1.Interpretation of Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines
Wenxi PENG ; Meng QIAO ; Lianxin WANG ; Yuanyuan LI ; Xiuhui LI ; Xin CUI ; Zijia CHEN ; Xinyi CHEN ; Yi DENG ; Yanming XIE ; Zhifei WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(6):152-160
The Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines (hereinafter referred to as the Guidelines) is first specialized in the field of drug safety for oral Chinese patent medicines (OCPMs) in China. Rooted in China's healthcare context, the Guidelines address the unique usage patterns and risk characteristics of OCPMs, filling a regulatory gap in the pharmacovigilance framework specific to this category. To facilitate accurate understanding and effective implementation of the Guidelines, and to promote the standardized development of pharmacovigilance practices for OCPMs, this study offered a systematic interpretation based on its three core components. In the domain of risk monitoring and reporting, the paper analyzed the rationale for multi-source information integration and clarified the criteria for identifying key products and target populations for intensive monitoring. Regarding risk assessment, the Guidelines were examined from three dimensions of formulation components, medication behaviors, and population to address complex safety issues arising from medicinal constituents, irrational use, and individual susceptibility. In the area of risk control, the analysis focused on context-based interventions and dynamic closed-loop management strategies, exploring practical pathways to shift from passive response to proactive risk mitigation. Furthermore, this paper evaluated the applied value of the Guidelines and identified implementation challenges, such as insufficient capacity at the primary-care level and limited digital infrastructure. In response, the study proposed optimization strategies including establishing a dynamic updating mechanism, strengthening training at the grassroots level, and incorporating artificial intelligence to enhance pharmacovigilance capacity. This interpretation aims to provide actionable insights for marketing authorization holders (including manufacturers), pharmaceutical distributors, healthcare institutions, and research organizations, ultimately supporting the establishment and refinement of a full lifecycle pharmacovigilance system for OCPMs.
2.Clinical Efficacy of Janus Kinase Inhibitors in Combination with Chinese Herbal Medicine for Rheumatoid Arthritis:A Retrospective Study and A Meta-analysis
Chenguang ZHAN ; Shengqin YANG ; Xin LI ; Yu WEN ; Peng ZHANG ; Xingrui YAN ; Haifang DU ; Maojie WANG ; Xiaodong WU ; Liyan MEI ; Xiumin CHEN ; Yanlin LI ; Runyue HUANG
Journal of Traditional Chinese Medicine 2026;67(5):534-543
ObjectiveTo evaluate the efficacy and safety of Janus kinase (JAK) inhibitors combined with Chinese herbal medicine (CHM) in treating rheumatoid arthritis (RA). MethodsClinical data from 169 RA patients were retrospectively collected. Among them, 71 cases received JAK inhibitors as the control group, while 98 cases received JAK inhibitors plus CHM as the observation group, both treated for 24 weeks. The rheumatoid factor (RF), cyclic citic peptide antibody (anti-CCP), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and white blood cell count (WBC) were recorded before and after treatment. Databases including CNKI, Wanfang, VIP, PubMed and Web of Science were searched from inception till August 31st, 2025 for randomized controlled trials (RCTs) on the combined use of JAK inhibitors and CHM for RA. The methodological quality of the included studies was evaluated using the risk of bias assessment tool. Meta-analyses were performed for RF, anti-CCP, ESR, CRP, 28-joint disease activity score (DAS28), overall clinical effective rate, and incidence of adverse events. Sensitivity analysis were also performed. ResultsThe retrospective study demonstrated that after treatment, ESR, CRP, and anti-CCP levels decreased in the observation group, while ESR and CRP levels decreased in the control group (P<0.05). Moreover, ESR and RF levels in the observation group were lower than those in the control group (P<0.05). A total of 9 RCTs involving 770 patients were included in the meta-analysis. The results indicated that the JAK inhibitors plus CHM group was superior to the JAK inhibitors group in reducing RF (MD=-8.97, 95%CI -15.01 to -2.94, P=0.004), CRP (MD=-3.34, 95%CI -3.82 to -2.86, P<0.001), ESR (MD=-5.33, 95%CI -7.98 to -2.69, P<0.001), and DAS28 score (MD=-0.54, 95%CI -0.74 to -0.34, P<0.001), as well as in improving the overall clinical effective rate (OR=4.53, 95%CI 2.55 to 8.03, P<0.001). No statistically significant differences were observed between groups in anti-CCP levels (SMD=-2.08, 95%CI -4.41 to 0.24, P=0.080) or incidence of adverse events (OR=0.93, 95%CI 0.55 to 1.57, P=0.790). ConclusionThe combination of JAK inhibitors and CHM demonstrates remarkable efficacy in treating RA, contributing to improved disease activity and reduced inflammatory markers with a favorable safety profile.
3.The Specificity of Electroacupuncture at Different Acupoints in Promoting Cerebrospinal Fluid Flow in Mice
Yu SHI ; Qian HUA ; Tian-Tian PENG ; Yu-Xin NIE ; Zhao-Heng LIU ; Chen-Geng DENG ; Xu WANG
Progress in Biochemistry and Biophysics 2026;53(5):1154-1164
ObjectiveCerebrospinal fluid (CSF) plays a crucial role in maintaining the homeostasis of the central nervous system (CNS). CSF rapidly exchanges with interstitial fluid (ISF) via the glymphatic system within the brain parenchyma. CSF-ISF circulation and its associated mechanisms are often referred to as the brain lymphatic system. This system is connected directly to meningeal lymphatic vessels (mLVs), jointly performing the function of clearing metabolic waste from the CNS. Emerging evidence indicates that this system is closely associated with the onset and progression of neurodegenerative diseases (NDs) such as Alzheimer’s disease (AD). Importantly, abnormal CSF circulation is not only a downstream consequence of AD pathology, but also a risk factor. In AD, the dynamics of CSF flow within the CNS are diminished, immune dysregulation occurs, and this may increase the risk of AD by exacerbating the burden of amyloid β-protein (Aβ). In the mouse model of AD, impaired CSF flow compromises this clearance function, leading to cognitive deficits. Clinically, acupuncture at cognition-related acupoints is commonly used for the prevention and treatment of AD. However, whether its therapeutic effects are mediated through the modulation of CSF dynamics remains unclear. This study aimed to evaluate the impact of acupuncture on CSF flow and investigate its acupoint specificity. MethodsMice were randomly assigned to experimental groups for the different electroacupuncture groups with the following acupoints: Baihui point (GV 20), Ear point, Neiguan point (PC 6), and Tianshu point (ST 25). Wild-type mice on a C57BL/6J background were used as controls. Fluorescent tracer was injected into the cisterna magna to label CSF flow. Fluorescence imaging was employed to assess the distribution of CSF within the brain before and after acupuncture stimulation. ResultsFollowing tracer injection into the cisterna magna, fluorescence signals rapidly reached the cerebellum and medulla—the regions closest to the injection site. Fluorescence intensity was higher in ventral brain regions compared to dorsal regions, likely due to greater vascular density in ventral areas facilitating CSF-ISF exchange. Electroacupuncture at the GV 20 produced the most pronounced enhancement of CSF across the whole brain, while stimulation at the ST 25 primarily augmented flow within subcortical regions. In contrast, electroacupuncture at the Ear point or the PC 6 had no observable effect on CSF in mice. ConclusionElectroacupuncture promotes CSF flow into the brain parenchyma in an acupoint-specific manner, with GV 20 exhibiting the most pronounced enhancement of CSF dynamics. These findings suggest that acupuncture-mediated facilitation of CSF flow may represent a potential therapeutic strategy for preventing or delaying age-related cognitive decline.
4.The Specificity of Electroacupuncture at Different Acupoints in Promoting Cerebrospinal Fluid Flow in Mice
Yu SHI ; Qian HUA ; Tian-Tian PENG ; Yu-Xin NIE ; Zhao-Heng LIU ; Chen-Geng DENG ; Xu WANG
Progress in Biochemistry and Biophysics 2026;53(5):1154-1164
ObjectiveCerebrospinal fluid (CSF) plays a crucial role in maintaining the homeostasis of the central nervous system (CNS). CSF rapidly exchanges with interstitial fluid (ISF) via the glymphatic system within the brain parenchyma. CSF-ISF circulation and its associated mechanisms are often referred to as the brain lymphatic system. This system is connected directly to meningeal lymphatic vessels (mLVs), jointly performing the function of clearing metabolic waste from the CNS. Emerging evidence indicates that this system is closely associated with the onset and progression of neurodegenerative diseases (NDs) such as Alzheimer’s disease (AD). Importantly, abnormal CSF circulation is not only a downstream consequence of AD pathology, but also a risk factor. In AD, the dynamics of CSF flow within the CNS are diminished, immune dysregulation occurs, and this may increase the risk of AD by exacerbating the burden of amyloid β-protein (Aβ). In the mouse model of AD, impaired CSF flow compromises this clearance function, leading to cognitive deficits. Clinically, acupuncture at cognition-related acupoints is commonly used for the prevention and treatment of AD. However, whether its therapeutic effects are mediated through the modulation of CSF dynamics remains unclear. This study aimed to evaluate the impact of acupuncture on CSF flow and investigate its acupoint specificity. MethodsMice were randomly assigned to experimental groups for the different electroacupuncture groups with the following acupoints: Baihui point (GV 20), Ear point, Neiguan point (PC 6), and Tianshu point (ST 25). Wild-type mice on a C57BL/6J background were used as controls. Fluorescent tracer was injected into the cisterna magna to label CSF flow. Fluorescence imaging was employed to assess the distribution of CSF within the brain before and after acupuncture stimulation. ResultsFollowing tracer injection into the cisterna magna, fluorescence signals rapidly reached the cerebellum and medulla—the regions closest to the injection site. Fluorescence intensity was higher in ventral brain regions compared to dorsal regions, likely due to greater vascular density in ventral areas facilitating CSF-ISF exchange. Electroacupuncture at the GV 20 produced the most pronounced enhancement of CSF across the whole brain, while stimulation at the ST 25 primarily augmented flow within subcortical regions. In contrast, electroacupuncture at the Ear point or the PC 6 had no observable effect on CSF in mice. ConclusionElectroacupuncture promotes CSF flow into the brain parenchyma in an acupoint-specific manner, with GV 20 exhibiting the most pronounced enhancement of CSF dynamics. These findings suggest that acupuncture-mediated facilitation of CSF flow may represent a potential therapeutic strategy for preventing or delaying age-related cognitive decline.
5.Consideration of Health Economics Evidence in Clinical Practice Guidelines: Methods and Steps
Dongrui PENG ; Qi ZHOU ; Xufei LUO ; Zijun WANG ; Hui LIU ; Junxian ZHAO ; Jinghong HUANG ; Hongyu HU ; Xin XING ; Jing WU ; Shitong XIE ; Xiaohui WANG ; Yaolong CHEN
Medical Journal of Peking Union Medical College Hospital 2026;17(3):862-870
Health economics evidence plays an important role in linking clinical value evidence with health resource allocation decisions in the development of clinical practice guidelines. It can not only effectively balance clinical effectiveness and economic feasibility but also avoid forming "idealized" recommendations that are detached from the affordability of the healthcare system or the burden-bearing capacity of patients. To promote guideline developers to use health economics evidence more standardizedly and fully, this paper conducts an in-depth analysis of the current application status, existing challenges, access channels, and application processes of health economics evidence in current guidelines, and on this basis, puts forward considerations and suggestions for strengthening and standardizing the application of health economics evidence in China's clinical practice guidelines.
6.Design and implementation of online continuing education platform for transfusion medicine
Haiying LI ; Xin LI ; Lixue CHEN ; Jinlian LUO ; Xiaodan PENG ; Jintong ZHONG ; Le BAI ; Nannan ZHANG ; Zebo YU ; Xue HU
Chinese Journal of Medical Education Research 2025;24(3):419-425
To provide in-service medical technicians and nurses with convenient access to continuing education resources in transfusion medicine, reduce transfusion-related adverse events, and ensure the safety, rationalization, and effectiveness of clinical transfusion, we designed and developed an online transfusion continuing education platform. The platform was based on the new managed code programming model.NET Core and the powerful functions of hypertext preprocessor PHP 7.4, addressing current issues in transfusion online continuing education. Through in-depth analysis of student attributes, learning behaviors, and teaching behaviors, a comprehensive online continuous teaching quality evaluation index system was established. This system not only facilitates the quantitative assessment of teaching quality but also successfully integrates the two core functions of teaching and management, thereby achieving unified online teaching.
7.Application,Challenges,and Prospects of Large Language Model in the Field of Traditional Chinese Medicine
Zijia CHEN ; Wenxi PENG ; Dezheng ZHANG ; Xin LIU ; Zhifei WANG
Medical Journal of Peking Union Medical College Hospital 2025;16(1):83-89
With the rapid development of the interdisciplinary area of artificial intelligence and medi-cine,large language model(LLM)has been widely used in the fields such as diagnosis and treatment,medi-cine,and healthcare.LLM has unique advantages in the field of traditional Chinese medicine(TCM),such as high consistency with the"Four Diagnostic Methods",perfect combination of natural language and self-super-vised learning in TCM,the ability to adapt to the characteristics TCM formulas,and the assistance in TCM di-agnosis and treatment.At present,various LLM models have been developed,including the"Qihuang Ask Big Model"and the Digital Traditional Chinese Medicine Big Model"GLM-130B",but they still face challenges such as value mismatch and medical abuse,increased demand for interpretability,lack of advanced technolo-gy,and domestic policy access.This article reviews the evolution of LLM,its unique advantages and applica-tions in the field of TCM,the problems and challenges,and the future development trends,in order to provide reference for the further promotion of LLM in traditional medicine.
8.Chemical constituents from the leaves of Drynaria fortunei and their antioxidant activity
Xin CHEN ; Jia-cheng WANG ; Yan-yan LIU ; Yong-wen ZHANG ; Ze-jing MU ; Hai-yan ZHANG ; Yu PENG ; Tong-lin WAN ; Yong-hong LIANG
Chinese Traditional Patent Medicine 2025;47(8):2587-2592
AIM To study the chemical constituents from the leaves of Drynaria fortunei(Kunze)J.Sm.and their antioxidant activity.METHODS ODS-AG-HG,Sephadex LH-20 and semi-preparative HPLC were used for separation and purification,then the structures of obtained compounds were identified by physicochemical properties and spectral data.The antioxidant activity was determined by DPPH mothod.RESULTS Fifteen compounds were isolated and identified as kaempferol-3-O-neohesperidoside(1),dihydrodehydrodiconiferyl alcohol(2),kaempferol-3,7-di-O-α-L-rahmnoside(3),astragalin(4),loliolid(5),trichothecene analogue(6),2,2-[bis-4-(2,3-dihydroxypropoxy)phenyl]propane(7),maculatin(8),trichothecin(9),4-[(Z)-but-2-enoyloxy]-8-chloro-12-hydroxy-7,13-epoxytrichothec-9-ene(10),8-deoxy-trichotecin(11),β-sitosterol(12),daucosterol(13),afzelin(14),samwinol(15).The IC50 values of the leaf and rhizome extracts against DPPH free radicals were(0.072±0.005),(0.287±0.012)mg/mL,respectively.CONCLUSION Compounds 1,2,5-11,15 are isolated from this plant for the first time.The leaves of D.fortunei exhibit strong antioxidant activity.
9.A machine learning-based model for predicting the risk of diabetic kidney disease in type 2 diabetes mellitus
Tingting LI ; Peng SU ; Jinbo CHEN ; Xiaoyan HE ; Yi CAO ; Xin ZHANG ; Qingling TANG ; Xubin MIAO ; Xiaohua LIANG ; Dong MA
Chinese Journal of Diabetes 2025;33(4):241-247
Objective To compare and find an optimal model for predicting the risk of DKD occurrence in patients with type 2 diabetes mellitus(T2DM).Methods A total of 2005 patients with T2DM were enrolled in this study from The Second Hospital of Shijiazhuang City during December 2017 to December 2022.All the subjects were divided into a training set(n=1403)and a validation set(n=602)according to the ratio of 3∶1 by simple random sampling.With the occurrence of DKD as the outcome variablein the training set,important feature variables were screened by LASSO regression.Six different machine learning models were established according to the feature variables,thenthe optimal model was determined by comparison,and anonlinerisk predictor for DKD occurrence was constructed in patients with T2DM.Results Taking the occurrence of DKD as the outcome variable in the training set,the results of LASSO regression analysis showed that the optimal value of the model was 10-fold cross validation lambda.1se=0.01662473,and 15 characteristic variables with nonzero coefficient were screened out to be related to the occurrence of DKD.The data included sex,age,family history of DM,DM duration,LDL-C,HbA1c,WBC,PDW,Scr,urine α1-microglobulin,urine β2-microglobulin,urine microalbumin,hypertension,hypokalemia,and DR.In the training set and validation set,the prediction performance of XGBoost model was better than that of other models(AUC=0.872,0.893,95%CI 0.853~0.891,0.865~0.921),the sensitivity was 0.779,0.863,and the specificity was 0.721,0.758,respectively.The F1 scores were 0.774 and 0.787.DCA analysis showed that the XGBoost model had a greater net benefit and threshold probability.According to the XGBoost model,the online predictor of DKD risk in T2DM patients was laid out,and two patients were selected for application,the results showed that the predictive value of the model was 0.185 in non-DKD patients,and the predictive value was 0.510 in DKD patients.Conclusions The XGBoost model is the best model for predicting the occurrence of DKD in T2DM patients,and an online predictor was successfully built.
10.Chinese experts' consensus on principles of preoperative hair removal
Yiping MAO ; Jun ZHENG ; Lei LI ; Deyan YANG ; Bing ZHANG ; Lei YANG ; Wang JIA ; Peng KANG ; Hui JIAO ; Yun YANG ; Qi QI ; Shiqing FENG ; Xiao LONG ; Yuewei ZHANG ; Xiaohui WANG ; Lize WANG ; Yuan WEI ; Jichao ZHOU ; Minghui MAO ; Pengju XIN ; Hongyu TAN ; Dahong ZHANG ; Lianxin LIU ; Lei TAO ; Xietong WANG ; Xiaoning YUAN ; Mang CAI ; Li MU ; Fang DU ; Rongzhu CHEN ; Fengmao ZHAO ; Jiuzuo HUANG ; Mingzi ZHANG ; Jie ZHANG ; Baoguo WANG ; Kun WANG ; Fang LUO ; Jinhua ZHANG ; Nong HE ; Ling LYU ; Zhiyong ZONG
Chinese Journal of Nosocomiology 2025;35(10):1441-1449
To formulate an expert consensus on the principles of preoperative hair removal and provide scientific guidance for standardized removal of hair before surgical procedures so as to reduce the incidence of surgical site infections.METHODS Led by the Hospital Management Institute of National Health Commission of the People's Republic of China,this consensus was reached with the joint efforts from the expects of relevant fields such as surgeries,interventional therapies,nursing,and infection prevention and control.The consensus facilitates the classification and evaluation of literatures by following the evidence grade formulated by Oxford Evidence-based Medicine Center and focuses on the association of preoperative hair removal with surgical site infection,it reaches the evidence grade of expert consensus and recommendation intensity by integrating with discussions on meetings and clinical experience of the expects from relevant fields.RESULTS A total of 6 items of consensus were reached by summarizing the latest evidence on the aspects including the indications for preoperative hair removal,tools,range,timing and places.CONCLUSION The consensus,to some extent,make supplements to and complete the exiting regulations and standards.It provides guidance for the medical institutions to carry out the preoperative hair removal.

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