4 +T cells,CD8 + T cells,NK cells,and Treg cells before and after BTK inhibitor treatment and controls were measured by flow cytometry.The Ig HV gene mutations and the TP 53 gene mutations were determined by FISH.For this study,statistical analysis was performed by SPSS 26.0,T-test for comparison between groups,Kaplan-Meier method for survival analysis,and univariate and multivariate analysis by COX regression,P <0.05 was considered statistically significant.Results :The 51 CLL patients were 31(60.8%)male and 20(39.2%)female,with a male to female ratio of approximately 1.5:1,and a median age of 64 years.According to Rai stage,it can be divided into stage I 5(9.8%),period 6(11.8%),13(25.5%)and 27(52.9%).According to the risk stratification,it can be divided into low risk 8(15.7%),medium risk 17(33.3%),23(45.1%),and 3(5.9%).21(41.2%),30(58.8%)of Ig HV mutations,6(11.8%)of TP 53 mutations,and 45(88.2%)of TP 53 mutations.The overall response rate(ORR)was 88%,with a complete response(CR)rate of 29% and a partial response(PR)rate of 59%.Neither median progression-free survival(PFS)nor median overall survival(OS)was achieved in CLL patients by the end of follow-up.There was no significant difference in PFS and OS survival among the low-risk,intermediate-risk,high-risk and extremely high-risk groups.The CD8 + T and NK cell counts of primary CLL patients were significantly lower than that of healthy controls,and the percentage of Treg cells was significantly higher than that of healthy controls,with a statistically significant difference(P <0.05).CD4+ T after BTK inhibitor counts,Treg cells and CD8 + T and NK cells increased(P <0.05).There was no statistical difference in peripheral blood cell immune function of CLL patients treated with BTK inhibitors compared with healthy people.It was also found that the Treg cell count of patients in the disease progression group was higher than that in the remission group,and the Treg cells of patients with Ig HV gene mutation were higher than that of the non-mutation group,showing a statistically significant difference(P<0.05).Univariate and multivariate COX regression analysis showed that patient Rai stage,pre-treatment Treg cells were independent prognostic risk factors for PFS in naive CLL patients,and pre-treatment Treg cells were independent prognostic risk factors for patient OS. |