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 Treats Esophageal Cancer via PI3K/Akt Signaling Pathway: A Review
Wei GUO ; Chen PENG ; Yikun WANG ; Zixuan YU ; Jintao LIU ; Jing DING ; Yijing LI ; Hongxin SUN
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(5):302-311
Esophageal cancer (EC) is a highly prevalent malignant tumor in China. The phosphatidylinositol 3-kinase (PI3K)/protein kinase B (Akt) signaling pathway, as one of the key oncogenic pathways, can promote the cell cycle progression, proliferation, migration, and invasion, induce chemoresistance, and inhibit apoptosis and autophagy of EC cells. Traditional Chinese medicine (TCM), with the advantages of targeting multiple points with multiple components to delay cancer progression, can target the PI3K/Akt signaling pathway for EC treatment. This article preliminarily discusses the molecular mechanism and role of the PI3K/Akt signaling pathway in EC and elaborates on the specific targets and efficacy of TCM in treating EC through intervention in the PI3K/Akt signaling pathway in the past five years. TCM materials and extracts inhibiting the PI3K/Akt signaling pathway in EC include Borneolum, spore powder of Ganoderma lucidum without spore coat, extract of Celastrus orbiculatus, root extract of Taraxacum, and Bruceae Fructus oil emulsion. TCM active ingredients exerting the effect include flavonoids, terpenoids, saponins, phenols, polysaccharides, alkaloids, and other compounds. TCM compound prescriptions with such effect include Qige San, Huqi San, Xuanfu Daizhetang, Tongyoutang and its decomposed prescriptions, Liujunzi Tang, and Xishenzhi Formula. In addition, TCM injections such as Compound Kushen Injection and Kang'ai injection also inhibit the PI3K/Akt signaling pathway in EC. This paper summarizes the role of the PI3K/Akt signaling pathway in EC and the TCM interventions, aiming to provide reference for the research and clinical application of new drugs for EC.
3.Status and implications of pharmacist competency assessment tools
Yu TIAN ; Bei DING ; Chenyang ZHANG ; Yi ZHAO ; Jiaying WANG
China Pharmacy 2026;37(5):553-558
OBJECTIVE To systematically review the status on pharmacist competency assessment tools both domestically and internationally, providing a theoretical basis for constructing scientific and applicable pharmacist competency assessment tools in China. METHODS Through literature review and comparative analysis, 15 representative domestic and international pharmacist competency assessment tools were systematically summarized, and their theoretical foundations, core dimensions, methodological characteristics and practical applications were compared and implications were given. RESULTS &CONCLUSIONS International research has established relatively mature evaluation systems. Represented by those developed from the United Kingdom, the United States, and the International Pharmaceutical Federation, these assessment tools demonstrate scientific structure, wide application, and dynamic and international applicability. While domestic research has progressed in sub-specialties such as clinical pharmacists, licensed pharmacists and pediatric pharmacists, it still faces challenges including insufficient standardization, inadequate validation, delayed updates, and limitations in practical application. The reasons for the disparities in assessment tools between China and other countries include differences in pharmaceutical care models, varying pharmacist training systems, cultural and social background factors, as well as differences in industry management and international influence. Based on this, the author suggests promoting the development and research of assessment tools for pharmacist job competency in China from four aspects: mechanism construction, system refinement, standardization development, and practical implementation.
4.Secular trends in energy and macronutrient intake across different occupational groups in nine provinces of China, 1989–2018
Yu WU ; Jiguo ZHANG ; Liusen WANG ; Lixin HAO ; Chang QU ; Yumeng SONG ; Zhihong WANG ; Huijun WANG ; Bing ZHANG ; Hongru JIANG ; Gangqiang DING
Journal of Environmental and Occupational Medicine 2026;43(2):145-152
Background With China's socio-economic development, the dietary structure of Chinese residents has gradually shifted from a traditional Eastern pattern characterized by high carbohydrate intake to a relatively high-fat Western dietary model, alongside a growing burden of chronic diseases. However, dietary changes may vary across different occupational groups. Objective To analyze the long-term trends in dietary energy and three major macronutrient intake among various occupational groups aged 18-59 years in nine provinces of China from 1989 to 2018, providing a scientific basis for developing occupation-specific dietary intervention strategies. Methods Based on 11 waves of data (1989–2018) from the China Health and Nutrition Survey (CHNS),
5.Cardiometabolic risk factor trends across different occupational groups in nine provinces of China, 2009–2018
Yu WU ; Hongru JIANG ; Lixin HAO ; Liusen WANG ; Weiyi LI ; Shaoshunzi WANG ; Zijian WANG ; Zhihong WANG ; Huijun WANG ; Bing ZHANG ; Lili CHEN ; Gangqiang DING
Journal of Environmental and Occupational Medicine 2026;43(2):153-159
Background With China's socioeconomic development, significant lifestyle changes have occurred among occupational groups, leading to alterations in cardiovascular metabolic risk factors. However, few studies have examined the secular trends of these risk factors in China's working population. Objective To analyze the trends in cardiovascular metabolic risk factors among the occupational population in nine provinces of China from 2009 to 2018, and to explore the associations between different occupational types and these risk factors, along with their clustering patterns, thereby providing evidence for targeted interventions. Methods This study utilized data from the China Health and Nutrition Survey (CHNS) in 2009, 2015, and 2018. The dataset covered
6.Construction of An Automated Segmentation Visual Foundation Model for Pathological Images of Hemorrhoids and Its Application in Traditional Chinese Medicine Clinical Syndrome Analysis
Shijie ZHANG ; Ao ZHANG ; Kang WANG ; Bin KANG ; Xiaofan YU ; Xujing FENG ; Jinyu CAO ; Wenzhen HUANG ; Kang DING
Journal of Traditional Chinese Medicine 2026;67(7):764-769
This paper proposes a two-stage method integrating visual foundation models (VFM) and diffusion models. The segment anything model (SAM) as VFM is combined with the SegRefiner diffusion model to construct the SAM-SegRefiner framework for automated segmentation of edema, inflammation, and thrombus regions in histopathological images of hemorrhoidal tissue, providing a reproducible technical tool for the objective quantification of pathological morphology and its application in traditional Chinese medicine (TCM) syndrome research. Trained and validated on multi-center retrospective data, the SAM-SegRefiner model achieved an average pixel accuracy of 95.32% and a mean intersection over union (mIoU) of 66.81% on an independent test set, significantly outperfor-ming comparative models such as U-Net, MixU-Net, and SAM-Med2D, and also demonstrating robust cross-center generalization capability. Furthermore, by correlating the quantitatively segmented results from the model with the patients' TCM syndrome types, the potential associations between pathomorphological features and TCM syndrome differentiation have been explored. The analysis revealed no statistically significant differences in the degree of inflammatory infiltration and thrombus formation among different syndrome types, suggesting a complex relationship between local pathological changes and systemic syndrome manifestations.
7.Effect of Wei's Huoxue Tongluo Formula(韦氏活血通络方)on Visual Function and Fundus Blood Flow in Treating Atrophic-Stage Non-Arteritic Anterior Ischemic Optic Neuropathy with Qi Deficiency and Blood Stasis
Yan WANG ; Linlin CAO ; Meiling HAO ; Xiaoding SHUI ; Simin SONG ; Kun DING ; Rilong ZHOU ; Yu LUO ; Yize HUANG ; Xiaoyu LIANG ; Liang LIAO
Journal of Traditional Chinese Medicine 2026;67(10):1062-1070
ObjectiveTo evaluate the efficacy and possible mechanism of Wei's Huoxue Tongluo Formula (韦氏活血通络方,WHTF) in treating atrophic-stage non-arteritic anterior ischemic optic neuropathy (NAION) with qi deficiency and blood stasis. MethodsA total of 82 atrophic-stage NAION patients with qi deficiency and blood stasis were randomly divided into a treatment group and a control group, with 41 cases in each group. The treatment group was given oral administration of WHTF twice a day plus acupoint injection of distilled water 2 ml at Taiyang (EX-HN5) once daily, while the control group received injection of compound anisodine injection 2 ml at Taiyang (EX-HN5) once daily and oral administration of WHTF placebo twice a day. Both groups received treatment for a course of 14 days. The best-corrected visual acuity (BCVA), optic disc perfusion density (PD), flux index (FI), macular superficial PD, vascular density (VD), and traditional Chinese medicine (TCM) syndrome scores were compared between groups before treatment and on day 7 and day 14 of treatment. Additionally, mean defect (MD) and mean sensitivity (MS) of visual fields were measured before treatment and on day 14, along with safety evaluation. ResultsAfter treatment, both groups showed significant improvement in BCVA, visual field MD and MS, and TCM syndrome scores (P<0.05 or P<0.01). On day 14 of treatment, the TCM syndrome score in the treatment group was significantly lower than that in the control group (P<0.05). There was no significant improvement in optic disc PD and FI, and macular superficial PD and VD after treatment in either group (P>0.05) except that on day 7 the macular superficial foveal PD in the control group was significantly better than that in the treatment group (P<0.05). During the treatment period, no serious adverse events occurred in either group. ConclusionWHTF can improve the visual function indicators including visual acuity and visual field, as well as TCM syndrome scores in atrophic-stage NAION patients with qi deficiency and blood stasis. It shows clinical safety, although it does not appear to have a significant effect on optic disc or macular blood flow.
8.Facial and tongue features in traditional Chinese medicine for coronary artery stenosis warning and their association chain with cardiac biomarkers
Yu Wang ; Pengcheng Ding ; Zhentao Li ; Jiyu Zhang ; Liping Tu ; Jijie Xu ; Jiatuo Xu
Digital Chinese Medicine 2026;9(2):184-196
Objective:
To explore whether digital facial and tongue diagnostic technologies can support the assessment of coronary heart disease (CHD) patients for coronary artery stenosis severity, and examine potential associations between digital tongue diagnosis features and myocardial biomarkers.
Methods:
The TFDA-1 face and tongue diagnosis instrument and the TDAS analysis system were used to perform intelligent visual examination and analysis of the facial and tongue in CHD patients who attended the Department of Cardiology at Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine between October 2, 2023 and July 31, 2024. Variables were screened using principal component analysis (PCA) and multicollinearity analysis to construct four machine learning models, including random forest, LightGBM, decision tree, and naive Bayes, for the early prediction of coronary artery stenosis severity. Model performance metrics, including sensitivity, specificity, precision, F1 score, accuracy, and the area under the receiver operating characteristic (ROC) curve (AUC), were evaluated. Visual analyses were performed using the SHapley Additive exPlanations (SHAP) interpreter and decision curve analysis. For patients after percutaneous coronary intervention (PCI), a conceptual model linking cardiac biomarkers and tongue diagnosis was constructed using the partial least squares structural equation modeling (PLS-SEM), and its validity was assessed.
Results:
A total of 459 CHD patients were enrolled and assigned to a PCI group and a non-PCI group (which comprised two subgroups: mild stenosis or less group, moderate stenosis or greater group). For sublingual vein (SV) features, the PCI group had lower SV-a and SV-b than the other groups (P < 0.01 and P < 0.05, respectively). For tongue surface features, the PCI group had significantly higher tongue body (TB)-L, TB-a, and TB-b (P < 0.05, P < 0.01, and P < 0.001, respectively), as well as higher tongue coating (TC)-a and TC-b (P < 0.01 and P < 0.001, respectively). Age, SV-a, SV-b, creatine kinase-myocardial band (CK-MB), CK, TC-a, lip-L, and lip-b were incorporated in the machine learning models. The random forest model performed best, with an AUC of 0.924, an F1 score of 0.839, precision of 0.807, accuracy of 0.864, sensitivity of 0.873, and specificity of 0.839. Decision curve analysis indicated that both LightGBM and random forest had clinical utility. PLS-SEM confirmed the pathway relationships: myocardial biomarkers → TB and myocardial biomarkers → TC (coefficient = – 0.238, t = 2.239, P = 0.025, and coefficient = – 0.270, t = 2.522, P = 0.012, respectively).
Conclusion
This study developed a noninvasive early warning model for coronary artery stenosis in patients with CHD. It applied PLS-SEM to investigate the association between post-PCI cardiac biomarkers and tongue diagnosis, and validated the proposed association chain. These findings suggest that intelligent traditional Chinese medicine (TCM) visual diagnosis integrated with modern digital technology may support CHD risk assessment and comprehensive health management.
9.Umbrella decision-making model for diagnosis and treatment of elderly lung cancer patients: Construction and practice
Lunxu LIU ; Jian ZHOU ; Xiang DING ; Nan CHEN ; Jianxin XUE ; Xuelei MA ; Ye WANG ; Weiya WANG ; Liqing PENG ; Xin YOU ; Minggang SU ; Xu CHENG ; Jiao WANG ; Ning GE ; Deying KANG ; Yuchen HUANG ; Jinghan WANG ; Yu TONG ; Yaoxi ZHANG ; Jirong YUE ; Hu LIAO
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(06):833-839
With the accelerating trend of population aging, the number of elderly patients with lung cancer continues to rise, and the disease burden is becoming increasingly heavy. The clinical management of these patients faces severe challenges due to their decreased physiological reserve, complex comorbidities, and significant individual heterogeneity. Consequently, under traditional diagnosis and treatment models, doctors often struggle to identify the individualized risks of elderly patients in a timely and comprehensive manner, which can easily lead to decision biases such as undertreatment or overtreatment. In view of this, this study advocates for the establishment of an umbrella decision-making model specifically tailored for elderly lung cancer patients. Grounded in a multidisciplinary team (MDT) platform, this model deeply integrates oncological indicators with the comprehensive geriatric assessment (CGA) system. By holistically considering multidimensional variables including tumor burden, organ function, frailty index, cognitive status, and social support, the model establishes an operational mechanism characterized by "single entry, precise stratification, and targeted selection". Accordingly, patients can be scientifically triaged into distinct intervention tiers, such as active surveillance, minimally invasive surgery, drug therapy, radiotherapy, and best supportive care, thereby achieving real-time alignment between treatment intensity and patient fitness. This article elaborates on the construction logic and key operational procedures of this novel decision-making framework, aiming to guide clinical practice beyond the limitations of a tumor-centric perspective toward a holistic, dynamic, whole-course management strategy. This transition seeks to ensure optimal quality of life and clinical net benefit for elderly patients alongside survival prolongation.
10.Construction of undergraduate rehabilitation engineering curriculum system based on World Health Organization rehabilitation competency framework
Yongli WEI ; Junhang DING ; Ping ZHOU ; Xiaoman YANG ; Zhen WANG ; Fujie YU ; Fangfang DUAN ; Enjing GUAN
Chinese Journal of Rehabilitation Theory and Practice 2026;32(6):731-738
ObjectiveTo address the shortage of high-caliber multidisciplinary professionals in China's rehabilitation engineering field and the prominent issue of "separation between medicine and engineering" in existing curricula, this study introduces the World Health Organization rehabilitation competency framework (RCF) to construct a systematic curriculum system for rehabilitation engineering. MethodsGuided by the four core competency domains of RCF (practice, professionalism, learning and development, management and leadership) and their associated supporting knowledge, the rehabilitation engineering curriculum was restructured into a modular framework, piloted and validated within the Biomedical Engineering (Intelligent Robotics) program at University of Health and Rehabilitation Sciences. ResultsA four-tiered curriculum system comprising General Education-Disciplinary Platform-Professional Core-Diverse Electives with a total of 160 credits was established, achieving precise mapping between competency objectives and course content. The students in the pilot cohort demonstrated outstanding academic performance (50% ranked in the top ten of their major), they also gained a deeper understanding and mastery of interdisciplinary knowledge integrating medicine and engineering. ConclusionThe RCF-based curriculum system effectively promotes the organic integration of medical and engineering knowledge, providing an internationally aligned competency-oriented paradigm for rehabilitation engineering talent cultivation, which holds significant value for broader application.

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