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 Regulates Related Signaling Pathways to Prevent and Control Breast Cancer and Precancerous Lesions: A Review
Yifei ZENG ; Di ZHAO ; Junyue WANG ; Mengjie WANG ; Yubo GUO ; Yu ZHOU ; Dongxiao ZHANG ; Wenjie ZHAO
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(5):290-301
Breast cancer has become the malignant tumor with the highest incidence rate among women, seriously threatening the life and health of women all over the world. The pathogenic factors and development mechanisms of breast cancer are complex and diverse. The development of breast cells from ordinary hyperplasia to atypical hyperplasia, and from pre-cancerous lesions to cancerous lesions, is a long-term progressive process. Therefore, early screening and prevention of breast cancer is particularly important. Western medicine has a relatively mature treatment program for breast cancer, which is mainly based on surgery and systemic treatment, whereas the ensuing complications and adverse reactions often bring a heavy burden to patients. For the precancerous lesions of breast cancer, surgery is also the mainstay of treatment. In recent years, traditional Chinese medicine (TCM) has increasingly highlighted its advantages in the prevention and treatment of breast cancer. Increasing studies have shown that in the prevention and treatment of breast cancer and pre-cancerous lesions, TCM compound prescriptions, single herbs or herb pairs, and active components are able to regulate a variety of intracellular signaling pathways through multi-targets to inhibit the proliferation and invasion, promote the apoptosis and autophagy of tumor cells, and regulate the cell cycle and the immune microenvironment, thus exerting anti-tumor effects. At the same time, they can significantly attenuate the toxic side effects of radiotherapy and drug resistance of patients. However, the specific mechanisms of TCM in the prevention and treatment of breast cancer and precancerous lesions have not been fully clarified. The available studies are tanglesome regarding the TCM inhibition of tumor development through the regulation of classical signaling pathways such as phosphatidylinositol 3-kinase (PI3K)/protein kinase B (Akt)/mammalian target of rapamycin (mTOR), Wnt/β-catenin, and Notch, which still need to be verified by a large number of clinical and experimental studies. Therefore, this paper reviews the research progress in the prevention and treatment of breast cancer and precancerous lesions by TCM through interfering with the relevant signaling pathways in recent years, aiming to summarize the possible mechanisms of TCM in the prevention and treatment of breast cancer and provide references for subsequent studies.
3.Empirical study of input, output, outcome and impact of community-based rehabilitation stations
Xiayao CHEN ; Ying DONG ; Xue DONG ; Zhongxiang MI ; Jun CHENG ; Aimin ZHANG ; Didi LU ; Jun WANG ; Jude LIU ; Qianmo AN ; Hui GUO ; Xiaochen LIU ; Zefeng YU
Chinese Journal of Rehabilitation Theory and Practice 2026;32(1):83-89
ObjectiveTo investigate the present situation of input, output, outcome and impact of all registered community-based rehabilitation stations in Inner Mongolia in China, and analyze how the input predict the output, outcome and impact. MethodsFrom March 1st to April 30th, 2025, a questionnaire survey was conducted on all registered community-based rehabilitation stations in Inner Mongolia, covering four dimensions: input, output, outcome and impact. A total of 1 365 questionnaires were distributed. The input included four items: laws and policies, human resources, equipment and facilities, and rehabilitation information management. The output included two items: technical paths and benefits/effectiveness. The outcome included three items: coverage rates, rehabilitation interventions and functional results. The impact included two items: health and sustainability. Each item contained several questions, all of which were described in a positive way. Each question was scored from one to five. A lower score indicated that the situation of the community-based rehabilitation station was more in line with the content described in the question. Regression analysis was performed using the total score of each item of input dimension as independent variables, and the total scores of the output, outcome and impact dimensions as dependent variables. ResultsA total of 1 262 valid questionnaires were collected. The mean values of input, output, outcome and impact of community-based rehabilitation stations were 1.827 to 1.904, with coefficient of variation of 45.892% to 49.239%. The regression analysis showed that, rehabilitation information management, human resources, and laws and policies significantly predicted the output dimension (R² = 0.910, P < 0.001). Meanwhile, all four items in the input dimension predicted both the outcome (R² = 0.850, P < 0.001) and impact dimensions (R² = 0.833, P < 0.001). ConclusionInput, output, outcome and impact of the community-based rehabilitation stations in Inner Mongolia were generally in line with the content of the questions, although some imbalances were observed. Additionally, the input of community-based rehabilitation stations could significantly predict their output, outcome and impact.
4.Research progress on effect of ambient particulate matters on Alzheimer's disease and potential mechanisms
Lu YU ; Chihang ZHANG ; Jianshu GUO ; Dongxia FAN ; Jinzhuo ZHAO
Journal of Environmental and Occupational Medicine 2025;42(6):748-755
With the accelerating aging of world population, the prevalence and disease burden of dementia such as Alzheimer's disease is increasing annually. As one of the major risk factors for dementia, air pollution is still an urgent global concern. Studies on the association between ambient particulate matter (PM), one of the major air pollutants, and dementia, such as Alzheimer's disease, are gaining attention. This paper reviewed the current evidence of relevant epidemiological and toxicological studies to illustrate the possible mechanisms underlying the effects of PM exposure on Alzheimer's disease through inflammatory responses, oxidative stress, endocrine disruption, excitatory neurotoxicity, glial cell activation, and intestinal flora disruption, which may provide clues for mitigating the health risks of air pollution and preventing Alzheimer's disease.
5.WANG Xiuxia's Clinical Experience in Treating Hyperprolactinemia with Liver Soothing Therapy
Yu WANG ; Danni DING ; Yuehui ZHANG ; Songli HAO ; Meiyu YAO ; Ying GUO ; Yang FU ; Ying SHEN ; Jia LI ; Fangyuan LIU ; Fengjuan HAN
Journal of Traditional Chinese Medicine 2025;66(14):1428-1432
This paper summarizes Professor WANG Xiuxia's clinical experience in treating hyperprolactinemia using the liver soothing therapy. Professor WANG identifies liver qi stagnation and rebellious chong qi (冲气) as the core pathomechanisms of hyperprolactinemia. Furthermore, liver qi stagnation may transform into fire or lead to pathological changes such as spleen deficiency with phlegm obstruction or kidney deficiency with essence depletion. The treatment strategy centers on soothing the liver, with a modified version of Qinggan Jieyu Decoction (清肝解郁汤) as the base formula. Depending on different syndrome patterns such as liver stagnation transforming into fire, liver stagnation with spleen deficiency, or liver stagnation with kidney deficiency, heat clearing, spleen strengthening, or kidney tonifying herbs are added accordingly. In addition, three paired herb combinations are commonly used for symptom specific treatment, Danggui (Angelica sinensis) with Chuanxiong (Ligusticum chuanxiong), Zelan (Lycopus lucidus) with Yimucao (Leonurus japonicus) , and Jiegeng (Platycodon grandiflorus) with Zisu (Perilla frutescens).
6."Inflammation-cancer Transformation" Mechanism of Chronic Atrophic Gastritis and Intervention of Traditional Chinese Medicine: A Review
Xinfang ZHANG ; Wenzhao GUO ; Chenyang YU ; Guanhua LYU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(17):295-304
“Inflammation-cancer” transformation of chronic atrophic gastritis (CAG) refers to the process in which the gastric mucosa, in the context of CAG, progresses through stages of precancerous lesions of gastric cancer (PLGC), such as intestinal metaplasia and dysplasia, and eventually develops into gastric cancer (GC). In China, the incidence and mortality rates of GC rank among the highest in the world, and the proportion of GC cases caused by gastric mucosal infection and inflammation has been increasing. Modern medical treatments for CAG and PLGC mainly rely on drug therapy, endoscopic resection, and regular surveillance. Although these disease management strategies are relatively mature, they present limitations in early lesion prevention and recurrence risk control. Therefore, it is imperative to identify therapeutic approaches for CAG and PLGC that offer preventive, reversible, and recurrence-reducing benefits. With advances in research on the mechanisms underlying inflammation-cancer transformation and the integration of traditional Chinese and Western medicine, the advantages of TCM in preventing and even reversing early-stage CAG and PLGC have gradually become apparent. This review explored the mechanisms of inflammation-cancer transformation in CAG from five aspects: inflammatory microenvironment, autophagy, glycolysis, bile acids, and ferroptosis. In conjunction with TCM theory and a deeper understanding of the distinct mechanisms involved in the inflammation-cancer transformation of CAG, this review further discussed the specific mechanisms through which TCM intervened in treating CAG and PLGC, with the aim of providing theoretical support and therapeutic insights for future clinical applications.
7."Inflammation-cancer Transformation" Mechanism of Chronic Atrophic Gastritis and Intervention of Traditional Chinese Medicine: A Review
Xinfang ZHANG ; Wenzhao GUO ; Chenyang YU ; Guanhua LYU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(17):295-304
“Inflammation-cancer” transformation of chronic atrophic gastritis (CAG) refers to the process in which the gastric mucosa, in the context of CAG, progresses through stages of precancerous lesions of gastric cancer (PLGC), such as intestinal metaplasia and dysplasia, and eventually develops into gastric cancer (GC). In China, the incidence and mortality rates of GC rank among the highest in the world, and the proportion of GC cases caused by gastric mucosal infection and inflammation has been increasing. Modern medical treatments for CAG and PLGC mainly rely on drug therapy, endoscopic resection, and regular surveillance. Although these disease management strategies are relatively mature, they present limitations in early lesion prevention and recurrence risk control. Therefore, it is imperative to identify therapeutic approaches for CAG and PLGC that offer preventive, reversible, and recurrence-reducing benefits. With advances in research on the mechanisms underlying inflammation-cancer transformation and the integration of traditional Chinese and Western medicine, the advantages of TCM in preventing and even reversing early-stage CAG and PLGC have gradually become apparent. This review explored the mechanisms of inflammation-cancer transformation in CAG from five aspects: inflammatory microenvironment, autophagy, glycolysis, bile acids, and ferroptosis. In conjunction with TCM theory and a deeper understanding of the distinct mechanisms involved in the inflammation-cancer transformation of CAG, this review further discussed the specific mechanisms through which TCM intervened in treating CAG and PLGC, with the aim of providing theoretical support and therapeutic insights for future clinical applications.
8.Clinical Practice of Coronary Microvascular Disease with the Integrated Approach of Traditional Chinese and Western Medicine
Aolin LI ; Xinnong CHEN ; Lerong YU ; Jun GE ; Wei ZHOU ; Kangzheng GUO ; Junping ZHANG
Journal of Traditional Chinese Medicine 2025;66(16):1662-1667
This paper analyzed the traditional Chinese medicine (TCM) and western medical understanding of coronary microvascular disease (CMVD) from the three dimensions of "disease-syndrome-symptom". In western medicine, by summarizing the suspected diagnosis and understanding of CMVD, it is believed that inflammatory responses and vascular endothelial damage are the key mechanisms of the pathogenesis. From the perspective of TCM, the disease location is at blood, vessels and heart, and the fundamental cause is spleen and kidney depletion, closely realted to phlegm, stasis, toxin, wind and qi. Integrating the understanding of both TCM and western medicine, clinical treatment advocates taking the CMVD pathology as the base, and the TCM understanding of pathogenesis as the main focus. The properties of Chinese herbal medicinals is used as the guidance for medication, and the pharmacological understanding as the assisstance of treatment, with the medical history and the severity of the condition are additionally considered. It is finally proposed that during the acute phase, the methods of nourishing yin and resolving toxins, softening hardness and dissipating masses, dispelling wind and unblocking collaterals should be applied to alleviate the emergency. In the subacute phase, the focus should be on raising and lifting qi promote its movement, with flexible use of medicinals that can unblock yang. In the remission phase, the method of tonifying spleen and fortifying kidney should be used to maintain the stability of the condition.
9.Compilation Instructions for Expert Consensus on Clinical Application of Yifei Zhike Capsules
Xin LI ; Hongchun ZHANG ; Xuefeng YU ; Weiwei GUO ; Chengjun BAN ; Zhifei WANG ; Yuanyuan LI ; Yingjie ZHI ; Xin CUI ; Yanming XIE
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(18):143-148
The compilation instructions for the Expert Consensus on Clinical Application of Yifei Zhike Capsules systematically expound the development background, methodological framework, and core achievements of this consensus. In view of the problems existing in the clinical application of Yifei Zhike Capsules, such as insufficient efficacy evidence and lack of standardized syndrome differentiation, the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences took the lead and collaborated with 21 tertiary grade-A hospitals and research institutions across China to form a multidisciplinary expert group (comprising 30 experts in clinical medicine, pharmacy, and methodology). The compilation work was carried out in strict accordance with the World Health Organization (WHO) guidelines, the GB/T 1.1-2020 standard, and the writing specifications for the explanatory notes of expert consensus on clinical application of Chinese patent medicines. Through systematic literature retrieval (including 32 studies, with 24 clinical studies), Grading of Recommendations Assessment, Development and Evaluations (GRADE)-based evidence grading, and multiple rounds of discussions using the nominal group method (25 experts voted to determine 17 clinical questions), 5 evidence-based recommendations and 11 expert consensus suggestions were formed. It is clarified that this medicine (Yifei Zhike Capsules) is applicable to the treatment of expectoration/hemoptysis in acute and chronic bronchitis and the adjuvant treatment of pulmonary tuberculosis. It is recommended that it can be used alone or in combination with anti-tuberculosis drugs. The safety evaluation shows that this medicine mainly induces the following adverse reactions: mild gastrointestinal reactions (such as nausea and abdominal pain) and rashes. The contraindicated populations include pregnant women and women during menstruation. The compilation process of the consensus underwent three rounds of expert letter reviews, two rounds of peer reviews, and quality control assessments to ensure methodological rigor and clinical applicability. In addition, through policy alignment, academic promotion, and a dynamic revision mechanism, the standardization of clinical application was promoted, providing a demonstration for the evidence-based transformation of characteristic therapies of Miao medicine.
10.Clinical Value of Tumor-Stroma Ratio Combined with KRAS/NRAS/BRAF Gene Status in Prognostic Assessment of Patients with Colorectal Cancer
Ziyang ZHANG ; Yuanfei LI ; Yuntong GUO ; Gen ZHU ; Guang YANG ; Yu WANG
Cancer Research on Prevention and Treatment 2025;52(8):676-681
Objective To investigate the clinical value of tumor-stroma ratio (TSR) in combination with KRAS, BRAF, NRAS, and microsatellite status for prognostic assessment of patients with colorectal cancer. Methods A total of 51 colorectal cancer cases meeting the inclusion and exclusion criteria were enrolled in this study. TSR levels were evaluated through optical microscopy. The KRAS/NRAS/BRAF mutation profiles and microsatellite status were determined in accordance with genetic testing results. Clinical data, pathological characteristics, and survival outcomes were systematically recorded. Results Among the 51 patients with colorectal cancer, 19 (37.3%) were categorized into the low stromal group and 32 (62.7%) into the high stromal group. Statistically significant differences were observed between the two groups in drug resistance, M stage, TNM stage, neural invasion, and microsatellite status (P<0.05). Compared with patients exhibiting high TSR, those with low TSR demonstrated significantly increased recurrence rates (5 vs. 21 cases, P=0.007), shortened disease-free survival (34.21 vs. 14.34 months, P=0.001), and reduced overall survival (38.79 vs. 23.09 months, P=0.021). Multivariate Cox regression analysis identified N stage, M stage, TNM stage, neural invasion, lymphovascular invasion, and TSR as independent risk factors for disease-free survival. N stage, M stage, neural invasion, lymphovascular invasion, and TSR emerged as independent prognostic factors for overall survival (P<0.05). Although the combined models of TSR with KRAS, NRAS, BRAF, and microsatellite status, respectively, demonstrated overall statistical significance (P<0.05), none of the dummy variables in these models reached individually statistical significance (P>0.05), and therefore cannot be considered independent prognostic factors. Conclusion TSR serves as an independent predictor of poor prognosis in advanced colorectal cancer, with patients exhibiting low TSR demonstrating a significantly higher risk of recurrence and metastasis than those with high TSR. For patients with colon cancer undergoing first-line palliative chemotherapy after postoperative recurrence, histopathological assessment of TSR in primary tumor sites holds prognostic value and may serve as a relevant factor for evaluating treatment resistance in clinical management.

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