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.Effects of serum potassium levels on prognosis in elderly patients with sepsis
Beibei YU ; Zhongxue SU ; Shilong LIN ; Yuying YANG ; Qingwu LIAO ; Chenghui QU
Chinese Journal of Clinical Medicine 2026;33(2):270-276
Objective To explore the effects of different serum potassium levels on the 28-day prognosis of elderly patients with sepsis. Methods A retrospective analysis was conducted on the clinical data and laboratory indicators within 24 hours after the diagnosis in 204 elderly patients with sepsis admitted to the Department of Critical Care Medicine, Zhongshan Hospital, Fudan University from January 2018 to January 2022. According to the potassium concentrations in the blood of the patients within 24 hours after admission to intensive care unit (ICU), the patients were divided into the hyperkalemia group (K+≥5.3 mmol/L), normokalemia group (K+ 3.5–<5.3 mmol/L), and hypokalemia group (K+<3.5 mmol/L). According to 28-day outcomes, the patients were divided into the death group and survival group. The acute physiological and chronic health evaluation (APACHE) Ⅱ score, sequential organ failure assessment (SOFA) score and laboratory indicators were analyzed. Multivariate logistic regression analysis was used to analyze the risk factors for 28-day mortality in elderly patients with sepsis. Results Compared with the normokalemia group (n=99), patients in both the hyperkalemia (n=61) and hypokalemia (n=44) groups had significantly higher levels of C-reactive protein (CRP) and procalcitonin (PCT), longer duration of mechanical ventilation, longer length of hospital stay and ICU stay, and higher mortality (P < 0.05). The death group (n=49) had significantly higher APACHE Ⅱ score, SOFA score, white blood cell (WBC) counts, CRP level, and PCT level than the survival group (n=155, P<0.05). Multivariate logistic regression analysis showed that increased or decreased serum potassium level, higher SOFA score, and increased WBC counts were independent risk factors for 28-day mortality in elderly patients with sepsis (P<0.05). Quadratic fitted curve showed a U-shaped association between serum potassium levels and 28-day mortality risk in elderly patients with sepsis, with the lowest mortality risk observed within the intermediate (normal) range, and both hypokalemia and hyperkalemia were associated with an increased mortality risk (P=0.182). Conclusion Both increased and decreased serum potassium levels are independent risk factors for 28-day mortality in elderly patients with sepsis, which should be given particular attention in clinical management.
3.Efficacy and safety of CT-guided radiofrequency ablation as a surgical alternative for multiple pulmonary nodules
Changhui MA ; Bin ZHANG ; Linxiang YU ; Zhong GUAN ; Junyi YANG ; Haiwen ZHEN
Chinese Journal of Clinical Medicine 2026;33(2):299-305
Objective To evaluate the efficacy and safety of CT-guided percutaneous radiofrequency ablation (RFA) as an alternative for video-assisted thoracoscopic surgery (VATS) in treating multiple pulmonary nodules. Methods A retrospective analysis was conducted on the clinical data of 113 patients with multiple pulmonary nodules admitted to Jiangsu Provincial Hospital of Traditional Chinese Medicine from October 2020 to October 2022. The patients were divided into the RFA group (n=50) and the VATS group (n=63) based on the treatment method. Perioperative indicators (operation time, intraoperative blood loss, postoperative length of hospital stay), oncological outcomes (recurrence-free survival [RFS], overall survival [OS]), and postoperative complication rates were compared between the two groups. Univariate and multivariate Cox regression analysis was performed to identify independent prognostic factors. Results The operation time in the RFA group was significantly shorter than that in the VATS group ([75.2±20.1] min vs [102.3±28.7]) min, P<0.001). No statistically significant differences were observed in intraoperative blood loss and postoperative length of hospital stay. After follow-up of 24 (12, 30) months, no statistically significant differences were found in RFS (HR=1.25, P=0.445) or OS (HR=1.42, P=0.402) between the two groups. Mixed ground-glass nodules with high solid component and solid nodule were identified as independent risk factors for RFS (HR=2.44, P=0.023; HR=2.97, P=0.007) and OS (HR=2.87, P=0.022; HR=3.43, P=0.005) in patients with multiple pulmonary nodules. The total complication rate in the RFA group was lower than that in the VATS group (12.0% vs 34.9%, P=0.009). Conclusions The efficacy of CT-guided RFA in treating multiple pulmonary nodules is comparable to that of VATS, with good safety, and it shows promise as an alternative to surgical treatment for multiple pulmonary nodules.
4.Inhibition of Epithelial-mesenchymal Transition Mechanism in Chronic Atrophic Gastritis Rats by Banxia Xiexintang via Regulating IL-17/ERK/C/EBPβ Signaling Pathway
Wenyu WU ; Xinyu ZENG ; Hao LI ; Weiqi SUN ; Jiahui REN ; Yang YU ; Tingting ZHOU ; Aili XU ; Wei WEI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(4):1-10
ObjectiveThis study aimed to investigate the action mechanism by which Banxia Xiexintang (BXT) inhibits epithelial-mesenchymal transition (EMT) in chronic atrophic gastritis (CAG) rats by regulating the interleukin-17(IL-17)/extracellular regulated protein kinases(ERK)/CCAAT enhancer binding protein β(C/EBPβ)signaling pathway, thereby providing new theoretical evidence for the treatment of CAG with classic traditional Chinese medicine formulas. MethodsA CAG rat model was established by using the combined factor method. After successful modeling, the rats were randomly divided into the model group, low-, medium-, and high-dose groups (0.549, 1.098, 2.196 g·kg-1, respectively) of BXT, and the positive drug group (vitacoenzyme, 0.3 g·kg-1). A normal control group was also set up. After 8 weeks of intervention, the pathological changes of gastric tissue were evaluated. The enzyme-linked immunosorbent assay (ELISA) was used to detect the contents of IL-17, tumor necrosis factor-α (TNF-α), cyclooxygenase-2 (COX-2), and C/EBPβ in serum, as well as the contents of EMT markers in gastric mucosal tissue including E-cadherin, N-cadherin, and vimentin. The immunohistochemistry method was employed to determine the localization and protein expression levels of IL-17, p-ERK, and C/EBPβ in gastric mucosal tissue. Western blot was used to detect the protein expressions of C/EBPβ, ERK, and its phosphorylated form (p)-ERK in gastric mucosa. Real-time polymerase chain reaction (Real-time PCR) was applied to measure the mRNA expression levels of ERK, COX-2, and C/EBPβ in gastric mucosa. ResultsCompared with those in the normal control group, the rats in the model group showed gastric mucosal glandular atrophy and inflammatory cell infiltration. The protein and their related mRNA expressions of C/EBPβ, ERK, and p-ERK in gastric mucosa were significantly increased (P<0.05,P<0.01). The levels of IL-17, TNF-α, COX-2, and C/EBPβ in serum were significantly increased (P<0.01). The contents of N-cadherin and vimentin in gastric mucosal tissue were significantly increased, while the content of E-cadherin was significantly decreased (P<0.01). Compared with the model group, after intervention with different doses of BXT, the pathological damage of the gastric mucosa was improved to varying degrees. The protein and mRNA expressions of C/EBPβ, ERK, and p-ERK in gastric mucosa were significantly reduced (P<0.05,P<0.01). The levels of IL-17, TNF-α, COX-2, and C/EBP β in serum were significantly decreased (P<0.01). The contents of N-cadherin and vimentin in gastric mucosa tissue were decreased, while the content of E-cadherin was increased (P<0.05,P<0.01). ConclusionBXT can effectively improve the pathological damage of gastric mucosal tissue in CAG rats. Its action mechanism may be related to reducing the levels of IL-17 and TNF-α in serum, regulating the IL-17/ERK/C/EBPβ signaling pathway and inhibiting the EMT process.
5.Efficacy and Application Characteristics of Cold Chinese Medicines Based on Chinese Pharmacopoeia (2020 Edition)
Lu YUE ; Yilong HU ; Jingying YANG ; Xiangxiang WU ; Mingsan MIAO ; Ming BAI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(4):241-248
ObjectiveTo provide a reference for the rational clinical use of cold Chinese medicines by sorting and analyzing their properties, flavors, meridian tropism, primary therapeutic indications, methods of administration, dosages, and precautions as recorded in the 2020 edition of Pharmacopoeia of the People's Republic of China (Chinese Pharmacopoeia). MethodsCold Chinese medicines for internal and external use included in the 2020 edition of Chinese Pharmacopoeia were entered one by one, and their efficacy, properties, flavors, meridian tropism, methods of administration, dosages, and usage precautions were statistically classified and summarized to guide clinical medication use. ResultsA total of 259 cold Chinese medicines for internal use were included and categorized into 18 efficacy groups, mainly comprising heat-clearing drugs, water-excreting and dampness-draining drugs, and phlegm-resolving, cough- and asthma-relieving drugs. Their predominant flavors were bitter, sweet, and pungent, and they primarily entered the liver, lung, and stomach meridians. The main methods of administration included decocting first, grinding into powder for oral use, or preparing into pills or powders, with most dosages ranging from 9 to 15 g. A total of 83 cold Chinese medicines for external use were included, involving 16 efficacy categories. Their main flavors were bitter, sweet, and pungent, primarily entering the liver, lung, and large intestine meridians. The main external application methods were grinding into powder for topical use or preparing decoctions for fumigation and washing, with most dosages ranging from 9 to 15 g. Whether for internal or external use, cold Chinese medicines should be used with caution or contraindicated in pregnant women. ConclusionThe cold Chinese medicines included in the 2020 edition of the Chinese Pharmacopoeia are mainly suitable for patients with carbuncles, swellings, and coughs. However, in clinical practice, it is necessary to strictly follow the principles of syndrome differentiation and treatment, pay attention to administration methods and dosages, and use cold medicines rationally and effectively to improve clinical efficacy.
6.Five Principles for the Development of Oncology Critical Care Medicine
Zhengheng YU ; Zeyu ZHANG ; Yanli YANG
Medical Journal of Peking Union Medical College Hospital 2026;17(1):10-15
With the deep integration of tumor diagnosis and treatment technologies and critical care medicine, oncology critical care has emerged as an innovative interdisciplinary field, whose standardized development is crucial for improving the prognosis of cancer patients. Based on complex system theory and incorporating cutting-edge clinical practices, this paper systematically elaborates on five core principles for promoting the high-quality development of oncology critical care: complex system thinking, value-based healthcare, interdisciplinary integration, spatiotemporal holism, and humanistic experience. These five principles provide a top-level design framework for the discipline in terms of conceptual understanding, comprehensive management, developmental paradigms, clinical treatment, and service models. They aim to establish a patient-centered oncology critical care system that balances medical quality and efficiency, ultimately maximizing patient survival benefits across their entire life cycle.
7.Research on dynamic monitoring of drug consumption based on seasonal Mann-Kendall trend test
Ziheng YU ; Chen CHEN ; Xiangyu YANG ; Lulu LI ; Shaohui ZHANG
China Pharmacy 2026;37(3):377-382
OBJECTIVE To investigate a dynamic monitoring of drug consumption (DMDC) model based on the seasonal Mann-Kendall trend test, aiming to provide scientific evidence for the efficient and macroscopic monitoring of drug use. METHODS A monitoring list of key outpatient drugs was established based on the top 20% of drugs ranked by sales volume in the outpatient pharmacy in October 2024. A DMDC model based on the Mann-Kendall trend test was constructed using the monthly usage data of key outpatient drugs from November 2021 to October 2024, aiming to eliminate the impact of seasonal fluctuations and analyze the temporal trends in drug consumption. Taking mucolytic expectorants, triazole derivatives for dermatophytosis, and single-agent hydroxymethylglutaryl coenzyme A (HMG-CoA) reductase inhibitors as examples, the monitoring effectiveness of the DMDC model was demonstrated, and its performance was compared with that achieved by the traditional sequential growth rate ranking method. RESULTS A total of 215 drug varieties were included in the monitoring list, and DMDC models were successfully established for all of them. Among these, 119 showed a significant increasing trend (P<0.05, S′>0). The model successfully monitored the monthly consumption of mucolytic expectorants, triazole derivatives for dermatophytosis, and single- agent HMG-CoA reductase inhibitors. The precision and recall rates of the DMDC model for identifying abnormal drug use were 60.7% and 85.0%, respectively, both significantly higher than those of the sequential growth rate ranking method (8.3% and 15.0%, respectively) (χ2=20.114, P<0.001; χ2=19.600, P<0.001). CONCLUSIONS DMDC model based on the seasonal Mann-Kendall trend test can effectively identify long-term trends in drug consumption, eliminate seasonal interference, enhance monitoring accuracy and management efficiency, and is suitable for the dynamic monitoring of drug consumption.
8.Analysis of the impact of intraoperative RhE antigen-matched transfusion on early prognosis in liver transplant patients
Xiaochao YU ; Xinyuan GAO ; Fan HAI ; Chao YANG ; Xingyu HOU ; Yaping XING ; Hongqiang GAO ; Hongwei ZHANG ; Gang SU ; Ronghua XU
Chinese Journal of Blood Transfusion 2026;39(1):44-50
Objective: To investigate the impact of RhE antigen-matched transfusion during liver transplantation on early postoperative recovery and complications. Methods: In this retrospective cohort study, ninety-five patients undergoing liver transplantation at Kunming First People's Hospital between January 2022 and July 2025 were enrolled. Patients were divided into two groups: Group 1 (RhE-mismatched transfusion, n=57) and Group 2 (RhE-matched transfusion, n=38). The baseline data, complete blood counts, hepatic and renal function, coagulation parameters, and complication rates between the two groups were compared at postoperative days 1, 3, 5, 7, and 10. Survival analysis was performed using the Kaplan-Meier method. Results: The baseline characteristics were well-balanced and comparable between the two groups (all P>0.05). The early postoperative mortality rate in the mismatched group (31.58%, 18/57) was significantly higher than that in the matched group (10.53%, 4/38) (P=0.017). The incidence of postoperative hepatic encephalopathy was significantly higher in the mismatched group (50.88%, 29/57) than in the matched group (10.53%, 4/38) (P<0.001). The incidence of postoperative haemorrhage in the mismatched group (24.56%, 14/57) was higher than that in the matched group (5.26%, 2/38), with a statistically significant difference (P=0.014). The incidence of perioperative infection in the mismatched group (28.07%, 16/57) was higher than that in the matched group (10.53%, 4/38), with a statistically significant difference (P=0.04). Corresponding odds ratios (OR) and 95% confidence intervals indicated a lower risk of these adverse events in the matched group. On postoperative day 1, the change in activated partial thromboplastin time (-1.6, 20.5) in the mismatched group was greater than in the matched group (-0.2, 5.5). The change in international normalised ratio (-0.56, 1.22) in the mismatched group was greater than in the matched group (-0.18, 0.32), while the change in albumin (-4.0, 4.8) was smaller in the mismatched group than in the matched group (-2.5, 8.8). On postoperative day 5, the change in albumin (-0.41±7.83) in the mismatched group was smaller than in the matched group (2.68±4.53). At postoperative day 7, the change in albumin in the mismatched group (-0.61±7.38) was smaller than that in the matched group (2.51±5.85), while the change in D-dimer in the mismatched group (0.73, 7.4) was greater than that in the matched group (-1.6, 4.3). On postoperative day 10, the mismatched group exhibited significantly higher fibrinogen levels (-1.21, 1.78) than the matched group (-0.49, 0.97), and significantly longer prothrombin times (-11.3, -2.7) than the matched group (-6.2, -0.8) (all P<0.05). The matched group exhibited a mean overall survival (OS) of 32.803 months (95% CI:29.171-36.436 months), significantly exceeding the mismatched group's 28.996 months (95% CI:24.202-33.790 months). The log-rank test yielded statistically significant results (χ
=4.307, P=0.038). Conclusion: Implementing RhE blood group-matched transfusion during liver transplantation may help reduce early postoperative mortality and the incidence of major complication rates, promote faster recovery of coagulation and liver function, and thereby improve short-term patient outcomes.
9.Evaluation of the application of a predictive model for red blood cell demand in surgical procedures
Xiaoyu CAI ; Yannan FENG ; Chunya MA ; Yuan ZHUANG ; Yang YU
Chinese Journal of Blood Transfusion 2026;39(1):51-55
Objective: To assess the clinical application value of a prediction model for red blood cell (RBC) demand in surgical procedures. Methods: Demographic data, laboratory parameters, anesthesia and transfusion records, and model prediction data were retrospectively collected from surgical patients at the First Medical Center of Chinese PLA General Hospital between 2018 and 2024. Statistical analysis was performed using the Chi-square test, t-test, and Mann-Kendall trend test. Results: From 2018 to 2024, the predictive model for RBC demand in surgical procedures was used to evaluate a total of 112 293 surgeries. During this period, the model call rate (77.49%-98.91%, P<0.05), compliance rate (56.81%-84.92%, P<0.05), and prediction accuracy rate (66.82%-94.17%, P<0.05) all showed significant upward trends. The total blood usage across the hospital (13645.4-7723.5 units, P<0.05) and the average blood usage per surgery (0.21-0.1 units, P<0.05) exhibited overall downward trends. Postoperative average hemoglobin levels in the non-compliance group (112.1-105.3 g/L in the non-compliance group vs 106.9-92.7 g/L in the compliance group, P<0.05) and the intraoperative excessive transfusion rate (5.06%-6.05% in the non-compliance group vs 0.09%-0.04% in the compliance group, P<0.05) were significantly higher in the non-compliance group compared to the compliance group. Conclusion: The predictive model for RBC demand in surgical procedures has played a positive role in conserving blood resources, optimizing blood resource allocation, and reducing intraoperative risks.
10.The current status of international health communication research and its implications for China
Lingyan YANG ; Zihan YU ; Yueqiao ZHAO ; Zhenping LI ; Jianyi YAO ; Hao LI ; Yuhui ZHOU
Journal of Public Health and Preventive Medicine 2026;37(1):18-21
Objective To systematically review international research on health communication, and to provide valuable insights and reference for China's health communication research and practice. Methods This study included 693 articles published from January 2023 to April 2024 in two authoritative academic journals in the field of health communication, “Health Communication” and the “Journal of Health Communication”. A systematic review was conducted on the themes, theoretical foundations, research methods, and populations of international health communication research. Results The findings in this study revealed that international health communication research topics were diverse, with hotspots including social media, health information behavior, health misinformation, stigmatization, trust, and risk perception. The results showed that 34% of the articles were based on theoretical foundations, and 93.3% employed research methods, focusing on adolescents, parents, women, and other key populations. Conclusion Domestic health communication research can expand its perspective from “information transmission” to “social interaction”, innovate theories and methods from “single paradigm" to “multi-integration” and shift focus from a “mass perspective” to “targeted care” for the health of all populations. Domestic health communication practice can delve into the localization of social media health communication practices, the comprehensive management of health misinformation, and the critical application of new technologies.


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