1.Compilation Instruction for Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines
Hongyan ZHANG ; Zhifei WANG ; Shuo YANG ; Ruili WEI ; Wenqian PENG ; Yuanyuan LI ; Xin CUI ; Xiaoxiao ZHAO ; Fumei LIU ; Mengmeng WANG ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):245-251
To standardize the clinical application of oral Chinese patent medicines (CPMs), and address the safety issues arising from their dosage form characteristics, irrational clinical use, and the lack of targeted pharmacovigilance systems, the China Association of Chinese Medicine organized the formulation and release of Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines, aiming to inform the safe clinical use of oral CPMs and related pharmacovigilance work. According to the principles of GB/T1.1—2020 and the Drug Administration Law of the People's Republic of China (2019 revision), the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, led a drafting group comprising 18 institutions. After multiple rounds of expert interviews, literature retrieval, evidence screening, and extensive solicitation of opinions, the Guidelines were registered internationally. Systematic standardization focused on safety monitoring, risk identification, assessment, control, and other aspects. The Guidelines clarified the characteristics of oral CPMs in terms of safety monitoring, known risks, and potential risks, compared to non-oral CPMs. Then, risk control measures were proposed, including medication in special populations and irrational medication. As a special guideline for pharmacovigilance in the clinical application of oral CPMs, the Guidelines systematically construct a technical system in line with the characteristics of traditional Chinese medicine (TCM), which is essential for improving the clinical safety management of oral CPMs and provides an important reference for medical institutions, pharmaceutical manufacturers, and regulatory authorities.
2.Compilation Instruction for Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines
Hongyan ZHANG ; Zhifei WANG ; Shuo YANG ; Ruili WEI ; Wenqian PENG ; Yuanyuan LI ; Xin CUI ; Xiaoxiao ZHAO ; Fumei LIU ; Mengmeng WANG ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):245-251
To standardize the clinical application of oral Chinese patent medicines (CPMs), and address the safety issues arising from their dosage form characteristics, irrational clinical use, and the lack of targeted pharmacovigilance systems, the China Association of Chinese Medicine organized the formulation and release of Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines, aiming to inform the safe clinical use of oral CPMs and related pharmacovigilance work. According to the principles of GB/T1.1—2020 and the Drug Administration Law of the People's Republic of China (2019 revision), the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, led a drafting group comprising 18 institutions. After multiple rounds of expert interviews, literature retrieval, evidence screening, and extensive solicitation of opinions, the Guidelines were registered internationally. Systematic standardization focused on safety monitoring, risk identification, assessment, control, and other aspects. The Guidelines clarified the characteristics of oral CPMs in terms of safety monitoring, known risks, and potential risks, compared to non-oral CPMs. Then, risk control measures were proposed, including medication in special populations and irrational medication. As a special guideline for pharmacovigilance in the clinical application of oral CPMs, the Guidelines systematically construct a technical system in line with the characteristics of traditional Chinese medicine (TCM), which is essential for improving the clinical safety management of oral CPMs and provides an important reference for medical institutions, pharmaceutical manufacturers, and regulatory authorities.
3.Immunomodulatory effect of short-chain fatty acids in hepatic encephalopathy and its potential diagnostic value
Weiyu CHEN ; Dewen MAO ; Han WANG ; Yang DU ; Wenqian FENG ; Lei FU ; Chun YAO
Journal of Clinical Hepatology 2025;41(5):954-962
Hepatic encephalopathy (HE) is a common complication of severe liver disease in the end stage, and it is urgently needed to improve the rate of effective treatment and clarify the pathogenesis of HE. The liver is a crucial hub for immune regulation, and disruption of immune homeostasis is a key factor in the pathological mechanisms of HE. As the main metabolites of intestinal flora, short-chain fatty acids (SCFAs) play a vital role in the biological processes of both innate and adaptive immunity and can regulate the proliferation and differentiation of immune cells maintain the homeostasis of intestinal microenvironment and the integrity of barrier function. Studies have shown that SCFAs participate in bidirectional and dynamic interactions with the liver-gut-brain axis through immunomodulatory pathways, thereby playing an important role in the diagnosis, treatment, and prognostic evaluation of HE. Starting from the immunoregulatory effect of SCFAs, this article summarizes and analyzes the crosstalk relationship between SCFAs and the liver-gut-brain axis and the significance of SCFAs in the diagnosis and treatment of HE, in order to provide new ideas for optimizing clinical prevention and treatment strategies.
4.Association between bile acid/short-chain fatty acid metabolic disorders and hepatic encephalopathy based on the traditional Chinese medicine theory of Yin and Yang
Luyi YAN ; Weiyu CHEN ; Han WANG ; Wenqian FENG ; Yang DU ; Xueru TIAN ; Yang HONG ; Dewen MAO ; Lei FU ; Chun YAO
Journal of Clinical Hepatology 2025;41(7):1443-1449
Hepatic encephalopathy is a neuropsychiatric syndrome secondary to severe liver disease.Recent studies have shown that the development of hepatic encephalopathy is closely associated with bile acid/short-chain fatty acid metabolic disorder.As the core theory of traditional Chinese medicine,the theory of Yin and Yang provides a unique perspective for analyzing the association between bile acids/short-chain fatty acids and hepatic encephalopathy.Bile acids function like Yang,governing the free flow of Qi and assisting in metabolic processes,while short-chain fatty acids belong to Yin,maintaining internal stability and conservation,preserving the intestinal barrier,and combating inflammation and toxins.Bile acids and short-chain fatty acids constrain each other and are interdependent to regulate the dynamic equilibrium of the gut-liver-brain axis.On this basis,by regulating the metabolic imbalance of bile acids and short-chain fatty acids,it is expected to restore the dynamic balance of Yin and Yang in patients with hepatic encephalopathy under the synergistic intervention of traditional Chinese medicine and Western medicine.
5.Approach to the patient with myxedema coma
Jianxia SHI ; Qiuyu FANG ; Wenqian REN ; Yunqin MA ; Qin ZHEN ; Li ZHAO ; Yufan WANG ; Yongde PENG ; Fang LIU
Chinese Journal of Endocrinology and Metabolism 2025;41(3):233-236
Myxedema coma is a rare condition, typically arising from long-standing, untreated hypothyroidism and triggered by factors such as infection, hypothermia, or severe illness. This report details a successfully treated case of myxedema coma with cardiac attest, accompanied by a literature review, to enhance clinical awareness and improve the diagnosis and management of this critical condition.
6.Artificial intelligence-based sequential ultrasound-MRI strategy for ovarian masses:dual evaluation of diagnostic accuracy and healthcare costs
Jingjing YU ; Ruixia DAI ; Xiaomin LIU ; Peijun HU ; Xiaochen WANG ; Sihui HU ; Shanshan ZHANG ; Wenqian WANG ; Yu TIAN ; Jiale QIN
Chinese Journal of Ultrasonography 2025;34(9):759-765
Objective:To develop an artificial intelligence(AI)-based sequential ultrasound-magnetic resonance imaging(US-MRI)diagnostic strategy to optimize the imaging workflow for ovarian masses.Methods:A total of 1 120 patients with pathologically confirmed ovarian masses who underwent both preoperative pelvic ultrasound and MRI between January 2021 and December 2023 at Women's Hospital,Zhejiang University School of Medicine were retrospectively included. Patients were randomly divided into the training( n=672)and internal test set( n=448)at a ratio of 6∶4. An external test set( n=128)was established at the Forth Affiliated Hospital of School of Medicine. Deep learning was used for automated segmentation of MRI lesions,followed by radiomic feature extraction and machine learning classification to construct both a US-MRI multimodal model and sequential US-MRI strategy. Diagnostic performance and potential healthcare cost-saving effects were evaluated across strategies. Results:In the internal test set( n=448),the AI-based sequential US-MRI strategy achieved a F1 score of 0.863 and a diagnostic accuracy of 82.14%,with no significant difference compared to the US-MRI multi-modal model( P>0.05). The sequential strategy identified 82 cases(18.30%,82/448)of patients as low-risk true negatives during initial ultrasound screening,suggesting a potential to reduce the need for MRI examinations in future clinical practice. In the external test set( n=128),the strategy achieved an F1 score of 0.800 and a confirmed diagnosis rate of 85.94%,with a theoretical reduction of 26.56%(34 cases)in MRI utilization while maintaining a diagnostic accuracy rate higher than that of the multi-modal model(82.18%). Conclusions:The AI-based US-MRI sequential diagnostic strategy demonstrates favorable diagnostic accuracy while offering the potential to optimize MRI utilization. This approach may enhance the efficiency of imaging resource allocation and reduce healthcare burden in the management of ovarian masses.
7.Effect of exercise on freezing of gait in Parkinson's disease:a meta-analysis
Wenqian DU ; Xu ZHANG ; Jiwei CHEN ; Xing WANG ; Kun ZHU
Chinese Journal of Rehabilitation Theory and Practice 2025;31(7):781-789
Objective To evaluate the effect of exercise on freezing of gait in Parkinson's disease.Methods After constructing a PICO framework,randomized controlled trials(RCTs)about exercise for freezing of gait in Parkinson's disease were systematically retrieved from Web of Science,PubMed,Cochrane Library,Embase,CNKI,VIP and Wanfang Data,from the establishment of the databases to March,2025.The PEDro scale was used to evaluate the quality of literature,Stata 17.0 was used for meta-analysis,and GRADE was used to assess the evidence quality.Results A total of twelve RCTs involving 463 patients were included,with PEDro scale scores of five to eight.Exercise improved the scores of Freezing of Gait Questionnaire(FOGQ)(SMD=-0.61,95%CI-0.85~-0.36,P<0.001)and Unified Parkinson's Disease Rating Scale Ⅲ(UPDRSⅢ)(SMD=-0.84,95%CI-1.27~-0.41,P<0.001).Subgroup analysis revealed that the patients aged 59 to 68 years,the course of disease
8.Guideline for diagnosis and treatment of infection after internal fixation of closed lower limb fractures in adults (version 2025)
Bobin MI ; Faqi CAO ; Weixian HU ; Wu ZHOU ; Chenchen YAN ; Hui LI ; Yun SUN ; Yuan XIONG ; Jinmi ZHAO ; Qikai HUA ; Xinbao WU ; Xieyuan JIANG ; Dianying ZHANG ; Zhongguo FU ; Dankai WU ; Guangyao LIU ; Guodong LIU ; Tengbo YU ; Jinhai TAN ; Xi CHEN ; Fengfei LIN ; Zhangyuan LIN ; Dongfa LIAO ; Aiguo WANG ; Shiwu DONG ; Gaoxing LUO ; Zhao XIE ; Dong SUN ; Dehao FU ; Yunfeng CHEN ; Changqing ZHANG ; Kun LIU ; Deye SONG ; Yongjun RUI ; Fei WU ; Ximing LIU ; Junwen WANG ; Meng ZHAO ; Biao CHE ; Bing HU ; Chengjian HE ; Guanglin WANG ; Xiao CHEN ; Guandong DAI ; Shiyuan FANG ; Wenchao SONG ; Ming CHEN ; Guanghua GUO ; Yongqing XU ; Lei YANG ; Wenqian ZHANG ; Kun ZHANG ; Xin TANG ; Hua CHEN ; Weiguo XU ; Shuquan GUO ; Yong LIU ; Xiaodong GUO ; Zhewei YE ; Liming XIONG ; Tian XIA ; Hongbin WU ; Qisheng ZHOU ; Mengfei LIU ; Yiqiang HU ; Yanjiu HAN ; Hang XUE ; Kangkang ZHA ; Wei CHEN ; Zhiyong HOU ; Bin YU ; Jiacan SU ; Peifu TANG ; Baoguo JIANG ; Guohui LIU
Chinese Journal of Trauma 2025;41(5):421-432
Postoperative infection of internal fixation of closed fractures the lower limbs in adults represents a devastating complication, characterized by diagnostic challenges, prolonged treatment duration and high disability rates. Current management of these infections faces multiple challenges, such as difficulties in early accurate diagnosis, and various controversies about the treatment plan, leading to poor overall diagnosis and treatment results. To address these issues, based on evidence-based medicine and principles with emphasis on scientific rigor, clinical applicability and innovation, the Trauma Branch of the Chinese Medical Association, Orthopedic Branch of the Chinese Medical Doctor Association, Orthopedics Branch of the Chinese Medical Association, and Trauma Orthopedics and Polytrauma Group of the Resuscitation and Emergency Committee of the Chinese Medical Doctor Association have collaboratively organized a panel of relevant experts to develop the Guideline for diagnosis and treatment of infection after internal fixation of closed lower limb fractures in adults ( version 2025). The guideline proposed 10 recommendations, aiming to provide a foundation for standardized diagnosis and treatment of postoperative infection in adults with closed lower limb fractures.
9.Predictive value of patient-reported outcomes combined with hematological indicators for moderate-to-severe endoscopic activity in patients with ulcerative colitis
Caimin LI ; Wenqian LI ; Sicong HOU ; Weiming XIAO ; Jie CHEN ; Mei WANG
Journal of Clinical Medicine in Practice 2025;29(13):55-60,65
Objective To analyze the predictive value of patient-reported outcomes(PRO)com-bined with hematological indicators for moderate-to-severe endoscopic activity in patients with ulcera-tive colitis(UC).Methods Clinical data of UC patients were retrospectively collected,including PRO,hematological parameters and endoscopic findings.Based on the Mayo endoscopic score,pa-tients were divided into remission and mild activity group(<2 points)and moderate-to-severe activity group(≥ 2 points).Independent influencing factors for moderate-to-severe endoscopic activity were screened through multivariate Logistic regression analysis,and a binary Logistic regression model was constructed.The receiver operating characteristic(ROC)curve was used to evaluate the discriminato-ry ability of the predictive model.The calibration of the model was assessed using calibration curves and the Spiegelhalter Z-test,and the model's performance was further validated in an external valida-tion cohort.Results Rectal bleeding(RB),C-reactive protein/albumin(CAR)and erythrocyte sed-imentation rate(ESR)were independent influencing factors for moderate-to-severe endoscopic activity(P<0.05).The area under the curve(AUC)of the nomogram predictive model constructed based on the logistic regression analysis results was 0.848(95%CI,0.798 to 0.900),with sensitivity of 76.6%and specificity of 79.6%.In the external validation cohort,the model's AUC was 0.778(95%CI,0.699 to 0.857),and there was no statistically significant difference compared with the AUC of the training cohort model(P>0.05).In both the training and validation cohorts,the Spiegelhalter Z-test results indicated that the model had good goodness-of-fit(P>0.05).Conclu-sion RB,CAR and ESR are independent influencing factors for moderate-to-severe endoscopic ac-tivity in UC patients.The combination of RB,CAR and ESR has high predictive value for moderate-to-severe endoscopic activity in UC patients,with good discriminatory and calibration abilities.
10.Immunomodulatory effect of short-chain fatty acids in hepatic encephalopathy and its potential diagnostic value
Weiyu CHEN ; Dewen MAO ; Han WANG ; Yang DU ; Wenqian FENG ; Lei FU ; Chun YAO
Journal of Clinical Hepatology 2025;42(5):954-962
Hepatic encephalopathy(HE)is a common complication of severe liver disease in the end stage,and it is urgently needed to improve the rate of effective treatment and clarify the pathogenesis of HE.The liver is a crucial hub for immune regulation,and disruption of immune homeostasis is a key factor in the pathological mechanisms of HE.As the main metabolites of intestinal flora,short-chain fatty acids(SCFAs)play a vital role in the biological processes of both innate and adaptive immunity and can regulate the proliferation and differentiation of immune cells maintain the homeostasis of intestinal microenvironment and the integrity of barrier function.Studies have shown that SCFAs participate in bidirectional and dynamic interactions with the liver-gut-brain axis through immunomodulatory pathways,thereby playing an important role in the diagnosis,treatment,and prognostic evaluation of HE.Starting from the immunoregulatory effect of SCFAs,this article summarizes and analyzes the crosstalk relationship between SCFAs and the liver-gut-brain axis and the significance of SCFAs in the diagnosis and treatment of HE,in order to provide new ideas for optimizing clinical prevention and treatment strategies.

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