Objective:To assess the safety and efficacy of Blinatumomab in treating children with acute B-lymphoblastic leukemia（B-ALL）.Methods:The clinical data of 10 B-ALL children who were admitted to the Department of Pediatrics，the First Affiliated Hospital of Xi’an Jiaotong University from May 2022 to April 2024 and treated with Blinatumomab were analyzed retrospectively.Results:All the 10 cases had a complete remission of bone marrow and all minimal residual disease（MRD）were negative. Serious adverse events were reported after chemotherapy，including intracranial venous sinus thrombosis with acute cerebral infarction，acute pancreatitis，paralytic ileus，syndrome of abnormal secretion of antidiuretic hormone，severe pneumonia，liver injury，sepsis（β-lactamase resistant Escherichia coli，Pseudomonas aeruginosa），oral mucositis，persistent agranulocytosis with bloodstream infection. All patients interrupted chemotherapy and received Blinatumomab injections for 14 days. During treatment，there was hematological toxicity，which resulted in grade 3-4 neutropenia in 5 cases within the first 7 days. Transient low-grade fever was observed in 4 cases of non-hematological toxicity during days 1-3 of treatment. One patient experienced a headache on the 7th day of treatment，which worsened on the 14th day，but it improved with mannitol treatment. Mild liver injury was present in 3 cases. Interleukin-6 reached a peak of 71.86 pg/mL on the second day of treatment in one case，whereas it was normal in others. All patients were found to be free of cytokine release syndrome. T lymphocyte count increased in 5 patients after 14 days of Blinatumomab treatment，but B lymphocyte count and serum immunoglobulin levels declined in 10 patients. Hypogammaglobulinemia was observed in 3 of these patients. The median follow-up time was 7.8（3.0-24.0）months. All patients achieved MRD-negative complete remission and 6-month overall survival rate and progression-free survival were both 100%.Conclusion:Children with B-ALL can benefit from using Blinatumomab，which is safer than conventional chemotherapy，as a new treatment strategy for those who cannot tolerate traditional chemotherapy.

Objective:To explore the longitudinal trajectory of sleep disorders and their influencing factors in newly diagnosed breast cancer patients, and provide theoretical basis for formulating intervention measures to improve sleep quality of breast cancer patients.Methods:A longitudinal study was conducted using convenience sampling to select newly diagnosed breast cancer patients from Shandong Provincial Third Hospital and Shandong First Medical University Affiliated Provincial Hospital from April 2023 to June 2024. General information questionnaires, the Pittsburgh Sleep Quality Index (PSQI), the Concerns About Recurrence Scale (CARS), and the Distress Disclosure Index (DDI) were used for the survey. The Kruskal-Wallis H test and generalized estimating equation models were used to examine sleep disorders and their influencing factors. Results:A total of 473 valid questionnaires were collected. Among the 473 newly diagnosed breast cancer patients, 435 were female and 38 were male, aged (49.5 ± 11.0) years old. The CARS score at admission was (3.00 ± 1.12) points, with concerns about death (0.71 ± 0.67) points and concerns about female characteristics (0.81 ± 0.72) points. The DDI score at admission was (27.00 ± 10.03) points. The PSQI scores at admission, discharge, and one month after discharge were (15.34 ± 3.05), (12.12 ± 3.01), and (10.13 ± 1.78) points, respectively, the difference was statistically significant ( H =33.19, P<0.05). The PSQI scores at these three time points were positively correlated with the CARS score and concerns about death and female characteristics ( r values were 0.42-0.79, all P<0.05), and negatively correlated with the DDI score ( r =-0.41, -0.37, -0.31, all P<0.05). The generalized estimating equation model showed that female gender ( β=1.35, 95% CI 0.27-2.30), education level of junior high school or below ( β=1.89, 95% CI 0.24-3.19), severe pain ( β=1.72, 95% CI 0.32-3.12), moderate pain ( β=2.51, 95% CI 0.37-4.66), invasive special cancer ( β=2.57, 95% CI 1.67-4.07), invasive non-special cancer ( β=2.11, 95% CI 1.98-3.12), partial understanding of the condition ( β=1.91, 95% CI 1.23-3.01), concerns about death ( β=1.61, 95% CI 0.17-2.78), and concerns about femininity ( β=1.34, 95% CI 0.37-2.15) positively predicted the sleep quality index in newly diagnosed breast cancer patients (all P<0.05). Non-invasive cancer ( β=-3.82, 95% CI -6.79--3.36), lack of understanding of the condition ( β=-3.96, 95% CI -7.09--4.62), and DDI score ( β=-1.45, 95% CI -2.14--0.15) negatively predicted the sleep quality index (all P<0.05). Conclusions:The overall sleep quality of newly diagnosed breast cancer patients is low, with the lowest at admission and gradual improvement at discharge and one month after discharge. Medical staff should pay attention to high-risk patients who are female, have lower education levels, higher pain scores, poorer pathological types, and partial understanding of their condition.

Objective:To assess the safety and efficacy of Blinatumomab in treating children with acute B-lymphoblastic leukemia（B-ALL）.Methods:The clinical data of 10 B-ALL children who were admitted to the Department of Pediatrics，the First Affiliated Hospital of Xi’an Jiaotong University from May 2022 to April 2024 and treated with Blinatumomab were analyzed retrospectively.Results:All the 10 cases had a complete remission of bone marrow and all minimal residual disease（MRD）were negative. Serious adverse events were reported after chemotherapy，including intracranial venous sinus thrombosis with acute cerebral infarction，acute pancreatitis，paralytic ileus，syndrome of abnormal secretion of antidiuretic hormone，severe pneumonia，liver injury，sepsis（β-lactamase resistant Escherichia coli，Pseudomonas aeruginosa），oral mucositis，persistent agranulocytosis with bloodstream infection. All patients interrupted chemotherapy and received Blinatumomab injections for 14 days. During treatment，there was hematological toxicity，which resulted in grade 3-4 neutropenia in 5 cases within the first 7 days. Transient low-grade fever was observed in 4 cases of non-hematological toxicity during days 1-3 of treatment. One patient experienced a headache on the 7th day of treatment，which worsened on the 14th day，but it improved with mannitol treatment. Mild liver injury was present in 3 cases. Interleukin-6 reached a peak of 71.86 pg/mL on the second day of treatment in one case，whereas it was normal in others. All patients were found to be free of cytokine release syndrome. T lymphocyte count increased in 5 patients after 14 days of Blinatumomab treatment，but B lymphocyte count and serum immunoglobulin levels declined in 10 patients. Hypogammaglobulinemia was observed in 3 of these patients. The median follow-up time was 7.8（3.0-24.0）months. All patients achieved MRD-negative complete remission and 6-month overall survival rate and progression-free survival were both 100%.Conclusion:Children with B-ALL can benefit from using Blinatumomab，which is safer than conventional chemotherapy，as a new treatment strategy for those who cannot tolerate traditional chemotherapy.

Objective:To explore the longitudinal trajectory of sleep disorders and their influencing factors in newly diagnosed breast cancer patients, and provide theoretical basis for formulating intervention measures to improve sleep quality of breast cancer patients.Methods:A longitudinal study was conducted using convenience sampling to select newly diagnosed breast cancer patients from Shandong Provincial Third Hospital and Shandong First Medical University Affiliated Provincial Hospital from April 2023 to June 2024. General information questionnaires, the Pittsburgh Sleep Quality Index (PSQI), the Concerns About Recurrence Scale (CARS), and the Distress Disclosure Index (DDI) were used for the survey. The Kruskal-Wallis H test and generalized estimating equation models were used to examine sleep disorders and their influencing factors. Results:A total of 473 valid questionnaires were collected. Among the 473 newly diagnosed breast cancer patients, 435 were female and 38 were male, aged (49.5 ± 11.0) years old. The CARS score at admission was (3.00 ± 1.12) points, with concerns about death (0.71 ± 0.67) points and concerns about female characteristics (0.81 ± 0.72) points. The DDI score at admission was (27.00 ± 10.03) points. The PSQI scores at admission, discharge, and one month after discharge were (15.34 ± 3.05), (12.12 ± 3.01), and (10.13 ± 1.78) points, respectively, the difference was statistically significant ( H =33.19, P<0.05). The PSQI scores at these three time points were positively correlated with the CARS score and concerns about death and female characteristics ( r values were 0.42-0.79, all P<0.05), and negatively correlated with the DDI score ( r =-0.41, -0.37, -0.31, all P<0.05). The generalized estimating equation model showed that female gender ( β=1.35, 95% CI 0.27-2.30), education level of junior high school or below ( β=1.89, 95% CI 0.24-3.19), severe pain ( β=1.72, 95% CI 0.32-3.12), moderate pain ( β=2.51, 95% CI 0.37-4.66), invasive special cancer ( β=2.57, 95% CI 1.67-4.07), invasive non-special cancer ( β=2.11, 95% CI 1.98-3.12), partial understanding of the condition ( β=1.91, 95% CI 1.23-3.01), concerns about death ( β=1.61, 95% CI 0.17-2.78), and concerns about femininity ( β=1.34, 95% CI 0.37-2.15) positively predicted the sleep quality index in newly diagnosed breast cancer patients (all P<0.05). Non-invasive cancer ( β=-3.82, 95% CI -6.79--3.36), lack of understanding of the condition ( β=-3.96, 95% CI -7.09--4.62), and DDI score ( β=-1.45, 95% CI -2.14--0.15) negatively predicted the sleep quality index (all P<0.05). Conclusions:The overall sleep quality of newly diagnosed breast cancer patients is low, with the lowest at admission and gradual improvement at discharge and one month after discharge. Medical staff should pay attention to high-risk patients who are female, have lower education levels, higher pain scores, poorer pathological types, and partial understanding of their condition.

Objective:To evaluate the clinical efficacy of allogeneic hematopoietic stem cell transplantation（allo-HSCT）in children with severe aplastic anemia（SAA）.Methods:Twenty-seven cases with SAA who had been treated with allo-HSCT from January 2020 to December 2022 were retrospectively analyzed and reviewed.Results:（1）A total of 27 SAA patients were enrolled，including 18 males and 9 females，with a median age of 8 (2-15) years.There were 20 cases of SAA-Ⅰ type,7 cases of SAA-Ⅱ type.Based upon donor sources，three cases of matched sibling donors hematopoietic stem cell transplantation,and 24 cases of haploidentical hematopoietic stem cell transplantation were adopted.（2）Hematopoietic reconstruction was achieved in all 27 cases.The median implantation time of neutrophils and platelets was 10（9-20）days and 12（7-26）days respectively.The cumulative incidence of acute graft-versus-host disease（GVHD）was 66.67%（18/27）.The incidence of grade Ⅰ-Ⅱ was 55.56%（15/27）and that of grade Ⅲ-Ⅳ was 11.11%（3/27）.The incidence of chronic GVHD was 7.41%（2/27）.Transplant-associated thrombotic microangiopathy (TA-TMA) occurred in 7.41%（2/27）patients,cytomegalovirus viremia in 62.96%（17/27）patients,epstein-barr virus infection in 33.33%（9/27）patients,and 14.81%（4/27）patients progressed to post-transplant lymphoproliferative disorder (PTLD).（3）The median follow-up time was 12 (2-28) months.The overall survival rate was 96.29%.Twenty-six patients survived,and one patient died due to multiple complications of severe acute GVHD,TA-TMA,cytomegalovirus infection,PTLD and secondary epilepsy.Conclusion:Allo-HSCT is an effective therapy for SAA in children.The effective rate of this research is 96.29%.Acute GVHD is still the key to therapy.The incidence rate of acute GVHD is 66.67% in this study.The blood incompatibility of donor and recipient may affect the incidence of GVHD.The intensity of GVHD prevention should be reduced after HLA-matched sibling donor-hematopoietic stem cell transplantation so as to avoid the complications of virus recurrence and PTLD.

The policy implementation model of G. C. Edwards was used to analyze the public policy health impact assessment in Zhejiang province, and summarize its practice and existing problems in four aspects of policy implementation standards, policy resources, policy executors′ intention and management organization structure, so as to provide reference for promoting the national health impact assessment pilot work. The analysis results showed that Zhejiang province has initially established the public policy health impact assessment mechanism and achieved phased results, but there were still some problems, including the imperfection of policy content and implementation strategy, the inadequacy of leadership decision-making and top-level design, the difference in attitude, understanding and implementation preference of policy implementation subjects, and the ambiguity of the authority and responsibility system of each department in cooperation. In order to further promote the smooth development of public policy health impact assessment, Zhejiang province should actively promote the top-level design to strengthen policy support, integrate and optimize policy resources, gradually establish and improve the health governance mechanism of multiple and overall coordination, and promote the high-quality development of public policy health impact assessment by taking cross departmental cooperation as the path of health co-construction.

Objective:To collect the date of radiation dose in reference air kerma(AK) and dose-area product (DAP) values in order to evaluate the feasibility of fluoroscopy time as a monitoring and warning indicator of radiation exposure in cardiovascular interventions.Methods:The study conducted a retrospective analysis of 736 patients who underwent coronary angiography(CAG)and percutaneous coronary intervention(PCI)from November 2016 to January 2018 in Shanghai Changhai Hospital. Based on the imaging equipments(a Siemens Ceiling system and a Siemens Biplane system)and cardiovascular interventions(CAG and PCI), the fluoroscopy time, AK values and DAP values were collected. The correlation of the radiation dose and fluoroscopy time was analyzed using Spearman correlation statistics.Results:The mean values of fluoroscopy time, fluoroscopy AK, total AK, fluoroscopy DAP and total DAP were(8.9±7.8)min, (472±474), (703±595)mGy, (4 578±4 085)and(6 253±4 938)μGy·m 2 for Ceiling system and(8.6±7.3)min, (510±509), (733±614)mGy, (4 255±3 781)and (5 681±4 432)μGy·m 2 for Biplane system, respectively. The mean values of CAG and PCI fluoroscopy time were(2.4±0.9)and(15.7±4.9)min, respectively.The ratio of fluoroscopy radiation dose (AK and DAP) to total dose was 74% and 78% in PCI procedures. There was a strongly correlation between fluoroscopy time and total AK ( r=0.822) or total DAP ( r=0.844) in cardiovascular interventions ( P<0.001). Conclusions:The radiation dose of fluoroscopy acquisition is the main source of overall radiation dose in cardiovascular interventions. Radiation dose is expected to increase as fluoroscopy time increases.The fluoroscopy timer as a protective tool of radiation exposure has a good reference and warning value in the clinical application of cardiovascular interventions.

The Chinese materia medica pharmaceutical process route designed for green manufacturing, also known as “green design”, aims to minimize the resource consumption and environmental effect of the life cycle of products process, coordinate and optimize economic and environmental efficiency. With membrane technology at the core of the pharmaceutical separation process technology closely related to green manufacturing of drugs. The three major requirements and maturity of “environment, performance, and cost” and separation technology principle are the basic elements of the pharmaceutical separation process green design. The development and adoption of clean technology not only conforms to the “principle of precautionary superior to governance”, but also reduces the consumption of raw materials and energy, and at the same time improves the economic efficiency of the enterprises. It is the best way to protect the coordinated development of the ecological environment and economic construction. In this paper, taking the construction of “membrane and resin technology system integration” as an example, the specific implementation plan for the green design of Chinese materia medica pharmaceutical process is introduced, and the technical economical problems in the design of pharmaceutical separation process are analyzed and discussed.

This study was carried out to investigate the pharmacokinetics/bioequivalence of levornidazole disodium phosphate by using stable isotope labeled drug, evaluated the pharmacokinetic profile and confirmed the prodrug characteristics of levornidazole disodium phosphate in monkey. Levornidazole (Drug A) and stable isotope ¹⁵N labeled levornidazole disodium phosphate (Drug B) were mixed with equal mole amount (experiment I); stable isotope ¹⁵N labeled levornidazole disodium phosphate (Drug B) and levornidazole disodium phosphate (Drug C) were mixed with equal mole amount, respectively. After giving the mixed drugs to the monkey, the concentration of ¹⁵N-levornidazole disodium phosphate, levornidazole disodium phosphate, ¹⁵N-levornidazole and levornidazole in plasma samples of pre-dosing and 24 h after administration were analyzed by a liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) method. Pharmacokinetic calculations were performed through non-compartmental analysis using WinNonlin software. Two-sided 90% confidence intervals (CI) were used to evaluate the bioequivalence of two drugs. The results showed that levornidazole disodium phosphate was metabolized to levornidazole rapidly after administration, the body exposure were increased with the dosage. The method of bioequivalence used in this study was different from the traditional two periods, crossover design. By using the method of this study, the effects of administration period, intra-individual variability, and sequence of administration on bioequivalence were avoided. The results of this study had successfully supported the pharmacokinetic and bioequivalence study of this drug in human using the same approach.