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Chinese Journal of Pharmacovigilance
17 February 2025, Volume 22 Issue 2

17 February 2025, Volume 22 Issue 2 Previous Issue   
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Research Progress in Triptolide-Induced Live Injury
TANG Qianhui, ZHANG Haoran, ZHANG Luyong, JIANG Zhenzhou
2025, 22(2): 121-127. 
DOI: 10.19803/j.1672-8629.20230658

Abstract ( 66 )   PDF (1355KB) ( 63 )  
Objective To summarize the research progress in the hepatotoxicity mechanism of triptolide and shed light on the mechanism of drug-induced liver injury caused by triptolide. Methods Based on literature research, the mechanism of drug induced liver injury caused by triptolide was summarized in terms of direct toxicity and indirect toxicity. Results The hepatotoxic mechanism of triptolide involved oxidative stress, mitochondrial damage, metabolic abnormalities, activation of NKT cells, imbalance between T helper cells and regulatory T cells, and increased liver sensitivity to inflammatory stimuli. Conclusion The hepatotoxicity mechanism of triptolide is complex, as there are a wide range of targets for direct toxicity. In addition, the indirect toxicity is highly concealed and complex. The elucidation of mechanisms of hepatotoxicity caused by triptolide provides a reference for enhancing the efficacy and reducing the toxicity of Tripterygium wilfordii Hook.f. and its preparations as well as for clinical safety and rational drug use.
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Roles of Hepatocellular NF-κB Signaling Pathway in Triptolide-Induced Indirect Liver Injury
TANG Qianhui, ZHU Ying, ZHANG Haoran, ZHANG Luyong, JIANG Zhenzhou
2025, 22(2): 128-138. 
DOI: 10.19803/j.1672-8629.20240855

Abstract ( 39 )   PDF (5602KB) ( 72 )  
Objective To investigate the role of hepatocellular nuclear factor-κB (NF-κB) signaling pathway in increasing hepatic sensitivity to lipopolysaccharide (LPS) mediated and drug-induced indirect liver injury caused by triptolide (TP). Methods In the in vivo experiment, female C57BL / 6N mice were randomly divided into the control group (Con), TP sequential LPS group (TP+LPS), and LPS sequential TP group (LPS+TP). Six hours after coadministration of TP and LPS, blood biochemistry, liver weight coefficient and hematoxylin eosin staining (HE) were detected to assess liver injury. Polymerase chain reaction (PCR) was used to detect the levels of inflammatory factors and genes related to anti-apoptosis. The expressions of apoptosis / anti-apoptosis related proteins were detected by Western Blot (WB) and immunohistochemistry (IHC), and the enzyme activity of apoptosis related proteins was also measured. Two hours after administration of LPS, the protein expressions of NF-κB inhibitory protein α (IκBα) and p65 were detected by WB. The translocation of p65 from the cytoplasm to the nucleus was observed by IHC. Changes in the levels of anti-apoptosis related genes were determined by PCR. In the in vitro experiment, the LDH content, enzyme activity of apoptosis related proteins, and levels of apoptosis / anti-apoptosis related proteins were detected after coadministration of TP and TNF-α. After administration of TP, changes in degradation of IκBα protein induced by TNF-α were determined by WB, and translocation of p65 was observed via immunofluorescence (IF). Phorbol 12-myristate 13-acetate (PMA) was selected to activate NF-κB signaling pathway in AML12 cells. The enzyme activity of apoptosis related proteins, protein levels of apoptosis / anti-apoptosis related proteins, and the content of LDH were measured to evaluate the changes caused by PMA pre-administration. Results Compared with the Con group, mice in the (TP+LPS) group showed a significant increase in aminotransferase levels, liver weight coefficient, and inflammatory factors, with significant pathological changes in the liver. However, there were no significant changes in the (LPS+TP) group compared with the Con group. The enzyme activity of caspase-8, expressions of apoptosis-related proteins, and IHC positive regions of cleaved caspase-3 increased significantly in the liver tissue of the (TP+LPS) group, and the expression of the anti-apoptotic protein FLIP showed a significant reduction, while the above-mentioned indexes were not significantly changed in the (LPS+TP) group. Pre-administration of TP significantly inhibited LPS-induced degradation of IκBα and p65 entry into the nucleus, and downregulated the expressions of anti-apoptosis related genes. In AML12 cells in in vitro, after coadministration of TP and TNF-α at a non-toxic concentration, the release of LDH and the expressions of apoptosis related proteins were significantly increased while the expressions of anti-apoptotic proteins were significantly decreased. TNF-α induced degradation of IκBα and the entry of p65 into the nucleus were significantly inhibited by TP. After pre-activation of the NF-κB signaling pathway in AML12 cells by administration of PMA, the expressions of apoptosis-related proteins, the enzyme activity of caspase-8 and the release of LDH were significantly decreased, while the expression of anti-apoptotic proteins was significantly increased. Conclusion NF-κB signaling pathway can make a big difference to the liver injury resulting from different sequential administrations of TP and LPS. TP can impair hepatocytes' ability to withstand the stimulation of exogenous pathogens and apoptosis signaling by inhibiting NF-κB activation, triggering a significant increase in apoptosis among hepatocytes, ultimately leading to the development of indirect drug-induced liver injury.
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Effects of Triptolide on Secretion of Steroid Hormone in Primary Adrenocortical Cells
WANG Hongli, DU Juan, CAO Mengqi, ZHANG Luyong, JIANG Zhenzhou, HUANG Xin
2025, 22(2): 139-146. 
DOI: 10.19803/j.1672-8629.20230660

Abstract ( 30 )   PDF (2216KB) ( 50 )  
Objective To establish a method for the extraction and verification of primary rat adrenocortical cells and to investigate the effect of triptolide on primary rat adrenocortical cells and the mechanism. Methods Primary adrenocortical cells were isolated and cultured in culture plates, their serum dependence and steroid hormone secretion function were verified, the toxicity of triptolide on primary adrenocortical cells and the effect of age on toxicity sensitivity to triptolide were investigated, and the mechanism was explored via PCR and WB experiments. Results The primary rat adrenocortical cells were serum-dependent and could secrete steroid hormone after 72 h in vitro. The toxicity sensitivity of triptolide was influenced by week age. Triptolide dose-dependently inhibited steroid hormone secretion and inhibited HSD3B2 gene and protein expressions. Conclusion The primary adrenocortical cells of female Wistar rats can serve as a good model to study the effect of drugs on adrenal steroid hormone secretion, whose inhibition by triptolide in primary adrenocortical cells is associated with decreased gene and protein expressions of HSD3B2.
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Screening of in vitro Stimulation Methods for iNKT Cells and Conditions for in vitro Activation of iNKT Cells by Triptolide
LIANG Xiaojing, CHEN Xin, NONG Cheng, LI Liang, DING Jian, ZHANG Luyong, JIANG Zhenzhou, WANG Xinzhi
2025, 22(2): 147-154. 
DOI: 10.19803/j.1672-8629.20230800

Abstract ( 27 )   PDF (2864KB) ( 55 )  
Objective To study the methods of activating iNKT cells and the conditions for TP's activation of iNKT cells in vitro. Methods Flow cytometry was performed to detect the activation marker CD69 and cytokine IL-2 of iNKT cell line DN32.D3 cells using either a combination of phorbol 12-myristate 13-acetate (PMA) and ionomycin (ION) or a combination of CD3e and CD28 antibodies. The liver nonparenchymal cells of mice were stimulated under different concentrations of PMA. The levels of CD69, IL-4, IL-17 and IL-10 in iNKT cells were detected by flow cytometry to screen the optimal methodological condition for the in vitro activation before the conditions for in vitro activation of DN32.D3 cells by TP were investigated. Results The best activation of iNKT cells was achieved when stimulated by the combination of PMA and ION with the concentration of PMA at 50 ng·mL-1. TP activated DN32.D3 cells when antigen-presenting cell (APC) RBL-CD1d cells were added for co-culture. Conclusion INKT cells are most activated when the PMA concentration is 50 ng·mL-1 with the combination of PMA and ION. TP activation of iNKT cells requires the presence of APCs.
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Safety and Efficacy of Chinese Herbal Patent Medicines for COVID-19: an Umbrella Review
LI Bo, XU Liu, XIE Yuqing, WANG Yiying, DONG Shuai, LIAN Jie, LI Guodong, CAO Huijuan
2025, 22(2): 155-161. 
DOI: 10.19803/j.1672-8629.20240011

Abstract ( 40 )   PDF (1466KB) ( 48 )  
Objective To summarize the current systematic review evidence for evaluating the efficacy and safety of Chinese herbal patent medicines (CHPMs) for the treatment of novel coronavirus pneumonia, assess the safety and efficacy of CHPMs as an intervention for the treatment of COVID-19, and to evaluate the quality of related evidence. Methods PubMed, Cochrane, Embase, Sinomed, China National Knowledge Infrastructure (CNKI), Wanfang database, and VIP were searched for systematic reviews of CHPMs in the treatment of COVID-19 that were published from the inception to June 15, 2023. Revman 5.3 software was used to conduct a secondary meta-analysis, AMSTAR-II was adopted to assess the methodological quality of articles, and the GRADE system was employed to evaluate the level of evidence before the results of evaluation were presented in the form of a bubble chart. Results Finally, 13 systematic reviews involving a total of 17 053 cases were included. Meta-analysis results showed that CHPMs combined with STs with Western medicine enjoyed advantages over STs with Western medicine alone in multiple outcome indicators, including the all-cause mortality (RR=0.26, 95%CI=0.09~0.81,P=0.02, I 2= 0%), viral clearance rate (RR=1.12, 95%CI=1.01~1.23, P=0.03, I 2= 44 %), rate of conversion to severe cases (RR=0.49, 95%CI=0.37~0.64, P<0.000 01, I 2= 0%), improvement in pulmonary imaging, clinical symptom recovery rate (including fever, cough, fatigue and shortness of breath) and recovery time of clinical symptoms (especially fatigue). There was no significant difference between the two groups in terms of adverse events or therapeutic efficacy against sore throat and diarrhea. Bubble chart results showed that there was extremely low-level evidence suggesting the effectiveness of Reyaning compounds. Jinhuaqinggan granules, Lianhuaqingwen granules, Shenhuag granules, Shufeng Jiedu capsules, Lianhuaqingwen capsules, Xuebijing injection, and Lianhuaqingke granules could make a big difference to nucleic acid conversion to negative, the incidence of severe cases, and to the recovery rate of pulmonary imaging, respectively. Conclusion CHPMs combined with conventional STs show better efficacy in treating novel coronavirus pneumonia compared to ST alone. However, the overall quality of evidence in these studies is generally low, and high-quality clinical trials are needed to validate these findings.
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Possible Molecular Mechanisms of Dachengqi Decoction for Improving Subjective Symptoms of Degenerative Lumbar Spinal Stenosis: a Network Pharmacology Study
GAN Yena, HAN Sheng, YUAN Yi, XUE Lijuan, HUANG Haowen, LI Huanxin, ZHANG Xinci, KUI Siyi, MENG Bofei, LI Qifei, ANARGUL Tudi, LIU Zhifeng, QIN Lingling, LI Duoduo
2025, 22(2): 162-168. 
DOI: 10.19803/j.1672-8629.20240536

Abstract ( 31 )   PDF (1429KB) ( 52 )  
Objective To explore the molecular mechanisms of Dachengqi decoction in the treatment of degenerative lumbar spinal stenosis (DLSS) using a network pharmacology approach. Methods The Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform (TCMSP) was searched to retrieve information on the chemical components and genes related to Dachengqi decoction as of July 10, 2024. For compounds not covered by TCMSP or without target gene information, the molecular formulas were obtained from the PubChem database, and SwissADME was used for screening. Target prediction for eligible compounds was performed using the SwissTargetPrediction database, and gene names were standardized using the UniProt database. On the same day, the GenCards, OMIM, and DrugBank databases were searched to collect information on DLSS-related disease genes, which was then mapped to the drug targets. Common genes were imported into the STRING (Search Tool for the Retrieval of Interacting Genes/Proteins) database to construct a protein-protein interaction (PPI) network, followed by pathway enrichment analysis using the Metascape database. Cytoscape 3.10.2 software was used to create a “drug-compound-target” network, and NetworkAnalyzer was applied for topological analysis of key compounds and targets. Results Ten key active compounds, including rutin, 5,7,4'-trimethylapigenin, and eucalyptol, as well as ten key targets, including prostaglandin-endoperoxide synthase 2 (PTGS2) and heat shock protein β (HSPCB), were identified. Pathway enrichment analysis suggested that Dachengqi decoction could improve the subjective symptoms of DLSS patients through the PI3K-Akt signaling pathway, AGE-RAGE signaling pathway, neurodegeneration pathway, and various cellular activities. Conclusion Dachengqi decoction can not only alleviate constipation and related symptom exacerbation in DLSS patients, but also modulate inflammation, oxidative stress, and nerve cell tissue repair through its active compounds, targets, and pathways.
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Chinese Patent Medicines for Preventing Myelosuppression in Adjuvant Treatment of Malignant Tumors: a Systematic Review and Network Meta-Analysis
WANG Han, WANG Cunxuan, LYU Xuehaiyue, ZHANG Lining, SUO Yusi, GU Zhi'en, WANG Ping, JIN Xuejing
2025, 22(2): 169-176. 
DOI: 10.19803/j.1672-8629.20240803

Abstract ( 25 )   PDF (1514KB) ( 57 )  
Objective To conduct a network Meta-analysis of eight Chinese patent medicines (CPMs) that are commonly used in clinical practice, have a large market share, and are relatively affordable for patients in order to assess their protective effects against myelosuppression in adjuvant radiotherapy and chemotherapy for malignant tumors. Methods CNKI, Wanfang Database, Chinese Science and Technology Journal Database, SinoMed, Cochrane Library, PubMed, and Embase were searched for related literature published from inception to April 9, 2024. Randomized controlled trials (RCTs) in which CPMs were used to prevent myelosuppression during radiotherapy in patients with solid tumors were enrolled. Two researchers independently screened the literature, retrieved the data, and evaluated the quality of the literature using the risk of bias assessment tool. Stata software was used for network Meta-analysis. Results The number of RCTs included was 48 involving a total of 4 204 patients and eight CPMs, namely, Diyu Shengbai tablets, Qijiao Shengbai capsules, compound E Jiao Jiang, compound Zaofan pills, Zhenqi Fuzheng granules (capsule and punch), Shengxuebao mixture, Shenqi Shiyiwei granules and Shiyiwei Shenqi capsules. The results showed that Diyu Shengbai tablets, Qijiao Shengbai capsules, and Fufang Zaofan pills could reduce the incidence of myelosuppression while compound E Jiao Jiang, Diyu Shengbai tablets, and Zhenqi Fuzheng granules could reduce the incidence of leukopenia. Conclusion CPMs of the “buqi shengxue” category can reduce the incidence of myelosuppression and leukopenia during adjuvant treatment of malignant tumors, among which Shenqi Shiyiwei granules, Zhenqi Fuzheng granules (capsule and punch), and compound E Jiao Jiang have the better protective effect against myelosuppression.
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Toxicity of “Aconitum Carmichaelii-Pinellia Ternata” Incompatible Combination: a Systematic Review and Meta-Analysis of Experimental Studies on Rats
WANG Ping, CAO Huijuan, LI Mengqi, ZHANG Guozhi, LIU Jianping, JIN Xuejing
2025, 22(2): 177-182. 
DOI: 10.19803/j.1672-8629.20240438

Abstract ( 30 )   PDF (1463KB) ( 69 )  
Objective To systematically assess the toxicity of “aconitum carmichaelii-pinellia ternate” incompatible combination in rats. Methods CNKI, Wanang database, VIP, SinoMed, PubMed, Embase and Web of Science database were searched for related literature on toxicity of “aconitum carmichaelii-pinellia ternate” incompatible combination in rats that was published from inception to April 3, 2024. Two reviewers independently screened the literature, retrieved the data, and used the SYRCLE animal experiment bias risk assessment tool to evaluate risk bias before turning to RevMan 5.4 software for meta-analysis. Results A total of 13 experiments were included in this study. The results of meta-analysis showed that compared with the blank control group, the compatibility between aconitum carmichaelii and pinellia ternata at the 1∶1 ratio made no much difference to the liver index or contents of ALT, Cr and BUN of normal rats. However, the cardiac index, kidney index, and contents of AST, ALP, CK and CK-MB were increased significantly. Compared with the aconitum carmichaelii used alone group, aconitum carmichaelii and pinellia ternata at the 1∶1 ratio could reduce the contents of AST, ALP, CK and kidney indexes rather than the cardiac indexes and CK-MB content. Compared with the blank control group, the compatibility of aconiti lateralis radix praeparata and pinellia ternata at the 1∶1 ratio led to a significant increase of the CK content alone, but could reverse the change of CK levels in model rats compared with ischemia-reperfusion injury model rats. The results of qualitative analysis showed that the aconitum carmichaelii and pinellia ternata compatibility had no effect on or caused only mild injury to the histopathology of the heart, liver and kidney of normal rats. However, the aconiti lateralis radix praeparata and pinellia ternata compatibility could mitigate the cardiac pathological injury in rats in the cardiac pathological model. Conclusion The compatibility between aconitum carmichaelii and pinellia ternata at the 1∶1 ratio has some effect on liver, heart and kidney parameters in normal rats by alleviating the hepatic and renal injuries induced by aconitum carmichaelii alone, but exerts minimal effect on the cardiac damage caused by aconitum carmichaelii. Such compatibility has a protective effect on cardiac pathological model rats. Therefore, the incompatible combination of aconitum carmichaelii and pinellia ternata has to be used with caution. Aconiti lateralis radix praeparata and pinellia ternate may achieve good effects once accurate diagnosis and proper prescriptions are ensured.
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Acceptance of Traditional Chinese Medicines in Patients with Ulcerative Colitis: a Multicenter Cross-Sectional Study
BU Zhijun, LIU Fang, HOU Wenbin, SU Juanping, LIU Yandi, SU Xiaolan, WANG Jianyun, LI Junxiang, SUN Yuxin, CHEN Yunru, ZHENG Youyou, WANG Xuehui, LIU Fengshuang, TIAN Yuanchun, LIU Jianping, LIU Zhaolan
2025, 22(2): 183-187. 
DOI: 10.19803/j.1672-8629.20240212

Abstract ( 30 )   PDF (1403KB) ( 45 )  
Objective To assess the level of acceptance of traditional Chinese medicine (TCM) among outpatients with ulcerative colitis (UC) and to find out what shapes their decision to accept or decline TCM treatment. Methods A survey was conducted among UC outpatients at various hospitals in Beijing. The collected data was analyzed using Statistical Package for the Social Sciences (SPSS) version 26.0. Results The survey yielded 236 questionnaires, with 208 valid responses. The median age of the participants was 40 years (interquartile range: 32, 50), comprising 123 males (59.13%) and 85 females (40.87%). Multivariable logistic regression revealed that gender [Odds Ratio (OR)=2.53, 95%CI: 1.07~6.01], prior use of Wuweikushen capsules (OR=5.08, 95%CI: 1.05~24.67), and the lack of compliance within the past two weeks (OR=0.27, 95%CI: 0.09~0.82) were significantly correlated with the acceptance of TCM for UC treatment (P<0.05). Among the participants, A questionnaire analysis was conducted to examine the reasons why patients were willing or unwilling to accept TCM treatment. The results showed that among the 175 patients who were willing to receive TCM treatment, the majority chose it primarily because of its fewer adverse effects. In contrast, among the 33 patients. Conclusion Gender and past medication experiences make a huge difference to the acceptance of TCM treatments among UC patients. In addition, medication compliance and the affordability of TCM are also focuses of attention in clinical practice.
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Current Progress and Considerations in Updating the Safety Information in Labels of Chinese Traditional Patent Medicines
ZHU Lan, SHAO Bo, ZHU Yan, DAI Jie, ZHONG Shiqi
2025, 22(2): 188-192. 
DOI: 10.19803/j.1672-8629.20240621

Abstract ( 85 )   PDF (1296KB) ( 123 )  
Objective To review Current status of updating safety information in labels of Chinese traditional patent medicines. Methods To analyze the guidelines and requirements for the updating of information on adverse reactions, contraindications, precautions and warnings information in the labels of Chinese traditional patent medicines, and to make suggestions based on working experience. Results For some historical reasons, safety information is missing from some Chinese traditional patent medicine labels and should be added to provide guidance to healthcare professionals and patients on the use of medicines. Conclusion Revision of labeling and updating of safety information is one of the risk management measures, after solving the problem of missing safety information, there is still a need for continuous monitoring of adverse reactions, post-marketing research to identify drug risks, and to control the risks by revising labels and other measures.
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Current Descriptions of Functions in Package Inserts of Chinese Herbal Patent Medicines
ZHANG Meiwei, LI Keqian, YAO Keyu, ZHU Yan
2025, 22(2): 193-196. 
DOI: 10.19803/j.1672-8629.20240666

Abstract ( 69 )   PDF (1308KB) ( 93 )  
Objective To analyze the current descriptions of functions in package inserts of Chinese herbal patent medicines and propose corresponding countermeasures in order to provide a reference for marketing authorization holders (MAHs). Methods The information about package inserts of Chinese herbal patent medicines was retrieved from the official website of the National Medical Products Administration, the Pharmacopoeia of the People's Republic of China (2020 edition), and from standards for pharmaceuticals at each level. A standard for determining descriptions of functions and retrieving terms of functions was established before a manual review and analysis of the results of retrieval were conducted. Results and Conclusion The descriptions of functions and indications in most of the package inserts of Chinese herbal patent medicines meet the current standards. However, the descriptions should be standardized and made more consistent with the targeted indications.
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Quality Evaluation and Control of Bupleuri Radix Decoction Pieces Based on ‘Shape-Chemistry-Biology' Sequential Detection
ZHENG Changhui, MA Lina, HE Ting, GU Yuanyuan, ZHAO Wei, WANG Hongbin, NIU Yuanfei, FU Yao, CHEN Yanjun, CAO Junling
2025, 22(2): 197-205. 
DOI: 10.19803/j.1672-8629.20240854

Abstract ( 25 )   PDF (2890KB) ( 52 )  
Objective To explore the quality evaluation system of Bupleuri Radix decoction pieces based on the ‘Shape-Chemistry-Biology' trinity so as to ensure the safety and effectiveness of clinical medications with Bupleuri Radix decoction pieces. Methods Twenty-six batches of Bupleuri Radix decoction pieces from different medicinal materials markets and from licensed decoction piece companies were purchased online, and 6 batches of special samples (water boiled and alcohol extracted) were prepared at the same time, so there were a total of 32 batches of samples. Bupleuri Radix decoction pieces from different sources were identified empirically using the Delphi method. The contents of 5 types of saikosaponins (a, b1, b2, c, d) were determined with HPLC, and the content differences of index components of Bupleuri Radix decoction pieces from different sources were analyzed. Orthogonal partial least squares discriminant analysis (OPLS-DA) and variable importance in projection (VIP) were carried out. The lipopolysaccharide-induced RAW264.7 cell inflammation model was used to investigate its anti-inflammatory activity by detecting its effect on expressions of interleukin 6 (IL-6) and tumor factor α (TNF-α) inflammatory factors. At the same time, the cytotoxicity of Bupleuri Radix decoction pieces from different sources was determined, and the safety range was clarified to effectively identify unqualified samples. Results The traditional trait identification method could effectively identify the Bupleurum marginatum var. stenophyllum with high contents of index components and the Bupleurum marginatum with indistinguishable traits. However, the special prepared samples (boiled and alcohol extracted) could not be effectively distinguished during trait identification. The results showed that the contents of saikosaponin a and d in the 32 batches of Bupleuri Radix decoction pieces except 4 batches of special prepared samples (TS2, TS4, TS5, TS6) did not meet the 0.3 % limit stipulated by the ‘Pharmacopoeia of the People's Republic of China' (2020 edition). However, the total contents of five saponins in all the six batches of special prepared samples (TS1-TS6) were lower than the lowest content of Bupleurum chinense samples, which were 0.53% to 1.09% and 3.40% to 4.01% in Bupleurum chinense and Bupleurum marginatum var. stenophyllum, respectively. The total content of Bupleurum marginatum var. stenophyllum was 3 to 4 times that of Bupleurum chinense, while that of the two doped varieties ranged from 2.02% to 3.41%. The total contents of 5 kinds of saikosaponins in boiled and alcohol-extracted samples decreased significantly to 50% and 25% of the contents of the original samples. Further biological evaluation showed that Bupleuri Radix decoction pieces from different sources had obvious anti-inflammatory activity (P<0.05,0.01), which was better in Bupleurum marginatum var. stenophyllum than in Bupleurum chinense (P<0.05,0.01). The cytotoxicity of Bupleurum marginatum var. stenophyllum was significantly higher than that of Bupleurum chinense (P<0.01). The anti-inflammatory activity and cytotoxicity of Bupleurum marginatum Wall. were close to those of Bupleurum chinense. Conclusion The sequential detection method of ‘traditional traits-chemical content determination-biological evaluation' can more accurately reflect the quality of Bupleuri Radix decoction pieces, more effectively detect unqualified samples, ensure the consistency and stability of the quality of Bupleuri Radix decoction pieces, and improve the effectiveness and safety of clinical medications.
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Adverse Drug Reaction in 385 Elderly Inpatients with Bacterial Pneumonia under Polypharmacy
LIU Biqing, ZHANG Xiaotong, WANG Ke, XING Xiaoxuan, WANG Zhizhou, ZHUANG Wei, ZHANG Qingxia, ZHANG Lan, LI Xiaoling, DONG Xianzhe
2025, 22(2): 206-210. 
DOI: 10.19803/j.1672-8629.20240645

Abstract ( 45 )   PDF (1417KB) ( 79 )  
Objective To analyze the characteristics of and risk factors for adverse drug reactions (ADR) in elderly inpatients with bacterial pneumonia and treated with polypharmacy. Methods The clinical data of elderly inpatients with bacterial pneumonia treated between January 1, 2018 and November 30, 2022 was retrospectively analyzed. The correlations between drugs and ADR were evaluated using the Naranjo evaluation method while the severity of ADR was graded with Common Terminology Criteria for Adverse Events version 5.0. A logistic regression equation was established using the backward selection method to analyze the risk factors. Results Among the 4 967 elderly inpatients with bacterial pneumonia, there were 464 cases of ADR in 385 of these patients, so the overall incidence rate of ADR was 7.75% that were mostly related to the gastrointestinal system (40.52%), circulatory system (14.44%) and liver function injury(12.28%). A total of 671 related drugs were involved in ADR, such as anti-infective drugs (63.79%), anticoagulants (6.56%) and antiplatelet drugs (6.41%). The severity of ADR was primarily grade 1(30.17%) and grade 2(59.91%). Multivariate logistic regression results showed that days of hospitalization, numbers of medications, drug allergy history, being female, cerebrovascular diseases and connective tissue diseases increased the risk of ADR in patients. Conclusion Clinicians and pharmacists should be alert to ADR in high-risk patients. This study is expected to contribute to the development of risk prediction models of ADR for elderly inpatients with bacterial pneumonia in the future.
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Usage of Nerve-Calming Chinese Herbal Patent Medicines in a Mental Health Center
ZHOU Kun, MA Liang, LI Zhaofeng, CAO Bing, GU Hongwei, LIU Qian
2025, 22(2): 211-216. 
DOI: 10.19803/j.1672-8629.20240456

Abstract ( 37 )   PDF (1489KB) ( 54 )  
Objective To investigate the usage of Chinese herbal patent medicines for calming nerves in a mental health center and to provide references for rational use of related drugs. Methods The YI-Yao Rational Drug Use Software System was used to review the prescriptions for nerve-calming Chinese herbal patent medicines from the Hospital Information System (HIS). The rationality of drug use was evaluated in terms of the days of drug use, defined daily dose (DDDs), defined daily cost (DDC) and drug utilization index (DUI). Results The top five drugs in terms of DDDs between 2018 and 2023 were Tian-meng oral liquid, Shu-gan-Jie-yu capsules, Jie-yu pills, Jian-nao capsules and Shu-mian capsules, and DUI ranged from 0.30 to 0.99. A total of 6657 improper prescriptions were screened out of 123 989 prescriptions for Chinese herbal patent medicines, so the rate of substandard prescriptions was 5.37% involving prescriptions for wrong indications (13.70%), inappropriate usage and dosage (12.36%), and inappropriate selection of drugs (2.60%). Conclusion From 2018 to 2023, the total usage and varieties of Chinese herbal patent medicines increased stably. Despite the low incidence rate of irrational use of these drugs, clinicians need to use some varieties with caution.
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One Case of Red Man Syndrome Caused by Locally-Used Low-Dose Vancomycin
LI Xiaobo, ZHOU Guojian, HUANG Yuling, LI Haiqiao, CHEN Tingting
2025, 22(2): 217-220. 
DOI: 10.19803/j.1672-8629.20240547

Abstract ( 36 )   PDF (1227KB) ( 78 )  
Objective To analyze the clinical characteristics and sensitization mechanisms of red man syndrome (RMS) induced by locally-used low-dose vancomycin, warn of associated risks and provide a reference for pharmacovigilance. Methods One case of RMS caused by low dose vancomycin locally used for prevention of surgical site infections (SSIs) was reported. The mechanism was studied based on ADR monitoring and a literature review while related pharmaceutical care was traced. Results According to the correlation evaluation of ADR, the score of Naranjo's scale and an analysis of sensitization mechanisms, vancomycin was considered to have caused RMS, so clinical pharmacists initiated adverse reaction monitoring and pharmaceutical care, and the symptoms of RMS were improved and disappeared. Conclusion Even locally-used low-dose vancomycin can potentially induce RMS, which is why pharmacovigilance is recommended.
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One Case of Acute Kidney Injury Induced by Evolocumab Injection in a Patient with Chronic Kidney Disease after Renal Transplantation
WANG Songlan, SUN Ying, CHEN Aiqun, JI Liwei
2025, 22(2): 221-223. 
DOI: 10.19803/j.1672-8629.20240156

Abstract ( 37 )   PDF (1233KB) ( 62 )  
Objective To provide evidence for clinical use of evolocumab injection and to prevent acute kidney damage. Methods The diagnosis and treatment process and cause of acute kidney injury induced by evolozumab injection in a patient with chronic kidney disease after kidney transplantation were analyzed. Based on literature review, the pathogenesis was discussed. Results A 58-year-old male patient who had received allogeneic renal transplantation was treated with atorvastatin calcium tablets and ezetimibe tablets for coronary heart disease and dyslipidemia. Due to poor efficacy, these tablets were replaced by evolocumab 140 mg for subcutaneous injection, which was used 5 times in 4 months. The serum creatinine increased gradually from 144 μmol·L-1 before medication to 218 μmol·L-1. After other factors for kidney injury were excluded, the symptom was considered to be related to evolocumab injection, which was then discontinued. Serum creatinine gradually decreased to 156 μmol·L-1 54 days after withdrawal. Renal function was stable during follow-up. Conclusion Evolocumab injection may possibly cause acute kidney injury, so clinicians need to monitor the level of serum creatinine and discontinue the drug when necessary.
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One Case of Acute Drug-Induced Liver Injury Caused by Tingli Jiangxuezhi Capsules
HU Yaping, ZHANG Aiwu
2025, 22(2): 224-226. 
DOI: 10.19803/j.1672-8629.20240453

Abstract ( 34 )   PDF (1140KB) ( 59 )  
Objective To identify the components of Tingli Jiangxuezhi capsules that may cause liver injury so as to provide a reference for safe and rational drug use. Methods One case of liver injury caused by Tingli Jiangxuezhi capsules was analyzed and the correlation between liver injury and components of this drug was studied based on related reports from CNKI, Wanfang, and VIP database that were published from inception to June 20, 2024. Results Before admission to the hospital, the patient was treated with Tingli Jiangxuezhi capsules alone, so these capsules were considered to have caused acute drug-induced liver injury after admission despite the lack of related literature. Rhei radix et rhizome, Scutellariae radix and Aucklandiae radix contained in these capsules could all cause liver injury. Conclusion Rhei radix et rhizome, Scutellariae radix and Aucklandiae radix may lead to liver injury, so clinicians and pharmacists should be alert to the occurrence of such adverse reactions.
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One Case of Thrombocytopenia and Leukopenia Induced by Teicolanin and Rebabapide
KOU Jiejian, WANG Yangai
2025, 22(2): 227-230. 
DOI: 10.19803/j.1672-8629.20240455

Abstract ( 39 )   PDF (1244KB) ( 60 )  
Objective To investigate the clinical characteristics and possible mechanism of thrombocytopenia and leukopenia induced by teicoplanin and rebamipide and provide a reference for safe clinical use. Methods One case of thrombocytopenia and leukopenia induced by teicoplanin and rebamipide was reported. Based on related literature, the mechanism of adverse reactions was analyzed. Results The patient experienced thrombocytopenia and leukopenia after using teicoplanin and rabamipide for 2 days respectively. Clinical pharmacists traced the patient's medications and consulted the drug instructions and related literature before they concluded that thrombocytopenia was related to teicolanin, and leukopenia to rebabapide. Therefore, they recommended that these two drugs be discontinued. Eight days and four days after discontinuation of teicoplanin and rebamipide, respecvtively, platelet transfusion was given and the platelet and white blood cell counts gradually returned to normal. Conclusion Clinicians are to be alert to the risk of such adverse reactions as thrombocytopenia and leukopenia caused by teicoplanin and rebamipide. In case of adverse reactions, related drugs should be discontinued promptly and symptomatic treatment should be given to ensure safe medication.
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Advancements in Treatment of Brucellosis with Traditional Chinese Medicine
LIANG Xiao, LI Li, XU Xiaolong, BAI Yinglu, YANG Yumei, ZHU Yong, LIU Qingquan
2025, 22(2): 231-234. 
DOI: 10.19803/j.1672-8629.20240905

Abstract ( 35 )   PDF (1345KB) ( 42 )  
Objective To seek safer and more effective treatment options against brucellosis, which is an infectious zoonotic disease involving multiple organs and systems. Methods Literature related to the treatment of brucellosis with Traditional Chinese Medicine (TCM) in recent years was reviewed. Based on four diagnostic systems - etiological differentiation, six-meridian syndrome differentiation of treatise on febrile diseases, eight-line syndrome differentiation, and wei-qi-ying-xue differentiation, the medications and formula composition for brucellosis were categorized. Results and Conclusion The treatment of brucellosis is divided into acute and chronic phases, with medications involving the six-meridian syndrome differentiation and the wei-qi-ying-xue differentiation. TCM has shown good clinical effects. This study is expected to provide a reference for future research on and clinical medications for brucellosis with TCM.
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Research Progress in the Treatment of Advanced Non-Small Cell Lung Cancer with Aumonertinib
YANG Shengxi, XU Juntong, TU Wenlian
2025, 22(2): 235-240. 
DOI: 10.19803/j.1672-8629.20240491

Abstract ( 33 )   PDF (1289KB) ( 45 )  
Objective To investigate the clinical efficacy of aumonertinib as the third representative epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKIs) in patients with advanced epidermal growth factor receptor (EGFR) mutated non-small cell lung cancer (NSCLC). Methods The clinical efficacy of aumonertinib against advanced NSCLC with classical EGFR mutation, advanced NSCLC with T790M drug-resistant mutation, and advanced NSCLC with rare EGFR mutation as well as the research progress in combined treatment with aumonertinib to delay the occurrence of drug resistance were reviewed. Results In real-world studies, aumonertinib extended the median progression-free survival (mPFS) to 20 months in NSCLC patients with classical EGFR mutations and to 15 months in NSCLC patients with T790M resistance mutations. Aumonertinib also showed good efficacy in NSCLC patients with rare mutations. The combination therapy with aumonertinib could effectively slow down the occurrence of drug resistance. Conclusion Aumonertinib has a marked clinical effect on patients with advanced NSCLC, which can effectively improve the survival time and prognosis of patients.
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