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.Change in the number of peripheral blood regulatory T cells in patients with chronic kidney disease and its correlation with vascular calcification
Di ZHANG ; Hui WU ; Jing CHEN ; Liyu LIN ; Shaomin GONG ; Xiaoyan ZHANG ; Xiaoqiang DING ; Han ZHANG
Chinese Journal of Clinical Medicine 2026;33(2):285-292
Objective To explore the number of peripheral blood regulatory T cells (Treg) in patients with chronic kidney disease (CKD) and its correlation with vascular calcification. Methods This was a single-center, cross-sectional, and observational study. Non-dialysis patients with CKD treated at Zhongshan Hospital, Fudan University from March 2021 to March 2022 were enrolled. Abdominal aortic calcification (AAC) was assessed using lateral abdominal X-ray. Number of Treg and cytokine levels were measured by flow cytometry. Logistic regression analysis was performed to evaluate the related factors for AAC in CKD patients. Results A total of 83 patients were included, aged 17–86 years, with 57 males (68.7%). The distribution of CKD stages was as follows: stage G1 in 7 patients (8.4%), stage G2 in 17 patients (20.5%), stage G3 in 21 patients (25.3%), stage G4 in 19 patients (22.9%), and stage G5 in 19 patients (22.9%). No AAC was observed in patients with stages G1 and G2, while the prevalence of AAC in patients with stages G3, G4, and G5 was 23.8%, 21.1%, and 26.3%, respectively. Compared with stage G1 patients, those with stages G3–5 showed decreased number of peripheral blood Treg and elevated levels of interleukin (IL)-6 and IL-17F (P<0.05). The area under the receiver operating characteristic curve for number of peripheral blood Treg in predicting AAC in CKD patients was 0.766 (95%CI 0.652–0.879, P=0.002). Logistic regression analysis showed that decreased number of Treg was related factor for AAC in CKD patients (OR=0.957, 95%CI 0.922–0.992, P=0.018). Conclusion As CKD progresses, number of peripheral blood Treg significantly decreases, which is correlated with AAC in CKD patients.
3.A-to-I RNA editing of miR-411 attenuates post-infarction cardiac fibrosis via dual targeting of TGFBR2 and CD44
Suling DING ; Zhiwei ZHANG ; Xiyang YANG ; Dili SUN ; Jianfu ZHU ; Xiaowei ZHU ; Xiangdong YANG ; Junbo GE
Chinese Journal of Clinical Medicine 2026;33(1):191-192
Objective To explore the functional impact of A-to-I editing in the seed region of miR-411 during post-myocardial infarction (MI) fibrosis and elucidate its therapeutic potential. Methods Integrating GEO database with myocardial RNA-seq data from MI mouse models, we identified dynamic A-to-I RNA editing in small noncoding RNAs across MI progression (1 day to 8 weeks post-MI). Four miRNAs exhibited differential editing rates between MI and controls, with miR-411 showing progressive editing enhancement at seed region position 4 (P<0.01). This editing event was validated in both murine MI models and human heart failure specimens. Results The A-to-I editing ratio change of the 4th nucleotide in the seed region of miR-411 mainly occurs in cardiac fibroblasts rather than cardiomyocytes, and the editing at this site depends on ADAR2 rather than ADAR1. Edited miR-411 (ED-miR-411) diverged from wild-type miR-411 (WT-miR-411) in suppressing collagen-related pathways (extracellular matrix [ECM]-receptor interaction, collagen-containing ECM, ECM organization; P<0.01) in cardiac fibroblasts. Mechanistically, dual-luciferase assays confirmed ED-miR-411 directly targeted the 3′UTR and suppressed expression of type Ⅱ transforming growth factor (TGF)-beta receptor (TGFBR2) and CD44, which were key drivers of TGF-β-mediated fibroblast activation. ED-miR-411 overexpression blunted TGF-β-induced collagen synthesis and myofibroblast proliferation (P<0.05). In vivo, intramyocardial delivery of ED-miR-411 mimics at 1 week post-MI reduced fibrosis by 40% and improved ejection fraction by 15% (P<0.01 vs controls), whereas WT-miR-411 showed no therapeutic effect. Conclusions A-to-I editing of miR-411 emerges as an endogenous anti-fibrotic mechanism by repressing TGFBR2 and CD44, thereby disrupting TGF-β signaling and ECM dysregulation. Our findings highlight ED-miR-411 as a novel RNA-based therapeutic candidate to mitigate post-infarction cardiac remodeling.
4.Reconceptualizing Critical Illness in Cancer Through the Lens of Host Unregulated Response
Yun CHU ; Shiyi GONG ; Xin DING ; Hua ZHAO ; Huan CHEN ; Qing ZHANG ; Xiaoting WANG
Medical Journal of Peking Union Medical College Hospital 2026;17(1):1-9
Onco-critical care has emerged as an important subspecialty at the intersection of critical care medicine and oncology, attracting increasing attention in recent years. With continuous innovations in cancer therapies, patient survival has improved significantly; however, the incidence of associated critical complications has also increased. The reasons for cancer patients requiring intensive care unit admission are diverse and can be broadly categorized into three groups: progression of the underlying malignancy, treatment-related complications, and coexisting classical critical illnesses. Traditional critical care concepts and practices face limitations in addressing the multidimensional and heterogeneous challenges of onco-critical care. Based on the core mechanism of critical illness development—host/organ unregulated response (HOUR)—this article systematically elaborates on how this framework advances understanding and clinical practice into onco-critical care, with emphasis on its manifestations in neuroendocrine, immune-inflammatory, and coagulation-metabolic pathways. The review summarizes recent advances in clinical assessment and phenotyping systems for onco-critical illness and discusses a multidisciplinary, integrated management strategy centered on the "Disease Control, Host Response Modulation, Organ Support" triad. Finally, major challenges and future directions in this field are outlined. By integrating existing evidence and theoretical insights, this review aims to provide new perspectives and a theoretical foundation for the clinical management of onco-critical illness, thereby promoting its evolution toward precision and standardization.
5.Standards for the Application of Hemodynamic Monitoring Technology in Critical Care
Hua ZHAO ; Hongmin ZHANG ; Xin DING ; Huan CHEN ; Jun DUAN ; Wei DU ; Bo TANG ; Yuankai ZHOU ; Dongkai LI ; Xinchen WANG ; Cui WANG ; Gaosheng ZHOU ; Xiaoting WANG
Medical Journal of Peking Union Medical College Hospital 2026;17(1):73-85
With the rapid advancement of hemodynamic indices and monitoring technologies, their classification methods and application processes have become increasingly complex. Currently, no unified standard hasbeen established, making it difficult to fully meet the clinical requirements for hemodynamic management. To assist in hemodynamic monitoring assessment and therapeutic decision-making in critically ill patients, the Critical Hemodynamic Therapy Collaborative Group, in conjunction with the Critical Ultrasound Study Group, has jointly developed the Standard for the Application of Hemodynamic Monitoring Techniques in Critical Care. The first part of this standard systematically categorizes hemodynamic indicators into flow indicators, pressure and its derivative indicators, and tissue perfusion indicators, while elaborating on the clinical application of each. The second part establishes a standardized clinical implementation pathway for hemodynamic monitoring. It proposes a tiered monitoring strategy-comprising basic, advanced, indication-specific, and special scenario monitoring-tailored to different clinical settings. It emphasizes the central role of critical care ultrasound across all levels of monitoring and establishes hemodynamic assessment standards for organs such as the brain, kidneys, and gastrointestinal tract. This standard aims to provide a unified framework for clinical practice, teaching, training, and research in critical care medicine, thereby promoting standardized development within the discipline.
6.Research advances in methods for personal dose monitoring in interventional radiology
Xuanrong ZHANG ; Wen GUO ; Xian XUE ; Yanqiu DING
Chinese Journal of Radiological Health 2026;35(1):141-147
This paper primarily reviews the current research status of passive and active monitoring methods for interventional radiology personnel, encompassing the types and wearing positions of personal dosimeters, simulation results versus measured outcomes, and discrepancies between different simulation results. By reviewing domestic and international literature, it lists effective dose estimation formulas for single- and dual-dosimeter systems developed by various researchers worldwide. Recommendations are proposed based on the current dosimeter wearing practices among interventional radiology staff, providing reference for the formulation of relevant standards.
7.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.
8.Comorbidity Mechanism Between Ulcerative Colitis and Atrial Fibrillation Based on "Gut Microbiota-gut-heart" Axis
Meiyu FENG ; Wenjing ZHANG ; Yihang DU ; Xuanye DING ; Yuanhui HU ; Haitai YUAN
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(7):276-281
The gut microbiota is regarded as the "eighth organ" of the human body and plays a critical regulatory role in the occurrence and progression of various diseases. Ulcerative colitis (UC) is a chronic inflammatory bowel disease with a complex etiology and a tendency toward recurrent episodes. In recent years, studies have shown that gut microbiota dysbiosis plays a key role in its pathological processes. Meanwhile, an increasing number of studies have demonstrated that imbalances in the gut microbiota and abnormalities in its metabolites are closely associated with the development of atrial fibrillation (AF). Although UC and AF belong to diseases of the digestive system and cardiovascular system, respectively, both exhibit systemic inflammatory characteristics and are often accompanied by gut microbiota dysregulation and abnormal metabolic products. However, systematic investigations into the mechanisms by which gut microbiota-derived metabolites act in these two diseases remain limited. Based on this, the present study adopts literature review and theoretical analysis methods, taking the "gut microbiota-gut-heart" axis as the entry point, to systematically summarize the signaling networks of three key classes of metabolites, i.e., short-chain fatty acids (SCFAs), bile acids (BAs), and trimethylamine N-oxide (TMAO), in the comorbidity mechanism of UC and AF. The findings indicate that these metabolites may activate key inflammatory pathways, such as NF-κB and NLRP3, thereby synergistically mediating intestinal barrier dysfunction and systemic inflammation and constructing a potential comorbidity network. On this basis, potential intervention strategies for the treatment of UC-AF comorbidity, including probiotic intervention and fecal microbiota transplantation, are further discussed. This study aims to provide new theoretical evidence and research perspectives for prevention and treatment strategies of cross-system diseases.
9.Intervention of Signaling Pathways Related to Ulcerative Colitis with Traditional Chinese Medicine: A Review
Hao WANG ; Jiali DING ; Guangjun SUN ; Xiaoyu ZHANG ; Aizhen LIN
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(7):331-340
Ulcerative colitis (UC) is a common digestive disease characterized by recurrence and remission alternation,which seriously affects the life quality and physical and mental health of patients. The pathogenesis of UC is complex,and studies have shown that the occurrence and development of UC are closely related to the transduction of multiple signaling pathways. The current western medicine treatment has many problems,such as single action target,more adverse reactions,poor patient tolerance,and easy recurrence after stopping the medicine. Traditional Chinese medicine has the advantages such as multi-targets,multi-pathways, and fewer adverse reactions, elucidating that the action mechanism of traditional Chinese medicine in the treatment of UC is the focus of current research. Therefore, this paper conducted a systematic review on how traditional Chinese medicine exerts therapeutic effects by regulating the signaling pathways related to UC in recent years,and it was found that traditional Chinese medicine can regulate nuclear factor-κB (NF-κB),adenylate-activated protein kinase (AMPK)/mammalian target of rapamycin (mTOR),Janus tyrosine protein kinase (JAK)/signal transducer and activator of transcription (STAT),phosphatidylinositol 3-kinase (PI3K) /protein kinase B (Akt),NOD-like receptor thermoprotein structural domain-related protein 3 (NLRP3)/cysteine protease-1 (Caspase-1),nuclear respiratory factor 2 (Nrf2)/heme oxygenase-1 (HO-1), and several other pathways,thereby inhibiting oxidative stress and cellular pyroptosis,regulating the Tregs/Th17 cellular balance, promoting autophagic response and M2-type macrophage polarization,restoring the diversity and abundance of intestinal flora,promoting the repair of intestinal mucosal barrier function,and alleviating the inflammatory damage of UC colonic tissues. The holistic concept and evidence-based treatment of traditional Chinese medicine were combined with the modern molecular mechanism research of traditional Chinese medicine, and the traditional Chinese medicine combinations with different mechanisms, following regulation, were formulated into compound formulas or pairs of medicines according to the pattern of evidence. It is expected to achieve better therapeutic efficacy and to provide ideas and references for the modification of classic compound formulae of traditional Chinese medicine in UC treatment and clinical translation.
10.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),

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