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.Therapeutic Effect of Wenweishu Granules on Functional Dyspepsia Rats with Spleen-stomach Deficiency Cold Syndrome Based on Bioinformatics Analysis and Experimental Validation
Xinyu YANG ; Xiaoyi JIA ; Zihua XUAN ; Shuangying GUI ; Yanfang WU ; Yuhan MA ; Qin RUAN ; Jia ZHENG ; Zhiyong JIAO
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(18):30-40
ObjectiveThis study aims to investigate the therapeutic effects of Wenweishu granule (WWSG) on functional dyspepsia (FD) with spleen-stomach deficiency cold syndrome in rats by integrating network pharmacology, molecular docking, and animal experiments. MethodsActive components and corresponding targets of WWSG were collected from the Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform (TCMSP) and the Bioinformatics Analysis Tool for Molecular Mechanism of Traditional Chinese Medicine (BATMAN-TCM). Disease-related targets for FD with spleen-stomach deficiency cold syndrome were screened using GeneCards and the Integrative Pharmacology-based Research Platform of Traditional Chinese Medicine (TCMIP). Core therapeutic targets were identified via Cytoscape and validated by molecular docking. A rat model of FD with spleen-stomach deficiency cold syndrome was established using vinegar gavage combined with tail-clamping. The rats were randomly divided into a model group, low-, medium-, and high-dose WWSG groups (2.0, 4.0, 8.0 g·kg-1), a domperidone group (3.0 mg·kg-1), a Fuzi Lizhong pillwan (0.8 g·kg-1), and a normal control group (n=10 per group). Drugs were administered once daily by gavage for 14 consecutive days. After treatment, body weight, symptom scores, and gastrointestinal motility indices were recorded. Gastric and duodenal pathologies changes were observed via hematoxylin-eosin (HE) staining. Brain-gut peptides were measured in serum and tissue using enzyme-linked immunosorbent assay (ELISA). Immunohistochemistry and Western blot were performed to assess stem cell factor (SCF) and receptor tyrosine kinase (c-Kit) protein expression in gastric tissues. ResultsA total of 305 drug targets, 1 140 disease targets, and 116 overlapping targets were identified. Cytoscape analysis revealed 104 core targets. Enrichment analysis indicated that the SCF/c-Kit signaling pathway was the key mechanism. Molecular docking confirmed a strong binding affinity between active components of WWSG and SCF/c-Kit proteins (binding energy<-5.1 kcal·mol-1). Compared with the normal group, model rats exhibited slower weight gain (P<0.05), reduced gastric emptying and intestinal propulsion (P<0.01), mild gastric mucosal shedding, duodenal inflammatory cell infiltration, decreased levels of gastrin (GAS), 5-hydroxytryptamine (5-HT), and vasoactive intestinal peptide (VIP) (P<0.05, P<0.01), and elevated somatostatin (SS) expression (P<0.05, P<0.01). WWSG treatment ameliorated weight gain, symptom scores, and low-grade inflammation in gastric/duodenal tissues. High-dose WWSG significantly improved gastric emptying and intestinal propulsion, upregulated GAS, 5-HT, and VIP, and downregulated SS expression in serum and tissues (P<0.05, P<0.01). Immunohistochemistry and Western blot demonstrated that SCF and c-Kit protein expression was decreased in the model group (P<0.05, P<0.01), which was reversed by WWSG intervention (P<0.05). ConclusionWWSG exerts therapeutic effects on FD with spleen-stomach deficiency cold syndrome in rats, potentially by regulating the SCF/c-Kit signaling pathway to enhance gastrointestinal motility.
3.Identification of novel pathogenic variants in genes related to pancreatic β cell function: A multi-center study in Chinese with young-onset diabetes.
Fan YU ; Yinfang TU ; Yanfang ZHANG ; Tianwei GU ; Haoyong YU ; Xiangyu MENG ; Si CHEN ; Fengjing LIU ; Ke HUANG ; Tianhao BA ; Siqian GONG ; Danfeng PENG ; Dandan YAN ; Xiangnan FANG ; Tongyu WANG ; Yang HUA ; Xianghui CHEN ; Hongli CHEN ; Jie XU ; Rong ZHANG ; Linong JI ; Yan BI ; Xueyao HAN ; Hong ZHANG ; Cheng HU
Chinese Medical Journal 2025;138(9):1129-1131
4. Clinical study of apatinib combined with chemotherapy for advanced non-small cell lung cancer with negative driving genes
Yanfang LI ; Haiying JIANG ; Qian LI ; Mei ZHU ; Jiao LYU ; Hongying ZHAO
Chinese Journal of Oncology 2019;41(10):775-781
Objective:
To evaluate the efficacy and safety of apatinib combined with chemotherapy in the first-line treatment of advanced non-small cell lung cancer (NSCLC) with negative driving genes.
Methods:
From January 2016 to March 2018, 62 advanced NSCLC patients with negative driving genes diagnosed at Xuzhou Cancer Hospital were randomly divided into study group (30 cases) and control group (32 cases), respectively. The patients in the study group were treated with standard first-line chemotherapy combined with apatinib, while those in control group were treated with chemotherapy alone.
Results:
The disease control rate (DCR) and objective remission rate (ORR) in the study group were 60.0% and 16.7%, respectively, higher than 46.9% and 9.3% in the control group, but without statistical difference (
5.Clinical study of apatinib combined with chemotherapy for advanced non?small cell lung cancer with negative driving genes
Yanfang LI ; Haiying JIANG ; Qian LI ; Mei ZHU ; Jiao LYU ; Hongying ZHAO
Chinese Journal of Oncology 2019;41(10):775-781
Objective To evaluate the efficacy and safety of apatinib combined with chemotherapy in the first?line treatment of advanced non?small cell lung cancer ( NSCLC) with negative driving genes. Methods From January 2016 to March 2018, 62 advanced NSCLC patients with negative driving genes diagnosed at Xuzhou Cancer Hospital were randomly divided into study group (30 cases) and control group (32 cases), respectively. The patients in the study group were treated with standard first?line chemotherapy combined with apatinib, while those in control group were treated with chemotherapy alone. Results The disease control rate (DCR) and objective remission rate (ORR) in the study group were 60.0% and 16.7%, respectively, higher than 46.9% and 9.3% in the control group, but without statistical difference (P>0.05). The median progression?free survival ( PFS) of study group and control group were 6.4 months and 4.9 months, respectively (P=0.004), and the median overall survival (OS) were 11.3 months and 9.2 months, respectively (P=0.006).Multivariate survival analysis indicated that treatment regimen (P=0.001) was the independent prognostic factor of PFS,and PS score (P=0.002), clinical stage ( P=0.02) and treatment regimen ( P<0.001) were the independent prognostic factors of OS. After treatment, the incidence of hypertension and hand?foot syndrome in the study group were 46.7% and 53.3%, respectively, significantly higher than 3.3% and 0 in the control group, respectively ( P<0.05). The incidence of grade 3?4 adverse drug reactions (ADRs) in the study group was 26.7%(8/30), mainly including hypertension, hand?foot syndrome and bone marrow suppression. The incidence of grade 3?4 ADRs in the control group was 15.6%(5/32), all of which were bone marrow suppression, without significant difference (P=0.286). There was no difference in serum levels of VEGF and CEA between the two groups before treatment. After treatment, the serum level of VEGF in the study group was (169.3±10.1) pg/ml, lower than (211.8±16.7) pg/ml of the control group ( P<0.05). Conclusion Apatinib combined with first?line chemotherapy for advanced NSCLC patients with negative driving genes is safe and beneficial for survival. This therapeutic strategy can significantly prolong the PFS and OS, and further improvement and application can be considered as a choice in the clinical treatment.
6.Clinical study of apatinib combined with chemotherapy for advanced non?small cell lung cancer with negative driving genes
Yanfang LI ; Haiying JIANG ; Qian LI ; Mei ZHU ; Jiao LYU ; Hongying ZHAO
Chinese Journal of Oncology 2019;41(10):775-781
Objective To evaluate the efficacy and safety of apatinib combined with chemotherapy in the first?line treatment of advanced non?small cell lung cancer ( NSCLC) with negative driving genes. Methods From January 2016 to March 2018, 62 advanced NSCLC patients with negative driving genes diagnosed at Xuzhou Cancer Hospital were randomly divided into study group (30 cases) and control group (32 cases), respectively. The patients in the study group were treated with standard first?line chemotherapy combined with apatinib, while those in control group were treated with chemotherapy alone. Results The disease control rate (DCR) and objective remission rate (ORR) in the study group were 60.0% and 16.7%, respectively, higher than 46.9% and 9.3% in the control group, but without statistical difference (P>0.05). The median progression?free survival ( PFS) of study group and control group were 6.4 months and 4.9 months, respectively (P=0.004), and the median overall survival (OS) were 11.3 months and 9.2 months, respectively (P=0.006).Multivariate survival analysis indicated that treatment regimen (P=0.001) was the independent prognostic factor of PFS,and PS score (P=0.002), clinical stage ( P=0.02) and treatment regimen ( P<0.001) were the independent prognostic factors of OS. After treatment, the incidence of hypertension and hand?foot syndrome in the study group were 46.7% and 53.3%, respectively, significantly higher than 3.3% and 0 in the control group, respectively ( P<0.05). The incidence of grade 3?4 adverse drug reactions (ADRs) in the study group was 26.7%(8/30), mainly including hypertension, hand?foot syndrome and bone marrow suppression. The incidence of grade 3?4 ADRs in the control group was 15.6%(5/32), all of which were bone marrow suppression, without significant difference (P=0.286). There was no difference in serum levels of VEGF and CEA between the two groups before treatment. After treatment, the serum level of VEGF in the study group was (169.3±10.1) pg/ml, lower than (211.8±16.7) pg/ml of the control group ( P<0.05). Conclusion Apatinib combined with first?line chemotherapy for advanced NSCLC patients with negative driving genes is safe and beneficial for survival. This therapeutic strategy can significantly prolong the PFS and OS, and further improvement and application can be considered as a choice in the clinical treatment.
7.Association between EGFR mutation status and efficacy of first-line EGFR-TKI in patients with ;advanced non-small cell lung cancer
Haiying JIANG ; Yanfang LI ; Mei ZHU ; Qian LI ; Jiao LYU
Journal of International Oncology 2017;44(1):19-23
Objective To evaluated the effect of first-line epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI)on advanced non-small cell lung cancer (NSCLC)patients with different EGFR mutation status (exon 1 9 deletion and exon 21 mutation).Methods Seventy-two advanced NSCLC patients with EGFR mutation confirmed by histopathology were enrolled.All of the patients received first-line EGFR-TKI.The relationships between EGFR mutation status and objective response rate (ORR),disease control rate (DCR),progression free survival (PFS ) and overall survival (OS ) were analyzed.Results Of the 72 patients,37 patients expressed exon 1 9 deletion,35 patients expressed exon 21 mutation,and all of them could be evaluated.The ORR and DCR of patients with exon 1 9 deletion were higher than those of patients with exon 21 mutation (75.7%vs.51 .4%,χ2 =4.583,P=0.032;89.2%vs.68.6%,χ2 =4.636,P=0.031 ).The modified median PFS of patients with exon 1 9 deletion was significantly higher than that of patients with exon 21 mutation (1 3.2 month vs.1 0.8 month,χ2 =4.700,P=0.030).The median OS of patients with exon 1 9 deletion was significantly higher than that of patients with exon 21 mutation (30.2 month vs.25.6 month,χ2 =4.686,P=0.030).The side effects were similar between the two groups.The most common adverse reaction was rash,and the incidence had no significant difference between the two groups (48.7% vs.48.6%,χ2 =0.000,P=0.995 ).Conclusion EGFR mutation status is a predictor for PFS,OS and ORR of first-line EGFR-TKI in patients with advanced NSCLC.NSCLC patients with EGFR exon 1 9 deletion are associated with longer survival time and better response rate compared with those with exon 21 mutation.
8.The challenges of forensic expert accepting cross-examination in trial-centered trial mode
Chinese Journal of Forensic Medicine 2017;32(1):1-4
Today, the direction of litigation reformation is changing trial pattern to be trial-centered and making the trial substantialized. Under this background, the relevant provisions have been launched from the supreme people's court and other departments to make sure that the forensic expert will appear in court and accept cross-examination, and this phenomenon should be normalized and substantiated. In order to ensure the expert opinion can be fully and effectively cross-examined, the medico-legal expert should fulfill obligations, such as respect for the court, answer questions honestly and explain expert opinions. We find that some problems show up in this process: the rate of forensic expert appearing in court is low; the legal nature of expert opinion is not clear; the requirements are not clear;the conflict between forensic expert opinion and other forms of expert evidence, including auxiliary expert, is very clearly. Based on this situation, the author give some suggestions to the forensic expert: keep on learning to improve professional skill; improve the legal knowledge; pay attention to practice and strengthen the ability of expression.
9.Relation between the gene status of epidermal growth factor receptor and efficacy of the first-line tyrosine kinase inhibitor in patients with advanced non-small cell lung cancer
Haiying JIANG ; Mei ZHU ; Yanfang LI ; Qian LI ; Jiao LYU ; Jing LI
Cancer Research and Clinic 2016;28(6):373-377
Objective To explore the relationship between mutation status of epidermal growth factor receptor (EGFR) and efficacy of EGFR tyrosine kinase inhibitor (EGFR-TKI) in patients with advanced nonsmall ccll lung cancer (NSCLC).Methods The data of 72 outpatients and inpatients with stage Ⅲ b/ⅣNSCLC diagnosed by histopathology and harbored EGFR-activating mutations (exon 19 and exon 21) from January 2008 to December 2013 in Xuzhou Cancer Hospital were collected.All of them received first-line EGFR-TKI.The relationships between EGFR gene status and response rate or progression-free survival (PFS)were analyzed.Results Of the 72 patients with EGFR mutation,37 patients harbored exon 19 deletion,and 35 patients harbored exon 21 L858R point mutation.The efficacies of all patients were assessable.The objective response rate (ORR) was 63.9 % (46/72) and disease control rate (DCR) was 79.2 % (57/72) in all patients,including 2 cases of complete remission (CR),44 cases of partial remission (PR),1 1 cases stable disease (SD) and 15 cases of disease progression (PD).Patients with exon 19 deletion had a higher ORR [75.7 % (28/37) vs 51.4 % (18/35),P =0.032] and a higher DCR [89.2 % (33/37) vs 68.6 % (24/35),P =0.031]than patients with exon 21 L858R mutation.The PFS of patients with exon 19 deletion was significantly longer than that of patients with exon 21 L858R mutation (12.0 months vs 9.5 months,P =0.030).Cox multivariate analysis indicated that the gender,histological type,smoking history were the major influence factors of PFS.The differences of toxicity between the two groups were not significant.Conclusion EGFR-activating mutation is a predictor for PFS and ORR of first-line EGFR-TKI in patients with advanced NSCLC.

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