ObjectiveTo observe the clinical efficacy of Anzi Tiaochong decoction combined with aspirin and the effects of this therapy on the peripheral blood phospholipid antibody titers， coagulation function， and CD19⁺CD24^hiCD27⁺regulatory B （Breg） cells in patients with obstetric antiphospholipid syndrome （OAPS） （pattern of kidney deficiency and blood stasis）. MethodsPatients who meet the inclusion criteria were randomly allocated into an observation group （50 patients， with 4 patients dropped out and 46 patients completed） and a control group （50 patients， with 2 patients dropped out， 1 patient excluded， and 47 patients completed） through a random number table method. The control group was treated with aspirin enteric-coated tablets， 75 mg/time， once a day， and the observation group with Anzi Tiaochong decoction， 1 bag/day on the basis of the therapy in the control group. The treatment course for both groups was 8 weeks， and the patients were followed up for 4 weeks. The traditional Chinese medicine （TCM） symptom scores， titers of peripheral blood phospholipid antibodies ［anti-cardiolipin antibody IgM （ACA IgM）， anti-cardiolipin antibody IgG （ACA IgG）， anti-β₂-glycoprotein 1 antibody IgM （β₂GP1-IgM）， and anti-β₂-glycoprotein 1 antibody IgG （β₂GP1-IgG）］， D-dimer （D-D）， thromboelastography parameters ［clotting factor activity （R）， platelet function maximum amplitude （MA）， coagulation composite index （CI）， and clot strength （G）］， CD19⁺CD24^hiCD27⁺ Breg expression rate， and adverse drug reactions were recorded for the two groups before and after treatment. ResultsAfter treatment， both groups showed decreased ACA IgM， ACA IgG， β₂GP1-IgM， β₂GP1-IgG， D-D， MA， and G （P<0.05） and increased R （P<0.05）. There was no statistically significant difference in CI. Compared with the control group， the observation group showed more significant decreases in TCM symptom scores and phospholipid antibody titers （P<0.05）. After treatment， the expression rate of Breg in the observation group was higher than that before treatment （P<0.05）.There was no significant difference in Breg expression rate before and after treatment in the control group. Neither group experienced significant adverse reactions. ConclusionAnzi Tiaochong decoction combined with aspirin can alleviate the symptoms， reduce the phospholipid antibody titers， and restore the coagulation status of patients with obstetric antiphospholipid syndrome （pattern kidney deficiency and blood stasis）. It may exert the therapeutic effects by regulating Breg to maintain the patient's immune balance.

Objective:To retrospectively analyze the treatment status of tyrosine kinase inhibitors (TKI) in newly diagnosed patients with chronic myeloid leukemia (CML) in China.Methods:Data of chronic phase (CP) and accelerated phase (AP) CML patients diagnosed from January 2006 to December 2022 from 77 centers, ≥18 years old, and receiving initial imatinib, nilotinib, dasatinib or flumatinib-therapy within 6 months after diagnosis in China with complete data were retrospectively interrogated. The choice of initial TKI, current TKI medications, treatment switch and reasons, treatment responses and outcomes as well as the variables associated with them were analyzed.Results:6 893 patients in CP ( n=6 453, 93.6%) or AP ( n=440, 6.4%) receiving initial imatinib ( n=4 906, 71.2%), nilotinib ( n=1 157, 16.8%), dasatinib ( n=298, 4.3%) or flumatinib ( n=532, 7.2%) -therapy. With the median follow-up of 43 ( IQR 22-75) months, 1 581 (22.9%) patients switched TKI due to resistance ( n=1 055, 15.3%), intolerance ( n=248, 3.6%), pursuit of better efficacy ( n=168, 2.4%), economic or other reasons ( n=110, 1.6%). The frequency of switching TKI in AP patients was significantly-higher than that in CP patients (44.1% vs 21.5%, P<0.001), and more AP patients switched TKI due to resistance than CP patients (75.3% vs 66.1%, P=0.011). Multi-variable analyses showed that male, lower HGB concentration and ELTS intermediate/high-risk cohort were associated with lower cytogenetic and molecular responses rate and poor outcomes in CP patients; higher WBC count and initial the second-generation TKI treatment, the higher response rates; Ph + ACA at diagnosis, poor PFS. However, Sokal intermediate/high-risk cohort was only significantly-associated with lower CCyR and MMR rates and the poor PFS. Lower HGB concentration and larger spleen size were significantly-associated with the lower cytogenetic and molecular response rates in AP patients; initial the second-generation TKI treatment, the higher treatment response rates; lower PLT count, higher blasts and Ph + ACA, poorer TFS; Ph + ACA, poorer OS. Conclusion:At present, the vast majority of newly-diagnosed CML-CP or AP patients could benefit from TKI treatment in the long term with the good treatment responses and survival outcomes.

Objective:To investigate the efficacy and safety of venetoclax (VEN) combined with hypomethylating agents (HMA) in the treatment of blastic plasmacytoid dendritic cell neoplasms (BPDCN).Methods:A retrospective case series study was conducted. The clinical data of 5 patients with BPDCN treated with VEN combined with azacitidine (AZA) or decitabine (DAC) in the First Affiliated Hospital of Soochow University and Suzhou Hongci Blood Disease Hospital from February 2017 to July 2023 were collected, and the therapeutic effect, adverse reaction and prognosis of all 5 patients were summarized.Results:All 5 BPDCN patients were male with the median onset age [ M ( Q1, Q3)] of 66 years (51 years, 73 years), of which 4 cases were presented with skin lesions and 1 case was presented with lymphadenopathy as the primary symptom. As for the treatment, 3 patients were initially treated with VEN in combination with AZA induction regimen, among which 2 patients achieved complete remission with incomplete blood count recovery (CRi) after 2 cycles of treatment, survived for 26.5 months and 14.6 months, respectively and finally died, and 1 patient achieved partial remission after 1 cycle of treatment and he still survived after 3-month follow-up; 1 patient was initially treated with VEN in combination with DAC induction regimen, and achieved clinical complete remission of non-active disease with residual skin abnormalities after 2 cycles of treatment followed by allogeneic hematologic stem cell transplantation (allo-HSCT) and he was in the state of disease-free survival for 15-month; and another 1 patient experienced a relapse after treatment with acute lymphocytic leukemia-like regimen in combination with allo-HSCT and again achieved CRi after 2 treatment courses of VEN in combination with AZA regimen, and he was in the state of disease-free survival for 30-month follow-up. Treatment-related haematological adverse effects of VEN combined with HMA were mainly neutropenia with fever, reduction of hemoglobin and thrombocytopenia; and non-haematological adverse effects were mainly gastrointestinal reactions such as nausea and vomiting. These adverse events improved with symptomatic supportive therapy, and no treatment-related deaths occurred. Conclusions:BPDCN patients who are unable to tolerate intensive chemotherapy regimens at initial time of diagnosis may attempt induction therapy with VEN+HMA regimen, which has a manageable adverse reaction and may serve as a bridge to allo-HSCT.

Objective: To study the value of unmethylated cytosine guanine dinucleotide oligodeoxynucleotide (DSP30) and IL-2 in the conventional cytogenetic (CA) detection of the chromosomal aberrations in chronic lymphocytic leukemia (CLL) . Methods: Bone marrow or peripheral blood cells of CLL patients were cultured with DSP30 plus IL-2 for 72 h, following which R-banding analysis was conducted. Fluorescence in situ hybridization (FISH) was performed in 85 patients. CA results were compared with data obtained by FISH. Results: Among 89 CLL patients, the success rate of chromosome analysis was 94.38% (84/89) . Clonal aberrations were detected in 51 patients (51/84, 60.71%) . Of them, 27 (27/51, 52.94%) were complex karyotype. Among 85 CLL patients tested by FISH, chromosomal abnormalities were detected in 74 (74/85, 87.06%) patients, of which 2 (2/74) patients were complex karyotypes, accounting for 2.70%. Of the 85 CLL patients examined by FISH, 50 had abnormal karyotype analysis, 30 had normal karyotype, 5 failed to have chromosome analysis. Among them, 25 cases showed clonal aberrations by FISH assay but normal by CA, and 4 cases were normal by FISH but displayed aberrations in chromosome analysis, and totally 78 (91.76%) cases with abnormality detected by the combination of the two methods. The frequency of 13q- abnormality detected by FISH was significantly higher than that by CA analysis (69.41%vs 16.67%, P<0.001) , while the frequency of 11q-,+12 and 17p- detected by two methods showed no significant difference (P>0.05) . The detection rate of complex abnormalities in conventional karyotype analysis was higher than that in FISH (50.98%vs 2.70%) . In addition, 11 low-risk and 9 intermediate-risk patients according to FISH results showed complex karyotype by cytogenetics, and were classified into high-risk cytogenetic subgroup. Conclusion DSP30 and IL-2 are effective in improving the detection rate of CA in CLL patients (60.71%) and CA is more effective to detect complex karyotype. However, FISH had a higher overall abnormality detection rate (87.06%) than CA, especially for 13q-. The combination of CA and FISH not only enhanced the detection rate of clonal aberrations to 91.76%, but also provided more precise prognosis stratification for CLL patients, thus to provide more information for clinical implication.

Objective:To analyze and summarize the process of integration between national clinical research center and the hospital to which it affiliated.Methods:Embeddedness was introduced to establish a framework for analysis. Information was collected from 81 respondents from 16 institutions to understand the expectations for national clinical research center.Results:The establishment of national clinical research center is expected to help researchers with research space, talent cultivation, funding, dada sharing, research outcome transformation and further cooperation. Research platform and communication cost are expected to be optimized.Conclusions:To further develop the national clinical research center, we need to identify the key indicators for performance appraisal, physician scientist play the role as administrative leader, coordination between university and hospitals, provide comprehensive compensation plan for the talents, conducting clinical research project, construction big data analysis platforms, promote research outcome transfer, reduce the communication cost between doctors and basic science researchers.

Humans ; Leukemia, Promyelocytic, Acute ; genetics ; Oncogene Proteins, Fusion ; genetics ; Receptors, Retinoic Acid ; genetics ; Retinoic Acid Receptor alpha ; STAT5 Transcription Factor ; genetics