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.Early recognition and intervention strategy of perioperative cardiopulmonary complications in elderly patients with lung cancer
Yuhao SONG ; Wenxin TIAN ; Donghang LI ; Jiangyu WU ; Hanbo YU ; Hongfeng TONG ; Yaoguang SUN ; Peng JIAO
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(05):710-716
Elderly patients with lung cancer have a significantly increased risk of perioperative cardiopulmonary complications due to physiological decline, high incidence of complications and reduced surgical tolerance, which directly affects postoperative recovery and long-term survival. Although the concepts of minimally invasive surgery and enhanced recovery after surgery have improved clinical outcomes, early recognition and intervention of postoperative complications in elderly patients remains a significant challenge in the field of thoracic surgery. By integrating recent literature and clinical practice, this paper systematically analyzes the pathophysiological mechanism and risk factors of perioperative cardiopulmonary complications in elderly patients with lung cancer, and discusses individualized intervention strategies based on risk stratification and multidisciplinary team, in order to provide theoretical basis and practical guidance for optimizing perioperative management and improving postoperative prognosis in elderly patients.
4.Research progress on the source and biosynthesis of tetrodotoxin
Wei WU ; Dunning YU ; Xingchi YANG ; Peng SUN ; Zhiyong CHU
Journal of Pharmaceutical Practice and Service 2026;44(1):1-6
Tetrodotoxin(TTX)is a potent neurotoxin known for its specific sodium channel blocking effects, widely used in biomedical research. While TTX has been identified in various marine organisms, its true origin remains unclear, and the specific biosynthetic pathways are yet to be elucidated. The reported sources of TTX and the progress in research on TTX biosynthesis were summarized, with a focus on potential microbial sources of TTX, which could provide scientific reference for the production and biosynthesis studies of TTX.
5.Effects and mechanisms of action of Yiqi wenyang huwei decoction in improving bronchial asthma in rats
Yunqing YANG ; Jianyu XIE ; Wei TANG ; Chao YE ; Qiangqiang YU ; Peng SUN ; Yuping YANG ; Jianwei YU
China Pharmacy 2026;37(10):1264-1271
OBJECTIVE To investigate the effects and potential mechanism of Yiqi wenyang huwei decoction (YQWY) in improving airway inflammation and remodeling in rats with bronchial asthma (BA) based on the Toll-like receptor 4 (TLR4)/myeloid differentiation primary response protein 88 (MyD88)/nuclear factor-κB (NF-κB) signaling pathway. METHODS Male SD rats were randomly divided into the normal group, the model group, the dexamethasone group (positive control, 0.5 mg/kg), and YQWY low-, medium- and high-dose groups (5, 10, 20 g/kg, calculated by the crude drug), with 8 rats in each group. Except for the normal group, rats in all other groups were sensitized twice with ovalbumin combined with aerosol challenge to establish a BA model. From day 14 to day 34 of the experiment, the rats in each group were administered the corresponding drug solution or normal saline intragastrically, once a day, 1 hour before aerosol challenge. At 24 hours after the final aerosol challenge, asthma symptom scores were assessed, serum levels of immunoglobulin E (IgE) were measured, and the levels of inflammatory cytokines (interleukin-4, interleukin-5, interleukin-13 and tumor necrosis factor-α) and the numbers of inflammatory cells (white blood cell, eosinophil, neutrophil, lymphocyte, monocyte and basophil) in bronchoalveolar lavage fluid were determined. Pathological changes in lung tissue were observed. The mRNA expressions of TLR4, MyD88 and NF-κB, as well as the protein expressions of TLR4, MyD88, NF-κB p65 and phosphorylated NF-κB p65 in lung tissue, were detected. RESULTS Compared with the model group, the pathological changes, such as inflammatory cell infiltration, abnormal deposition of collagen fibers, and goblet cell hyperplasia in the lung tissue of rats in each drug group, were alleviated to varying degrees. The asthma symptom scores (except for the YQWY low-dose group), the levels of IgE and inflammatory cytokines (except for interleukin-5 in the YQWY medium-dose group), the number of inflammatory cells (except for monocyte and basophil in the YQWY low-dose group), the mRNA expression of TLR4, MyD88 and NF-κB, as well as the protein expressions of TLR4, MyD88, NF-κB p65 and phosphorylated NF-κB p65 (except for MyD88 and NF-κB p65 proteins in the YQWY low-dose group as detected by Western blo t) were all significantly reduced or down-regulated ( P <0.05 or P <0.01). CONCLUSIONS YQWY can alleviate asthma-like manifestations in BA rats and improve their airway inflammation and remodeling; these effects may be related to the formula’s inhibition of the abnormal activation of the TLR4/MyD88/NF-κB signaling pathway.
6.Expert consensus on the application of artificial intelligence in lung cancer screening, diagnosis, and treatment (2026 edition)
Wenzhao ZHONG ; Haibo WANG ; Yi HU ; Hao ZHANG ; Jigang DAI ; Junqiang FAN ; Guibin QIAO ; Fan YANG ; Jian HU ; Fengwei TAN ; Xuening YANG ; Qiang PU ; Zihao CHEN ; Hongxia TIAN ; Lunxu LIU ; Hecheng LI ; Xiaolong YAN ; Zongyang YU ; Zhenbin QIU ; Yihua SUN ; Jing HU ; Yuhang SHI ; Zhifei GUO ; Peng ZHANG ; Kezhong CHEN ; Shugeng GAO ; Yilong WU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(06):848-856
With the continuous deepening of the concept of precision diagnosis and treatment for lung cancer, how to achieve higher efficiency and accuracy in the screening, diagnosis, and treatment pathways in clinical practice has become an important issue that urgently needs to be overcome. The current clinical difficulty lies in the fact that despite continuous advancements in imaging and molecular diagnostic technologies, there are still limitations in manual efficiency and subjective experience when it comes to massive data analysis and multi-scale feature extraction. Artificial intelligence (AI), especially algorithm systems based on deep learning, is an innovative technology capable of deeply empowering medical big data. This method utilizes algorithms such as convolutional neural networks, combined with radiomics, pathomics, and multi-modal data fusion analysis, demonstrating immense potential in early precise detection and benign-malignant differentiation of pulmonary nodules, digital pathological subtype recognition and non-invasive prediction of driver genes, precise 3D surgical planning and automatic delineation of radiotherapy target volumes, as well as dynamic risk warning during follow-up. This innovative technology provides a brand-new solution for realizing intelligent and individualized lung cancer diagnosis and treatment models. This consensus, based on the latest evidence from evidence-based medicine and combined with the development trends in the AI field and real-world clinical needs, was ultimately formed by gathering the consensus opinions of multidisciplinary experts in radiology, pathology, thoracic surgery, and other fields. The main content covers the application specifications of AI in the three core scenarios of lung cancer screening, diagnosis, and treatment, the technical standards for data collection and algorithm validation, as well as the ethical and regulatory challenges faced at the current stage. It aims to clarify the applicable boundaries of AI as a clinical auxiliary decision support tool, providing scientific guidance and standardized exploration directions for peers currently engaged in or planning to carry out AI-assisted clinical diagnosis, treatment, and translation of lung cancer.
7.Prevalence and risk factors of dry eye disease in male computer professionals under different meteorological and air quality conditions
Ke* HU ; Yu* GUI ; Huanhuan KONG ; Peng CHEN ; Lijuan SUN
International Eye Science 2026;26(9):1670-1674
AIM: To investigate the prevalence of dry eye symptoms among computer professionals in different climate zones and to identify the risk factors associated with dry eye disease.METHODS: A cross-sectional study was conducted by distributing questionnaires from December 2023 to January 2024 to computer professionals in six prefecture-level cities located in three distinct climate zones. Mixed-effects logistic regression analysis was employed to explore the relationship between environmental factors and the severity of dry eye disease. Environmental factors, including meteorological parameters and air pollutant concentrations, were obtained from the National Meteorological Information Center and the China Air Quality Online Monitoring and Analysis Platform, respectively. The annual mean values of environmental parameters served as independent variables, while the participants' Ocular Surface Disease Index(OSDI)scores were used as the dependent variable in the regression analysis.RESULTS:A total of 364 male participants aged 18-50 y were enrolled in this study. Among them, 80 participants presented with dry eye symptoms, corresponding to a detection rate of 22.0%.There was a significant difference in the detection rate of dry eye symptoms across different regions(P<0.05). Mixed-effects logistic regression analysis identified the following risk factors: daily eye use time(P<0.001, OR=1.669), relative humidity(P=0.047,OR=1.237), NO2 concentration(P=0.042, OR=1.283), PM2.5 concentration(P=0.006,OR=1.485), and CO concentration(P=0.018, OR=1.388). Temperature was found to be a protective factor(P=0.003, OR=0.701).CONCLUSION: Meteorological conditions and air quality significantly influence the occurrence of dry eye symptoms in male computer professionals. Prevention and treatment strategies for dry eye diseases should be tailored to the environmental characteristics of different regions to protect the ocular surface health of this occupational group.
8.Study of adsorption of coated aldehyde oxy-starch on the indexes of renal failure
Qian WU ; Cai-fen WANG ; Ning-ning PENG ; Qin NIE ; Tian-fu LI ; Jian-yu LIU ; Xiang-yi SONG ; Jian LIU ; Su-ping WU ; Ji-wen ZHANG ; Li-xin SUN
Acta Pharmaceutica Sinica 2025;60(2):498-505
The accumulation of uremic toxins such as urea nitrogen, blood creatinine, and uric acid of patients with renal failure
9.Discriminating Tumor Deposits From Metastatic Lymph Nodes in Rectal Cancer: A Pilot Study Utilizing Dynamic Contrast-Enhanced MRI
Xue-han WU ; Yu-tao QUE ; Xin-yue YANG ; Zi-qiang WEN ; Yu-ru MA ; Zhi-wen ZHANG ; Quan-meng LIU ; Wen-jie FAN ; Li DING ; Yue-jiao LANG ; Yun-zhu WU ; Jian-peng YUAN ; Shen-ping YU ; Yi-yan LIU ; Yan CHEN
Korean Journal of Radiology 2025;26(5):400-410
Objective:
To evaluate the feasibility of dynamic contrast-enhanced MRI (DCE-MRI) in differentiating tumor deposits (TDs) from metastatic lymph nodes (MLNs) in rectal cancer.
Materials and Methods:
A retrospective analysis was conducted on 70 patients with rectal cancer, including 168 lesions (70 TDs and 98 MLNs confirmed by histopathology), who underwent pretreatment MRI and subsequent surgery between March 2019 and December 2022. The morphological characteristics of TDs and MLNs, along with quantitative parameters derived from DCE-MRI (K trans , kep, and v e) and DWI (ADCmin, ADCmax, and ADCmean), were analyzed and compared between the two groups.Multivariable binary logistic regression and receiver operating characteristic (ROC) curve analyses were performed to assess the diagnostic performance of significant individual quantitative parameters and combined parameters in distinguishing TDs from MLNs.
Results:
All morphological features, including size, shape, border, and signal intensity, as well as all DCE-MRI parameters showed significant differences between TDs and MLNs (all P < 0.05). However, ADC values did not demonstrate significant differences (all P > 0.05). Among the single quantitative parameters, v e had the highest diagnostic accuracy, with an area under the ROC curve (AUC) of 0.772 for distinguishing TDs from MLNs. A multivariable logistic regression model incorporating short axis, border, v e, and ADC mean improved diagnostic performance, achieving an AUC of 0.833 (P = 0.027).
Conclusion
The combination of morphological features, DCE-MRI parameters, and ADC values can effectively aid in the preoperative differentiation of TDs from MLNs in rectal cancer.
10.Discussion on the medication law of TCM external therapy for the treatment of diabetes foot based on data mining
Wenhan LI ; Hao LI ; Quanxin LIU ; Juqin PENG ; Tianren YU ; Qiang JIAO ; Ping WANG ; Lin SUN ; Weiwei JIAO ; Jinbao WANG
International Journal of Traditional Chinese Medicine 2025;47(10):1448-1453
Objective:To explore the medication law of TCM external therapy for the treatment of diabetic foot using data mining methods.Methods:Literature on TCM external treatment for diabetic foot was retrieved from CNKI, Wanfang Data, and Chongqing VIP from the establishment of the databases to June 30, 2024. Excel 2019 software was used to conduct frequency statistics on drug frequency, properties, tastes and meridian tropism, drug efficacy, and commonly used drug pairs. Ancient and Modern Medical Cases Cloud Platform V3.5 was used for association rules, and SPSS Statistics 27.0 was used for complex network analyses.Results:A total of 425 articles were included, involving 328 prescriptions and 232 drugs. The drugs with higher frequency were Carthami Flos, Angelicae Sinensis Radix, Cinnamomi Ramulus, Olibanum, etc. The main tastes were pungent, bitter, and sweet; the main properties were cold and warm; the main meridians were heart, spleen, and liver meridians. The main efficacy was promoting blood circulation and removing blood stasis, clearing heat, and tonifying deficiency; association rule analysis obtained 20 commonly used drug pairs; clustering analysis resulted in four core drug combinations; complex network analysis led to one core prescription.Conclusions:TCM external therapy for diabetic foot follows the guiding principles of "promoting blood circulation and unblocking collaterals, tonifying deficiency and clearing heat" with coordinated regulation of the "heart-liver-spleen meridians". The core prescription and stage-specific formulation strategies reflect a trinity diagnostic and therapeutic approach of "disease differentiation-syndrome differentiation-stage differentiation", providing valuable reference and insights for clinical prescription practices.

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