1.Evaluation of the pharmacokinetic and pharmacodynamic similarity of recombinant human insulin in healthy Chinese volunteers by eug-lycemic clamp technology
Qian ZHANG ; Jingjing YANG ; Juan WU ; Qin ZHANG ; Huiling QIN ; Liang YU ; Yijun DU ; Wei HU
Chinese Journal of Clinical Pharmacology and Therapeutics 2025;30(3):385-391
AIM:To evaluate the pharmacokinet-ics(PK)and pharmacodynamics(PD)of two recom-binant human insulin injection by euglycemic clamp technology in healthy male subjects after a single subcutaneous injection.METHODS:We con-ducted a randomized,open-label,single dose,two period,crossover study.A total of 24 healthy male subjects were enrolled and randomized to receive single subcutaneous doses(0.2 U/kg)of the investi-gational products every period.The PK and PD characteristics were assessed by euglycemic clamp up to 14 hours after dosing.RESULTS:Euglycemic clamp technique was successfully established.C-peptide levels detected at each time point before and after administration indicated that endoge-nous insulin secretion was inhibited in the two groups after administration.The geometric mean ratio of Cmax and AUC0-tand 90%confidence interval(CI)of test preparation and reference preparation under fasting condition were in the range of 80.00%-125.00%.CONCLUSION:The human insulin produced by KP Biotech demonstrated similarity to the reference preparation Humulin? in PK and PD characteristics in healthy Chinese subjects.
2.Analysis of the proactive coping status and influencing factors of schizophrenia patients with auditory hallucinations
Yanan LI ; Wei SHEN ; Shuna WANG ; Xueying ZHAO ; Yao QIN ; Jing LI ; Jingjing CHAO
China Modern Doctor 2025;63(8):14-17
Objective To investigate the proactive coping of schizophrenia patients with auditory hallucinations and to analyze its influencing factors.Methods A total of 240 schizophrenia patients with auditory hallucinations hospitalized in Shandong Mental Health Center from February to October 2023 were selected as subjects.General information questionnaire,simplified coping style questionnaire,perceived social support scale,insight and treatment attitude questionnaire were used to conduct the survey.Results A total of 236 valid questionnaires were collected,and effective questionnaire response rate was 98.33%.The proactive coping score of schizophrenia patients with auditory hallucinations was(18.55±7.74)points,which was at a moderate level.The results of multiple linear regression analysis showed that education level,perceived of social support,and self-awareness were the influencing factors of proactive coping to schizophrenia patients with auditory hallucinations(P<0.05).Conclusion The proactive coping of schizophrenia patients with auditory hallucinations needs to be further improved,and nursing staff can focus on patients with low education level,low ability to perceive social support and poor self-awareness,and formulate targeted interventions to improve their proactive coping to auditory hallucinations.
3.Evaluation of the pharmacokinetic and pharmacodynamic similarity of recombinant human insulin in healthy Chinese volunteers by eug-lycemic clamp technology
Qian ZHANG ; Jingjing YANG ; Juan WU ; Qin ZHANG ; Huiling QIN ; Liang YU ; Yijun DU ; Wei HU
Chinese Journal of Clinical Pharmacology and Therapeutics 2025;30(3):385-391
AIM:To evaluate the pharmacokinet-ics(PK)and pharmacodynamics(PD)of two recom-binant human insulin injection by euglycemic clamp technology in healthy male subjects after a single subcutaneous injection.METHODS:We con-ducted a randomized,open-label,single dose,two period,crossover study.A total of 24 healthy male subjects were enrolled and randomized to receive single subcutaneous doses(0.2 U/kg)of the investi-gational products every period.The PK and PD characteristics were assessed by euglycemic clamp up to 14 hours after dosing.RESULTS:Euglycemic clamp technique was successfully established.C-peptide levels detected at each time point before and after administration indicated that endoge-nous insulin secretion was inhibited in the two groups after administration.The geometric mean ratio of Cmax and AUC0-tand 90%confidence interval(CI)of test preparation and reference preparation under fasting condition were in the range of 80.00%-125.00%.CONCLUSION:The human insulin produced by KP Biotech demonstrated similarity to the reference preparation Humulin? in PK and PD characteristics in healthy Chinese subjects.
4.Comprehensive Analysis of Flavonoid Content in Chrysanthemum Indicum:Germplasm Variation,Tissue Distribution,and Developmental Stage Changes
Jiahao LIAO ; Haiqiong ZHANG ; Zhiwei QIN ; Xu WANG ; Yifei LIU ; Jingjing ZHANG
World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(6):1546-1554
Objective To provide a scientific basis for the quality control of Chrysanthemi Indici Flos medicinal materials and the sustainable development of this resource,the germplasm differences,tissue distribution,and developmental stage changes of flavonoid content in Chrysanthemum indicum was explored.Methods High-performance liquid chromatography(HPLC)was used to quantitatively analyze the five main flavonoid compounds,including linarin,tilianin,cynaroside,apigenin,and acacetin.Real-time fluorescence quantitative PCR(qPCR)technology was used to evaluate the relative expression levels of the rhamnosyltransferase(RhaT)gene at different developmental stages.Results The study found significant differences in flavonoid accumulation among different Chrysanthemum indicum germplasms,with the highest content of linarin observed in the Hubei diploid.Flavonoid content was significantly higher in leaves,flower buds,and flowers compared to stems and roots.Linarin and tilianin peaked at the flower bud stage and then gradually decreased,while the contents of apigenin and acacetin increased with flower development.The qPCR analysis further showed that the expression level of the RhaT gene was highly consistent with the accumulation pattern of linarin.Conclusion The results reveal that flavonoid content in Chrysanthemum indicum is significantly affected by germplasm,tissue type,and developmental stage,providing important data support for the quality evaluation of Chrysanthemum indicum medicinal materials and the rational development of this resource.
5.Principles and Methods of Using Metering Unit in National Technical Specification of Medical Service Items(Version 2023)
Jingjing LANG ; Jinming KONG ; Lihua YU ; Huanhuan CHANG ; Xingyu YANG ; Hailong ZHOU ; Qin JIANG
Chinese Health Economics 2025;44(7):10-12,15
Metering unit is important component of medical service items and also serve as significant bases for scientifically estimating the costs of medical services.National Technical Specification of Medical Service Items(2023 Edition)has set up elements such as"metering unit"and"adjustment coefficient for resource consumption in special circumstances",which clearly stipulate the metering units of each medical service item and the multiples for discretionary increases or decreases in the overall resource consumption when special circumstances occur.These two elements are important references for the cost accounting in medical institutions.The project team has elaborated on the definitions,establishment principles and special circumstances of these two types of elements,namely"metering units"and"adjustment coefficient for resource consumption in special circumstances",providing references for the application of relevant governments and healthcare institutions.
6.The Rationale and Implementation of the Financial Classification of Medical Service Items
Xingyu YANG ; Lihua YU ; Huanhuan CHANG ; Jingjing LANG ; Qin JIANG
Chinese Health Economics 2025;44(7):16-18
As an important indicator to assess the revenue structure of hospitals,healthcare service revenue can truly reflect the labor value of medical personnel.A unified financial classification is the premise of accurate calculation of revenue structure.Meeting the needs of financial management of medical institutions through mapping with current healthcare service items in various regions,Financial Classification of Medical Service Items has unified the financial classification from the aspects of bill classification,accounting subject and expense classification in medical record.
7.Design and Application Prospect of Item Codes in National Technical Specification of Medical Service Items(Version 2023)
Xingyu YANG ; Lihua YU ; Huanhuan CHANG ; Hailong ZHOU ; Jingjing LANG ; Jinming KONG ; Qin JIANG
Chinese Health Economics 2025;44(7):4-6
The assignment of the"item code"element in National Technical Specification of Medical Service Items(Version 2023)continues the classification framework and coding rules of National Specification of Medical Service Price Items(Version 2012).The project team experts are members of the WHO-Family of International Classifications(WHO-FIC)China Classification,Terminology and Standards Collaborating Center.The design concept of project coding is the same as that of the International Classification of Health Interventions(ICHI).Both adopt an alphanumeric characters hybrid coding classification method based on multi-axis classification,clarified the definition and scope of these four key classification axis which including anatomy system,anatomical site,surgical procedure and surgical approach,and optimize and update item property,sub-classifications and coding.Unified medical service item code can make contribution to the comparability of statistics related to health care items across regions,promote cross-regional healthcare and healthcare insurance settlement at the national level;improve its refined management level in hospital,and play an important role in performance management and data statistical analysis.
8.Influence of inflammatory cytokines related to different endotypes on the transcriptome of nasal epithelial cells
Jingjing GUO ; Zhou YU ; Yuanyuan QIN ; Zhiqiu ZHU ; Ming WANG
Chinese Archives of Otolaryngology-Head and Neck Surgery 2025;32(7):455-459
OBJECTIVE To investigate the impact of inflammatory cytokines related to different endotypes of chronic rhinosinusitis on the transcriptome of nasal epithelial cells.METHODS Human primary nasal epithelial cells were cultured in vitro,and treated with type 1,type 2,and type 3 inflammatory cytokines IFN-γ(10 ng/ml),IL-4(50 ng/ml),and IL-17A(50 ng/ml),respectively.After 48 hours,cells were collected for RNA extraction and transcriptome analysis.Differentially expressed genes were identified,followed by functional annotation and pathway enrichment analysis.Additionally,common regulated genes among different cytokines were analyzed.RESULTS Treatment of primary nasal epithelial cells with IFN-γ,IL-4,and IL-17A induced significant transcriptomic alterations,with 650,540,and 192 differentially expressed genes,respectively,compared to the control group.Functional annotation and pathway enrichment analysis showed that IFN-γ was mainly associated with defense response to virus,antigen processing and presentation,leukocyte and lymphocyte mediated immunity,and NOD-like receptor signaling pathway;IL-4 was mainly related to the regulation of leukocyte chemotaxis,cell-cell adhesion,ECM-receptor interaction,and MAPK signaling pathway;IL-17A was involved in the regulation of neutrophil chemotaxis,response to molecule of bacterial origin,chemokine signaling pathway,and NF-κB signaling pathway.Genes commonly regulated by IFN-γ,IL-4,and IL-17A were identified,with DUOX2 being upregulated by all the three cytokines.CONCLUSION IFN-γ,IL-4,and IL-17A reshapes the transcriptomic profile of nasal epithelial cells,which mainly regulates signaling pathways related to defense response to virus,leukocyte chemotaxis,and response to bacteria,respectively.
9.Clinical Observation on the Therapeutic Efficacy of Lingnan Fire Needling for Plaque Psoriasis
Jingjing LI ; Ruiming CHEN ; Guo'ao SHI ; Ting WU ; Haiyan XU ; Shiyun CHEN ; Xianhao ZHANG ; Wen CHEN ; Qianpeng HUANG ; Guojian GUO ; Ye QIN ; Peng ZHOU
Journal of Guangzhou University of Traditional Chinese Medicine 2025;42(2):382-389
Objective To observe the clinical efficacy of Lingnan fire needling in the treatment of plaque psoriasis.Methods A total of 60 cases of patients with plaque psoriasis admitted to Bao'an Hospital of Chinese Medicine Affiliated to Guangzhou University of Chinese Medicine from August 2021 to January 2023 were selected,and the patients were randomly divided into the observation group and the control group according to the random number table method,with 30 cases in each group.The observation group was given Lingnan fire needling for treatment,and the control group was given topical application of Calcipotriol Ointment.The course of treatment covered eight weeks continuously.After eight weeks of treatment,the clinical efficacy of the two groups was evaluated,and the changes of Psoriasis Area and Severity Index(PASI)scores and Dermatology Life Quality Index(DLQI)scores,as well as the diameter of glomus under dermoscopy of the patients in the two groups were observed before the treatment and after 2,4,6,and 8 weeks of treatment.Changes in Generalized Anxiety Disorder Scale(GAD-7)scores before treatment and after 2,4,6,and 8 weeks of treatment were compared between the two groups.Results(1)After 2,4,6 and 8 weeks of treatment,the scores of PASI,DLQI and GAD-7 of patients in the two groups were improved significantly(P<0.05),and the improvement in the observation group was significantly superior to that in the control group,the difference being statistically significant(P<0.05).(2)The cured and markedly rate of the observation group was 86.67%(26/30);and that of the control group was 66.67%(20/30).The efficacy of the observation group was superior to that of the control group,the difference being statistically significant(P<0.05).(3)After 2,4,6,and 8 weeks of treatment,the diameter of glomus under dermoscopy of the patients in the two groups were improved significantly(P<0.05),and the improvement in the observation group was significantly superior to that in the control group,the difference being statistically significant(P<0.05).Conclusion Lingnan fire needling therapy for plaque psoriasis can effectively improve the clinical symptoms of the patients,relieve the anxiety symptoms induced by skin lesions and itching,so as to improve their quality of life.
10.Clinical Efficacy of Compound Shenghua Prescription Assisting Tranexamic Acid in the Treatment of Postpartum Hemorrhage and Its Effect on Plasma AT-Ⅲ,D-D and FIB Levels
Jingjing WU ; Lixin QIN ; Xuejing LU
Journal of Guangzhou University of Traditional Chinese Medicine 2025;42(5):1111-1118
Objective To investigate the clinical efficacy of Compound Shenghua Prescription(derived from Shenghua Decoction)assisting tranexamic acid in the treatment of postpartum hemorrhage and to observe its effect on plasma antithrombin Ⅲ(AT-Ⅲ),D-dimer(D-D)and fibrinogen(FIB)levels.Methods A total of 216 patients with postpartum hemorrhage admitted to Shijiazhuang Maternal and Child Health Hospital from January 2023 to March 2024 were selected.The patients were randomly divided into conventional group and trial group by random number table method,with 108 cases in each group.Two groups of patients were given postpartum routine treatment of blood transfusion,anti-shock,fluid infusion,and promoting uterine contraction.Additionally,the conventional group was given tranexamic acid treatment,and the trial group was given Compound Shenghua Prescription assisting tranexamic acid treatment.The course of treatment for the two groups covered 3 days.Before and after treatment,the changes of traditional Chinese medicine(TCM)syndrome scores and levels of coagulation factors and inflammation-stress factors in the two groups were observed.Time for the symptom improvement,hospitalization time,clinical efficacy and incidence of adverse reactions were compared between the two groups.Results(1)After 3 days of treatment,the total effective rate of the trial group was 98.15%(106/108)and that of the conventional group was 91.67%(99/108).The curative effect of the trial group was significantly superior to that of the conventional group(P<0.05).(2)The duration of bleeding symptoms,hemostasis time,time for the bloody lochia disappearance and hospitalization time in the trial group were significantly shorter than those in the conventional group(P<0.01).(3)After 3 days of treatment,the scores of primary symptoms,secondary symptoms,and tongue and pulse manifestations in the two groups were significantly lowered compared with those before treatment(P<0.05),and the decrease in the trial group was significantly superior to that in the conventional group(P<0.01).(4)After 3 days of treatment,the levels of plasma D-D and FIB in the two groups were significantly decreased compared with those before treatment(P<0.05),and the level of plasma AT-Ⅲ was significantly increased compared with that before treatment(P<0.05).The decrease of plasma D-D and FIB levels and the increase of plasma AT-Ⅲ level in the trial group were significantly superior to those in the conventional group(P<0.01).(5)After 3 days of treatment,the levels of serum C-reactive protein(CRP),lipid peroxide(LPO)and interleukin 8(IL-8)in the two groups were significantly decreased compared with those before treatment(P<0.05),and the level of serum superoxide dismutase(SOD)was significantly increased compared with that before treatment(P<0.05).The decrease of serum CRP,LPO and IL-8 levels and the increase of serum SOD level in the trial group were significantly superior to those in the conventional group(P<0.01).(6)The incidence of adverse reactions in the trial group was 8.33%(9/108),and that in the conventional group was 10.19%(11/108).There was no significant difference between the two groups(P>0.05).Conclusion Compound Shenghua Prescription assisting tranexamic acid is effective in the treatment of postpartum hemorrhage.It can effectively shorten the bleeding time,relieve clinical symptoms,improve coagulation function and inhibit the expression of inflammation-stress factors.

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