1.Expert consensus on the medication catalog for drug-induced liver injury and rational drug use
Jianchun LI ; Di CHEN ; Pengfei JIN ; Gerontology NATIONAL ; Association GERIATRIC ; Research PHARMACY ; Society PHARMACY ; Association GERIATRIC
China Pharmacy 2026;37(3):273-280
OBJECTIVE To systematically sort out the drugs causing drug-induced liver injury (DILI) and their relevant information, and to develop the Expert consensus on the medication catalog for drug-induced liver injury and rational drug use (hereinafter referred to as the Consensus), so as to provide a reference for rational clinical use. METHODS Systematic searches were conducted across various literature databases, guideline retrieval websites and professional liver injury websites. Drugs identified as causing DILI from the included literature and online resources were extracted and assigned scores based on source credibility: three points for LiverTox A-class drugs and two points for B-class drugs; two points for drugs from Hepatox and guidelines; and one point for drugs from consensus and related literature sources. Drugs classified as LiverTox category A/B or with total scores ≥4 were included in the preliminary list of DILI-causing drugs. Opinions were collected and integrated from a multidisciplinary expert panel comprising 45 medical and pharmaceutical experts from 27 provinces across China through three rounds of the Delphi method (including questionnaires and discussion sessions), and after revision, the final version of Consensus was formed. RESULTS & CONCLUSIONS This Consensus included 12 traditional Chinese medicines (TCMs) such as Polygoni Multiflori Radix and Ephedrae Herba, 151 Western medicines including amiodarone and atorvastatin, along with rational use information. For TCM, eight rational use information were included: evidence-based score, liver injury classification based on pathogenesis, liver injury classification based on biochemical abnormality pattern, clinical phenotype, laboratory examination manifestations, latency period, recovery time, and management strategies. For Western medicines, six additional items were included based on the TCM, namely liver function monitoring, discontinuation, contraindications, cautions, dose adjustments, and risk factors, totaling 14 items. This Consensus systematically compiles DILI drugs and their rational use information, which will support clinicians in enhancing the prevention, identification, and management of DILI, reducing the incidence of liver injury, and ensuring patient medication safety and efficacy.
2.Clinical comprehensive evaluation of 16 commonly used kinds of enteral nutrition preparations in Hebei province
Zhihan ZHANG ; Yue CHENG ; Lamei XU ; Qingsong LI ; Yuan GAO ; Congxin LI ; Shuqing GAO
China Pharmacy 2026;37(3):281-287
OBJECTIVE To comprehensively evaluate the 16 commonly used kinds of enteral nutrition preparations in Hebei province, aiming to provide a reference for the selection of drugs in medical institutions and clinical drug decision-making. METHODS Based on the Quick Guide for Drug Evaluation and Selection in Chinese Medical Institutions (the Second Edition), evaluation evidence was collected, and the included drugs were scored and evaluated from four dimensions of pharmaceutical characteristics, clinical characteristics, economy and other attributes. RESULTS & CONCLUSIONS The scores for Enteral nutritional emulsion (TPF-T), Enteral nutritional emulsion (TPF-D), Enteral nutritional emulsion (TPF), Enteral nutritional emulsion (TPF-HE), Enteral nutritional emulsion (TP), Enteral nutritional emulsion (SP), Enteral nutritional suspension (TPF) (1.5 kcal/mL, 1 kcal=4.184 kJ), Enteral nutritional suspension (TPF) (1.0 kcal/mL), Intact protein enteral nutrition (powder), Enteral nutritional suspension (TPF-DM), Enteral nutritional suspension (TPF-MCT), Enteral nutritional suspension (SP), Short- peptide enteral nutrition, Enteral nutritional powder (TP), Enteral nutritional suspension (TPF-D) and Enteral nutritional suspension (TPF-FOS) were 82.9, 84.1, 84.1, 86.1, 78.4, 79.1, 82.6, 82.3, 82.4, 80.2, 83.0, 82.4, 82.1, 85.7, 76.0, 82.4 points, respectively. All medications scored above 70 points. In practice, appropriate drugs can be selected according to clinical requirements and patient needs.
3.Upgrade and practice of the drug traceability code management system in children’s hospital under the “payment by code”background
Jinxiang LIN ; Suping LI ; Yanqing SU ; Dehui YE ; Xianwen CHEN ; Yushuang CHEN ; Zhihui JI ; Dongchuan LAI ; Xiayang WU
China Pharmacy 2026;37(3):288-293
OBJECTIVE To upgrade the drug traceability code management system for a pediatric hospital under the “payment by code” background, aiming to comprehensively enhance traceability integrity, efficiency, and compliance. METHODS Taking Xiamen Children’s Hospital as the implementation setting, a before-and-after control design was adopted to construct an intelligent drug traceability code management system through systematic upgrades involving the technology platform, core mechanisms, and coordination with medical insurance. Key interventions included: upgrading a traceability code management platform and designing a dynamic code pool; innovating differentiated traceability mechanisms for routine, split-dose, and special drugs; establishing a tiered early-warning and emergency response system; and constructing a data coordination and quality control system. The drug traceability code upload rate served as the primary outcome. Process indicators such as the root causes distribution of failed uploads and the duration of medication returns, and a comprehensive outcome (the number of insurance-flagged abnormal prescriptions) were also analyzed. The data between the baseline period (April 2025) and the observation period (June-August 2025) were compared and evaluated. RESULTS After the upgrade, the overall upload rate of drug traceability codes increased from 9.21% (baseline) to 99.86% (August 2025). The upload rate of traceability codes in previously unmanaged areas, such as the inpatient pharmacy and pharmacy intravenous admixture services, soared from 0 to nearly 100%. The proportion of non-uploads due to system issues fell from 66.44% (June 2025) to 2.62% (August Additionally, the number of insurance-flagged) abnormal prescriptions dropped sharply from 2 275.00 in the first “payment by code” policy month (July 2025) to 212.00 by the end of the observation period (August 2025), a 90.70% decrease. CONCLUSIONS The developed management system effectively addresses complex scenario challenges such as high-frequency drug splitting. It significantly enhances traceability code upload performance and ensures a high degree of compliance with medical insurance data requirements. These outcomes contribute to proactive risk mitigation against insurance claim denials and demonstrate a concurrent optimization of pharmacy operations.
4.Study on the role definition of full-time pharmacists in the management of early-phase clinical trials of antineoplastic drugs
Juan ZHAO ; Li GONG ; Jie SHEN ; Huiyao YANG ; Bin LIAO
China Pharmacy 2026;37(3):294-298
OBJECTIVE To clarify the roles and functions of full-time pharmacists in the management of early-phase clinical trials of antineoplastic drugs, and to provide theoretical and practical support for their transformation from traditional drug managers to multi-dimensional roles in clinical research. METHODS Combined with relevant regulations such as the Good Clinical Practice (GCP) (2020 Edition), and based on the clinical practice experience of the Phase Ⅰ Clinical Ward in our hospital, this study systematically sorted out full-time pharmacists’ roles and functions in early-phase clinical trials of antineoplastic drugs, and explored the core challenges and optimization pathways for role transformation and capacity-building of domestic full-time clinical trial pharmacists. RESULTS & CONCLUSIONS Full-time pharmacists assumed multiple roles in early-phase clinical trials of antineoplastic drugs, including providing pharmaceutical support for protocol design, implementing whole-process standardized management of clinical trial drugs, ensuring medication safety for clinical trial subjects/participants, conducting quality control throughout the clinical trial process, and serving as a bridge for interdisciplinary collaboration and communication. Currently, there are challenges in this field in China, such as unclear roles, an imperfect capacity building system, and insufficient regulatory support. This paper proposes that by establishing a standardized role framework, clarifying the core responsibilities and authorities of full-time pharmacists, and leveraging cutting-edge technologies to provide comprehensive support for their roles, so as to fully harness their pharmaceutical expertise and contribute to the standardization and efficiency of the antineoplastic new drug development process.
5.Ameliorative effects and mechanisms of Buyang huanwu decoction and its active fractions on non-alcoholic fatty liver disease
Jinbiao YANG ; Xingtong CHEN ; Yunyue ZHOU ; Ruihong YANG ; Qiao WANG ; Shuang XUE ; Yukun ZHANG ; Wenying NIU
China Pharmacy 2026;37(3):299-304
OBJECTIVE To investigate the effects and mechanisms of Buyang huanwu decoction (BYHWD) and its active fractions in ameliorating non-alcoholic fatty liver disease. METHODS BYHWD and its effective fractions obtained through ethanol precipitation, as well as 30% ethanol, 50% ethanol, and 75% ethanol fractions (namely, the CC effective fraction, 30YC effective fraction, 50YC effective fraction, and 75YC effective fraction), were prepared. These preparations were administered to rats via intragastric administration to prepare corresponding drug-containing serum (blank serum and simvastatin-containing serum were prepared using the same protocol). Human L02 hepatocytes were divided into control group, model group, simvastatin-containing serum group, BYHWD-containing serum group, CC-containing serum group, 30YC-containing serum group, 50YC-containing serum group, and 75YC-containing serum group. Except for the control group, other groups were given 0.2 mol/L oleic acid for 24 h to induce a lipid accumulation model, and then intervened with 20% drug-containing serum/blank serum for 24 h. The lipid deposition in cells was observed, and the proportion of lipid droplet area was calculated; the levels of triglycerides (TG) and indicators of oxidative stress [malondialdehyde (MDA), superoxide dismutase (SOD)] as well as liver function [alanine amino- transferase (ALT), aspartate amino-transferase (AST)] in cells were detected; protein and mRNA expressions of AMP-activated protein kinase (AMPK)/sterol regulatory element-binding protein-1 (SREBP-1)/glycerol-3-phosphate acyltransferase (GPAT) signaling pathway were also measured. RESULTS Compared with the control group, cells in the model group exhibited severe cellular steatosis, with a significantly increased proportion of lipid droplet area, as well as the elevated levels of TG, ALT, AST, and MDA in cells, along with significantly up-regulated mRNA and protein expression levels of SREBP-1 and GPAT (P<0.05). The level of SOD, mRNA expression of AMPK, as well as the protein phosphorylation level of AMPK were decreased significantly (P<0.05). Compared with the model group, cellular steatosis was alleviated in all drug-containing serum groups, and the levels of most of the aforementioned quantitative indicators were significantly reversed (P<0.05). CONCLUSIONS BYHWD and its active fractions can exert a therapeutic effect on improving non-alcoholic fatty liver disease by regulating the AMPK/SREBP-1/GPAT signaling pathway, inhibiting oxidative stress responses, and reducing lipid deposition.
6.Ameliorative effect and mechanism of Forsythia suspensa-Lonicera japonica herb pair on acute lung injury via regulating serum exosomal miRNA
Zhaohua CHEN ; Shumin XIE ; Wanshun CHANG ; Yuqing HAN ; Yanwen CHEN ; Yanhui ZHU ; Mingzhuo CAO ; Haiying HUANG
China Pharmacy 2026;37(3):305-310
OBJECTIVE To study the ameliorative effect and mechanism of Forsythia suspensa-Lonicera japonica herb pair on acute lung injury (ALI) based on serum exosomal microRNA (miRNA). METHODS The rats were randomly divided into a blank group (normal saline), model group (nomal saline), and F. suspensa-L. japonica herb pair group (2.55 g/kg), with 10 rats in each group. Except for the blank group, the other groups were used to establish an ALI model by intratracheal dripping of 5 mg/ mL lipopolysaccharides. After modeling, each group was given relevant medicine/normal saline intragastrically, once a day, for 3 consecutive days. After the last medication, the pathological status of lung tissue was observed; lung wet-to-dry weight ratio and leukocyte counts in bronchoalveolar lavage fluid (BALF) were determined. The levels of inflammatory factors [tumor necrosis factor-α(TNF-α), interleukin-1β (IL-1β), IL-10] in BALF were determined. Exosomes were isolated from rat serum, and high- throughput sequencing technology was employed to screen differentially expressed miRNA within the exosomes, followed by Kyoto Encyclopedia of Genes and Genomes (KEGG) enrichment analysis. Based on the screened differentially expressed miRNA and the enriched KEGG pathways, in vitro cellular experiments were conducted for validation. RESULTS The animal experimental results demonstrated that after intervention with the F. suspensa-L. japonica herb pair, the wet-to-dry weight ratio, the number of leukocytes in BALF, as well as the levels of TNF-α and IL-1β in BALF of ALI rats were all significantly reduced (P<0.01), while the level of IL-10 was significantly increased (P<0.01). The results of high-throughput sequencing experiments revealed that the F. suspensa-L. japonica herb pair could significantly up-regulate the expressions of miR-345-3p, miR-194-5p, miR-653-5p, and others in exosomes. Among them, the KEGG pathways involved in the target genes of differentially expressed miRNA included the hypoxia-inducible factor-1(HIF-1) signaling pathway, among others. The results of cellular E-mail:huang.haiying@126.com validation experiments showed that overexpressed miR-345-3p could significantly elevate the level of IL-10 in the cell supernatant (P<0.01), while significantly reducing the levels of TNF-α and IL-1β in the cell supernatant, as well as the mRNA and protein expression levels of protein kinase B1, phosphatidylinositol 3- kinase, and HIF-1α (P<0.01). CONCLUSIONS F. suspensa-L. japonica herb pair can alleviate inflammatory responses and thereby exert a therapeutic effect in improving ALI by up-regulating the expression of miR-345-3p in serum exosomes and inhibiting the activity of the HIF-1 signaling pathway.
7.Effects of total flavonoids from Carthamus tinctorius L. on hepatic stellate cell activation based on miRNA-204/NUAK1/Hippo signaling axis
Mingqi LI ; Xiaolu ZHAO ; Chenlu ZHANG ; Yinghe WANG ; Yuehong MA
China Pharmacy 2026;37(3):311-316
OBJECTIVE To investigate the effects of total flavonoids from Carthamus tinctorius L. (TFCTL) on hepatic stellate cell (HSC) activation based on the microRNA (miRNA)-204/NUAK family SNF1-like kinase 1 (NUAK1)/Hippo signaling axis, thereby elucidating the potential mechanism underlying their antifibrotic effects. METHODS The HSC-T6 cells were divided into control group, model group, TFCTL low-concentration group (20 μg/mL), TFCTL medium-concentration group (40 μg/mL), and TFCTL high-concentration group (60 μg/mL). Except for control group, the remaining groups were treated with 5 ng/mL of transforming growth factor-β to induce the activation of hepatic stellate cells, followed by the addition of corresponding drug solutions/culture medium and incubation for 24 hours. Cell apoptosis was assessed, the expression levels of α-smooth muscle actin (α-SMA), type Ⅰ collagen (Collagen Ⅰ) and proteins associated with the Hippo/Yes-associated protein (YAP) pathway [YAP, large tumor suppressor kinase 1 (LATS1), and mammalian STE20-like kinase 1 (MST1)] were detected. Additionally, cell transfection was used to investigate the activity of the miRNA-204/NUAK1/Hippo signaling axis at both the genetic and protein levels. RESULTS After intervention with TFCTL, the apoptosis rate of HSC-T6 cells and the protein expressions of MST1 (except for the TFCTL high-concentration group) and LATS1 were significantly increased (P<0.05), while the protein expressions of α-SMA, CollagenⅠ, and YAP (except for the TFCTL medium-concentration group) were significantly decreased (P<0.05). Further results from cell transfection experiments revealed that after transfection with miRNA-204 mimics, the mRNA it’s protein expressions of α-SMA, CollagenⅠ, NUAK1, and YAP in HSC-T6 cells were significantly decreased (P<0.05), while the mRNA and protein expressions of LATS1 and the mRNA expression of MST1 were significantly increased (P<0.05). Conversely, the results were opposite following transfection with miRNA-204 inhibitors. CONCLUSIONS TFCTL can exert anti-hepatic fibrosis effects by up-regulating the expression of miRNA-204, thereby down- regulating the expressions of NUAK1, inactivating the Hippo/YAP pathway, which in turn suppresses the activation of HSC and promotes their apoptosis.
8.Mechanism of drug-containing serum of Dianxianqing granules in inhibiting microglial ferroptosis
Guangkun FAN ; Yue QI ; Jixian WANG ; Wei CHEN ; Chunpeng XIA ; Yihang WANG ; Yue ZHAO ; Yang AN
China Pharmacy 2026;37(3):317-323
OBJECTIVE To explore the potential mechanism by which drug-containing serum of Dianxianqing granules (DXQ) inhibits microglial ferroptosis. METHODS Male SD rats were given normal saline and Dianxianqing granules solution via intragastric administration to prepare normal serum and DXQ, respectively. Mice microglia BV2 cells were collected and successfully transfected with a negative control small interfering RNA (si-NC), and then they were included in the si-NC group and cultured under normal conditions. Cells successfully transfected with small interfering RNA targeting glutathione peroxidase 4 (GPX4) (si-GPX4) were divided into the si-GPX4 group, the CsA group (treated with 1 μmol/L cyclosporine A), and the DXQ- L, DXQ-M and DXQ-H groups (treated with 5%, 7% and 10% DXQ, respectively). These groups were subsequently treated with their corresponding drug solutions and ferroptosis inducer Erastin (10 μmol/L). The intracellular levels of total iron ions, glutathione (GSH), reactive oxygen species (ROS), and the expression of mitochondrial superoxide were determined in each group after 48 h of treatment. Additionally, mitochondrial membrane potential, the opening degree of mitochondrial permeability transition pore (MPTP), and mRNA expressions of GPX4 and cyclophilin D (CypD) were detected. Furthermore, the expressions of ferroptosis-related proteins[GPX4, transferrin receptor 1 (TfR1) and ferritin heavy chain 1 (FTH1)], as well as MPTP-related proteins [adenine nucleotide translocator (ANT), cytochrome C (CytC), mitochondrial calcium uniporter (MCU) and CypD] were assessed. RESULTS Compared with si-NC group, the levels of total iron ions and ROS, the expression level of mitochondrial superoxide, the opening degree of MPTP, protein and its mRNA expressions of CypD as well as protein expressions of TfR1 and MCU were increased or up-regulated significantly (P<0.01); however, GSH content, mitochondrial membrane potential, protein and mRNA expressions of GPX4, and protein expressions of FTH1, ANT and CytC were decreased or down-regulated significantly (P<0.01). Compared with the si-GPX4 group, the cells in the DXQ-M, DXQ-H groups showed a general improvement in the above quantitative indicators (P<0.01 or P<0.05). CONCLUSIONS DXQ can enhance antioxidant capacity by activating the GSH/GPX4 pathway, regulate the expressions of TfR1 and FTH1 protein to correct iron ion homeostasis, inhibit excessive opening of MPTP to improve mitochondrial function, and ultimately suppress microglial ferroptosis.
9.Mechanism of Xibining Ⅱ in alleviating cold stimulus pain sensitivity in rats with cold-damp obstruction-type KOA by regulating SETDB2/H3K9me3 signaling axis
Enrui HU ; Yibao WEI ; Deren LIU ; Maimaitituxun AOBULIAISAN ; Peimin WANG ; Taiyang LIAO
China Pharmacy 2026;37(3):324-330
OBJECTIVE To investigate the mechanism by which the traditional Chinese medicine formula Xibining Ⅱ modulates cold-stimulus pain sensitivity in rats with cold-damp obstruction-type knee osteoarthritis (KOA) based on the SET domain bifurcated histone lysine methyltransferase 2 (SETDB2)/histone H3 lysine 9 trimethylation (H3K9me3) signaling axis. METHODS Fifty SD rats were randomly divided into control group (intragastric administration and intrathecal injection of equal volumes of normal saline), model group (intragastric administration and intrathecal injection of equal volumes of normal saline), Xibining Ⅱ low- and high-dose groups (4, 8 g/kg Xibining Ⅱ, intragastric administration), and high-dose of Xibining Ⅱ+small interfering RNA (siRNA) group (8 g/kg of Xibining Ⅱ via intragastric administration and intrathecal injection of SETDB2 siRNA at 0.2 mmol/L, 20 μL per rat), with 10 rats in each group. Except for the control group, cold-damp obstruction-type KOA model was induced in other groups. Drug administration commenced 14 days post-modeling and continued for 28 days. Following the final administration, the following were assessed: behavioral changes in cold-stimulation pain sensitivity, histopathological changes in the articular cartilage of the knee joint, the contents of inflammatory factors [tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β)] and pain mediators [calcitonin gene-related peptide (CGRP), nerve growth factor (NGF)], as well as the expressions of SETDB2/H3K9me3 signaling axis,inflammatory factors and pain mediators related proteins and mRNAs in dorsal root ganglion (DRG) tissue. RESULTS After 28 days of drug administration, compared with the model group, Xibining Ⅱ low- and high-dose groups exhibited significantly prolonged cold-stimulus paw withdrawal latency (P<0.05); the number of positive responses in the acetone low-temperature test was significantly reduced (P<0.05); Mankin score and the Osteoarthritis Research Society International score for knee joint tissue, as well as the levels of inflammatory factors and pain mediators in the serum and their expression in DRG tissue were all significantly decreased (P<0.05); the protein expressions of SETDB2 and H3K9me3 in DRG tissue were significantly increased (P<0.05). Intrathecal injection of SETDB2 siRNA reversed the above effects of high-dose of Xibining Ⅱ (P<0.05). CONCLUSIONS Xibining Ⅱ may alleviate inflammatory and pain responses by activating the SETDB2/H3K9me3 signaling axis, ultimately improving cold-stimulus pain sensitivity in rats with cold-damp obstruction-type KOA.
10.Improvement effects and mechanism of Achyranthes bidentata total saponins extract on vascular endothelial dysfunction in spontaneously hypertensive rats
Ruifeng LIANG ; Wenjing GE ; Xiaobo KOU ; Ping TIAN ; Hongzhi AN ; Zheng WEI ; Mingli ZHANG
China Pharmacy 2026;37(3):331-337
OBJECTIVE To investigate the improvement effects and mechanism of Achyranthes bidentata total saponins (ABS) extract on vascular endothelial dysfunction in spontaneously hypertensive rat (SHR) based on cytochrome P450 4A (CYP4A)/20-hydroxyeicosatetetraenoic acid (20-HETE)/G protein-coupled receptor 75 (GPR75) axis. METHODS Ten Wistar- Kyoto rats were taken as the normal control group. Forty SHR were first stratified by systolic blood pressure and then, within each stratum, randomly assigned using a random-number table to the model group (MOD group), captopril positive control group (CAP group, 10 mg/kg), ABS low- and high-dose extract groups (ABS-L group, ABS-H group, 60 and 120 mg/kg), with 10 rats in each group. Animals in each group were given the corresponding drug or equal volume of pure water by gavage, once a day, for 28 consecutive days. After the last administration, systolic blood pressure of rats was measured. The levels of vasoactive substances, inflammatory factors and oxidative stress indicators in serum were measured. The pathological changes of rat thoracic aorta were observed. The level of reactive oxygen species (ROS) in aortic tissue was analyzed. The expressions of endothelial nitric oxide synthase (eNOS), CYP4A, GPR75, nuclear factor-κB p65 (NF-κB p65), phosphorylated NF-κB p65, p22phox, and reduced nicotinamide adenine dinucleotide phosphate oxidase 4(NOX4) in thoracic aorta tissue were detected. RESULTS After 28 d of treatment, compared with MOD group, the systolic blood pressure of rats in the ABS-L and ABS-H groups decreased significantly. The levels of 20-HETE, angiotensin Ⅱ, interleukin-1β, interleukin-6, tumor necrosis factor-α, intercellular cell adhesion molecule-1 and malondialdehyde in serum were significantly reduced (P<0.05 or P<0.01), while the levels of nitric oxide, superoxide dismutase, glutathione peroxidase and catalase were significantly increased (P<0.05 or P<0.01). Intimal damage of thoracic aorta was reduced, and endothelial cell morphology was improved. The expressions of ROS, CYP4A, GPR75, p22phox, NOX4 and the phosphorylation level of NF-κB p65 protein in thoracic aorta were down-regulated or reduced (P<0.05 or P<0.01), while the expression of eNOS was up-regulated (P<0.05 or P<0.01). CONCLUSIONS ABS extract may alleviate the inflammatory response and oxidative stress in SHR effectively by down-regulating the expression of CYP4A, reducing the production of 20-HETE, inhibiting the activation of GPR75, and subsequently suppressing the activation of downstream NF-κB and NOX4, thereby improving hypertension-related vascular endothelial dysfunction.
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