最新刊期
卷 34 ， 期 8 ， 2023
- 摘要：OBJECTIVETo learn from 340B drug pricing program （short for 340B program） in the United States， and provide reference for optimizing the operation and management of designated retail pharmacies under the “dual channel” policy in China.METHODSThe status quos of the implementation of out-of-hospital pharmacies under the 340B program in the United States was reviewed to summarize the experience of the management of out-of-hospital pharmacies under the program in the United States， and to propose thoughts of management and possible problems for designated retail pharmacies under the “dual channel” policy in China. RESULTS &CONCLUSIONSOut-of-hospital pharmacies under the 340B program lacked sufficient basic information and medical insurance status of patients compared to medical institutions， which easily led to duplicate discounts and drug diversion issues. Due to the separation of out-of-hospital pharmacies from the management and restrictions on the use of drugs in medical institutions， coupled with the economic incentives brought by the sale of drugs， the 340B program in the United States faced high medical expenditure and adverse selection risks for out-of-hospital pharmacies. In this regard， when China is carrying out the construction of designated retail pharmacies under the “dual channel” policy， it is necessary to clarify the selection criteria for designated retail pharmacies， enhance the financial transparency of medical institutions and designated retail pharmacies， establish a scientific prescription circulation mechanism， strengthen the review and certification of insured patients and prescriptions， and improve the supervision and management mechanism. Meanwhile， the drug sales situation of designated retail pharmacies should be reasonably incorporated into the drug use management of medical institutions， so as to achieve the availability of drugs without abuse， and effectively control costs.关键词：dual-channel;designated retail pharmacy;duplicate discounts;drug diversion
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发布时间：2023-04-25 - 摘要：OBJECTIVETo provide reference for the normalization of drug volume-based procurement （hereinafter referred to as “VBP”） and the establishment of local emergency management mechanism.METHODSBased on the equilibrium theory of the whole process of emergency management with Chinese conditions， referring to the “6+1” stage model， the emergency management mechanism of VBP was constructed； 21 provincial-level procurement projects in China from 2019 to 2022 were evaluated accordingly.RESULTSThe emergency management mechanism of VBP including 14 measures in 7 stages of preparation， prevention， mitigation， response， recovery， learning and monitoring was successfully constructed. The total score of the 21 provincial-level procurement projects was 3 to 11 points， and the average score of each project in the past 4 years fluctuated slightly within 6 to 7 points. Among the 5 evaluated stages， the scores of the prevention and response stage were relatively high， followed by the mitigation and preparation stage， and the lowest in the recovery stage. Among the 11 rated emergency management measures， more than half had an average score greater than 0.5， but the average score of “determining alternative enterprise selection methods” was only 0.19.CONCLUSIONSSome emergency management measures of drug VBP are lacking， and the emergency management mechanism still needs to be perfected， which is not conducive to the development of emergency management work. The procurement organizer should focus on building a complete emergency management mechanism covering all stages， and clarify the specific measures at each stage， so as to ensure procurement effective and good in operation.关键词：volume-based procurement;emergency management mechanism;“6+1” stage model
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发布时间：2023-04-25 - 摘要：OBJECTIVETo provide reference for the prevention and treatment of hepatitis C and the formulation and improvement of medical insurance payment policy for direct-acting antiviral （DAA） drugs.METHODSAn questionnaire survey was conducted among the patients who received hepatitis C treatment in a third-grade class-A hospital in Sichuan province from 2019 to 2020 and enjoyed Chengdu medical insurance policy. The patients’ hepatitis C treatment and satisfaction with the medical insurance policy for DAA drugs were compared before and after DAA drugs were included in the medical insurance list.RESULTSA total of 203 patients effectively responded among 644 investigated patients. In terms of treatment plans， although there were significant differences in the treatment plan between patients who saw a doctor in 2019 and 2020 （P＜0.05）， the vast majority of patients were cured within the course of treatment （200 cases， 98.52%）， and there were no obvious adverse reactions （193 cases， 95.07%）. In terms of economic burden， the out-of-pocket costs and economic burden of patients treated with DAA drugs in 2020 were significantly lower than those treated with DAA drugs in 2019 （P＜0.05）； in terms of patient services， 78.82% of patients received expert consultation services from designated medical institutions， but 9.85% of patients still did not receive any patient services provided by the hospital. In terms of satisfaction with outpatient reimbursement policy， the overall satisfaction of patients who saw a doctor in 2020 （95.37%） was significantly higher than those who saw a doctor in 2019 （81.05%）（P＜0.05）.CONCLUSIONSThe surveyed patients with hepatitis C obtain good efficacy after DAA drugs treatment， and are satisfied with the medical insurance policy of DAA drugs， but the standardized management of patient services in designated medical institutions is insufficient.关键词：direct-acting antiviral drugs;medicare security;patient satisfaction;effect
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发布时间：2023-04-25 - 摘要：OBJECTIVETo provide scientific basis for establishing the evaluation index system of professional and specialized drug inspectors in China.METHODSThrough the method of literature research， group discussions and behavioral event interview， combined with the practice situation of drug inspection at home and abroad， in accordance with the requirements of Chinese laws and regulations and department rules， the evaluation indexes for drug inspectors were extracted and screened. In addition， the Delphi method was used to conduct correspondence with experts in relevant fields so as to determine the evaluation index system of drug inspectors. RESULTS &CONCLUSIONSFinally， 62 experts completed two rounds of anonymous online questionnaires， including 29 experts in the first round and 33 experts in the second round. The questionnaire recovery rates were 96.67% and 94.29% respectively， and the expert authority coefficients were 0.81 and 0.79， indicating a high level of authority among experts. After expert consultation， evaluation index system for professional and specialized drug inspectors had been constructed， including five first-level indexes （personal characteristics， professional knowledge， professional skills， professional behavior and professional ethics） and their corresponding 27 second-level indexes. The average score of the importance of second-level indexes was 4.224-4.879， the full score ratio was 81.8%-100%， the coefficient of variation was 0.067-0.177， and Kendall’s W was 0.643 （P＜0.001）. It indicates that this evaluation index system is relatively reliable and is expected to become a management tool for promoting the construction of professional and specialized drug inspector team and ensuring the quality of drug inspection.关键词：professional;specialization;evaluation index;Delphi method
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发布时间：2023-04-25 - 摘要：OBJECTIVETo establish a method for simultaneous determination of atorvastatin （ATV） and its active metabolites 2-hydroxy atorvastatin acid （2-HAT）， 4-hydroxy atorvastatin acid （4-HAT） and toxic metabolite atorvastatin lactone （ALT） in rat plasma and apply it for pharmacokinetic study.METHODSLC-MS/MS method was adopted for analysis. The one-step precipitation method was used for processing plasma samples （plasma samples were pretreated by acidification to adjust pH value so as to prevent inversion of configuration）， gradient elution was used to analyze the samples， and the analysis time was 5 min. Electrospray positive ionization was adopted， and positive ion scanning was performed in multi-reaction monitoring. The m/z of quantified ion pairs of ATV and its metabolites such as 2-HAT， 4-HAT and ATL， and internal standard pitavastatin were 559.3→440.2， 575.2→440.3， 575.0→440.2， 540.9→448.2 and 422.2→290.0， respectively. After conducting a comprehensive methodological investigation of the analytical method， the concentrations of ATV and its metabolites 2-HAT， 4-HAT， and ATL were determined， and the pharmacokinetic parameters of ATV and its metabolites were calculated using the non-compartment model of WinNonlin 6.1.RESULTSThe results of methodological validation showed that endogenous substances in blank plasma did not interfere with the determination of the components to be tested， and the standard curve had a good linear relationship； the lower limits of quantification for ATV， 2-HAT， 4-HAT and ATL were 0.5， 0.5， 0.25 and 0.063 nmol/L， respectively. The precision， accuracy， recovery， matrix effect and stability investigation were all in line with the requirements of biological analysis. Pharmacokinetic analysis showed that after intragastric administration in rats， ATV calcium metabolized rapidly， and was mainly exposed to blood circulation in the form of ATV and 2-HAT， with the lowest concentration of lactone-type metabolites.CONCLUSIONSThe established method is precise， rapid and accurate for plasma concentration analysis of ATV and its active/toxic metabolites. The application of the method could help to fully elucidate the pharmacokinetic characteristics of atorvastatin calcium in rats.关键词：LC-MS/MS;hydroxy atorvastatin;atorvastatin lactone;pharmacokinetics
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发布时间：2023-04-25 - 摘要：OBJECTIVETo optimize the extraction process and to primarily evaluate the anti-anxiety and anti-depression efficacy of polysaccharide from Baihe dihuang decoction.METHODSBased on Plackett-Burman experimental design， using the comprehensive score of yield and content of polysaccharide as indicators， with extraction time， water amount， alcohol precipitation concentration as factors， Box-Behnken response surface methodology was used to optimize the extraction process of polysaccharide from Baihe dihuang decoction； and the validation test was conducted. Forty ICR mice were divided into control group， venlafaxine group [positive control， 13.5 mg/（kg·d）]， Baihe dihuang polysaccharide high-dose and low-dose groups [5.28， 2.64 g/（kg·d），by raw material]， with 10 mice in each group （half male and half female）. Administration groups were given corresponding drug solution intragastrically， and control group was given water 10 mL/kg intragastrically， once a day， for 7 consecutive days. The elevated cross maze test， open field test， forced swimming test and tail suspension test were used to evaluate the effects of the extract prepared by the optimal process on the anxiety-like and depression-like behavior of mice； enzyme-linked immunosorbent assay was used to detect the effects of the extract on the levels of neurotransmitter in cerebral tissue of mice.RESULTSThe optimal extraction process of Baihe dihuang decoction was： the water amount of 25 times， extract time of 1.5 hours， and alcohol precipitation concentration of 70%. In 3 times of validation test， the average yield and content of polysaccharide were 33.10% and 0.62 mg/mg， the relative deviations of which from the predicted values （36.14% and 0.65 mg/mg） were 8.40% and 4.62% respectively （RSD＜2%， n＝3）. The polysaccharide extract of Baihe dihuang decoction could effectively increase the percentages of open-arms entry， the percentages of open-arms time， the total distance of voluntary activities and the activity distance in central area， and significantly shortened the immobility time of forced swimming test and tail suspension test （P＜0.05 or P＜0.01）. The polysaccharide extract could significantly increase the levels of 5-hydroxytryptamine， norepinephrine （except for the Baihe dihuang polysaccharide low-dose group） and gamma-aminobutyric acid in cerebral tissue of mice， while significantly decrease the levels of glutamic acid （except for the Baihe dihuang polysaccharide low-dose group） （P＜0.05 or P＜0.01）.CONCLUSIONSThe optimized extraction process of polysaccharide from Baihe dihuang decoction is stable and feasible， and the obtained polysaccharide extract has obvious anti-anxiety and anti-depression effect in vivo.关键词：polysaccharide;extraction process;Plackett-Burman design;Box-Behnken response surface methodology;anti-depression;anti-anxiety;mice
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发布时间：2023-04-25 - 摘要：OBJECTIVETo study the effects of Ganbao capsules on intestinal mucosal barrier and gut microbiota in rats with non-alcoholic fatty liver disease （NAFLD）， and to explore its mechanism of prevention and treatment of NAFLD.METHODSEight of 26 SD rats were randomly selected as blank group and fed with ordinary diet， and the remaining 18 rats were fed with high diet to establish NAFLD model （2 for modeling inspection）； after successful modeling， they were divided into model group and Ganbao group， with 8 rats in each group. Ganbao group were given Ganbao capsules solution （1 440 mg/kg） intragastrically， and the blank group and model group were given the constant volume of distilled water intragastrically， once a day， for consecutive 5 weeks. The contents of alanine aminotransferase （ALT）， aspartate aminotransferase （AST） and triglyceride （TG） in serum of rats were detected by automatic analyzer； the contents of lipopolysaccharide， tumor necrosis factor-α （TNF-α）， interleukin-6 （IL-6） and IL-1β in serum of rats were detected by enzyme-linked immunosorbent assay. The pathological morphology of liver and ileum tissues were observed by HE staining， the expressions of Occludin and zonula occludens-1 （ZO-1） were detected by immunohistochemistry method， and the intestinal flora were detected by 16S ribosomal RNA gene sequencing technology.RESULTSCompared with the model group， the serum contents of ALT， AST， TG， lipopolysaccharide， TNF-α， IL-6 and IL-1β in Ganbao group were decreased significantly （P＜0.01）， the pathological changes of liver and ileum tissues were improved significantly， and the expressions of Occludin and ZO-1 were increased significantly （P＜0.01）. Intestinal microbiota analysis revealed that compared with the model group， Ganbao capsules could recover the abundance and diversity of the gut microbiota in rats. At the phylum level， Ganbao capsules could significantly increase the relative abundance of Bacteroidetes， and significantly reduce the relative abundance of Firmicutes and the ratio of Firmicutes to Bacteroidetes （P＜0.01）. At the genus level， Ganbao capsules could significantly increase the relative abundance of Lactobacillus， Blautia， Bacteroides and Akkermansia， and significantly reduce the relative abundance of Prevotella， Turicibacter， Weissella， SMB53 and Desulfovibrio （P＜0.05 or P＜0.01）. There were different species among the gut microbiota of rats in each group.CONCLUSIONSGanbao capsules may improve NAFLD by protecting intestinal mucosal barrier function and regulating gut probiotics/harmful bacteria structure.关键词：non-alcoholic fatty liver disease;intestinal mucosal barrier;gut microbiota;16S ribosomal RNA
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发布时间：2023-04-25 - 摘要：OBJECTIVETo analyze the main components of Chelidonii Herba-Corydalis Rhizoma （CHCR）， and to predict pharmacodynamic substances against estrogen receptor （ER） -positive breast cancer and their potential targets and signaling pathways， followed by verifying experiments.METHODSThe ethanol extract of CHCR was analyzed by ultra-performance liquid chromatography-quadrupole time-of-flight mass spectrometry （UPLC-Q-TOF-MS/MS）. The network pharmacology analysis was performed for the screened components. The network diagram of CHCR “active components-target-pathway” was constructed， and the enrichment pathway in vitro was validated.RESULTSA total of 58 chemical components were identified， including 57 alkaloids and 1 organic acid. A total of 38 active ingredients were screened from the network pharmacology， and 38 core targets were found in the protein-protein interaction network of “component-disease” intersection targets； 258 gene ontology entries and 137 Kyoto encyclopedia of genes and genomics pathways were obtained， mainly including estrogen signal pathway， phosphatidylinositol-3-kinase/protein kinase B （PI3K/Akt） signal pathway， etc. The results of validation test showed that the median inhibitory concentration of CHCR to MCF-7 cells was 693 μg/mL； 150， 300， 600 μg/mL CHCR could significantly reduce the expressions of phosphorylated PI3K， phosphorylated Akt， ERα protein and ESR1 mRNA （P＜0.01）.CONCLUSIONSThe anti-ER-positive breast cancer effect of CHCR may be related to the regulation of ER and PI3K/Akt pathways， which has the characteristics of multi-component and multi-target effects.关键词：Corydalis yanhusuo;estrogen receptor-positive breast cancer;UPLC-Q-TOF-MS/MS;network pharmacology;experimental verification
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发布时间：2023-04-25 - 摘要：OBJECTIVETo evaluate the quality of Indigo Naturalis， and to provide reference for the quality control of Indigo Naturalis.METHODSUPLC-MS/MS method was used to determine the contents of 6 indole alkaloids （indigo， indirubin， isatin， tryptanthrin， indole and indole-3-carboxaldehyde） in Indigo Naturalis from different origins. Cluster analysis， principal component analysis and partial least squares-discriminant analysis （PLS-DA） were used to evaluate the quality of Indigo Naturalis from different origins.RESULTSThe contents of indigo， indirubin， isatin， tryptanthrin， indole and indole-3-carboxaldehyde in Indigo Naturalis from different origins were 20 320.83-26 585.01， 1 327.69-3 102.25， 141.69-894.50， 2.17-5.27， 2.14-5.93 and 1.69-4.34 μg/g， respectively. The Indigo Naturalis from different areas were clustered into two categories by cluster analysis. Samples S1， S2， S4， S6， S7， S9 and S10 were clustered into category Ⅰ， and samples S3， S5， S8， S11 and S12 were clustered into category Ⅱ. Indigo Naturalis from different origins was evaluated with 3 principal components. The results showed that category Ⅰ sample scored higher and had better quality， while category Ⅱ sample scored lower and had worse quality. PLS-DA showed that indigo， indirubin， tryptanthrin and isatin were the main substances that reflected the quality difference of Indigo Naturalis.CONCLUSIONSThe quality of Indigo Naturalis from different origins is different， and the quality of Indigo Naturalis of different batches from the same area is not stable. The quality evaluation method of Indigo Naturalis established in this paper is stable and reliable， which can provide a basis for the quality control of Indigo Naturalis.关键词：indole alkaloid;UPLC-MS/MS;content determination;chemometrics;quality evaluation
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发布时间：2023-04-25 - 摘要：OBJECTIVETo study the improvement effect and possible mechanism of N-butylphthalide on inflammatory injury of bone marrow mesenchymal stem cells （BMSCs） in rats.METHODSBMSCs of rats were divided into control group， model group， N-butylphthalide low-concentration， medium-concentration and high-concentration groups （10， 20， 50 μmol/L）. BMSCs were cultured in vitro and lipopolysaccharide （the final concentration of 10 mg/L） was used to establish the inflammatory injury model. After the intervention of N-butylphthalide， the survival rate， apoptotic rate， the contents of tumor necrosis factor α （TNF-α）， interleukin 1β （IL-1β） and IL-6 in cell culture medium， the mRNA expression of nuclear factor-κB（NF-κB） p65， and the protein expressions of caspase-3， B-cell lymphoma 2 （Bcl-2）， Bcl-2 related X protein （Bax） and NF-κB p65 in cells were detected.RESULTSCompared with control group， the survival rate and protein expression of Bcl-2 were decreased significantly in model group （P＜0.05）； the apoptotic rate， contents of TNF-α， IL-1β and IL-6， the mRNA expression of NF-κB p65， and the protein expressions of caspase-3， Bax and NF-κB p65 were increased significantly （P＜0.05）. Compared with model group， above indexes were significantly reversed in all concentration groups of N-butylphthalide （P＜0.05）， in concentration-dependent manner.CONCLUSIONSN-butylphthalide can ameliorate the inflammatory injury of BMSCs induced by lipopolysaccharide， and its mechanism may be related to the inhibition of NF-κB signaling pathway.关键词：bone marrow mesenchymal stem cell;lipopolysaccharide;inflammatory injury;rat
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发布时间：2023-04-25 - 摘要：OBJECTIVETo establish the method for the content determination of 5-hydroxymethylfurfural （5-HMF） in glucosamine hydrochloride tablets， and to analyze its regularity and influential factors.METHODSQuantitative analysis of 5-HMF was performed using high-performance liquid chromatography. The analysis was conducted on Shim-pack GIST C18-AQ column with mobile phase consisted of 0.1% phosphoric acid solution-methanol （90∶10， V/V） at the flow rate of 1.0 mL/min. The column temperature was 30 ℃， and detection wavelength was 284 nm. The injection volume was 20 μL. Reaction kinetics test of different temperatures was adopted to analyze the relationship of 5-HMF content with reaction temperature and reaction time， and utilized to build its formation kinetic model.RESULTSThe linger range of 5-HMF was 0.057-5.698 μg/mL （r＝0.999 9）. The limits of detection and quantitation were 5.70 and 17.09 ng/mL； RSDs of precision， repeatability and stability （24 h） tests were all lower than 1.0% （n＝6）. The average recoveries ranged from 99.38% to 99.73%（RSD＝0.53%， n＝9）. The contents of the 5-HMF in 8 batches of samples ranged 4.10-35.13 μg/g. Results of data fitting in reaction kinetics test showed that the higher reaction temperature and the longer reaction time， the higher 5-HMF content in the sample. At 50， 60， 70 and 80 ℃， the relationship between the content of 5-HMF and the reaction time was linear， in accordance with a zero-order kinetic model. The reaction rate constants were 6.789， 7.715， 8.815 and 11.430， respectively.CONCLUSIONSThe established method has strong specificity， high sensitivity， and good accuracy； the reaction temperature and reaction time are important influential factors for the formation of 5-HMF in glucosamine hydrochloride tables. The change rule of its content conforms to the zero-order kinetic model.关键词：5-hydroxymethylfurfural;HPLC;content determination;formation kinetics
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发布时间：2023-04-25 - 摘要：OBJECTIVETo investigate the inhibitory effects of ursolic acid on interleukin-6 （IL-6）-mediated invasion and migration of breast cancer MDA-MB-231 cells （hereinafter referred to as “231 cells”）.METHODSThe effects of 20， 40， 80， 160 and 320 µmol/L ursolic acid on the proliferation rate of 231 cells were measured by CCK-8 method. The breast cancer 231 cells were divided into control group， model group and administration group. The migration and invasion abilities of cells were detected by scratch assay and Transwell assay. Real-time quantitative polymerase chain reaction （q-PCR） assay and Western blot assay were used to detect the mRNA and protein expressions of epithelial-mesenchymal transition-related makers such as E cadherin （E-cad）， matrix metalloprotein 2 （MMP2）， MMP9， vimentin （Vim）， CD44 molecule （CD44） and aldehyde dehydrogenase 1 family member A1 （ALDH1A1）. The phosphorylation levels of JAK2 and STAT3 in the Janus kinase 2/signal transducer and activator of transcription 3 （JAK2/STAT3） signaling pathway （in terms of p-JAK2/JAK2 ratio and p-STAT3/STAT3 ratio） were detected by Western blot assay.RESULTSA low concentration of ursolic acid of 20 µmol/L （no significant inhibitory effect on cell proliferation ability） was selected as the subsequent administration concentration. Compared with the control group， the migration and invasion abilities of cells in the model group were significantly enhanced （P＜0.05）； compared with the model group， the migration and invasion abilities of cells in the administered group were significantly reduced （P＜0.05）. Compared with the control group， the relative mRNA and protein expressions of epithelial-mesenchymal transition-related markers MMP9， MMP2， Vim， ALDH1A1 and CD44 were all elevated to different extents， and the mRNA and protein expressions of E-cad were all decreased to different extents in the model group cells， and part of the differences had statistical significance （P＜0.05）， the p-JAK2/JAK2 ratio and p-STAT3/STAT3 ratio were significantly increased in the model group （P＜0.05）； compared with the model group， the expressions of the above indicators were reversed to some extent in the administration group.CONCLUSIONSUrsolic acid blocks the activation of JAK2/STAT3 signaling pathway and thus inhibits the epithelial-mesenchymal transition induced by the inflammatory factor IL-6， which ultimately interrupts the invasion and metastasis of breast cancer cells.关键词：IL-6;breast cancer;JAK2/STAT3 pathway;invasion;migration
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发布时间：2023-04-25 - 摘要：OBJECTIVETo provide information service support for research on proteolysis targeting chimera （PROTAC） in China and provide reference for technical development and patent layout of relevant drug research and development institutions.METHODSThe patent analysis method was used to search the patent applications related to PROTAC technology that had been applied to China National Intellectual Property Administration and had been issued before Feb. 2022， using the HimmPat patent database as the search platform. The patent application trend， technology life cycle， main applicants， technology source countries， technology themes， improvement routes and other patent data were analyzed. RESULTS &CONCLUSIONSA total of 133 patents were included in this study. The patent application for PROTAC technology started relatively late in China， with the number of applicants increasing from 2 in 2015 to 30 in 2020， and the number of applications increasing from 2 in 2015 to 38 in 2020. Both the annual patent application volume and the number of applicants were in a period of rapid growth， but the average annual application volume of a single applicant was still less than 2， indicating that research in this field was still in the early stage of technology development； the number of applications from Arvinas， Hisco， and Hinova Pharmaceutical Inc. ranked among the top. Although the number of domestic applications led that of foreign applications in China， the average number of simple peer applications and the average number of simple peer countries in domestic patent applications was only 1.5， which was far lower than that of foreign applications in China， reflecting that there was still room for improvement in the “quality” level of domestic applications. The initial improvements in PROTAC technology mainly focused on the selection of E3 ligands， targets and ligands， and then new improvements such as new PROTAC development， linker design and matching methods emerged， indicating that the patent applicant had started a multi-track layout in the early stages of the development of PROTAC technology. It is suggested that the research and development of PROTAC drugs in China should focus on improving the oral bioavailability and biosafety of PROTAC drugs， overcoming potential drug resistance， and exploring rational design and evaluation methods.关键词：patent analysis;technology innovation;drugs research
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发布时间：2023-04-25 - 摘要：OBJECTIVETo evaluate the cost-effectiveness of regorafenib in the treatment of hepatocellular carcinoma after failure of sorafenib from the perspective of Chinese health system.METHODSBased on a phase Ⅲ trial（RESORCE）， the partition survival model （PSM） and Markov model were constructed. The cycle was set as four weeks， the duration of the study lasted for lifetime， the annual discount rate was 5%. Drug cost data was obtained from yaozhi.com， other cost data were obtained from Anhui Provincial Medical Insurance Bureau and related literature， and utility values were obtained from literature. The incremental cost-effectiveness ratio （ICER） was used as the evaluation index， and the value of willingness to pay （WTP） was three times of China’s gross domestic product （GDP） per capita in 2022； one-way sensitivity analysis and probabilistic sensitivity analysis were used to verify the robustness of the basic analysis results.RESULTSThe incremental cost of regorafenib group versus placebo group in PSM and Markov model was 112 116.95 yuan and 96 617.19 yuan， respectively. The incremental effectiveness was 0.31 QALYs and 0.32 QALYs， respectively. The ICERs were 360 751.01 yuan/QALY and 301 114.45 yuan/QALY， which were both greater than the value of WTP； regorafenib was not cost-effective. Results of one-way sensitivity analysis showed that the utility of progression-free survival and progressive disease， the unit cost of regorafenib had the greatest influence on the results， but ICER was always greater than the WTP within the floating range of each parameter. Under the WTP of 3 times China’s per capita GDP in 2022， the probabilities of regorafenib with cost-effectiveness were 0.8% （PSM） and 11.4% （Markov）.CONCLUSIONSUnder the WTP of 3 times the per capita GDP of China， regorafenib is not cost-effective in the treatment of hepatocellular carcinoma after failure of sorafenib treatment， compared with placebo.关键词：hepatocellular carcinoma;partition survival model;Markov model;pharmacoeconomics
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发布时间：2023-04-25 - 摘要：OBJECTIVETo explore the efficacy and safety of intra-articular injection of ropivacaine combined with alfentanil for postoperative analgesia in patients who underwent knee arthroscopic surgery.METHODSA total of 60 patients who underwent knee arthroscopic surgery were collected from the Central Hospital of Enshi Tujia and Miao Autonomous Prefecture from March to September in 2022， and then divided into trial group and control group with random number table method， with 30 cases in each group. The control group received intra-articular injection of 0.25% ropivacaine 50 mg， and the trial group received intra-articular injection of 0.25% ropivacaine 50 mg+alfentanil 0.15 μg/kg.The first postoperative remedial analgesia time， the total amount of postoperative remedial drugs， numerical rating scale at rest （NRS-R） scores， numerical rating scale at movement （NRS-M） scores， heart rate， mean arterial blood pressure， and pulse oxygen saturation during exercise at different monitoring time points after surgery， the incidence of adverse drug reactions such as hypotension， respiratory depression， nausea， and vomiting after surgery were compared between 2 groups.RESULTSCompared with the control group， the first postoperative remedial analgesia time was significantly longer in the trial group， and the total amount of postoperative remedial drugs was significantly reduced （P＜0.001）. The trial group had lower NRS-R and NRS-M scores at each monitoring time point， with statistically significant differences （P＜0.001）， and there was an interactive effect between time and groups （P＜0.001）. The changes in heart rate， mean arterial blood pressure， and pulse oxygen saturation of patients in the trial group were relatively small， with no statistically significant differences （P＞0.05）， and there was no interactive effect between time and groups （P＞0.05）. There was no statistical significance in the incidence of adverse drug reactions between 2 groups， such as postoperative hypotension， respiratory depression， nausea， vomiting （P＞0.05）.CONCLUSIONSThe intra-articular injection of ropivacaine combined with alfentanil shows good efficacy and safety for post-knee arthroscopic analgesia， and significantly prolongs the analgesic duration of ropivacaine.关键词：alfentanil;ropivacaine;analgesic effect;safety
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发布时间：2023-04-25 - 摘要：OBJECTIVETo evaluate efficacy， safety and cost-effectiveness of edaravone dexborneol and compound porcine cerebroside ganglioside in the treatment of acute ischemic stroke， and to provide decision-making reference for clinical treatment selection.METHODSThe medical records of 488 patients with acute ischemic stroke hospitalized from Jan. 2021 to Dec. 2021 were collected and divided into two groups according to the treatment plan， i.e. 268 patients in edaravone dexborneol group， and 220 patients in compound porcine cerebroside ganglioside group. After baseline levels of the two groups were balanced using propensity score matching method， curative effect was evaluated according to the changes of NIHSS scores before and after treatment； the occurrence of adverse drug reactions in patients were collected from the hospital adverse reaction reporting system； from the perspective of China’s health system， the cost-effectiveness of the two options were analyzed， and one-way sensitivity analysis was conducted.RESULTSAfter the propensity score matching， 125 patients were included in the edaravone dexborneol group and compound porcine cerebroside ganglioside group， respectively. The response rates were 81.6% and 74.4%， respectively， with no significant difference. The average costs were 13 560.30 yuan and 14 958.68 yuan， respectively； the cost of edaravone dexborneol group was lower than that of compound porcine cerebroside ganglioside group. No adverse reaction reporting information was retrieved in both groups. Results of one-way sensitivity analysis showed that other drug costs in compound porcine cerebroside ganglioside group was relatively sensitive parameters.CONCLUSIONSShort-term efficacy and safety of edaravone dexborneol are equivalent to those of compound porcine cerebroside ganglioside in treating acute ischemic stroke. But edaravone dexborneol regimen had lower cost and is a more economical scheme.关键词：compound porcine cerebroside ganglioside;neuroprotective agent;ischemic stroke;efficacy;safety;cost-effectiveness;cost-minimization analysis
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发布时间：2023-04-25 - 摘要：OBJECTIVETo reevaluate systematic reviews/meta-analysis of efficacy and safety of tolvaptan for hyponatremia.METHODSRetrieved from CNKI， Wanfang Data， VIP， CBM， PubMed， Embase and the Cochrane Library database， systematic reviews/meta-analysis about tolvaptan for the treatment of hyponatremia were included from the inception to June 15， 2022. After screening literature and extracting data， the PRISMA statement， AMSTAR 2 scale and GRADE method were used to evaluate the reporting quality， methodological quality and evidence quality of the included literature， respectively.RESULTSA total of 6 articles were included， of which 1 was systematic review and 5 were meta-analysis， including 56 outcome indicators. All of the 6 studies had PRISMA scores ranging from 15.0 to 20.5， and the quality of them was moderate. Results of the AMSTAR 2 scale showed that the methodological quality of 5 literatures were very low， and the quality of 1 literature was low. The quality of GRADE evidence showed that there were 6 moderate-quality indicators， 13 low-quality indicators， 35 very low-quality indicators， and 2 indicators that could not be assessed due to missing data. The main factors causing degradation were limitations， inconsistency， imprecision and publication bias. In terms of efficacy， tolvaptan could effectively increase the level of serum sodium， increase urine volume， reduce body weight， reduce abdominal circumference， relieve edema， and reduce alanine transaminase level. In terms of safety， the incidence of total adverse drug reaction induced by tolvaptan was controversial； it may increase the risk of dry mouth， thirst， frequent urination or excessive correction of serum sodium.CONCLUSIONSTolvaptan has great efficacy in the treatment of hyponatremia， but serum sodium overcorrection should be avoided in terms of safety. Relevant systematic reviews/meta-analysis have shortcomings of low reporting quality， methodological quality and evidence quality， which may reduce the reliability of the results， so the results should be treated with caution.关键词：hyponatremia;efficacy;safety;systematic reviews;meta-analysis;reevaluate
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发布时间：2023-04-25 - 摘要：OBJECTIVETo compare the efficacy， safety and economy of tacrolimus （TAC）， cyclosporin A （CsA）， cyclophosphamide （CTX） and rituximab （RTX） in the treatment of membranous nephropathy （MN）.METHODSRetrieved from Pubmed， the Cochrane Library， Wanfang data， CNKI and health technology assessment （HTA） official website， HTA reports， systematic reviews/meta-analysis and pharmacoeconomic studies about TAC， CsA， CTX and RTX combined with glucocorticoid in the treatment of MN were collected during the inception and Mar. 2022. After data extraction and quality evaluation， descriptive analysis was performed on the results of the included studies.RESULTSA total of 15 articles were included， involving 13 systematic reviews/meta-analysis and 2 pharmacoeconomic studies. In terms of efficacy， TAC and CsA showed significant advantages in increasing the response rate， and could improve the levels of urine protein， serum albumin， serum creatinine and serum total cholesterol. In terms of safety， the incidence of adverse reaction induced by TAC， CsA and RTX was low and the symptoms were mild. In terms of economics， CTX cost lower but caused severe adverse reaction； TAC cost higher but showed higher remission rate and good safety.CONCLUSIONSTAC combined with glucocorticoid may be the recommended scheme for MN.关键词：membranous nephropathy;cyclosporine A;tacrolimus;cyclophosphamide;rituximab
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发布时间：2023-04-25 - 摘要：OBJECTIVETo compare the efficacy and safety of bimatoprost and latanoprost in the treatment of glaucoma， and to provide evidence-based reference for clinical rational drug use.METHODSPubMed， Embase， the Cochrane Library， China Biology Medicine disc， CNKI， Wanfang Data， and VIP databases were searched by computer to collect the randomized controlled trials （RCTs） about bimatoprost （trial group） versus latanoprost （control group） in the treatment of glaucoma from the inception to March 2022. After screening the literature and extracting the data， the qualities of the included literature were evaluated using the bias risk assessment tool recommended by the Cochrane system evaluator manual 5.1.0. Meta-analysis， sensitivity analysis and publication bias analysis were performed by using RevMan 5.4 and Stata 12 software.RESULTSA total of 2 181 patients were enrolled in 19 RCTs. Meta-analysis results showed that， the end point intraocular pressure reduction （IOPR） [MD＝0.89， 95%CI （0.53，1.25）， P＜0.000 01] of patients in trial group was significantly lower than control group， while the incidence of conjunctival congestion [RR＝1.89， 95%CI （1.59， 2.24）， P＜0.000 01] and eyelash growth [RR＝3.17， 95%CI （1.97，5.08）， P＜0.000 01] were significantly higher than control group. There was no significant difference in the incidence of eye irritation/foreign body sensation， pruritus， dry eye， eye inflammation， eye pain， visual impairment or iris/skin pigmentation between 2 groups （P＞0.05）. Results of subgroup analysis based on different medication time points showed that， the IOPR of patients in the trial group after 1， 3 and 6 months of treatment was significantly lower than control group （P＜0.05）. Results of sensitivity analysis showed that the result of this study was robust. The publication bias analysis showed that there was little possibility of publication bias in this study.CONCLUSIONSCompared with latanoprost， bimatoprost has more advantages in improving intraocular pressure， but the risk of conjunctival congestion and eyelash growth is higher than latanoprost.关键词：latanoprost;glaucoma;efficacy;safety;meta-analysis
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发布时间：2023-04-25 - 摘要：OBJECTIVETo explore the pharmaceutical service model in multidisciplinary diagnosis and treatment （MDT） of rare diseases in children.METHODSClinical pharmacists of West China Second University Hospital （hereinafter referred to as “our hospital”） participated in the process of MDT of children’s rare diseases. Clinical pharmacists took part in the entire diagnosis and treatment process of children and established the MDT pharmaceutical service model of children’s rare diseases by formulating drug treatment plans based on evidence-based practice， improving the accessibility of drugs， pharmaceutical monitoring and drug treatment management.RESULTSFrom January 2021 to April 2022， clinical pharmacists of our hospital had participated in a total of 39 cases of rare diseases MDT in children， including 21 hospitalized children with rare diseases and 18 outpatient children with rare diseases， involving a total of 23 rare diseases. Clinical pharmacists completed 45 pharmaceutical rounds and 26 pharmaceutical consultations for rare diseases inpatients， 25 outpatients’ MDT and 5 pharmaceutical outpatient service for outpatients with rare diseases， 38 medication educations for inpatients and outpatients with rare diseases and 25 follow-up services for out-of-hospital patients. There were 24 cases （61.54%） of off-label drug use， involving 13 rare diseases and 16 therapeutic drugs， among which off-label drug use registration of 11 drugs had been completed or was in progress. The temporary purchase evaluations of 3 drugs had been completed； 268 cases of medical insurance drug and high-value drug prescription had been reviewed.CONCLUSIONSOur hospital have primarily established a loop pharmaceutical service model of MDT for children with rare diseases， which covers inpatients and outpatients. The model improves the availability and standardization of clinical application of therapeutic drugs， and diagnosis and treatment level for children with rare diseases in our hospital.关键词：rare diseases;multidisciplinary team diagnosis and treatment;clinical pharmacists;pharmaceutical service
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发布时间：2023-04-25 - 摘要：OBJECTIVETo establish a database of rational drug use for children in our hospital， and to provide reference for ensuring the safety of drug use in children.METHODSThe construction and filling of the knowledge base of rational drug use for children were performed by establishing the basic structure of the knowledge base， formulating reference standards for the quality level of pediatric medication evidence， and refining evidence-based evidence of pediatric medication. The rule base of rational drug use for children was designed and built from four aspects： preliminary determination rules for patient information， basic drug information rules， prescription suitability review rules， result labeling and post-processing rules. The database was embedded into prescription review system of our hospital and was applied online to test its effectiveness.RESULTSA set of database containing 672 commonly used pediatric medicines and more than 15 000 rules for rational drug use for children was initially constructed. The average interception rate of unreasonable medical orders for hospitalized children after database application（from December 2021 to May 2022）was 2.03%， and was higher than 0.80% before database application（from June 2021 to November 2021）（χ 2＝5 784.389， P＜0.001）； after post-sampling and prescription review， the average qualified rate of medication orders in discharged medical records for children after the application of the database was 99.10%， and was higher than 94.58% before the application of the database （χ 2＝301.237， P＜0.001）.CONCLUSIONSSelf-constructed evidence-based rational drug use database for children is close to the actual clinical needs of pediatrics in medical institutions， which can effectively reduce clinical irrational drug use behaviors in pediatrics， improve the pass rate of prescriptions， and ensure the safety of children’s drug use.关键词：rational use of drug;database;pre-prescribing review
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发布时间：2023-04-25 - 摘要：OBJECTIVETo provide reference for pharmaceutical care of multidrug-resistant bacterial infection patients with tigecycline-induced hypofibrinogenemia and the safe use of tigecycline.METHODSClinical pharmacists participated in a case of hypofibrinogenemia caused by tigecycline with multidrug-resistant bacterial infection， to determine the correlation of hypofibrinogenemia and tigecycline， and to analyze the risk factors and possible mechanisms of the occurrence of hypofibrinogenemia caused by tigecycline in combination with relevant literature. Clinical pharmacists recommended that physicians discontinued tigecycline and provided human fibrinogen and plasma for correction. RESULTS & CONCLUSIONSTigecycline was associated with hypofibrinogenemia of the patient. The physician followed the advice of clinical pharmacists and the patient’s fibrinogen level returned to normal. The risk factors of hypofibrinogenemia induced by tigecycline included high dose， long course of treatment， and complication with renal dysfunction. Clinical pharmacists should timely advise physicians to stop taking the drug， and give human fibrinogen and blood product infusion for correction when necessary， so as to avoid the occurrence of serious life-threatening coagulation disorders and ensure the safety of tigecycline use.关键词：pharmaceutical care;hypofibrinogenemia;multidrug-resistant bacterial infection
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发布时间：2023-04-25 - 摘要：Hedgehog （Hh） signaling pathway plays an important regulatory role in the process of cell proliferation， differentiation and tissue formation. Proper intensity and action time of Hh signal are crucial for the normal development of various tissues of the body， and its abnormal activation will lead to the occurrence and development of most malignant tumors， including breast cancer， liver cancer， pancreatic cancer， and lung cancer， which makes Hh signaling pathway an ideal target for anti-tumor drug research and development. At present， the main targets of Hh signaling pathway inhibitors include Hh ligand， receptor Smoothened （Smo） and transcription factor Gli. Among them， the compounds that depend on the Hh ligand pathway still remain at the stage of laboratory research because they cannot act on the non-classical Hh signaling pathway. The special structure of Smo protein enables it to combine with drugs efficiently and selectively， which is a powerful and effective drug target. Therefore， Smo selective inhibitors have been an active field of related research， and many Smo inhibitors have entered the clinical use or trial stage. Gli can regulate multiple carcinogenic genes， promote abnormal cell proliferation and lead to tumor， and can also cause feedback inhibition to Hh signaling pathway. Therefore， the development of drugs that can inhibit the activity of Gli has broad prospects. In the future， a combination of multiple pathway inhibitors can be designed to avoid drug resistance and other side effects.关键词：inhibitors;anti-tumor;progress
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发布时间：2023-04-25 - 摘要：Remimazolam （toluenesulfonate） is a new type of ultra short-acting water-soluble benzodiazepine sedative-hypnotic drug， which was launched in China on December 26， 2019， for sedation during routine gastroscopy and colonoscopy as well as induction and maintenance under general anesthesia， breaking a 30-year period in which no innovative sedation drugs were marketed in China. This article reviewed the pharmacological characteristics， safety and combined use of remimazolam. Remimazolam had the advantages of high clearance rate， short action time， rapid recovery， stable hemodynamics， and low respiratory inhibition. It is independent of liver and kidney metabolism， and can be quickly antagonized by flumazenil， with little impact on the cognitive function of patients. Remimazolam has shown good respiratory and circulatory stability in combination with intravenous anesthetics such as propofol and esketamine， and opioid analgesics such as sufentanil， remifentanil， and alfentanil， as well as advantages such as rapid awakening and recovery. However， its safety still needs to be further monitored and explored during clinical use.关键词：pharmacological characteristics;safety;combined medication;clinical anesthesia
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发布时间：2023-04-25
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