1.Study on population pharmacokinetics of levetiracetam in post-stroke epilepsy patients
Chenxi LIU ; Yin WU ; Caiyun JIA ; Sai CUI ; Huizhen WU ; Suxing WANG
China Pharmacy 2025;36(5):594-599
OBJECTIVE To establish population pharmacokinetic model of levetiracetam (Lev) for Chinese patients with post- stroke epilepsy (PSE), and provide reference for formulating individualized dosing regimens for Lev therapy in this specific population. METHODS Blood concentration data and clinical diagnosis and treatment information of PSE patients meeting the inclusion criteria were retrospectively collected and divided into model group and validation group at an 8∶2 ratio using a random number method. Based on the model group data, a population pharmacokinetic model was developed using nonlinear mixed-effects modeling. Internal evaluation was performed through goodness-of-fit tests and bootstrap analysis, while external validation was conducted using the validation group data. RESULTS A total of 75 blood concentration measurements from 70 PSE patients were collected, with 60 measurements from 55 patients used for model development and 15 measurements from 15 patients reserved for external validation. The final model estimated a population typical value of clearance at 2.98 L/h. Estimated glomerular filtration rate, daily dose, and homocysteine level significantly influenced clearance of Lev (P<0.01). The model demonstrated satisfactory predictive performance, as evidenced by goodness-of-fit tests, bootstrap analysis, and external validation results. CONCLUSIONS Daily dose, estimated glomerular filtration rate, and homocysteine level are identified as significant covariates influencing Lev clearance in Chinese PSE patients. When making clinical decisions, comprehensive consideration should be given to the patient’s treatment response, physiological and pathological conditions, and the occurrence of adverse reactions, etc. The dosage of Lev should be adjusted based on the results of population pharmacokinetic model.
2.Challenges and future directions of medicine with artificial intelligence
Xiaoqin ZHOU ; Huizhen LIU ; Ting WANG ; Xueting LIU ; Fang LIU ; Deying KANG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(02):244-251
This comprehensive review systematically explores the multifaceted applications, inherent challenges, and promising future directions of artificial intelligence (AI) within the medical domain. It meticulously examines AI's specific contributions to basic medical research, disease prevention, intelligent diagnosis, treatment, rehabilitation, nursing, and health management. Furthermore, the review delves into AI's innovative practices and pivotal roles in clinical trials, hospital administration, medical education, as well as the realms of medical ethics and policy formulation. Notably, the review identifies several key challenges confronting AI in healthcare, encompassing issues such as inadequate algorithm transparency, data privacy concerns, absent regulatory standards, and incomplete risk assessment frameworks. Looking ahead, the future trajectory of AI in healthcare encompasses enhancing algorithm interpretability, propelling generative AI applications, establishing robust data-sharing mechanisms, refining regulatory policies and standards, nurturing interdisciplinary talent, fostering collaboration among industry, academia, and medical institutions, and advancing inclusive, personalized precision medicine. Emphasizing the synergy between AI and emerging technologies like 5G, big data, and cloud computing, this review anticipates a new era of intelligent collaboration and inclusive sharing in healthcare. Through a multidimensional analysis, it presents a holistic overview of AI's medical applications and development prospects, catering to researchers, practitioners, and policymakers in the healthcare sector. Ultimately, this review aims to catalyze the deep integration and innovative deployment of AI technology in healthcare, thereby driving the sustainable advancement of smart healthcare.
3.Interpretation of the TRIPOD-LLM reporting guideline for studies using large language models
Xiaoqin ZHOU ; Huizhen LIU ; Ting WANG ; Xuemei LIU ; Deying KANG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(07):940-946
As the volume of medical research using large language models (LLM) surges, the need for standardized and transparent reporting standards becomes increasingly critical. In January 2025, Nature Medicine published statement titled by TRIPOD-LLM reporting guideline for studies using large language models. This represents the first comprehensive reporting framework specifically tailored for studies that develop prediction models based on LLM. It comprises a checklist with 19 main items (encompassing 50 sub-items), a flowchart, and an abstract checklist (containing 12 items). This article provides an interpretation of TRIPOD-LLM’s development methods, primary content, scope, and the specific details of its items. The goal is to help researchers, clinicians, editors, and healthcare decision-makers to deeply understand and correctly apply TRIPOD-LLM, thereby improving the quality and transparency of LLM medical research reporting and promoting the standardized and ethical integration of LLM into healthcare.
4.Methodology for the Development of Clinical Practice Guideline for Chinese Patent Medicine(Part 1): Development Status and Characteristics
Ning LIANG ; Lijiao YAN ; Yujing ZHANG ; Fuqiang ZHANG ; Ziteng HU ; Yaxin CHEN ; Huizhen LI ; Haili ZHANG ; Zhao CHEN ; Yin JIANG ; Bin LIU ; Nannan SHI ; Yanping WANG
Journal of Traditional Chinese Medicine 2024;65(1):44-49
The irrational use of Chinese patent medicines (CPM) is becoming more and more prominent, which makes the demand for clinical practice guidelines of CPM gradually increase. In order to make domestic scholars understand the latest developments and existing problems of the CPM guidelines, and promote its development, this paper introduced the concept of CPM guidelines, summarized the characteristics of the two development modes, namely “taking CPM as the key” and “taking disease/syndrome as the key”, and analyzed the current methodological status of developing and reporting CPM guidelines. Based on the existed problems, three suggestions have been put forward to optimize the quality of CPM guidelines, which were clarifying the target users and scope of CPM guidelines, establishing an open and transparent mechanism of the personnel involvement and process steps, and formulating implementable and operable recommendations for the use of CPM.
5.Clinical research progress in the treatment of transthyretin amyloid with tafamidis
Panpan JIN ; Yang LIU ; Bo QIU ; Huizhen WU
China Pharmacy 2024;35(17):2171-2175
Tafamidis is a selective stabilizer for transthyretin (TTR), used for the treatment of transthyretin amyloidosis with cardiomyopathy (ATTR-CM) and transthyretin amyloidosis with polyneuropathy (ATTR-PN). This article provides a review of the basic information and clinical studies on the efficacy and safety of tafamidis. It is found that tafamidis slows down or prevents the progression of TTR amyloidosis by inhibiting the dissociation of TTR tetramers. Multiple clinical studies have shown that tafamidis has good efficacy and safety, significantly reducing all-cause mortality and cardiovascular-related hospitalization rates in patients with amyloidosis, and delaying disease progression. Although tafamidis treatment may have certain limitations, it is still a key drug for the treatment of TTR amyloidosis, and the first drug approved for the treatment of ATTR-CM.
6.Methodological Consideration on Combination Model of TCM Clinical Practice Guidelines and Real-world Study
Guozhen ZHAO ; Huizhen LI ; Ning LIANG ; Haili ZHANG ; Bin LIU ; Qianzi CHE ; Feng ZHOU ; He LI ; Xiaowen CHEN ; Long YE ; Jiahao LIN ; Xingyu ZONG ; Dingyi WANG ; Nannan SHI ; Yanping WANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(22):87-93
The clinical practice guidelines of traditional Chinese medicine (TCM) have problems such as limited clinical application and unclear implementation effects, which may be related to the lack of clinical practice evidence. To provide reliable and precise evidence for clinical practice, this article proposes a model of combining TCM guidelines with real-world study, which includes 4 steps. Firstly, during the implementation process of the guidelines, a high-quality research database is established. Secondly, the recommendations in the guidelines are evaluated based on the established database in multiple dimensions, including applicability, effectiveness, safety, and cost-effectiveness, and thus their effectiveness in practical applications can be determined. Thirdly, based on the established database, core prescriptions are identified, and the targeted populations and medication plans are determined. That is, the best treatment regimen is established based on the analysis of abundant clinical data regarding the effects of different medication frequencies, dosages, and duration on efficacy. Fourthly, the guidelines are updated according to the real-world evidence. The research based on this model can provide real-world evidence for ancient and empirical prescriptions, improving their application in clinical practice. Moreover, this model can reduce research costs and improve research efficiency. When applying this model, researchers need to pay attention to the quality of real-world evidence, ensuring that it can truly reflect the situation in clinical practice. In addition, importance should be attached to the clinical application of guideline recommendations, ensuring that doctors can conduct standardized diagnosis and treatment according to the guidelines. Finally, full-process participation of multidisciplinary experts is encouraged to ensure the comprehensiveness and scientificity of the study. In conclusion, the application of this model will contribute to the development of TCM guidelines responsive to the needs of clinical practice and achieve the goal of promoting the homogenization of TCM clinical diagnosis and treatment.
7.Methods and Challenges for Identifying and Controlling Confounding Factors in Traditional Chinese Medicine Observational Studies
Guozhen ZHAO ; Ziheng GAO ; Chen ZHAO ; Huizhen LI ; Ning LIANG ; Bin LIU ; Qianzi CHE ; Haili ZHANG ; Yixiang LI ; Feng ZHOU ; He LI ; Bo LI ; Nannan SHI
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(22):120-126
As a supplement to randomized controlled trials, observational studies can provide evidence for the effectiveness of traditional Chinese medicine (TCM) treatment measures. They can also study influencing factors of diseases, etiology, and prognosis. However, there is a confounding effect due to the lack of randomization, which seriously affects the causal inference between the study factors and the outcome, resulting in confounding bias. Therefore, identifying and controlling confounding factors are key issues to be addressed in TCM observational studies. According to the causal network and the characteristics of TCM theory, confounding factors can be categorized into measured and unmeasured confounding factors. In addition, attention must be paid to identifying confounding factors and intermediate variables, as well as the interaction between confounding factors and study factors. For methods of controlling confounding factors, measured confounding factors can be controlled by stratification, multifactor analysis, propensity scores, and disease risk scores. Unmeasured and unknown confounding factors can be corrected using instrumental variable methods, difference-in-difference methods, and correction for underlying event rate ratios. Correcting and controlling confounding factors can ensure a balance between groups, and confounding bias can be reduced. In addition, methods such as sensitivity analysis and determination of interactions make the control of confounding factors more comprehensive. Due to the unique characteristics of TCM, observational studies of TCM face unique challenges in identifying and controlling confounding factors, including the ever-changing TCM treatment measures received by patients, the often-overlooked confounding effects in the four diagnostic information of TCM, and the lack of objective criteria for TCM evidence-based diagnosis. Some scholars have already conducted innovative explorations to address these issues, providing a methodological basis for conducting higher-quality TCM observational studies, so as to obtain more rigorous real-world evidence of TCM and gradually develop quality evaluation criteria for OS that are consistent with the characteristics of TCM.
8.Key Techniques and Methodological Considerations for Formation of Traditional Chinese Medicine Syndrome Classification Standards
Guozhen ZHAO ; Xingyu ZONG ; Xueyao ZHAO ; Huizhen LI ; Feng ZHOU ; Xuanling ZENG ; Jiahao LIN ; Ning LIANG ; Haili ZHANG ; Qianzi CHE ; Bin LIU ; Nannan SHI
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(24):257-261
The classification of traditional Chinese medicine (TCM) syndromes is one of the core technical elements in the industry standard of Specification of Diagnosis and Therapeutic Effect Evaluation of Diseases and Syndromes in TCM. In the past,when clinical standards for TCM were formulated,the determination of TCM syndrome classification relied heavily on textbooks and expert experience,lacking systematic research. This approach thus failed to reflect the advancement and scientificity of the standards,thereby affecting their implementation and application. This article reviewed the presentation forms and technical methods of TCM syndrome classification,including the two-tier syndrome classification model with primary and secondary symptoms,as well as the application of modern literature research,ancient literature research,Delphi method,in-depth expert interviews,consensus conferences,and real-world research. When syndrome classification standards are developed,it is necessary to build upon modern literature research,adopt a mixed approach combining qualitative research and quantitative analysis results,and reach expert consensus through consensus conferences. Through systematic research,the scientificity,applicability,and coordination of TCM syndrome classification standards can be enhanced,providing guidance for the standardization of TCM.
9.Theory of "Yin-Yang Five-State People" in Inner Canon of Yellow Emperor (《黄帝内经》) and Its Application in the Prevention and Treatment of Psychosomatic Diseases in the Elderly
Journal of Traditional Chinese Medicine 2024;65(21):2178-2183
The theory of "yin-yang five-state people" in The Inner Canon of Yellow Emperor (《黄帝内经》) is based on the different forms, personality, psychology and behavioural characteristics of the crowd for typing the "five-state people", which embodies the ideas of traditional Chinese medicine (TCM) of the correspondence between human beings and nature, the unity of body and spirit, and tailored to suit the needs of the individual, and has important guiding significance for modern clinical application and scientific research. Elderly people are prone to mental and physical illnesses due to original qi deficiency, easy injury of emotions, and different personalities. According to the physiological and pathological characteristics of the elderly, the prevention and treatment of psychosomatic diseases in the elderly are guided by the theory of "yin-yang five-state people", which analyses the corresponding personality and psychological characteristics of typical "five-state people" (i.e., taiyang, shaoyang, taiyin, shaoyin, and yin-yang balance) under the conditions of emotional stimulation. This study explored the close relationship with the pathogenesis and disease tendency of psychosomatic diseases in the elderly, and put forward the corresponding ideas of prevention and treatment, stressing the importance of the psychological factors, regulating body and spirit, providing a new perspective for the prevention and treatment of psychosomatic diseases of the elderly in clinic.
10.Construction and efficacy evaluation of a short-term prognostic model for emergency patients with acute ischemic cerebral stroke
Xiaomeng LIU ; Junyu LI ; Wei HE ; Na WANG ; Shubin GUO ; Huizhen LIU
Chinese Journal of Emergency Medicine 2024;33(1):51-58
Objective:To establish a 14-day prognosis model for emergency patients with acute ischemic cerebral stroke and evaluate its predictive efficacy.Methods:A prospective cohort study was conducted. Patients with acute ischemic stroke admitted to the emergency department of Beijing Bo’ai Hospital within 72 hours of onset from October 2018 to December 2020 were enrolled. Univariate and multivariate logistic regression analysis were used to screen the risk factors of poor prognosis. The ROC curve was drawn to determine the cut-off value of continuous variables and discretise data with reference to clinical practice. The corresponding scores were set up according to the β regression coefficient of each variable, and the clinical scale prediction model of short-term prognosis of acute cerebral infarction was established. Patients with ischemic stroke in the hospital from January to December 2021 were selected as the internal validation, to verify the constructed predictive model.Results:A total of 321 patients were included in the study, including 223 in the training set and 98 in the internal validation set. Multivariate logistic regression analysis showed that age, hypersensitive C-reactive protein, prealbumin (PA), infarct volume, Frailty Screening Questionnaire (FSQ) and National Institute of Health Stroke Scale (NIHSS) were independent risk factors for poor short-term prognosis of acute cerebral infarction. The total score of the clinical prediction scoring system for short-term prognosis of acute cerebral infarction in the emergency department was 15 points, including age ≥74 years (1 point), PA ≤373 mg/L (2 points), large artery atherosclerosis (1 point), cardiogenic embolism (2 points), infarct volume ≥ 2.18 cm 3 (2 points), FSQ ≥3 points (1 point), NIHSS ≥4 points (6 points); The area under the ROC curve (AUC) of the scoring system for predicting short-term poor prognosis of acute cerebral infarction was 0.927 (95% CI: 0.894-0.960). The optimal cut-off value was ≥5 points, and the sensitivity and specificity were 0.770 and 0.976, respectively. In the internal validation set, the scoring system had similar predictive value for poor outcomes (AUC=0.892, 95% CI:0.827-0.957). Conclusion:The scoring system for short-term prognosis prediction of acute ischemic cerebral infarction has good diagnostic efficacy, and could guide clinicians to judge the prognosis of emergency patients in the early stage.

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