最新刊期

    34 16 2023
    • RONG Hongguo,HAO Jiaxin,HAN Mei,LIU Jianping,FEI Yutong
      Vol. 34, Issue 16, Pages: 1921-1925(2023) DOI: 10.6039/j.issn.1001-0408.2023.16.01
      摘要:OBJECTIVETo analyze the research status, hotspots, and trend of the clinical comprehensive evaluation of Chinese patent medicine in China.METHODSBased on CNKI, VIP and Wanfang database, clinical comprehensive evaluation of Chinese patent medicine was used as the subject of retrieval, and the retrieval time was from the inception to October 30th, 2022. CiteSpace 6.1.R3 and VOSviewer were used to conduct a visualization analysis of the relative literature of clinical comprehensive evaluation of Chinese patent medicine in terms of annual publication quantity, authors, institutions, keywords, etc. RESULTS &CONCLUSIONSA total of 1 460 pieces of literature related to the clinical comprehensive evaluation of Chinese patent medicine were included. The overall annual publication quantity showed a growth trend. There were 714 authors in the included literature. The institutions with a large publication quantity included the Chinese Academy of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Tianjin University of Traditional Chinese Medicine, etc., and there was little cooperation among the authors and institutions. High-frequency keywords included Chinese patent medicine, safety, adverse drug reactions, rational drug use, etc. Research hotspots focused on the safety and effectiveness evaluation of Chinese patent medicine. It may be a research trend in this field to strengthen the prescription review of Chinese patent medicine, and build a multi-dimensional and multi-criteria clinical comprehensive evaluation system for the rational use of Chinese patent medicine.  
      关键词:clinical compre-hensive evaluation;research hotspots;research trend;visuali-zation analysis   
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      发布时间:2023-08-24
    • CUI Kaixia,LI Zhuoran,ZHAO Yaowei,HAO Zhiying
      Vol. 34, Issue 16, Pages: 1926-1930(2023) DOI: 10.6039/j.issn.1001-0408.2023.16.02
      摘要:OBJECTIVETo analyze the effects of centralized volume-based procurement policy (hereinafter referred to as “centralized procurement”) on the use of anti-tumor drugs in medical institutions.METHODSThe interrupted time series model was used to analyze the changes in the monthly purchase volume and purchase amount of docetaxel, gemcitabine and pemetrexed disodium in a third-grade class-A cancer hospital in Shanxi province from January 2018 to December 2021. RESULTS &CONCLUSIONSAfter the implementation of the centralized procurement policy, both the selected drugs and the non-selected drugs had different degrees of price reduction, and the price reduction of the selected drugs was far greater than that of the non-selected drugs; average monthly purchase volume and amount of docetaxel decreased significantly in that month after the implementation of the policy, while those of gemcitabine and pemetrexed disodium increased significantly (P<0.05 or P<0.01). After the implementation of the policy, the average monthly purchase volume and amount of gemcitabine showed a downward trend, while those of docetaxel and pemetrexed disodium showed an upward trend (P<0.05 or P<0.01). It is suggested that hospitals should strengthen pharmaceutical administration, and avoid adopting a “one size fits all” approach to non-selected drugs; relevant departments should further expand the collection range of anti-tumor drugs or carry out special collection of anti-tumor drugs, so as to save medical insurance funds and reduce medical expenses.  
      关键词:interrupted time series;docetaxel;gemcitabine;pemetrexed disodium   
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      发布时间:2023-08-24
    • ZHANG Licheng,GAO Ming,FENG Yufei,MA Yanliang,LENG Jiahua
      Vol. 34, Issue 16, Pages: 1931-1935(2023) DOI: 10.6039/j.issn.1001-0408.2023.16.03
      摘要:OBJECTIVETo provide a reference for the standardized treatment of chronic obstructive pulmonary disease (COPD) and the adjustment of therapeutic drugs for COPD in the national essential medicine list.METHODSRelevant clinical experts, pharmaceutical experts and medical insurance experts were invited to sort out the COPD treatment drugs involved in the domestic and foreign COPD clinical guidelines, the national essential medicine list, the WHO standard list of essential medicine, the national medical insurance catalogue, and comparatively analyzed the COPD treatment drugs. RESULTS &CONCLUSIONSCompared with domestic clinical guidelines, foreign clinical guidelines included an additional COPD triple preparation, while involving fewer types of expectorants and antioxidants; there were only 12 kinds of COPD treatment drugs included in the WHO standard list of essential medicine, while there were 18 kinds in the national essential medicine list in China, and more theophylline drugs, expectorants and antioxidants were included. In addition, 15 kinds of COPD treatment drugs were found in both the national clinical guidelines and the national medical insurance catalogue, but not in the national essential medicine list, including terbutaline, levalbuterol hydrochloride, salmeterol, formoterol, indacaterol, beclometasone, mometasone furoate, salbutamol ipratropium, glycopyrronium formoterol, umeclidinium vilanterol, indacaterol glycopyrronium, beclometasone formoterol, budesonide/glycopyrrolate/formoterol fumarate, fluticasone furoate/vilanterol/umeclidinium, and fudosteine, which were mainly long-acting beta 2-agonists and COPD triple preparations. These drugs had certain evidence-based medicine evidence, their efficacy and economy had certain advantages, and their impact on the budget of the medical insurance fund was controllable. Therefore, it is suggested that the aforementioned drugs should be included in the essential medicines list in the subsequent update.  
      关键词:essential medicine list;medical insurance catalogue;long-acting beta 2-agonist;triple preparations   
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      发布时间:2023-08-24
    • LIU Xiaorui,XU Zhichao,WANG Zhaotao,ZHANG Meimei,JIAN Xiaoshun,PENG Huaidong
      Vol. 34, Issue 16, Pages: 1936-1942(2023) DOI: 10.6039/j.issn.1001-0408.2023.16.04
      摘要:OBJECTIVETo investigate the improvement effect and mechanism of calycosin (CA) on acute inflammatory injury secondary to intracerebral hemorrhage.METHODSMale C57BL/6 mice were injected with type Ⅶ collagenase into the basal ganglia to establish an intracerebral hemorrhage model, which were divided into sham-operation group(phosphate buffered saline instead of collagenase), model group, and different CA dose groups(15,30,60,120 mg/kg). Based on the modified neurological severity score (mNSS) to screen the intervention doses, the volume of intracerebral hemorrhage, brain water content, the expressions of ionized calcium-binding adaptor molecule 1 (Iba1) in brain tissue, Toll-like receptor 4 (TLR4) and its downstream inflammatory factors [tumor necrosis factor-α (TNF-α), inducible nitric-oxide synthase (iNOS), interleukin-1β (IL-1β)] in brain tissue, and the apoptosis of cells in brain tissue were detected. Primary microglia were cultured in vitro, and the expressions of TLR4 and its downstream inflammatory factors were detected. Primary neurons and primary microglia were co-cultured in vitro, and the apoptosis of neurons was detected.RESULTSThe doses of 30 mg/kg and 60 mg/kg were selected as intervention doses of CA for subsequent experiments. Compared with the sham-operation group, the mice in the model group had cerebral hemorrhage, the volume of cerebral hemorrhage and brain water content were significantly increased (P<0.05); the positive expression rate of Iba1 protein in brain tissue was significantly increased, and the relative expression levels of TLR4, TNF-α, IL-1β and iNOS protein in brain tissue were up-regulated significantly. The apoptosis rate also increased significantly (P<0.05). Compared with model group, the above indexes of the mice in the 30 and 60 mg/kg CA groups were significantly improved (P<0.05). CA significantly reduced the relative expression levels of TLR4 and its downstream inflammatory factors in microglia, and reduced the apoptosis of neurons in the co-culture system of primary neurons and primary microglia (P<0.05).CONCLUSIONSCA can exert a protective effect on the brain, which may be related to relieving the secondary acute inflammatory injury after intracerebral hemorrhage by inhibiting TLR4-mediated inflammatory response.  
      关键词:intracerebral hemorrhage;secondary acute inflammatory injury;Toll-like receptor 4;microglia   
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      发布时间:2023-08-24
    • Ayiziba·Tuerhong,YANG Jianhua,WANG Xiaomei,WANG Xinling,HU Junping
      Vol. 34, Issue 16, Pages: 1943-1948(2023) DOI: 10.6039/j.issn.1001-0408.2023.16.05
      摘要:OBJECTIVETo study the effects of Hugan buzure formula (HBF) on intrahepatic cholestatic liver injury in rats and its potential mechanism.METHODSRats were randomly divided into control group, model group, ursodeoxycholic acid (UDCA) group (positive control, 60 mg/kg ) and HBF low-dose, middle-dose and high-dose groups (HBF-L, HBF-M, HBF-H groups, 0.4, 0.8, 1.6 g/kg ), with 6 rats in each group. The rats in each drug group were given the corresponding drug solution intragastrically, once a day, for 7 consecutive days. The rats in the control group and the model group were given equal volumes of water intragastrically. On the 5th day, except for the control group, the rats in other groups were single intragastrically administered with alpha-naphthyl isothiocyanate olive oil solution (100 mg/kg) to establish the model. After 48 h of modeling, the contents of liver function indexes (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, total bile acid, total bilirubin, direct bilirubin) and oxidative stress indexes [malondialdehyde (MDA), glutathione (GSH), superoxide dismutase] in serum of rats were detected; the pathological changes of liver tissue were observed. The mRNA expressions of inflammation-related factors [tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β)] and farnesoid X receptor (FXR) signaling pathway-related factors [FXR, small heterodimer partner (SHP), multidrug resistance protein 2 (MRP2), bile salt export pump (BSEP), Na+-taurocholate cotransporting polypeptide (NTCP), organic anion-transporting polypeptide 2 (OATP2) and cholesterol 7α-hydroxylase (CYP7A1)], the expressions of FXR signaling pathway-related proteins (FXR, MRP2, BSEP, NTCP) and nuclear factor-κB p65 (NF-κB p65) in liver tissue were detected.RESULTSCompared with the model group, the contents of liver function indexes and the level of MDA in serum, the mRNA expressions of the above inflammation-related factors and CYP7A1, and the relative expression of NF-κB p65 in liver tissue were significantly decreased; the levels of GSH in serum, the mRNA expressions of FXR, SHP, MRP2, BSEP, NTCP and OATP2, and the relative expressions of FXR, MRP2, BSEP and NTCP in liver tissue were significantly increased (P<0.05 or P<0.01); the pathological changes of liver tissue were significantly improved. Only some indexes in HBF-L group, HBF-M group and UDCA group were significantly reversed (P<0.05 or P<0.01).CONCLUSIONSHBF can prevent intrahepatic cholestatic liver injury in rats, and the effects may be related to the activation of FXR signaling pathway and the reduction of inflammation and oxidative stress.  
      关键词:intrahepatic cholestatic liver injury;farnesoid X receptor signaling pathway;inflammatory reaction;oxidative stress   
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      发布时间:2023-08-24
    • CHEN Yun,SHI Hui,FENG Tingting,ZHANG Liyan,DONG Xiu,ZHANG Jinhe,HUANG Bei,ZHOU Ying
      Vol. 34, Issue 16, Pages: 1949-1954(2023) DOI: 10.6039/j.issn.1001-0408.2023.16.06
      摘要:OBJECTIVETo establish the fingerprints of Ardisia crenata, Sophora tonkinensis and their couplet medicines, and to determine the contents of five components in them.METHODSUsing water as solvent, single lyophilized powder of A. crenata and S. tonkinensis and combined lyophilized powder of their couplet medicines were prepared by combining lyophilization technology. The fingerprints of three lyophilized powder samples were established by using high-performance liquid chromatography (HPLC), and the contents of 5 kinds of components such as gallic acid were determined simultaneously.RESULTSThere were 5, 10 and 14 common peaks in the fingerprints for single lyophilized powder of A. crenata and S. tonkinensis and combined lyophilized powder of their couplet medicines; the similarities of them with the control fingerprints were all greater than 0.90. For combined lyophilized powder of couplet medicines, peak 3 was identified as gallic acid, peak 4 as matrine, peak 6 as oxymatrine, peak 8 as bergenin, and peak 14 as trifolirhizin. In single lyophilized powder of A. crenata, the average contents of gallic acid and bergenin were 0.499 3 and 4.962 6 mg/g, respectively. In single lyophilized powder of S. tonkinensis, the average contents of matrine, oxymatrine and trifolirhizin were 3.046 0, 2.336 6 and 0.278 6 mg/g, respectively. In combined lyophilized powder of couplet medicines, the average contents of gallic acid, matrine, oxymatrine, bergenin and trifolirhizin were 0.560 6, 2.548 7, 1.382 2, 5.960 7 and 0.279 1 mg/g, respectively. The transfer rates were 8.87%-513.19%.CONCLUSIONSThe established fingerprint and content determination methods are stable and feasible, and can be used for the quality control of A. crenata and S. tonkinensis and their couplet medicines. The average contents of matrine and oxymatrine in combined lyophilized powder of A. crenata-S. tonkinensis couplet medicines are decreased.  
      关键词:Sophora tonkinensis;couplet medicines;fingerprint;content determination;high-performance liquid chromatography   
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      发布时间:2023-08-24
    • LIU Ming,LIU Xipeng,LI Chun,ZHEN Cheng,LIU Chunjiang,WANG Haiyang,GONG Jianqing
      Vol. 34, Issue 16, Pages: 1955-1960(2023) DOI: 10.6039/j.issn.1001-0408.2023.16.07
      摘要:OBJECTIVETo investigate the inhibitory effects of silymarin (SM) on glioma in vivo and in vitro and its potential mechanism.METHODSHuman glioma cell line U87 cells were randomly divided into control group, SM low-concentration, SM medium-concentration and SM high-concentration groups (50, 100, 200 μg/mL), protein kinase B (Akt) activator group (SC79 20 μmol/L), high-concentration of SM combined with Akt activator group (SM 200 μg/mL+SC79 20 μmol/L). After drug treatment (except for the control group), optical density (OD) value, clone formation rate, apoptotic rate, the expressions of proliferation/apoptosis-related proteins [proliferating cell nuclear antigen (PCNA), B-cell lymphoma-2 (Bcl-2), Bcl-2-associated X protein (Bax), caspase-3], the phosphorylation levels of Akt/mitogen-activated protein kinase (MAPK) signaling pathway related proteins [Akt, p38 MAPK, extracellular signal-regulated kinase 1/2 (ERK1/2)] were detected in each group. The xenograft tumor model in nude mice was established by injecting U87 cells subcutaneously via the right armpit, and then divided into control group, SM low-dose, SM medium-dose and SM high-dose groups (25, 50, 100 mg/kg), Akt activator group (SC79 40 mg/kg), high-dose of SM combined with Akt activator group (SM 100 mg/kg+SC79 40 mg/kg), with 5 mice in each group. After drug intervention (except for the control group of nude mice), the tumor mass was weighed and the tumor volume was calculated.RESULTSCompared with control group, the OD values, clone formation rates, protein expressions of PCNA and Bcl-2, phosphorylation levels of Akt, p38 MAPK and ERK1/2 in SM groups, tumor mass and volume in nude mice of SM groups were all decreased significantly, while the apoptosis rates, protein expressions of Bax and caspase-3 were increased significantly, in a dose-dependent manner (P<0.05);the trend of changes in the above indicators in the Akt activator group was opposite (P<0.05), and Akt activator could significantly attenuate the inhibitory effect of high-concentration/high-dose SM on glioma in vivo and in vitro (P<0.05).CONCLUSIONSSM may promote the apoptosis of U87 cells, and inhibit its proliferation, clone formation and tumor growth in xenograft nude mice by inhibiting Akt/MAPK signaling pathway.  
      关键词:glioma;protein kinase B/mitogen-activated protein kinase signaling pathway;proliferation;clone formation;apoptosis   
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      发布时间:2023-08-24
    • WANG Hong,KANG Li,JIANG Qian,LIU Weiwei,ZHANG Yan,FU Yu
      Vol. 34, Issue 16, Pages: 1961-1966(2023) DOI: 10.6039/j.issn.1001-0408.2023.16.08
      摘要:OBJECTIVETo study the protective effect and potential mechanism of Hypericum perforatum on cerebral ischemia-reperfusion in rats.METHODSThe male SD rats were randomly divided into sham operation group, model group, positive control group (nimodipine 0.012 g/kg), H. perforatum high-dose and low-dose groups (5.212, 1.303 g/kg), with 10 rats in each group. Except for sham operation group, the left middle cerebral artery ischemia-reperfusion model was established with the modified suture method. Administration groups were given relevant medicine intragastrically since the second day after surgery, once a day, for 7 consecutive days. The neurological function scores of rats were measured before drug intervention (the first day after modeling) and after the last administration, and the cerebral infarction after the last administration was observed using TTC staining method;HE staining and TUNEL staining methods were used to observe the pathological changes of the cerebral cortex and hippocampus, and the apoptosis of nerve cells, respectively. Western blot and RT-PCR were used to observe the protein and mRNA expressions of erythropoietin (EPO), erythropoietin receptor (EPOR), Janus kinase 2 (JAK2) and signal transduction and activator of transcription 3 (STAT3), and protein expression of phosphorylated STAT3 (p-STAT3), respectively.RESULTSCompared with sham operation group, neurological function score and the proportion of cerebral infarction in model group were significantly increased before intervention and after the last administration (P<0.01), with significant damage to nerve cells in cerebral cortex and hippocampus, an increase in apoptotic nerve cells, and a significant increase in apoptosis rate (P<0.01); protein and mRNA expressions of EPO and EPOR in the brain tissue were significantly reduced (P<0.01), while the protein expressions of JAK2, p-STAT3 and STAT3, and mRNA expressions of JAK2 and STAT3 were significantly increased (P<0.01). Compared with model group, the damage and apoptosis of nerve cells in cerebral cortex and hippocampus of rats in administration groups were improved, and the quantitative indicators were almost significantly improved (P<0.05 or P<0.01).CONCLUSIONSH. perforatum has a protective effect against cerebral ischemia-reperfusion injury in rats, and the related mechanism may be related to the regulation of EPO-mediated JAK2/STAT3 signaling pathway.  
      关键词:cerebral ischemia-reperfusion;erythropoietin;Janus kinase 2/signal transduction and activator of transcription 3 signaling pathway   
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      发布时间:2023-08-24
    • LIU Yakun,LI Gang,YAN Juan,XU Huizhi,WU Yanjiang,YOU Shuai,NIU Jingya,LI Hongjian,ZHANG Binggui
      Vol. 34, Issue 16, Pages: 1967-1971(2023) DOI: 10.6039/j.issn.1001-0408.2023.16.09
      摘要:OBJECTIVETo explore the effects of pterostilbene (PTE) on wound healing in diabetic skin ulcer model rats and its mechanism.METHODSTen SD rats were grouped into control group; after diabetic skin ulcer model of other rats was induced by giving high-fat and high-sugar diet+intraperitoneal injection of streptozotocin+cutting off the skin and subcutaneous tissue in the marked area of the back, model rats were randomly divided into model group, PTE low-dose group (40 mg/kg), PTE high-dose group (80 mg/kg), PTE high-dose+PP2 group (80 mg/kg PTE+2 mg/kg SRC inhibitor PP2), with 10 rats in each group. On the second day after modeling, the rats in each drug group were intraperitoneally injected with corresponding drug solutions, while the rats in control group and model group were intraperitoneally injected with normal saline, once a day, for 14 consecutive days. The wound healing rate of rats in each group was measured on the 7th and 14th day of administration; the contents of interleukin-1β (IL-1β), IL-6, tumor necrosis factor-α (TNF-α) and vascular endothelial growth factor (VEGF) in the serum of rats were detected; the pathological changes of wound granulation tissue were observed, and the expressions of SRC/mitogen-activated protein kinase kinase (MEK)/extracellular signal-regulated kinase (ERK) signaling pathway-related proteins in wound granulation tissue were detected.RESULTSCompared with control group, the wound healing rate, serum content of VEGF, the phosphorylation levels of SRC, MEK1/2 and ERK1/2 were decreased significantly (P<0.05), while serum contents of IL-1β, IL-6 and TNF-α were increased significantly (P<0.05); there was obvious infiltration of inflammatory cells in the wound granulation tissue, and the number of new blood vessels decreased. Compared with model group, above indexes of PTE low-dose and high-dose groups were improved significantly (P<0.05), and the pathological injury of granulation tissue in wound was improved. PP2 significantly reversed the improvement effects of PTE on the above indexes (P<0.05).CONCLUSIONSPTE can promote the wound healing of diabetic skin ulcer model rats, the mechanism of which may be related to activating SRC/MEK/ERK signaling pathway.  
      关键词:diabetic skin ulcer;wound healing;SRC/mitogen-activated protein kinase kinase/extracellular signal-regulated kinase signaling pathway   
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      发布时间:2023-08-24
    • LIU Fanqi,WANG Jingyuan,LI Nan,LI Ziqiang,HUANG Yuhong,WANG Baohe
      Vol. 34, Issue 16, Pages: 1972-1978(2023) DOI: 10.6039/j.issn.1001-0408.2023.16.10
      摘要:OBJECTIVETo investigate the effects of Compound troxerutin and poreine cerebroside injection on the activity of cytochrome P450 (CYP450) enzyme in vivo and in vitro.METHODSHuman liver microsomes were incubated with Compound troxerutin and poreine cerebroside injection (volume fraction 0.05%-10%) and the specific probe substrates of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 and CYP3A4 for 30 min. The production of corresponding metabolites was detected by ultra-high performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS), and the half inhibitory concentration (IC50) was calculated. The relative mRNA expression (i.e. induction multiple) of CYP450 enzyme was determined by real-time fluorescence quantitative PCR after human primary hepatocytes were incubated with Compound troxerutin and poreine cerebroside injection (volume fraction 0.05%-10%) or 3 positive inducers of CYP1A2, CYP2B6, CYP3A4 for 48 hours. Male SD rats were randomly divided into control group (normal saline+probe substrates of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A4 8, 2, 1, 1, 10, 10, 8 mg/kg) and experimental group (Compound troxerutin and poreine cerebroside injection 0.9 mL/kg+probe substrates of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A4 8, 2, 1, 1, 10, 10, 8 mg/kg), with 6 rats in each group. The pharmacokinetic parameters of probe substrates were detected by UPLC-MS/MS and Cocktail probe drug method.RESULTSAfter the treatment of 0.05%-10% Compound troxerutin and poreine cerebroside injection, the activities of CYP2B6, CYP2C8 and CYP2C19 in human liver microsomes had no significant change, and IC50 could not be fitted; IC50 of CYP1A2, CYP2C9, CYP2D6 and CYP3A4 were 419.90%, 97.78%, 176.00%, 19.42%, respectively. After the treatment of 0.05%-10% Compound troxerutin and poreine cerebroside injection, the average induction multiple of CYP3A4 mRNA in human primary hepatocytes (No. MHK) was 4.88 (and the average induction multiples of 2 concentration points were higher than 2). After the treatment of Compound troxerutin and poreine cerebroside injection, AUC0-t and AUC0-∞ of CYP2C8, CYP2C9 and CYP2C19 substrates were increased significantly, CL of CYP2C8 and CYP2C19 substrates were decreased significantly, while t1/2 of CYP2C9 substrate was prolonged significantly (P<0.05).CONCLUSIONSCompound troxerutin and poreine cerebroside injection has no obvious inhibitory effect on CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 and CYP3A4 in human liver microsomes in vitro, but can induce the mRNA expression of CYP3A4 in human primary hepatocytes in vitro, and can inhibit the activities of CYP2C8, CYP2C9 and CYP2C19 in rats in vivo.  
      关键词:cytochrome P450;enzyme inhibition;enzyme induction;drug interaction   
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      发布时间:2023-08-24
    • YU Hengyi,XU Yanjiao,XIANG Dong,LIU Lu,LI Xiping,LIU Dong,GONG Xuepeng
      Vol. 34, Issue 16, Pages: 1979-1983(2023) DOI: 10.6039/j.issn.1001-0408.2023.16.11
      摘要:OBJECTIVETo establish a method for simultaneous determination of two third-generation anti-epileptic medicines such as lacosamide and perampanel in human plasma and apply this method in clinical practice.METHODSUsing clozapine as internal standard, the concentrations of lacosamide and perampanel of plasma samples in 10 epileptic patients were determined by LC-MS/MS after protein precipitation with acetonitrile and dilution with acetonitrile-water (20∶80,V/V), and the plasma minimum concentrations were obtained by dilution of multiple. The determination was performed on Welch Ultimate XB-C18 column, with mobile phase A consisted of 10 mmol/L ammonium formate and mobile phase B consisted of methanol-acetonitrile-isopropanol (0.2% formic acid) mixed solution (7∶1.5∶1.5, V/V/V) for gradient elution at the flow rate of 0.4 mL/min. The column temperature was set at 40 ℃, and the sample size was 5 μL. The electrospray ion source and multi-reaction monitoring mode were used for positive iron scanning. The ion pair used for quantitative analysis of lacosamide, perampanel and internal standard were m/z 251.2→144.1, m/z 350.2→219.2 and m/z 327.2→270.0, respectively.RESULTSThe linear ranges of lacosamide and perampanel were 0.001 25-0.125 μg/mL(r>0.99), 0.037 5-3.75 ng/mL (r>0.99); the limits of quantification were 0.001 25 μg/mL and 0.037 5 ng/mL, respectively. The precision and accuracy within and between batches, extraction recovery rate, matrix effect, and stability all met relevant requirements. The minimum concentrations of lacosamide in No.1-5 patients were 5.3-12.2 μg/mL, and the minimum concentrations of perampanel in No.6-10 patients were 208-510 ng/mL, respectively.CONCLUSIONSThe established method is simple, rapid and suitable for the therapeutic drug monitoring of lacosamide and perampanel.  
      关键词:perampanel;plasma concentration;therapeutic drug monitoring;LC-MS/MS   
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      发布时间:2023-08-24
    • MAO Jiaojiao,CAO Guowen,ZHU Zhu,TAO Hong,XU Feng
      Vol. 34, Issue 16, Pages: 1984-1988(2023) DOI: 10.6039/j.issn.1001-0408.2023.16.12
      摘要:OBJECTIVETo observe the efficacy and safety of ceftazidime and avibactam sodium (CAZ/AVI) in the treatment of carbapenem-resistant organism (CRO) infection.METHODSThe information of patients with CRO infection admitted to the Second Affiliated Hospital of Soochow University from September 2019 to March 2022 was collected, and the patients were retrospectively divided into observation group (48 cases) and control group (48 cases) according to the treatment plan. The control group was given Polycolistin B sulfate for injection intravenously at a dose of 500 000 U every 12 hours; no dose adjustment was performed in patients with renal insufficiency or receiving continuous renal replacement therapy (CRRT). The observation group was given continuous micropump of CAZ/AVI for injection intravenously at a dose of 2.5 g every 8 hours for 2 continous hours; among them, the patients with renal insufficiency received an adjusted dose based on creatinine clearance, and no dose adjustment was performed in patients receiving CRRT. The clinical efficacy and microbiological efficacy as well as body temperature, white blood cell (WBC), C-reactive protein (CRP) and procalcitonin (PCT) before and after treatment were compared between 2 groups. The prognosis and the occurrence of adverse drug reactions were recorded. The factors influencing the clinical efficacy were screened by Logistic regression analysis.RESULTSThe effective rate and microbial clearance rate of the observation group were significantly higher than the control group (P<0.05). After treatment, body temperature, PCT and CRP of 2 groups were significantly lower than before treatment, and CRP of the observation group was significantly lower than the control group (P<0.05). There was no statistically significant difference between the two groups in terms of rehabilitation discharge rate, the proportion of patients transferred to general wards, the proportion of dead patients, and the total incidence of adverse drug reactions (P>0.05). CAZ/AVI and prolonging therapy duration were more likely to achieve clinical benefits (odds ratios of 1.146, 7.707,P<0.05), while lung infection and CRRT may be independent risk factors for treatment failure (odds ratios of 0.182, 0.236, P<0.05).CONCLUSIONSCAZ/AVI has good efficacy and safety in the treatment of CRO infection, the appropriate extension of antibacterial treatment time can achieve a higher clinical response rate, while lung infection or CRRT may lead to treatment failure.  
      关键词:carbapenem-resistant organism;infection;efficacy;safety   
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    • CAO Xinrui,YAN Simin,ZHANG Ruobin,GE Weihong
      Vol. 34, Issue 16, Pages: 1989-1994(2023) DOI: 10.6039/j.issn.1001-0408.2023.16.13
      摘要:OBJECTIVETo analyze the research status and development trends of the use of sacubitril/valsartan.METHODSRelated literature about the use of sacubitril/valsartan were retrieved from CNKI and the core database of Web of Science. CiteSpace 5.8.R3 software was used to analyze authors, countries/areas, institutions and keywords. RESULTS &CONCLUSIONSTotally 1 193 Chinese literature and 1 060 English literature were included. The number of literature increased, with numerous literature covering the United States (429), the United Kingdom (185) and China (184). ZHANG Jing (5) and Solomon S D (118) published the highest number of Chinese and English articles. The authors of Chinese literature had less cooperation while the authors of English literature were in close contact. Dept. of Cardiology in the First Affiliated Hospital of Zhengzhou University (9), Dept. of Cardiology in the Affiliated Hospital of Xuzhou Medical University (9) and Novartis AG (134) had the highest quantity of publications of Chinese and English literature. The institutions of Chinese literature had a small number of overall publications and less cooperation while the institutions of English literature were closely connected. The clinical efficacy of sacubitril/valsartan for heart failure, hypertension and their complications were research hotspots in Chinese and English literature. Chinese scholars and research teams need to strengthen cooperation and communication in the future, as well as conduct research from the perspectives of sacubitril/valsartan in the treatment of heart failure, hypertension and related complication, the improvement of oxidative stress, and the evaluation of the efficacy of combination therapy with dapagliflozin.  
      关键词:CiteSpace;visual analysis;hotspot   
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    • HAN Guanying,MA Bingjie,WANG Yu,CHEN Chao,JIN Shurong,CANG Aijun
      Vol. 34, Issue 16, Pages: 1995-1998(2023) DOI: 10.6039/j.issn.1001-0408.2023.16.14
      摘要:OBJECTIVETo evaluate the post-marketing safety of Compound porcine cerebroside and ganglioside injection in patients with ischemic stroke.METHODSA drug-induced, prospective, non-controlled clinical study design was conducted. Using the patients with ischemic stroke who received Compound porcine cerebroside and ganglioside injection at least once in 46 secondary class A and above medical institutions across the country from April 2020 to May 2021 as the monitoring objects, and their basic data, medication information and the occurrence of adverse drug reactions were analyzed.RESULTSAmong 13 514 patients with ischemic stroke, the incidence of adverse events was 10.01%, and the incidence of adverse reactions related to Compound porcine cerebroside and ganglioside injection was 0.33%. Drug-related adverse drug reactions were mild or moderate, concentrated in the gastrointestinal system (18 cases), skin and subcutaneous tissue (10 cases), nervous system (7 cases) and other systems/organs, mainly including constipation, abdominal pain, diarrhea, rash, pruritus, dizziness and other symptoms. Most of the patients (91.03%) recovered or improved after treatment, and 2 patients died. Among the 45 patients with adverse drug reactions, 84.44% were cured or improved after drug withdrawal or symptomatic treatment, and 15.56% had no significant change. The incidence of adverse drug reactions in tertiary hospitals was significantly higher than that in secondary hospitals, and the incidence of adverse drug reactions in patients with allergic history was significantly higher than that in patients without allergic history (P<0.05). Irrational drug use was found in 2.76% of patients, and the incidence of adverse drug reactions(2.95%) was significantly higher than that in patients without irrational drug use(0.26%,P<0.05).CONCLUSIONSThe adverse drug reaction symptoms of ischemic stroke patients treated with Compound porcine cerebroside and ganglioside injection are relatively common, the incidence rate is generally low, and it is related to the patients’ physique and whether the drug use is standardized.  
      关键词:ischemic stroke;adverse drug reactions;post-marketing safety reevaluation   
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      发布时间:2023-08-24
    • ZHENG Yongfei,LIU Huina
      Vol. 34, Issue 16, Pages: 1999-2002(2023) DOI: 10.6039/j.issn.1001-0408.2023.16.15
      摘要:OBJECTIVETo investigate the characteristics and regularity of denosumab-associated atypical fractures (AF), so as to provide references for clinical rational use of drugs.METHODSThe case reports of AF related to denosumab were retrieved from PubMed, Web of Science, CNKI, Wanfang data and VIP databases, and the reports were descriptively analyzed.RESULTSA total of 19 references were retrieved, including 20 patients. There were 3 males and 17 females, with an average age of (69.80±15.39) years. Among 20 patients, primary diseases of 14 patients were osteoporosis, and 6 cases were malignant tumor bone metastasis and giant cell tumor of bone. The occurrence time of AF ranged from 3 to 132 months after the administration of denosumab, with an average of (42.14±29.49) months. Fourteen cases had prodromal symptoms before AF. There were 3 cases of ulna fractures, and the remaining 17 cases were femoral fractures. The vast majority of patients recovered well after discontinuing medication and undergoing surgical fixation, but some patients experienced delayed fracture healing.CONCLUSIONSLong-term use of denosumab should be vigilant against AF. When patients experience prodromal symptoms such as thigh, groin, hip joint and forearm pain, they should seek medical attention in a timely manner to ensure medication safety.  
      关键词:atypical fractures;osteoporosis;literature analysis   
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    • YU Xin,ZHAI Wensheng,ZHANG Mengmeng,REN Xiangge
      Vol. 34, Issue 16, Pages: 2003-2007(2023) DOI: 10.6039/j.issn.1001-0408.2023.16.16
      摘要:OBJECTIVETo evaluate the efficacy and safety of belimumab in the treatment childhood-onset systemic lupus erythematosus (cSLE), and to provide evidence-based references for clinical medication.METHODSRandomized controlled trials (RCTs) about belimumab or belimumab combined with hormone or belimumab combined with hormone and traditional drugs (test group) compared with placebo or hormone or traditional drugs or traditional drugs combined with hormone (control group) were collected by computer searching CNKI, Wanfang data, VIP, SinoMed, PubMed, Embase, Web of Science and the Cochrane Library; the search deadline was from the establishment of the databases to April 9th, 2023. After screening the literature and extracting the data, the quality of the included literature was evaluated by using the bias risk assessment tool recommended by Cochrane system evaluation manual 5.1.0; meta-analysis and sensitivity analysis were conducted by using RevMan 5.4 software.RESULTSA total of 510 children were included in 7 RCTs. Results of the meta-analysis showed that the clinically effective rate of test group was significantly better than the control group [OR=6.16, 95%CI (2.23, 17.00), P=0.000 4]. There were no statistically significant differences in SLE disease activity index (SLEDAI) [MD=-1.73, 95%CI (-3.50, 0.05), P=0.06], the incidence of adverse drug reactions [OR=0.72, 95%CI (0.43, 1.19), P=0.02], complement C3 levels [MD=0.12, 95%CI (-0.06, 0.30), P=0.18], complement C4 levels [MD=0.08, 95%CI (-0.07,0.24), P=0.30] or the response rate of SLE responder index 4 [OR=1.52, 95%CI (0.94,2.44), P=0.09] between 2 groups. The results of sensitivity analysis showed that when SLEDAI, the complement C3 levels and complement C4 levels were used as indicators, the results obtained in this study were robust.CONCLUSIONSThe efficacy of belimumab in the treatment of cSLE is good, and its safety is comparable to the basic treatment.  
      关键词:childhood-onset systemic lupus erythematosus;efficacy;safety;meta-analysis   
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    • YU Qiaoling,ZHAI Weiwei,LIU Ping,QIU Bo,WU Huizhen
      Vol. 34, Issue 16, Pages: 2008-2013(2023) DOI: 10.6039/j.issn.1001-0408.2023.16.17
      摘要:OBJECTIVETo systematically evaluate the efficacy and safety of new oral anticoagulants (NOACs) in patients with nonvalvular atrial fibrillation after left atrial appendage occlusion (LAAO).METHODSRetrieved from PubMed, Embase, Web of Science, the Cochrane Library, CNKI and Wanfang data, randomized controlled trials (RCTs) and cohort studies about NOACs (trial group) versus warfarin or dual antiplatelet agents (control group) were collected during the inception and November 2022. After literature screening, data extraction and quality evaluation, meta-analysis was performed by using RevMan 5.4 software.RESULTSA total of 10 studies were included, involving 2 RCTs and 8 cohort studies, with a total of 2 653 patients. RCT results showed that there was no statistically significant difference in the incidence of device-related thrombosis (DRT), stroke/systemic embolism (SSE), major bleeding events, total bleeding events or all-cause mortality between 2 groups (P>0.05). Results of cohort studies showed that compared with dual antiplatelet agents, there was no statistically significant difference in the incidence of DRT, stroke/SSE, major bleeding events or all-cause mortality in the trial group (P>0.05). Compared with warfarin, the incidence of DRT [RR=0.40, 95%CI (0.19,0.82), P=0.01] and total bleeding events [RR=0.28, 95%CI (0.18, 0.44), P<0.000 01] in the trial group were decreased significantly; there was no statistical significance in the incidence of stroke/SSE, major bleeding events or all-cause mortality (P>0.05).CONCLUSIONSFor patients with nonvalvular atrial fibrillation after LAAO, NOACs have comparable antithrombotic efficacy and safety with dual antiplatelet agents, and the incidence of DRT and total bleeding events are lower than warfarin.  
      关键词:nonvalvular atrial fibrillation;left atrial appendage occlusion;postoperative antithrombotic therapy;efficacy;safety;meta-analysis   
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    • LAI Shu,RUAN Yi,HE Yao
      Vol. 34, Issue 16, Pages: 2014-2017(2023) DOI: 10.6039/j.issn.1001-0408.2023.16.18
      摘要:OBJECTIVETo introduce the drug diagnosis, treatment plan and pharmaceutical care of a case of central nervous system infection caused by Mycobacterium malmoense combined with drug-induced liver injury, and to provide a reference for clinical pharmacists to carry out pharmaceutical practice.METHODSClinical pharmacists participated in the whole treatment of a case of central nervous system infection caused by M. malmoense combined with drug-induced liver injury. Considering the patient’s headache worsened and the skin appeared red spot again, clinical pharmacists suggested stopping isoniazid and adjusted the quadruple anti-infection regimen to Rifampicin capsules+Ethambutol hydrochloride tablets+Amikacin sulfate injection+Clarithromycin tablets, and sending cerebrospinal fluid samples for the next-generation sequencing to identify the pathogen. After the pathogen was identified as M. malmoense, clinical pharmacists recommend continuing the above quadruple regimen. When the patient suffered from drug-induced liver injury, clinical pharmacists assisted physicians to adjust the medication plan, and suggested that Rifampicin capsules should be discontinued, Moxifloxacin hydrochloride tablets should be used for anti-infection treatment, Glutathione tablets should be used for liver protection treatment, and renal function and electrocardiogram monitoring should be performed. RESULTS &CONCLUSIONSThe physicians adopted the advice of clinical pharmacists, and the patient was discharged after the condition improved. Clinical pharmacists review the patient’s medical and medication history, consult guidelines/consensus, research reports, and other literature materials, analyze the causes of adverse reactions based on the patient’s condition and the characteristics of drug action, adjust the medication plan of anti-infective drugs in a timely manner, and provide targeted treatment for adverse reactions. From a pharmaceutical perspective, they assist physicians in improving clinical treatment decisions and ensuring the efficacy and safety of clinical medication.  
      关键词:central nervous system infection;drug-induced liver injury;clinical phama-cists;pharmaceutical practice   
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    • QIU Tingting,YAN Yingying,ZHANG Yuchen,ZHANG Chenchen,CHENG Yinchu,KONG Xianwei,YANG Yiheng
      Vol. 34, Issue 16, Pages: 2018-2021(2023) DOI: 10.6039/j.issn.1001-0408.2023.16.19
      摘要:OBJECTIVETo provide a reference for establishing an automatic checking mode and improving the checking efficiency of the unit dose dispensing system of oral drugs in hospital.METHODSThe automatic checking process reengineering team was established in our hospital. ECRSI method was adopted to sort out the verification process and mode of drug bags for the unit dose formula of our hospital through five principles of eliminating, combining, rearranging, simplifying and increasing, and the hardware series problem and the problem of excessive system false-positive proportion were optimized. The drug bags for the unit dose formula were randomly selected from 10 wards, the efficiency and external error rates of manual check and automatic checking mode before and after optimization were compared, and the false-positive reporting failure in automatic checking mode was also compared before and after optimization.RESULTSAfter the establishment of the automatic checking mode of the unit dose formula for oral drugs, the average checking time of drug bags was significantly shorter than that of manual checking mode in the other 8 wards except for cardiovascular and renal departments (P<0.05). After the optimization of the automatic checking mode, the average checking time of drug bags in all wards was significantly shorter than that in manual checking mode (P<0.05). Compared with before optimization of the automatic checking mode, the average checking time of drug bags was shortened by 0.43 s, and the average checking time of drug bags in half of the wards was shortened significantly (P<0.05). At the same time, the false-positive proportion decreased from 96.83% before optimization to 92.76% after optimization (P<0.05). The external error rate dropped from 0.039‰ in manual checking mode to 0.019‰ before optimization and 0.015‰ after optimization (P<0.05).CONCLUSIONSBased on ECRSI method, the automatic checking mode for the unit dose dispensing system of oral drugs can effectively reduce the average checking time of drug bags, reduce external error and improve the work efficiency of pharmacists.  
      关键词:ECRSI;automatic checking mode;manual checking mode;oral drugs   
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    • LIU Yingqi,LI Jingru,MENG Fan,XING Haonan,ZHENG Aiping
      Vol. 34, Issue 16, Pages: 2022-2027(2023) DOI: 10.6039/j.issn.1001-0408.2023.16.20
      摘要:As a natural drug delivery carrier with rough and porous surface and hollow core, yeast microcapsules have good safety, high targeting and high stability, and have excellent application prospects in oral drug delivery systems. Yeast cells can be treated and washed with acid-base and organic solvents to obtain loose and porous yeast microcapsules. Yeast microcapsules can encapsulate drugs through electrostatic interactions, passive diffusion, hydrophobic interaction and other methods. The surface of yeast microcapsules is mainly composed of β-glucan, which can maintain stability in the gastrointestinal environment; it can be recognized by the surface-related receptors of immune cells, thus activating the immune response, and can be transported to the lesion site with the movement of lymphocytes after being ingested. Yeast microcapsules are safe and very suitable for delivering vaccines, anti-inflammatory drugs, and anti-tumor drugs. They can not only achieve oral delivery of the aforementioned drugs, but also enhance drug efficacy and improve drug targeting. In the future, more research on systemic transport mechanisms or the development of more efficient combination drug delivery systems can be carried out to fully exhibit the clinical value of yeast microcapsules.  
      关键词:β-glucan;drug delivery carrier;oral drug   
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    • LIANG Meijing,NING Hongxin,WANG Chuangchuang,LI Mengyi,HOU Wenbin,LI Yiliang,WANG Yang
      Vol. 34, Issue 16, Pages: 2028-2033(2023) DOI: 10.6039/j.issn.1001-0408.2023.16.21
      摘要:timulus-responsive transdermal drug delivery systems can achieve specific drug release and improve drug utilization. According to the different stimulation modes, these preparations can be divided into endogenous stimulus-responsive, exogenous stimulus-responsive and combined stimulus-responsive transdermal drug delivery systems. The endogenous stimulation-responsive transdermal drug delivery system can respond specifically to changes in temperature and pH of the lesion site through carrier materials, so as to deliver drugs to the target site. Exogenous stimulus-responsive transdermal drug delivery system can use light, heat, magnetic, electric and other external stimulation to make the carrier material phase change, so as to achieve drug delivery. The combined stimulus-responsive transdermal drug delivery system is a combination of two or more stimulus-responsive percutaneous drug delivery systems, such as temperature-pH dual-responsive drug delivery system. At present, the relevant studies of stimulus-responsive transdermal drug delivery systems are mostly in the experimental stage, and further evaluation of stability, toxicity and skin irritation is needed in the future to lay a theoretical foundation for clinical application.  
      关键词:transdermal delivery system;endogenous stimulation;exogenous stimulation;research progress   
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    • LIU Jianbo,BI Xiaoling,WANG Shihua,ZHANG Lei
      Vol. 34, Issue 16, Pages: 2034-2038(2023) DOI: 10.6039/j.issn.1001-0408.2023.16.22
      摘要:anggenon C is a kind of flavonoid compound mainly extracted from the traditional Chinese medicine Morus alba. The pharmacological effects and mechanisms of sanggenon C are systematically reviewed and summarized, and it is found that this component can improve pulmonary fibrosis by regulating transforming growth factor-β1 and nuclear factor-κB; it can exert anti-tumor effects by inhibiting the proliferation of tumor cells and inducing the apoptosis of tumor cells; it can exert cardioprotective, neuroprotective and hepatoprotective effects by regulating multiple signaling pathways, such as calcineurin/nuclear factor of activated T cells 2, peroxisome proliferators-activated receptor α, and Ras homolog gene family member A/Rho-associated coiled-coil containing protein kinase, enhancing autophagy, reducing inflammatory response and reducing the level of oxidative stress; it can treat osteoporosis by inhibiting osteoclast uptake and promoting osteoblast formation; it has certain inhibitory effect on many enzymes; it can exert anti-inflammatory effects by regulating nuclear factor-κB signaling pathway; it can exert antioxidant effects by scavenging free radicals. However, researches on the pharmacological effects of sanggenon C mostly focus on the cellular and animal field, and the specific mechanism of action is not yet clear. In the future, basic research and clinical trials are still needed to explore and verify.  
      关键词:pharmacological effect;hepatoprotective effect;anti-tumor effect;cardioprotective effect   
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    • ZHANG Huanqi,LIN Xu,SHEN Shuying,LI Yangling
      Vol. 34, Issue 16, Pages: 2039-2043(2023) DOI: 10.6039/j.issn.1001-0408.2023.16.23
      摘要:mall cell lung cancer (SCLC) accounts for about 15% in lung cancer and is highly malignant, heterogeneous and invasive. Etoposide combined with platinum-based chemotherapy is the basis of standard first-line treatment for extensive-stage SCLC, but suffers from the problem of susceptibility to drug resistance and relapse. In recent years, the emergence of new immunological drugs and novel cytotoxic drugs has improved the survival of SCLC patients to a certain extent, especially bringing therapeutic hope to patients with relapsed/refractory SCLC. In this paper, we review the current clinical drug regimens and the new progress of potential target drug therapeutic regimens for the treatment of SCLC. At present, the first-, second- and third-line schemes of SCLC include etoposide+carboplatin, atezolizumab+etoposide+platinum, adebrelimab, topotecan, docetaxel, etc.; the current drug targets for the treatment of SCLC mainly focus on topoisomerase Ⅱ/Ⅰ, DNA, the immune checkpoint molecules programmed death-1/programmed death-ligand 1, tubulin, etc. The potential target drug therapeutic options include alisertib+paclitaxel, rovalpituzumab, APG-1252, etc., and mainly focus on DNA damage response pathways and immune pathways, which can achieve the prolongation of patient survival by exerting anti-tumor effects through aurora kinase A and other potential targets.  
      关键词:chemotherapy;immunotherapy;therapeutic targets;potential target drug therapeutic options   
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    • LI Ping,LIU Chang,GU Xiaoce,SHEN Lixia
      Vol. 34, Issue 16, Pages: 2044-2048(2023) DOI: 10.6039/j.issn.1001-0408.2023.16.24
      摘要:β-blocker is one of the commonly used anti-hypertensive drugs, and there are obvious differences in the selection of this class of drugs. Nebivolol is a third-generation β-blocker with a unique mechanism of action. This article summarizes the clinical application of nebivolol in anti-hypertensive treatment in recent years, and it is found that compared with other β-blockers, nebivolol has certain clinical treatment advantages. In addition to having a significant antihypertensive effect, it also has little impact on sexual function and heart rate of patients, and does not affect the blood glucose and lipid metabolism, so the drug is more suitable for some special groups of patients, including sexually active male hypertensive patients, hypertensive patients with complications such as type 2 diabetes mellitus and metabolic syndrome.  
      关键词:β-blocker;anti-hypertensive;clinical advantages   
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