最新刊期
卷 34 ， 期 15 ， 2023
- 摘要：OBJECTIVETo provide a reference for strengthening the post-admission management of drugs on the medicare formulary in China.METHODSThe basic situation， implementation process and effect of post-market reviews （PMR） were introduced after marketing approval of the Australian pharmaceutical benefits scheme （PBS） subsidized medicines. The suggestions were put forward for post-admission management of medicare formulary drugs in China. RESULTS & CONCLUSIONSPMR system exemplified Australia’s concept of life-cycle management of medicines on the PBS catalogue； as a mechanism for managing the admission and adjustment of PBS medicines， it provided a continuous evaluation of medicines in the PBS catalogue； the process mainly included two types： the pre-initiation process of PBS drug review and the PBS drug review process， involving steps such as drug selection， determination of review scope， and implementation management. Through PMR， Australia had completed the review of multiple medicines in nine treatment areas including diabetes， childhood asthma and Alzheimer’s disease in the PBS catalogue. The author suggests that China can improve the post-admission review of medicines at the institutional level （clarifying the selection criteria and methods of the review object， main procedures and responsible parties， and ensuring the transparency of the review process）； specify the National Healthcare Security Administration or the third-party organization until a special technical organization is established to take charge of this work； at the same time， further improve the construction of data collection and monitoring systems.关键词：post-market reviews;Australian pharmaceutical benefits scheme
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发布时间：2023-08-10 - 摘要：OBJECTIVETo establish a total quality management system for pharmacy intravenous admixture services （PIVAS）， in order to promote the standardization， accuracy and rationalization of clinical intravenous infusion.METHODSBased on information system in PIVAS， the management system and quality monitoring items of the whole process before， during and after PIVAS infusion preparation were formulated. The quality control and quality improvement were carried out regularly with quality management tools and methods such as PDCA （plan， do， check， process） cycle， quality control circle， and root cause analysis. The main quality control indexes of PIVAS were retrospectively analyzed before （in 2019） and after PDCA cycle management （in 2020 and 2021）.RESULTSThe indexes of quality monitoring in the whole process of PIVAS infusion preparation， such as the score of drug quality management， the drug residue qualification rate and the qualified rate of drug content in infusion， were increased from 92 points， 79%， 86.4% in 2019 to 99 points， 92%， 99.8% in 2021， respectively. The indexes of safe and rational drug use， such as the ratio of intravenous irrational medical orders， the rate of drug repercussion， the rate of antibiotics use， and the rate of TCM injection use decreased from 0.98%， 6.1%， 40.55%， 39.70% to 0.23%， 3.2%， 37.18%， 26.00%， respectively.CONCLUSIONSThe established total quality management system for PIVAS can improve the quality management level in the infusion preparation process， improve the quality of infusion preparation and promote clinical safe and rational drug use.关键词：total quality management;quality improvement;infusion quality;safe infusion
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发布时间：2023-08-10 - 摘要：OBJECTIVETo study the protective effects of twin drugs of tetramethylpyrazine-scutellarein （TMSC4） on cerebral ischemia-reperfusion injury （CIRI） model rats and its mechanism.METHODSOne hundred and five SD rats were randomly divided into sham operation group， model group， scutellarein group （0.7 mmol/kg）， tetramethylpyrazine group （0.7 mmol/kg）， and TMSC4 low-dose， medium-dose and high-dose groups （0.35， 0.7， 1.4 mmol/kg）， with 15 rats in each group. Sham operation group and model group were given constant volume of normal saline intragastrically， and other groups were given relevant drug intragastrically， once a day， for consecutive 14 d. Except for sham operation group， all other groups were treated to establish the CIRI model using the thread occlusion method. After 2 hours of ischemia and 22 hours of reperfusion， the brain index and brain water content of the rats were measured. Serum levels of interleukin 1β （IL-1β）， IL-6 and tumor necrosis factor α （TNF-α）， the levels of superoxide dismutase （SOD）， malondialdehyde （MDA）， glutathione peroxidase （GSH-Px） and catalase （CAT） in brain tissues， the situation of neuronal cell apoptosis， and the protein expressions of B-cell lymphoma 2 （Bcl-2）， Bcl-2-associated X protein （Bax） and cleaved-caspase-3 were evaluated.RESULTSCompared with sham operation group， the brain index， brain water content， the serum levels of IL-1β， IL-6 and TNF-α， the levels of MDA in brain tissues， the brain cell apoptosis and the protein expressions of Bax and cleaved-caspase-3 in model group were significantly increased （P＜0.05）； the levels of SOD， GSH-Px and CAT and the protein expression of Bcl-2 in brain tissues were significantly decreased （P＜0.05）. Compared with model group， the above indexes of rats were reversed significantly in administration groups （P＜0.05）， while the reverse effects of TMSC4 medium-dose and high-dose groups were significantly better than those of scutellarein group and tetramethylpyrazine group （P＜0.05）.CONCLUSIONSTMSC4 has a certain protective effect in CIRI model rats， the mechanism of which may be related to relieving inflammatory reaction and oxidative stress， inhibiting cell apoptosis.关键词：scutellarein;twin drugs;cerebral ischemia-reperfusion injury;neuroprotective effect;rat
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发布时间：2023-08-10 - 摘要：OBJECTIVETo investigate the improvement effects of Arisaema Cum Bile on Parkinson’s disease （PD） model mice and its potential mechanism.METHODSSixty male C57BL/6J mice were randomly divided into normal group， model group， Arisaema Cum Bile low-dose group [0.39 g/（kg·d）]， Arisaema Cum Bile high-dose group [1.56 g/（kg·d）] and positive control drug Levodopa tablet group [80 mg/（kg·d）]， with 12 mice in each group. Except that normal group was given constant volume of normal saline， other groups were given 1-methyl-4-phenyl-1，2，3，6-tetrahydropyridine [MPTP，35 mg/（kg·d）] intraperitoneally for 5 consecutive days to induce subacute PD model； after modeling， they were given relevant medicine continuously for 7 d； rod climbing test and line suspension test were performed 1 d before modeling， on the 5th day of modeling and after the last medication. The number of tyrosine hydroxylase （TH）-positive neurons in the substantia nigra of mice were measured by immunofluorescence； the levels of interleukin 1β （IL-1β） and tumor necrosis factor α （TNF-α） in serum and the levels of IL-1β， TNF-α， cyclooxygenase-2 （COX-2） and inducible nitric oxide synthase （iNOS） in the substantia nigra of mice were measured by enzyme-linked immunosorbent assay. The expression levels of cAMP-dependent protein kinase catalytic subunit α （PKA C-α）， glutathione peroxidase 4 （GPX4） and ferritin heavy chain polypeptide 1 （FTH1） proteins in the substantia nigra of mice was measured by Western blot.RESULTSAfter last medicine， compared with the normal group， mice in the model group had significantly longer pole-climbing time （P＜0.01）， significantly lower line suspension scores （P＜0.01）， significantly fewer TH-positive neurons in the substantia nigra （P＜0.01）， significantly higher serum concentrations of IL-1β and TNF-α and nigrostriatal concentrations of IL-1β， TNF-α， COX-2 and iNOS （P＜0.01）， while lower protein expression levels of GPX4， PKA C-α and FTH1 in the substantia nigra （P＜0.05 or P＜0.01）. Compared with the model group， the above indexes of mice were significantly returned in Arisaema Cum Bile high-dose group （P＜0.05 or P＜0.01）.CONCLUSIONSArisaema Cum Bile can improve motor impairment and reduce apoptosis of nigrostriatal TH neurons in MPTP-induced PD mice， and has neuroprotective effects on model mice； this may be related to its inhibition of neuroinflammation and the inhibition of ferroptosis by up-regulating PKA signaling pathway.关键词：Parkinson’s disease;1-methyl-4-phenyl-1，2，3，6-tetrahydropyridine;cAMP-dependent protein kinase signaling pathway;neuroinflammation;ferroptosis
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发布时间：2023-08-10 - 摘要：OBJECTIVETo study the pharmacokinetics of paeoniflorin， hesperidin， naringenin， formononetin and enoxolone from Chitong xiaoyanling granules in rats.METHODSSix male SD rats fasted but not deprived of water for 12 h were given Chitong xiaoyanling granules （5.0 g/kg） intragastrically at one time. Blood was collected from inner canthus of rats at different time points after administration. Plasma samples were pretreated with acetonitrile precipitated protein （sulfamethoxazole as internal standard）， and the concentrations of 5 ingredients in plasma were determined by liquid chromatography-tandem mass spectrometry （LC-MS/MS）. The pharmacokinetic parameters of each ingredient were calculated using DAS 3.0 software.RESULTSAfter intragastric administration of Chitong xiaoyanling granules， tmax and t1/2 of formononetin were the shortest among 5 ingredients （0.25 h and 0.39 h， respectively）. For naringenin and enoxolone， the tmax was shorter， but t1/2 was longer， and there was an obvious double-peak phenomenon in the drug-time curve of naringenin. Compared with the other three components， cmax and AUC of paeoniflorin and hesperidin were not directly proportional to the content of in vitro components.CONCLUSIONSFormononetin， naringin and enoxolone in Chitong xiaoyanling granules were absorbed rapidly in rats， while paeoniflorin and hesperidin were absorbed slowly.关键词：rat;pharmacokinetics;LC-MS/MS
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发布时间：2023-08-10 - 摘要：OBJECTIVETo investigate the effects of Forsythia suspensa ethanol extract on the proliferation， migration and invasion of lung cancer cells NCI-H226.METHODSAs research objects， lung cancer cells NCI-H226 were divided into control group， F. suspensa ethanol extract low-， medium- and high-concentration groups （5， 10， 20 mg/mL）， activator group [10 mg/mL F. suspensa ethanol extract+0.5 μmol/L nuclear factor kappa B （NF-κB） signaling pathway activator PMA]， inhibitor group （10 mg/mL F. suspensa ethanol extract+10 μmol/L NF-κB signaling pathway inhibitor BAY 11-7082） and positive control group （20 μg/mL cisplatin）. Except for the control group of cells without intervention， all other groups of cells were cultured with corresponding drugs for 24 hours； the proliferation， migration and invasion of cells were all detected， and the proliferation rate， migration rate， and the number of invading cells were also calculated； protein expressions of NF-κB p65， NF-κB inhibitory protein α （IκBα）， phosphorylated NF-κB p65 （p-NF-κB p65） and phosphorylated IκBα （p-IκBα） were determined.RESULTSCompared with control group， the proliferation rate， migration rate， and the number of invading cells as well as the protein expressions of p-IκBα and p-NF-κB p65 were decreased significantly in F. suspensa ethanol extract groups and positive control group （P＜0.05）. Compared with F. suspensa ethanol extract medium-concentration group， the proliferation rate， migration rate， and the number of invading cells as well as above protein expressions were all decreased significantly in inhibitor group （P＜0.05）， while those of activator group were increased significantly （P＜0.05）.CONCLUSIONSF. suspensa ethanol extract can inhibit the proliferation， migration and invasion of lung cancer cells NCI-H226， and the mechanism of which may be related to the inhibition of NF-κB signaling pathway.关键词：lung cancer;NF-κB;proliferation;migration;invasion
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发布时间：2023-08-10 - 摘要：OBJECTIVETo establish the methods for simultaneous determination of rutin， forsythiaside A， （+）-pinoresinol-4-O-β-D-glucopyranoside， forsythin and forsythigenin in Forsythia suspensa flower.METHODSUPLC method was adopted. The determination was performed on ACQUITY UPLC HSS T3 C18 column with mobile phase consisted of acetonitrile-0.1% phosphoric acid solution （gradient elution） at the flow rate of 0.3 mL/min. The detection wavelengths were set at 275 nm （0-8 min），330 nm （8-10.5 min），275 nm （10.5-32 min）， respectively. The column temperature was 25 ℃， and sample size was 1 μL. Taking rutin as reference， the content of each component was determined by quantitative analysis of multi-components by single-marker （QAMS） method， and then compared with external standard method.RESULTSThe contents of forsythiaside A， （+）-pinoresinol-4-O-β-D-glucopyranoside， forsythin and forsythigenin by QAMS were 7.472-7.671， 2.919-2.986， 1.439-1.486， 1.523-1.566 mg/g； the results obtained by the external standard method were 7.454-7.664， 2.913-2.996， 1.444-1.484， 1.519-1.562 mg/g， respectively. There was no significant difference in the measurement results between the two methods， with a relative deviation less than 1.0%.CONCLUSIONSThis study successfully establishes the UPLC-QAMS method for simultaneous determination of five components in F. suspensa flower， and the results obtained by this method are not significantly different from those obtained by the external standard method. It can be used for quality control of F. suspensa flower.关键词：quantitative analysis of multi-components by single-marker method;Forsythia suspensa flower;rutin;forsythiaside A;forsythin;forsythigenin;（+）-pinoresinol-4-O-β-D-glucopyranoside
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发布时间：2023-08-10 - 摘要：OBJECTIVETo establish a method for simultaneous determination of the contents of 6 kinds of N-nitrosamines genotoxic impurities in losartan potassium raw material and its formulations.METHODSGC-MS/MS was adopted to determine 6 kinds of N-nitrosamines genotoxic impurities in losartan potassium raw material， Losartan potassium tablet， Losartan potassium capsule and Losartan potassium hydrochlorothiazide tablets， such as N-nitrosodimethylamine （NDMA）， N-nitrosodiethylamine （NDEA）， N-ethyl-N-nitroso-2-propanamine （NEiPA）， N-nitrosodiisopropylamine （NDiPA）， N-nitrosodipropylamine （NDPA） and N-nitrosodibutylamine （NDBA）. The separation was performed on SHIMADZU SH-L-17Sil MS capillary column by temperature-programmed GC， with injector temperature of 250 ℃， sample size of 1 μL， carrier gas of helium， and carrier flow rate of 1 mL/min. Electron ionization and multiple reaction monitoring （MRM） data acquisition mode were used， with an ion source temperature of 250 ℃ and solvent delay time of 3.1 min.RESULTSThe separation among NDMA， NDEA， NEiPA， NDiPA， NDPA， NDBA and adjacent chromatographic peaks was good， and the separation rate was higher than 3.8； the linear ranges of them were 4.9-486.0， 4.9-488.5， 4.5-451.5， 6.8-683.5， 5.2-525.0 and 5.2-520.0 ng/mL（all r≥0.999 8）. The limits of quantitation were 4.86， 4.88， 4.52， 6.84， 5.25 and 5.20 ng/mL； the limits of detection were 0.97， 0.98， 0.90， 1.37， 1.05 and 1.04 ng/mL. RSDs of repeatability tests were 2.2%-5.6%（n＝6）， those of precision tests were 0.5%-1.4%（n＝6）， and those of stability tests were 1.5%-3.4%（n＝5）， respectively. Average recoveries of low-， medium- and high-concentration solution were 83.4%- 103.0% （RSDs were 1.2%-6.3%， n＝3）， respectively. No one among the 6 kinds of N-nitrosamines genotoxic impurities was detected in both losartan potassium raw material and formulations.CONCLUSIONSThe method is good in separation effect， highly accurate， sensitive and simple. It can be used in the determination of the 6 kinds of N-nitrosamines genotoxic impurities.关键词：losartan potassium;raw material;formulations;N-nitrosamines;genotoxic impurities
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发布时间：2023-08-10 - 摘要：OBJECTIVETo study the pharmacokinetic behavior of novel lung-targeted Docetaxel liposome （DTX-LP） in in-situ lung cancer model rabbit.METHODSThe content of DTX in rabbit plasma was determined by UPLC-MS/MS， and methodology investigation was conducted. in-situ lung cancer model rabbit was made by the ultra-minimal invasive percutaneous puncture inoculation method. Model rabbits were randomly divided into Docetaxel injection （DTX-IN） group and DTX-LP group. The rabbits were given relevant medicine via ear vein at a dose of 1.0 mg/kg （calculated by DTX）； blood was taken at 5， 15， 30， 60， 90， 120， 240 and 480 minutes to measure the concentration of DTX in plasma. DAS 3.3 software was adopted for fitting and analysis， and to calculate pharmacokinetic parameters.RESULTSUPLC-MS/MS method used in this study was accurate and precise， which met the requirements of biological sample analysis. Compared with DTX-IN group， drug concentration-time curve of DTX-LP was smoother， the blood concentration at each time point was lower， and cmax， t1/2， AUC0→480 min and AUC0→∞ were significantly decreased （P＜0.05）.CONCLUSIONSThe drug exposure of DTX-LP in plasma is significantly reduced than DTX-IN， indicating it can be rapidly distributed from systemic circulation to liver target organs.关键词：liposome;in-situ lung cancer model;pharmacokinetics
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发布时间：2023-08-10 - 摘要：OBJECTIVETo investigate the effect and potential mechanism of sodium ferulate （SF） on corneal endothelial dysfunction and corneal endothelial cell （CEC） injury.METHODSThe male New Zealand rabbits were divided into control group， benzalkonium chloride （BAK） group and BAK+SF group， with 6 rabbits in each group. Except for control group， the other groups were given BAK into the anterior chamber to induce bullous keratopathy model， and BAK+SF group then given SF solution 200 mg/kg intraperitoneally the next day after surgery， twice a day， for consecutive 14 d. The transparency of corneal and edema of corneal stroma in each group of rabbits （before and on the 1st， 7th， and 14th day after surgery） were observed， and the corneal thickness （14th day after surgery） and intraocular pressure （1st to 14th day after surgery） were measured. On the 14th day after operation， the corneal endothelial structure was evaluated and the expressions of functionally related proteins [phalloidin， zonula occludens-1 （ZO-1）， Na+/K+-ATPase， Ki67] were detected. On the 14th day after surgery， the corneal tissue was collected in BAK group， the primary rabbit CECs were isolated and cultured， and they were divided into blank group and SF groups with different mass concentrations. The cell viabilities after being cultured for different time， and the protein expressions of Ras homologous gene family A （RhoA）， bone morphogenetic protein receptor 1A （BMPR1A） and BMRP2 were determined in each group.RESULTSCompared with BAK group， the transparency of corneal and edema of corneal stroma were gradually improved， and the corneal thickness was significantly decreased in BAK+SF group （P＜0.05）. The rabbit CECs in BAK+SF group were only damaged to zone B and showed a normal hexagonal endothelial cells structure. The protein expressions of phalloidin， ZO-1， Na+/K+-ATPase and Ki67 in BAK+SF group were significantly increased （P＜0.05）. When SF concentration was lower than and equal to 200 mg/L， it could promote the proliferation of rabbit CEC， in concentration manner （P＜0.05） and time-dependent trend. SF at concentrations of 50， 100， and 200 mg/L could up-regulate the protein expressions of RhoA， BMPR1A and BMPR2 in concentration-dependent manner （P＜0.05）.CONCLUSIONSSF can improve the transparency of corneal and edema of corneal stroma in bullous keratopathy model rabbits， reduce corneal thickness， maintain the integrity of corneal endothelium structure， and promote the recovery of corneal endothelial function； this compound can promote the proliferation of CEC， the mechanism of which may be related to the activation of RhoA-ROCK-BMP pathway.关键词：corneal endothelial cells;bullous keratopathy;RhoA-ROCK-BMP pathway
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发布时间：2023-08-10 - 摘要：OBJECTIVETo investigate the effects of β-sitosterol on the function of rheumatoid arthritis （RA） fibroblastic synoviocytes MH7A cells and its mechanism.METHODSNetwork pharmacology was adopted to screen the targets of β-sitosterol and the targets for the treatment of RA. After the intersection of them， topological analysis was performed to find the most critical target in the treatment of RA. MH7A cells were treated with different concentrations （0， 5， 10， 20， 40 μmol/L） of β-sitosterol， and CCK-8 was used to assay cell viability for screening the optimal concentration of β-sitosterol. MH7A cells were induced by 10 ng/mL TNF-α in vitro and treated with β-sitosterol （the optimum concentration）. CCK-8 and EdU were used to detect the ability of cell proliferation. Scratch experiment and Transwell invasion assay were used to analyze cell migration and invasion. The levels of interleukin-1β （IL-1β） and IL-6 in cell supernatant were detected by enzyme-linked immunosorbent assay （ELISA）. The mRNA and protein expressions of peroxisome proliferator-activated receptor α （PPARα） were measured by qRT-PCR and Western blot， respectively. The siRNA targeting PPARα was transfected into MH7A cells， and the effects of β-sitosterol on cell proliferation， migration， invasion， the secretion of inflammatory factors and the expression of PPARα after PPARα knockdown were detected by the above experimental methods.RESULTSPPARα was the most critical target of β-sitosterol in the treatment of RA. The optimal concentration of β-sitosterol was 20 μmol/L. Compared with model group， β-sitosterol decreased the viability of MH7A cells， and the number of proliferating cells also decreased significantly （P＜0.05）； the cell migration rate and the number of cell invasion decreased significantly （P＜0.05）. The levels of IL-1β and IL-6 were also significantly decreased （P＜0.05）， and the mRNA and protein expression levels of PPARα were significantly increased （P＜0.05）. Compared with negative control small interfering RNA group， after PPARα knockdown， the cell viability increased by about 35.6% （P＜0.05）， the number of cell proliferation， the cell migration rate and the number of cell invasion increased significantly （P＜0.05）， and the levels of IL-1β and IL-6 also increased significantly （P＜0.05）.CONCLUSIONSβ-sitosterol could effectively inhibit the proliferation， migration， invasion and secretion of inflammatory factors in MH7A cells， the mechanism of which may be associated with activating PPARα pathway.关键词：rheumatoid arthritis;peroxisome proliferator-activated receptor α;proliferation;migration;invasion;inflammatory factor
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发布时间：2023-08-10 - 摘要：OBJECTIVETo study the improvement effects of Shangke xiaoyan hydrogel plaster on osteoarthritis （OA） model rats.METHODSRats were randomly divided into blank group， model group， voltaren group （200 mg/rat）， Shangke xiaoyan ointment group （500 mg/rat， containing Shangke xiaoyan fluid extract 50 mg） and Shangke xiaoyan hydrogel plaster group （200 mg/rat， containing Shangke xiaoyan fluid extract 50 mg）， with 8 rats in each group. Except for blank group， OA model was established in the other groups by injecting papain and L-cysteine into the right knee joint cavity of the rats； they applied the corresponding drugs， and changed the dressing once a day， for 14 consecutive days. The degree of knee joint swelling in rats was detected， and the magnetic resonance imaging characteristics of the knee joint in rats were observed； the levels of interleukin 1β （IL-1β）， IL-6， IL-18 and tumor necrosis factor （TNF-α） in rat serum were detected； the pathological and morphological characteristics of knee joint tissue were observed， and the histopathological and cartilage Mankin scores were performed； the protein expressions of IL-1β， IL-6 and TNF-α in knee joint tissue were all detected.RESULTSCompared with blank group， severe joint swelling， obvious joint effusion and patchy wear of the anterior horn of the lateral meniscus were observed in model group； the serum levels of IL-1β， IL-6， IL-18 and TNF-α and histopathological score and Mankin score were significantly increased （P＜0.05）； protein expressions of IL-1β， IL-6 and TNF-α in knee joint tissue were increased. Compared with model group， the knee swelling degree of the rats in Shangke xiaoyan hydrogel plaster group was reduced， a small amount of joint cavity effusion could be seen， and the shape of the meniscus was completely normal； the histopathological score and Mankin score were significantly reduced （P＜0.05）； the levels of inflammatory factors in serum were reduced （P＜0.05） and those of knee tissue were decreased.CONCLUSIONSShangke xiaoyan hydrogel plaster can improve OA of rats， the mechanism of which may be associated with reducing the levels of inflammatory factors in joint and serum.关键词：osteoarthritis;inflammatory factors;rat
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发布时间：2023-08-10 - 摘要：OBJECTIVETo optimize the extraction process of Xuelian yishen formula.METHODSThe contents of total flavone， echinacoside and acteoside， and extraction yield in Xuelian yishen formula were chosen as indexes， entropy weight method-analytic hierarchy process was adopted to determine the weight coefficient. Box-Behnken response surface methodology was used to optimize the extraction process of Xuelian yishen formula with extraction time， solid-liquid ratio and extraction times as factors， using comprehensive score of above indexes as index.RESULTSThe optimal extraction process of Xuelian yishen formula was extraction time of 2 h， solid-liquid ratio of 1∶12， extracting for 3 times. Average comprehensive score of 3 validation tests was 96.40 points （RSD＝0.28%）， the deviation of which with predictive value was 0.98%.CONCLUSIONSThe optimized extraction process is stable， feasible and reproducible， which can provide reference for the extraction process of Xuelian yishen formula.关键词：entropy weight method;analytic hierarchy process method;Box-Behnken response surface methodology;extraction process
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发布时间：2023-08-10 - 摘要：OBJECTIVETo investigate the inhibitory effect of berberine （BER） on the invasion and migration of human renal carcinoma cells and its potential mechanism.METHODSUsing human renal carcinoma OSRC-2 cell as object， alamarBlue assay was adopted to detect the inhibitory effects of 0 （control group）， 25， 50， 75， 100， 125， 150， 175 and 200 μmol/L BER on the proliferation of OSRC-2 cell after treatment for 24 h and 48 h. After treated with 0（control group）， 50， 100 μmol/L BER for 48 h， the effect of BER on cell cycle was analyzed by flow cytometry. The migration of OSRC-2 cells in 24 h and 36 h was observed by cell scratch test， and the invasion ability of OSRC-2 cells in 24 h was detected by Transwell assay. The protein expression of methyltransferase-like 3 （METTL3） was detected by Western blot after treatment for 48 h， and RNA methylation quantification kit was used to detect the levels of N6-methyladenosine （m6A） in OSRC-2 cells.RESULTSCompared with control group， BER at different concentrations could significantly decrease the survival rate of OSRC-2 cells （P＜0.01）， and showed a dose-dependent and time-dependent manner. After 48 h of BER treatment at 50， 100 μmol/L， the cell was arrested in G0/G1 phase （P＜0.01）. Compared with control group， the migration and invasion abilities of cells in 50， 100 μmol/L BER group were significantly decreased （P＜0.05 or P＜0.01）； the protein expression of METTL3 and the level of m6A in RNA were significantly decreased（P＜0.01）.CONCLUSIONSBER can inhibit level of m6A by down-regulating the expression of METTL3， thereby inhibiting the invasion and metastasis of human renal carcinoma cells.关键词：human renal carcinoma OSRC-2 cell;migration;invasion;methyltransferase-like 3;N6-methyladenosine
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发布时间：2023-08-10 - 摘要：OBJECTIVETo evaluate the cost-effectiveness of vericiguat combined with standard treatment in the treatment of heart failure with reduced ejection fraction （HFrEF）.METHODSBased on the results of the VICTORIA trial and related literature， a three-state （including stable state of heart failure， hospitalized state of heart failure and death state） Markov model was constructed. The cycle length was 1 month， the time horizon was 20 years， the discount rate was 5%， and one time China’s per capita gross domestic product （GDP） in 2021 was the willing-to-pay （WTP） threshold. Cost-utility analysis was performed to evaluate the cost-effectiveness of vericiguat combined with standard treatment in the treatment of HFrEF. The output indicators included quality-adjusted life year （QALY） and incremental cost-effectiveness ratio （ICER）. The robustness of the results of the basic analysis was verified by one-way sensitivity analysis and probability sensitivity analysis.RESULTSThe ICER of vericiguat combined with the standard treatment plan compared to the standard treatment plan alone was 444 341.95 yuan/QALY， which was more than WTP of this study （80 976 yuan/QALY）. One-way sensitivity analyses showed that the probability of cardiovascular death in both groups was the main influencing parameter for the robustness of the model， but they had little influence on the results of the basic analysis. The probabilistic sensitivity analysis displayed that under the WTP threshold of this study， the possibility of vericiguat combined with the standard treatment plan being more cost-effective was 2.6%.CONCLUSIONSCompared with the standard treatment plan， vericiguat combined with the standard treatment plan is not cost-effective in patients with HFrEF.关键词：heart failure;reduced ejection fraction;cost-utility analysis;Markov model;pharmacoeconomics
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发布时间：2023-08-10 - 摘要：OBJECTIVETo compare the efficacy of Danning tablet， taurosodeoxycholic acid and ursodeoxycholic acid in preventing the recurrence of choledocholithiasis after endoscopic retrograde cholangiopancreatography （ERCP）.METHODSThe clinical data of 153 patients who underwent ERCP choledocholithotomy from January 2017 to January 2020 in Nantong First People’s Hospital were retrospectively analyzed. According to the different drug treatment received after surgery， patients were divided into three groups， namely， Danning tablet group （group A， 49 cases）， tauroursodeoxycholic acid group （group B， 44 cases） and ursodeoxycholic acid group （group C， 60 cases）. The above groups of drugs are all single-use， starting from 2 weeks after surgery for a course of 180 days. The effects of bile component indicators [total bilirubin （Tbil）， direct bilirubin （Dbil）， alkaline phosphatase （ALP）， glutamyltransferase （GGT）]， lipid metabolism indicators [total cholesterol （TC）， triglyceride （TG）， low-density lipoprotein （LDL）， high-density lipoprotein （HDL）]， the occurrence of clinical symptoms （abdominal pain， bloating， nausea， and poor appetite） at 6 months after ERCP， and the recurrence of choledocholithiasis at 6， 12， 18 and 24 months after surgery were compared among 3 groups.RESULTSCompared with before surgery， the serum levels of Tbil， Dbil， ALP， GGT， TC， TG and LDL were significantly reduced （P＜0.05）， while serum HDL levels were significantly increased （P＜0.05） in the three groups at 6 months after surgery. The proportion of patients who experienced abdominal pain， bloating， nausea， and poor appetite at 6 months after surgery was significantly reduced （P＜0.05）. The Tbil levels of groups A and B were significantly lower than those of group C （P＜0.05）， while the Dbil and ALP levels of group A were significantly lower than those of groups B and C （P＜0.05）； however， there was no statistically significant difference in GGT levels among the 3 groups （P＞0.05）. Compared with groups A and C， the levels of four lipid metabolism indicators in group B were significantly improved （P＜0.05）； the proportion of patients with abdominal pain， bloating， and poor appetite in group A was significantly lower than groups B and C （P＜0.05）， but there was no statistically significant difference in the proportion of patients with nausea among the 3 groups （P＞0.05）. At 6，12 and 18 months after surgery， there was no statistically significant difference in the rate of choledocholithiasis recurrence among the 3 groups （P＞0.05）； at 24 months after surgery， the rate of choledocholithiasis recurrence in group A （2.04%） was significantly lower than group B （15.91%） and group C （15.00%） （P＜0.05）.CONCLUSIONSCompared with tauroursodeoxycholic acid and ursodeoxycholic acid， the application of Danning tablet after ERCP is more beneficial to reduce the secretion of bile acid， prevent the recurrence of gallstones， and improve clinical symptoms， but tauroursodeoxycholic acid can significantly accelerate the lipid metabolism of patients compared with the other two drugs.关键词：tauroursodeoxycholic acid;ursodeoxycholic acid;endoscopic retrograde cholangiopancreatography;choledocholithiasis;recurrence
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发布时间：2023-08-10 - 摘要：OBJECTIVETo mine and analyze adverse drug event （ADE） signals after the marketing of pazopanib and provide references for clinically safe medication.METHODSOpenVigil 2.1 data platform was used to mine ADE signals from the US FDA adverse event reporting system （FAERS） database. ADE reports of pazopanib from October 2009 to June 2022 were collected， and ADE signals were analyzed using proportional reporting ratio （PRR） method and reporting odds ratio （ROR） method in the proportional imbalance method.RESULTSA total of 16 655 ADE reports were identified with pazopanib as the primary suspect drug. Through ROR and PRR analysis， 220 ADE signals involving 19 system organ classes were identified. The top 10 ADE signals by frequency were recorded in the drug instruction. Additionally， 88 new ADE signals were discovered， mainly related to the gastrointestinal system， various investigations， and the renal and urinary system. Decreased basophil count， nail bed hemorrhage， tumor rupture， and vaginal fistula were both new ADE signals and the top 10 ADE signals by strength.CONCLUSIONSThe occurrence of common ADEs （diarrhea， hair color changes， hypertension， etc.） during the use of pazopanib after marketing is generally consistent with its drug instruction； the number of reported cases for new suspected risk signals （decreased basophil count， nail bed hemorrhage， tumor rupture， and vaginal fistula， etc.） is limited， and continuous monitoring is required.关键词：adverse drug event;signal mining;adverse drug reaction;proportional imbalance method
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发布时间：2023-08-10 - 摘要：OBJECTIVETo provide a reference for the safe use of abatacept in clinic.METHODSBased on the United States FDA Adverse Event Reporting System （FAERS） database， the generic name of the drug “abatacept” and the trade name “Orencia” were used as the search keywords to retrieve drug adverse event （ADE） signal of abatacept as primary suspected drug. The reported odds ratio method and proportional reporting ratio method in the proportional imbalance method and Excel 2020 software were used to mine and analyze the signals.RESULTSA total of 93 189 abatacept-induced ADE reports were retrieved， mainly female cases （75.98%）， and the age was mainly concentrated in 18-64 years old （35.17%）； main countries reporting data were the United States （47.41%） and Canada （30.59%）， and the number of reports was generally increasing year by year. A total of 3 092 ADE signals were screened， of which the signals associated with the primary disease were similar to those described in the drug instruction of abatacept， such as rheumatoid arthritis， arthralgia， joint swelling， etc.； followed by ADE signals related to infusion reactions， including pain， fatigue， rash， etc. All selected ADE signals involved 27 system organ classes， mainly involved systemic diseases and drug site conditions， musculoskeletal and connective tissue diseases， injury， poisoning and surgical complications， infections and invasive diseases， gastrointestinal diseases， neurological diseases， respiratory， thoracic and mediastinal diseases， heart diseases， benign， malignant and unspecified tumors and reproductive system and breast diseases， etc. A total of 22 ADE signals were not included in the drug instructions of abatacept among the top 50 ADE signals in the number list of reported cases， including fatigue， drug intolerance， abdominal discomfort， swelling， lupus erythematosus， peripheral swelling， cell sores， diarrhea， elevated liver enzymes and lower respiratory tract infection， etc.CONCLUSIONSIn the process of clinical use of abatacept， special attention should be paid to infection and its carcinogenicity， while assessing the risk of respiratory and cardiovascular system diseases in patients； when patients suffer from these two underlying diseases， the pros and cons should be weighed carefully before selecting drug； in addition， the drug-induced ADE in the neurological， gastrointestinal and reproductive system cannot be ignored.关键词：adverse drug events;data mining;adverse drug reactions;proportional imbalance method
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发布时间：2023-08-10 - 摘要：OBJECTIVETo systematically evaluate the efficacy and safety of eltrombopag combined with immunosuppressive therapy （IST） for severe aplastic anemia （SAA）， and to provide evidence-based basis for clinical treatment of SAA.METHODSRetrieved from PubMed， Embase， Cochrane Library， ClinicalTrials.gov， VIP， CNKI and Wanfang data， randomized controlled trials （RCTs） and cohort studies about eltrombopag combined with IST （trial group） versus IST alone （control group） were collected from the inception to May 2023. After data extraction and quality evaluation （Cochrane manual 5.1.0） of included studies， meta-analysis， subgroup analysis， sensitivity analysis and publication bias analysis were performed by using RevMan 5.4 software.RESULTSA total of 12 studies were screened， including 1 344 patients. Compared with control group， objective remission rate （ORR） （RR＝1.34， 95%CI was 1.06-1.69， P＝0.01） and complete response rate （CRR） （RR＝1.88， 95%CI was 1.31-2.71， P＝0.000 6） at 3 months， ORR （RR＝1.33，95%CI was 1.23-1.43， P＜0.000 01） and CRR （RR＝1.88，95%CI was 1.57-2.25，P＜0.000 01） at 6 months were significantly increased in trial group. There was no statistically significant difference between the two groups in ORR （RR＝0.99， 95%CI was 0.82-1.18， P＝0.88） and CRR （RR＝1.02， 95%CI was 0.78-1.34， P＝0.87） at 12 months， two-year overall survival （OS） rate （HR＝0.61， 95%CI was 0.31-1.22， P＝0.17）， two-year event-free survival （EFS） rate （HR＝0.81， 95%CI was 0.61-1.07， P＝0.14）， clone evolution rate（RR＝1.01， 95%CI was 0.51-2.00， P＝0.98） or the incidence of adverse drug reactions such as liver/renal insufficiency， rash （P＞0.05）. Results of subgroup analysis showed that ORR and CRR of trial group at 6 months were higher than those of the control group in RCT and the cohort study subgroups （P＜0.05）. There was no statistically significant difference in the two-year OS rate， two-year EFS rate or clone evolution rate between trial group and control group in the two subgroups （P＞0.05）. The results of sensitivity analysis and publication bias analysis showed that the results of this study were robust and the possibility of publication bias was small.CONCLUSIONSThe addition of eltrombopag in the IST regimen of SAA can improve the early hematological remission rate of patients， has no significant impact on short-term survival， and will not increase the occurrence of adverse drug reactions and clonal evolution.关键词：eltrombopag;immunosuppressive therapy;adverse reaction
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发布时间：2023-08-10 - 摘要：OBJECTIVETo explore the construction of mind map by clinical pharmacists for the consultation of pulmonary nocardiosis and its application in clinical practice， and to provide reference for promoting the correct selection of nocardiosis treatment drugs in clinical practice and ensuring drug safety and efficacy.METHODSA total of 7 patients with Nocardia pulmonary infection from January 2017 to April 2022 in our hospital were collected. Based on evidence-based medicine， a consultation mind map （mainly including understanding the medical history， identifying infectious bacteria， identifying risk factors， developing treatment plans， and conducting evaluations） was constructed to address the difficulties of large differences in drug sensitivity among different strains of Nocardia and numerous adverse reactions of Compound sulfamethoxazole as a first-line drug. The treatment plan was developed for 7 patients with pulmonary nocardiosis， and whole-process pharmaceutical care was provided.RESULTSCombined with the mind map， different antibiotic combination regimens were given according to the drug sensitivity results of Nocardia， the different species of Nocardia， and the patient’s allergy history. Among them， 4 cases were treated with imipenem cilastatin， the patients receiving Compound sulfamethoxazole and linezolid for a long time were given full pharmaceutical care， and the adverse drug reactions were timely treated.CONCLUSIONSClinical pharmacists apply the consultation mind map of pulmonary nocardiosis to the treatment of inpatients， take advantage of pharmacy， participate in clinical drug therapy， and really play a role in the clinical treatment team so as to promote rational drug use.关键词：clinical pharmacists;mind map;pharmacy practice;consultation
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发布时间：2023-08-10 - 摘要：OBJECTIVETo provide a reference for continuing education and training of clinical pharmacists.METHODSThe revision of the syllabus and the improvement of training methods of practical skills training class for clinical pharmacists in the neurology department held by Xuanwu Hospital of Capital Medical University from 2007 to 2022 was sorted to summarize its advantages and characteristics.RESULTSTraining programs were developed to benefit clinical pharmacists at different levels， and the training contents were adjusted according to the training programs and the needs of trainees. Teachers with teaching experience were selected to participate in the teaching. Theory teaching was combined with practice teaching in the teaching process， and case teaching and question-based teaching methods were adopted to benefit both senior clinical pharmacists and new clinical pharmacists. In addition， the influence of the training class was expanded through online teaching， so that doctors and pharmacists could communicate and learn together on the platform of the training class. For example， when designing the training program， we replaced one common neurological disease every two years， and carried rollover study on its new progress and new ideas； clinical pharmacist skill course was reduced， drug history writing， information retrieval and test index interpretation were compressed into clinical pharmacy skill course.CONCLUSIONSThe continuing education platform is established for clinical pharmacists； new knowledge and concepts that clinical pharmacists of this specialty need to be familiar with are compiled into the teaching syllabus， and the experts who are familiar with the training of clinical pharmacists are selected to explain to the students so that the students could follow the platform to constantly update their knowledge and improve the ability of clinical pharmacists to participate in the clinic work.关键词：clinical pharmacist;continuing education and training
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发布时间：2023-08-10 - 摘要：Arnebiae Radix is used widely in TCM external treatment. It has obvious curative effect on skin diseases， wound infection and local inflammation， and is used to treat water and fire burns， skin ulcers， eczema， psoriasis， vitiligo and atopic dermatitis， etc. The clinical and commercial preparations mainly include ointment， liniment and suppository. Modern research has proved that microcapsules， nano-micelles， nanofiber membranes， nanogels and other novel nanoformulations can significantly improve the stability of drug-effective substances， improve local drug concentration and targeting， and perform sound drug release properties in vitro. This paper reviews the variety and application of Arnebiae Radix traditional preparations for external use and the research progress of novel nanoformulations of Arnebiae Radix， from which we prospect to provide some valuable references for the future application and development of Arnebiae Radix external preparations.关键词：external preparations;traditional preparations;nanoformulations
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发布时间：2023-08-10 - 摘要：Biapenem is a carbapenem antibiotic， and can be used for the treatment of sepsis， pneumonia， lung abscess， chronic respiratory lesions secondary infection， complex urinary tract infection and pyelonephritis， etc. This article reviewed the studies on the pharmacokinetics， pharmacodynamics and therapeutic drug monitoring （TDM） of biapenem. The pharmacokinetic parameters of biapenem are not significantly different in healthy subjects， and there is no accumulation after multiple doses of biapenem. However， there are large differences in pharmacokinetic parameters in patients with severe disease and patients with abnormal renal function compared with healthy subjects， which leads to conventional treatment regimens not achieving the desired outcome. In terms of pharmacodynamics， biapenem can improve the rate of reaching the target value by increasing the frequency of administration and prolonging the infusion time. For patients with anuria in end-stage renal disease， dosing intervals can be extended to avoid drug accumulation. However, for patients with severe infection, a daily dose of 1.2 g still can not control infections caused by Acinetobacter baumannii or Pseudomonas aeruginosa, which limits its use in patients with severe disease. It is recommended to implement TDM in severe patients and patients with abnormal renal function， and explore the best dosing regimen for biapenem in combination with pharmacokinetic models to ensure that the time that the free blood concentration of biapenem remains above minimum inhibitory concentration as a percentage of the time between doses （%fT＞MIC） is within the effective range，so that biapenem can exert a greater efficacy in severe patients and patients with abnormal renal function. For medical institutions that cannot carry out TDM， the efficacy of biapenem can be maximized by increasing the frequency of administration and prolonging the infusion time. For infections caused by P. aeruginosa， A. baumannii and Serratia marcescens with high drug resistance rates， it is recommended to combine or replace other antibiotics.关键词：pharmacokinetics;pharmacodyna-mics;therapeutic drug monitoring
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发布时间：2023-08-10
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