Objective To evaluate the efficacy of the DAP database in reducing radiation hazards during cardiovascular intervention.Methods The study conducted a retrospective analysis of all consecutive cardiovascular cases in the database from April 1st,2016 to June 30th,2016.Based on the imaging systems,an inage intensifier (Ⅱ) and a flat panel detector (FPD),the cases of patients undergoing coronary angiography (CAG) and percutaneous coronary interventions (PCI) were collected to observe Body Mass Index (BMI),fluoroscopy time (FT) and dose area product (DAP).Results The FT and DAP values in CAG were (3.26-±2.59) min and (1 938±1 296) μGy·m2 for the Ⅱ system and (3.00 ± 2.89) min and (3 718 ± 2 859) μGy· m2 for the FPD system,respectively,whereas,the FT and DAP values in PCI were (17.81 ± 12.71) min and (8 899 ±7 032) μGy·m2 for the Ⅱ system and (21.99 ± 15.91) min and (19 526 ± 14 134) μGy · m2 for the FPD system,respectively.The differences in DAP values (x ± s) for CAG and PCI between the angiography systems were significant(t =-10.664,11.239,P ＜ 0.05).The DAP and total DAP values during PCI for fluoroscopy from the FPD systen were 3 596 755.60 and 4 881 484.50 μGy · m2,respectively.Conclusions The DAP values in CAG and PCI using FPD system are much higher than the relevant data.The use of an FPD system resulted in higher DAP values compared to the Ⅱ system in cardiovascular interventional procedures.Reduction in fluoroscopy time may decrease radiation hazards during PCI.The DAP database allows for a fast,convenient and enough objective data to discovery timely difference and variation in dose in cardiovascular interventional procedures.

Objective: To establish a determination method for the related substances in nortriptyline hydrochloride by HPLC. Methods:An Agilent C18 (250 mm × 4. 6 mm,5 μm) column was adopted with a mobile phase consisting of acetonitrile-0. 2% trieth-ylamine(pH 3. 0)(34 ∶66). The flow rate was 1. 0 ml·min-1, the detection wavelength was set at 210 nm, the column temperature was 40℃ and the injection volume was 20 μl. Results:The resolutions of the related substances were acceptable. The detection limit and the quantitation limit of the samples was 0. 40 ng and 1. 35 ng, respectively. Conclusion: The method is sensitive, accurate and specific, and can be used to determine the related substances in nortriptyline hydrochloride.

Objective To evaluate mini-dose pre-injection test in the use of contrast-enhanced magnetic resonance angiography (CEMRA), and to inspect the possibility of contrast medium peak-time prediction by age, body weight and heart rate.Methods The data from mini-dose pre-injection test of contrast medium before vertebral artery CEMRA were retrospectively reviewed in 55 patients. The linear correlation and regression of the data including age, body weight, heart rate, and the reaching-time, peak-value-time, duration and peak-value-signal of contrast medium was performed by using SPSS software.Results The age (n=55, =62 years old, M=59 years old), body weight (n=55, = 63 kg), heart rate (n=40, =73 beats per minute), peak-value-time (n=55,=17.5 seconds), peak signal intensity (n=55,=472), and duration of contrast (n=49,=10.35 seconds)were analyzed. No statistically significant correlation existed between peak-value-time of contrast medium and the age (r=0.231, t=1.728, P=0.090), body weight (r=0.118, t=0.865, P=0.392), and heart rate (r= -0.046, t=-0.284, P=0.776). The peak-value-time correlated negatively with peak signal intensity (r=-0.322, t=-2.56, P=0.016)and positively with duration of contrast (r=0.658, t=5.99, P=0.000). The peak signal intensity was negatively correlated with body weight(r=-0.356, t=-2.77, P=0.008). The linear regression analysis show b=-0.284, t=-2.285, P=0.026 between peak-value-signal and peak-value-time, b=-0.322, t=2.590, P=0.012 between peak-value-signal and body weight.Conclusion Mini-dose pre-injection test was more helpful to adjust the rate of contrast medium injection and determine the time delay during scanning. But the prediction of contrast peak-time based on age, body weight and heart rate was unreliable.

Objective To investigate the relationship between body mass index (BMI) and dose area product (DAP) as well as fluoroscopy time during coronary angiography (CAG) in Han nationality subjects in order to improve early judging and reducing high radiation risk. Methods CAG materials of 451 Han nationality subjects were retrospectively analyzed. The patients included 276 males (age 32-87 years) and 175 females (age 42-84 years), and the BMI values ranged from 17.30 to 35.42 kg/m2. According to BMI values, the patients were divided into group A(BMI<20 kg/m2,n=25), group B (BMI 20-24.9 kg/m2,n=204), group C (BMI 25-29.9 kg/m2,n=192) and group D (BMI>30 kg/m2,n=30). The mean DAP and fluoroscopy time of each group were calculated; the DAP values were compared between each other among the four groups by using nonparametric Kruskal-Wallis test, while the fluoroscopy time was compared between each other among the four groups by using single factor analysis of variance or LSD-t test. Results The mean DAP of group A, B, C and D was(1 070.07±541.33) μGym2,(1 326.82±606.91) μGym2,(1 937.99±1 030.31) μGym2 and (2 654.53±1 296.69) μGym2 respectively. The mean fluoroscopy time of group A, B, C and D was (3.53± 2.08) min, (2.70 ±1.80) min, (2.75 ±1.88) min and (2.71 ±1.69) min respectively. Statistically significant difference in DAP values existed between each other among the four groups (P<0.05) except between group A and group B (P=0.232). Statistically significant difference in fluoroscopy time existed between group A and other three groups (P<0.05), while the difference in fluoroscopy time between each other among B, C and D groups was not significant (P>0.05). Conclusion The DAP values of adult Han subjects receiving CAG are increased with the increase of BMI values; the fluoroscopy time is significantly prolonged in patients with BMI<20 kg/m2. In performing interventional procedure, the operator should not only understand that the increase of BMI can cause the increase of DAP, but also need to pay special attention to the increase of DAP value caused by operation difficulty when the patient’s BMI is <20 kg/m2.

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.

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.

Objective To evaluate the application value of Smart Mask technology guiding micro-catheter in place for intracranial aneurysm embolization in endovascular interventional treatment. Methods The DSA data of 61 consecutive patients with unruptured intracranial aneurysm in the Department Neurosurgery,Changhai Hospital,the Second Military Medical University from August 5 to December 20,2016 were collected retrospectively. The conditions of the guildewire catheter reaching the aneurysms and the coil embolization in the Smart Mask technology group (n = 31)and conventional road map group (n = 30)were compared. The observation indexes included the differences in contrast agent dosage,exposure time,and operation time. Results The contrast agent dosage of the Smart Mask technology group and road map technology group were 192 ± 37 and 215 ± 40 ml respectively,the X-ray illumination quantity were 5913 ±1682 and 6975 ±2036 mGy respectively,and the operation time were 2. 62 ± 0. 29 h and 2. 94 ± 0. 35 h respectively. The differences were statistically significant (all P < 0. 05 ). Conclusion Using Smart Mask technology to assist endovascular embolization of intracranial aneurysms can effectively shorten the operation time,reduce the amount of X-ray radiation and contrast agent,and reduce the risk of operation.

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.

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.