Objective To establish an evaluation indicator system for pharmacovigilance(PV)work in medical institutions of Fujian province,and provide a reference for the PV work in healthcare facilities.Methods Based on literature analysis and interpretation of policies and regulations,combined with the practical pharmacovigilance work in Fujian province,a preliminary indicator system was constructed.Following this,three rounds of expert consultation were conducted,including two rounds of the Delphi method to determine the content of the index system,and one round of the Analytic Hierarchy Process(AHP)to determine the weights of each index.Results A total of 9 primary indicators,23 secondary indicators,and 59 tertiary indicators were selected for the evaluation of pharmacovigilance work in health facilities of Fujian province,including pharmacovigilance organizational structure,human resources,equipment resources,development and documentation of the quality management system's procedural documents,Performance indicators for monitoring and reporting,risk identification,assessment,control and research capabilities.The consensus coefficients for three rounds of consultation with experts were 100％,100％,and 100％.The average authority coefficient of the experts was 0.878,and the expert coordination coefficients for the two rounds of Delphi method were 0.081 and 0.343,respectively(P＜0.001).In the AHP,the weight vector for primary indicators ranged from 0.023 to 0.263,with a maximum eigenvalue of 9.195.The weight vector values of the secondary indicators were from 0.096 to 1.000,and the maximum eigenvalues were 3.018-4.061;The weight vectors of the tertiary indicators were 0.143 to 1.000,and the maximum eigenvalues were from 3.000 to 5.078.The consistency ratio(CR)of each judgment matrix was between 0 and 0.051.Conclusions The constructed indicator of capability assessment model,integrating regulatory functions and the practical situation of medical institutions,can be used by regulatory authorities to assess pharmacovigilance work in medical institutions.It provides a solid reference for improving the pharmacovigilance capabilities of medical institutions in Fujian province.

Objective To investigate the difference of spontaneous hemorrhagic transformation(HT)in enlarged perivascular space(EPVS)of different site and various dilation in patients with acute ischemic stroke.Methods A total of 595 patients admitted to our department acute ischemic stroke from January 2021 to June 2024 were recruited in this study.Brain magnetic resonance ima-ging was conducted in all of them within 72 h after admission,and their EPVS status was collect-ed.According to the results of brain MRI,they were divided into EPVS(384 cases)and non-EPVS(211 cases)groups.Based on EPVS site,the EPVS group was further assigned into basal ganglia(135 cases),centrum semiovale(132 cases),and midbrain(117 cases)subgroups,and based on the severity,the group was also into mild(155 cases)and severe(229 cases)subgroups.Brain CT or MRI examination was re-performed on the 7th to 10th day during hospitalization to investigate the intracranial condition,and then spontaneous HT was evaluated.The incidence of spontaneous HT in the EPVS patients of different sites and severity was analyzed and compared.Results The incidence of spontaneous HT was significantly higher in the EPVS group than the non-EPVS group(27.08％vs 8.53％,P＜0.01),and the incidence of spontaneous HT was also obviously higher in the basal ganglia subgroup than the centrum semiovale subgroup and then the midbrain subgroup(40.00％vs 21.97％vs 17.95％,P＜0.01).What's more,the severe subgroup had nota-bly higher incidence of spontaneous HT than the mild subgroup(33.19％vs 18.06％,P＜0.01).Conclusion There is difference in spontaneous HT among acute ischemic stroke patients with EPVS of different site and severity.EPVS in the basal ganglia and of severe level indicates a high-er risk of spontaneous HT,and the two features can better predict the incidence of spontaneous HT.

Objective To establish an evaluation indicator system for pharmacovigilance(PV)work in medical institutions of Fujian province,and provide a reference for the PV work in healthcare facilities.Methods Based on literature analysis and interpretation of policies and regulations,combined with the practical pharmacovigilance work in Fujian province,a preliminary indicator system was constructed.Following this,three rounds of expert consultation were conducted,including two rounds of the Delphi method to determine the content of the index system,and one round of the Analytic Hierarchy Process(AHP)to determine the weights of each index.Results A total of 9 primary indicators,23 secondary indicators,and 59 tertiary indicators were selected for the evaluation of pharmacovigilance work in health facilities of Fujian province,including pharmacovigilance organizational structure,human resources,equipment resources,development and documentation of the quality management system's procedural documents,Performance indicators for monitoring and reporting,risk identification,assessment,control and research capabilities.The consensus coefficients for three rounds of consultation with experts were 100％,100％,and 100％.The average authority coefficient of the experts was 0.878,and the expert coordination coefficients for the two rounds of Delphi method were 0.081 and 0.343,respectively(P＜0.001).In the AHP,the weight vector for primary indicators ranged from 0.023 to 0.263,with a maximum eigenvalue of 9.195.The weight vector values of the secondary indicators were from 0.096 to 1.000,and the maximum eigenvalues were 3.018-4.061;The weight vectors of the tertiary indicators were 0.143 to 1.000,and the maximum eigenvalues were from 3.000 to 5.078.The consistency ratio(CR)of each judgment matrix was between 0 and 0.051.Conclusions The constructed indicator of capability assessment model,integrating regulatory functions and the practical situation of medical institutions,can be used by regulatory authorities to assess pharmacovigilance work in medical institutions.It provides a solid reference for improving the pharmacovigilance capabilities of medical institutions in Fujian province.

Objective To investigate the difference of spontaneous hemorrhagic transformation(HT)in enlarged perivascular space(EPVS)of different site and various dilation in patients with acute ischemic stroke.Methods A total of 595 patients admitted to our department acute ischemic stroke from January 2021 to June 2024 were recruited in this study.Brain magnetic resonance ima-ging was conducted in all of them within 72 h after admission,and their EPVS status was collect-ed.According to the results of brain MRI,they were divided into EPVS(384 cases)and non-EPVS(211 cases)groups.Based on EPVS site,the EPVS group was further assigned into basal ganglia(135 cases),centrum semiovale(132 cases),and midbrain(117 cases)subgroups,and based on the severity,the group was also into mild(155 cases)and severe(229 cases)subgroups.Brain CT or MRI examination was re-performed on the 7th to 10th day during hospitalization to investigate the intracranial condition,and then spontaneous HT was evaluated.The incidence of spontaneous HT in the EPVS patients of different sites and severity was analyzed and compared.Results The incidence of spontaneous HT was significantly higher in the EPVS group than the non-EPVS group(27.08％vs 8.53％,P＜0.01),and the incidence of spontaneous HT was also obviously higher in the basal ganglia subgroup than the centrum semiovale subgroup and then the midbrain subgroup(40.00％vs 21.97％vs 17.95％,P＜0.01).What's more,the severe subgroup had nota-bly higher incidence of spontaneous HT than the mild subgroup(33.19％vs 18.06％,P＜0.01).Conclusion There is difference in spontaneous HT among acute ischemic stroke patients with EPVS of different site and severity.EPVS in the basal ganglia and of severe level indicates a high-er risk of spontaneous HT,and the two features can better predict the incidence of spontaneous HT.

Heart failure(HF)is the final stage of various cardiovascular diseases.The period of high incidence of death and readmission in patients with HF within 2 to 3 months after discharge is defined as the"vulnerable period".The management of vulnerable period focuses on how to identify high-risk groups with the need of close follow-up and more active intervention.Despite the application of various effective medical treatment and nursing strategies,readmissions in HF patients remain high,which not only poses a significant financial burden on the healthcare system but also carries the prognostic impact of worsening survival associated with repeated hospitalizations.Remote monitoring is a promising approach for early detection of worsening HF and intervention before apparent decompensation.Remote monitoring includes patient reporting of remote vital signs monitoring,wearable devices,information from cardiac implantable electronic devices and invasive remote hemodynamic monitoring.Remote cardiac monitoring devices have developed rapidly.A wide variety of monitoring devices have been developed,and trials have been conducted to explore the availability and safety of remote monitoring devices and their effectiveness in reducing the risk of HF re-hospitalization.Wearable devices are easy to be accepted by patients because of their non-invasive,portable,cost and other factors.

Objective To construct a model that can predict the risk of diagnosing ABO-blood group sys-tem hemolytic disease of the newborn(ABO-HDN)and to verify its effectiveness.Methods A total of 446 children with neonatal hyperbilirubinemia who met the inclusion criteria and were first diagnosed in this hos-pital from January 2022 to March 2023 were selected as the modeling group,and were divided into the develo-ping group(200 cases)and the non-developing group(246 cases)according to whether ABO-HDN was diag-nosed.Totally 17 potential influencing factors were included for univariate analysis and multi-factor analysis,and independent risk factors were included in R software to establish a Nomogram model to predict the risk of ABO-HDN.Another 105 cases of neonatal hyperbilirubinemia in the hospital from April to September 2023 were selected as the verification group.Results In the modeling group,Logistic regression analysis showed that maternal pregnancy number,prenatal serum titer,hemoglobin level,white blood cell count,creatine ki-nase level and neonatal Apgar 1 min score were all independent risk factors for ABO-HDN(P＜0.05).Multi-variate Logistic regression analysis showed that the area under receiver operating characteristic(ROC)curve of the modeling group was 0.819(95％CI:0.779-0.859),sensitivity was 0.655,specificity was 0.878.In the verification group,the area under ROC curve was 0.867(95％CI:0.800-0.933),the sensitivity was 0.803,and the specificity was 0.773.Conclusion The established predictive model scoring system can effec-tively predict the risk of ABO-HDN.

Objective To investigate the effects of body weight and length of SD rats on the carotid artery balloon injury-induced vascular stenosis model in order to provide a reference for replicating an ideal vascular stenosis mod-el.Methods Male rats were divided into three groups based on body weight and length.The CONQUEROR? SC PTCA balloon catheter was employed,with a fixed balloon inflation volume of 0.2 mL to induce injury in the left common carotid artery,while the right side served as a control.As soon as surgery operation,one rat from each group was selected for Evans Blue dye verification.Fourteen days later,the injured and contra lateral common ca-rotid arteries from remaining rats were harvested for HE staining to check the extent of stenosis.Based on these find-ings,six rats within the optimal range of body weight and length were selected for further validation.Results Rats with body weights ranging from 280 to 380 g(corresponding body lengths of 21.0-26.5 cm)underwent balloon catheter injury,resulting in endothelial detachment and varying degrees of stenosis in the common carotid artery.In rats weighing 280-300 g(body lengths of 21.0-22.5 cm)had severe stenosis or occlusion of the common carotid artery with thrombosis.In rats weighing 320-340 g(body lengths of 23.0-24.5 cm),the internal and external elastic plates of the common carotid artery were ruptured and the vascular morphology was abnormal.Conversely,rats weighing 360-380 g(body lengths of 25.0-26.5 cm)did not show any ruptured elastic laminae or thrombus formation in the common carotid artery,and the extent of vascular stenos in rats with a body weight of 360 g was moderate and uniform.The results of the repeated validation experiments were consistent.Conclusions Rats with a body weight range of 360 g(corresponding body length of 25.0-26.5 cm)are suitable for development of an ideal vascular stenosis model.

Heart failure(HF)is the final stage of various cardiovascular diseases.The period of high incidence of death and readmission in patients with HF within 2 to 3 months after discharge is defined as the"vulnerable period".The management of vulnerable period focuses on how to identify high-risk groups with the need of close follow-up and more active intervention.Despite the application of various effective medical treatment and nursing strategies,readmissions in HF patients remain high,which not only poses a significant financial burden on the healthcare system but also carries the prognostic impact of worsening survival associated with repeated hospitalizations.Remote monitoring is a promising approach for early detection of worsening HF and intervention before apparent decompensation.Remote monitoring includes patient reporting of remote vital signs monitoring,wearable devices,information from cardiac implantable electronic devices and invasive remote hemodynamic monitoring.Remote cardiac monitoring devices have developed rapidly.A wide variety of monitoring devices have been developed,and trials have been conducted to explore the availability and safety of remote monitoring devices and their effectiveness in reducing the risk of HF re-hospitalization.Wearable devices are easy to be accepted by patients because of their non-invasive,portable,cost and other factors.

Objective To assess the incidence of contrast-induced nephropathy(CIN)in patients with chronic thromboembolic pulmonary hypertension(CTEPH)after receiving balloon pulmonary angioplasty(BPA),and to evaluate the effect of the contrast agents on renal function.Methods A total of 143 CTEPH patients,who received BPA at the China-Japan Friendship Hospital of China from December 2018 to May 2022,were enrolled in this study.The clinical data,hemodynamic indicators,and serum creatinine(SC)concentrations within one week before and 48-72 h after BPA were collected.The estimated glomerular filtration rate(eGFR)was calculated according to the Modification of Diet in Renal Disease(MDRD)formula.The SC concentration and eGFR changes before and after each BPA procedure were compared.The incidence of CIN and its risk factors were evaluated,and the changes in hemodynamics,SC and eGFR after the initial and last time of BPA treatment were analyzed.Results A total of 192 BPA procedures were performed in 115 CTEPH patients,including 88 BPA procedures in males and 103 BPA procedures in females.The mean amount of contrast agent used for each BPA was(145.58±47.26)mL.After BPA,12 patients developed 13 times of CIN,with an incidence of 6.8％.There was no significant differences(P＞0.05)in the baseline characteristics and SC concentration before BPA between CIN patients and non-CIN patients.In terms of the hemodynamic indexes,the mixed venous oxygen saturation(SvO2)in CIN patients was significantly lower than that in non-CIN patients(58.58％±10.38％vs.66.15％±8.02％,P=0.002),and no statistically significant differences(P＞0.05)in the other hemodynamic indexes existed between CIN group and non-CIN group.No statistically significant differences in SC concentration and eGFR existed before and after each BPA procedure.In patients who had received several BPA procedures,significant improvements in the SC[(78.09±18.760)μmol/L vs.(82.26±21.37)μmol/L,P＜0.001]and eGFR[(86.08±21.22)mL/(min·1.73 m2)vs.(82.07±22.05)mL/(min·1.73 m2),P=0.007]was achieved when compared with their baseline values.Conclusion CTEPH patients may develop CIN after receiving BPA treatment.After receiving several BPA treatments the patient's clinical symptoms and hemodynamics can be improved,and the patient's renal function is also significantly improved.

BACKGROUND: Pulmonary arterial hypertension (PAH) presents a significant health burden in Asia and remains a critical challenge. This study aims to delineate the PAH burden in Asia from 1990 to 2021. METHODS: Using the latest data from the Global Burden of Disease 2021, we evaluated and analyzed the distributions and patterns of PAH disease burden among various age groups, sexes, regions, and countries in Asia. Additionally, we examined the associations between PAH disease burden and key health system indicators, including the socio-demographic index (SDI) and the universal health coverage (UHC) index. RESULTS: In 2021, there were 25,989 new PAH cases, 103,382 existing cases, 13,909 PAH-associated deaths, and 385,755 DALYs attributed to PAH in Asia, which accounted for approximately 60% of global PAH cases. The age-standardized rates (ASRs) for prevalence and deaths were 2.05 (95% uncertainty interval [UI]: 1.66-2.52) per 100,000 population and 0.31 (95% UI: 0.23-0.38) per 100,000 population, respectively. From 1990 to 2021, Asia reported the lowest ASRs for PAH prevalence but the highest ASRs for deaths compared to other continents. While the ASRs for prevalence increased slightly, ASRs for mortality and DALYs decreased over time. This increasing burden of PAH was primarily driven by population growth and aging. The burden was especially pronounced among individuals aged ≥60 years and <9 years, who collectively accounted for the majority of deaths and DALYs. Moreover, higher SDI and UHC levels were linked to reduced incidence, but higher prevalence rates. CONCLUSIONS Although progress has been made in reducing PAH-related mortality and DALYs, the disease continues to impose a substantial burden in Asia, particularly among older adults and young children. Region-specific health policies should focus on improving early diagnosis, expanding access to treatment, and effectively addressing the growing PAH burden in the region.
Humans ; Global Burden of Disease ; Male ; Female ; Middle Aged ; Adult ; Asia/epidemiology* ; Prevalence ; Aged ; Pulmonary Arterial Hypertension/mortality* ; Adolescent ; Young Adult ; Child ; Child, Preschool ; Infant ; Hypertension, Pulmonary/epidemiology*