Decentralized clinical trials(DCT)must adhere to the core concept of"patient-centered".DCT has many advantages,such as faster recruitment of diverse study participants,lower participation costs,increased compliance,friendliness to study participants,electronic informed consent,expedited investigational medical product delivery,and convenient data collec-tion.DCT in China faces new requirements for both clinical trial institutions and medical services,inadequate support for infor-mation systems,compliance with electronic informed consent,higher requirements for data security and personal information pro-tection,and the need for multiple training,and other challenges.To accelerate the implementation of DCT in China,the author believes that the following measures can be taken,such as strengthening the construction of information infrastructure to facilitate the participation of grassroots medical institutions and data collection of study participants;establishing communication channels and strengthening training;carefully designing the protocol,establishing standard operating procedures for clinical trials,and strengthening ethical review;conducting remote safety monitoring and reporting safety information;clarifying the data reporting procedure and obtaining high-quality trial data through data collection and management.

Decentralized clinical trials(DCT)must adhere to the core concept of"patient-centered".DCT has many advantages,such as faster recruitment of diverse study participants,lower participation costs,increased compliance,friendliness to study participants,electronic informed consent,expedited investigational medical product delivery,and convenient data collec-tion.DCT in China faces new requirements for both clinical trial institutions and medical services,inadequate support for infor-mation systems,compliance with electronic informed consent,higher requirements for data security and personal information pro-tection,and the need for multiple training,and other challenges.To accelerate the implementation of DCT in China,the author believes that the following measures can be taken,such as strengthening the construction of information infrastructure to facilitate the participation of grassroots medical institutions and data collection of study participants;establishing communication channels and strengthening training;carefully designing the protocol,establishing standard operating procedures for clinical trials,and strengthening ethical review;conducting remote safety monitoring and reporting safety information;clarifying the data reporting procedure and obtaining high-quality trial data through data collection and management.

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 IA regimen which contains idarubicin (IDA) 8 mg/m², 10 mg/m² or 12 mg/m² as induction chemotherapy for adult patients with de-novo acute myeloid leukemia (AML) . Methods: A total of 1 215 newly diagnosed adult AML patients, ranging from May 2011 to March 2015 in the First Affiliated Hospital of Soochow University and other 36 clinical blood centers in China were enrolled in the multicenter, single-blind, non-randomized, clinical controlled study. To compare the response rate of complete remission (CR) , adverse events between different dose idarubicin combined with cytarabine (100 mg/m²) as induction chemotherapy in newly diagnosed patients of adult AML. Results: Of 1 207 evaluable AML patients were assigned to this analysis of CR rate. The CR rates of IDA 8 mg/m² group, IDA 10 mg/m² group and IDA 12 mg/m² group were 73.6% (215/292) , 84.1% (662/787) and 86.7% (111/128) , respectively (P<0.001) . After adjusted for age, blast ratio of bone marrow, FAB classification and risk stratification, the odds ratios (95% CI) of IDA 10 mg/m² group and IDA 12 mg/m² group were 0.49 (0.34-0.70) and 0.36 (0.18-0.71) , as compared with the IDA 8 mg/m² group (P<0.001, P=0.003) . In the intermediate and favorable groups, CR rates was 76.5% (163/213) , 86.9% (506/582) and 86.1% (68/79) in different doses of IDA (P=0.007) . Interestingly, IA regimen with IDA 10 mg/m² was the only beneficial factor affecting CR in this group after adjusted for age, blast ratio of bone marrow and FAB classification[OR=0.47 (95% CI 0.31-0.71) , P<0.001]. CR rates in adverse group was 50.0% (18/36) , 60.6% (43/71) and 81.8% (18/22) respectively (P=0.089) . However, the odds ratios (95% CI) of IDA 12 mg/m² when compared with the IDA 8 mg/m² was 0.22 (0.06-0.80) , after adjusted for age, blast ratio of bone marrow and FAB classification. The median time (days) of neutrophil count less than 0.5×10⁹/L in IDA 8 mg/m² group, IDA 10 mg/m² group and IDA 12 mg/m² group were 14 (11-18) , 15 (11-20) and 18 (14-22) , respectively (P=0.012) and of platelet count lower than 20×10⁹/L were 14 (7-17) , 15 (11-20) and 17 (15-21) , respectively (P=0.001) . The incidences of lung infection in the three groups were 9.8%, 13.5% and 25.2%, respectively (P<0.001) . Conclusions For young adult patients (aged 18-60 years) with AML in China, intensifying induction therapy with idarubicin 10 mg/m² is clinically superior to IDA 8 mg/m² and IDA 12 mg/m² in favorable intermediate AML subgroup. However, idarubicin 12 mg/m² is more suitable to adverse AML subgroup.

Objective To evaluate the anatomic localization and size of acute necrotic myocardium in the ischemic-reperfused rat hearts using 99m TC-Glucarate and microSPECT/CT.Methods The ischemic-reperfused ( IR) rat heart models were established by ligating left anterior descending coronary artery for 60 min.99mTC-Glucarate was intravenously injected into the rats 24 hours after IR operations .Images were acquired 30 min after administration of 99m TC-Glucarate using microSPECT/CT. Anatomic localization and size of acute necrotic myocardium were analyzed with microSPECT/CT imaging , and these results were compared to those determined by triphenyltetrazolium chloride ( TTC ) staining.Results The microSPECT/CT images showed hot spot accumulations of 99mTC-Glucarate in IR hearts (the heart-to-liver ratio was 1.90 ±0.33), not in controls (P <0.05).The anatomic localization of 99mTC-Glucarate-labeled necrotic myocardium were in correspondence with TTC staining results .The hot spot size was related significantly to necrotic myocardial size determined by TTC staining ( R2 =0.964 ) .Conclusions The localization and size of acute necrotic myocardium can be assessed by non-invasive microSPECT/CT imaging with99m Tc-Glucarate.