Transfusion and Anemia Expertise Initiative-Control/Avoidance of Bleeding developed a strategy for platelet and plasma infusion management in critically ill children based on systematic reviews and consensus meetings of international multidisciplinary experts. One good practice statement and six expert consensus statements were proposed for plasma and platelet transfusions in critically ill children following severe trauma, traumatic brain injury, and/or intracranial hemorrhage. This article introduces the specific methods and basis for the formation of recommendations in this part of the guide.

Objective:To evaluate the cost-effectiveness and impact on mortality of health management services for the elderly aged 65 years and older in national essential public health service project.Methods:Based on the data of county-level medical institutions in Henan Province from 2019 to 2024,the Random Forest Method was used to construct a counterfactual framework to predict the hospitalization expenses under the unmanaged scenario,and then the cost-benefit ratio(BCR)and net income were calculated.Time-dependent Cox proportional hazards model was used to evaluate the effect of health management on all-cause mortality and cardiovascular and cerebrovascular disease mortality in the elderly.Results:A total of 962 955 elderly patients were included,451 119(46.85%)were included in the management group.The average hospitalization cost of the management group was significantly lower than that of the non-management group(P<0.05).Except for 2020-2021,BCRS in 2019 and 2022-2024 were 6.34,2.05,4.45 and 6.60,respectively.The risk of all-cause death was reduced by 76.96%,and the risk of cardiovascular and cerebrovascular death was reduced by 75.57%in the elderly patients included in the management group compared with those not included in the management group.Suggestions:It is necessary to establish a health outcomes-based evaluation system and promote the transformation and upgrading of the service model from single chronic disease management to"integrated health services with multi-disease management".

Objective:To investigate the effect of risk forewarning hierarchical management on mental state,major adverse cardiovascular events(MACE)and quality of life in patients with acute coronary syndrome after percutane-ous coronary intervention(PCI).Methods:This randomized controlled study enrolled 152 patients with acute coro-nary syndrome who underwent PCI in the First Hospital of Qinhuangdao between July 2021 and June 2023.Patients were randomly divided into control group(n=76,conventional intervention program)and intervention group(n=76,additional risk forewarning hierarchical management).After 3-month intervention,mental state[Hamilton anxiety scale(HAMA)and Hamilton depression scale(HAMD)scores],health literacy[perceived knowledge scale for coronary heart diseases(PKS-CHD)score],quality of life[Seattle angina questionnaire(SAQ)score]and in-cidence of MACE were compared between the two groups.Results:Compared to those in the control group,patients in the intervention group had significantly higher total score of PKS-CHD[(35.08±3.59)points vs.(30.53±3.85)points],SAQ dimensional scores of physical limitation[(15.24±1.73)points vs.(13.26±1.45)points],an-ginal stability[(16.84±1.39)points vs.(15.18±1.48)points],disease perception[(17.00±1.46)points vs.(14.34±1.93)points],anginal frequency[(18.55±1.18)points vs.(16.11±1.39)points]and treatment satis-faction[(17.12±1.45)points vs.(14.04±1.93)points](P＜0.001 all),and significantly lower HAMA score[(11.89±1.64)points vs.(13.55±1.56)points],HAMD score[(12.61±1.76)points vs.(16.42±1.92)points]and the incidence of MACE(8.00％vs.28.38％)(P＜0.001 all).Conclusion:Risk forewarning hierarchical man-agement may effectively relieve patients'negative emotions,improve their health literacy and quality of life,and significantly reduce the risk of MACE in patients with acute coronary syndrome after PCI.

Objective To explore the serum levels of citrate(CITR)and 3-hydroxybutyrate(3-HB)in patients with acute heart failure(AHF)and their relationship with prognosis.Methods 109 AHF patients(AHF group)and 101 healthy volunteers(control group)admitted to Yan'an University Affiliated Hospital from March 2020 to March 2023 were selected,according to the New York Heart Association(NYHA)cardiac function classification,AHF patients were divided into grade II group(n=31),grade III group(n=43)and grade IV group(n=35).Serum CITR and 3-HB levels were measured,and patient survival was followed up after discharge.Multivariate logistic regression analysis was used to identify the factors that affect the prognosis of AHF patients.Receiver working characteristic curve analysis was used to assess the predictive value of serum CITR and 3-HB in predicting the prognosis of AHF patients.Results The serum CITR(3.26±1.08 μmol/L)and 3-HB(4.69±1.37 μmol/L)levels in the AHF group were higher than those in the control group(1.21±0.33μmol/L,2.35±0.61μmol/L),and the differences were statistically significant(t=18.298,15.775,all P<0.05).The serum CITR(3.97±0.26μmol/L)and 3-HB(5.25±0.53μmol/L)levels in the Grade IV group were higher than those in the Grade III group(3.29±0.77μmol/L,4.85±0.95μmol/L),Grade II group(2.42±0.25μmol/L,3.84±0.46μmol/L),and the differences were statistically significant(t=24.610,4.993;11.470,2.224,all P<0.05).The serum CITR(3.85±0.33μmol/L)and 3-HB(5.12±0.39μmol/L)levels in the poor prognosis group were higher than those in the good prognosis group(2.98±0.51μmol/L,4.49±0.82μmol/L),and the differences were statistically significant(t=9.209,4.313,all P<0.05).Multivariate Logistic regression analysis NYHA grade IV,high NT-proBNP,high CITR,and 3-HB were risk factors for poor prognosis in AHF patients(Wald χ2=6.059～9.607,all P<0.05).The area under the curve[AUC(95%CI)]of CITR and 3-HB predicting poor prognosis in AHF patients was higher than that predicted separately,and the differences were statistically significant(Z=3.173,2.997,all P<0.05).Conclusion The serum levels of CITR and 3-HB are increased in AHF patients,which are related to the increase of NYHA classification and poor prognosis.The combination of CITR and 3-HB can predict the risk of poor prognosis in AHF patients.

Objective To explore the serum levels of citrate(CITR)and 3-hydroxybutyrate(3-HB)in patients with acute heart failure(AHF)and their relationship with prognosis.Methods 109 AHF patients(AHF group)and 101 healthy volunteers(control group)admitted to Yan'an University Affiliated Hospital from March 2020 to March 2023 were selected,according to the New York Heart Association(NYHA)cardiac function classification,AHF patients were divided into grade II group(n=31),grade III group(n=43)and grade IV group(n=35).Serum CITR and 3-HB levels were measured,and patient survival was followed up after discharge.Multivariate logistic regression analysis was used to identify the factors that affect the prognosis of AHF patients.Receiver working characteristic curve analysis was used to assess the predictive value of serum CITR and 3-HB in predicting the prognosis of AHF patients.Results The serum CITR(3.26±1.08 μmol/L)and 3-HB(4.69±1.37 μmol/L)levels in the AHF group were higher than those in the control group(1.21±0.33μmol/L,2.35±0.61μmol/L),and the differences were statistically significant(t=18.298,15.775,all P<0.05).The serum CITR(3.97±0.26μmol/L)and 3-HB(5.25±0.53μmol/L)levels in the Grade IV group were higher than those in the Grade III group(3.29±0.77μmol/L,4.85±0.95μmol/L),Grade II group(2.42±0.25μmol/L,3.84±0.46μmol/L),and the differences were statistically significant(t=24.610,4.993;11.470,2.224,all P<0.05).The serum CITR(3.85±0.33μmol/L)and 3-HB(5.12±0.39μmol/L)levels in the poor prognosis group were higher than those in the good prognosis group(2.98±0.51μmol/L,4.49±0.82μmol/L),and the differences were statistically significant(t=9.209,4.313,all P<0.05).Multivariate Logistic regression analysis NYHA grade IV,high NT-proBNP,high CITR,and 3-HB were risk factors for poor prognosis in AHF patients(Wald χ2=6.059～9.607,all P<0.05).The area under the curve[AUC(95%CI)]of CITR and 3-HB predicting poor prognosis in AHF patients was higher than that predicted separately,and the differences were statistically significant(Z=3.173,2.997,all P<0.05).Conclusion The serum levels of CITR and 3-HB are increased in AHF patients,which are related to the increase of NYHA classification and poor prognosis.The combination of CITR and 3-HB can predict the risk of poor prognosis in AHF patients.

To compare and analyze the clinical manifestations,laboratory characteristics,imaging findings,and treatment outcomes of patients with acute and chronic brucellosis,a retrospective analysis was conducted on 258 patients with brucellosis(202 in the acute group and 56 in the chronic group)hospitalized in Xinkang Hospital in Dalad Banner,Ordos City,Inner Mongolia Autonomous Region,from November 2023 to November 2024.General data,epidemiological characteristics,clinical presentations,laboratory test results,imaging findings,treatment outcomes,and prognosis were collected.The incidences of fever(51.5%vs 7.1%),fatigue(30.2%vs 12.5%),joint pain(42.9%vs 16.1%),and muscle pain(9.9%vs.1.8%)were significantly higher in the acute phase group(all P<0.05).The incidence of osteoarthritis complications was higher in the chronic brucellosis group(51.8%vs 8.9%,χ2=75.697,P<0.01).Univariate ANOVA analysisshowed that the Serum Agglutination Tests(SAT),alanine aminotransferase(ALT),aspartate aminotransferase(AST),total bilirubin(TBIL),creatinine(CRE),C-reactive protein(CRP),erythrocyte sedimentation rate(ESR),and bone destructionexhibited statistically significant differences between the acute and chronic phases of brucellosis(all P<0.05).Multivariate logistic regression analysis indicated that abnormal ALT(OR=14.18,95%CI:1.11-181.72;P=0.041)and bone destruction(OR=0.16,95%CI:0.04-0.63;P=0.009)were associated with chronic brucellosis.After treatment,all patients experienced have symptom relief in varying degrees,with 157 patients(60.9%)cured and 101 patients(39.1%)symptomatic improved(P<0.01).In conclusion,the incidences of fever,fatigue,and joint pain in patients during the acute phase is significantly higher than that those in patients during the chronic phase,while the incidence of osteoarthritis complications is higher in chronic phase patients.The incidences of abnormal SAT,ALT,AST,TBIL,CRE,CRP,and ESR,and bone destruction varies at different stages of brucellosis.Of those,abnormal ALT and bone destruction show a stronger association with,which can assist the clinical staging of brucellosis.

Since the promulgation of the first Drug Administration Law of the People's Republic of China 40 years ago in 1984, China has undergone four main stages in the traditional Chinese medicine(TCM) regulation: the initial establishment of TCM regulation rules(1984-1997), the formation of a modern TCM regulatory system(1998-2014), the reform of the review and approval system for new TCM drugs(2015-2018), and the construction of a scientific regulation system for TCM(2019-2024). Over the past five years, a series of milestone achievements of TCM regulation in China have been achieved in the six aspects, including its strategic objectives and the establishment of a science-based regulatory system, the reform of the review and approval system for new TCM drugs, the optimization and improvement of the TCM standard system and its formation mechanism, comprehensive enhancement of regulatory capabilities for TCM safety, international harmonization of TCM regulation and its role in promoting innovation. Looking ahead, centered on advancing TCMRS to establish a sound regulatory framework tailored to the unique characteristics of TCM, TCM regulation will evolve into new reform patterns, advancing and extending across eight critical fronts, including the legal framework and policy architecture, the review and approval system for new TCM drugs, the quality standard and management system of TCM, the comprehensive quality & safety regulation and traceability system, the research and transformation system for TCMRS, AI-driven innovations in TCM regulation, the coordination between high-quality industrial development and high-level regulation, and the leadership in international cooperation and regulatory harmonization. In this way, a unique path for the development of modern TCM regulation with Chinese characteristics will be pioneered.
Humans ; China ; Drugs, Chinese Herbal/standards* ; History, 20th Century ; History, 21st Century ; Medicine, Chinese Traditional/trends*

Objective To establish a stable,reliable,and clinically relevant porcine model of endotoxin-induced acute respiratory distress syndrome(ARDS).Methods Ten 8-month-old male Bama minipigs were deeply sedated,followed by invasive mechanical ventilation and electrocardiographic monitoring.Lipopolysaccharide(LPS)was intravenously pumped at 600 μg/(kg·h)for 3 hours,then maintained at 15 μg/(kg·h)thereafter.Dynamic monitoring was performed at five time points after LPS injection(LPS 0,1,3,5,and 8 h),including arterial blood gas analysis and chest computed tomography(CT)scans.Pathological examination of lung tissues obtained via bronchoscopic biopsy(HE staining and transmission electron microscopy)was conducted.These indicators were comprehensively used to evaluate the success of the animal model.Results At 5 hours after LPS administration,8 minipigs developed symptoms such as skin cyanosis,elevated body temperature,and respiratory distress.The oxygenation index decreased to<300 mmHg.Chest CT scans showed diffuse pulmonary infiltrates.Histopathology revealed alveolar edema and hyaline membrane formation.Transmission electron microscopy demonstrated disruption of pulmonary blood-air barrier,depletion of lamellar bodies in type Ⅱ pneumocytes,inflammatory cell infiltration,and exudation of plasma proteins and fibrin.Compared with LPS 0 h,at LPS 8 h,the oxygenation index and arterial blood pH were significantly decreased(P<0.001),while blood lactic acid and serum potassium were significantly increased(P<0.05);serum calcium and base excess were significantly decreased(P<0.05),and the lung injury score based on HE-stained lung sections was significantly increased(P<0.01).Conclusion The porcine ARDS model established by continuous LPS injection can dynamically simulate the pathophysiological characteristics and typical pathological manifestations of clinical septic ARDS,making it an effective tool to study the pathogenesis,prevention,and treatment strategies of septic ARDS.

Oral solid dosage forms require processes such as disintegration and dissolution to release the drug before it can be absorbed and utilized by the body. In this manuscript, imaging technology was used to continuously visualize and characterize the in vitro static drug release process of gliclazide modified release tablets from 15 manufacturers, combined with the traditional method of in vitro dissolution testing, to determine the release profile of gliclazide modified release tablets, to evaluate the similarity of the release profiles by using the similarity factor (f₂) method and based on the analysis of the release profiles fitted with a variety of mathematical models. The results indicate that the gliclazide modified release tablets produced by 14 companies are hydrophilic gel matrix tablets. Compared to the reference listed drug, the release profiles of formulations from 11 companies show high similarity (f₂ > 50) to the reference. Among these, formulations with visual characteristics similar to the reference exhibit similar release curves. This study provides an alternative method for the in vitro consistency evaluation of gliclazide modified release tablets, aiming to assess the in vitro release behaviour of generic formulations more accurately and comprehensively.

To guide transfusion practice in critically ill children who often need plasma and platelet transfusions, the Transfusion and Anemia Expertise Initiative-Control/Avoidance of Bleeding (TAXI-CAB) developed Recommendations and Expert Consensus for Plasma and Platelet Transfusion Practice in Critically Ill Children. This guideline addresses 53 recommendations related to plasma and platelet transfusion in critically ill children with 8 kinds of diseases, laboratory testing, selection/treatment of plasma and platelet components, and research priorities. This paper introduces the specific methods and results of the recommendation formation of the guideline.