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.The role of necroptosis in liver fibrosis
Xuan WU ; Hui LI ; Haijian DONG ; Xikun YANG ; Kaixin WANG
Journal of Clinical Hepatology 2024;40(8):1677-1681
As a crucial link in the progression of various chronic liver diseases to liver cirrhosis,liver fibrosis affects the prognosis and outcome of chronic liver diseases.Necrotosis is a novel pattern of programmed cell death(PCD),and studies have shown that it plays an important role in the pathophysiology of various diseases and is considered a potential target for improving liver fibrosis.Necroptosis of various types of intrahepatic cells(including hepatocytes,hepatic stellate cells,liver macrophages,and hepatic sinusoidal endothelial cells)can promote or inhibit liver fibrosis.This article elaborates on the above mechanisms and discusses the therapeutic strategies for targeting liver fibrosis mediated by necroptosis.
5.Role of statins in chronic liver disease
Xikun YANG ; Hui LI ; Zijian ZENG ; Xuan WU ; Kaixin WANG
Journal of Clinical Hepatology 2024;40(10):2104-2108
Chronic liver disease is the"devil's trilogy"in which the liver progresses from inflammation and fibrosis to liver cirrhosis and hepatocellular carcinoma,which poses a great challenge for hepatologists worldwide.Statins have played a significant role in the treatment of cardiovascular diseases and hyperlipidemia since their introduction,and in recent years,they have also demonstrated the potential to improve hepatic steatosis,exert an anti-inflammatory effect,regulate the phenotype of hepatic stellate cells,reduce portal venous pressure,and improve hepatic microcirculation in chronic liver disease.This article reviews the latest advances in the basic and clinical studies of statins in chronic liver disease,in order to provide new insights into the research,prevention,and treatment of chronic liver disease.
6.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.
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 observation of neck Gongfa exercise intervening people at high risk for cervical spondylosis
Ji MA ; Yu ZHANG ; Fei GU ; Yumin LIU ; Junliang WANG ; Cheng WANG ; Yazhou LI ; Kaixin SUN ; Jun ZHANG ; Jue HONG
Journal of Acupuncture and Tuina Science 2024;22(6):489-496
Objective:To observe the clinical efficacy of neck Gongfa exercise in intervening people at high risk for cervical spondylosis. Methods:A total of 212 participants from 8 companies at high risk for cervical spondylosis were divided into two groups using the random number table method,with 105 participants in the control group receiving health education and 107 participants in the trial group receiving an additional neck Gongfa exercise.After successive 3-month interventions,the two groups were compared in terms of cervical soft tissue tension and neck disability index(NDI)score.The incidence of cervical spondylosis was observed 3 months later. Results:During the process,10 cases dropped out in the trial group,and the control group had 9 dropout cases.After the intervention,the cervical soft tissue tension value and NDI score improved in both groups(P<0.05)and showed significant differences between the two groups(P<0.05).At the 3-month follow-up,the trial group had a lower incidence rate of cervical spondylosis than the control group(P<0.05). Conclusion:For people at high risk for cervical spondylosis,neck Gongfa exercise can effectively improve cervical soft tissue tension and motor dysfunction and lower the incidence of cervical spondylosis in the short run.
9.Metabonomics Combined with Prescription Compatibility Theory to Explore the Lipid-lowering Effect of Qige Decoction Compatibility
Kaixin GUO ; Hui TANG ; Yanfang LI ; Xiaoqing YU ; Haoyang WEI ; Keer HUANG ; Wei CHEN ; Xuehong KE
Traditional Chinese Drug Research & Clinical Pharmacology 2024;35(7):971-984
Objective To explore the lipid-lowering effect of Qige Decoction before and after compatibility through the combination of pharmacodynamics and liver metabolomics,and to provide new research strategies for exploring the scientific notation of traditional Chinese medicine compatibility.Methods According to the pharmacodynamic strategy,three groups of drug administration were set up as Qige Decoction group,Astragali Radix-Puerariae Radix group,and Pericarpium Citri Tangerinae group.Four indices of blood lipids,serum biochemical indicators,and liver morphology and pathology were used to evaluate the intervention effect of Qige Decoction on hyperlipidemic rats.Liver metabolomics technology was used to analyze the effects of Qige Decoction on metabolites before and after compatibility,and multivariate statistical analysis was used to evaluate the differences between groups in terms of differential metabolites and metabolic pathways.Results Compared with the model group,the callback abilities of four indices of blood lipid in the Qige Decoction group were higher than those in Astragali Radix-Puerariae Radix group and Pericarpium Citri Tangerinae group,among which the total cholesterol(TC)and triglyceride(TG)levels in the Qige Decoction group decreased(P<0.05).A total of 86 potential biomarkers were identified by liver metabolomics,with 23,13,and 7 metabolites being significantly different in the Qige Decoction group,Astragali Radix-Puerariae Radix group,and Pericarpium Citri Tangerinae group,respectively(P<0.05).Metabolic pathway analysis of 29 specific biomarkers with significant callback effects showed that they were related to glycerophospholipid metabolism,linoleic acid metabolism,α-linolenic acid metabolism,sphingolipid metabolism,arachidonic acid metabolism,and unsaturated fatty acid biosynthesis.Qige Decoction mainly regulates glycerophospholipid and linoleic acid metabolism,and uniquely acts on sphingolipid metabolism.Conclusion Qige Decoction has more lipid-lowering targets after compatibility,with better lipid-lowering effects than the Astragali Radix-Puerariae Radix group and Pericarpium Citri Tangerinae group.This study provides experimental evidence and research strategies for further revealing the scientific notation of traditional Chinese medicine compatibility.
10.Research progress on the application of virtual reality technology in patients with kinetophobia
Zhaoyuan WANG ; Shujuan LIU ; Kaixin LI ; Mengxue GUO ; Tong SUN ; Yujing LI ; Yujiao CHI ; Junting WANG
Chinese Journal of Modern Nursing 2024;30(24):3336-3340
Virtual reality technology is an emerging technology that integrates multiple disciplines. It has the advantages of immersion, interactivity and imagination, which provides convenience for intelligent nursing in the field of rehabilitation treatment. This paper summarizes the application research of virtual reality technology in patients with kinetophobia, focusing on classification, application mechanism, application status, limitations and future development of virtual reality technology in various diseases of kinetophobia, so as to provide reference and basis for the rehabilitation nursing of patients with kinetophobia based on virtual reality technology in the future.

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