Objective:To analyze the association between standardized management of clinical research, initiated by investigators and guided by clinical research management policies in healthcare institutions, and changes in the research behavior of graduate students.Methods:Theses related to cardiovascular health published by graduate students in the Sichuan-Chongqing region of China between January 2019 and June 2024 were retrieved from the China National Knowledge Infrastructure database. Multilevel models were used to analyze changes in ethical compliance awareness, research methodology standardization, and academic collaboration of graduate students before and after policy implementation. Using Shapiro Wilk test and percentage representation.Results:Among the 712 theses included in this study, the proportion of studies with ethical review reports increased from 44.50% to 55.32% following the implementation of standardized management [odds ratio ( OR)=1.80, P=0.017]. Standardized management significantly improved the quality scores of cross-sectional studies and randomized controlled trials ( P<0.001), as well as significantly increased the frequencies of multi-center collaboration ( OR=2.84, P=0.001) and intra-provincial collaboration ( OR=2.80, P=0.001). Conclusions:Standardized clinical research management shows significant association with positive changes in the research behavior of graduate students. Further optimization of management measures is recommended to comprehensively enhance the clinical research capabilities of graduate students.

Objective:To analyze the association between standardized management of clinical research, initiated by investigators and guided by clinical research management policies in healthcare institutions, and changes in the research behavior of graduate students.Methods:Theses related to cardiovascular health published by graduate students in the Sichuan-Chongqing region of China between January 2019 and June 2024 were retrieved from the China National Knowledge Infrastructure database. Multilevel models were used to analyze changes in ethical compliance awareness, research methodology standardization, and academic collaboration of graduate students before and after policy implementation. Using Shapiro Wilk test and percentage representation.Results:Among the 712 theses included in this study, the proportion of studies with ethical review reports increased from 44.50% to 55.32% following the implementation of standardized management [odds ratio ( OR)=1.80, P=0.017]. Standardized management significantly improved the quality scores of cross-sectional studies and randomized controlled trials ( P<0.001), as well as significantly increased the frequencies of multi-center collaboration ( OR=2.84, P=0.001) and intra-provincial collaboration ( OR=2.80, P=0.001). Conclusions:Standardized clinical research management shows significant association with positive changes in the research behavior of graduate students. Further optimization of management measures is recommended to comprehensively enhance the clinical research capabilities of graduate students.

Objective:To investigate the related factors of pleasure loss in patients with human immunodefi-ciency virus(HIV)/acquired immune deficiency syndrome(AIDS).Methods:Totally 237 patients with HIV/AIDS from a certain infectious disease hospital were selected and surveyed with a self-designed general information ques-tionnaire,the Temporal Pleasure Experience Scale(TEPS),Self Acceptance Scale(SAQ),Discrimination Percep-tion Scale(SIS),and Perceived Social Support Scale(PSSS).Results:The patient's TEPS score was(73.4±16.1).Stepwise linear regression analysis showed that the PSSS total scores,education level,and personal monthly income were positively correlated with the TEPS total scores(β=0.41,5.17,4.63),and age was negatively corre-lated with the TEPS total scores(β=-0.30).Conclusion:It suggests that more attention should be paid to the lack of pleasure in patients with HIV/AIDS,and the lack of pleasure is related to personal monthly income,educa-tion level,age and perceived social support.

Objective:To explore the predictive value of peripheral blood cytokine models on organ functional impairment after chimeric antigen receptor T(CAR-T) cell therapy in children with B-lineage lymphocytic leukemia.Methods:The clinical data of 44 children with acute B-lineage lymphoblastic leukemia who received CAR-T cell therapy at Children′s Hospital of Soochow University from September 2018 to October 2020 were retrospectively analyzed.Peripheral blood cytokines, including interleukin(IL)-2, IL-4, IL-6, IL-10, tumor necrosis factor-α, interferon(IFN)-γ and IL-17A, were measured daily for 14 days after receiving CAR-T cell therapy.The trend of peripheral blood cytokine levels was analyzed at the endpoint of organ function recovery or death within 14 days after CAR-T cell treatment.Receiver operating characteristic curve was used to establish a mathematical prediction model to predict the occurrence of organ damage in the children.Results:Of the 44 children, 31 cases were boys and 13 cases were girls, with a median age of 7.96 (5.19, 11.48)years.Cytokine release syndrome(CRS) response occurred in 95.5% (42/44) children, with 88.1% (37/42) had a grade 1-3 CRS response, and 16.7% (7/42) had a severe grade 4-5 CRS response.Using IL-6>3 892.95 pg/mL as cut-off value, the area under the curve(AUC) for predicting acute respiratory failure was 0.818, with a sensitivity of 0.8 and a specificity of 0.735, while combining IFN-γ>414.4 pg/mL, IL-6>3 892.95 pg/mL and IL-2>27.05 pg/mL were the three cut-off values, with an AUC of 0.741, sensitivity of 0.6 and specificity of 0.912 for predicting acute respiratory failure. Using IFN-γ>1 699.5 pg/mL as cut-off value, the AUC for predicting shock was 0.908, with a sensitivity of 0.722 and a specificity of 1.With IL-6>4 607.3 pg/mL as cut-off value, the AUC for predicting liver injury was 0.964, with a sensitivity of 1 and a specificity of 0.906, while combining both IL-6>4 607.3 pg/mL and IFN-γ>1 446.2 pg/mL as cut-off values, the AUC for predicting liver injury was 0.977, with a sensitivity of 1 and a specificity of 0.906.Combining both IL-6>6 972.2 pg/mL and IFN-γ>3 981.5 pg/mL predicted a positive predictive value of 62.5% and a negative predictive value of 94.4% for grade 4-5 CRS response, with an AUC of 0.846, a predictive sensitivity of 0.714 and a specificity of 0.838, and all children had a combination of two or more organ function injuries.Conclusion:The combination of IL-6 and IFN-γ can effectively predict the incidence of liver injury and cytokine release syndrome.The combination of peripheral blood cytokines IFN-γ, IL-6 and IL-2 can be used to predict the incidence of acute respiratory failure after the treatment of CAR-T cells in children with acute B-lineage lymphoblastic leukaemia.IFN-γ single index can be used to predict the incidence of shock.The combination of IL-6 and IFN-γ can be used to predict the incidence of liver injury and the severity of CRS.

Objective: This study’s objective is to assess the efficacy and safety of Pulsed Magnetic Therapy System (PMTS) in improving insomnia disorder. Methods: Participants with insomnia disorder were randomly assigned to receive either PMTS or sham treatment for four weeks (n= 153; PMTS: 76, sham: 77). Primary outcomes are the Insomnia Severity Index (ISI) scores at week 0 (baseline), 1, 2, 3, 4 (treatment), and 5 (follow-up). Secondary outcomes are the Pittsburgh Sleep Quality Index at baseline and week 4, and weekly sleep diary-derived values for sleep latency, sleep efficiency, real sleep time, waking after sleep onset, and sleep duration. Results: The ISI scores of the PMTS group and the sham group were 7.13±0.50, 11.07±0.51 at week 4, respectively. There was a significant group×time interaction for ISI (F3.214, 485.271=24.25, p<0.001, ηp 2=0.138). Only the PMTS group experienced continuous improvement throughout the study; in contrast, the sham group only experienced a modest improvement after the first week of therapy. At the end of the treatment and one week after it, the response of the PMTS group were 69.7% (95% confidence interval [CI]: 58.6%–79.0%), 75.0% (95% CI: 64.1%–83.4%), respectively, which were higher than the response of the sham group (p<0.001). For each of the secondary outcomes, similar group×time interactions were discovered. The effects of the treatment persisted for at least a week. Conclusion PMTS is safe and effective in improving insomnia disorders.

β-thalassemia is a single-gene genetic disease caused by β globin gene mutations leading to the fact that red blood cells are unable to form normal adult hemoglobin, and then patients develop hemolytic anemia. Current treatment regimens mainly include allogenetic hematologic stem cell transplantation, symptomatic regular blood transfusions and the use of iron removers to reduce iron load. Some severe patients have quite poor prognoses and deadly consequences if not treated timely. Genetically modified autohematopoietic stem cells can provide a new treatment option for patients with β thalassemia, which may achieve a long-term and stable increase in hemoglobin level through a single dose, making one-time cure β-thalassemia possible. This paper reviews the key elements of clinical trial design for β-thalassemia gene therapy from the aspects of efficacy evaluation endpoints, clinical trial design, enrollment population, and subject monitoring in order to provide a reference for pharma-therapeutic research and development enterprises.

Objective To investigate the pollution levels of six indicator polychlorinated biphenyls (PCBs) in animal-derived foods in Hebei Province. Methods A total of 96 food samples (including beltfish, snakehead, egg, pork liver, pork and beef meat) were collected from Hebei Province in 2019. The contents of six indicator PCBs (PCB 28, PCB 52, PCB 101, PCB 138, PCB 153 and PCB180) in different food samples were determined using isotope dilution-high resolution gas chromatography-high resolution mass spectrometry (HRGC-HRMS). Results The contents of indicative PCBs in fish samples ranged from 0.12 to 0.32 ngg-1 fresh weight, while the content of PCBs in other samples ranged from 0.11 to 1.10 ng g-1 fat. PCB 138 and PCB 153 were the main compounds detected in fish samples, while PCB 28 and PCB 52 were the main compounds detected in other samples. The average estimated daily dietary intake of PCBs for residents in Hebei Province was 0.14 ng kg^-1·bw^-1·d^-1, and the highest contribution rate was beltfish (61.52%). Conclusion The pollution levels of indicator PCBs in animal-derived foods in Hebei Province are relatively low, and the residents has lower health risks through dietary intake of indicator PCBs.

Objective:To analyze the efficacy and prognostic factors of radiotherapy combined with asparaginase/peaspartase-based chemotherapy regimen in the treatment of early stage extranodal natural-killer/T cell lymphoma of the upper aerodigestive tract (UADT ENKTCL).Methods:267 early stage UADT ENKTCL patients were treated in Guizhou Cancer Hospital from October 2003 to February 2020. Among them, 229 patients received radiotherapy or radiotherapy combined with menpartaminase/permenidase-based chemotherapy regimen and 38 patients were treated with radiotherapy or chemotherapy alone. The overall survival (OS) and progression-free survival (PFS) were calculated by Kaplan- Meier method, log-rank test was conducted for univariate analysis and Cox regression model was performed for multivariate analysis. Results:The 5-year OS and PFS were 67.2% and 61.5% in all patients. The 5-year OS and PFS in patients treated with radiotherapy combined with chemotherapy, radiotherapy alone and chemotherapy alone were 71.7%, 35% and 49%(all P<0.001), and 66.4%, 35% and 28%(all P<0.001), respectively. According to the NRI risk stratification, 246 patients treated with radiotherapy and chemotherapy were divided into the favourable and the unfavourable prognosis groups. The 5-year OS was 93.3% and 64.3%( P<0.001) and the 5-year PFS was 91.1% and 56.7%( P<0.001) in two groups. For patients receiving radiotherapy with a dose ≥50 Gy and<50 Gy, the 5-year OS was 72.4% and 55.7%( P<0.001), and the 5-year PFS was 68.3%, and 36.5%( P<0.001). In the unfavourable prognosis group, the 5-year OS of patients receiving ≥ 4 and<4 cycles of chemotherapy was 65.5% and 59.2%( P=0.049), and the 5-year PFS was 60.7% and 50.6%( P=0.018). Univariate analysis showed that stage Ⅱ, ECOG≥2, primary tumor invasion, radiotherapy alone, NRI≥1(Nomogram-revised risk index), EBV-DNA≥2 750 copies/ml, radiotherapy dose < 50 Gy, and<4 cycles of chemotherapy were associated with unfavorable 5-year OS and PFS (all P<0.05), and CHOP-like regimen was the risk factor of unfavorable 5-year PFS ( P<0.05). Multivariate analysis demonstrated that primary tumor invasion, ECOG≥2, and radiotherapy dose <50 Gy were associated with unfavorable OS and PFS (all P<0.05), and stage Ⅱ was the risk factor of unfavorable 5-year OS ( P<0.05). Conclusions:The prognosis of early stage low-risk UADT ENKTCL of is favourable. Sufficient dose of extended involved-field radiotherapy is an important curative modality in early stage UADT ENKTCL. Compared with radiotherapy alone, radiotherapy combined with chemotherapy can significantly improve the prognosis of early stage UADT ENKTCL patients in the unfavourable prognosis group. Full-course chemotherapy can significantly prolong the long-term survival in the unfavorable prognosis group. The chemotherapy containing asparaginase can significantly enhance the prognosis of patients with early stage UADT ENKTCL.

【Objective】 To improve method for determinating of biological potency of IgG Fc fragment in Chinese Pharmacopoeia and establish a method which is suitable for enzyme-labeled instrument. 【Methods】 The biological properties of FC fragment of IVIG in Chinese Pharmacopiea(General 3514) was adjusted, including sensitization process, sample treatment and dynamic curve parameters. Meanwhile, the kinetic curve of hemolysis was fitted with Origin, which made the method more suitable for enzyme plate. The biological properties of Fc fragment of IVIG was calculated by kinetics curve reaction of reference and sample. 【Results】 The method are stable, the RSD of repeatability and intermediate is 10%, also with significant improvement in efficiency. 【Conclusion】 The detection of properties of Fc fragment of IVIG is stable and efficient, it can be used for properties of Fc fragment of IVIG.

Objective: To analyze the clinical efficacy and prognostic factors of patients with early-stage diffuse large B-cell lymphoma of Waldeyer′s ring (WR-DLBCL) treated with CHOP-based chemotherapy. Methods: A total of 137 patients diagnosed with WR-DLBCL admitted to our hospitalfrom 2006 to 2018 were enrolled, including 22 patients with stage Ⅰ and 115 patients with stage Ⅱ WR-DLBCL. All patients received CHOP-based chemotherapy, of whom 62 receiving rituximab and 87 receiving involved-field radiotherapy. The overall survival (OS), progression-free survival (PFS) and local recurrence-free survival (LRRFS) were calculated by Kaplan-Meier method. Log-rank test, was conducted for univariate analysis and Cox’s regression model was performed for multivariate analysis. Results: The 5-year OS, PFS, and LRFFS in the whole group were 78.6%, 69.5% and 83.2%, and 87.5%, 80.2%, 90.9% in the comprehensive treatment group, and 64.2%, 53.6% 72.9% in the chemotherapy group, respectively. Univariate analysis showed that lactate dehydrogenase (LDH), international prognostic index score, large mass, rituximab, chemotherapy cycle and comprehensive treatment were the prognostic factors of OS and PFS. In addition, LDH, large mass and comprehensive treatment were the prognostic factors associated with LRFFS. Multivariate analysis demonstrated that LDH, comprehensive treatment mode and rituximab were the prognostic factors of OS. LDH and comprehensive treatment mode were the prognostic factors associated with PFS. LDH was a prognostic factor of LRFFS. Conclusion Patients with early-stage WR-BLBCL obtain excellent clinical prognosis. In the era of rituximab treatment, chemotherapy combined with radiotherapy remains an efficacious treatment of early-stage WR-BLBCL.