1.Effect evaluation of pharmaceutical service based on root cause analysis combined with KAP theory on decreasing the protocol violations of investigational medicinal products rate in pediatric clinical trials
Chunyan GUO ; Yi ZHANG ; Yuxin YANG ; Yuguang LIANG ; Qian DING ; Qian WANG ; Chengyue ZHANG ; Yu SUN ; Peng GUO
China Pharmacy 2026;37(9):1206-1210
OBJECTIVE To investigate the effect of pharmaceutical services guided by root cause analysis (RCA) in a problem-oriented manner combined with knowledge-attitude-practice (KAP) theory on reducing the incidence of protocol violations of investigational medicinal products in pediatric clinical trials. METHODS A total of 617 participants from 69 drug clinical trial projects conducted in our hospital from January 2016 to December 2020 were selected as the control group, and 868 participants from 72 drug clinical trial projects from January 2022 to December 2025 as the observation group. RCA was performed on the protocol violations of investigational medicinal product in the control group to identify the types and underlying causes. The control group received routine pharmaceutical services for drug clinical trials, while the observation group was provided with precision pharmaceutical services from the three dimensions of knowledge, attitude and practice on the basis of routine pharmaceutical services, according to the root causes identified by RCA. The occurrence of investigational medicinal products protocol violations was compared between the two groups. RESULTS The total incidence of protocol violations of investigational medicinal products, as well as the incidences of minor and major protocol violations, were all significantly lower in the observation group than in the control group ( P <0.001). The main types of protocol violations in both groups included missed/under-/over-dosing of medications, non-adherence to administration time, failure to adjust dosage as required, and combined medication/vaccination in violation of the protocol. Regarding the responsible subjects of protocol violations, the incidences of protocol violations attributed to participants and their guardians as well as investigators and accidental factors were significantly lower in the observation group than in the control group ( P <0.001, P <0.001, P =0.025). However, there were no statistically significant differences in the incidences of protocol violations caused by sponsor-related reasons between the two groups ( P >0.05). CONCLUSIONS Pharmaceutical services led by pharmacists, based on problem-oriented RCA and combined with KAP theory, can effectively reduce the protocol violations of investigational medicinal products rate in pediatric clinical trials, thereby safeguarding the safety and rights of study participants.
2.Traditional Chinese Medicine in Treatment of Chronic Atrophic Gastritis by Regulating PI3K/Akt Signaling Pathway:A Review
Yuxue DING ; Zhiwei SU ; Juan XUE ; Jun SUN ; Chunyan JI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(6):307-315
Chronic atrophic gastritis (CAG) is a digestive system disease characterized by the reduction and atrophy of the intrinsic glands of the gastric mucosa. This disease is closely related to risk factors such as Helicobacter pylori (Hp) infection,long-term unhealthy eating habits and lifestyle. As CAG is a key link in the development of gastric cancer,effectively preventing its deterioration is of great significance for the prevention of gastric cancer. At present,Western medicine mainly uses symptomatic treatments such as eradicating Hp,protecting gastric mucosa, and promoting gastrointestinal motility. However, long-term use is prone to drug resistance and cannot reverse limitations such as gland atrophy, making it urgent to explore new intervention strategies. In recent years,with the deepening of CAG mechanism research,the phosphatidylinositol 3-kinase (PI3K)/protein kinase B (Akt) signaling pathway,as one of the classic signaling pathways,plays a significant role in the occurrence and development of CAG,while its systematic summary is still blank. Based on the regulatory advantages of "multi-target,multi-pathway,and low toxicity",traditional Chinese medicine can improve the pathological process of CAG by intervening in key nodes of the PI3K/Akt pathway. In this paper,the research progress of traditional Chinese medicine regulating PI3K/Akt pathway to improve CAG was systematically reviewed for the first time. The expression of PI3K/Akt signaling pathway in CAG was discussed,including the regulation of inflammation and oxidative stress,cell proliferation and apoptosis,and autophagy. The traditional Chinese medicine flavonoids,alkaloids,terpenoids and other compounds that regulate this pathway were summarized. The traditional Chinese medicine compounds mainly include classic famous prescriptions such as Xiaochaihu Tang,Banxia Xiexin Tang,Morodan concentrated pills,Elian granules and other traditional Chinese patent medicines,as well as empirical prescriptions such as modified Leweiyin formula,and Qiling prescription. This study aims to give full play to the advantages of traditional Chinese medicine and lay a solid foundation for the wide application and further development of CAG treatment,and provide new ideas for clinical research and drug research on CAG.
3.Treatment of Liver Cancer by Intervening TGF-β Signaling Pathway with Traditional Chinese Medicine: A Review
Hao CHENG ; Haohao GUO ; Jun SUN ; Juan XUE ; Chunyan JI ; Shiyi LI ; Yuxue DING ; Huaqiang YUE
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):318-326
Liver cancer is one of the most common malignant tumors in the digestive system and ranks sixth among newly diagnosed malignant tumors worldwide. Transforming growth factor-β (TGF-β) regulates cell differentiation, proliferation, apoptosis, and other physiological and pathological mechanisms and exerts cancer-suppressive and pro-cancerous dual effects in the process of tumor development. In recent years, with the continuous exploration of the mechanism of liver cancer, it has been found that the conversion of the cancer-suppressive effect into a pro-cancerous effect of this pathway plays a key role in the development of liver cancer. Traditional Chinese medicine (TCM) provides a unique perspective for the classification, diagnosis, and treatment of liver cancer with its comprehensive regulatory effects of multi-components, multi-targets, and multi-pathways. This paper summarized that the cancer-suppressive mechanisms of the TGF-β signaling pathway included promoting cancer cell cycle arrest, apoptosis, autophagy, et al, while the pro-cancerous mechanisms included promoting cancer cell proliferation, invasion and metastasis, immunosuppression, angiogenesis, et al. The TCM compounds intervening this pathway were sorted out, including Jianpi Huayu compound, Fuyang Baoyuan compound, Yipi Yanggan compound, Fuzheng Jiedu compound, compound Astragalus and Salvia, Biejia Jianwan, Dahuang Zhechong pill, and Qingxiang powder. The single TCMs mainly included Schizocapsa plantaginea, Dendrobii Caulis, Gleditsia sinensis, and Dracaena cochinchinensis. The active ingredients of TCM are mainly concentrated on flavonoids, alkaloids, glycosides, phenolics, terpenoids, polysaccharides, and other kinds of compounds. At the same time, it summarized that the liver cancer inhibition mechanism of TCM by regulating this pathway mainly included promoting apoptosis of liver cancer cells, blocking the cell cycle, and inhibiting liver cancer cell proliferation, migration, invasion, angiogenesis, immune escape, etc. The mechanism aims to give full play to the advantages of TCM and precisely regulate the TGF-β signal, thereby exerting positive anti-tumor effects, opening up a new direction for the precise targeted treatment of liver cancer, and providing a scientific basis and a new strategy for the application of TCM in the treatment of liver cancer.
4.Treatment of Liver Cancer by Intervening TGF-β Signaling Pathway with Traditional Chinese Medicine: A Review
Hao CHENG ; Haohao GUO ; Jun SUN ; Juan XUE ; Chunyan JI ; Shiyi LI ; Yuxue DING ; Huaqiang YUE
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):318-326
Liver cancer is one of the most common malignant tumors in the digestive system and ranks sixth among newly diagnosed malignant tumors worldwide. Transforming growth factor-β (TGF-β) regulates cell differentiation, proliferation, apoptosis, and other physiological and pathological mechanisms and exerts cancer-suppressive and pro-cancerous dual effects in the process of tumor development. In recent years, with the continuous exploration of the mechanism of liver cancer, it has been found that the conversion of the cancer-suppressive effect into a pro-cancerous effect of this pathway plays a key role in the development of liver cancer. Traditional Chinese medicine (TCM) provides a unique perspective for the classification, diagnosis, and treatment of liver cancer with its comprehensive regulatory effects of multi-components, multi-targets, and multi-pathways. This paper summarized that the cancer-suppressive mechanisms of the TGF-β signaling pathway included promoting cancer cell cycle arrest, apoptosis, autophagy, et al, while the pro-cancerous mechanisms included promoting cancer cell proliferation, invasion and metastasis, immunosuppression, angiogenesis, et al. The TCM compounds intervening this pathway were sorted out, including Jianpi Huayu compound, Fuyang Baoyuan compound, Yipi Yanggan compound, Fuzheng Jiedu compound, compound Astragalus and Salvia, Biejia Jianwan, Dahuang Zhechong pill, and Qingxiang powder. The single TCMs mainly included Schizocapsa plantaginea, Dendrobii Caulis, Gleditsia sinensis, and Dracaena cochinchinensis. The active ingredients of TCM are mainly concentrated on flavonoids, alkaloids, glycosides, phenolics, terpenoids, polysaccharides, and other kinds of compounds. At the same time, it summarized that the liver cancer inhibition mechanism of TCM by regulating this pathway mainly included promoting apoptosis of liver cancer cells, blocking the cell cycle, and inhibiting liver cancer cell proliferation, migration, invasion, angiogenesis, immune escape, etc. The mechanism aims to give full play to the advantages of TCM and precisely regulate the TGF-β signal, thereby exerting positive anti-tumor effects, opening up a new direction for the precise targeted treatment of liver cancer, and providing a scientific basis and a new strategy for the application of TCM in the treatment of liver cancer.
5.Influenza surveillance results in Ordos City in 2017 - 2023
Xiaomin ZHANG ; Hongtao XIAO ; Sheng WANG ; Rong SUN ; Shangwu JIN ; Di ZHANG ; Jiming HAO ; Jialin LYU ; Chunyan YANG
Journal of Public Health and Preventive Medicine 2026;37(2):54-58
Objective To analyze the influenza-like illness (ILI) data in Ordos City from 2017 to 2023 and conduct nucleic acid detection of the virus to understand the local influenza epidemic situation, and to provide a reliable basis for influenza prevention and control in the city. Methods Real-time quantitative polymerase chain reaction (qPCR) was used to identify virus subtypes in ILI throat swab samples. Comparisons of positive rates were conducted using the chi-square test, with a significance level of α=0.05. Results From 2017 to 2023, a total of 3,283,434 outpatient and emergency visits were recorded at the Ordos City Central Hospital, including 74,159 ILI cases, with an ILI proportion of 2.26%. The majority of ILI cases (74.43%) occurred in children aged 0~14 years old. The overall positive rate of influenza virus nucleic acid detection was 10.87%, with the highest proportion being subtype A (seasonal H3) at 43.03%. The highest detection rate was observed in the 5~14 years age group, with statistically significant differences in positive rates across age groups (χ2=155.638, P<0.001). Influenza peaks occurred mainly from November to March of the following year. From January to April, three types of influenza were prevalent alternately or mixed, while from October to December, subtype A (seasonal H3) predominated. Positive rates varied significantly across months (χ2=250.923, P<0.001). The temporal trends of ILI proportions and PCR-positive rates were consistent. Conclusion Influenza in Ordos City exhibits distinct seasonal and age distribution characteristics, with alternating or mixed circulation of three virus types. Continued efforts are needed to strengthen influenza surveillance, especially the prevention and control of influenza in infants and adolescents.
6.Regulatory Mechanisms of miRNA in Hepatocellular Carcinoma and Current Status of Traditional Chinese Medicine Intervention: A Review
Shiyi LI ; Hao CHENG ; Chunyan JI ; Jun SUN ; Juan XUE
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(11):323-332
Hepatocellular carcinoma(HCC), as one of the common malignant tumours, has seen a continuous rise in incidence and mortality worldwide, posing a serious threat to human health. However, traditional treatments have certain limitations, therefore, the exploration of new therapeutic strategies is particularly urgent. In recent years, with in-depth research on the regulatory mechanisms of microRNA(miRNA) in tumour occurrence and development, it has become new targets for HCC diagnosis and treatment. As a traditional treatment method, Chinese medicine, due to its multi-component, multi-pathway, and multi-target overall regulatory characteristics, shows broad prospects in treating HCC by regulating miRNAs. Accordingly, this paper reviews recent studies on the role of miRNAs in HCC and research advances in traditional Chinese medicine interventions, finding that various miRNAs play key roles in HCC cell cycle regulation, proliferation and apoptosis, invasion and metastasis, immune microenvironment, and drug resistance. It summarises how active ingredients, extracts, medicinal pairs, and formulas of Chinese medicine act on specific miRNAs to regulate their downstream target gene expression, affecting the malignant behaviour of HCC cells and exerting anti-cancer effects. This study aims to provide a theoretical basis for miRNAs as potential biomarkers and therapeutic targets for HCC, as well as to offer new ideas for developing miRNA-based targeted Chinese medicine therapies.
7.Coronary artery stenosis associated with right ventricular dysfunction in acute pulmonary embolism: A case-control study.
Yuejiao MA ; Jieling MA ; Dan LU ; Yinjian YANG ; Chao LIU ; Liting WANG ; Xijie ZHU ; Xianmei LI ; Chunyan CHENG ; Sijin ZHANG ; Jiayong QIU ; Jinghui LI ; Mengyi LIU ; Kai SUN ; Xin JIANG ; Xiqi XU ; Zhi-Cheng JING
Chinese Medical Journal 2025;138(16):2028-2036
BACKGROUND:
The potential impact of pre-existing coronary artery stenosis (CAS) on right ventricular (RV) function during acute pulmonary embolism (PE) episodes remains underexplored. This study aimed to investigate the association between pre-existing CAS and RV dysfunction in patients with acute PE.
METHODS:
In this multicenter, case-control study, 89 cases and 176 controls matched for age were enrolled at three study centers (Peking Union Medical College Hospital, Fuwai Hospital, and the Second Affiliated Hospital of Harbin Medical University) from January 2016 to December 2020. The cases were patients with acute PE with CAS, and the controls were patients with acute PE without CAS. Coronary artery assessment was performed using coronary computed tomographic angiography. CAS was defined as ≥50% stenosis of the lumen diameter in any coronary vessel >2.0 mm in diameter. Conditional logistic regression analysis was used to evaluate the association between CAS and RV dysfunction.
RESULTS:
The percentages of RV dysfunction (19.1% [17/89] vs. 44.6% [78/176], P <0.001) and elevated systolic pulmonary artery pressure (sPAP) (19.3% [17/89] vs. 39.5% [68/176], P = 0.001) were significantly lower in the case group than those in the control group. In the multivariable logistic regression model, CAS was independently and negatively associated with RV dysfunction (adjusted odds ratio [OR]: 0.367; 95% confidence interval [CI]: 0.185-0.728; P = 0.004), and elevated sPAP (OR: 0.490; 95% CI: 0.252-0.980; P = 0.035), respectively.
CONCLUSIONS
Pre-existing CAS was significantly and negatively associated with RV dysfunction and elevated sPAP in patients with acute PE. This finding provides new insights into RV dysfunction in patients with acute PE with pre-existing CAS.
Humans
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Pulmonary Embolism/complications*
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Case-Control Studies
;
Male
;
Ventricular Dysfunction, Right/physiopathology*
;
Female
;
Middle Aged
;
Aged
;
Coronary Stenosis/complications*
;
Logistic Models
;
Adult
8.Application of domestic single-port robotic surgical system in thyroid cancer.
Qian MA ; Sicheng ZHANG ; Longyue ZHANG ; Jinyuan LIU ; Ronghao SUN ; Yuqiu ZHOU ; Linjie MA ; Chunyan SHUI ; Yongcong CAI ; Chao LI
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2025;39(11):1044-1047
Objective:To explore the feasibility and preliminary efficacy of domestic single-port robotic surgical system in the surgical treatment of thyroid cancer. Methods:Thyroid cancer patients who underwent domestic single-port robotic surgery in the Department of Head and Neck Surgery of Sichuan Cancer Hospital from June 2024 to January 2025 were prospectively included. Clinical data, oncological characteristics, and perioperative indicators were systematically collected. Results:A total of 7 patients were included, including 3 males and 4 females, with an age of (34.57±10.26) years. All procedures were successfully completed without conversion to open surgery. Operative time was(180.00±30.41) minutes. Blood loss was(5.00[15.00 ])mL. Postoperative drainage volume was (167.86±130.95) mL. The postoperative pathological results were all thyroid papillary carcinoma. There were no system failures, no device-related complications and adverse events were observed during the operation and perioperative period. No tumor recurrence or metastasis was observed during the follow-up period. Conclusion:Preliminary data indicate that the domestic single-port robotic surgical system is safe and feasible for the surgical treatment of thyroid cancer, providing a practical basis for subsequent multi-disease, multi-center, and large-sample studies.
Humans
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Thyroid Neoplasms/surgery*
;
Robotic Surgical Procedures/instrumentation*
;
Male
;
Female
;
Adult
;
Thyroidectomy/methods*
;
Operative Time
;
Middle Aged
;
Prospective Studies
9.SAE1 promotes tumor cell malignancy via SUMOylation and liquid-liquid phase separation facilitated nuclear export of p27.
Ling WANG ; Jie MIN ; Jinjun QIAN ; Xiaofang HUANG ; Xichao YU ; Yuhao CAO ; Shanliang SUN ; Mengying KE ; Xinyu LV ; Wenfeng SU ; Mengjie GUO ; Nianguang LI ; Shiqian QI ; Hongming HUANG ; Chunyan GU ; Ye YANG
Acta Pharmaceutica Sinica B 2025;15(4):1991-2007
Most cancers are currently incurable, partly due to abnormal post-translational modifications (PTMs). In this study, we initially used multiple myeloma (MM) as a working model and found that SUMOylation activating enzyme subunit 1 (SAE1) promotes the malignancy of MM. Through proteome microarray analysis, SAE1 was identified as a potential target for bioactive colcemid or its derivative colchicine. Elevated levels of SAE1 were associated with poor clinical survival and increased MM proliferation in vitro and in vivo. Additionally, SAE1 directly SUMOylated and upregulated the total protein expression of p27, leading to LLPS-mediated nuclear export of p27. Our study also demonstrated the involvement of SAE1 in other types of cancer cells, and provided the first monomer crystal structure of SAE1 and its key binding model with colchicine. Colchicine also showed promising results in the Patient-Derived Tumor Xenograft (PDX) model. Furthermore, a controlled clinical trial with 56 MM patients demonstrated the clinical efficacy of colchicine. Our findings reveal a novel mechanism by which tumor cells evade p27-induced cellular growth arrest through p27 SUMOylation-mediated nuclear export. SAE1 may serve as a promising therapeutic target, and colchicine may be a potential treatment option for multiple types of cancer in clinical settings.
10.Discovery of fernane-type triterpenoids from Diaporthe discoidispora using genome mining and HSQC-based SMART technology.
Yajing WANG ; Yongfu LI ; Yan DONG ; Chunyan YU ; Chengwei LIU ; Chang LI ; Yi SUN ; Yuehu PEI
Chinese Journal of Natural Medicines (English Ed.) 2025;23(3):368-376
In this study, we employed a combination of genome mining and heteronuclear single quantum coherence (HSQC)-based small molecule accurate recognition technology (SMART) technology to search for fernane-type triterpenoids. Initially, potential endophytic fungi were identified through genome mining. Subsequently, fine fractions containing various fernane-type triterpenoids were selected using HSQC data collection and SMART prediction. These triterpenoids were then obtained through targeted isolation and identification. Finally, their antifungal activity was evaluated. As a result, three fernane-type triterpenoids, including two novel compounds, along with two new sesquiterpenes and four known compounds were isolated from one potential strain, Diaporthe discoidispora. Their structures were elucidated through analysis of high-resolution electrospray ionization mass spectrometry (HR-ESI-MS) and nuclear magnetic resonance (NMR) spectroscopic data. The absolute configurations were determined using single-crystal X-ray diffraction analysis and electron capture detector (ECD) analysis. Compound 3 exhibited moderate antifungal activity against Candida albicans CMCC 98001 and Aspergillus niger.
Triterpenes/isolation & purification*
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Antifungal Agents/isolation & purification*
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Molecular Structure
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Candida albicans/drug effects*
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Ascomycota/genetics*
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Magnetic Resonance Spectroscopy
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Aspergillus niger/drug effects*
;
Genome, Fungal
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Microbial Sensitivity Tests


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