1.National biological standards for antibiotics: an overview
Bufang MA ; Hui LIU ; Xuan JIN ; Yanchun FENG ; Jin LI
Journal of China Pharmaceutical University 2026;57(1):108-114
National biological standards for antibiotics are critical components of the antibiotic quality control system and serve as reference materials for measuring and calibrating the biological activity of antibiotics. This article systematically reviews the classification, definition of potency units, and current research status of commercially available national antibiotic biological standards in China. At present, these standards can be categorized based on chemical structure, number of components, and development methods. The definition of potency units has evolved from an early “arbitrarily assigned unit” to “being represented by the mass of the antibiotic salt” and, more recently, to the current mainstream approach of “being represented by the mass of the active ingredient”. This evolution reflects a shift in quality control philosophy from primarily biological analysis to a system dominated by chemical analysis supplemented by biological methods. Current research focuses on optimizing potency determination methods, studying the unification of content and potency, and implementing dual quality control of both the potency and the ratio/content of active components in multi-component antibiotics. For complex multi-component antibiotics, the microbiological assay based on biological activity remains irreplaceable in quality control. Future efforts should emphasize further method optimization, ensuring batch-to-batch consistency of standards, and advancing precision quality control as key research priorities for antibiotic biological standards.
2.Assessment of left ventricular systolic function in patients with systemic lupus erythematosus using aCMQ technique
Ziran JIN ; Yan LI ; Xuan LIU ; Haotian SUN ; Jing GAO
China Modern Doctor 2025;63(5):57-61
Objective To evaluate the value of left ventricular(LV)systolic function impairment in patients with different activity levels of systemic lupus erythematosus(SLE)by applying automatic myocardial motion quantification(aCMQ)technique,and to explore the correlation between left ventricular strain parameters and clinical laboratory indexes,systemic lupus erythematosus disease activity index(SLEDAI).Methods A total of 80 patients diagnosed with SLE from November 2023 to August 2024 in the First Afticiated Hospital of Jinzhou Medical University were selected and divided into two groups:40 cases with SLEDAI<10points were in mild lupus group,34 cases with SLEDAI ≥ 10points were in moderately severe lupus group.Forty healthy volunteers for physical examination at the same time were randomly selected as control group,relevant parameters were obtained by conventional echocardiography and aCMQ technique respectively.Results aCMQ technique related parameters were compared,and the differences in left ventricular global longitudinal strain(LVGLS),apical two-chamber longitudinal strain(AP2LS),apical three-chamber longitudinal strain(AP3LS),and apical four-chamber longitudinal strain(AP4LS)were statistically significant in all three groups(P<0.05).The differences in left ventricular global circumferential strain(LVGCS)in lupus moderate-severe group were statistically significant when compared with other two groups(P<0.05),Pearson correlation analysis showed LVGLS,AP2LS,AP3LS,AP4LS and LVGCS were positively correlated with complement 3 and complement 4,and negatively correlated with anticardiolipin antibody(ACA)IgA,IgG,IgM,and sedimentation,and ultrasensitive C-reactive protein,and the SLEDAI was correlated with LVGLS,AP2LS,AP3LS,AP4LS were negatively correlated,and there was no significant correlation with LVGCS.Conclusion aCMQ technique can detect changes in LV systolic function in SLE patients at an early stage,and the impairment of LV systolic function is more severe with higher disease activity.Better correlation between LV strain parameters and clinical laboratory indexes and SLED AI may help to better assess cardiac involvement in SLE patients.
3.Assessment of left ventricular systolic function in patients with systemic lupus erythematosus using aCMQ technique
Ziran JIN ; Yan LI ; Xuan LIU ; Haotian SUN ; Jing GAO
China Modern Doctor 2025;63(5):57-61
Objective To evaluate the value of left ventricular(LV)systolic function impairment in patients with different activity levels of systemic lupus erythematosus(SLE)by applying automatic myocardial motion quantification(aCMQ)technique,and to explore the correlation between left ventricular strain parameters and clinical laboratory indexes,systemic lupus erythematosus disease activity index(SLEDAI).Methods A total of 80 patients diagnosed with SLE from November 2023 to August 2024 in the First Afticiated Hospital of Jinzhou Medical University were selected and divided into two groups:40 cases with SLEDAI<10points were in mild lupus group,34 cases with SLEDAI ≥ 10points were in moderately severe lupus group.Forty healthy volunteers for physical examination at the same time were randomly selected as control group,relevant parameters were obtained by conventional echocardiography and aCMQ technique respectively.Results aCMQ technique related parameters were compared,and the differences in left ventricular global longitudinal strain(LVGLS),apical two-chamber longitudinal strain(AP2LS),apical three-chamber longitudinal strain(AP3LS),and apical four-chamber longitudinal strain(AP4LS)were statistically significant in all three groups(P<0.05).The differences in left ventricular global circumferential strain(LVGCS)in lupus moderate-severe group were statistically significant when compared with other two groups(P<0.05),Pearson correlation analysis showed LVGLS,AP2LS,AP3LS,AP4LS and LVGCS were positively correlated with complement 3 and complement 4,and negatively correlated with anticardiolipin antibody(ACA)IgA,IgG,IgM,and sedimentation,and ultrasensitive C-reactive protein,and the SLEDAI was correlated with LVGLS,AP2LS,AP3LS,AP4LS were negatively correlated,and there was no significant correlation with LVGCS.Conclusion aCMQ technique can detect changes in LV systolic function in SLE patients at an early stage,and the impairment of LV systolic function is more severe with higher disease activity.Better correlation between LV strain parameters and clinical laboratory indexes and SLED AI may help to better assess cardiac involvement in SLE patients.
4.Effects of Yiqi Jiedu Tongluo Formula on renal injury in a rat model of type 2 diabetes mellitus via TGF-β/SMAD and VEGF pathways
Wen-xuan XU ; Lei-lei MA ; Ming-yu SHEN ; Xiao-jin LA ; Bi-wei ZHANG ; Shuo WANG ; Chao LI ; Peng CUI ; Zhen CHEN ; Ji-an LI
Chinese Traditional Patent Medicine 2025;47(2):421-429
AIM To observe the effects of Yiqi Jiedu Tongluo Formula(YQJDTL)on renal microvascular endothelial function and prevention of renal injury in a rat model of type 2 diabetes mellitus(T2DM).METHODS The SD rats were randomly divided into a normal group and a model group.The model group was administered with high-fat diet combined with a single intraperitoneal injection of STZ to establish the T2DM model.The successfully modeled rats were randomly divided into the model group,the canagliflozin group(9 mg/kg),and the low-dose and high-dose YQJDTL groups(4.77,9.45 g/kg).The corresponding doses of the drug were administered by gavage for a total of 12 weeks,during which the rats underwent observation of their general condition and blood glucose changes.After the end of administration,the rats had their levels of renal index,24-hour UP,serum SCr,BUN,TC,TG,HDL-C,LDL-C,ET-1 and NOS measured;their changes in renal microvasculature and the degree of renal fibrosis observed using HE staining,Masson staining,PAS staining,and PASM staining;their ultrastructure of the glomeruli observed using transmission electron microscopy;their renal protein expressions of TGF-β,SMAD2,SMAD3,Col-1,VEGFA and PKC detected by immunohistochemical staining and Western blot;and their renal mRNA expressions of VEGFA,TGF-β,SMAD2 determined by RT-qPCR.RESULTS Compared with the model group,the high-dose YQJDTL group showed decreased levels of renal index,blood glucose,TG,TC,HDL,24 h UP,BUN,SCr and ET-1(P<0.05,P<0.01);increased LDL and NOS levels(P<0.05,P<0.01);reduced renal inflammatory infiltration and fibrosis degree,inhibited fusion of foot processes and thickening of basement membrane;decreased renal protein expressions of TGF-β,SMAD2,SMAD3,VEGFA,PKC and Col-1(P<0.05,P<0.01);and decreased mRNA expressions of VEGFA,TGF-β and SMAD2(P<0.01).CONCLUSION In the rat models of T2DM,YQJDTL can reduce their levels of blood glucose and lipids by improving the renal indices levels and the renal microvascular endothelial functions to alleviate renal fibrosis and microangiopathy as well,and the mechanism may be associated with the down-regulated expressions of TGF-β/SMAD and VEGF pathway-related proteins.
5.Effect of ultrasound-guided percutaneous microwave ablation on postoperative condition,thyroid hormones and nodule volume in patients with micropapillary thyroid cancer
Jingyu LI ; Xuan CHU ; Xing JIN ; Yongchao CHEN
China Medical Equipment 2025;22(6):70-75
Objective:To investigate the effects of ultrasound-guided percutaneous microwave ablation on postoperative conditions,thyroid hormone levels and nodule volume in patients with micropapillary thyroid cancer.Methods:A total of 176 patients with micropapillary thyroid cancer admitted to Hefei Cancer Hospital of Chinese Academy of Sciences and the First Affiliated Hospital of Anhui Medical University from February 2022 to December 2023 were selected,and they were divided into control group(92 cases)and observation group(84 cases)according to the difference of the treatment protocols.In them,3 cases were lost to visit in the control group and 2 cases were lost to visit in the observation group,and finally 89 cases were in the control group and 82 cases were in the observation group in the study.The control group was treated with surgical resection,and the observation group was treated with ultrasound-guided percutaneous microwave ablation.Both groups were followed up for 12 months after surgery.The surgical indexes,hospitalization cost,hospitalization time,and the thyroid hormone levels and quality of life before and 12 months after surgery between two groups were compared,and the occurrence of complications,postoperative recurrence and metastasis during the follow-up period were compared also between the two groups.The changes in nodule volume in the observation group were analyzed before and 3rd,6th and 12th month after surgery.Mental component summary(MCS),physical component summary(PCS)score and the MOS 36-item short-form health survey(SF-36)score were used in this study.Results:The surgical incision,the amount of surgical blood loss,the duration of surgery,the duration of hospitalization and the cost of hospitalization of the observation group were respectively(2.09±0.32)mm,(2.13±0.16)ml,(26.73±6.54)min,(2.10±0.52)d and(10 976.23±1132.56)CNY,which were less,or lower,or shorter,or less than these of the control group,and the differences were significant(t=51.031,31.853,27.924,27.028 and 21.925,P<0.05).Compared with preoperative serum thyroid stimulating hormone(TSH)level,that of control group increased at the 12th months after surgery,which was higher than that of observation group,and the difference between the two groups was statistically significant(t=22.482,P<0.05).The difference of the serum TSH level in the observation group between before and at the 12th month after surgery was not statistically significant(P>0.05).Compared with preoperative nodule volume,that of observation group first increased and then decreased at the 6th month and 12th month after surgery,and nodule volume at the 12th month after surgery was less than that before surgery(t=13.731,P<0.05).The MCS,PCS score,and SF-36 score both two groups at the 12th month after surgery increased than preoperative them,and these indicators of observation group were higher than them of control group,and the differences were statistically significant(t=14.624,11.986,and 13.582,P<0.05).The total incidence of complication during the follow-up period was 2.44%in observation group,which was lower than 10.11%in control group,and the difference was statistically significant(x2=4.175,P<0.05).There was no recurrence or metastasis in the two groups after surgery.Conclusion:Compared with surgery,ultrasound-guided percutaneous microwave ablation can improve the surgical index of patients with micropapillary thyroid cancer,and shorten the time of hospitalization,and reduce the hospitalization cost,and reduce the occurrence of complications.The recovery of patients are well after surgery,and there is not obvious recurrence and metastasis.At the same time,this treatment plan can significantly shorten the volume of the patient's nodules,and does not have significant effect on thyroid hormone.
6.Comparison of clinical characteristics between primary bilateral macronodular adrenal hyperplasia and adrenal cortisol-producing adenoma
Bing LI ; Ming-Xiu YANG ; Huai-Jin XU ; Jing-Xuan WANG ; Qing-Zheng WU ; Ya-Jing WANG ; Yi-Jun LI ; Kang CHEN ; Yu CHENG ; Qi NI ; Ya-Qi YIN ; Li ZANG ; Qing-Hua GUO ; Jian-Ming BA ; Wei-Jun GU ; Jing-Tao DOU ; Zhao-Hui LYU ; Yi-Ming MU
Medical Journal of Chinese People's Liberation Army 2025;50(7):779-785
Objective To comparatively analyze the clinical characteristics of primary bilateral macronodular adrenal hyperplasia(PBMAH)and adrenal cortisol-producing Adenoma(CPA),and enhance the understanding of two diseases.Methods The clinical data of 85 PBMAH patients(PBMAH group)and 195 CPA patients(CPA group)diagnosed at Department of Endocrinology,the First Medical Center of Chinese PLA General Hospital,from September 2014 to August 2024 were retrospectively analyzed.The demographic characteristics,comorbidities,biochemical indicators,adrenocorticotropic hormone-cortisol(ACTH-F)levels,and adrenal imaging features and treatment conditions were compared between the two groups.Results(1)General characteristics:Compared with CPA group,PBMAH group had older age at diagnosis and a higher proportion of male patients.(2)Clinical characteristics:Compared with CPA group,PBMAH group had a longer disease duration,a higher proportion of subclinical Cushing's syndrome(CS),and a higher proportion of hypertension,impaired glucose tolerance/diabetes,bone mass reduction or osteoporosis,with higher serum potassium levels,and the differences were statistically significant(P<0.01).(3)Hormone levels:Both PBMAH and CPA groups showed ACTH-F rhythm disorder,significantly increased cortisol levels and suppressed ACTH.Compared with PBMAH group,CPA group had stronger autonomous cortisol secretion ability,manifested by increased midnight serum cortisol(F0:00),16:00 serum cortisol(F16:00),24-hour urinary free cortisol(24 h UFC)levels and lower 8:00 serum ACTH(ACTH8:00)and 16:00 serum ACTH(ACTH16:00)(P<0.01).After low-dose dexamethasone suppression test(LDDST),CPA group showed lower suppression rates of ACTH and cortisol,and higher proportions of paradoxical elevation in serum cortisol and 24 h UFC compared with PBMAH(P<0.01).Conclusions PBMAH has a longer disease course and higher proportions of comorbid metabolic disorders than CPA,mostly manifested as subclinical Cushing's syndrome.CPA has stronger autonomous cortisol secretion ability,with cortisol less likely to be suppressed after LDDST and more obvious paradoxical elevation of cortisol and 24 h UFC.
7.Exercise alleviating fear and anxiety in mice with post-traumatic stress disorder by promoting hippocampal neuroregeneration and dendritic development
Chang SU ; Zi-Xuan XU ; Shuo JIN ; Xiao-Xiao ZHANG ; Chao XI ; Li-Na SUN
Acta Anatomica Sinica 2025;56(4):389-397
Objective To investigate the mechanism of hippocampal neuronal plasticity of newborn neurons in the hippocampus by which exercise improves the fear and anxiety symptoms of post-traumatic stress disorder(PTSD).Methods Totally 40 C57BL/6J male mice were randomly divided into by control group(Ctrl)and PTSD group,the PTSD group was divided into a no-exercise group(PTSD),a low-intensity exercise group(L)and a high-intensity exercise group(H).The PTSD model mice were constructed by combining conditioned plantar-foot shock(CF)and single-session sustained stress(SPS).After the exercise intervention,the fear and anxiety levels of the mice were assessed using the conditioned fear test and the elevated cross maze test;Subsequently,the densities of the newborn mature neurons in dentate gyrus(DG)of hippocampus were detected by immunofluorescent double-labelling staining,and the newborn neuron morphology was marked by injecting retrovirus pRetro-U6-EF1-EGFP-3xFLAG-WPRE in DG of hippocampus to observe its morphology.The morphology of the newborn neurons was labelled to observe their dendritic length and the number of branch points;Meanwhile,the concentration level of adiponctin(APN)in the hippocampal area was determined by ELISA.Results The result showed that both high and low-intensity exercise interventions significantly reduced the freezing time of PTSD mice in the conditioned fear test,and in the elevated cross maze experiment,the residence time and the number of entries in the open arm of the mice in the H group increased significantly compared with those in the PTSD group,while the residence time and the number of entries in the closed arm were significantly reduced.In addition,both high and low-intensity exercise interventions significantly increased the surface density and dendritic length of newborn mature neurons in the hippocampal DG region of PTSD mice,and high-intensity exercise significantly increased the number of dendritic branching points,and the density of newborn mature neurons in the H group was more significantly increased compared with that in the L group.At the same time,the hippocampal APN concentration increased significantly in both L and H groups compared with the PTSD group,and it was more significant in the H group.Conclusion Exercises have an ameliorative effect on anxiety and fear symptoms in PTSD mice,and at the same time,it can increase hippocampal neuroplasticity and adiponctin secretion in PTSD mice,suggesting that the improvement of fear and anxiety symptoms in PTSD by exercise may be related to the increase of hippocampal neuroplasticity and APN secretion,and the improvement effect is better with high-intensity exercise.
8.The Expression Characteristics,Clinical Relevance and Tumor Inhibition of KCNN3 in Gastric Adenocarcinoma
Zi-Qing ZHAN ; Jia-Bei JIN ; Yu-Xuan LI ; Jia-Xin SHI ; Meng YE ; Xiao-Feng JIN
Chinese Journal of Biochemistry and Molecular Biology 2025;41(4):560-575,中插1-中插4
Potassium-calcium activates channel subfamily N member 3(KCNN3/SK3/KCa2.3)is in-volved in regulating cellular calcium signaling,muscle contraction and neurotransmitter release.Dysregu-lation of the KCNN3 channel is associated with the development of various tumors.We use bioinformatics analysis to identify whether KCNN3 regulates the occurrence and development of stomach adenocarcinoma(STAD)as a prognostic target.By analyzing the Human Protein Atlas(HPA)database and The Cancer Genome Atlas(TCGA)database,we found that the protein and mRNA levels of KCNN3 were dramatic-ally reduced in STAD,and TCGA database showed that KCNN3 significantly correlated with the prognosis and clinical features of STAD.In addition,we found that high expression of KCNN3 in STAD reduced the IC50 of several drugs in STAD cells,suggesting that high expression of KCNN3 correlated with the drug sensitivity of STAD.To investigate the underlying biological mechanism,we identified a potential KCNN3 interaction factor,tumor necrosis factor receptor superfamily member 7(CD27/TNFRSF7),which is expressed at low levels in STAD.RT-qPCR and Western blotting confirmed that KCNN3 and CD27 positively correlated with each other at protein and mRNA levels,and co-immunoprecipitation and immunofluorescence experiments confirmed that the two proteins interact and colocalize in the cytoplasm.Moreover,we confirmed the inhibitory effect of KCNN3 on the proliferation,migration and invasion of hu-man STAD cells in vitro and in vivo through subcutaneous tumorigenesis and cellular experiments.Fur-thermore,GO/KEGG enrichment analysis showed that KCNN3 was enriched in signaling pathways regula-ting the immune response and calcium or metal ion transport.Lastly,we verified through cell co-culture,RT-qPCR and CCK8 assays that high expression of KCNN3 can promote the increase of T cell activating factor and the killing effect of T cells on STAD cells.Therefore,our results suggest that KCNN3 is a po-tential inhibitory factor affecting the occurrence and progression of STAD.
9.Mouth breathing and functional speech sound disorders in children: A correlational analysis
Yanna WANG ; Xuan LI ; Jun WANG ; Xing JIN ; Xinyi HU ; Tongjie YAO ; Ping WAN
Chinese Journal of Physical Medicine and Rehabilitation 2025;47(7):619-623
Objective:To explore the association between mouth breathing (MB) and functional speech sound disorders (FSSDs) in children, aiming to establish a novel theoretical basis for FSSD interventions.Methods:Eighty-nine children with an FSSD aged 4-12 years formed the FSSD group, while eighty-five age-matched healthy children served as controls. Their clinical data were processed using independent sample t-tests and chi-square tests to test for any significant differences between the two groups in terms of gender, age, mouth breathing status, post-frenotomy condition, Mandarin exposure before age 4, and delayed speech onset. Multivariate logistic regressions were evaluated to identify risk factors for FSSD in such children and to seek any association between mouth brea-thing and FSSD.Results:The regression analysis identified the following risk factors for childhood FSSD, ranked by odds ratio ( OR) magnitude: mouth breathing (adjusted OR=22.168, 95% CI=7.849-62.608, P≤0.01), delayed speech onset (adjusted OR=20.091, 95% CI=4.812-83.878, P≤0.01), age (a protective effect) (adjusted OR=0.979, 95% CI=0.962-0.997, P≤0.05). Univariate analysis of mouth breathing and associated factors revealed significant associations of FSSD with mouth breathing (χ 2=52.15, P≤0.01) and delayed speech onset (χ 2=25.873, P≤0.01). Conclusions:The significant risk factors for childhood functional speech sound disorders are mouth breathing (showing the highest adjusted OR), delayed speech onset and age. These findings suggest that early screening and therapeutic interventions for mouth breathing should be clinically prioritized to minimize FSSD risk.
10.Preferences for achievements transformation of Traditional Chinese Medicine(TCM)Preparation among medical staff in TCM hospitals in Beijing
Yi-xuan CHEN ; Xue-feng SHI ; Wan-jin YANG ; Xin-qi GENG ; Han-lin NIE ; Ming-li MA ; Xiao-wei NIU ; Yao-qi WANG
Chinese Journal of Health Policy 2025;18(11):66-73
Objective:To analyze the preferences of medical staff in TCM hospitals in Beijing regarding the achievements transformation of hospital traditional Chinese medicine preparations,and to provide a reference for formulating incentive policies.Methods:233 medical staff from five TCM hospitals in Beijing were taken as the research objects,and surveyed with a questionnaire designed based on the discrete choice experiment(DCE).Mixed logit models and latent class models were then used to analyze their transformation preferences.Results:The mixed Logit model revealed that seven key attributes significantly influenced medical staff's preferences for the achievements transformation of traditional Chinese medicine preparations(P<0.05).Latent class analysis identified three distinct preference groups among respondents:an organization-dependent group(27.0%),a pro-transformation group(61.4%),and a conservative group(11.6%).Conclusions:Medical Staff preferred transformation conditions that increased monthly income;utilized"human use+re-experimentation";involved the hospital's achievements transformation department as the entity;were funded by the hospital;offered a 70%profit share;enabled promotion three years earlier,and assigned patents to the hospital.The study recommends implementing diverse incentive measures and developing differentiated strategies tailored to the distinct Medical Staff categories to facilitate the transformation of hospital traditional Chinese medicine preparations into new drugs.

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