1.Overview of the amendments and revisions to the General Technical Requirements adopted by the Volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition
ZHANG Jun ; NING Baoming ; WEI Shifeng ; SHEN Haoyu ; SHANG Yue ; ZHU Ran ; XU Xinyi ; CHEN Lei ; LIU Tingting ; MA Shuangcheng
Drug Standards of China 2025;26(1):034-044
To introduce the general thinking, guidelines, work objectives and elaboration process of the general technical requirements adopted by volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition, and to summarize and figure out the main characteristics on dosage forms, physico-chemical testing, microbial and biological testing, reference standards and guidelines The newly revised general chapters of pharmacopoeia give full play to the normative and guiding role of the Chinese Pharmacopoeia standard, track the frontier dynamics of international drug regulatory science and the elaboration of monographs, expand the application of state-of-the-art technologies, and steadily promote the harmonization and unification with the ICH guidelines; further enhance the overall capacity of TCM quality control, actively implement the 3 R principles on animal experiments, and practice the concept of environmental-friendly; replace and/or reduce the use of toxic and hazardous reagents, strengthen the requirements of drug safety control This paper aims to provide a full-view perspective for the comprehensive, correct understanding and accurate implementation of general technical requirements included in the Chinese Pharmacopoeia 2025 Edition.
2.Neutrophil activation is correlated with acute kidney injury after cardiac surgery under cardiopulmonary bypass
Tingting WANG ; Yuanyuan YAO ; Jiayi SUN ; Juan WU ; Xinyi LIAO ; Wentong MENG ; Min YAN ; Lei DU ; Jiyue XIONG
Chinese Journal of Blood Transfusion 2025;38(3):358-367
[Objective] To explore the relationship between neutrophil activation under cardiopulmonary bypass (CPB) and the incidence of cardiac surgery-associated acute kidney injury (CS-AKI). [Methods] This prospective cohort study enrolled adult patients who scheduled for cardiac surgery under CPB at West China Hospital between May 1, 2022 and March 31, 2023. The primary outcome was acute kidney injury (AKI). Blood samples (5 mL) were obtained from the central vein before surgery, at rewarming, at the end of CPB, and 24 hours after surgery. Neutrophils were labeled with CD11b, CD54 and other markers. To assess the effect of neutrophils activation on AKI, propensity score matching (PSM) was employed to equilibrate covariates between the groups. [Results] A total of 120 patients included into the study, and 17 (14.2%) developed AKI. Both CD11b+ and CD54+ neutrophils significantly increased during the rewarming phase and the increases were kept until 24 hours after surgery. During rewarming, the numbers of CD11b+ neutrophils were significantly higher in AKI compared to non-AKI (4.71×109/L vs 3.31×109/L, Z=-2.14, P<0.05). Similarly, the CD54+ neutrophils counts were also significantly higher in AKI than in non-AKI before surgery (2.75×109/L vs 1.79×109/L, Z=-2.99, P<0.05), during rewarming (3.12×109/L vs 1.62×109/L, Z=-4.34, P<0.05), and at the end of CPB (4.28×109/L vs 2.14×109/L, Z=-3.91, P<0.05). An analysis of 32 matched patients (16 in each group) revealed that CD11b+ and CD54+ neutrophil levels of AKI were 1.74 folds (4.83×109/L vs 2.77×109/L, Z=-2.72, P<0.05) and 2.34 folds (3.32×109/L vs 1.42×109/L, Z=-4.12, P<0.05), respectively, of non-AKI at rewarming phase. [Conclusion] Neutrophils are activated during CPB, and they can be identified by CD11b/CD54 markers. The activated neutrophils of AKI patients are approximately 2 folds of non-AKI during the rewarming phase, with disparity reached peak between groups during rewarming. These findings suggest the removal of 50% of activated neutrophils during the rewarming phase may be effective to reduce the risk of AKI.
3.Phenomics of traditional Chinese medicine 2.0: the integration with digital medicine
Min Xu ; Xinyi Shao ; Donggeng Guo ; Xiaojing Yan ; Lei Wang ; Tao Yang ; Hao LIANG ; Qinghua PENG ; Lingyu Linda Ye ; Haibo Cheng ; Dayue Darrel Duan
Digital Chinese Medicine 2025;8(3):282-299
Abstract
Modern western medicine typically focuses on treating specific symptoms or diseases, and traditional Chinese medicine (TCM) emphasizes the interconnections of the body’s various systems under external environment and takes a holistic approach to preventing and treating diseases. Phenomics was initially introduced to the field of TCM in 2008 as a new discipline that studies the laws of integrated and dynamic changes of human clinical phenomes under the scope of the theories and practices of TCM based on phenomics. While TCM Phenomics 1.0 has initially established a clinical phenomic system centered on Zhenghou (a TCM definition of clinical phenome), bottlenecks remain in data standardization, mechanistic interpretation, and precision intervention. Here, we systematically elaborates on the theoretical foundations, technical pathways, and future challenges of integrating digital medicine with TCM phenomics under the framework of “TCM phenomics 2.0”, which is supported by digital medicine technologies such as artificial intelligence, wearable devices, medical digital twins, and multi-omics integration. This framework aims to construct a closed-loop system of “Zhenghou–Phenome–Mechanism–Intervention” and to enable the digitization, standardization, and precision of disease diagnosis and treatment. The integration of digital medicine and TCM phenomics not only promotes the modernization and scientific transformation of TCM theory and practice but also offers new paradigms for precision medicine. In practice, digital tools facilitate multi-source clinical data acquisition and standardization, while AI and big data algorithms help reveal the correlations between clinical Zhenghou phenomes and molecular mechanisms, thereby improving scientific rigor in diagnosis, efficacy evaluation, and personalized intervention. Nevertheless, challenges persist, including data quality and standardization issues, shortage of interdisciplinary talents, and insufficiency of ethical and legal regulations. Future development requires establishing national data-sharing platforms, strengthening international collaboration, fostering interdisciplinary professionals, and improving ethical and legal frameworks. Ultimately, this approach seeks to build a new disease identification and classification system centered on phenomes and to achieve the inheritance, innovation, and modernization of TCM diagnostic and therapeutic patterns.
4.Development and validation of a prediction model for severe community-acquired pneumonia in adults based on peripheral blood inflammatory indicators
Shuang CHEN ; Haike LEI ; Xinyi TANG ; Jiao WANG ; Ling LIU ; Weibo HU ; Yulin HUANG ; Jian'e HU ; Xiangju XING ; Zailin YANG
International Journal of Laboratory Medicine 2024;45(3):282-288
Objective To explore the development and validation of a prediction model for severe communi-ty-acquired pneumonia in adults based on peripheral blood inflammatory indicators.Methods Venous blood samples of 204 community-acquired pneumonia in adults patients admitted to 7 hospitals in Chongqing area from April 2021 to August 2022 were collected to detect C-reactive protein(CRP),peripheral white blood cell count(WBC),neutrophil to lymphocyte ratio(NLR),cytokines,lymphocyte subgroups and neutrophil CD64 index.All of patients were divided into a training group and a validation group according to the time of admis-sion.Univariate and multivariate Logistic regression were used to analyze the data of the training group,the characteristic factors of severe progression for pneumonia were selected to construct the nomogram model,and the data of the validation group was used to verify the model.The receiver operating characteristic(ROC)curve,calibration curve and decision curve analysis(DCA)were used to evaluate the prediction ability of the model for severe community-acquired pneumonia in adults.Results Logistic regression analysis showed that age,CRP,WBC,interleukin(IL)-4/interferon gamma ratio and IL-6/IL-10 ratio were independent risk factors for severe community-acquired pneumonia in adults.The area under the ROC curve of the nomogram model in the training group and the validation group was 0.893 and 0.880,respectively.The calibration curve and DCA results shown that the model had a good prediction effect for severe community-acquired pneumonia in adults.Conclusion The inflammatory indicators included in this model are simple and easy to obtain clinically.This model with good differentiation and accuracy,it can be used as a practical tool to predict severe community-ac-quired pneumonia in adults,and has certain clinical application value.
5.The Association Between Causality Orientation and Internet Gaming Disorder, and the Role of Sensation Seeking, Anxiety, and Depression
Yanjie PENG ; Yuxiang WANG ; Zhenle PENG ; Xiaoyuan LIAO ; Ke GONG ; Cheng QIN ; Mingyuan TIAN ; Xiaotong CHENG ; Xinyi ZHOU ; Juan DENG ; Yuwen CHEN ; Shuang FENG ; Maomao ZHANG ; Kezhi LIU ; Bo XIANG ; Wei LEI ; Jing CHEN
Psychiatry Investigation 2024;21(11):1268-1278
Objective:
Self-determination theory (SDT) deems that people have three causality orientations: autonomy orientation, control orientation, and impersonal orientation. Previous studies suggested that lower autonomy orientation or higher control and impersonal orientations may be associated with more addictive behaviors. Our study aimed to investigate if these associations exist in Internet gaming disorder (IGD), and if sensation seeking, anxiety, and depression could influence the associations between causality orientations and IGD symptoms.
Methods:
A total of 1,400 college students completed the Internet Gaming Disorder Scale, General Causality Orientation Scale, Brief Sensation Seeking Scale, Generalized Anxiety Disorder Scale, and Patient Health Questionnaire. Correlation, multiple linear regressions, structural equation model (SEM) analyses, and moderation analyses were conducted to explore the associations.
Results:
The control and impersonal orientations were positively associated with IGD symptoms, while the autonomy orientation was negatively associated with them. Moreover, SEM analyses showed that the autonomy-IGD relationship was totally mediated by anxiety and depression, the impersonal-IGD relationship was partially mediated by anxiety, and the control-IGD relationship was partially mediated by depression. Finally, the effects of causality orientations on IGD were moderated by sensation seeking.
Conclusion
Overall, autonomy orientation is linked to fewer gaming problems, whereas control and impersonal orientations are associated with more gaming problems. Moreover, the relationships between causality orientations and IGD symptoms are mediated by anxiety and depression and moderated by sensation seeking. Our findings inform theory on the motivations of gaming behaviors and may shed light on the prevention and intervention of IGD from the perspective of SDT.
6.Cognition and participation intention of patient-reported outcomes in patients with lower limb deep vein thrombosis: a qualitative study
Ranxun AN ; Yuan XU ; Lei WANG ; Yu WANG ; Haibo DENG ; Jianhua SUN ; Xiaojie WANG ; Liyun ZHU ; Qiaodan LU ; Xinyi ZHOU ; Yufen MA
Chinese Journal of Modern Nursing 2024;30(1):95-100
Objective:To explore the cognition and intention of patients with lower limb deep vein thrombosis (DVT) to participate in patient-reported outcomes (PROs), so as to provide references for the promotion, application, and practice of PROs in lower limb DVT patients in China.Methods:This study adopted the phenomenological qualitative research method. From February to June 2023, 13 lower limb DVT patients admitted to Peking Union Medical College Hospital were selected for semi-structured in-depth interviews. Colaizzi 7-step analysis method was used for analyzing and summarizing data.Results:Thirteen patients with lower limb DVT highly recognized their own value in participating in PROs, namely health benefits, prevention of DVT complications, and reduction of disease uncertainty. Lower limb DVT patients expected to receive support from healthcare professionals, families, and portable and simplified reporting formats to promote their participation in PROs. From the patient 's own perspective, they perceived that insufficient attention to DVT caused by lack of awareness of the hazards of DVT and limited understanding of PROs made it difficult for them to participate in PROs. Conclusions:Lower limb DVT patients have a high intention to participate in PROs. The application and promotion of PROs in lower limb DVT patients in China require joint support from various sectors of society, among which strengthening effective health education for patients and their families and providing multi-channel reporting forms are the key to promoting of PROs.
7.Development of the PICC-related Thrombosis Prevention Knowledge, Attitude, and Practice Questionnaire for Nurses and its reliability and validity
Ning ZHANG ; Yuan XU ; Haibo DENG ; Lei WANG ; Liyun ZHU ; Qiaodan LU ; Ranxun AN ; Xinyi ZHOU ; Yu WANG ; Jianhua SUN ; Yufen MA ; Xiaojie WANG
Chinese Journal of Modern Nursing 2024;30(4):453-460
Objective:To construct a tool to evaluate the knowledge, attitude, and practice of nurses in the prevention of thrombosis related to peripherally inserted central catheter (PICC) .Methods:From December 2022 to April 2023, based on the theory of knowledge, attitude, and practice, a preliminary draft of the PICC-related Thrombosis Prevention Knowledge, Attitude, and Practice Questionnaire for Nurses was formed through systematic literature review, two rounds of Delphi expert consultations, and pre-survey. In May 2023, convenience sampling was used to select 573 nurses from Chinese Academy of Medical Sciences & Peking Union Medical College Hospital as the research subject for a survey to conduct item analysis, validity testing, and reliability testing on the questionnaire.Results:The final version of the PICC-related Thrombosis Prevention Knowledge, Attitude, and Practice Questionnaire for Nurses included 20 knowledge items, 10 attitude items, and 10 practice items. In the content validity of the questionnaire, the average content validity index was 0.984, the overall consensus content validity index was 0.850, and the item level content validity index was 0.857 to 1.000. Exploratory factor analysis extracted three common factors with eigenvalues>1.000, with a cumulative variance contribution rate of 64.540% and factor loadings of 0.450 to 0.908 for each item. The total Cronbach's α coefficient of the questionnaire was 0.895, the half reliability coefficient was 0.947, and the retest reliability coefficient was 0.966.Conclusions:The PICC-related Thrombosis Prevention Knowledge, Attitude, and Practice Questionnaire for Nurses has good reliability and validity, and can be used to evaluate PICC-related thrombosis prevention knowledge, attitude, and practice among nurses.
8.Progress in research on quality-sensitive indicators for prevention nursing care of venous thromboembolism
Ning ZHANG ; Yuan XU ; Liyun ZHU ; Xinyi ZHOU ; Ranxun AN ; Qiaodan LU ; Yu WANG ; Haibo DENG ; Lei WANG ; Jianhua SUN ; Yufen MA ; Xiaojie WANG
Chinese Journal of Modern Nursing 2024;30(8):1004-1009
Quality-sensitive indicators in nursing, as standards for evaluating nursing quality management, can quantitatively determine nursing outcomes. This article provides a comprehensive review of the framework and content of quality-sensitive indicators for venous thromboembolism (VTE) prevention nursing care. The indicators are discussed from three dimensions: structure, process, and outcome. The aim is to provide a reference for the future development of unified and standardized quality-sensitive indicators for VTE prevention nursing care, in order to guide clinical nurses in standardized preventive practices.
9.Progress in research on risk assessment models for cancer-associated thrombosis
Haoran SHI ; Qiaodan LU ; Yuan XU ; Xiaojie WANG ; Haibo DENG ; Lei WANG ; Jianhua SUN ; Yu WANG ; Liyun ZHU ; Ranxun AN ; Xinyi ZHOU ; Yufen MA
Chinese Journal of Modern Nursing 2024;30(8):1010-1017
Cancer-associated thrombosis (CAT) is a common complication and cause of death in cancer patients. Accurately and efficiently identifying high-risk groups for CAT using risk assessment models and implementing targeted early prevention is key. Although numerous CAT risk assessment models currently exist, their predictive capabilities vary across different populations. This article provides a comprehensive review of CAT risk assessment models and their application status, aiming to offer a reference for clinical nursing staff to understand and choose appropriate risk assessment tools.
10.Development of the Cancer-associated Thrombosis Prevention Knowledge, Attitude and Practice Questionnaire for Nurses and its reliability and validity tests
Haoran SHI ; Yuan XU ; Xiaojie WANG ; Haibo DENG ; Lei WANG ; Jianhua SUN ; Yu WANG ; Liyun ZHU ; Qiaodan LU ; Ranxun AN ; Xinyi ZHOU ; Yufen MA
Chinese Journal of Modern Nursing 2024;30(16):2124-2130
Objective:To develop the Cancer-associated Thrombosis (CAT) Prevention Knowledge, Attitude and Practice Questionnaire for Nurses, and conduct reliability and validity tests.Methods:This study was a questionnaire development study. Guided by the theory of knowledge, attitude, and practice, an initial CAT Prevention Knowledge, Attitude, and Practice Questionnaire for Nurses was formed through literature review, group discussion, two rounds of expert consultation, and pre-survey. From April to May 2023, convenience sampling was used to select 700 in-service nurses from Chinese Academy of Medical Sciences & Peking Union Medical College as the research subject, and the reliability and validity of the questionnaire were tested.Results:A total of 700 questionnaires were distributed, and 593 valid questionnaires were collected, with a valid response rate of 84.71% (593/700). The final version of the CAT Prevention Knowledge, Attitude, and Practice Questionnaire for Nurses included three dimensions of knowledge, attitude, and practice, with a total of 39 items. The scale-level content validity index ( S- CVI) was 1.000, with an average S- CVI of 0.971 and an item-level CVI (I- CVI) of 0.860 to 1.000. Exploratory factor analysis extracted a total of seven common factors, with a cumulative variance contribution rate of 77.376%. The total Cronbach's α coefficient of the questionnaire was 0.937, and the Cronbach's α coefficients for each dimension were 0.923, 0.987, and 0.979. The half reliability coefficient was 0.984. After two weeks, the reliability coefficients for each dimension of retesting were 0.959, 1.000, and 0.994. Conclusions:The CAT Prevention Knowledge, Attitude, and Practice Questionnaire for Nurses developed in this study has good reliability and validity, and can be used as an evaluation tool for the cognition of clinical nurses in CAT prevention.

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