1.Research status of quality assessment of hospice care for children with cancer abroad
Jing WU ; Xianhong ZHANG ; Lu WEI ; Xiaochuan ZHU
Chinese Medical Ethics 2025;38(3):275-280
The effectiveness and professionalism of hospice care services for children with cancer are of great significance for improving their quality of life and reducing the mental and economic burden on their families. Currently, a relatively complete quality evaluation system for hospice care for children with cancer has been established abroad, while research in this field in China is still in its infancy. By elaborating on the concept and connotation of quality assessment of hospice care for children with cancer in detail, systematically reviewing the research status of quality assessment of hospice care for children with cancer abroad, and addressing the problems and challenges faced by quality assessment of hospice care for children with cancer in China, corresponding inspirations and improvement strategies were proposed, aiming to provide a reference for improving the quality of hospice care for children with cancer in China.
2.Major changes and implementation considerations of the 2024 version of the Declaration of Helsinki
Chinese Medical Ethics 2025;38(4):403-411
The World Medical Association approved the latest revision of the Declaration of Helsinki on October 19, 2024, which was revised again after 11 years. As the international ethical principles for medical research involving research participants worldwide, this revision aims to respond to the dynamic and rapidly changing research environment and to ensure its relevance. The main contents of this revision include changing subjects to research participants as partners; adding other researchers as the implementing subjects and requiring individuals, teams, and organizations to comply; adding social value, always for the purpose of improving individual and public health; requiring free and full informed consent and maintaining the autonomy of research participants; advocating fair distribution and encouraging community participation; responsibly integrating vulnerable individuals, groups and communities; supporting the maintenance of independent review and authority, and clarifying the dual ethical review of international collaborative research; strengthening the supervision of biological samples and data to prevent risks; emphasizing that the welfare of research participants should be continuously maintained after the end of the clinical trials; adding environmental sustainability and expanding the scope of attention; requiring scientific integrity and maintaining the research environment; demonstrating the scientific validity of research plans and avoiding research waste; adding ethical principles should be observed during public health emergencies; using placebos cautiously and avoiding abuse; clarifying the conditions for the use of unproven interventions. To implement the revised contents of the Declaration of Helsinki, measures that could be taken include applying to all human-related research to protect research participants; centering on patients to ensure that research meets patients’ needs; implementing responsible inclusion through the collaboration of all parties; strictly supervising biological samples and data to protect privacy and maintain sustainable and healthy development; strengthening the supervision of the use of unproven interventions to safeguard the long-term interests of patients; continuously constructing ethics committees and embracing the support of artificial intelligence; standardizing effective informed consent and implementing the principles of freedom and adequacy. The Declaration of Helsinki, which aims to promote and ensure respect and protection of participants in a rapidly innovating medical research ecosystem, will continue to face revisions brought about by new challenges in the future.
3.Current situation, ethical challenges, and key points of ethical review for non-human primate experiments
Qin HE ; Youzhi DENG ; Jiyin ZHOU
Chinese Medical Ethics 2025;38(4):455-461
Non-human primates are the closest relatives of human beings and possess similar morphological, anatomical, physiological, and behavioral characteristics, making them indispensable in fields such as neuroscience, reproduction, infectious diseases, and drug research and development. Currently, the restrictions on using non-human primates in experiments are becoming increasingly stringent in Europe and the United States. These experiments have ethical particularities that are different from those involving ordinary animals, and they also pose ethical challenges such as lack of necessity assessment, no unified assessment standards, and ethical dumping hazards. Supervision and ethical review should be strengthened. The key points of their ethical review include the necessity of the experiments, the assessment of the harm-benefit ratio, and the implementation of the “3R” principles.
4.Advances in the application of physiologically-based pharmacokinetic model in EGFR-TKI precision therapy
Yingying YANG ; Jiaqi SHAO ; Qiulin XIANG ; Guoxing LI ; Xian YU
China Pharmacy 2025;36(8):1013-1018
Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) represent a class of small-molecule targeted therapeutics for oncology treatment, and serve as first-line therapy for advanced non-small cell lung cancer (NSCLC) with EGFR- sensitive mutations, with representative agents including gefitinib, dacomitinib, and osimertinib. In clinical practice, dose adjustment of EGFR-TKI may be required for cancer patients under special circumstances such as drug combinations or hepatic/ renal impairment. Physiologically-based pharmacokinetic (PBPK) model, capable of predicting pharmacokinetic (PK) processes in humans, has emerged as a vital tool for clinical dose optimization. This article sorts the modeling methodologies, workflows, and commonly used software tools for PBPK model, and summarizes the current applications of PBPK model in EGFR-TKI precision therapy as of June 30, 2024. Findings demonstrate that PBPK modeling methods commonly employ the “bottom-up” approach and the middle-out approach. The process typically involves four steps: parameter collection, compartment selection, model validation, and model application. Commonly used software for modeling includes Simcyp, GastroPlus, and open-source software such as PK- Sim. PBPK model can be utilized for predicting drug-drug interactions of EGFR-TKI co-administered with metabolic enzyme inducers or inhibitors, acid-suppressive drugs, or traditional Chinese and Western medicines. It can also adjust dosages in conjunction with genomics, predict PK processes in special populations (such as patients with liver or kidney dysfunction, pediatric patients), evaluate the efficacy and safety of drugs, and extrapolate PK predictions from animal models to humans.
5.Analyzing the occupational health literacy level and its influencing factors among six key occupational populations in the Jiulongpo District, Chongqing City
Yu LUO ; Shimin DENG ; Yuqin WEN
China Occupational Medicine 2025;52(1):66-70
Objective To evaluate the occupational health literacy (OHL) level and its influencing factors among individuals of six key industries from Jiulongpo District, Chongqing City. Methods A total of 2 022 frontline workers from six key industries in the Jiulongpo District of Chongqing City were selected as the research subjects using a cluster sampling method. The OHL level of the workers were assessed using the Occupational Health Literacy Questionnaire of National Key Populations. Results The overall OHL level among the 2 022 frontline workers was 51.43%. The OHL level in the four dimensions of basic knowledge of occupational health protection, healthy work practices and behaviors, legal knowledge of occupational health, and basic skills of occupational health protection were 81.45%, 56.08%, 43.42%, and 37.59%, respectively. The OHL levels of the six key industries from high to low were electrical machinery and equipment manufacturing, healthcare, education, express delivery/food delivery, transportation, and environmental hygiene, accounted for 91.43%, 61.98%, 52.64%, 40.58%, 36.70% and 31.15% (P<0.01). The results of logistic regression analysis showed that population of Han had higher OHL level than ethnic minorities (P<0.01), married individuals had lower OHL level than unmarried individuals (P<0.05), individuals with college education or above had higher OHL level than those with junior high school education or below (P<0.01), and higher personal monthly income was associated with higher OHL levels (all P<0.05). The OHL levels of workers of environmental hygiene, transportation, education, express delivery/food delivery, and healthcare were lower than those in electrical machinery and equipment manufacturing (all P<0.01). Conclusion The OHL level among occupational populations in the six key industries in Jiulongpo District, Chongqing City, needs to be further improved. And the OHL monitoring and intervention should be focused on the occupational population of express delivery/food delivery industry, transportation, environmental hygiene, and occupational population with low income, low educated, and ethnic minorities.
6.Association of health literacy with overweight and obesity among middle school students in Chongqing
WANG Hong, YANG Siwei, LUO Yu, CHEN Gen, WANG Zhouyan
Chinese Journal of School Health 2025;46(4):470-473
Objective:
To explore the association of health literacy with overweight and obesity among middle school students in Chongqing, so as to provide evidence for obesity prevention and control strategies.
Methods:
From November to December 2019, a stratified cluster sampling method was used to select 7 851 middle school students from 8 complete middle schools across 4 districts/counties in Chongqing. Participants completed the Adolescent Health Literacy Questionnaire and underwent nutritional status assessments. Chisquare tests and multivariate Logistic regression analyses were performed to evaluate associations.
Results:
The prevalence of overweight and obesity among adolescents was 12.95%. The overall health literacy rate and rates for functional, interactive, and critical health literacy dimensions were 62.01%, 66.02%, 50.07%, and 72.42%, respectively. Significant differences in overweight and obesity prevalence were observed across districts/counties, urban/rural areas, sex, school stages, and onlychild status (χ2=25.93, 3.86, 80.55, 8.80, 6.43, P<0.05). After adjusting for confounding factors, multivariate Logistic regression revealed that middle school students with overall health literacy (OR=0.86, 95%CI=0.75-0.99), interactive health literacy (OR=0.85, 95%CI=0.74-0.97), and critical health literacy (OR=0.84, 95%CI=0.73-0.98) had a lower risk of overweight and obesity (P<0.05).
Conclusions
Health literacy is inversely associated with overweight and obesity among middle school students. Strengthening health education and improving interactive and critical health literacy may create favorable conditions for adolescent overweight and obesity prevention and control.
7.Action Mechanism of Resolving Dampness and Phlegm of Pinelliae Rhizoma Praeparatum Based on Interconnection Between Lung and Large Intestine
Xingbao TAO ; Chentao ZHAO ; Xiaofu ZHU ; Hao WU ; Jun HE ; Weiguo CAO
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):122-131
ObjectiveTo investigate the effects of Pinelliae Rhizoma Praeparatum (PRP) on lung tissue, gut microbiota, and short-chain fatty acid (SCFA) metabolism in a model of mice with cold fluid retention in the lung and explore its mechanism of action in resolving dampness and phlegm based on the interconnection between the lung and large intestine. MethodsFifty female ICR mice were randomly divided into a normal group, model group, positive control group (Xiaoqinglong granules, 6.5 g·kg-1), and high-dose and low-dose PRP decoction groups (3.0, 1.5 g·kg-1), with 10 mice in each group. A model of mice with cold fluid retention in the lung was established using ovalbumin (OVA) sensitization combined with cold-water immersion. Drug interventions were conducted from day 18 to day 33 for 15 consecutive days. The airway resistance value of the mice was measured using a non-invasive pulmonary function analyzer. Phlegm-resolving effects were evaluated via a microplate reader. Eosinophil and neutrophil counts in bronchoalveolar lavage fluid (BALF) were analyzed using an automated hematology analyzer. Serum levels of total immunoglobulin E (IgE), interferon-γ (IFN-γ), interleukin-4 (IL-4), and BALF levels of interleukin-6 (IL-6) and interleukin-8 (IL-8) were quantified by enzyme-linked immunosorbent assay (ELISA). Lung histopathology was assessed using hematoxylin-eosin (HE) staining. Immunohistochemistry (IHC) was employed to detect mucin 5AC (MUC5AC) and aquaporin 5 (AQP5) protein expression in lung tissue. Gut microbiota composition was analyzed via agarose gel electrophoresis, and fecal SCFA levels were measured by gas chromatography-mass spectrometry (GC-MS). ResultsCompared with the normal group, the model group exhibited significantly increased airway resistance value (RI) (P<0.05), elevated eosinophil and neutrophil counts and IL-6 and IL-8 levels in BALF (P<0.05), increased serum IgE and IL-4 levels (P<0.05), with reduced IFN-γ levels (P<0.05). It also showed thickened bronchial walls, widened alveolar septa, narrowed lumens, and mucus plugs in lung tissue, upregulated MUC5AC protein expression and downregulated AQP5 protein expression (P<0.05), decreased relative abundance of beneficial gut microbiota (Firmicutes, Clostridia, Clostridiales, Lactobacillaceae, and Lactobacillus), and increased abundance of harmful microbiota (Bacteroidetes, Bacteroidia, Bacteroidales, Muribaculaceae, and Muribaculum). In addition, the model group presented reduced fecal SCFA levels (acetate, propionate, and butyrate) (P<0.05). After the intervention of PRP decoction, compared to the model group, all drug administration groups showed decreased RI (P<0.05), increased phenol red excretion, declined eosinophil and neutrophil counts and IL-6, IL-8, IgE, and IL-4 levels (P<0.05), and improved IFN-γ levels (P<0.05) and lung pathology improved. The MUC5AC protein expression decreased (P<0.05), and the AQP5 protein expression increased (P<0.05). The disorder of gut microbiota was improved, and the diversity of gut microbiota was restored, with a significantly increased relative abundance ratio of beneficial microbiota (P<0.05) and a significantly reduced relative abundance ratio of harmful microbiota (P<0.05). The SCFA levels (acetate, propionate, and butyrate) increased (P<0.05). The efficacy indicators of serum inflammatory factors (IgE, IL-4, and IFN-γ), phlegm-resolving effect, airway resistance, total pathological score, and the protein expression of MUC5AC and AQP5 were correlated with gut microbiota and SCFAs. ConclusionPRP decoction alleviates cold-phlegm syndrome by modulating the gut-lung axis, promoting beneficial gut microbiota, enhancing SCFA production, restoring the balance of gut microbiota, and suppressing respiratory inflammation. This study provides novel insights into the TCM theory of interconnection between the lung and large intestine.
8.Action Mechanism of Resolving Dampness and Phlegm of Pinelliae Rhizoma Praeparatum Based on Interconnection Between Lung and Large Intestine
Xingbao TAO ; Chentao ZHAO ; Xiaofu ZHU ; Hao WU ; Jun HE ; Weiguo CAO
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):122-131
ObjectiveTo investigate the effects of Pinelliae Rhizoma Praeparatum (PRP) on lung tissue, gut microbiota, and short-chain fatty acid (SCFA) metabolism in a model of mice with cold fluid retention in the lung and explore its mechanism of action in resolving dampness and phlegm based on the interconnection between the lung and large intestine. MethodsFifty female ICR mice were randomly divided into a normal group, model group, positive control group (Xiaoqinglong granules, 6.5 g·kg-1), and high-dose and low-dose PRP decoction groups (3.0, 1.5 g·kg-1), with 10 mice in each group. A model of mice with cold fluid retention in the lung was established using ovalbumin (OVA) sensitization combined with cold-water immersion. Drug interventions were conducted from day 18 to day 33 for 15 consecutive days. The airway resistance value of the mice was measured using a non-invasive pulmonary function analyzer. Phlegm-resolving effects were evaluated via a microplate reader. Eosinophil and neutrophil counts in bronchoalveolar lavage fluid (BALF) were analyzed using an automated hematology analyzer. Serum levels of total immunoglobulin E (IgE), interferon-γ (IFN-γ), interleukin-4 (IL-4), and BALF levels of interleukin-6 (IL-6) and interleukin-8 (IL-8) were quantified by enzyme-linked immunosorbent assay (ELISA). Lung histopathology was assessed using hematoxylin-eosin (HE) staining. Immunohistochemistry (IHC) was employed to detect mucin 5AC (MUC5AC) and aquaporin 5 (AQP5) protein expression in lung tissue. Gut microbiota composition was analyzed via agarose gel electrophoresis, and fecal SCFA levels were measured by gas chromatography-mass spectrometry (GC-MS). ResultsCompared with the normal group, the model group exhibited significantly increased airway resistance value (RI) (P<0.05), elevated eosinophil and neutrophil counts and IL-6 and IL-8 levels in BALF (P<0.05), increased serum IgE and IL-4 levels (P<0.05), with reduced IFN-γ levels (P<0.05). It also showed thickened bronchial walls, widened alveolar septa, narrowed lumens, and mucus plugs in lung tissue, upregulated MUC5AC protein expression and downregulated AQP5 protein expression (P<0.05), decreased relative abundance of beneficial gut microbiota (Firmicutes, Clostridia, Clostridiales, Lactobacillaceae, and Lactobacillus), and increased abundance of harmful microbiota (Bacteroidetes, Bacteroidia, Bacteroidales, Muribaculaceae, and Muribaculum). In addition, the model group presented reduced fecal SCFA levels (acetate, propionate, and butyrate) (P<0.05). After the intervention of PRP decoction, compared to the model group, all drug administration groups showed decreased RI (P<0.05), increased phenol red excretion, declined eosinophil and neutrophil counts and IL-6, IL-8, IgE, and IL-4 levels (P<0.05), and improved IFN-γ levels (P<0.05) and lung pathology improved. The MUC5AC protein expression decreased (P<0.05), and the AQP5 protein expression increased (P<0.05). The disorder of gut microbiota was improved, and the diversity of gut microbiota was restored, with a significantly increased relative abundance ratio of beneficial microbiota (P<0.05) and a significantly reduced relative abundance ratio of harmful microbiota (P<0.05). The SCFA levels (acetate, propionate, and butyrate) increased (P<0.05). The efficacy indicators of serum inflammatory factors (IgE, IL-4, and IFN-γ), phlegm-resolving effect, airway resistance, total pathological score, and the protein expression of MUC5AC and AQP5 were correlated with gut microbiota and SCFAs. ConclusionPRP decoction alleviates cold-phlegm syndrome by modulating the gut-lung axis, promoting beneficial gut microbiota, enhancing SCFA production, restoring the balance of gut microbiota, and suppressing respiratory inflammation. This study provides novel insights into the TCM theory of interconnection between the lung and large intestine.
9.Systematic review on medication risk prediction models for hospitalized adult patients
Yang YANG ; Xuefeng SHAN ; Haidong LI ; Yaozheng LI ; Qiwen ZHOU ; Hongmei WANG
China Pharmacy 2025;36(10):1254-1259
OBJECTIVE To systematically evaluate medication risk prediction models for hospitalized adult patients and provide references for their development and clinical application. METHODS Databases including PubMed, Embase, Web of Science, CNKI, Wanfang data, VIP and CBM were searched for studies on medication risk prediction models from their inception to May 2024. After screening the literature, extracting data, and evaluating the quality of the literature, descriptive analysis was performed on the results of the included studies. RESULTS A total of 13 studies were included, involving 12 models. Nine studies used Logistic regression algorithm for modeling, and the number of included predictive factors ranged from 3 to 11; the area under the receiver operating characteristic curve ranged from 0.65 to 0.865. The literature quality evaluation results showed that 10 studies had high risk of bias; 10 studies had high applicability risk. A total of 31 predictive factors were extracted, including 15 items of basic patient information, 3 test indicators, and 5 items of medication information, and 8 others. CONCLUSIONS The existing medication risk prediction models for hospitalized adult inpatients are mainly Logistic regression algorithm, with predictive factors mainly focusing on basic indicators such as demographics. The overall prediction performance of the models needs to be improved, and the overall risk of bias is relatively high.
10.A Single-Arm Phase II Clinical Trial of Fulvestrant Combined with Neoadjuvant Chemotherapy of ER+/HER2– Locally Advanced Breast Cancer: Integrated Analysis of 18F-FES PET-CT and Metabolites with Treatment Response
Qing SHAO ; Ningning ZHANG ; Xianjun PAN ; Wenqi ZHOU ; Yali WANG ; Xiaoliang CHEN ; Jing WU ; Xiaohua ZENG
Cancer Research and Treatment 2025;57(1):126-139
Purpose:
This Phase II trial was objected to evaluate the efficacy and safety of adding fulvestrant to neoadjuvant chemotherapy in patients with estrogen receptor (ER)+/human epidermal growth factor receptor 2 (HER2)– locally advanced breast cancer (LABC). Additionally, the study aimed to investigate the association of 16α-18F-fluoro-17β-fluoroestradiol (18F-FES) positron emission tomography (PET)–computed tomography (CT) and metabolites with efficacy.
Materials and Methods:
Fulvestrant and EC-T regimen were given to ER+/HER2– LABC patients before surgery. At baseline, patients received 18F-FES PET-CT scan, and plasma samples were taken for liquid chromatography–mass spectrometry analysis. The primary endpoint was objective response rate (ORR). Secondary endpoints included total pathologic complete response (tpCR) and safety.
Results:
Among the 36 patients enrolled, the ORR was 86.1%, the tpCR rate was 8.3%. The incidence of grade ≥ 3 treatment-emergent adverse events was 22%. The decrease in ER value in sensitive patients was larger than that in non-sensitive patients, as was Ki-67 (p < 0.05). The maximum standardized uptake value, mean standardized uptake values, total lesion ER expression of 18F-FES PET-CT in sensitive patients were significantly higher than those in non-sensitive patients (p < 0.05). Moreover, these parameters were significantly correlated with Miller and Payne grade and the change in ER expression before and after treatment (p < 0.05). Thirteen differential expressed metabolites were identified, which were markedly enriched in 19 metabolic pathways.
Conclusion
This regimen demonstrated acceptable toxicity and encouraging antitumor efficacy. 18F-FES PET-CT might serve as a tool to predict the effectiveness of this therapy. Altered metabolites or metabolic pathways might be associated with treatment response.


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