1.Exploration of a new model for the construction of medical institution formulation platforms from the perspective of industry-university-research collaborative innovation theory
Kana LIN ; Anle SHEN ; Yejian WANG ; Yanqiong WANG ; Hao LI ; Yanfang GUO ; Youjun WANG ; Xinyan SUN
China Pharmacy 2026;37(2):137-141
OBJECTIVE To explore a model for constructing a platform for medical institution formulation and provide insights for promoting their development. METHODS By systematically reviewing the development status and challenges of medical institution preparations in China, and based on the theory of industry-university-research collaborative innovation, the organizational structure, collaborative processes, and safeguard mechanisms of the platform were designed. RESULTS & CONCLUSIONS Medical institution formulations in China mainly faced challenges such as weak research and development (R&D) capacity, uneven quality standards, and blocked transformation pathways. This study established a full-chain, whole- industry collaborative innovation network covering the government, medical institutions, universities/research institutes, pharmaceutical enterprises, and the market, forming a new “government-industry-university-research-application” five-in-one platform model for medical institution formulations. By establishing mechanisms such as multi-entity collaborative cooperation, full- chain intellectual property management, contribution-based benefit distribution, staged risk-sharing, and third-party evaluation, the model clarified the responsibilities and collaborative pathways of all parties. The new model highlights the whole-process transformation of clinical experience-based prescriptions, enabling precise alignment between clinical needs and technological R&D, as well as between preparation achievements and industrial transformation. While breaking down the barriers of traditional platform construction, it effectively achieves optimal resource allocation and complementary advantages, addresses problems emerging in the development of medical institution preparations, and provides reference value for the formulation of relevant systems.
2.Expert consensus on neoadjuvant PD-1 inhibitors for locally advanced oral squamous cell carcinoma (2026)
LI Jinsong ; LIAO Guiqing ; LI Longjiang ; ZHANG Chenping ; SHANG Chenping ; ZHANG Jie ; ZHONG Laiping ; LIU Bing ; CHEN Gang ; WEI Jianhua ; JI Tong ; LI Chunjie ; LIN Lisong ; REN Guoxin ; LI Yi ; SHANG Wei ; HAN Bing ; JIANG Canhua ; ZHANG Sheng ; SONG Ming ; LIU Xuekui ; WANG Anxun ; LIU Shuguang ; CHEN Zhanhong ; WANG Youyuan ; LIN Zhaoyu ; LI Haigang ; DUAN Xiaohui ; YE Ling ; ZHENG Jun ; WANG Jun ; LV Xiaozhi ; ZHU Lijun ; CAO Haotian
Journal of Prevention and Treatment for Stomatological Diseases 2026;34(2):105-118
Oral squamous cell carcinoma (OSCC) is a common head and neck malignancy. Approximately 50% to 60% of patients with OSCC are diagnosed at a locally advanced stage (clinical staging III-IVa). Even with comprehensive and sequential treatment primarily based on surgery, the 5-year overall survival rate remains below 50%, and patients often suffer from postoperative functional impairments such as difficulties with speaking and swallowing. Programmed death receptor-1 (PD-1) inhibitors are increasingly used in the neoadjuvant treatment of locally advanced OSCC and have shown encouraging efficacy. However, clinical practice still faces key challenges, including the definition of indications, optimization of combination regimens, and standards for efficacy evaluation. Based on the latest research advances worldwide and the clinical experience of the expert group, this expert consensus systematically evaluates the application of PD-1 inhibitors in the neoadjuvant treatment of locally advanced OSCC, covering combination strategies, treatment cycles and surgical timing, efficacy assessment, use of biomarkers, management of special populations and immune related adverse events, principles for immunotherapy rechallenge, and function preservation strategies. After multiple rounds of panel discussion and through anonymous voting using the Delphi method, the following consensus statements have been formulated: 1) Neoadjuvant therapy with PD-1 inhibitors can be used preoperatively in patients with locally advanced OSCC. The preferred regimen is a PD-1 inhibitor combined with platinum based chemotherapy, administered for 2-3 cycles. 2) During the efficacy evaluation of neoadjuvant therapy, radiographic assessment should follow the dual criteria of Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and immune RECIST (iRECIST). After surgery, systematic pathological evaluation of both the primary lesion and regional lymph nodes is required. For combination chemotherapy regimens, PD-L1 expression and combined positive score need not be used as mandatory inclusion or exclusion criteria. 3) For special populations such as the elderly (≥ 70 years), individuals with stable HIV viral load, and carriers of chronic HBV/HCV, PD-1 inhibitors may be used cautiously under the guidance of a multidisciplinary team (MDT), with close monitoring for adverse events. 4) For patients with a poor response to neoadjuvant therapy, continuation of the original treatment regimen is not recommended; the subsequent treatment plan should be adjusted promptly after MDT assessment. Organ transplant recipients and patients with active autoimmune diseases are not recommended to receive neoadjuvant PD-1 inhibitor therapy due to the high risk of immune related activation. Rechallenge is generally not advised for patients who have experienced high risk immune related adverse events such as immune mediated myocarditis, neurotoxicity, or pneumonitis. 5) For patients with a good pathological response, individualized de escalation surgery and function preservation strategies can be explored. This consensus aims to promote the standardized, safe, and precise application of neoadjuvant PD-1 inhibitor strategies in the management of locally advanced OSCC patients.
3.Establishment and Evaluation of New Mouse Model of Rheumatoid Arthritis Combined with Interstitial Lung Disease
Liting XU ; Qingyu ZHAO ; Chao YANG ; Lianhua HE ; Congcong SUN ; Shuangrong GAO ; Lili WANG ; Chunfang LIU ; Na LIN
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(6):81-90
ObjectiveTo establish a mouse model of rheumatoid arthritis with interstitial lung disease (RA-ILD) in DBA/1 mice using Porphyromonas gingivalis (Pg) infection combined with collagen-induced arthritis (CIA), and to comprehensively evaluate pathological characteristics in joints, lungs, and serum. MethodsForty DBA/1 mice were randomly divided into four groups, i.e., Control, Pg infection (Pg), CIA, and Pg infection combined with CIA (Pg+CIA), with 10 mice in each group. Arthritis clinical symptoms were evaluated by recording arthritis incidence and clinical scores. Micro-CT scanning was used to assess knee joint pathology. Histopathological changes and collagen deposition in knee joints and lung tissues were analyzed using hematoxylin-eosin (HE) and Masson staining. Immunohistochemistry was performed to detect protein expression of α-smooth muscle actin (α-SMA), typeⅠ collagen (ColⅠ), and fibronectin (FN) in lung tissues. Real-time quantitative polymerase chain reaction(Real-time PCR)was used to measure mRNA expression levels of α-SMA, ColⅠ, FN, tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), and IL-1β in lung tissues. Enzyme-linked immunosorbent assay (ELISA) was used to detect serum levels of Pg, cyclic citrullinated peptide (CCP), and immunoglobulin G (IgG). ResultsJoint lesions: The CIA and Pg+CIA groups showed 100% arthritis incidence, with evident joint redness, swelling, and deformity. The number of affected limbs was 27 and 28, and clinical scores were 68 and 70, respectively. No obvious clinical symptoms were observed in the Pg group. Histopathological and imaging analyses showed severe joint lesions in the CIA and Pg+CIA groups, with significantly increased histopathological scores, bone mineral density, bone volume fraction, trabecular thickness, and trabecular number compared to the Control group (P<0.01). No obvious joint pathology was observed in the Pg group. Lung lesions: The Pg+CIA group exhibited marked alveolar inflammation, interstitial inflammatory cell infiltration, and alveolar wall thickening, with pronounced blue staining of collagen fibers. Histopathological scores and collagen area ratios were significantly higher than those of the Control, Pg, and CIA groups (P<0.05). Lung protein and mRNA expression levels of α-SMA, ColⅠ, and FN were markedly increased, and mRNA levels of IL-6, TNF-α, and IL-1β were significantly elevated compared to the Control group (P<0.05). Serology: The Pg+CIA group showed significantly higher levels of CCP, Pg, and IgG compared with the Control, Pg, and CIA groups (P<0.05). ConclusionDBA/1 mice subjected to Pg infection combined with CIA exhibited pronounced symptoms and pathological features of RA-ILD, along with elevated serum anti-CCP antibody levels. This model represents a novel RA-ILD mouse model, providing a valuable experimental tool for investigating RA-ILD pathogenesis and developing new therapeutics, and serves as a basis for establishing anti-cyclic citrullinated peptide antibody (ACPA)-positive RA-ILD animal models.
4.LC-MS Analysis on Material Basis of Famous Classical Formula Xuefu Zhuyutang
Shujing ZHONG ; Zhaoyue LIU ; Mengge WANG ; Lan MIAO ; Changying REN ; Mingqian SUN ; Li LIN
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(6):188-196
ObjectiveTo systematically identify the chemical constituents of Xuefu Zhuyutang(XFZY) and quantitatively determine its main components, aiming to elucidate its pharmacodynamic material basis and provide a scientific foundation for improving its quality control standards. MethodsUltra-performance liquid chromatography-quadrupole-time-of-flight mass spectrometry(UPLC-Q-TOF-MS/MS) was employed for qualitative analysis of XFZY, and the identification of compounds was accomplished by comparing their retention times, secondary MS fragment ion information, 52 reference standards and relevant databases, followed by attribution of their herbal sources. A total of 22 representative compounds were screened out, and UPLC-quadrupole-linear ion trap mass spectrometry(UPLC-Q-TRAP-MS/MS) was applied for quantitative analysis of the compounds in the formula. ResultsA total of 77 compounds were identified in XFZY, including 31 flavonoids mainly derived from Aurantii Fructus, Glycyrrhizae Radix et Rhizoma, Persicae Semen, Carthami Flos, Bupleuri Radix, Paeoniae Radix Rubra and Achyranthis Bidentatae Radix, 24 terpenoids mainly derived from Platycodonis Radix, Glycyrrhizae Radix et Rhizoma, Paeoniae Radix Rubra and Rehmanniae Radix, 9 phenylpropanoids and their derivatives mainly derived from Chuanxiong Rhizoma, Angelicae Sinensis Radix and Rehmanniae Radix, 4 phenolic acids mainly derived from Chuanxiong Rhizoma, Angelicae Sinensis Radix and Paeoniae Radix Rubra, 3 saccharides mainly derived from Rehmanniae Radix and Achyranthis Bidentatae Radix, and 6 other compounds mainly derived from Persicae Semen, Rehmanniae Radix and Angelicae Sinensis Radix. The results of quantitative analysis showed that the contents of protocatechuic acid, hydroxypaeoniflorin, amygdalin, vanillic acid, paeoniflorin, liquiritin apioside, liquiritin, isoquercitrin, naringin, cosmosiin, hesperidin, neohesperidin, isoliquiritin, liquiritigenin, naringenin, benzoylpaeoniflorin, hesperetin, isoliquiritigenin, formononetin, glycyrrhizic acid, nobiletin and ligustilide in XFZY were determined to be 0.12, 1.57, 54.53, 0.29, 36.17, 4.29, 4.84, 0.09, 46.67, 0.04, 3.44, 31.95, 0.82, 0.10, 0.11, 0.43, 0.07, 0.03, 0.01, 8.24, 0.13, 1.81 mg·g-1. ConclusionThe qualitative method established in this study enables rapid and sensitive analysis of the chemical constituents in XFZY. Among the identified compounds, 52 are confirmed by reference standards, ensuring the accuracy of identification. The quantitative analysis of 22 key components provides a reliable experimental basis for the pharmacodynamic material basis research and quality control standard improvement of XFZY.
5.Analysis of the management status and project undertaking of drug clinical trial institutions in Jiangxi Province after the implementation of the filing system
Min JIANG ; Li LIN ; Chenxi GAN ; Wenxiong SUN ; Qingsong XU ; Xiuli ZHAO
China Pharmacy 2025;36(3):275-279
OBJECTIVE To investigate and analyze the current management of drug clinical trial institutions in Jiangxi Province and the situation of undertaking drug clinical trials after the implementation of the filing system. METHODS A survey was conducted on 38 new institutions (obtained qualifications during the implementation of the filing system) and old institutions (obtained qualifications during the implementation of the recognition system) that had completed drug clinical trial institution qualification filing for more than one year in Jiangxi Province. The survey focused on the basic information of the institutions, the number of registered principal investigator (PI), institutional hardware and information construction, personnel allocation and training, and drug registration clinical trials undertaken by the institutions. RESULTS Of 38 institutions surveyed, there were 22 general hospitals and 16 specialized hospitals; there were 24 old institutions and 14 new institutions. Whether in general hospitals or specialized hospitals, the old institutions were better than the new institutions in the number of approved beds, the number of outpatients, the number of inpatients, the number of specialties, and the number of PI; both old and new institutions had separate offices; all new institutions were set up with GCP pharmacy. The adoption of clinical trial management system in new institutions is significantly less than in old institutions. In the general hospital, both the number of full-time managers and the number of quality controllers in old institutions were significantly more than in the new institutions, while the opposite was true at the level of specialized hospitals. In terms of centralized training on GCP, new institutions were all better than the old ones. Whether in general hospitals or specialized hospitals, the number of drug registration clinical trial projects undertaken by new institutions was significantly less than that of old ones. CONCLUSIONS The new institutions are worse than the old institutions in comprehensive strength and information construction of hospitals, and the number of clinical trials undertaken by new institutions is also less than old institutions.
6.Epidemiological investigation of a maternal Listeria monocytogenes ST2 infection case
XU Wei ; LIN Yun ; ZHU Guoying ; SONG Hejia ; JIA Juanjuan ; SUN Yangming
Journal of Preventive Medicine 2025;37(2):189-191
Abstract
On September 26, 2024, a municipal hospital in Jiaxing City reported a maternal case of Listeria monocytogenes infection. In order to clarify the source of infection, the Jiaxing Center for Disease Control and Prevention immediately conducted the epidemiological investigation, laboratory testing and related disposal work. The case presented with fever (37.9 ℃), gradually intensifying paroxysmal abdominal pain without obvious cause, and went to hospital on the day of onset. Due to fetal intrauterine distress, a male infant was delivered by cesarean section on the same day. The epidemiological investigation identified that the case usually consumed fruits, often store fruits such as watermelon and grapes in the refrigerator alongside raw meat, and the refrigerator had never been cleaned or disinfected, posing a risk of cross contamination. Laboratory tests on amniotic fluid sample from the pregnant woman, infant blood sample showed positive results for Listeria monocytogenes infection. One strain of Listeria monocytogenes was detected in a smear sample from the inner wall of the refrigerator, and all the strains were ST2 type. Consuming fruits contaminated with Listeria monocytogenes may be the main source of infection. Food safety education for pregnant women and their family members should be strengthened to reduce the risk of infection.
7.Professor LIU Jinmin's Clinical Experience in Treating Epilepsy Based on the Method of Closing Yangming and Regaining Vital Activity
Lin ZOU ; Tianye SUN ; Mingyuan YAN ; Mi ZHAGN ; Shuai ZHAO ; Kaiyue WANG ; Lili LI ;
Journal of Traditional Chinese Medicine 2025;66(4):344-348
To summarize the clinical experience of Professor LIU Jinmin in treatment for epilepsy. It is believed that main pathogenesis of epilepsy is yangming failure to close and vital activity loss control, so a therapeutic approach focused on restoring the closure of yangming and regaining vital activity was proposed for the treatment of epilepsy. For excess syndrome, the treatment focuses on draining excess and descending qi, promoting purgation and restoring spirit. When yangming dryness-heat predominates, the approach involves unblock the bowels and regulating the spirit, descending qi and reducing fire, with modified Chengqi Decoction (承气汤) as prescription; when yangming phlegm-fire predominates, the treatment focuses on clearing heat and resolving phlegm, calming mind and suppressing fright, with modified Qingxin Wendan Decoction (清心温胆汤) as prescription; when yangming blood stasis predominates, the approach involves breaking up blood stasis and promoting purgation, eliminating stasis and awakening the mind, with Taoren Chengqi Decoction (桃核承气汤) as prescription. For deficiency syndrome, the treatment emphasizes tonifying deficiency and raising qi, strengthening the stomach and nourishing the spirit. When center qi deficiency and sinking of clear qi of the nutrients from food, the approach involves replenishing and uplifting qi while nourishing vital activity, with modified Liujunzi Decoction (六君子汤) as prescription; when yin deficiency and fluid consumption, the treatment focuses on nourishing stomach and tonifying yin, promoting fluid production and calming the spirit, with modified Maimendong Decoction (麦门冬汤) combined with Yiwei Decoction (益胃汤) as prescriptions. In clinical situations of deficiency-excess complex, it is essential to distinguish the primary condition from the secondary, applying both supplementing and draining methods flexibly to achieve optimal treatment.
8.Guidelines for Establishing Animal Models of Rheumatoid Arthritis with Cold-dampness Obstruction Syndrome and Dampness-heat Obstruction Syndrome
Na LIN ; Yanqiong ZHANG ; Changhong XIAO ; Shenghao TU ; Jianning SUN ; Shijun XU ; Representation Preparation GROUP
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(6):47-54
Rheumatoid arthritis belongs to arthralgia syndrome in the theory of traditional Chinese medicine, and cold-dampness obstruction syndrome and dampness-heat obstruction syndrome are core syndromes and main syndrome differentiation types of this disease. Fine therapeutic effects have been obtained in the long-term clinical practice of many famous traditional Chinese medicine practitioners following the syndrome differentiation and treatment based on the guiding principles of cold and heat. To adapt to the clinical diagnosis practice of combining disease differentiation and syndrome differentiation, and to better carry out basic research on integrated Chinese and Western medicine and preclinical study on new traditional Chinese medicines, Guidelines for Establishing Animal Models of Rheumatoid Arthritis with Cold-Dampness Obstruction Syndrome and Dampness-Heat Obstruction Syndrome (hereinafter referred to as the Guidelines) were compiled by our research group, in cooperation with the renowned experts in research fields including traditional Chinese medicine, clinical medicine, zoology and evidence-based medicine, which provide a meaningful reference for scientific research, teaching and clinical applications. The compilation process of the Guidelines was guided by the theory of disease and syndrome integration and the principles of "evidence takes the main place, consensus plays an auxiliary role, and experience serves as the reference". Based on the comprehensive evaluation of pathogenesis homology, behavioral phenotypic consistency, and drug treatment predictability compared between animal models and human diseases, by the nominal group method, "recommendations" were formed for recommendations supported by evidence, and "consensus recommendations" were formed for recommendations not supported by evidence. Guidelines were formed involving content such as animal types, arthritis modeling methods, external stimulation conditions, and modeling assessment indicators during the establishment of the animal models of rheumatoid arthritis with cold-dampness obstruction syndrome and dampness-heat obstruction syndrome. The Guidelines are applicable for the disease and syndrome research on rheumatoid arthritis, investigation of therapeutic mechanisms, and development of new traditional Chinese medicine. The Guidelines also provide a reference for the establishment of guidelines on other types of diseases and syndromes combined with animal models to further promote the modernization of traditional Chinese medicine research and its integration with international academic development.
9.Editorial Explanation of Guidelines for Establishing Animal Models of Rheumatoid Arthritis with Cold-dampness Obstruction Syndrome and Dampness-heat Obstruction Syndrome
Na LIN ; Yanqiong ZHANG ; Changhong XIAO ; Shenghao TU ; Jianning SUN ; Shijun XU ; Xia MAO ; Representation Preparation GROUP
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(6):55-59
The Guidelines for Establishing Animal Models of Rheumatoid Arthritis with Cold-dampness Obstruction Syndrome and Dampness-heat Obstruction Syndrome (hereinafter referred to as the Guidelines) (No. T/CACM1567-2024) was published by Chinese Association of Chinese Medicine on January 11, 2024. To assist researchers and medical workers in understanding and applying the Guidelines more accurately, and also to provide reference and assistance for the establishment of guidelines on other types of diseases and syndromes combined with animal models, this paper made a declaration of the workflow, technological links, development references, promotion of its application and after-effect evaluation of the Guidelines that has been made according to the requirements of "Draft Group Standard of the Standardization Office of the Chinese Association of Traditional Chinese Medicine".
10.Varieties and Prescription Characteristics of Chinese Patent Medicines for Stroke in China
Jingdan ZHANG ; Wanping SUN ; Xiaoxia LIN ; Shuo ZHANG ; Xue ZHANG ; Jiahui YAO ; Yiming LIU ; Ming XIE
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(6):270-274
ObjectiveTo explore the listed varieties and prescription characteristics of Chinese patent medicines for stroke in China, explore the medication rules of Chinese medicine for stroke, and provide guidance for further clinical research and development of Chinese patent medicines. MethodsExcel 2021 and the Ancient and Modern Medical Record Cloud Platform (V2.3.5) were used to systematically mine and analyze the varieties and prescriptions of Chinese patent medicines for stroke in China. ResultsA total of 244 Chinese patent medicines (two for different dosage forms of the same prescription), 1 736 approval documents for Chinese patent medicines, 792 manufacturers, and 83 varieties of protected Chinese patent medicines were finally included in the database. The top three dosage forms were capsules (75), pills (53), and tablets (42). There were 28 Chinese patent medicines for stroke in the National Essential Drug Catalogue (2018), 129 in the National Essential Medical Insurance, Industrial Injury Insurance and Maternity Insurance Drug Catalogue (2023), and 4 in the National Non-prescription Drug Catalogue. Among the 138 prescriptions screened out, Chinese patent medicines mainly treated stroke patients with the syndrome of Qi deficiency and blood stasis. The top three most frequent medicinal herbs were Chuanxiong Rhizoma (63), Pheretima (47), and Salviae Miltiorrhizae Radix et Rhizoma (47). The medicinal herbs used were mainly warm, pungent, with the meridian tropism to the liver meridian. The correlation analysis showed that the herb pair with the highest support was Astragali Radix-Chuanxiong Rhizoma, and that with the highest confidence was Carthami Flos-Chuanxiong Rhizoma. Five herb combinations were identified based on the cluster analysis. ConclusionThe Chinese patent medicines for stroke mainly treat patients with the syndrome of Qi deficiency and blood stasis. The medicinal herbs used in the prescriptions mainly have the functions of activating blood and resolving stasis, extinguishing wind and stopping convulsions. Drug compatibility usually focuses on activating blood and resolving stasis, as well as expelling phlegm and opening orifices. This review of the varieties and prescription characteristics of Chinese patent medicines for stroke helps optimize clinical decision-making, guide drug research and development, promote medical research and scientific progress, and provide more effective support and guarantee for the treatment of stroke patients.


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