1.International experience and enlightenment of patient engagement in drug regulation
Jingjing WU ; Kaixin ZENG ; Yufei YANG ; Mengyan TIAN ; Fangzheng DONG ; Yimeng ZHANG ; Jun LI ; Ningying MAO
China Pharmacy 2025;36(8):908-913
OBJECTIVE To provide suggestions for improving the path and system construction of patient engagement in drug regulation in China. METHODS By reviewing initiatives and experiences from the United States (U. S.), European Union (EU), and Japan in promoting patient engagement, this study summarizes the roles and contributions of patients in the entire drug regulatory process internationally. Combining China’s current progress and challenges in patient engagement, specific proposals are formulated to refine regulatory pathways and institutional systems. RESULTS & CONCLUSIONS With growing global emphasis on patient engagement as a regulatory strategy, countries or regions such as the U.S., EU, and Japan have established clear policies, designated oversight agencies, and developed diversified pathways for patient engagement. Patients contribute to regulatory processes through advisory meetings, direct decision-making roles, and leveraging lived experiences and expertise to optimize drug evaluation and monitoring. In contrast, China’s patient engagement remains primarily limited to clinical value- oriented drug development, lacking formal policy guidance. It is recommended that China, based on its existing policy system, further strengthen the construction of a safeguard system for patient engagement, improve the capacity building and pathway models for patient participation in pharmaceutical regulation, and promote the continuous development of patient engagement in pharmaceutical regulation in our country.
2.Research progress on the role of efferocytosis in liver diseases.
Kaixin WANG ; Hui LI ; Haijian DONG ; Qun NIU ; Xikun YANG ; Xiaoyan ZENG ; Xuan WU
Chinese Journal of Cellular and Molecular Immunology 2025;41(1):71-76
Efferocytosis refers to the process of phagocytes engulfing and clearing the cells after programmed cell death. In recent years, an increasing number of studies have shown that the mechanisms of efferocytosis are closely related to drug-induced liver injury, hepatic ischemia-reperfusion injury, viral hepatitis, cholestatic liver diseases, metabolic-associated fatty liver disease, alcoholic liver disease, and other liver disorders. This review summarized the research progress on the role of efferocytosis in liver diseases, with the hope of providing new targets for the prevention and treatment of liver diseases.
Humans
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Liver Diseases/metabolism*
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Animals
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Phagocytosis/physiology*
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Phagocytes
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Efferocytosis
3.Research advances in the reprogramming of glucose and lipid metabolism in liver fibrosis: Targeting hepatic macrophages and hepatic stellate cells
Xikun YANG ; Hui LI ; Kaixin WANG ; Xuan WU
Journal of Clinical Hepatology 2025;41(11):2379-2383
Liver fibrosis has a complex pathogenesis, and as research deepens, an increasing number of evidence has revealed extensive metabolic reprogramming in the development and progression of liver fibrosis. This article reviews the origin and role of hepatic macrophages, the distribution of hepatic stellate cells, and the changes in glycolysis and lipid metabolism in the two types of cells, in order to provide new insights into the research on liver fibrosis and the prevention and treatment of this disease.
4.Efficacy variations of adjuvant chemotherapy across disease stages in duodenal adenocarcinoma: a multivariate survival analysis based on the SEER database
Yu WANG ; Kaixin HU ; Fengqing ZHAO ; Huangbao LI
Journal of Surgery Concepts & Practice 2025;30(5):428-437
Objective To investigate the efficacy of adjuvant chemotherapy for patients with duodenal adenocarcinoma (DAC) at different stages. Methods A retrospective analysis was performed on patients diagnosed with DAC between January 2000 and December 2021 using data from the SEER database. Kaplan-Meier curves were utilized to evaluate the impact of adjuvant chemotherapy on survival outcomes in DAC patients with different stages. Univariate and multivariate COX regression analyses were performed to determine whether adjuvant chemotherapy served as an independent prognostic factor for cancer-specific survival (CSS) and overall survival (OS). Results A total of 1 195 patients meeting the inclusion criteria were included in the study. Of these, 620 patients (51.9%) received adjuvant chemotherapy after surgery were defined as the adjuvant chemotherapy group, whereas 575 patients (48.1%) underwent surgery alone were defined as the other group. After propensity score matching, 634 patients were retained for subsequent analysis. Subgroup analysis demonstrated that there were statistically significant differences in CSS and OS between the adjuvant chemotherapy group and other group for stage ⅢA and ⅢB patients (P < 0.05), while no statistically significant differences in CSS and OS between the adjuvant chemotherapy group and other group for stageⅠ, stageⅡA, stage ⅡB patients (P > 0.05). Multivariate analysis identified adjuvant chemotherapy as an independent protective factor for both CSS and OS in DAC patients. Additionally, age, year of diagnosis, tumor grade, number of regional lymph nodes examined (RNE), and TNM stage were identified as independent protective or risk factors for CSS and OS (all P < 0.05). Conclusions Based on substage stratification, the survival benefits of adjuvant chemotherapy for DAC patients are as follows: patients with stage ⅢA and ⅢB benefit in both CSS and OS, while patients with stage Ⅰ, Ⅱ A, and ⅡB do not benefit in either CSS or OS.
5.Effects of ovarian torsional reduction in young rats on ovary tissue structure and reproductive function on torsional side in adult stage
Zhongyan ZHANG ; Hong MA ; Kaixin LI ; Peng ZHAO ; Guangxu ZHOU ; Bin LIU ; Guangyou LANG
Chongqing Medicine 2025;54(1):31-36
Objective To conduct the reductive reservation for torsional ovary in different states(.un-necrotic ovary,suspected necrotic torsional ovary and torsional necrotic ovary)after the ovarian torsion in pre-maturity SD rat,and to investigate its effect on the ovarian reproductive function in maturity stage.Methods A total of 32 SD rats with 3 weeks old were selected and randomly divided into 4 groups,8 cases in each group.The animal model of ovarian torsion was made by using the Turner method,which was similar to the animal model of testicular torsion,and either group was selected to undergo the sham operation as the con-trol group(CG group).The non-necrotic torsional ovary detorsion group(NNTOD group),suspected necrotic torsional ovary detorsion group(SNTOD group)and necrotic torsional ovary detorsion group(NTOD group)were established respectively.When the animals were fed to sexual maturity at 8 weeks of age,the experimen-tal animals were sacrificed by vertebral dislocation method,and the ovary tissues on the torsional side were cut for HE staining and transmission electron microscopy to examine the changes of ovarian histomorphology and mitochondrial structure.Ovarian cell apoptosis was detected by Tunel assay.ELISA method was used to de-tect the follicle-stimulating hormone(FSH),luteinizing hormone(LH)and anti-mullerian duct hormone(AMH)levels in centrifugal blood.Results The ovarian structure in the CG group and NNTOD group was clear,the ovarian follicles at different levels were developed well;the electron microscopy showed normal mi-tochondria.The ovarian partial structure in the SNTOD group was disorganized,the number of follicles at all levels of growth was decreased;electron microscopic examination showed a little damage of mitochondria.In the NTOD group,the arrangement of ovarian structure was obviously disordered,the number of growing folli-cles at all levels was significantly reduced;the electron microscopy showed that most of the mitochondria were obviously swollen and severely damaged.Compared with the CG group,the apoptosis rate in the SNTOD group and NTOD group was significantly increased(P<0.05).There was no statistically significant differ-ence between CG group and NNTOD group(P>0.05).Compared with the NTOD group,the apoptosis rate in the SNTOD group was decreased(P<0.05).Compared with the CG group,the levels of LH and FSH in the SNTOD and NTOD groups were increased,and the AMH level was decreased(P<0.05).The LH and FSH levels in the SNTOD group were lower than those in the NTOD group,the AMH level was higher than that in the NTOD group(P<0.05).Conclusion After reduction of the torsional suspected necrotic ovary in the prematurity rat,the ovarian reproductive function in the torsional side during sexual maturity period is slightly injured;while after reduction of torsional necrotic ovary restoration,its reproductive function is appar-ently damaged.
6.Periodontitis Aggravates Chronic Obstructive Pulmonary Disease Progression by Promoting Pulmonary Macrophage M1 Polarizations
Jing LI ; Kaixin XIONG ; Boyu TANG ; Ziyi XIA ; Zhao TANG ; Yan LI
Journal of Sichuan University (Medical Sciences) 2025;56(5):1281-1288
Objective To investigate the critical role of macrophage M1 polarization in mediating the effect of periodontitis on the progression of chronic obstructive pulmonary disease(COPD).Methods Alveolar lavage fluid samples were collected from COPD patients with comorbid periodontitis,and gene expression analysis was performed to validate the changes in the expression of M1 polarization-related genes.A mouse model of COPD,with experimentally induced periodontitis,were established.Hematoxylin and eosin(HE)staining of pathological sections was performed to observe the effect of periodontitis on COPD progression.Flow cytometry,immunofluorescence staining,and reverse transcription quantitative polymerase chain reaction(RT-qPCR)were performed to analyze the effect of periodontitis on macrophage M1 polarization and the expression of relevant genes in the alveolar lavage fluid and lung tissues.Results In clinical samples of alveolar lavage fluid from COPD patients with periodontitis,the expression of macrophage M1 polarization-related genes,including CD86,inducible nitric oxide synthase(iNOS),interleukin(IL)-1β,tumor necrosis factor(TNF)-α,IL-23,and IL-6,was upregulated compared with that of COPD patients without periodontitis.Analysis of a mouse disease model revealed that periodontitis affected the growth of COPD mice,with the final body mass of mice in the periodontitis and COPD comorbid group([21.3±0.52]g,day 34)lower than that of the COPD group([23.93±0.45]g,day 34).Pathological sections of the lung tissue showed that periodontitis exacerbated COPD progression,with more pronounced alveolar expansion and alveolar wall destruction observed in the periodontitis and COPD comorbid group.Flow cytometry revealed a higher proportion of M1-polarized macrophages in alveolar lavage fluid from COPD and periodontitis comorbid mice([31.36±2.51]%)compared with the COPD mice([23.19±1.07]%).Immunofluorescence assays indicated that periodontitis also promoted macrophage M1 polarization in the lung tissue of COPD mice.Gene expression analysis demonstrated that M1 polarization-related gene expression was significantly upregulated in both the alveolar lavage fluid and lung tissue of mice in the COPD and periodontitis co-morbid group compared to the COPD group.Conclusion Periodontitis exacerbates COPD progression by promoting macrophage M1 polarization in the lungs.Enhancing oral hygiene management and targeting the inhibition of macrophage M1 polarization may represent new therapeutic strategies for the clinical prevention and control of COPD.
7.Chidamide plus prednisone, cyclophosphamide, and thalidomide for relapsed or refractory peripheral T-cell lymphoma: A multicenter phase II trial
Jinhua LIANG ; Li WANG ; Xiaodong WANG ; Guohui CUI ; Jianfeng ZHOU ; Tongyao XING ; Kaixin DU ; Jingyan XU ; Luqun WANG ; Rong LIANG ; Biyun CHEN ; Jian CHENG ; Haorui SHEN ; Jianyong LI ; Wei XU
Chinese Medical Journal 2024;137(13):1576-1582
Background::Although the treatment of peripheral T-cell lymphoma (PTCL) has undergone advancements during the past several years, the response rate and long-term effects with respect to patients with PTCL remain unsatisfactory—particularly for relapsed or refractory (R/R) patients. This phase II trial was designed to explore the efficacy and safety of an all-oral regimen of chidamide plus prednisone, cyclophosphamide, and thalidomide (CPCT) for R/R PTCL patients who could not tolerate the standard chemotherapy for a variety of reasons.Methods::We conducted a multicenter phase II clinical trial in which we combined chidamide (30 mg twice weekly) with prednisone (20 mg daily after breakfast), cyclophosphamide (50 mg daily after lunch), and thalidomide (100 mg daily at bedtime) (the CPCT regimen) for a total of fewer than 12 cycles as an induction-combined treatment period, and then applied chidamide as single-drug maintenance. Forty-five patients were ultimately enrolled from August 2016 to April 2021 with respect to Chinese patients at nine centers. Our primary objective was to assess the overall response rate (ORR) after the treatment with CPCT.Results::Of the 45 enrolled patients, the optimal ORR and complete response (CR)/CR unconfirmed (CRu) were 71.1% (32/45) and 28.9% (13/45), respectively, and after a median follow-up period of 56 months, the median progression-free survival (PFS) and overall survival (OS) were 8.5 months and 17.2 months, respectively. The five-year PFS and OS rates were 21.2% (95% confidence interval [CI], 7.9-34.5%) and 43.8% (95% CI, 28.3-59.3%), respectively. The most common adverse event was neutropenia (20/45, 44.4%), but we observed no treatment-related death.Conclusion::The all-oral CPCT regimen was an effective and safe regimen for R/R PTCL patients who could not tolerate standard chemotherapy for various reasons.Trial Registration::ClinicalTrials.gov, NCT02879526.
8.Clinical analysis of 346 minor patients with maxillofacial fractures
Kaixin YAN ; Maoye LI ; Xinnan CHANG ; Hui LI ; Xiaohui ZHENG ; Lei LIU
West China Journal of Stomatology 2024;42(3):340-345
Objective This study aims to analyze the clinical epidemiology,diagnostic and treatment characteristics of minor patients with maxillofacial fracture and provide a reference for the prevention and treatment.Methods The clinical data of minor patients with maxillofacial fracture in Department of Traumatic and Plastic Surgery,West China Hospital of Stomatology,Sichuan University,from January 1,2015 to December 31,2020 were retrospectively studied and statistically analyzed in terms of age,gender,etiology,anatomic sites and treatment modalities.Results The mean age of the patients was(10.65±5.15)years,and the male-to-female ratio was 1.91∶1.High fall was the primary cause of maxillofacial fractures in minors aged 0-6 years.Traffic accident injuries were the main cause of maxillofacial fractures in minors aged 7-12 and 13-17 years.About 65.13%of the midface and 83.08%non-condylar fractures were mainly treated by surgery,and condylar fractures were treated conservatively in 74.73%and by surgical treatment in 25.27%.Conclusion The etiology of maxillofacial fractures in minors differs at different ages,so prevention strategies should be adjusted according to age.Surgical treatment has become the preferred treatment modality for midface and non-condylar fractures.Conservative treatment is still the main treatment method for condylar fractures,but the proportion of surgical treatment increases.
9.Comparative analysis of depressive symptoms between adolescents and adults based on SCL-90
Bing HU ; Su HONG ; Tianyu YANG ; Kaixin HUANG ; Xiaying LI ; Dandan CHENG ; Li KUANG
Chongqing Medicine 2024;53(5):754-759,765
Objective To investigate the difference of depressive symptoms between adolescents and adults,and to provide possible basis for early detection of adolescent depression.Methods From July 2021 to June 2022,a total of 4 096 patients with"depression"in the psychiatric clinic of the First Affiliated Hospital of Chongqing Medical University were selected as the research objects.They were divided into the adolescent group(n=2 439)and adult group(n=1 657)according to their ages,and the results of self-rating depression scale(SDS)and symptom checklist 90(SCL-90)were collected and analyzed.Results There were significant differences in nationality,residence,native place,family history and degree of depression between the two groups(P<0.05).The adolescent group has more severe depressive symptoms,which were mainly manifes-ted in negative ideas,obsessive-compulsive symptoms,hostile and interpersonal relationship,and psychotic symptoms(P<0.05).The adult group showed more obvious in sleep(P<0.05).Conclusion Early inter-vention should be carried out for adolescents'depressive symptoms such as negative thoughts.
10.Effects of Modified Xiaoyao Powder (逍遥散) on the Programmed Cell Death of Hypothalamic Dopaminergic Neurons in Rat Model of Hyperprolactinemia with Liver Depression and Spleen Deficiency
Yan LI ; Yan LI ; Kaixin LIU ; Kangli DAI ; Xiao LIU ; Hui YANG ; Dan LUO
Journal of Traditional Chinese Medicine 2024;65(3):317-323
ObjectiveTo investigate the possible mechanisms of modified Xiaoyao Powder (逍遥散) in the treatment of hyperprolactinemia (HPRL) with liver constraint and spleen deficiency. MethodsNinety-six female SD rats were randomly divided into a normal group (n=16) and a modeling group (n=80). In the modeling group, rats were subjected to chronic unpredictable stress combined with intraperitoneal injection of metoclopramide to establish a rat model of HPRL with liver constraint and spleen deficiency. The 80 successfully modeled rats were randomly divided into a model group, a high, medium, and low-dose group of modified Xiaoyao Powder, and a bromocriptine group, with 16 rats in each group. The high, medium, and low-dose groups of modified Xiaoyao Powder were orally administered doses of 60, 30, and 15 g/(kg·d) respectively, the bromocriptine group was orally administered bromocriptine tablets at a dose of 1 mg/(kg·d), and the normal group and model group were orally administered 10 ml/(kg·d) of normal saline for 14 consecutive days. ELISA was used to detect serum prolactin (PRL) level; immunohistochemistry was used to determine the expression of tumor necrosis factor-alpha (TNF-α) and tyrosine hydroxylase (TH) in the hypothalamus; Western blot was used to detect the protein expression of tumor necrosis factor receptor 1 (TNFR1) in the hypothalamus; Real-time PCR was used to detect the mRNA expression of receptor interacting protein kinase 3 (RIP3) in the hypothalamus; immunofluorescence was used to detect the co-expression of RIP3 and dopamine neurons in the hypothalamus. ResultsCompared with the normal group, the serum PRL levels were increased in the model group, and the expression of hypothalamic TNF-α, TNFR1, RIP3 mRNA, and the co-expression of RIP3 with dopamine neurons were significantly increased, while TH expression was decreased (P<0.05 or P<0.01). Compared with the model group, the expression of hypothalamic TNF-α was decreased in the bromocriptine group and low-dose group of modified Xiaoyao Powder, and the expression of TH was significantly increased in the medium and high-dose groups of modified Xiaoyao Powder and the bromocriptine group. The serum PRL levels, hypothalamic TNFR1 and RIP3 mRNA expression, and the co-expression of RIP3 with dopamine neurons were significantly decreased in all dose groups of modified Xiaoyao Powder and the bromocriptine group (P<0.05 or P<0.01). Compared with the bromocriptine group, the serum PRL level were significantly increased in the high and low-dose groups of modified Xiaoyao Powder, TH expression was significantly increased in the medium-dose group of modified Xiaoyao Powder, hypothalamic RIP3 mRNA expression was decreased in the low-dose group of modified Xiaoyao Powder, and the co-expression of RIP3 with dopamine neurons was significantly increased in the high-dose group of modified Xiaoyao Powder (P<0.01). ConclusionModified Xiaoyao Powder can regulate the programmed cell death of hypothalamic dopamine neurons, affect DA expression, and regulate PRL levels, which may be one of its mechanisms in the treatment of HPRL with liver constraint and spleen deficiency.

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