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    15 April 2024, Volume 21 Issue 4 Previous Issue    Next Issue

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    Chinese patent medicines for recurrent spontaneous abortion: a scoping review of clinical evidence
    YU Xin, GONG Leilei, YAO Weijie, YUAN Sisi, FENG Xin
    2024, 21(4): 361-365. 
    DOI: 10.19803/j.1672-8629.20240057

    Abstract ( 187 )   PDF (2126KB) ( 743 )  
    Objective To systematically sort out the drug information and current status of clinical research on the treatment of Recurrent Spontaneous Abortion (RSA) with Chinese patent medicines, so as to provide reference evidence for the rational use of medicines in the clinic, and a basis for the decision-making in the clinical practice and healthcare. Methods We carried out Chinese and English database document retrieval to review the clinical studies on Chinese patent medicines for the treatment of RSA. Relevant software was used to manage the literature, extract the basic information of the drugs and studies, and carry out visual comparative analyses in the form of textual descriptions and charts. Results A total of 95 research articles on Chinese patent medicines were screened out, including 2 systematic reviews and 93 clinical studies. 11 types of Chinese patent medicines were involved, including 1 Chinese medicine injection. The drugs with a higher number of clinical studies were Zishenyutai pills, Gushenantai pills, and Baotailing preparation. Since 2005, the number of related studies has been on an overall elevated trend, and has been carried out in 24 regions of China, the largest number of studies with sample sizes of 51~100 cases included 67 (72.04%); the type of comparison with the largest number of studies was the comparison of Chinese patent medicines in combination with Western medicines versus Western medicines, with a total number of studies amounted to 75 (80.65%). At present, there is no uniform clinical treatment protocol and efficacy judgement standard, and some studies (43.01%) recorded the occurrence of adverse reactions during drug administration in patients. Conclusion Chinese patent medicines have good suitability for the treatment of RSA, and their effectiveness in combination with western medicines is clear. However, there are problems such as lack of content in the drug instruction, timing and duration of medication and outcome evaluation indexes are not standardised, insufficient attention to medication safety, insufficient embodiment of Chinese medicine characteristics , which needs to be improved in the future.
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    Molecular mechanism of Yangxue Antai granules for the treatment of recurrent spontaneous abortion based on network pharmacology and molecular docking
    LI Xinlei, GONG Leilei, WANG Xiaoxia, ZHANG Xueyan, ZHAO Han, YAO Weijie, YUAN Sisi, FENG Xin
    2024, 21(4): 366-370. 
    DOI: 10.19803/j.1672-8629.20240051

    Abstract ( 207 )   PDF (4325KB) ( 96 )  
    Objective To reveal the mechanism of Yangxue Antai granules (YXATG) in the treatment of Recurrent spontaneous abortion (RSA) based on network pharmacology and molecular docking. Method The main chemical components and their targets of YXATG were collected from TCM Systematic Pharmacology Database and Analysis Platform (TCMSP) and TCM Integrated Pharmacology Research Platform (TCMIP) databases. The targets for RSA were identified from OMIM, GeneCards, Drugbank, PharmGkb and TTD databases. The intersection of drugs and disease targets was analyzed by drawing venn diagram, an online tool, and imported into the database, and analyzed the drug-disease target intersection through the online tool draw venn diagram, imported into STRING database, analysed the shared target interaction relationship (PPI), and performed bioinformatics analysis on it. In addition, the core targets of YXATG for RSA were analyzed according to Degree value, and molecular docking technology was used to study the binding degree between the targets and chemical components to validate the results of network pharmacological analysis. Results A total of 70 chemical components and 236 targets of YXATG were collected, and 453 disease targets were obtained after de-weighting. A total of 66 common targets were obtained by intersection analysis, and PPI interaction analysis revealed that IL6, MMP9, TNF, IL1B and IL10 were the core targets of YXATG for the treatment of RSA. Bioinformatics enrichment analysis revealed that these common targets mainly acted in TNF signaling pathway, HIF-1 signaling pathway, FoxO signaling pathway, estrogen signaling pathway and other signaling pathways. Further molecular docking results showed that the target MMP9 with the highest degree value docked well with paeoniflorin, sesamin, quercetin and kaempferol. Especially, paeoniflorin docked better than the positive control. Conclusion Through network pharmacology and molecular docking analysis, it was found that the main active ingredients in YXATG exerted their therapeutic effects on RSA by affecting multiple signaling pathways through their action on MMP9.
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    Effect of Yangxue Antai prescription on the regulation of placental angiogenesis and autophagy in recurrent spontaneous abortion mice
    YAO Weijie, YAN Shiqi, YUAN Sisi, GONG Leilei, FENG Xin
    2024, 21(4): 371-377. 
    DOI: 10.19803/j.1672-8629.20240058

    Abstract ( 49 )   PDF (3046KB) ( 72 )  
    Objective To explore the molecular mechanism of Recurrent spontaneous abortion (RSA) treated by Yangxue Antai prescription. Methods RSA mouse model with kidney deficiency and blood stasis was constructed, and the placentas of mice were collected after the intervention of Yangxue Antai prescription, The pathological changes of mouse placenta were observed by HE staining and Masson staining, and the expressions of PCNA, Fibrinogen and CD34 protein in mouse placenta were determined by immunohistochemistry. The protein expression of VEGF, p-VEGFR2, p62, Beclin1, LC3Ⅰ and LC3Ⅱ in mouse placenta were determined by Western blot. The ultrastructure of mouse placenta was observed by transmission electron microscopy (TEM). Results Compared with RSA group, the body weight of mice in RSA+ Yangxue Antai group increased significantly, and the embryo absorption rate decreased significantly. HE staining, Masson staining and the expression of PCNA and Fibrinogen protein showed significantly improve in mice placenta. TEM results and the protein expression of p62, Beclin1, LC3II/LC3Ⅰ showed that the level of autophagy of the placenta of the mice was significantly decreased. CD34, VEGFA and p-VEGFR2 proteins expression showed a significant increase in placental angiogenesis. Conclusion Yangxue Antai prescription improve placental development and promote placental angiogenesis in RSA mice, which may be related to inhibiting the fusion of autophagosome and lysosome, thus inhibiting autophagy.
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    Study on the mechanism of Yangxue Antai prescription regulating autophagy in the treatment of recurrent spontaneous abortion mice
    YAO Weijie, YAN Shiqi, YUAN Sisi, GONG Leilei, FENG Xin
    2024, 21(4): 378-385. 
    DOI: 10.19803/j.1672-8629.20240060

    Abstract ( 43 )   PDF (3397KB) ( 58 )  
    Objective To investigate the mechanism of Yangxue Antai prescription regulating autophagy and affecting placental angiogenesis in the treatment of Recurrent spontaneous abortion (RSA). Methods Rapamycin, 3-methyladenine and Yangxue Antai prescription were used to intervene in pregnant mice, and then the placentas of mice were collected, and the pathological changes of pregnant mice were observed by HE staining and Masson staining; Proliferating Cell Nuclear Antigen (PCNA), Fibrinogen and CD34 protein expression were determined by immunohistochemistry; The expression of vascular endothelial growth factor (VEGF), vascular endothelial growth factor receptor 2 (p-VEGFR2), p62, Beclin1, LC3Ⅰ and LC3Ⅱ were determined by Western blot, and the ultrastructure of the placenta was observed by transmission electron microscopy. Results Compared with the Control group, the body weight in Rapa group decreased significantly, and the embryo absorption rate increased significantly. HE staining, Masson staining and the expression of PCNA and Fibrinogen protein showed poor placental development. The results of transmission electron microscopy(TEM) and the expression of p62, Beclin1 and LC3Ⅱ/LC3Ⅰ protein showed that the level of placental autophagy increased significantly. The expression of CD34, VEGFA and p-VEGFR2 showed abnormal placental angiogenesis. Compared with Rapa group, the body weight of mice in Rapa+Yangxue Antai group increased significantly, and the embryo absorption rate decreased significantly. HE staining, Masson staining, and the expression of PCNA and Fibrinogen protein showed that the placental development of mice improved significantly. The results of TEM and the expression of p62, Beclin1 and LC3Ⅱ/LC3Ⅰ protein showed that the level of placental autophagy decreased significantly, and the expression of CD34, VEGFA and p-VEGFR2 protein showed increased placental angiogenesis. Conclusion Yangxue Antai prescription can inhibit autophagy by inhibiting the fusion of autophagy and lysosome, improve placental development and promote placental angiogenesis in pregnant mice, and thus reduce the abortion rate.
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    Content determination of aristolochic acid Ⅰ and aristolochic acid Ⅱ in Ditong Biyan Shui by UPLC-MS/MS
    GUO Rixin, XIAO Meng, LIU Jing, DAI Zhong, MA Shuangcheng
    2024, 21(4): 386-390. 
    DOI: 10.19803/j.1672-8629.20230740

    Abstract ( 39 )   PDF (2487KB) ( 58 )  
    Objective To determine the contents of aristolochic acid I and aristolochic acid Ⅱ in Ditong Biyan Shui, and to provide reference for quality control. Methods A UPLC-MS/MS method was established to determine the contents of aristolochic acid I and aristolochic acid Ⅱ. An Waters-ACQUI UPLC HSS T3 C18(2.1 mm×100 mm, 1.8 μm) was used as the chromatographic column. The mobile phase was eluted with acetonitrile (A), 0.1% formic acid solution (B) using a gradient elution method. The electrospray spray ion source (ESI) and positive ion multi-reaction monitoring mode were adopted. The contents were calculated using the standard curve method. Results Aristolochic acid I was not detected in 9 samples of 17 batches of Ditong Biyan Shui (detection limit 0.13 pg), but was detected in 8 batches of samples, with the contents ranging from 0.41 to 3.60 ng·mL-1. Aristolochic acid Ⅱ was not detected in any of the samples (detection limit 0.41 pg). Conclusion A UPLC-MS/MS method has been established to determine the contents of aristolochic acid I and aristolochic acid Ⅱ in Ditong Biyan Shui, with high specificity, high sensitivity, good repeatability, which can provide reference for quality control of aristolochic acid I and aristolochic acid Ⅱ in Ditong Biyan Shui.
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    Effect of ropivacaine hydrochloride and its dextroisomer (R)-ropivacaine hydrochloride on hERG currents using manual patch clamp method in HEK293 cells that stably overexpress hERG channel
    WANG Jingwen, XU Daiyue, CHEN Hua, YIN Lihui
    2024, 21(4): 391-396. 
    DOI: 10.19803/j.1672-8629.20230326

    Abstract ( 25 )   PDF (1804KB) ( 61 )  
    Objective To compare the effect of ropivacaine hydrochloride and (R)- ropivacaine hydrochloride on the human-ether-a-go-go-related gene(hERG) current in HEK293 cells that stably overexpress hERG potassium channels. Methods Manul patch clamp techniques were employed to investigate the effects of ropivacaine hydrochloride and (R)- ropivacaine hydrochloride on Iherg-tail in the HEK293 cell line that stably overexpresses hERG potassium channels. Results The inhibition rate of ropivacaine hydrochloride on hERG was (6.12±0.30)%,(13.04±1.20)%, (19.21±0.33)%, (35.56±0.66)% and (65.37±4.17)% at the doses of 0.37, 1.11, 3.33, 10.00 and 30.00 μmol·L-1. The half-maximal inhibitory concentration (IC50) of ropivacaine hydrochloride on hERG was 19.482 μmol·L-1 (n=15). The inhibition rate of (R)- ropivacaine hydrochloride on hERG was (4.13±3.43)%, (7.34±5.60)%, (9.49±2.75)%, (16.60±0.87)% and (31.36±1.45)% at the doses of 30.00, 10.00, 1.11 and 0.37 μmol·L-1. The half-maximal inhibitory concentration (IC50) of (R)-ropivacaine hydrochloride on hERG exceeded 30 μmol·L-1 (n=15). The inhibition rate of dofetilide on hERG was (7.81±2.77)%, (19.67±1.88)%, (57.16±4.39)%, (89.71±3.55)% and (99.66±0.89)% at the doses of 0.001 85, 0.005 56, 0.016 67, 0.050 00 and 0.150 00 μmol·L-1. The half-maximal inhibitory concentration (IC50) of dofetilide on hERG was 0.015 μmol·L-1(n=15).Conclusion Compared with dofetilide, ropivacaine hydrochloride has weak inhibitory effect on the hERG channel and (R)- ropivacaine hydrochloride has no obvious inhibitory effect on the hERG channel.
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    Compatibility and mechanism of a Chinese medicine compound in treating Sjogren's syndrome
    RU Chen, HOU Xiujuan, QIAN Tangliang, DU Mengmeng, LI Yuan, LIU Xiaoping, ZHU Yuelan
    2024, 21(4): 397-403. 
    DOI: 10.19803/j.1672-8629.20230429

    Abstract ( 201 )   PDF (2732KB) ( 78 )  
    Objective To analyze the ways in which Chinese medicinal compound formulas are used in the treatment of Sjogren's syndrome based on the National Patent Database and to predict the potential targets of action and molecular mechanisms of high frequency drugs in the treatment of Sjogren's syndrome using analytical methods of network pharmacology. Methods Data on patent Chinese medicinal compound formulas for treating Sjogren's syndrome was retrieved from the Chinese Patent Search Database as of December 10, 2022. Microsoft Excel 2022 and IBM SPSS Modeler 18.0 were used to analyze these included compounds in terms of frequency, correlations and clustering analysis. The chemical components of TCM and their potential targets were retrieved from the Traditional Chinese Medicine Systematic Pharmacology Database (TCMSP) platform. OMIM and GeneCards were used to screen the Sjogren' Syndrome-related disease targets. The Venny diagram was drawn to identify the intersection targets of high-frequency drugs and Sjogren's syndrome targets. The protein interaction network was constructed while the final core targets were screened by using the STRING database. The Metascape website was used to find the pathways and functions of high core target enrichment. Results According to the screening results via the national patent database, 69 eligible Chinese medicine compound patents for the treatment of Sjogren's syndrome were obtained, including 353 drugs, and the top 5 high-frequency drugs were Maidong(Dwarf Lilyturf Tuber), Dihuang (Rehmanniae Radix), Gancao (Licorice), Shihu (Dendrobium nobile Lindl) and Baishao (White Peony Root). These five drugs involved 161 compounds and 1 585 related targets, 1 058 targets related to the Sjogren's syndrome, 81 treatment targets and 28 core targets. Through enrichment analysis, 177 KEGG pathways were obtained, including IL-17 signaling pathway, PD-1/PD-L1 pathway and JAK-STAT signaling pathway. A total of 3 106 GO biological processes (BPs) were retrieved, involving cellular responses to biological stimuli and lipopolysaccharides and the processes of positive regulation of cytokine production. The 193 GO cellular components (CCs) involved the outer plasma membrane and membrane microregions. Conclusion Sjogren' Syndrome is generally treated with Chinese medicinal compound formulas by nourishing Yin, moistening dryness and generating fluid. The medications for Sjogren's Syndrome have multi-component, multi-target and multi-pathway properties and are closely related to IL-6, MMP3, SATA3 and TNF possibly through IL-17, PD-1/PD-L1 pathways. This study is expected to provide reference for subsequent clinical treatment of Sjogren's syndrome.
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    Effect of Foshao granules on spastic abdominal pain in rats
    LI Shuran, GUO Shanshan, BAO Lei, ZHAO Ronghua, SUN Jing, GENG Zihan, BAO Yanyan, ZHANG Jingsheng, XU Yingli, LYU Yaozhong, WANG Zhenzhong, CUI Xiaolan, WANG Hongmei
    2024, 21(4): 404-407. 
    DOI: 10.19803/j.1672-8629.20230283

    Abstract ( 34 )   PDF (2875KB) ( 52 )  
    Objective To study the effects of Foshao granules on spastic abdominal pain in rats. Methods Six-week-old SD rats were divided into the normal control group, model group, domperidone control group(6.00 mg·kg-1), Sini powder control group(1.50 g·kg-1) and Foshao granule groups (24 g crude drug·kg-1, 12 g crude drug·kg-1 and 6 g crude drug·kg-1), with 10 mice in each. Spastic abdominal pain in rats was induced by intraperitoneal injection with neostigmine. The incubation, duration and incidence of pain as well as the pathological changes in the stomach and colon of the rats were observed, while serum contents of substance P, GT and MTL were detected by ELISA. Results Foshao granules could prolong pain incubation (P<0.05, P<0.01), shorten the pain duration (P<0.01), lower the incidence of pain, reduce the serum contents of substance P (P<0.01), GT (P<0.01), MTL (P<0.01), and inhibit mucosal hyperplasia, interstitial inflammation and the enlargement and increase of goblet cells in of the stomach and colon of rats. Conclusion Foshao granules can improve neostigmine-induced spastic abdominal pain.
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    Effect of extracts of Pith-nodecayed and Pith-decayed of Scutellariae Radix on intestinal flora and protective mechanism of intestinal mucosal barrier in damp-heat ulcerative colitis rats
    HUANG Wei, LUO Yaqin, YU Xinyang, DONG Hongjing, WANG Xiao
    2024, 21(4): 408-414. 
    DOI: 10.19803/j.1672-8629.20230552

    Abstract ( 28 )   PDF (2299KB) ( 67 )  
    Objective To investigate the effect of extracts from Pith-decayed and Pith-nodecayed products of Scutellariae Radix on intestinal flora and the protective mechanism of intestinal mucosal barrier in rats with damp-heat ulcerative colitis(UC). Methods Fifty healthy SD rats were randomly divided into 5 groups: normal group, model group, Pith-decayed products of Scutellariae Radix group, Pith-nodecayed products of Scutellariae Radix group and mesalazine group, with 10 rats in each group. The damp-heat UC rat model was established by the combination of high-fat and high-sugar diet+high-liquor administration+5% dextran sodium sulfate (DSS). Each group was given intragastric administration on the first day of modeling, respectively. The dosage of Pith-decayed products group and Pith-nodecayed products group was 5.25 g·kg-1·d-1, and that of mesalazine group was 0.266 g·kg-1·d-1. Normal group and model group were given equal volume of normal saline. The drug was administered continuously for 28 days. After administration, sterile feces were collected, and the colonic mucous tissues were dissected and homogenized. The levels of interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α) and interleukin-1β (IL-1β) in colonic mucosa of rats were detected by Elisa. Real-time fluorescence quantitative polymerase chain reaction (qRT-PCR) was used to detect the mRNA expression levels of Claudin-1, MUC2, Occludin, ZO-1 in colon tissue of rats. 16S rDNA sequencing technology was used to detect the quantity and abundance of intestinal flora in stool of rats. Results Compared with normal group, the contents of IL-6, TNF-α and IL-1β in colonic mucosa of rats in model group were significantly increased (P<0.01), and mRNA expression levels of Claudin-1, MUC2, Occludin and ZO-1 were significantly increased (P<0.01). After 28 days of administration, compared with the model group, the levels of IL-6, TNF-α and IL-1β in colonic mucosa of rats in each administration group were significantly decreased (P<0.01), and the mRNA expression levels of Claudin-1, MUC2, Occludin and ZO-1 indexes were significantly decreased in different degrees (P<0.05 or P<0.01). Compared with Pith-decayed products group, Pith-nodecayed products group and mesalazine group were superior to Pith-decayed products group in reducing the levels of IL-6, TNF-α, IL-1β, and mRNA expression of Claudin-1, Occludin, ZO-1 (P<0.05 or P<0.01), but had no significant improvement on MUC2 index. Mesalazine group has the best efficacy. The intestinal flora sequencing results showed that the diversity and abundance of intestinal bacteria in the damp-heat UC model group decreased, and the relative abundance of Firmicutes and Bacteroidota decreased significantly (P<0.05). The relative abundance of Proteobacteria was significantly increased (P<0.05), Firmicutes and Bacteroides were significantly increased in Pith-decayed products group and Pith-nodecayed products group (P<0.05), Proteobacteria was significantly decreased (P<0.05), and mesalazine group had no significant effect on regulating the flora (P>0.05). There was also some difference between Pith-decayed products group and Pith-nodecayed products group. Pith-decayed products group was mainly increased in Firmicutes, while Pith-nodecayed products group was mainly increased in Bacteroidetes. Conclusion Pith-decayed and Pith-nodecayed products of Scutellariae Radix may protect the damaged intestinal mucosal barrier and inhibit the inflammatory response by regulating the unbalanced intestinal flora, and play a role in the treatment of damp-heat UC.
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    Pharmacodynamics of peptide drug BR0336 in a mouse model of T2DM combined with NASH
    HUANG Shuguang, ZHANG Xuenong
    2024, 21(4): 415-421. 
    DOI: 10.19803/j.1672-8629.20240081

    Abstract ( 29 )   PDF (2253KB) ( 58 )  
    Objective To investigate the pharmacological efficacy of the peptide-based drug BR0336 injection in a male C57BL/6 mouse model of T2DM combined with NASH induced by STZ-HFD. Methods Neonatal male mice were induced with streptozotocin to establish a T2DM model and fed a high-fat diet from one month of age. They were randomly assigned to the model group, TZP-0.15 mg∙kg-1 control group, and BR0336-0.05 mg∙kg-1, 0.15 mg∙kg-1, 0.5 mg∙kg-1 groups based on fasting blood glucose levels and body weight. Such parameters as body weight, food intake, fasting blood glucose, serum insulin, HbA1C%, liver function and blood lipid profiles of mice were recorded. Additionally, histopathological NAS and fibrosis analysis of liver tissues was conducted. Results BR0336 at various doses could significantly reduce body weight, food intake, fasting blood glucose, insulin levels and HbA1c% of model mice, and decrease liver NAS scores and fibrosis rates. Furthermore, BR0336 could protect liver function and improve dyslipidemia in model mice. Compared with the positive control group, an equivalent dose of BR0336 exhibited superior effects in terms of food intake, insulin levels, liver function and blood lipid profiles, and significantly delayed the progression of NASH and fibrosis. Conclusion BR0336 has a significant therapeutic effect against hyperglycemia and lipid metabolism disorders in model mice of STZ-HFD-induced T2DM combined NASH.
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    Management of risks to pediatric medications based on drug instructions of Chinese patent medicines in a hospital
    LIU Jie, ZHANG Jianmin, ZHANG Xiaomeng, LIU Fang, SONG Yuan, ZHONG Xuli
    2024, 21(4): 422-427. 
    DOI: 10.19803/j.1672-8629.20230625

    Abstract ( 120 )   PDF (1907KB) ( 168 )  
    Objective To investigate the types, drug instructions and current usage of Chinese patent medicines for pediatric use in our hospital, analyze the risks, and provide data for safe and rational use of pediatric drugs. Methods The way in which 128 types of Chinese patent medicines were used in our hospital was investigated. The labeling of usage and dosage, adverse reactions, contraindications, precautions, drug interactions, clinical trials or pharmacology and toxicology in the instructions were analyzed. Prescriptions of traditional Chinese patent medicines given by outpatient and emergency departments in June and October 2021 were randomly selected to find out whether these prescriptions were up to standard and proper before the potential risks to pediatric drugs were explored. Results Among the 128 types of Chinese patent medicines, 54 were children specific medicines, accounting for 42.19%. There were 47 types of drugs containing toxic decoction pieces, involving 21 types of toxic Chinese medicinal materials. According to the survey on the contents marked in the instructions, 52.35% of the drugs were marked with clear usage and dosage for children, and 32.03%, 32.81% and 82.03% of the drugs labeled with adverse reactions, contraindications and precautions, respectively. The rate at which drug interactions, clinical trials or pharmacological and toxicological labeling were specified was not high. Improper prescriptions of Chinese patent medicines in the outpatient and emergency departments included the lack of diagnosis by TCM clinicians and inappropriate use and dosage. There were some drug risks. Conclusion The limited diversity of traditional Chinese patent medicines and the lack of information on children's drug use in the instructions can increase the risk of clinical drug use. It is recommended that the research and development of children specific drugs be enhanced and multi-dimensional research be conducted to supplement the information on traditional Chinese patent medicines for children. Based on the characteristics of children's s bodies, conditions and medications, pharmacists should provide targeted, refined and personalized pharmaceutical service, strengthen the supervision and guidance of drug use for children, and ensure the rational and safe use of drugs for children.
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    Roles of licensed pharmacists in drug classification management
    ZHOU Yue, LIU Shuo, SONG Haibo
    2024, 21(4): 428-434. 
    DOI: 10.19803/j.1672-8629.20230532

    Abstract ( 98 )   PDF (1934KB) ( 102 )  
    Objective To offer recommendations about how to improve the quality of licensed pharmacists and promote drug classification. Methods The current requirements for (licensed) pharmacists in domestic and foreign regulations on drug classification were analyzed, and the role of licensed pharmacists in promoting drug classification was studied . Results Drug classification systems at home and abroad attached importance to the responsibilities of licensed pharmacists. There were specific and detailed requirements for (licensed) pharmacists in other countries. In terms of drug classification, licensed pharmacists in China were characterized by irreplaceability, feasibility, representativeness and extensiveness, whose roles should be brought into full play. Conclusion It is recommended that guidelines for drug classification be formulated as soon as possible, the duties of licensed pharmacists align with the requirements of drug classification, multiple measures be taken to produce more licensed pharmacists, related training be improved, and that drug classification be promoted.
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    Immune-related adverse events of tirelizumab in 424 cases of cancer patients
    ZHANG Jian, ZHANG Lingli, LI Xin
    2024, 21(4): 435-439. 
    DOI: 10.19803/j.1672-8629.20240091

    Abstract ( 95 )   PDF (2623KB) ( 101 )  
    Objective To find out about the occurrence, development and characteristics of immune-related adverse events (irAEs) among tumor patients under immunotherapy with tirelizumab and recommend countermeasures so as to provide reference for early clinical identification and effective response. Methods The clinical data of patients with malignant tumor who received immunotherapy with tirelizumab in the First Affiliated Hospital of Nanjing Medical University between October 1, 2021 and September 30, 2023 was analyzed retrospectively, including the age, gender, disease, concomitant medications, occurrence of irAEs, clinical manifestations, toxicity classification and clinical treatments. The characteristics of IREAS caused by tirelizumab were summarized. Results Among the 424 patients who used tirelizumab, 243 patients (57.31%) had 364 cases of irAES while the rest (42.69%) did not. IrAEs occurred once in 163 cases (67.08%), and twice or more in 80 cases (32.92%). IrAEs involved 11 kinds of systems and organs, the highest incidence is 161cases (44.23%) of endocrine system abnormalities, and 51 cases of blood system abnormalities (14.01%), digestive system damage in 33 cases (9.07%)、Cardiovascular system in 29 cases (7.97%), skin and its accessories in 19 cases (5.22%). There were 345 cases (94.78%) with irAEs of G1-G2 grades, which improved after symptomatic treatment. There were 14 cases (3.85%) of G3 grade, which required hospitalization. Five cases (1.37%) were G4 that involved rescue and treatment. There was no death caused by irAEs. Conclusion Tirelizumab-related irAEs can involve a variety of organs and systems in the body, which can be generally monitored and controlled. Patients can be seriously injured without quick interventions. Early monitoring, quick identification and effective countermeasures can help ensure the safety of medications.
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    Signal detection of adverse reaction of sofosbuvir/velpatasvir and ledipasvir/sofosbuvir based on FAERS database
    HAN Li, CHEN Li, CHEN Qian, XIAO Hongtao
    2024, 21(4): 440-446. 
    DOI: 10.19803/j.1672-8629.20230248

    Abstract ( 62 )   PDF (1955KB) ( 103 )  
    Objective To provide reference for safe and rational use of sofosbuvir/velpatasvir(SOF/VEL) and ledipasvir/sofosbuvi(LED/SOF) by analyzing signals of post-marketing adverse drug reactions (ADR) of the two drugs. Methods Data on adverse events reported by the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) between January 1, 2017 and September 30, 2021 was mined by adopting the reporting odds ratio (ROR) method and the information component (IC) method. Description terms of ADR in the reports were standardized using the medical dictionory for regulatory activities(MedDRA) terminology. ADR with signals were screened out and compared. Results A total of 16 signals of SOF/VEL and 18 signals of LED/SOF were finally obtained, including 7 overlapping signals which mainly involved systemic, gastrointestinal, hepatobiliary, neurological and mental system damage, and the risk of HBV reactivation. The specific ADR of SOF/VEL were increased appetite, alcohol use and heavy menstrual bleeding while those of LED/SOF were nonacute porphyria, cholangiocarcinoma and cryoglobulinaemia. Conclusion In this study, ROR and IC methods have been used to dig out the ADR risk signals of SOF/VEL and LED/SOF, which provides new evidence for their safe and rational use.
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    Safety assessment and risk factor analysis of PD-1 immunotherapy in a cohort of 385 patients
    YANG Bo, WANG Mengjiao, HU Lili, WANG Laicheng, LI Qian, KONG Feifei, LYU Dongmei, SHEN Jiani
    2024, 21(4): 447-450. 
    DOI: 10.19803/j.1672-8629.20230304

    Abstract ( 58 )   PDF (3138KB) ( 85 )  
    Objective To explore the risk factors of domestic PD-1 related ADR, and provide prognostic indexes and experience for the safety of PD-1 immunotherapy. Methods Collected and recorded domestic PD-1 cases from June 2020 to December 2022 in our hospital: Gender, age, body mass index, tumor type, underlying disease, PD-1variety. etc. Followed up for at least two treatment cycles, identified and evaluated the type and degree of irAE. Then evaluated with univariate and multivariate Logistic regression analysis. Results A total of 385 cases were collected, including 134(34.81%) irAE, 251(65.19%) non-irAE, and 29(7.53%) ≥grade 3 irAE. Univariate analysis showed that the incidence of irAE was related to age, smoking, type of tumor and PD-1(P<0.05). Multivariate analysis showed that age<65 increased 1.590 times(95%CI: 1.006, 2.512), smoking increased 1.920 times(95%CI: 1.021, 3.611), respiratory diseases were 2.061 times (95%CI: 1.205, 3.527) more likely to develop irAE, Carrilizul had a higher risk than sindilid, Tirelizul and triripril (P<0.05). Conclusion Age<65, smoking and respiratory tumor is the higher risk factors of irAE of PD-1, the short-term irAE rate of Carrilizumab is higher, more attention should be paid to monitoring such patients and offering irAE treatment in time.
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    Pharmaceutical care of a patient with type 2 diabetes mellitus treated with a combination of traditional Chinese and Western medicine during acute exacerbation of gout
    CHEN Liye, ZHU Li, GONG Leilei
    2024, 21(4): 451-453. 
    DOI: 10.19803/j.1672-8629.20230759

    Abstract ( 77 )   PDF (1399KB) ( 95 )  
    Objective To explore the role of clinical pharmacists in the treatment of a patient with type 2 diabetes mellitus in the acute exacerbation stage of gout. Methods Clinical pharmacists participated in the treatment of a patient with type 2 diabetes mellitus in the stage of acute exacerbation, analyzed the drug-related causes of poor blood glucose control, studied the effect of hypoglycemic drugs on blood uric acid, recommended switch to SGLT-2i and optimized the Chinese and Western medicine regimens for hypoglycemic and gout treatment. Results The symptoms of swelling and pain were significantly alleviated, and the blood glucose decreased steadily. Conclusion Clinical pharmacists can play an active role in clinical treatment by participating in the pharmaceutical care of patients with type 2 diabetes mellitus during acute exacerbation of gout, assisting physicians in optimizing treatment plans, and providing individualized medication to patients.
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    Pharmaceutical care of serious adverse reactions due to methotrexate treatment of ectopic pregnancy
    LI haiyan, YANG Zhongxu, LIU Yuekun, WANG Lihong
    2024, 21(4): 454-456. 
    DOI: 10.19803/j.1672-8629.20230616

    Abstract ( 81 )   PDF (2129KB) ( 122 )  
    Objective To monitor the use of methotrexate for the treatment of one ectopic pregnancy patient based on the China Hospital Pharmacovigilance System (CHPS) so as to explore the role of clinical pharmacists in providing pharmacological care. Methods The process in which clinical pharmacists monitored adverse reactions during methotrexate therapy in a patient with ectopic pregnancy through the CHPS and participated in revising the medication regimen was analyzed. Results and Conclusion Clinical pharmacists can monitor adverse drug reactions via the CHPS, assist clinicians in treating adverse reactions, ensure the safety of medication, and improve the quality of pharmacy services.
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    Two cases of uveitis caused by TNF-α inhibitor recombinant human tumor necrosis factor-α receptor II: IgG Fc fusion protein for injection / etanercept for injection
    SUN Wu, CHEN Shuiling, ZHOU Wanyu, SHI Hang, LIU Lu, HE Yan, FU Wentao, CHU Liqun
    2024, 21(4): 457-460. 
    DOI: 10.19803/j.1672-8629.20230281

    Abstract ( 39 )   PDF (1566KB) ( 72 )  
    Objective To investigate the correlations between TNF-α inhibitor and uveitis and to analyze the clinical features of TNF-α inhibitor-induced uveitis. Methods The clinical data of 2 patients with uveitis treated with the recombinant human tumor necrosis factor-alpha receptor II: IgG Fc fusion protein / ETANERCEPT for injection in our hospital between July 2021 and February 2023 was retrospectively analyzed, and the related literature was reviewed. Results Two female patients were collected. The onset of uveitis occurred at 2 and 6 weeks after medication, respectively, with one case of anterior uveitis and one case of anterior and intermediate uveitis. The conditions of both patients improved after symptomatic treatment. Literature review revealed that TNF-α inhibitors that caused uveitis included infliximab, adalimumab, and ETANERCEPT, which were mostly used for the treatment of rheumatoid arthritis, tumor, ankylosing spondylitis, and uveitis. The patients ranged from 5 to 77 in age, and the duration of onset ranged from 1 week to 4 years after medication. The vast majority of patients with TNF-α inhibitors-induced uveitis could recover their vision after systematic treatment and cessation of immunosuppressive agents. Conclusion The occurrence of uveitis is closely related to the use of TNF-α inhibitors, and the type of uveitis is predominantly anterior uveitis with a high chance of recurrence. Most patients have a favorable visual prognosis after prompt diagnosis and treatment.
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    One case of hyponatremia caused by omeprazole sodium for injection
    LI Shaoqiang, KONG Xudong, LI Pengmei
    2024, 21(4): 461-463. 
    DOI: 10.19803/j.1672-8629.20230716

    Abstract ( 146 )   PDF (1511KB) ( 129 )  
    Objective To analyze one case of hyponatremia caused by omeprazole sodium for injection and its metabolic genotypes with triazole antifungals so as to provide reference for safe use of proton pump inhibitors. Methods The clinical data of an 80-year-old patient with invasive pulmonary aspergillosis was analyzed, and the cause of hyponatremia was investigated. Results The patient's hyponatremia might have been related to omeprazole, an adverse reaction caused by omeprazole sodium. Conclusion The possibility of adverse reactions being caused by proton pump inhibitors should be considered when dealing with refractory hyponatremia in clinical practice. When a patient with slow metabolism for CYP2C19 uses hepatic enzyme inhibitors, proton pump inhibitors should be used with caution.
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    Research progress in correlations between epithelial-mesenchymal transition and hepatic fibrosis
    LI Mingqi, ZHAO Xiaolu, GAO Xiaoyang, MA Yuehong
    2024, 21(4): 464-468. 
    DOI: 10.19803/j.1672-8629.20230536

    Abstract ( 27 )   PDF (2872KB) ( 66 )  
    Hepatic fibrosis is a pathophysiological process, which refers to abnormal hyperplasia of hepatic connective tissue caused by various pathogenic factors. Any liver injury undergoes liver fibrosis in the process of liver repair and healing. As long as injury persists, fibrosis will evolve into cirrhosis or even liver cancer. Therefore, it is of great significance to reverse liver fibrosis. In recent years, increasing research has been conducted on epithelial mesenchymal transition that has been found to occur in liver fibrosis, which is why reversing epithelial mesenchymal transition is one of the mechanisms for reversing liver fibrosis. This paper reviews the cell types of epithelial mesenchymal transition in hepatic fibrosis, the mechanism of epithelial mesenchymal transition-related signaling pathways in hepatic fibrosis, and the non-coding RNAs that affects hepatic fibrosis through epithelial mesenchymal transition in order to provide data the research and treatment of hepatic fibrosis.
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    Pharmacological effect and clinical evaluation of rezafungin in treating candidemia and invasive candidiasis
    GU Xiaotong, SUN Xuelin, ZHENG Li
    2024, 21(4): 469-472. 
    DOI: 10.19803/j.1672-8629.20230470

    Abstract ( 60 )   PDF (1653KB) ( 50 )  
    Rising global fungal infections represent a significant public health burden, which are among the most difficult diseases to manage in humans. Candida spp, a major aetiologic agent of fungal infections, can cause severe invasive and systemic diseases that can even be deadly. On March 22, 2023, the FDA approved a novel echinocandin antifungal rezafungin to treat candidemia and invasive candidiasis. Clinical studies have shown that rezafungin has a good efficacy and safety for candidiasis infections. This review describes its pharmacological action, clinical evaluation, safety, usage and dosage.
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    Research progress in pharmacokinetic interactions of edoxaban
    WU Shiqi, YAN Suying, ZHANG Qingxia
    2024, 21(4): 473-480. 
    DOI: 10.19803/j.1672-8629.20230799

    Abstract ( 167 )   PDF (2321KB) ( 72 )  
    Objective To find out about the mechanism of pharmacokinetic interactions (PK-DDIs) of edoxaban and methods of dose adjustment, and to provide reference for rational drug combinations in clinic. Methods PubMed, Web of Science, CNKI, Wanfang data and VIP databases were searched for literature related to DDIs of edoxaban. The 2021 European Heart Rhythm Association Guidelines, the US Food and Drug Administration (FDA) specifications, the European Union Product Profile (SmPC) and Lexicomp database were also reviewed. The mechanism of PK-DDIs, clinical evidence and recommended dose adjustment methods of different drugs and edoxaban were summarized. Results A total of 69 drugs in 17 categories were involved, including 24 drugs without the need for dose adjustment and 45 drugs that should be prohibited, cautiously used or adjusted in dosage. Conclusion PK-DDIs of edoxaban involve a variety of drugs, and the mechanism is mainly related to CYP3A4 and P-glycoprotein inhibitors/inducers. However, PK data is currently lacking, and more studies are needed to improve and update the strategies for combinations of drugs. In addition, the individual difference and conditions of patients will affect the in vivo process of edoxaban. Research on multiple factors is lacking, so more research is required to provide evidence for clinical rational drug use.
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