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.Pharmacoeconomic evaluation of finerenone combined with standard treatment regimen in the treatment of diabetic nephropathy
Hai LIANG ; Runan XIA ; Panpan DI ; Mengmeng ZHAO ; Pengcheng ZHANG ; Yashen HOU ; Hong ZHANG ; Wei WU ; Miao YANG
China Pharmacy 2025;36(1):86-90
OBJECTIVE To evaluate the cost-effectiveness of finerenone combined with standard treatment regimen in the treatment of diabetic nephropathy (DN). METHODS From the perspective of healthcare service providers, a Markov model was established to simulate the dynamic changes of each stage in DN patients who received finerenone combined with the standard treatment regimen or the standard treatment regimen alone based on the phase Ⅲ clinical trial study of finerenone for DN. Markov model was used to perform the cost-effectiveness of long-term effects and the costs of the two therapies with a simulation cycle of 4 months, a simulation period of 15 years and an annual discount rate of 5%. At the same time, one-way sensitivity analysis and probability sensitivity analysis were performed, and the stability of the results was validated. RESULTS Accumulative cost of the standard treatment regimen was 579 329.54 yuan, and the accumulative utility was 8.052 4 quality-adjusted life year (QALYs); the accumulative cost of finerenone combined with the standard treatment regimen was 332 520.61 yuan, and the accumulative utility was 8.187 4 QALYs. Finerenone combined with the standard treatment regimen was more cost-effective. The results of one-way sensitivity analysis showed that dialysis status utility value, DN stage 3 utility value and DN stage 4 utility value had a great influence on the incremental cost-effectiveness ratio, but did not affect the robustness of the model. The results of probability sensitivity analysis showed that finerenone combined with the standard treatment regimen was more cost-effective with 100% probability. CONCLUSIONS For DN patients, finerenone combined with the standard treatment regimen is more cost-effective as an absolute advantage option.
4.Clinical Safety Monitoring of 3 035 Cases of Juvenile Feilike Mixture After Marketing in Hospital
Jian ZHU ; Zhong WANG ; Jing LIU ; Jun LIU ; Wei YANG ; Yanan YU ; Hongli WU ; Sha ZHOU ; Zhiyu PAN ; Guang WU ; Mengmeng WU ; Zhiwei JING
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(10):194-200
ObjectiveTo explore the clinical safety of Feilike Mixture (FLK) in the real world. MethodsThe safety of all children who received FLK from 29 institutions in 12 provinces between January 21,2021 and December 25,2021 was evaluated through prospective centralized surveillance and a nested case control study. ResultsA total of 3 035 juveniles were included. There were 29 research centers involved,which are distributed across 12 provinces,including one traditional Chinese medicine (TCM) hospital and 28 general hospitals. The average age among the juveniles was (4.77±3.56) years old,and the average weight was (21.81±12.97) kg. Among them,119 cases (3.92%) of juveniles had a history of allergies. Acute bronchitis was the main diagnosis for juveniles,with 1 656 cases (54.46%). FLK was first used in 2 016 cases (66.43%),and 142 juvenile patients had special dosages,accounting for 4.68%. Among them,92 adverse drug reactions (ADRs) occurred,including 73 cases of gastrointestinal system disorders,10 cases of metabolic and nutritional disorders,eight cases of skin and subcutaneous tissue diseases,two cases of vascular and lymphatic disorders,and one case of systemic diseases and various reactions at the administration site. The manifestations of ADRs were mainly diarrhea,stool discoloration,and vomiting,and no serious ADRs occurred. The results of multi-factor analysis indicated that special dosages (the use of FLK)[odds ratio (OR) of 2.642, 95% confidence interval (CI) of 1.105-6.323],combined administration: spleen aminopeptide (OR of 4.978, 95%CI of 1.200-20.655),and reason for combined administration: anti-infection (OR of 1.814, 95%CI of 1.071-3.075) were the risk factors for ADRs caused by FLK. Conclusion92 ADRs occurred among 3 035 juveniles using FLK. The incidence of ADRs caused by FLK was 3.03%,and the severity was mainly mild or moderate. Generally,the prognosis was favorable after symptomatic treatment such as drug withdrawal or dosage reduction,suggesting that FLK has good clinical safety.
5.Ancient and Modern Literature Analysis and Key Information Research of Classic Formula Qingfeitang
Lyuyuan LIANG ; Jinyan ZHANG ; Jialei CAO ; Jing TANG ; Mengmeng GENG ; Yiqing ZHAO ; Hejia WAN ; Yiping WANG ; Bingqi WEI ; Bingxiang MA ; Wenli SHI
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(24):179-189
Qingfeitang, specialized in resolving phlegm to stop cough and producing fluid to moisten dryness, is a classic prescription inherited and developed by physicians of successive generations and has been included in the Catalogue of Ancient Classic Prescriptions (First Batch) published by the National Administration of Traditional Chinese Medicine (TCM) in 2018. Relevant ancient books data and modern literature were collected by bibliometrics to analyze the historic origin, formula composition, herb origin, preparation methods, processing methods, clinical effect, and indications of Qingfeitang. The key information of Qingfeitang was summarized to provide reference for the clinical application of the decoction. In this study, a total of 43 pieces of effective data on relevant ancient literature, including 35 ancient TCM books, were collected based on a systematic collation of relevant historic and modern literature. Results showed that "Qingfeitang" was originated from the "Renshen Qingfeitang" recorded in the Taiping Holy Prescriptions for Universal Relief from the Qing dynasty. The name of "Qinfeitang" was first recorded in the Yeshi Luyanfang written by YE Dalian in the Song dynasty. We suggested the modern dosage and usage of Qingfeitang as follows: "Scutellariae Radix of 5.60 g, Platycodon grandiflora, Poria, Tangerine, Fritillaria, and Cortex Mori of 3.73 g respectively, Angelicae Sinensis Radix, Asparagi Radix, Gardeniae Fructus, Armeniacae Semen Amarum, and Ophiopogonis Radix of 2.61 g respectively, Schisandra of 1 g, and Glycyrrhizae Radix et Rhizoma of 1.12 g, and they were taken 3 times daily. The above formula is recommended to be decocted with 400 mL of water, with 3.37 g ginger and 6 g jujubae fructus, to 320 mL, and taken after a meal, three times per day". Qingfeitang has the effect of resolving phlegm to stop cough and producing fluid to moisten dryness, specialized in treating cough, asthma, rash, and other symptoms in ancient times. Modern applications are mainly focused on the respiratory system, used for treating diseases such as bronchopneumonia and cough. The above research results provide a reference basis for the later development and research of Qingfeitang.
6.Research on arrhythmia classification algorithm based on adaptive multi-feature fusion network.
Mengmeng HUANG ; Mingfeng JIANG ; Yang LI ; Xiaoyu HE ; Zefeng WANG ; Yongquan WU ; Wei KE
Journal of Biomedical Engineering 2025;42(1):49-56
Deep learning method can be used to automatically analyze electrocardiogram (ECG) data and rapidly implement arrhythmia classification, which provides significant clinical value for the early screening of arrhythmias. How to select arrhythmia features effectively under limited abnormal sample supervision is an urgent issue to address. This paper proposed an arrhythmia classification algorithm based on an adaptive multi-feature fusion network. The algorithm extracted RR interval features from ECG signals, employed one-dimensional convolutional neural network (1D-CNN) to extract time-domain deep features, employed Mel frequency cepstral coefficients (MFCC) and two-dimensional convolutional neural network (2D-CNN) to extract frequency-domain deep features. The features were fused using adaptive weighting strategy for arrhythmia classification. The paper used the arrhythmia database jointly developed by the Massachusetts Institute of Technology and Beth Israel Hospital (MIT-BIH) and evaluated the algorithm under the inter-patient paradigm. Experimental results demonstrated that the proposed algorithm achieved an average precision of 75.2%, an average recall of 70.1% and an average F 1-score of 71.3%, demonstrating high classification accuracy and being able to provide algorithmic support for arrhythmia classification in wearable devices.
Humans
;
Arrhythmias, Cardiac/diagnosis*
;
Algorithms
;
Electrocardiography/methods*
;
Neural Networks, Computer
;
Signal Processing, Computer-Assisted
;
Deep Learning
;
Classification Algorithms
7.PARylation promotes acute kidney injury via RACK1 dimerization-mediated HIF-1α degradation.
Xiangyu LI ; Xiaoyu SHEN ; Xinfei MAO ; Yuqing WANG ; Yuhang DONG ; Shuai SUN ; Mengmeng ZHANG ; Jie WEI ; Jianan WANG ; Chao LI ; Minglu JI ; Xiaowei HU ; Xinyu CHEN ; Juan JIN ; Jiagen WEN ; Yujie LIU ; Mingfei WU ; Jutao YU ; Xiaoming MENG
Acta Pharmaceutica Sinica B 2025;15(9):4673-4691
Poly(ADP-ribosyl)ation (PARylation) is a specific form of post-translational modification (PTM) predominantly triggered by the activation of poly-ADP-ribose polymerase 1 (PARP1). However, the role and mechanism of PARylation in the advancement of acute kidney injury (AKI) remain undetermined. Here, we demonstrated the significant upregulation of PARP1 and its associated PARylation in murine models of AKI, consistent with renal biopsy findings in patients with AKI. This elevation in PARP1 expression might be attributed to trimethylation of histone H3 lysine 4 (H3K4me3). Furthermore, a reduction in PARylation levels mitigated renal dysfunction in the AKI mouse models. Mechanistically, liquid chromatography-mass spectrometry indicated that PARylation mainly occurred in receptor for activated C kinase 1 (RACK1), thereby facilitating its subsequent phosphorylation. Moreover, the phosphorylation of RACK1 enhanced its dimerization and accelerated the ubiquitination-mediated hypoxia inducible factor-1α (HIF-1α) degradation, thereby exacerbating kidney injury. Additionally, we identified a PARP1 proteolysis-targeting chimera (PROTAC), A19, as a PARP1 degrader that demonstrated superior protective effects against renal injury compared with PJ34, a previously identified PARP1 inhibitor. Collectively, both genetic and drug-based inhibition of PARylation mitigated kidney injury, indicating that the PARylated RACK1/HIF-1α axis could be a promising therapeutic target for AKI treatment.
8.Expert consensus on the diagnosis and treatment of cemental tear.
Ye LIANG ; Hongrui LIU ; Chengjia XIE ; Yang YU ; Jinlong SHAO ; Chunxu LV ; Wenyan KANG ; Fuhua YAN ; Yaping PAN ; Faming CHEN ; Yan XU ; Zuomin WANG ; Yao SUN ; Ang LI ; Lili CHEN ; Qingxian LUAN ; Chuanjiang ZHAO ; Zhengguo CAO ; Yi LIU ; Jiang SUN ; Zhongchen SONG ; Lei ZHAO ; Li LIN ; Peihui DING ; Weilian SUN ; Jun WANG ; Jiang LIN ; Guangxun ZHU ; Qi ZHANG ; Lijun LUO ; Jiayin DENG ; Yihuai PAN ; Jin ZHAO ; Aimei SONG ; Hongmei GUO ; Jin ZHANG ; Pingping CUI ; Song GE ; Rui ZHANG ; Xiuyun REN ; Shengbin HUANG ; Xi WEI ; Lihong QIU ; Jing DENG ; Keqing PAN ; Dandan MA ; Hongyu ZHAO ; Dong CHEN ; Liangjun ZHONG ; Gang DING ; Wu CHEN ; Quanchen XU ; Xiaoyu SUN ; Lingqian DU ; Ling LI ; Yijia WANG ; Xiaoyuan LI ; Qiang CHEN ; Hui WANG ; Zheng ZHANG ; Mengmeng LIU ; Chengfei ZHANG ; Xuedong ZHOU ; Shaohua GE
International Journal of Oral Science 2025;17(1):61-61
Cemental tear is a rare and indetectable condition unless obvious clinical signs present with the involvement of surrounding periodontal and periapical tissues. Due to its clinical manifestations similar to common dental issues, such as vertical root fracture, primary endodontic diseases, and periodontal diseases, as well as the low awareness of cemental tear for clinicians, misdiagnosis often occurs. The critical principle for cemental tear treatment is to remove torn fragments, and overlooking fragments leads to futile therapy, which could deteriorate the conditions of the affected teeth. Therefore, accurate diagnosis and subsequent appropriate interventions are vital for managing cemental tear. Novel diagnostic tools, including cone-beam computed tomography (CBCT), microscopes, and enamel matrix derivatives, have improved early detection and management, enhancing tooth retention. The implementation of standardized diagnostic criteria and treatment protocols, combined with improved clinical awareness among dental professionals, serves to mitigate risks of diagnostic errors and suboptimal therapeutic interventions. This expert consensus reviewed the epidemiology, pathogenesis, potential predisposing factors, clinical manifestations, diagnosis, differential diagnosis, treatment, and prognosis of cemental tear, aiming to provide a clinical guideline and facilitate clinicians to have a better understanding of cemental tear.
Humans
;
Dental Cementum/injuries*
;
Consensus
;
Diagnosis, Differential
;
Cone-Beam Computed Tomography
;
Tooth Fractures/therapy*
9.Textual Research on Classical Formula Juanbitang
Lyuyuan LIANG ; Jinyan ZHANG ; Jialei CAO ; Hejia WAN ; Tongyi HUANG ; Mengmeng GENG ; Bingqi WEI ; Bingxiang MA ; Yajing HE
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(24):190-197
This paper discussed the historic evolution of Juanbitang and similar decoctions, clarified the historic development of Yangshi Juanbitang and Chengshi Juanbitang, and probed into the key information of the meaning, original plants, processing methods, and modern dosage and usage of Chengshi Juanbitang. A total of 267 pieces of relevant information were collected from ancient traditional Chinese medicine (TCM) books, among which 53 pieces of effective data were included in this study. The results showed that both Chenshi Juanbitang and Yangshi Juanbitang were originated from Duhuo Jishengtang recoded in the Important Prescriptions Worth a Thousand Gold for Emergency (Bei Ji Qian Jin Yao Fang). According to the standard of "1 qian roughly equals 3.73 g" in the measurement system of the Qing Dynasty, we suggest Chenshi Juanbitang is composed of 3.73 g Notopterygii Rhizoma et Radix, 3.73 g Angelicae Pubescentis Radix, 3.73 g Gentianae Macrophyllae Radix, 11.19 g Angelicae Sinensis Radix, 11.19 g Mori Ramulus, 2.61 g Chuanxiong Rhizoma, 1.87 g Cinnamomi Cortex, 1.87 g stir-fried Glycyrrhizae Radix et Rhizoma, 7.46 g Piperis Kadsurae Caulis, 2.98 g Olibanum, and 2.98 g Aucklandiae Radix, which should be decocted with 600 mL water to reach a volume of 300 mL. The decoction should be taken 3 times a day before meals. Juanbitang, a classical formula specialized for treating impediment diseases, has the effects of dispelling wind, removing dryness, and alleviating impediment to relieve pain. It can be used for treating vexing pain in body, spasm of nape and back, and heaviness in waists and legs. Modern studies have shown that Juanbitang can be used for treating rheumatoid arthritis, knee osteoarthritis, and periarthritis of shoulder. The above results served as a reference for the future development of Juanbitang.
10.Infodemiology:A new opportunity for hospital library
Xin LAI ; Meiyu FAN ; Mengmeng WEI
China Modern Doctor 2024;62(10):68-71
Objective To discuss the significance and feasibility of infodemiology researches in hospital library.Methods This paper analyzed the background,significance,advantages,constraints,research direction and themes of the hospital library's researches on infodemiology.Results Hospital library had the advantages of disciplinary background and convenient resources to carry out researches on infodemiology,and can carry out researches in many aspects such as network health information evaluation,network health information monitoring,medical intervention measures evaluation,public opinion analysis and management.Conclusion It is feasible for hospital libraries to carry out infodemiology researches to promote their own transformation and to help hospital make decisions.

Result Analysis
Print
Save
E-mail