This paper provides a systematic review of the policies, regulations, and management requirements in the development and use of in vitro diagnostic reagents by healthcare institutions, along with their current implementation status both domestically and internationally, and includes a case analysis of the pilot program at Peking Union Medical College Hospital (PUMCH). The Medical Affairs Department of PUMCH, serving as the leading and operational management unit, established a multi-department collaborative governance structure and developed a full-lifecycle management model encompassing project selection, manufacturing approach determination, regulatory submission and approval, batch production, and clinical implementation. Under this management model, the hospital successfully completed five projects within just one year, achieving the highest number of project filings nationwide. Economic benefit evaluation of the first approved reagent, which is urgently required by clinical practice and named allergen-specific immunoglobulin E detection assay for Fraxinus pennsylvanica pollen, demonstrates that the project realized controllable risk and predictable commercial value, and proves that proactive implementation of systematic management model and project systematic construction is the key to successfully advancing laboratory-developed test programs. The experiences provide both theoretical insights and practical guidance for peer medical institutions seeking to develop and implement self-developed in vitro diagnostic reagents.

Objective To discuss the curative effect of interventional embolization using vascular plug together with spring coil in treating varicocele.Methods A total of 15 patients with varicocele,who were admitted to authors'hospital between March 2022 and October 2022 to receive treatment,were enrolled in this study.Interventional embolization therapy by using vascular plug together with spring coil via the left elbow vein access or via the femoral vein access was carried out in all the 15 patients.The instant surgical success rate,complications,time spent for operation,average hospital stay,and postoperative clinical efficacy were recorded and analyzed.Results Successful interventional embolization using vascular plug together with spring coil was accomplished in all the 15 patients,and no complications occurred during the perioperative period.The time spent for operation was(19±12)min,and the average hospital stay was 2.3 days.The patients were followed up for one month,the degree of the scrotal varices was obviously improved,and the swelling feeling of the perineum was significantly reduced.Conclusion For the treatment of varicocele,the interventional embolization using vascular plug together with spring coil carries certain advantages,such as reliable curative effect,easy to operate,patient being more comfortable,fast recovery,and less complications.Therefore,this technique is a therapeutic approach worth further investigation.(J Intervent Radiol,2024,32:73-76)

Objective To investigate the prediction model of hypotension in patients with hepato-cellular carcinoma resection using controlled low central venous pressure technique(CLCVP).Methods A total of 144 patients with liver cancer admitted from January 2020 to June 2023 were retrospectively ana-lyzed,including 81 males and 63 females,aged 45-64 years,BMI 22-26 kg/m2,ASA physical status Ⅰ or Ⅱ.144 patients were randomly divided into trial set(n=96)and verification set(n=48)according to 2:1.The trial set and verification set were divided into hypotensive group and non-hypotensive group ac-cording to whether hypotension occurred after operation.Preoperative albumin,preoperative hemoglobin,op-eration method,operation time,tumor site,tumor size,hilar block time,number of hilar block times,hilar block interval time,blood loss,mean intraoperative CVP,intraoperative fluid volume,and intraoperative u-rine volume were collected.Univariate and multivariate Logistic analysis were used to analyze the risk factors of hypotension in the experimental group,and a risk prediction model was established.The risk prediction model was verified in the validation group.Results There were 29 patients(30.2％)of postoperative hy-potension in the test group and 15 patients(31.3％)of postoperative hypotension in the validation group.Compared with the non-hypotensive group,the preoperative albumin in the hypotensive group was signifi-cantly decreased(P<0.05),the operation time was significantly prolonged,the ratio of tumor diameter≥5 cm,and the amount of blood loss were significantly increased(P<0.05).Multivariate analysis showed that preoperative albumin elevation(OR=0.216,95％CI 0.164-0.665,P<0.05)was an independent protective factor for postoperative hypotension.Prolonged operative time(OR=2.649,95％CI 1.802-7.553,P<0.05),tumor diameter≥5 cm(OR=3.789,95％CI 2.011-12.458,P<0.05),in-creased blood loss(OR=8.873,95％CI 2.750-17.553,P<0.05)was an independent risk factor for postoperative hypotension.According to the results of multi-factor analysis,the risk factors of postoperative hypotension in patients with controlled low central venous pressure hepatocellular carcinoma resection were established:F=-408.64-(1.534×preoperative albumin)+(0.974×operation time)+(1.332×tumor diameter≥5 cm)+(2.183×blood loss).The risk model was validated in the validation set,and the area under the ROC curve(AUC)was0.821(0.695-0.943),the sensitivity was71.7％,and the speci-ficity was 86.5％.The Hosmer-Lemeshow goodness of fit test showed that χ2=10.654,P=0.222.Conclusion Prolonged operative time,tumor diameter≥5 cm and increased blood loss are risk factors for hypotension after hepatocellular carcinoma resection using CLCVP technique,and higher preoperative albumin is protective factor.The establishment of risk prediction model through multi-factor analysis has good forecasting value.

Objective:To observe the effects of acupuncture and moxibustion on phosphatase and PTEN-induced putative kinase 1(PINK1)/Parkin signaling pathway in the midbrain substantia nigra of Thy1-α synuclein(αSyn)transgenic model mice with Parkinson disease(PD). Methods:Twenty-four Thy1-αSyn transgenic mice were randomly divided into a model group,an acupuncture group,an acupuncture + moxibustion group,and a Western medicine group.Six wild-type mice in the same litter were used as the wild-type group.In the acupuncture group,Baihui(GV20)and Yanglingquan(GB34)were selected for acupuncture.In the acupuncture + moxibustion group,Guanyuan(CV4)was added on the basis of the acupuncture group.The Western medicine group was given rapamycin intraperitoneal injection at a dose of 10 mg/(kg·bw).The wild-type group and the model group were fixed without intervention.The overall rod performance(ORP)score of mice was observed in each group.The immunohistochemical method was used to detect the tyrosine hydroxylase(TH)positive neurons in the substantia nigra of mice in each group.The αSyn was detected by the immunofluorescence chemical method.The expression levels of αSyn,microtubule-associated protein 1 light chain 3(LC3)-Ⅱ/LC3-Ⅰ,autophagy protein sequestosome-1/protein 62(SQSTM-1/p62),PINK1,Parkin,and ubiquitin-specific protease 30(USP30)proteins were detected by Western blotting assay.The expression levels of LC3B,p62,PINK1,Parkin,and USP30 mRNAs were detected by fluorescence quantitative polymerase chain reaction. Results:Compared with the wild-type group,the ORP score,the p62,PINK1,and Parkin protein expression levels decreased significantly(P<0.01),the PINK1 mRNA expression level decreased(P<0.05),while the protein and mRNA expression levels of USP30 increased(P<0.05)in the model group.Compared with the model group,the ORP score in the acupuncture group and the acupuncture + moxibustion group increased(P<0.05);the expression level of LC3-Ⅱ/LC3-Ⅰ protein in the acupuncture + moxibustion group and the Western medicine group increased(P<0.05);the protein expression levels of p62,PINK1,and Parkin increased(P<0.05),while the USP30 protein expression level decreased significantly(P<0.01)in the acupuncture group,the acupuncture + moxibustion group,and the Western medicine group;the Parkin mRNA expression level in the acupuncture group and the acupuncture + moxibustion group increased(P<0.05);the USP30 mRNA expression level in the acupuncture + moxibustion group decreased(P<0.05). Conclusion:Acupuncture and moxibustion regulate the related molecule expression levels of PINK1/Parkin signaling pathway in the Thy1-αSyn transgenic PD model mice and promote the autophagy degradation of αSyn to exert the protective effect of dopaminergic neurons.

Myocardial fibrosis is a key link in the occurrence and development of diabetic cardiomyopathy. Its etiology is complex, and the effect of drugs is not good.Cardiomyocyte apoptosis is an important cause of myocardial fibrosis. The purpose of this study was to investigate the effect of gaseous signal molecule sulfur dioxide (SO2 ) on diabetic myocardial fibrosis and its internal regulatory mechanism. Masson and TUNEL staining, Western-blot, transmission electron microscopy, RT-qPCR, immunofluorescence staining, and flow cytometry were used in the study, and the interstitial collagen deposition, autophagy, apoptosis, and changes in phosphatidylinositol 3-kinase (PI3K)/AKT pathways were evaluated from in vivo and in vitro experiments. The results showed that diabetic myocardial fibrosis was accompanied by cardiomyocyte apoptosis and down-regulation of endogenous SO2 -producing enzyme aspartate aminotransferase (AAT)1/2 . However, exogenous SO2 donors could up-regulate AAT1/2 , reduce apoptosis of cardiomyocytes induced by diabetic rats or high glucose, inhibit phosphorylation of PI3K/AKT protein, up-regulate autophagy, and reduce interstitial collagen deposition. In conclusion, the results of this study suggest that the gaseous signal molecule SO2 can inhibit the PI3K/AKT pathway to promote cytoprotective autophagy and inhibit cardiomyocyte apoptosis to improve myocardial fibrosis in diabetic rats. The results of this study are expected to provide new targets and intervention strategies for the prevention and treatment of diabetic cardiomyopathy.

Background: Global spread and impact of the coronavirus disease 2019 (COVID-19) pandemic are determined to a large extent,by resistance to the pandemic and public response of all countries in the world;while a country's resistance and response are in turn determined by its political and socio economic conditions.To inform future disease prevention and control,we analyzed global data to exam the relationship between state vulnerabilities and COVID-19 incidences and deaths.Methods: Vulnerability was measured using the Fragile States Index (FSI).FSI is created by the Fund for Peace to assess levels of fragility for individual countries.Total FSI score and scores for 12 specific indicators were used as the predictor variables.Outcome variables were national cumulative COVID-19 cases and deaths up to September 16,2020,derived from the World Health Organization.Cumulative incidence rates were computed using 2019 National population derived from the World Bank,and case fatality rates were computed as the ratio of deaths/COVID-19 cases.Countries with incomplete data were excluded,yielding a final sample of 146 countries.Multivariate regression was used to examine the association between the predictor and the outcome measures.Results: There were dramatic cross-country variations in both FSI and COVID-19 epidemiological measurements.FSI total scores were negatively associated with both COVID-19 cumulative incidence rates (β =-0.0135,P ＜ 0.001) and case fatality rates (β =-0.0147,P ＜ 0.05).Of the 12 FSI indicators,three negatively associated with COVID-19 incidences were E1(Economic Decline and Poverty),E3 (Human Flight and Brain Drain),and S2 (Refugees and Internally Displaced Persons);two positively associated were P1 (State Legitimacy) and X1 (External Intervention).With regard to association with case fatality rates,C1 (Security Apparatus) was positive,and P3 (Human Rights and Rule of Law) and X1 was negative.Conclusion: With FSI measures by the Fund of Peace,overall,more fragile countries are less likely to be affected by the COVID-19 pandemic,and even if affected,death rates were lower.However,poor in state legitimacy and lack of external intervention are risk for COVID-19 infection and lack of security apparatus is risky for COVID-19 death.Implications of the study findings are discussed and additional studies are needed to examine the mechanisms underpinning these relationships.

Objective · To explore the correlation of serum S100B protein with depressive episode of bipolar disorder (BD) and its prognosis.Methods· Based on BD criteria of Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-Ⅳ),80 patients with depressive episode of BD (case group) and 42 healthy controls (control group) were enrolled.Patients were randomly assigned into quetiapine group who were treated with lithium and quetiapine and modified electroconvulsive therapy (MECT) group who received lithium and MECT.The serum S100B level and Hamilton Rating Scale for Depression (HAMD) were assayed before and after 4-week treatment.Results· The serum S100B levels before treatment in patients with depressive episode of BD were significantly higher than those in healthy controls (P=0.000).The levels of S100B in both drug and MECT groups decreased after 4-week treatment.The HAMD score after treatment significantly decreased than that before treatment (P=0.000).Pearson correlation analysis showed that the change of S 100B level was positively correlated with the change of HAMD score before and after treatment in case group (r=0.33,P=0.013).Conclusion· S100B may be associated with depressive episode of BD and its prognosis.

Objective To evaluate the feasibility of the three-dimensional brain artery vessel wall imaging technology reverse rotation angle of fast spin echo (T1 W-SPACE)in the diagnosis of ischemic cerebrovascular disease by comparing it with TOF vascular imaging in magnetic resonance. Methods Patients undergoing stroke but stable condition,including 50,patients with transient cerebral ischemia (TIA)or a history of stroke,examined by TOF-MRA and routine MRI sequence first,then followed by T1 W-SPACE.Results In 43 of 50 cases,conventional MRI sequences detectiog was positive,TOF-MRA found the vascular stenosis in 76 branches,T1 W-SPACE found the vascular stenosis in 73 branches,there was no difference between the two groups(χ2 =0.625,P >0.05);Conventional TOF-MRA cannot detect the vascular wall, T1 W-SPACE found that arterial wall thickening,plaque in 48 branches.Conclusion Compared with the TOF-MRA,T1 W-SPACE can not only detect the vessel stenosis,but also the vessel wall and plaque,and can also type on plaque from pathology angle,has im-portant clinical significance for early prevention and treatment of stroke.

BACKGROUND:Cytochrome P450 ( CYP) epoxygenases metabolize arachidonic acids ( AA) to form epoxyeicosatrienoic acids
(EETs), which exert beneficial roles in the treatment of cardiovascular diseases , but little is known about its role on adventitial remo-deling.METHODS:We used C57BL/6J mice in vivo and primary rat adventitial fibroblasts ( AFs) in vitro treated with angiotensin II (Ang II) to investigate the effects of CYP2J2 gene delivery and exogenous EETs administration on adventitial remodeling .RESULTS:CYP/sEH system was found to exist in human adventitia , and involved in adventitial remodeling process .Exogenous EETs administra-tion significantly inhibited Ang II-induced AFs activation , characterized by differentiation , proliferation, migration, and collagen syn-thesis.These protective effects were partially reversed by PPARγantagonist GW9662 pretreatment or SOCS3 siRNA transfection.EETs suppressed Ang II-induced IκBαphosphorylation , subsequent NF-κB nuclear translocation via PPARγdependent signaling pathway in AFs.Additionally, EETs reduced Ang II-induced JAK2, STAT3 phosphorylation and subsequent phosphor-STAT3 nuclear transloca-tion, which were mediated by SOCS3 induction but independent of PPARγactivation.Furthermore, rAAV-CYP2J2 gene delivery re-duced vessel wall thickening , AFs differentiation , proliferation and collagen deposition in aortic adventitia induced by Ang II infusion , which were mediated by NF-κB and SOCS3/JAK/STAT signaling pathways in blood pressure-dependent and -independent manners , re-spectively.CONCLUSION:We concluded that CYP2J2 overexpression attenuated Ang II-induced adventitial remodeling via PPARγ-dependent NF-κB and PPARγ-independent SOCS 3/JAK/STAT inflammatory signaling pathways .

OBJECTIVETo investigate the cytochrome P450 2E1 (CYP2E1) RsaI/PstI and DraI polymorphisms in workers exposed to benzene.

METHODSA cross-sectional survey was carried out. A total of 71 workers exposed to benzene were included in observation group and the same number of people without occupational benzene exposure were included in control group. Blood samples from the two groups were collected and genotyping for CYP2E1 RsaI/PstI and DraI were conducted using the polymerase chain reaction-restriction fragment length polymorphism.

RESULTSThere were no significant differences in CYP2E1 DraI genotype and allele distributions between the observation group and the control group (χ² = 2.374, P > 0.05; χ² = 2.113, P > 0.05). Significant differences in CYP2E1 RsaI/PstI genotype and allele distributions between the two groups were observed (χ² = 9.129, P < 0.01; χ² = 6.028, P < 0.05).

CONCLUSIONMutations at CYP2E1 RsaI/PstI can enhance the expression of CYP2E1 and this suggests individuals with the mutated gene have increased susceptibility to chronic benzene poisoning.

Alleles ; Benzene ; poisoning ; Cross-Sectional Studies ; Cytochrome P-450 CYP2E1 ; genetics ; metabolism ; Genetic Predisposition to Disease ; Genotype ; Humans ; Poisoning ; genetics ; Polymerase Chain Reaction ; Polymorphism, Genetic ; genetics ; Polymorphism, Restriction Fragment Length