1.Study on the immunotoxicity and mechanism of Carthamus tinctorius extract on RBL-2H3 cells
Silan WU ; Xiaoli MEI ; Jinping LUO ; Li ZHANG ; Sixing HUANG ; Chonggang HUANG
China Pharmacy 2026;37(8):1003-1008
OBJECTIVE To investigate the immunotoxicity and potential mechanism of Carthamus tinctorius extract on RBL-2H3 cells via direct induction and induction by sensitized serum prepared with an overdose of the extract. METHODS For direct induction by C. tinctorius extract, RBL-2H3 cells were divided into normal control group (no treatment) and C. tinctorius extract group (10 mg/mL). For induction by sensitized serum prepared with an overdose of C. tinctorius extract, rats were divided into normal control group (no treatment), adjuvant-treated group (1 mL adjuvant), C. tinctorius extract-induced sensitization group (2.04 g/mL), and ovalbumin (OVA)-induced sensitization group (50 mg/mL). Sensitization was performed once every other day for a total of 3 times. Morphological changes of RBL-2H3 cells were observed, the degranulated rate of cells was counted, and histamine content was determined; the release rate of β -hexosaminidase ( β -Hex) was calculated, the levels of interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α) and intracellular Ca²⁺ concentration were detected. RESULTS Under direct induction by C. tinctorius extract, compared with the normal control group, the volume of cells in the C. tinctorius extract group was significantly reduced and cell density decreased; the degranulation rate of cells, histamine content, β -Hex release rate, IL-6 and TNF-α levels, as well as intracellular Ca²⁺ concentration were all significantly increased ( P <0.01). Under i nduction by sensitized serum prepared with an overdose of C. tinctorius extract, compared with the adjuvant-treated group, the above indicators in the C. tinctorius extract-induced sensitization group and the OVA-induced sensitization group showed consistent changes with those in the C. tinctorius extract group under direct induction, all being significantly elevated ( P <0.01). CONCLUSIONS C. tinctorius extract may affect degranulation of RBL-2H3 cells and promote Ca²⁺ influx accompanied by the release of pro-inflammatory cytokines through two approaches: direct induction and induction by sensitized serum prepared under overdose administration. Its mechanism may be related to the activation of the calcium signaling pathway and the regulation of inflammatory pathways under the synergistic effect of multiple components.
2.Treatment Principles and Paradigm of Diabetic Microvascular Complications Responding Specifically to Traditional Chinese Medicine
Anzhu WANG ; Xing HANG ; Lili ZHANG ; Xiaorong ZHU ; Dantao PENG ; Ying FAN ; Min ZHANG ; Wenliang LYU ; Guoliang ZHANG ; Xiai WU ; Jia MI ; Jiaxing TIAN ; Wei ZHANG ; Han WANG ; Yuan XU ; .LI PINGPING ; Zhenyu WANG ; Ying ZHANG ; Dongmei SUN ; Yi HE ; Mei MO ; Xiaoxiao ZHANG ; Linhua ZHAO
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(5):272-279
To explore the advantages of traditional Chinese medicine (TCM) and integrative TCM-Western medicine approaches in the treatment of diabetic microvascular complications (DMC), refine key pathophysiological insights and treatment principles, and promote academic innovation and strategic research planning in the prevention and treatment of DMC. The 38th session of the Expert Salon on Diseases Responding Specifically to Traditional Chinese Medicine, hosted by the China Association of Chinese Medicine, was held in Beijing, 2024. Experts in TCM, Western medicine, and interdisciplinary fields convened to conduct a systematic discussion on the pathogenesis, diagnostic and treatment challenges, and mechanism research related to DMC, ultimately forming a consensus on key directions. Four major research recommendations were proposed. The first is addressing clinical bottlenecks in the prevention and control of DMC by optimizing TCM-based evidence evaluation systems. The second is refining TCM core pathogenesis across DMC stages and establishing corresponding "disease-pattern-time" framework. The third is innovating mechanism research strategies to facilitate a shift from holistic regulation to targeted intervention in TCM. The fourth is advancing interdisciplinary collaboration to enhance the role of TCM in new drug development, research prioritization, and guideline formulation. TCM and integrative approaches offer distinct advantages in managing DMC. With a focus on the diseases responding specifically to TCM, strengthening evidence-based support and mechanism interpretation and promoting the integration of clinical care and research innovation will provide strong momentum for the modernization of TCM and the advancement of national health strategies.
3.Theory and practice of medical humanistic care: a decade of implementation by the medical humanities team at Harbin Medical University
Yu WANG ; Xuesong WU ; Mei YIN
Chinese Medical Ethics 2026;39(2):182-187
On October 9, 2024, the General Office of the National Health Commission, the General Office of the Ministry of Education, the General Department of the National Administration of Traditional Chinese Medicine, and the General Department of the National Bureau of Disease Control and Prevention jointly issued the Action Plan for Enhancing Medical Humanistic Care (2024-2027), stating that medical humanistic spirit is a concrete manifestation of humanistic spirit in the medical field. Aiming at caring for and respecting patients, this spirit reflects the attitude of medicine towards life. The cultivation of medical humanistic care competencies should serve as a core element of modern medical education, running through the entire process of the medical students’ training system and the full stage of medical workers’ career development. The humanities team of Harbin Medical University pioneered the “consistent system” concept of medical humanities education, inherited the “four-stage” with clinical practice as the primary approach, and closely focused on “three combinations, two considerations, and one assessment.” Through deeply integrating medicine with the humanities, as well as theory with practice, they have embarked on a distinctive implementation path of medical humanities, laying a solid foundation for the cultivation of high-quality medical talents with both skills and expertise in practice.
4.Establishment of graded management standards for off-label use of Shenqi fuzheng injection
Min WU ; Mei YU ; Shengnan YIN ; Dongmei LIU
China Pharmacy 2026;37(5):650-654
OBJECTIVE To establish the graded management standards for off-label use of Shenqi fuzheng injection. METHODS Systematic searches were conducted in databases including CNKI, PubMed and the Cochrane Library to retrieve guidelines/consensuses, systematic reviews/meta-analyses, and randomized controlled trials (RCTs) of Shenqi fuzheng injection. The quality of evidence was evaluated using AGREE Ⅱ, AMSTAR Ⅱ, and the Risk of Bias 1.0 tool recommended by Cochrane Collaboration, and the graded management standard for off-label use of Shenqi fuzheng injection was developed by using the Thomson grading system. RESULTS A total of 534 articles were involved, including 11 guidelines, 22 systematic reviews/meta-analysis, and 501 RCTs. They covered 79 off-label indications for Shenqi fuzheng injection: cancer-related fatigue, colorectal cancer and breast cancer, all with high-quality evidence were classified under grade A management (grade Ⅰ commendation), allowing all physicians across the hospital to prescribe relevant treatments; five diseases, such as ovarian cancer, liver cancer, leukemia, heart failure and cerebral infarction, were classified under grade B management (grade Ⅱa commendation), with prescription restricted to physicians with intermediate or higher professional titles in specific departments; eleven diseases, including sepsis, cervical cancer, esophageal cancer, etc., were classified under grade C management (grade Ⅱb commendation), requiring strict evaluation by senior physicians before prescription; the use of Shenqi fuzheng injection for other conditions was explicitly prohibited due to a lack of sufficient evidence. CONCLUSIONS Off-label use of Shenqi fuzheng injection is prevalent. The graded management standard established by evidence-based medical approach provides a scientific basis for standardizing the clinical application of traditional Chinese medicine injections and offers an operable paradigm for implementing differentiated drug use supervision in medical institutions.
5.Research Tackling Paradigm and Technological Layout Strategies Based on Erectile Dysfunction, A Clinical Dominant Disease of Traditional Chinese Medicine
Qi ZHAO ; Yun CHEN ; Baoxing LIU ; Xuejun SHANG ; Fei SUN ; Xiaozhi ZHAO ; Zhigang WU ; Chao SUN ; Peihai ZHANG ; Wanjun CHENG ; Xing ZHOU ; Zhan QIN ; Yufeng PAN ; Weiwei TAO ; Jianhuai CHEN ; Mei MO ; Xiaoxiao ZHANG ; Xing ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(7):291-299
To thoroughly implement the strategic deployment outlined in the Opinions of the Central Committee of the Communist Party of China and the State Council on Promoting the Inheritance and Innovative Development of Traditional Chinese Medicine regarding research on dominant diseases of traditional Chinese medicine and to uphold the development philosophy of equal emphasis on traditional Chinese medicine and western medicine,the China Association of Chinese Medicine has fully played a leading academic role by systematically organizing and conducting a series of academic youth salons on clinical dominant diseases of traditional Chinese medicine. On September 13,2024,the 36th Youth Salon on Clinical Dominant Diseases was successfully held in Nanjing,focusing on the advantages of traditional Chinese medicine and the integrative traditional Chinese medicine and western medicine in the diagnosis and treatment of erectile dysfunction (ED). The conference brought together leading experts from traditional Chinese medicine,western medicine,and interdisciplinary fields,facilitating in-depth multidisciplinary discussions that led to key consensus on optimizing traditional Chinese medicine treatment protocols for ED,researching and developing new drugs of traditional Chinese medicine,and advancing interdisciplinary development in traditional Chinese medicine. This salon systematically sorted out the clinical strengths and distinctive features of traditional Chinese medicine in the diagnosis and treatment of ED. Based on current research foundations and clinical needs,it identified key directions for future scientific layout and scientific research tackling: (1) Standardization of syndrome differentiation system of traditional Chinese medicine for ED. (2) Optimization and standardization of intervention methods of integrated traditional Chinese medicine and western medicine. (3) High-quality clinical research guided by evidence-based medicine. (4) In-depth analysis of the pharmacological mechanisms of traditional Chinese medicine in the treatment of ED. (5) Clinical translation and application promotion of new drugs of traditional Chinese medicine. (6) Interdisciplinary integration and innovation in traditional Chinese medicine. For each research direction,key focus areas,expected objectives,and clinical value were further refined,along with the establishment of a scientifically sound priority funding level evaluation system. Therefore,building on the series of salons on the ED-focused dominant diseases of traditional Chinese medicine,this paper provides standardized guidance for clinical practice of traditional Chinese medicine in ED management,effectively contributing to the high-quality development of traditional Chinese medicine. It serves as a valuable reference for national scientific and technological strategic layout, research and development decision-making in new drugs of traditional Chinese medicine,research topic planning,and clinical guideline formulation.
6.Prevalence and associated factors analysis of the co-occurrence of elevated blood pressure and depressive symptoms among junior and senior high school students in Anhui Province
WANG Yuting, CHEN Guoping, WU Jing, ZHANG Yukun, YANG Yang, MEI Xuenong
Chinese Journal of School Health 2026;47(4):584-588
Objective:
To investigate the prevalence and influencing factors of the co-occurrence of elevated blood pressure and depressive symptoms among junior and senior high school students in Anhui Province, so as to provide evidence for comprehensive interventions on physical and mental health among adolescents.
Methods:
From September to December 2024, a multi stage random cluster sampling method was used to select 103 225 junior and senior high school students from 16 prefecture level cities in Anhui Province. Data were collected through questionnaire surveys and physical measurements. Elevated blood pressure was determined according to the Reference of Screening for Elevated Blood Pressure among Children and Adolescents Aged 7-18 Years. Depressive symptoms among middle school students were assessed using the Center for Epidemiologic Studies Depression Scale (CES-D). Chi-square test, Chi-square test for trend, and multivariate Logistic regression model were used to analyze the risk factors for the co-occurrence of elevated blood pressure and depressive symptoms.
Results:
The detection rate of elevated blood pressure was 15.22%, the detection rate of depressive symptoms was 18.56%, and the co-occurrence rate of the two conditions was 2.67% among junior and senior high school students. Multivariate Logistic regression analysis showed that after controlling for gender, school stage, household registration, and overweight and obesity status,compared with those who don t drink sugary drink and eat fried food, and get enough sleep, sugar sweetened beverage intake <1 and ≥1 time/d( OR =1.28,1.61), fried food consumption ≥1 time/d( OR =1.37), and insufficient sleep ( OR =1.54) were all associated with an increased risk of the co-occurrence of elevated blood pressure and depressive symptoms(all P <0.05). Daily fresh vegetable intake ≥1 time/d( OR =0.78) and fresh fruit intake ≥1 time/d( OR =0.85) were both associated with a decreased risk of the co-occurrence(both P <0.05). Compared with students who did not eat breakfast, students who ate breakfast sometimes and every day ( OR =0.62,0.36) had a lower co-occurrence risk(both P < 0.05). Junior and senior high school students with daily outdoor activity duration≥1 h ( OR =0.81) had a lower risk of the co-occurrence of elevated blood pressure and depressive symptoms ( P <0.05).
Conclusions
Sugar sweetened beverage drink and fried food consumption, inadequate consumption of fresh vegetables, fruits and breakfast, lack of outdoor activity, and insufficient sleep are risk factors for the co-occurrence of elevated blood pressure and depressive symptoms among junior and senior high school students in Anhui Province. It is necessary to establish school health promotion strategies integrating nutrition, exercise and sleep management as intervention targets to reduce the co-occurrence risk of elevated blood pressure and depressive symptoms among junior and senior high school students.
7.Nanopackaged Astaxanthin Improves Demyelination in Multiple Sclerosis Model Mice by Scavenging Excessive Endogenous Formaldehyde
Wan-Jia LÜ ; Xin ZENG ; Zhi-Qian TONG ; Yang XING ; Xu YANG ; Mei-Na WU ; Ping MA
Progress in Biochemistry and Biophysics 2026;53(2):442-457
ObjectiveMultiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS); however, its underlying neurological pathogenic mechanisms remain incompletely understood. Endogenous formaldehyde (FA), a metabolic byproduct of methylation-demethylation cycles, has recently been implicated in neurotoxicity, oxidative damage, and cognitive impairment. This study aimed to investigate whether excessive FA contributes to myelin sheath demyelination in mice and to evaluate the protective effects and mechanisms of two FA-elimination strategies: sodium bisulfite (NaHSO3), a classical FA scavenger, and polyethylene glycol-modified astaxanthin nanoparticles (PEG-ATX@NPs), a brain-targeted nano-antioxidant formulation. MethodsA chronic demyelination model was established by feeding female C57BL/6J mice a diet containing 0.2% cuprizone (CPZ) for four weeks, followed by a two-week intervention period. Eighty mice were randomly assigned to four groups: NS (normal saline), CPZ+NS, CPZ+NaHSO3, and CPZ+PEG-ATX@NPs. Behavioral tests, including open-field, Y-maze, and pole-climbing assays, were conducted to assess locomotor activity, motor coordination, and working memory. FA levels in serum, corpus callosum, and spinal cord were measured using an Na-FA fluorescent probe and quantified via in vivo and ex vivo fluorescence imaging. Neuroinflammatory responses were evaluated by measuring TNF-α, IL-1β, and IL-6 levels using ELISA, while oxidative stress was assessed by reactive oxygen species (ROS) fluorescence intensity. Demyelination was examined via Luxol fast blue staining, and microglial activation was analyzed by Iba1 immunofluorescence. Correlation analyses were performed to explore relationships among FA levels, inflammatory cytokines, ROS intensity, and behavioral parameters. ResultsCompared with the NS group, mice in the CPZ+NS group exhibited significant weight loss, impaired motor coordination and memory, and markedly reduced myelin regeneration (P<0.05). FA levels and pro-inflammatory cytokines were significantly elevated in serum, corpus callosum, and spinal cord (P<0.05). FA-associated fluorescence in brain and spinal tissues, as well as ROS intensity across all tissues examined, also increased substantially (P<0.05). CPZ treatment induced pronounced microglial activation and severe demyelination in the corpus callosum (P<0.01). Both NaHSO3 and PEG-ATX@NPs effectively reduced FA accumulation in the brain and spinal cord, attenuated demyelination, suppressed microglial activation, decreased inflammatory cytokine levels, and improved motor and cognitive performance. These results confirm that CPZ induced severe demyelination accompanied by oxidative stress, neuroinflammation, and abnormal FA accumulation. Following intervention with either NaHSO3 or PEG-ATX@NPs, endogenous FA levels in the CNS were substantially reduced. Both treatments alleviated demyelination and significantly decreased the number of activated microglia. Levels of TNF-α, IL-1β, and IL-6 in serum, corpus callosum, and spinal cord were downregulated. Behavioral performance improved significantly, as evidenced by enhanced locomotor activity, better coordination, and improved memory function. These findings indicate that both FA-scavenging agents mitigate CPZ-induced biochemical and behavioral abnormalities. ConclusionThis study demonstrates that excessive endogenous FA is closely associated with cognitive impairment, inflammatory dysregulation, and demyelination in a CPZ-induced chronic demyelination mouse model. Clearing abnormally elevated FA effectively reduces neuroinflammation, suppresses microglial overactivation, decreases oxidative stress, and alleviates demyelination, ultimately improving motor and cognitive outcomes in mice. These results suggest that targeting endogenous FA represents a promising therapeutic strategy for MS and other demyelinating disorders. Further investigations are warranted to explore the long-term safety, dosage optimization, and molecular pathways involved in FA-mediated neurotoxicity.
8.Nanopackaged Astaxanthin Improves Demyelination in Multiple Sclerosis Model Mice by Scavenging Excessive Endogenous Formaldehyde
Wan-Jia LÜ ; Xin ZENG ; Zhi-Qian TONG ; Yang XING ; Xu YANG ; Mei-Na WU ; Ping MA
Progress in Biochemistry and Biophysics 2026;53(2):442-457
ObjectiveMultiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS); however, its underlying neurological pathogenic mechanisms remain incompletely understood. Endogenous formaldehyde (FA), a metabolic byproduct of methylation-demethylation cycles, has recently been implicated in neurotoxicity, oxidative damage, and cognitive impairment. This study aimed to investigate whether excessive FA contributes to myelin sheath demyelination in mice and to evaluate the protective effects and mechanisms of two FA-elimination strategies: sodium bisulfite (NaHSO3), a classical FA scavenger, and polyethylene glycol-modified astaxanthin nanoparticles (PEG-ATX@NPs), a brain-targeted nano-antioxidant formulation. MethodsA chronic demyelination model was established by feeding female C57BL/6J mice a diet containing 0.2% cuprizone (CPZ) for four weeks, followed by a two-week intervention period. Eighty mice were randomly assigned to four groups: NS (normal saline), CPZ+NS, CPZ+NaHSO3, and CPZ+PEG-ATX@NPs. Behavioral tests, including open-field, Y-maze, and pole-climbing assays, were conducted to assess locomotor activity, motor coordination, and working memory. FA levels in serum, corpus callosum, and spinal cord were measured using an Na-FA fluorescent probe and quantified via in vivo and ex vivo fluorescence imaging. Neuroinflammatory responses were evaluated by measuring TNF-α, IL-1β, and IL-6 levels using ELISA, while oxidative stress was assessed by reactive oxygen species (ROS) fluorescence intensity. Demyelination was examined via Luxol fast blue staining, and microglial activation was analyzed by Iba1 immunofluorescence. Correlation analyses were performed to explore relationships among FA levels, inflammatory cytokines, ROS intensity, and behavioral parameters. ResultsCompared with the NS group, mice in the CPZ+NS group exhibited significant weight loss, impaired motor coordination and memory, and markedly reduced myelin regeneration (P<0.05). FA levels and pro-inflammatory cytokines were significantly elevated in serum, corpus callosum, and spinal cord (P<0.05). FA-associated fluorescence in brain and spinal tissues, as well as ROS intensity across all tissues examined, also increased substantially (P<0.05). CPZ treatment induced pronounced microglial activation and severe demyelination in the corpus callosum (P<0.01). Both NaHSO3 and PEG-ATX@NPs effectively reduced FA accumulation in the brain and spinal cord, attenuated demyelination, suppressed microglial activation, decreased inflammatory cytokine levels, and improved motor and cognitive performance. These results confirm that CPZ induced severe demyelination accompanied by oxidative stress, neuroinflammation, and abnormal FA accumulation. Following intervention with either NaHSO3 or PEG-ATX@NPs, endogenous FA levels in the CNS were substantially reduced. Both treatments alleviated demyelination and significantly decreased the number of activated microglia. Levels of TNF-α, IL-1β, and IL-6 in serum, corpus callosum, and spinal cord were downregulated. Behavioral performance improved significantly, as evidenced by enhanced locomotor activity, better coordination, and improved memory function. These findings indicate that both FA-scavenging agents mitigate CPZ-induced biochemical and behavioral abnormalities. ConclusionThis study demonstrates that excessive endogenous FA is closely associated with cognitive impairment, inflammatory dysregulation, and demyelination in a CPZ-induced chronic demyelination mouse model. Clearing abnormally elevated FA effectively reduces neuroinflammation, suppresses microglial overactivation, decreases oxidative stress, and alleviates demyelination, ultimately improving motor and cognitive outcomes in mice. These results suggest that targeting endogenous FA represents a promising therapeutic strategy for MS and other demyelinating disorders. Further investigations are warranted to explore the long-term safety, dosage optimization, and molecular pathways involved in FA-mediated neurotoxicity.
9.Guidelines for standardized implementation of pharmacist-managed clinics (2026 edition)
Pengxiang ZHOU ; Maobai LIU ; Xiaoli DU ; Xiaoyang LU ; Mei DONG ; Rong DUAN ; Ruigang HOU ; Xiaoyu LI ; Qi CHEN ; Yanxiao XIANG ; Weiyi FENG ; Rong CHEN ; Deshi DONG ; Yong YANG ; Li LI ; Xiaocong ZUO ; Jinfang HU ; Hongliang ZHANG ; Qingchun ZHAO ; Qi LIN ; Yang HU ; Jiaying WU ; Rongsheng ZHAO
China Pharmacy 2026;37(9):1105-1112
OBJECTIVE To formulate Guidelines for the standardized implementation of pharmacist-managed clinics ( 2026 edition ) in response to the challenges faced by such clinics in China, including uneven development, large discrepancies in service specifications, insufficient patient awareness, and limited medical insurance coverage. METHODS Led by the Pharmaceutical Affairs Professional Committee of the Chinese Hospital Association, the Evidence-based Pharmacy Professional Committee of the Chinese Pharmaceutical Association, and the Hospital Pharmacy Professional Committee of the Cross-strait Medical and Health Exchange Association, a total of 19 domestic hospital pharmacy experts were organized. Through a systematic review of national policies and literature research, current practical experience was summarized. Consensus on the contents of the guidelines was reached after in-depth discussions. RESULTS &CONCLUSIONS The guidelines covered five sections: definition and connotation of pharmacist-managed clinics, establishment requirements, implementation and management, post competency, and practical research. Firstly, the definition and connotation included three operational forms of pharmacist-managed clinics (independent mode, physician-pharmacist joint mode, and online pharmacist-managed clinic mode) and classified service modes (specialty-specific, drug-specific, and disease-specific pharmacist-managed clinics). The establishment requirements were further refined, covering system construction (pharmaceutical service management system, quality control and assessment mechanism), personnel qualifications (professional credentials, continuing education and professional training, etc), service recipients, as well as service venues and facilities. Subsequently, the implementation and management of pharmacist-managed clinics were proposed, involving service procedures, intervention measures, documentation and records, patient education and follow-up, humanistic care, as well as risk management and quality control. Finally, post competency encompassed the competency requirements for pharmacists providing services in pharmacist-managed clinics, as well as the suggestions on teaching methods; practical research encouraged the conduct of high-quality pharmaceutical practice in the setting of pharmacist-managed clinics. The guidelines provide valuable guidance for the standardized implementation of pharmacist-managed clinics in China in terms of establishment, management, teaching, and research, fill the guideline gap in this field, and can promote the high-quality development of pharmacist-managed clinics.
10.Retrospective analysis of adverse events associated with traditional Chinese medicine formula granules and decoction pieces in hospitalized patients using the global trigger tool
Yaxiong LI ; Fusang WANG ; Mei ZHANG ; Jiawei LIN ; Wenge CHEN ; Min HUANG ; Junyan WU
China Pharmacy 2025;36(5):606-611
OBJECTIVE To provide technical support for improving recognition rate of adverse drug events (ADEs) related to traditional Chinese medicine (TCM) formula granules and decoction pieces among inpatient patients. METHODS By referencing the global trigger tool (GTT) whitepaper, literature on adverse reactions to TCM, and expert review opinions, ADE trigger items for TCM formula granules and decoction pieces used in the inpatients were established. GTT was applied to analyze ADEs in inpatients who had used TCM formula granules and decoction pieces in our hospital from August 2013 to August 2023, utilizing the Chinese Hospital Pharmacovigilance System. The effectiveness of GTT and the characteristics of these ADEs were analyzed. RESULTS A total of forty-eight triggers were established, including thirty-two laboratory test indexes, thirteen clinical symptoms, and three antidotes. Among the 1 682 patients included, GTT identified 652 potential ADEs, 284 true positive ADEs,with a trigger rate of 38.76% and a positive predictive value of 43.56%. After review by the auditor, 278 cases of ADEs were finally confirmed, with an incidence rate of 16.53%, significantly higher than the number of spontaneously reported ADEs during the same period (0). The 278 cases of ADEs were mostly grade 1 (223 cases), mainly involving hepatobiliary system, gastrointestinal system, blood- lymphatic system, etc;a total of 219 types of TCMs are involved,and the top five suspected TCMs used at a frequency higher than 1% were Poria cocos, Codonopsis pilosula, Atractylodes macrocephala, fried Glycyrrhiza uralensis, and Scutellaria baicalensis. CONCLUSIONS The established GTT can improve the recognition rate of ADEs for hospitalized patients using traditional Chinese medicine formula granules and decoction pieces.


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