Following the release of the Technical Requirements on Quality Control and Standard Establishment of Traditional Chinese Medicine Formula Granules by the National Medical Products Administration in 2021, Chinese Pharmacopoeia Commission has promulgated 296 national drug standards so far, and most provinces have started the work of establishing provincial standards as supplements. The promulgation of standards fostered high-quality development of the industry. Since the implementation of national and provincial standards for more than three years, enterprises have gained deep understanding and hands-on experiences on the characteristics, technical requirements, production process, and quality control of traditional Chinese medicine(TCM) formula granules. Meanwhile, challenges have emerged restricting the high-quality development of this industry, including how to formulate quality control strategies for medicinal materials and decoction pieces, how to reduce manufacturing costs, and how to improve the pass rate and product stability under high standards. Based on the work experiences from standard management and process research, this article analyzed the distribution of sources, processing methods, dry extract rate ranges, process requirements for volatile oil-containing decoction pieces, control measures of safety indices, characteristics and trends of setting characteristic chromatograms or fingerprints, characteristics and trends of setting content ranges, and main differences between national standards and provincial standards. On the one hand, this article aims to present main characteristics for deeply understanding different indicators in standards and provide basic ideas for establishing quality and process control systems. On the other hand, from the perspective of industrial practice, suggestions are put forward on the important aspects that need to be focused on in the quality and process control of TCM formula granules.
Drugs, Chinese Herbal/chemistry* ; Quality Control ; Medicine, Chinese Traditional/standards* ; China ; Drug Industry/standards*

Objective:To discuss the protective effect of dexmedetomidine(DEX)on intestinal function in rats with enterogenous sepsis,and to clarify its potential mechanism based on E2F transcription factor 1(E2F1)/nuclear factor kappa B(NF-κB)signaling pathway.Methods:Sixty SD rats were selected,among which 50 rats were used to establish enterogenous sepsis models by cecal ligation and puncture(CLP),and the remaining 10 rats were used as sham operation group(only cecal separation without ligation or puncture).The 40 successfully modeled rats were randomly divided into model group,low dose of DEX group,medium,doses of DEX group,and high dose of DEX group,with 10 rats in each group.The rats in low,medium,and high dose of DEX groups were intraperitoneally injected with 20,40 and 60 μg·kg-1 DEX immediately after modeling,while the rats in sham operation group and model group were intraperitoneally injected with the same volume of saline.After 24 h of administration,the intestinal myoelectric activities of the rats in various groups were detected;the colony counts of Escherichia coli,Lactobacillus and Bifidobacterium in cecal contents of the rats in various groups were detected;the pathomorphology of small intestinal tissue of the rats was observed by HE staining;the levels of secretory immunoglobulin A(sIgA)in supernatant of small intestinal tissue homogenate and the levels of diamine oxidase(DAO)and D-lactic acid in serum of the rats in various groups were detected by kit;real-time fluorescence quantitative PCR(RT-qPCR)method was used to detect the mRNA expression levels of macrophage polarization markers in small intestinal tissues of the rats in various groups;Western blotting method was used to detect the protein expression levels of macrophage polarization markers,E2F1,phosphorylated NF-κB p65(p-NF-κB p65),and NF-κB p65 in small intestinal tissue of the rats in various groups.Results:Compared with sham operation group,the slow wave frequency and amplitude of intestinal smooth muscle of the rats in model group were decreased(P<0.05);compared with model group,the slow wave amplitude of intestinal smooth muscle of the rats in low dose of DEX groups was increased(P<0.05),the slow wave frequency and amplitude of intestinal smooth muscle of the rats in medium and high doses of DEX groups were increased(P<0.05);compared with low dose of DEX group,the slow wave frequency and amplitude of the rats in medium and high doses of DEX groups were increased(P<0.05);compared with medium dose of DEX group,the slow wave frequency and amplitude of intestinal smooth muscle of the rats in high dose of DEX group were increased(P<0.05).Compared with sham operation group,the colony count of Escherichia coli in intestinal tract of the rats in model group was increased(P<0.05),while the colony counts of Bifidobacterium and Lactobacillus were decreased(P<0.05);compared with model group,the colony count of Bifidobacterium in intestinal tract of the rats in low dose of DEX group was decreased(P<0.05),the colony count of Escherichia coli in intestinal tract of the rats in medium,and high doses of DEX groups was decreased(P<0.05),while the colony counts of Bifidobacterium and Lactobacillus were increased(P<0.05);compared with low dose of DEX group,the colony count of Escherichia coli in intestinal tract of the rats in medium and high dose of DEX groups was decreased(P<0.05),while the colony counts of Bifidobacterium and Lactobacillus were increased(P<0.05);compared with medium dose of DEX group,the colony count of Escherichia coli in intestinal tract of the rats in high dose of DEX group was decreased(P<0.05),while the colony counts of Bifidobacterium and Lactobacillus were increased(P<0.05).The HE staining results showed that the small intestinal mucosal structure in sham operation group was normal and intact;the small intestinal mucosal epithelial cells in model group were necrotic,with damaged,collapsed and disordered villi;Compared with model groups,the pathological changes of small intestinal tissues in low,medium,and high doses of DEX groups were improved.Compared with sham operation group,the level of sIgA in supernatant of small intestinal tissue homogenate of the rats in model group was decreased(P<0.05),while the protein expression levels of DAO and D-lactic acid in serum were increased(P<0.05);compared with model group,the level of DAO in serum of the rats in low dose of DEX groups was decreased(P<0.05),the level of sIgA in supernatant of small intestinal tissue homogenate of the rats in medium and high doses of DEX groups was increased(P<0.05),while the protein expression levels of DAO and D-lactic acid in serum were decreased(P<0.05);compared with low dose of DEX group,the level of sIgA in supernatant of small intestinal tissue homogenate of the rats in medium and high doses of DEX groups was increased(P<0.05),while the protein expression levels of DAO and D-lactic acid in serum were decreased(P<0.05);compared with medium dose of DEX group,the level of sIgA in supernatant of small intestinal tissue homogenate of the rats in high dose of DEX group was significantly increased(P<0.05),while the protein expression levels of DAO and D-lactic acid in serum were decreased(P<0.05).The RT-qPCR results and Western blotting results showed that compared with sham operation group,the mRNA and protein expression levels of CD86,monocyte chemoattractant protein-1(MCP-1),and CD80 in small intestinal tissue of the rats in model group were increased(P<0.05),while the mRNA and protein expression levels of CD206,interleukin-4(IL-4)and,CD163 were decreased(P<0.05);compared with model group,the expression levels of CD80 mRNA,CD86 protein and MCP-1 protein in small intestinal tissue of the rats in low dose of DEX group were decreased(P<0.05),and the expression levels of IL-4 mRNA,CD163 mRNA,CD206 protein,and CD163 protein were decreased(P<0.05),the mRNA and protein expression levels of CD86,MCP-1,and CD80 in small intestinal tissue of the rats in medium and high doses of DEX groups were decreased(P<0.05),while the mRNA and protein expression levels of CD206,IL-4 and CD163 were increased(P<0.05);compared with low dose of DEX group,the mRNA and protein expression levels of CD86,MCP-1,and CD80 in small intestinal tissue of the rats in medium and high doses of DEX groups were decreased(P<0.05),while the mRNA and protein expression levels of CD206,IL-4,and CD163 were increased(P<0.05);compared with medium dose of DEX group,the mRNA and protein expression levels of CD86,MCP-1,and CD80 in small intestinal tissue of the rats in high dose of DEX group were decreased(P<0.05),while the mRNA and protein expression levels of CD206,IL-4,and CD163 were increased(P<0.05).The Western blotting results showed that compared with sham operation group,the protein expression level of E2F1 in small intestinal tissue of the rats in model group was decreased(P<0.05),while the ratio of p-NF-κB p65/NF-κB p65 was increased(P<0.05);compared with model group,the protein expression levels of E2F1 and ratio of p-NF-κB p65/NF-κB p65 in small intestinal tissue of the rats in low,medium and high doses of DEX groups were decreased(P<0.05);compared with low dose of DEX group,the protein expression level of E2F1 in small intestinal tissue of the rats in medium and high doses of DEX groups was increased(P<0.05),while the ratio of p-NF-κB p65/NF-κB p65 was decreased(P<0.05);compared with medium dose of DEX group,the protein expression level of E2F1 in small intestinal tissue of the rats in high dose of DEX group was increased(P<0.05),while the ratio of p-NF-κB p65/NF-κB p65 was decreased(P<0.05).Conclusion:DEX can improve the small intestinal mucosal injury in the rats with enterogenous sepsis and promote the polarization of macrophages to M2 type in small intestinal tissues,and its mechanism may be related to the regulation of E2F1/NF-κB signaling pathway by DEX.

OBJECTIVE: Serological and molecular biological analysis of a B(A) subtype family was carried out to explore the underlying mechanism of B(A) subtype and clinical safe blood transfusion strategies. METHODS: The ABO blood type of the proband and her four family members were identified by serological methods, and serological experiments such as anti-H, anti-A1 and absorption-elution tests was added. In addition, the exons 6 and 7 of the ABO gene were sequenced by PCR-SSP (polymerase chain reaction - sequence specific primer). RESULTS: The serological results showed that the agglutination intensity of the proband, her mother and her maternal grandmother was imbalanced during forward typing, showing weak A and strong B antigens, and there were strong H antigens and their intensity were higher than that of normal B type. The results of reverse typing indicated the presence of weak anti-A1 antibodies, and human anti-A was positive in the absorption-elution test. Genetic sequencing revealed a characteristic mutation of c.700 C>G in all three individuals. The sequencing results showed that the proband was B(A)02/B01, her mother was B(A)02/O02, and her maternal grandmother was B(A)02/O01 . According to the compatibility principle, 1.5 units of type O washed red blood cells were transfused intraoperatively, resulting in no adverse reactions. CONCLUSION The c.700 C > G mutation on exon 7 is the molecular basis for the formation of B(A)02, and pedigree analysis shows that the B(A)02 allele was inherited from the proband's maternal grandmother to the proband's mother and then to the proband, showing a stable cis-inheritance pattern rather than a spontaneous mutation. For patients with B(A)02 subtype, type O washed red blood cells and type AB plasma can be transfused according to the principle of compatibility.
Humans ; ABO Blood-Group System/genetics* ; Female ; Blood Transfusion ; Blood Grouping and Crossmatching ; Pedigree ; Male ; Mutation ; Adult ; Exons

BACKGROUND: Medical informatics accumulated vast amounts of data for clinical diagnosis and treatment. However, limited access to follow-up data and the difficulty in integrating data across diverse platforms continue to pose significant barriers to clinical research progress. In response, our research team has embarked on the development of a specialized clinical research database for cardiology, thereby establishing a comprehensive digital platform that facilitates both clinical decision-making and research endeavors. METHODS: The database incorporated actual clinical data from patients who received treatment at the Cardiovascular Medicine Department of Chinese PLA General Hospital from 2012 to 2021. It included comprehensive data on patients' basic information, medical history, non-invasive imaging studies, laboratory test results, as well as peri-procedural information related to interventional surgeries, extracted from the Hospital Information System. Additionally, an innovative artificial intelligence (AI)-powered interactive follow-up system had been developed, ensuring that nearly all myocardial infarction patients received at least one post-discharge follow-up, thereby achieving comprehensive data management throughout the entire care continuum for high-risk patients. RESULTS: This database integrates extensive cross-sectional and longitudinal patient data, with a focus on higher-risk acute coronary syndrome patients. It achieves the integration of structured and unstructured clinical data, while innovatively incorporating AI and automatic speech recognition technologies to enhance data integration and workflow efficiency. It creates a comprehensive patient view, thereby improving diagnostic and follow-up quality, and provides high-quality data to support clinical research. Despite limitations in unstructured data standardization and biological sample integrity, the database's development is accompanied by ongoing optimization efforts. CONCLUSION The cardiovascular specialty clinical database is a comprehensive digital archive integrating clinical treatment and research, which facilitates the digital and intelligent transformation of clinical diagnosis and treatment processes. It supports clinical decision-making and offers data support and potential research directions for the specialized management of cardiovascular diseases.

Objective:To develop a treatment-related quality of life scale for Chinese patients with multiple myeloma (MM) and to test its reliability and validity.Methods:The initial scale was constructed through a literature search, Delphi expert correspondence, and cognitive testing. This study conducted a preliminary survey of 379 patients with MM and a formal survey of 865 patients from the hematology departments of 155 hospitals nationwide from February 2024 to March 2024. The final scale was obtained after conducting item analysis and reliability and validity tests on the initial scale.Results:The constructed scale contains 36 items covering six domains: physiological, psychological, social, treatment side effects, general health, and others. In the preliminary survey, the Cronbach’s alpha coefficient of each item ranged from 0.597 to 0.939, and the test-retest reliability was 0.747 ( P<0.001). Exploratory factor analysis extracted eight common factors with a cumulative variance contribution of 60.058%. In the formal survey, the Cronbach’s alpha coefficient of each item ranged from 0.484 to 0.930, and the test-retest reliability was 0.835 ( P<0.001). Confirmatory factor analysis revealed a comparative fit index of 0.750, a root-mean-square error of approximation of 0.090, and a root-mean-square residual of 0.067. Conclusion:The treatment-related quality of life scale for Chinese patients with MM designed in this study exhibited good reliability and validity, reflecting the impact of treatment on the quality of life of patients. This scale can provide a reference to clinicians for assessing the disease status of patients.

Objective:To investigate the application effect of entrustable professional activities (EPAs) in competency evaluation of dermatology residents, to practice the goal of hierarchical progressive training for EPAs competency in dermatology residents, and to improve the competency of physicians.Methods:A questionnaire survey was conducted among 8 clinical instructors and 165 residents who received standardized residency training in Department of Dermatology, The First Affiliated Hospital of Jinzhou Medical University, from September 2019 to September 2022, and self-assessment and trainer-assessment were performed based on EPAs. The Kruskal-Wallis H test and the Mann-Whitney U test were used for comparison of entrustable level between the dermatology residents of different grades. Results:The scores of both trainer-assessment and self-assessment based on EPAs increased with the increase in the grade of the resident physicians, and the resident physicians of the third year (the PGY3 group) had the highest levels of trainer-assessment and self-assessment based on EPAs. The resident physicians of all grades showed relatively low assessment scores of EPA4 (making a medical decision), EPA8 (recognize a patient requiring urgent or emergent care and initiate evaluation and management), EPA14 (clinical teaching), and EPA15 (public health events management). There were significant differences in all EPAs items of trainer-assessment and self-assessment between the residents of different grades (Kruskal-Wallis test, P<0.05). There was a significant difference in trainer-assessment between PGY1 and PGY2 and between PGY1 and PGY3 (Bonferroni P correction, P<0.05), while there was no significant difference between the PGY2 and PGY3 groups ( P>0.05). Conclusions:There are differences in the evaluation of EPAs in dermatology residents of different grades, and hierarchical progressive training of EPAs competency can effectively improve the clinical competency of dermatology residents. Given the inconsistency between the scores of self-assessment and trainer-assessment, it is necessary to improve the feedback plan in the future.

Objective To understand the current situation of healthcare-associated infection(HAI)in China,pro-vide data support and decision-making basis for formulating scientific and effective strategies for HAI prevention and control.Methods A nationwide cross-sectional survey on HAI was conducted among various types and levels of medical institutions in China according to a unified protocol of bedside surveys and case investigations.Results In 2024,a total of 5 736 medical institutions and 2 751 765 patients were surveyed.Among them,34 889 HAI cases were identified,with a prevalence rate of 1.27％.The number of HAI episodes was 38 032,and case prevalence rate was 1.38％.The prevalence rate of HAI in medical institutions in different regions of China ranged from 0.66％to 2.35％.Among medical institutions of different scales,those with a bed capacity of ≥900 had the high-est incidence of HAI,reaching 1.65％.The most common infection site was the lower respiratory tract(44.66％),followed by the urinary tract(12.94％),surgical site(9.32％),upper respiratory tract(7.02％),and bloodstream infection(5.78％).The top 3 departments with the highest HAI rates were the general intensive care unit(10.02％),department of neurosurgery(5.51％),and department(group)of hematology(5.34％).A total of 23 238 strains of HAI pathogens were detected,with 10 714 strains(46.10％)from lower respiratory tract speci-mens.The top 5 detected strains were Klebsiella pneumoniae(14.76％),Pseudomonas aeruginosa(13.33％),Escherichia coli(12.79％),Acinetobacter baumannii(9.23％),and Staphylococcus aureus(7.88％).231 944 pa-tients underwent class Ⅰ incision surgery were monitored,with 1 647 cases experienced surgical site infection,and the prevalence rate of surgical site infection was 0.71％.The number of patients who should undergo pathogen de-tection(patients receiving therapeutic and therapeutic combined prophylactic antimicrobial agents)was 715 179,while the actual number was 480 492,with a pathogen detection rate of 67.18％.425 225 patients received patho-genic detection before treatment,with a detection rate of 59.46％.Conclusion The overall HAI prevalence in Chi-na is lower,showing disparities among medical institutions of different regions and scales.Therefore,precise imple-mentation of measures is necessary for HAI prevention and control,with a focus on high-risk institutions and high-risk departments,key areas,and critical procedures.All levels of medical institutions should continuously reduce the incidence of HAI by strengthening monitoring,standardizing the use of antimicrobial agents,and reinforcing basic HAI prevention and control measures.

Mesenchymal stem cells(MSCs)are multipotent stromal cells that possess the capacity for self-renewal and differentiation into multiple cell lineages.Due to the ease of procurement,robust expansion in vitro,the multipotency,they are recognized as a vital source of stem cells in the field of regenerative medicine.MSCs can be isolated from various tissues,including bone marrow,adipose tissue,and umbilical cord.Research indicates that Human umbilical cord mesenchymal stem cells(hUCMSCs)play an effective role in wound healing and tissue regeneration,and can be utilized for the repair of skin wounds.They are also considered to be the most promising seed cells for skin tissue engineering.This review aims to provide an overview of the biological characteristics of hUCMSCs,the mechanisms in promoting skin wound healing,and their clinical applications.

Objective:To investigate the impact of antenatal corticosteroid (ACS) exposure on neonatal outcomes in late preterm infants.Methods:This retrospective cohort study analyzed 406 late preterm infants (gestational age 34 +0-36 +6 weeks) born at Tongji University Affiliated Dongfang Hospital between January 2021 and June 2024. Participants were divided into ACS-exposed ( n=254) and control ( n=152) groups. Maternal characteristics, neonatal profiles, and outcomes [respiratory disorders (respiratory distress syndrome, respiratory failure, bronchopulmonary dysplasia), neonatal hypoglycemia, and early-onset sepsis] were compared. And they were stratified by plurality (154 twins, 252 singletons) and gestational age (96 at 34 +0-34 +6 weeks; 111 at 35 +0-35 +6 weeks; 199 at 36 +0-36 +6 weeks), the effects of ACS exposure on neonatal outcomes were analyzed. Late preterm infants were also divided into affected ( n=13) and unaffected ( n=393) groups according to whether they had respiratory disorders, and the risk factors of respiratory disorders were analyzed. Statistical methods included independent t-test, Mann-Whitney U, Chi-square test, and multivariate logistic regression. Results:The ACS-exposed group exhibited significantly higher rates of assisted reproductive technology conception [53.1% (135/254) vs. 37.5% (57/152), χ2=9.37], twin pregnancy [43.3% (110/254) vs. 28.9% (44/152), χ2=6.84], cesarean delivery [83.5% (212/254) vs. 66.4% (101/152), χ2=15.66], and neonatal intensive care unit admission than those in the control group [59.1% (150/254) vs. 40.8% (62/152), χ2=12.61] (all P<0.05). No significant differences emerged between ACS-exposed and control groups in respiratory disorders [3.1% (8/254) vs. 3.3% (5/152), χ2=0.01], early-onset sepsis [1.6% (4/254) vs. 1.3% (2/152), χ2=0.71], or neonatal hypoglycemia [1.6% (4/254) vs. 1.3% (2/152), χ2=0.71] (all P>0.05). Stratified analyses by plurality or gestational age strata revealed no significant differences in respiratory disorders, early-onset sepsis or neonatal hypoglycemia between ACS-exposed and control groups (all P>0.05). Multivariate logistic regression identified ACS exposure as non-protective against respiratory disorders ( OR=0.37, 95% CI: 0.10-1.39, P=0.144), with maternal glucose metabolism disorders (pre-gestational/gestational diabetes) as a risk factor ( OR=5.26, 95% CI: 1.57-17.71, P=0.007) and higher gestational age as protective ( OR=0.34, 95% CI: 0.15-0.78, P=0.012). Conclusions:ACS administration at 34 +0-36 +6 weeks demonstrated no significant benefits for preventing respiratory disorders in late preterm infants and did not increase risks of hypoglycemia or early-onset sepsis. Maternal glucose dysregulation and lower gestational age elevate respiratory morbidity risk in this population.

Objective To explore the changes of durability properties of reusable surgical gowns when used in dry and wet conditions.Methods Reusable surgical gowns made of single-layer polyester fiber or 3-layer composite material were selected as test samples,and a Martindale abrasion and pilling tester was used as the basic test platform and modified to form fixtures suitable for the wet state environment.The reusable surgical gowns underwent abrasion experiments in wet and dry conditions to observe the changes in their fiber structure,and were subjected to water penetration resistance and swelling strength tests.Results Visually the reusable surgical gowns had few changes of the microscopic textile fiber structure in dry and wet conditions,and the gowns made of single-layer polyster fiber gained advantages over the outer layers of those of 3-layer composite material in abrasion resistance with the same friction cycles.In dry and wet conditions,the hydrostatic pressure values of the gowns of single-layer polyster fiber gradually decreased with the increase of the degree of abrasion,which were always lower than those of the gowns of 3-layer composite material;the swelling strength of the gowns of single-layer polyster fiber was always greater than that of the gowns of 3-layer composite material,which decreased with the deterioration of the wear more significantly than that of the gowns of 3-layer composite material.Conclusion The reusable surgical gowns made of single-layer polyester fiber or 3-layer composite material have few differences in durability and protective properties at the early stages of ablation in dry and wet conditions.The durability of the gowns decreases as the degree of wear increases,while the trend of the decrease is slowing down until the fabric breaks down and completely loses its barrier effect.[Chinese Medical Equipment Journal,2025,46(6):28-33]