1.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.
2.Evidence-based expert consensus on the clinical application and pharmaceutical management of antibody-based drugs for the treatment of myasthenia gravis
Rong DUAN ; Zhengxiang LI ; Xiaocong ZUO ; Rongsheng ZHAO ; Ruigang HOU ; Chunsheng YANG ; Guoyan QI
China Pharmacy 2026;37(9):1113-1121
OBJECTIVE To provide standardized guidance for the rational clinical use of antibody-based drugs for the treatment of myasthenia gravis, and to enhance the evidence-based system of guidelines and consensus in this field. METHODS The consensus expert team consisted of 71 multidisciplinary experts from 28 provinces/autonomous regions/municipalities directly under the Central Government. Evidence was systematically retrieved through multiple databases, drug package inserts, and official websites of international and national health administrative authorities, drug regulatory agencies, healthcare security departments, and related industry associations, up to April 30, 2025. Evidence was graded according to the 2014 version of JBI pre-grading system for evidence from intervention studies. Based on full consideration of the current best evidence and multidisciplinary expert experience, the expert consensus recommendations were formulated using a modified Delphi method. RESULTS The Evidence-based expert consensus on the clinical application and pharmaceutical management of antibody-based drugs for the treatment of myasthenia gravis standardized the key points of whole-process pharmaceutical management for four antibody-based drugs approved for marketing in the mainland of China for the treatment of myasthenia gravis (efgartigimod alfa, efgartigimod alfa/hyaluronidase, eculizumab, and rozanolixizumab). It formulated 37 expert consensus recommendations covering nine pharmaceutical management aspects: drug suitability selection, medication in special populations, administration methods, drug storage, therapeutic drug monitoring and pharmacogenetic testing, immunization management, drug interactions, pharmaceutical care, and off-label drug use. CONCLUSIONS Based on the current best evidence and multidisciplinary expert experience, this consensus establishes a whole-process management framework for antibody-based drugs for the treatment of myasthenia gravis, from clinical application to pharmaceutical management. It provides a scientific basis for the rational and precise use of these drugs in clinical practice, effectively promotes the enhancement of pharmaceutical management efficiency, and helps improve the overall therapeutic benefits for patients.
3.Construction of hospital preparation cost item library based on the Delphi method
Shunlong OU ; Hong LIN ; Qian JIANG ; Zhaohui JIN
China Pharmacy 2026;37(9):1122-1126
OBJECTIVE To establish a hospital preparation cost item library, providing a reference for the refined accounting management of preparation costs in medical institutions. METHODS Based on literature analysis and practical work experience, a preliminary list of cost items was drafted. The Delphi method was employed to screen and optimize the items by analyzing the questionnaire recovery rate, expert authority coefficient, item importance score, coefficient of variation, and Kendall’s W of concordance. RESULTS The questionnaire recovery rates for the two rounds of expert consultation were 95.7% and 100%, respectively; the expert authority coefficients were 0.937 and 0.939, respectively; Kendall’s W of concordance were statistically significant ( P <0.001). The finally established hospital preparation cost item library included 6 first-level items (such as raw material and packaging material costs, human resource costs, and production operation costs) and 29 second-level items (including main drug raw material costs, production personnel compensation, and finished product full-item testing costs), comprehensively covering dimensions such as raw materials and packaging materials, fixed asset depreciation and equipment maintenance, human resources, production operations, energy and environment, and R & D and other costs. CONCLUSIONS This study successfully establishes a scientific and reliable cost item library for medical institution preparations, which can guide institutions to itemize actual expenditures, provide structured evidence for autonomous pricing, and support data needs for the formulation of insurance access and payment policies for innovative preparations.
4.Mechanism of Qingre antai decoction in improving pregnancy outcomes of threatened abortion rats with blood heat syndrome based on JAK2/STAT3 and PI3K/AKT dual signaling pathways
Liya MA ; Yanduo SHEN ; Jiale ZHANG ; Liujun WU ; Bingheng XIE ; Xingfei WU ; Chen LIU ; Minghao ZHANG ; Xuelin ZHANG ; Dawei ZHANG
China Pharmacy 2026;37(9):1127-1133
OBJECTIVE To explore the mechanism by which Qingre antai decoction improves pregnancy outcomes of threatened abortion rats with blood heat syndrome. METHODS The pregnant rats were randomly divided into normal group, model group, dydrogesterone group (0.002 g/kg), and Qingre antai decoction group (44.1 g/kg), with 13 rats in each group. Except for normal group, other groups were given warming-yang Chinese medicine and corresponding drugs intragastrically, once a day, for 12 consecutive days. On the 13th day of pregnancy, a single intragastric administration of mifepristone (5 mg/kg) was performed to establish a model of threatened abortion with blood heat syndrome. On the 14th day of pregnancy, the abortion rate and uterine coefficient were calculated; the pathological morphology of pregnant uterine was observed; the serum levels of 3,5,3′-triiodothyronine (T3), thyroid hormone (T4), thyroid stimulating hormone (TSH), as well as the levels of vascular endothelial growth factor (VEGF) and nitric oxide (NO) in the pregnant uterus were all determined; the expressions of mRNA and protein related to Janus kinase 2 (JAK2)/signal transducer and activator of transcription 3 (STAT3) and phosphatidylinositol 3-kinase (PI3K)/protein kinase B (AKT) pathways were detected. RESULTS Compared with normal group, the model group exhibited endometrial tissue damage, a reduced number of decidual cells, and a significant presence of blood stasis within the uterus; abortion rate, the serum levels of T3, T4 and TSH, the mRNA expressions of JAK2, STAT3 and suppressor of cytokine signaling 3 (SOCS3) as well as protein expressions of p-JAK2, p-STAT3 and SOCS3 in the pregnant uterus were increased significantly ( P <0.05); uterine coefficient, the levels of VEGF and NO in pregnant uterus, mRNA expressions of VEGFR2, PI3K, AKT and endothelial nitric oxide synthase(eNOS), protein expressions of VEGFR2, PI3K and eNOS as well as phosphorylation level of AKT in the pregnant uterus were significantly reduced ( P <0.05). Compared with model group, the endometrial tissue damage and congestion in the Qingre antai decoction group were significantly improved, and the levels of the aforementioned quantitative indicators were significantly reversed ( P <0.05). CONCLUSIONS Qingre antai decoction can improve the pregnancy outcomes in rats with threatened abortion of blood heat syndrome, the mechanism of which may be associated with inhibiting JAK2/STAT3 pathway and activating PI3K/AKT pathway.
5.Study on the mechanism of Euphorbia hirta L.-derived exosome-like nanovesicles regulating Nrf2/HO-1/NQO1 pathway to improve acetaminophen-induced liver injury
Yanyu WANG ; Lei CHEN ; Renjie LIU ; Shijian XIANG ; Benjie ZHOU
China Pharmacy 2026;37(9):1134-1140
OBJECTIVE To investigate the ameliorative effect and mechanism of Euphorbia hirta L.-derived exosome-like nanovesicles(Eh-ENVs) on acetaminophen (APAP)-induced liver injury based on the nuclear factor erythroid 2 related factor 2 (Nrf2)/heme oxygenase-1 (HO-1)/NAD(P)H:quinone oxidoreductase 1 (NQO1) pathway. METHODS The safety of Eh-ENVs was evaluated by examining their effects on the viability of RAW264.7 and AML12 cells, as well as serum liver and kidney function indicators and histopathology of liver, lung, and other tissues in normal mice. A lipopolysaccharide (1 μg/mL)-induced RAW264.7 cell inflammation model was constructed to investigate the effects of 10 and 20 μg/mL Eh-ENVs on the mRNA expression of inflammatory factors and reactive oxygen species (ROS) level in model cells, and the uptake efficiency of Eh-ENVs by RAW264.7 cells was also examined. An APAP-induced liver injury mouse model was established to investigate the effects of 4 mg/kg Eh-ENVs on serum liver function indicators, liver histopathology, mRNA expression of inflammatory factors, malondialdehyde (MDA) level, superoxide dismutase (SOD) level, and mRNA and protein expressions related to the Nrf2/HO-1/NQO1 pathway in liver tissue of model mice. RESULTS In vitro results showed that Eh-ENVs had no inhibitory effect on the proliferation of RAW264.7 and AML12 cells;Eh-ENVs could be efficiently taken up by RAW264.7 cells and significantly reduced the mRNA expression of interleukin-1β (IL-1β), tumor necrosis factor-α (TNF-α), and ROS level in cells ( P <0.05). In vivo results showed that 4 mg/kg Eh-ENVs had no obvious toxic side effects on normal mice,could significantly decrease the serum alanine transaminase (ALT) and aspartate transaminase (AST) levels in model mice ( P <0.05),upregulated/increased the mRNA expressions of IL-10, as well as the mRNA and protein expressions of Nrf2, HO-1, and NQO1, and SOD level in liver tissue ( P <0.05), and down-regulated/decreased the mRNA expression of TNF-α, IL-1β and MDA level in liver tissue ( P <0.05). CONCLUSIONS Eh-ENVs may activate the Nrf2/HO-1/NQO1 pathway to inhibit inflammatory response and alleviate oxidative stress, thereby improving APAP-induced liver injury.
6.Protective effect of the active component DMDD from Averrhoa carambola root on myocardial injury in diabetic mice and its correlation with the NCOA4/FTH1/ATG8 axis
Yongxin CHEN ; Yuxuan LI ; Kailei GU ; Jiajun YOU ; Xiaohan SUN ; Jing MA ; Yanping ZHOU ; Xiaojie WEI
China Pharmacy 2026;37(9):1141-1147
OBJECTIVE To investigate the protective effect of 2-dodecyl-6-methoxy-2,5-diene-1,4-cyclohexanedione (DMDD), an active component from Averrhoa carambola root, on myocardial injury in diabetic mice based on the nuclear receptor coactivator 4/ferritin heavy chain 1/autophagy-related protein 8 (NCOA4/FTH1/ATG8) axis. METHODS The successfully modeled diabetic mice were randomly divided into model group and DMDD low-, medium-, and high-dose (12.5, 25, 50 mg/kg) groups, while an additional non-modeled control group was established, with 6 mice in each group. Each group received the corresponding drug solution or an equal volume of normal saline intragastically once daily for 21 consecutive days. After the administration, the levels of fasting blood glucose (FBG), serum lactate dehydrogenase (LDH), and creatine kinase isoenzyme MB (CK-MB) were measured. Myocardial pathological changes, degree of fibrosis, and myocardial cell ultrastructure were observed. Myocardial cell death index and NCOA4 protein positive index were detected. The protein expression levels of NCOA4, FTH1, ATG8, solute carrier family 7 member 11 (SLC7A11), and glutathione peroxidase 4 (GPX4) in cardiac tissue were measured. RESULTS Compared with model group, each DMDD group showed significant alleviation of cardiac pathological injury and varying degrees of improvement in the myocardial cell ultrastructure. The FBG and serum LDH and CK-MB levels, the myocardial cell death index and NCOA4 protein positive index,the protein expression levels of NCOA4, FTH1, and ATG8 in cardiac tissue were significantly decreased ( P <0.001), while the protein expression levels of SLC7A11 and GPX4 were significantly increased ( P <0.001). CONCLUSIONS DMDD can reduce blood glucose levels, alleviate myocardial histopathological injury, and inhibit cell death in diabetic mice. The mechanism is associated with inhibiting excessive activation of the NCOA4/FTH1/ATG8 axis and reducing ferritinophagy.
7.Study on the discrimination of roasting degree of Ziziphus jujuba based on the correlation of colorimetric values with component content
Yuan LI ; Yanmei LIU ; Cheng HUANG ; Tangyi PENG ; Yanquan HAN
China Pharmacy 2026;37(9):1148-1154
OBJECTIVE To investigate the correlation of component content with colorimetric values during the roasting process of Ziziphus jujuba , and to provide criteria for discriminating the roasting degree of Z. jujuba . METHODS Samples were prepared by dry stir-frying for different roasting times. The eight main components in raw Z. jujuba and the samples stir-fried for different roasting times-namely adenosine, magnoflorine, jujuboside A, spinosin, 6-feruloylspinosin, betulinic acid, oleic acid, and linoleic acid-were quantitativel y analyzed using ultra-performance liquid chromatography. The chromaticity values were determined using a UV spectrophotometer. The correlation and differences between the chromaticity values of Z. jujuba at different roasting times and their components content were analyzed by Pearson correlation analysis, linear regression analysis, principal component analysis (PCA) , cluster heatmap analysis (CHA), and partial least squares discriminant analysis (PLS-DA) to clarify the processing endpoint. RESULTS As the roasting time increased, the contents of linoleic acid and oleic acid decreased, while the contents of other components exhibited an increasing trend. Concurrently, the colorimetric value L* and E*ab were observed to decline, whereas the a* value demonstrated a gradual increase. Pearson correlation analysis revealed that L* and E*ab exhibited a significant negative correlation with the contents of adenosine, spinosin, 6-feruloylspinosin, jujuboside A, betulinic acid and magnoflorine ( P <0.05). The results of linear regression analysis indicate that the content of six components, including adenosine, in the medicinal material can be preliminarily predicted by analyzing the colorimetric values of Z. jujuba powder. PCA and CHA successfully classified raw and stir-fried samples. The PLS-DA results indicated that L*, E*ab, a*, linoleic acid content, and oleic acid content were the main parameters that differentiated the color and quality of Z. jujuba at different roasting times. After frying for 9 to 10 minutes, the colorimetric values L* and E*ab decreased to their minimum values and stabilized, while a* remained consistently high with little variation;simultaneously, the concentrations of the six major components, excluding linoleic acid and oleic acid, reached their peak levels. CONCLUSIONS A significant correlation between the colorimetric values of Z. jujuba and the contents of six components, including adenosine, is confirmed. The optimal roasting time range is determined to be 9-10 minutes. Furthermore, the colorimetric value-component content correlation analysis method established in this study proved to be practical and applicable for discriminating the roasting degree of Z. jujuba .
8.Mechanism of Yigan huayu formula in alleviating liver fibrosis based on proteomics
Conghui WANG ; Guiping MA ; Longzhu WANG ; Fenping LU ; Yanfang LI ; Qiuhan GE ; Shiping HU
China Pharmacy 2026;37(9):1155-1160
OBJECTIVE To investigate the effects and mechanism of Yigan huayu formula in alleviating liver fibrosis in mice. METHODS Mice were randomly divided into blank group (normal saline), model group (normal saline), Yigan huayu formula low- and high-dose groups (28.98, 57.96 g/kg, calculated by crude drug), with 8 mice in each group. Except for the blank group, the liver fibrosis model was induced by intraperitoneal injection of 15%CCl 4 -olive oil solution. From the third week, the mice received the medicine/normal saline intragastrically, once a day, for 4 consecutive weeks. After the last medication, liver indexes were calculated, the activities of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in serum, as well as the hydroxyproline (HYP) content in liver tissue, were measured. Liver histopathology was evaluated. Differentially expressed proteins (DEPs) in liver tissue were analyzed based on proteomics, followed by bioinfo rmatics analysis. The expressions of core DEPs were validated using Western blot (WB) and immunohistochemistry (IHC) methods. RESULTS Compared with the blank group, the model group showed significantly elevated liver indexes, serum activities of ALT and AST, and hepatic HYP content ( P <0.05), along with obvious pathological damage and collagen deposition. Compared with the model group, the above indexes of mice in the Yigan huayu formula high-dose group were decreased significantly ( P <0.05), with marked improvement in liver pathological damage and collagen deposition. Proteomics identified 210 DEPs between the model group and Yigan huayu formula high-dose group. DEPs were significantly enriched in extracellular matrix (ECM)-receptor interaction and lipid metabolism pathways. WB and IHC confirmed that Yigan huayu formula could significantly inhibit the abnormally elevated expressions of collagen type Ⅳ alpha1 chain (COL4A1), secreted protein acidic and rich in cysteine (SPARC), vitronectin (VTN) and laminin subunit alpha5 (LAMA5) in liver tissue of mice ( P <0.05). CONCLUSIONS Yigan huayu formula may exert anti-hepatic fibrosis effects by inhibiting the expressions of proteins such as COL4A1, LAMA5, SPARC, and VTN, thereby blocking the ECM-receptor interaction signaling pathway, and subsequently suppressing excessive ECM deposition and basement membrane remodeling.
9.Analysis of differential metabolites in different parts of Angelica dahurica( Fisch.ex Hoffm.) Benth. et Hook. f. ex Franch. et Savat. based on untargeted metabolomics
Xing WANG ; Zishan ZHOU ; Enwei TIAN
China Pharmacy 2026;37(9):1161-1166
OBJECTIVE To investigate the metabolic differences in roots, stems and leaves of Angelica dahurica (Fisch.ex Hoffm.) Benth. et Hook. f. ex Franch. et Savat. (shortened for A. dahurica ), and to provide a basis for the development and utilization of its medicinal resources. METHODS UPLC-MS/MS untargeted metabolomics technology was employed to detect metabolites in roots, stems and leaves of A. dahurica . Multivariate statistical analysis was used to screen differential metabolites and perform cluster analysis. Furthermore, Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway enrichment analysis was conducted on these differential metabolites. RESULTS A total of 769 metabolites were identified in roots, stems and leaves of A. dahurica . Among t hem, lipids, alkaloids, amino acids and their derivatives accounted for the highest proportion, which accounted for 14.31%, 13.91% and 13.65%, respectively, and the coumarin compounds accounted for 3.25%. Results of principal component analysis, orthogonal partial least squares-discriminant analysis and cluster analysis indicated that there were certain differences in metabolites among the three tissues. A total of 205 differential metabolites were identified between stems and roots (82 up-regulated and 123 down-regulated), 326 differential metabolites between leaves and roots (247 up-regulated and 79 down-regulated), and 293 differential metabolites between the leaves and stems (263 up-regulated and 30 down-regulated). Further analysis of the differential coumarin metabolites in different plant parts revealed that several compounds, including ( R )-oxypeucedanin, 4-hydroxycoumarin, 4-methylumbelliferyl acetate, exhibited relatively high contents in the leaves. KEGG pathway enrichment analysis indicated that differential metabolites predominantly accumulated in the phenylpropanoid biosynthesis and ABC transporter pathways. CONCLUSIONS There are significant differences in metabolites among roots, stems and leaves of A. dahurica . Coumarin compounds are highly enriched in the leaves, and their synthesis and transport may be related to the synergistic effect of the phenylpropanoid biosynthesis pathway and the ABC transporter pathway.
10.Study on the effect and mechanism of processed Oxytropis falcata in improving renal fibrosis in rats
Qing ZHANG ; Xinhuan MA ; Mingjing YANG ; Zhiwei XU ; Wenjing WANG ; Hui SONG
China Pharmacy 2026;37(9):1167-1172
OBJECTIVE To investigate the improvement effect and mechanism of processed Oxytropis falcata on renal fibrosis (RF) in rats. METHODS RF model was induced by adenine. After modeling, the rats were divided into the model group, positive control group (colchicine, 0.45 mg/kg), and processed O. falcata low-, medium- and high-dose groups (0.5, 1, 2 g/kg), respectively. Additionally, a blank group without modeling was set up, with 8 rats in each group. The positive control group and the various dosage groups of processed O. falcata were given the corresponding medicinal solutions intragastrically, while the blank group and model group were given equal volume of normal saline intragastrically, once daily for 28 consecutive days. The appearance and histopathological morphology of the rats’ kidneys were observed. Serum levels of renal function indexes [bl ood urea nitrogen (BUN), creatinine (Cr) ] and inflammatory factors [interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α) ] in rats were detected. Protein expressions of fibronectin (FN), α -smooth muscle actin ( α -SMA) and collagen type Ⅰ (Col-Ⅰ) in renal tissue of rats were determined. mRNA expressions of transforming growth factor-β 1 (TGF-β 1 ), Smad3 and extracellular signal-regulated kinase 1/2 (ERK1/2) in renal tissues were measured. Protein expression of TGF-β 1 and phosphorylation levels of Smad3 and ERK1/2 in renal tissues were detected. RESULTS Compared with the blank group, the rats in the model group exhibited enlarged kidneys with pale color, rough and uneven surface. There was a significant infiltration of inflammatory cells and vacuolated cells in the renal tubules, along with marked proliferation of collagen fibers. Serum levels of BUN, Cr, IL-6 and TNF-α, protein expressions of α -SMA, Col-Ⅰ and FN in renal tissues, mRNA expressions of TGF-β 1 , Smad3, ERK1 and ERK2 and protein expression of TGF-β 1 as well as phosphorylation levels of Smad3 and ERK1/2 in renal tissues were increased significantly ( P <0.05). Compared with the model group, renal pathological changes of rats were alleviated in processed O. falcata groups, with reduced infiltration of inflammatory cells and proliferation of collagen fibers. The levels of the aforementioned quantitative indicators were all significantly reversed ( P <0.05). CONCLUSIONS Processed O. falcata can improve renal function in RF rats, alleviate inflammatory responses, and reduce abnormal collagen fiber deposition. Its mechanism of action may be related to the inhibition of the activity of the TGF-β 1 /Smad signaling pathway.
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