最新刊期
卷 33 ， 期 11 ， 2022
- 摘要：OBJECTI VE To understand the current status of the issuance a nd implementation of China ’s folk medicine-related policies，and to provide reference for the subsequent formulation and implementation of folk medicine-related policies. METHODS Based on the theory of policy tools ，content analysis was adopted to construct a two-dimensional analysis framework for basic policy tools and policy development stages ，code，sort and quantitatively analyze the relevant policy texts of folk medicine issued by the central government from 2009 to 2021. RESULTS & CONCLUSIONS Finally，23 folk medicine-related policies issued by the central government were included ，and a total of 284 policy item codes were sorted. From the perspective of basic policy tools ， the proportions of supplying policy tools ，demanding policy tools ，and environmental policy tools were 28.17％（80/284），22.89％ （65/284）and 48.94％（139/284），respectively. From the perspective of the policy development stage ，the proportions of policy tools in the exploratory development stage ，the perfect supplement stage ，and the mature promotion stage were 25.35％（72/284）， 16.55％（47/284）and 58.10％（165/284），respectively. At present ，overall use of folk medicine policy tools is not coordinated ， supply-oriented policy tools pay most attention to talent training and the investment in funds is obviously insufficient. There is a shortage of demand-oriented policy tools ，and the impetus for the development of folk medicine is insufficient. The use of environmental policy tools is too frequently ，and regulation and management policies overflow. It is recommended to optimize the use of supply-oriented policy tools and increase capital investment in the future ；attach importance to the use of demand-based policy tools ，and strengthen the impetus for the development of folk medicine from three aspects ：government purchase ，industrial cultivation and service trade ；adjust the structure ofenvironmental policy tools ，and balance the internal elements.关键词：folk medicine;Policy tool;policy text
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发布时间：2022-06-21 - 摘要：OBJECTI VE To introduce the evaluation system for clinical value of antineoplastic agents at home and abroad ，and to provide reference for continuous improvement of clinical value-oriented antineoplastic agents development and research guideline in China. METHODS The suggestions were put forward to improve the evaluation system for clinical value of antineoplastic agents in China by consulting the relevant data of evaluation system for clinical value of antineoplastic agents at home and abroad and domestic antineoplastic agents R&D and management policies ，sort outing and analyzing comparatively their dimensions ， perspectives，target audiences ，application scope ，advantages and disadvantages. RESULTS & CONCLUSIONS Seven foreign value evaluation systems （value assessment framework of American Society of Clinical Oncology ，clinical benefit scale of European Society of Clinical Oncology ，value evaluation framework of American Institute of Clinical and Economic Evaluation ， etc.）had their own characteristics and unique advantages under different settings ；several value evaluation systems differed in the criteria for defining value ，depending on the perspective and population they focus on. The value dimensions were constantly changing dynamically in response to scientific values and social needs ，including not only safety ，efficacy and cost-effectiveness ， but also innovation ，fairness，quality of life attributes. Some evaluation systems adopted value assessment tools that followed the trend of the information age in the presentation form and assessment mode ，which promoted shared decision-making between doctors and patients. Combining the characteristics of foreign value evaluation system and the current situation of development and application of antineoplastic agents in China ，we can have a deeper understanding of drug efficacy ，safety，quality of life ，research and development cost and pricing in the future. Antineoplastic 2021-10-28） agents will have a more reasonable position to solve the unmet needs of patients from the perspectives of drug research and development， clinical application ， drug accessibility and fairness.关键词：antineoplastic agents;clinical value;value
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发布时间：2022-06-21 - 摘要：OBJECTIVE To boost access to medical insurance for drugs and improve the accessibility and affordability of drugs. METHODS The current status of the application of international and domestic drug Managed Entry Agreement （MEA）were investigated through literature research method and other methods ，and analyzed comparatively from the aspects of the scope of agreement drugs ，the types of agreements and the content of the agreement ，etc. The problems existing in the application of drug MEA in China were summarized to put forward the suggestions. RESULTS & CONCLUSIONS The UK ，Australia and Italy had rich experience in the application of drug MEA ，and the operation management mechanism were complete. The scope of drugs included in MEA in these countries were relatively broad and the types of agreements were relatively diversified. In China ，drugs included in MEA were mainly oncology drugs and rare disease drugs. The types of agreements mainly included “finance-based agreements”and effect guarantee/effect-based payment in individual-level of“performance-based agreements ”. China ’s evidence collection platform was imperfect and lacked standardized process of MEA. It is suggested that stakeholders should consider increasing the types of drugs ，diversified types of agreements ，improving the accuracy and continuity of evidence collection ， establishing a standardized process for MEA.关键词：drug mangement;Managed Entry Agreement;innovative payment agreement;Accessibility;Affordability
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发布时间：2022-06-21 - 摘要：OBJECTIVE To explore the difference in th e mechanis m of baicalein and wogonin inhibiting the energy metabolism of hepatoma cells. METHODS Human hepatoma HepG 2 cells were divided into blank control group （without medicine），different dose groups of baicalein and wogonin （1.25，2.5，5，10 and 20 μmol/L）. The effects of baicalein and wogonin on the viability of HepG 2 cells were detected by MTT assay. HepG 2 cells were divided into blank control group （without medicine），baicalein group and wogonin group. After administration ，the concentration of ATP in cell was detected by enhanced ATP kit. The levels of cell glycolysis and mitochondrial energy metabolism were evaluated by glycolysis and mitochondrial pressure test kit ；the affinity of baicalein and wogonin with key enzymes of energy metabolism was predicted by molecular docking ，and the key enzymes of energy metabolism with high affinity were screened ；the expression of key enzymes of energy metabolism was detected by Western blot. RESULTS Within the dose range of 2.5-20 μmol/L，the half inhibitory concentrations of baicalein and wogonin were 12.84 and 24.09 μmol/L；baicalein 1.25 μmol/L and wogonin 2.5 μmol/L had no effect on cell viability ，so it was selected as the dosage for subsequent experiments. Compared with blank control group ，the concentration of ATP in HepG 2 cells decreased significantly in baicalein group and wogonin group （P＜0.05）；the inhibitory effects on basic acidification rate of HepG 2 cells in wogonin group were significantly stronger than those of baicalein group （P＜0.05），but there was no significant difference between them on the basic oxygen consumption rate （P＞0.05）；baicalein had strong binding to pyruvate kinase M 2 and mitochondrial enzyme complexes Ⅰ（CⅠ），C Ⅱ and C Ⅳ，while wogonin only had strong binding to pyruvate kinase M 2； wogonin could significantly down-regulate the protein expressions of hexokinase ，phosphofructokinase，pyruvate kinase M 2，CⅠ， C Ⅱ and C Ⅳ（P＜0.05），but there was no statistical significance in the effect of baicalein on the regulation of these enzymes （P＞ 0.05）. CONCLUSIONS Both baicalein and wogonin can inhibit the energy metabolism of hepatoma HepG 2 cells，but the mechanism is different ：the effect of baicalein is related to the activity of key enzymes ，while the effect of wogonin is related to the inhibition of the expression of key enzymes of energy metabolism.
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发布时间：2022-06-21 - 摘要：O BJECTIVE To investigate the regulatory effect of total fla vonoids of Matricaria recutita on lipid abnormalities in human hepatoma HepG 2 cells and its lipid-lowering mechanism. METHODS The high-content total flavonoids extract from M. recutita was isolated and purified by macroporous resin. HepG 2 cells were divided into control group （without administration ）， model group （without administration ），fenofibrate group （positive control ，3.61 μg/mL）and M. recutita total flavonoids low-dose ， medium-dose and high-dose groups （100，150 and 200 μg/mL）. Except for control group ，lipid deposition model of HepG 2 cells in other groups were established by 1 mmol/L mixture of oleic acid and palmitic acid. After 24 hours of intervention ，the levels of free fatty acids （FFA）in cell supernatant and triglyceride （TG）and FFA in cells were detected ；Oil red O staining was used to observe the deposition of lipid droplets in cells and detect the content of lipid ；DAPI staining was used to observe the protein expression of diacylglycerol acyltransferase 2（DGAT2）in cells ，and fluorescence intensity of protein expression of DGAT 2 were also detected ； protein expressions of key enzymes of TG synthesis as acetyl CoA carboxylase （ACC），fatty acid synthase （FAS）and DGAT 2 were detected by Western blot. RESULTS After separation and purification ，the content of total flavonoids from M. recutita increased from 6.72％ to 56.20％. The results of cell experiment showed that compared with control group ，the levels of TG and FFA in cells and FFA in the cell supernatant increased significantly in the model group ，the content of lipid in cells increased significantly，the fluorescence intensity of protein expression of DGAT 2 increased significantly ，and the protein expressions of ACC，FAS and DGAT 2 increased significantly （P＜0.01）； large number of lipid dro plets were accumulated in the cells. Compared with model group ，the levels of above indexes in M. recutita total flavonoids low-dose ， medium-dose andhigh-dose groups were significantly reversed （P＜0.01）；the accumulation of lipid droplets in cells decreased significantly. CONCLUSIONS M. recutita total flavonoids can inhibit the TG synthesis of lipid depos ition model HepG 2 cell，reduce the lipid accumulation of cells and prevent the lipid damage of cells. Its mechanism may be related to the down-regulation of the expression of ACC/FAS/DGAT 2 pathway.关键词：total flavonoids from Matricaria recutita;lipid deposition;lipid-lowering effect
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发布时间：2022-06-21 - 摘要：OBJECTIVE To explore the regulatory mechanism of compatibility of ginseng and gecko dispensing granule on kidney yang deficiency model rats. METHODS Male SD rats were randomly divided into normal group （no modeling ，no administration），model group （modeling，no administration ），Jinkui shenqi pill group （modeling，dose of 2.33 g/kg），ginseng group（modeling，dose of 0.53 g/kg），gecko group （modeling，dose of 0.21 g/kg）and compatibility group （modeling，ginseng 0.53 g/kg and gecko 0.21 g/kg）. The body mass and anal temperature of rats were measured at different time points ；the serum levels of cAMP ，cGMP，CRH，ACTH，CORT，T，T3，T4，E2，IgG and IgM were measured ；the pathomorphological changes of adrenal gland ，thyroid gland and testis were observed ；mRNA expression of CRH ，thyroid stimulating hormone releasing hormone （TRH）and gonadotropin releasing hormone （GnRH）in hypothalamus were detected. RESULTS Compared with model group ，the anal temperature ，the levels of cAMP ，CRH，ACTH，CORT，T3，T and cAMP/cGMP ，T/E2 in serum and mRNA expressions of TRH and GnRH in hypothalamus were significantly increased in the compatibility group （P＜0.05 or P＜0.01）；the levels of cGMP，E2 and IgG in serum and mRNA expression of CRH in hypothalamus decreased significantly （P＜0.05 or P＜0.01）； the pathological injuries of adrenal gland ，thyroid gland and testis were all improved. Compared with ginseng or gecko dispensing granules alone ，the anal temperature and T/E 2 of rats in the compatibility group increased significantly ，and mRNA expression of CRH in hypothalamus decreasedsignificantly （P＜0.05 or P＜0.01）. CONCLUSIONS Thecompatibility of ginseng and gecko dispensing granule has a synergistic regulatory effect on kidney yang deficiency model rats ， the mechanism of which may be associated with hypothalamus-pituitary-adrenal axis ， hypothalamus-pituitary-thyroid axis ， hypothalamus-pituitary-gonad axis and neuroendocrine immune network formed by immune function. Compatible drugs are better than single drugs.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To screen t he active component s of Euchresta japonica against nasopharyngeal carcinoma. METHODS Main chemical components of E. japonica were selected ，and their target proteins were predicted in Swiss Target Prediction database. The target proteins of nasopharyngeal cancer were obtained with GeneCards database. Protein-protein interaction（PPI）network was established after the target of chemical components of E. japonica was intersected with the target of nasopharyngeal carcinoma ；PPI network was analyzed by using Cytoscape 3.6.1 software，and the potential active components and key targets of E. japonica against nasopharyngeal carcinoma were screened. The molecular docking technology was used to evaluate binding ability of active component-key target ；active components of E. japonica against nasopharyngeal carcinoma were screened. The anti-nasopharyngeal cancer effect of potential active components of E. japonica was verified by cell proliferation experiment. RESULTS Seven potential active components （tonkinensisol，quercetin，sophoranone，matrine，genistein，coumarin，maackiain） and 10 core targets （SRC，PIK3CA，MAPK1，MAPK3，AKT1，MAPK8，MAP2K1，PTK2，EGFR，JAK3）of E. japonica against nasopharyngeal carcinoma were screened. The molecular docking results showed that above potential active components all possessed certain anti-nasopharyngeal cancer effect. Cell proliferation activity test showed that tonkinensisol ，sophoranone and maackiain had a very significant inhibitory activity on nasopharyngeal carcinoma cells CNE- 1. CONCLUSIONS Tonkinensisol， sophoranone and maackiain might be the main active components of E. japonica against nasopharyngeal carcinoma.关键词：Euchresta japonica;Nasopharyngeal carcinoma;active components;tonkinensisol;sophoranone;maackiain
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发布时间：2022-06-21 - 摘要：OBJECTIVE To study the improvement effects and mechan ism of thalidomide on Alzheimer ’s disease （AD）model of Caenorhabditis elegans . METHODS In this study ，the BR 5270 strain of C. elegans was used as AD model and BR 5271 strain as the control. The effects of thalidomide （0.5，2.0，6.0，15.0 mg/mL）on the motility of BR 5270 strains of C. elegans were studied by the basal slowing response assay ；the effects of thalidomide （0.5，2.0，6.0，15.0 mg/mL）on the survival time of BR 5270 strain of C. elegans were studied by life assay ；the effects of thalidomide （0.5，2.0，6.0 mg/mL）on learning and memory ability of BR 5270 strain of C. elegans were studied by short-term and long-term learning and memory assay. RT-PCR technology was used to study the effects of thalidomide （0.5，2.0，6.0 mg/mL）on mRNA expression of phosphatidylinositol 3-kinase（PI3K）/protein kinase B （Akt）signal pathway related genes （Age-1，Akt-1，Gsk-3）and calpain homologous gene （Clp-1）in BR 5270 strain of C. elegans . RESULTS After the intervention of thalidomide ，oscillation times of BR 5270 strain of C. elegans increased significantly within 30 s （except for 0.5 mg/mL group ），and the 10％ of maximum life span was prolonged significantly （only 0.5 mg/mL group ）；the short-term and long-term learning indexes were improved significantly （only 6.0 mg/mL group ）；mRNA expression of Age-1 and Akt-1（except for 0.5，2.0 mg/mL groups ）were increased significantly ，mRNA expression of Gsk-3（except for 0.5 mg/mL group ） and Clp-1 were decreased （P＜0.05 or P＜0.01）. CONCLUSIONS Thalidomide can ameliorate the dyskinesia of AD model of C. elegans，prolong the lifespan of this strain ，and enhance its learning and memory ability. Its mechanism of action may be related to activation of PI 3K/Akt signaling pathway and inhibition of calpain.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To stud y the regulation mechanism of miRNA- 18a and miRNA-4802 on drug resistance of lymphoma cells via autophagy. METHODS Using human burkitt ’s lymphoma cell Daudi and human mantle cell lymphoma cell JeKo- 1 as the research objects ，adriamycin（ADR）and vincristine （VCR）as experimental drugs. After treatment of ADR and VCR ，relative cell viability was detected with CCK- 8 kit；the expression of apoptosis marker protein activated cleaved caspase- 9 and cleaved caspase-6 were detected by Western blot assay. The drug resistances of the two cells to ADR and VCR were investigated. The difference of autophagy activity between the two kinds of cells by expression detection of autophagy related proteins LC 3-Ⅱ and p62，autophagy flow experiment and transmission electron microscope observation. Fluorescence quantitative polymerase chain reaction was used to investigate the expression differences of miRNA- 18a and miRNA- 4802，ULK1 and ATG 7 mRNA in the two cells，and to detect the expression differences of ULK 1 and ATG 7 proteins. Taking JeKo- 1 cells as the research object ，the changes of autophagy activity and drug resistance were investigated after treatment with endogenous miRNAs （miRNA-18a mimics ， miRNA-4802 mimics）of two simulated organisms. RESULTS After ADR and VCR treatment ，compared with Daudi cells ，JeKo-1 cells had stronger drug resistance and autophagy activity. The expression of miRNA- 18a and miRNA- 4802 in JeKo- 1 cells were significantly lower than Daudi cells ，mRNA and protein expression of ULK 1 and ATG 7 were significantly higher than those of Daudi cells （P＜0.001）. After treatment of miRNA- 18a mimics and miRNA- 4802 mimics，the autophagy activities and drug resistances of JeKo- 1 cells were decreased significantly. CONCLUSIONS miRNA-18a and miRNA- 4802 can decrease drug resistances of lymphoma cells to ADR and VCR by reducing 2 the expression of autophagy-initiating genes ULK1 and ATG7， and inhibiting the autophagy activity of lymphoma cells.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To study the improvement effects of different polar parts fro m total f lavonoids of Scutellaria amoena on non-alcoholic fatty liver disease （NAFLD）model rats. METHODS The total flavonoids of S. amoena （SAF）were extracted by reflux extraction with ethanol ，suspended with water ，and then extracted with ethyl acetate and n-butanol in order to obtain the extraction parts of SAF （recorded as SAFA and SAFB respectively ）. Thirty-six rats were randomly divided into normal group （n＝ 6）and modeling group （n＝30）. Modeling group was given high-lipid diet to induce NAFLD model. After modeling ，modeling group was randomly divided into model group （normal saline ），fenofibrate group （positive control ，20 mg/kg），SAF group （300 mg/kg），SAFA group （300 mg/kg）and SAFB group （300 mg/kg）；they were given relevant intragastical administration ，once a day，for consecutive 6 weeks. After last administration ，the liver index was calculated ；the levels of total cholesterol （TC）， triacylglycerol（TG），aspartate transaminase （AST），alanine transaminase （ALT），high-density lipoprotein cholesterol （HDL-C）， low-density lipoprotein cholesterol （LDL-C） in serum ，the levels of superoxide dismutase （SOD），glutathione peroxidase （GSH-Px），malondialdehyde（MDA），interleukin-1β（IL-1β），IL-6 and tumor necrosis factor-α（TNF-α）in liver tissue were detected；the pathomorphological changes of liver tissue were observed. RESULTS Compared with normal group ，the liver index ， the levels of TC ，TG，AST，ALT，LDL-C，MDA，IL-1β， IL-6 and TNF-α in serum/liver tissue of model group were all increased significantly （P＜0.05）， while the levels of HDL-C，SOD and GSH-Px were all decreased significantly （P＜0.05）. Compared with model group ，except there was no statistical significance in the serum levels of HDL-C and ALT in SAFA group （P＞0.05），above indexes in serum/liver tissue of rats in groups of polar parts from total flavonoids of S. amoena were significantly improved （P＜0.05）；inflammatory cell infiltration and fatty vacuoles in liver tissue were significantly improved. Compared with SAF group and SAFA group ，the levels of TC，TG，AST，MDA，IL-6 and TNF-α were decreased significantly in SAFB group（P＜0.05），while the level of SOD was increased significantly （P＜0.05）；pathomorphological changes of liver tissue were improved more significantly. CONCLUSIONS Each polar part from total flavonoids of S. amoena can improve NAFLD by regulating oxidative stress and inhibiting the secretion of inflammatory factors. The n-butanol polar part has more obvious effect .
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发布时间：2022-06-21 - 摘要：OBJECTIVE To establish the fingerprints of Danggui buxue pills a nd the method for the content determination of three indicative constituents （ferulic acid ，calycosin 7-O-β-D-glucoside and astragaloside Ⅳ）. METHODS Fifteen batches of Danggui buxue pills from two manufacturers were analyzed by high performance liquid chromatography （HPLC）. The determination was performed on a Hypersil ODS 2 C18 column with mobile phase consisted of acetonitrile- 0.2％ formic acid （gradient elution ）at the flow rate of 1.0 mL/min. The column temperature was set at 25 ℃，and the sample size was 20 μL. UV detector [detection wavelengths were 250 nm （calycosin 7-O-β-D-glucoside），323 nm （ferulic acid ）] and evaporative light scattering detector （astragaloside Ⅳ）were selected as detectors. HPLC fingerprints of 15 batches of Danggui buxue pills were established with Similarity Evaluation System of TCM Chromatographic Fingerprint （2012 edition）. The chromatographic peaks were identified and assigned by comparing with the chromatogram of the reference substance and reference medicinal material ；the contents of ferulic acid ，calycosin 7-O-β-D-glucoside and astragaloside Ⅳ were also determined. RESULTS There were 33 common peaks in the fingerprints of 15 batches of samples with the similarities not lower than 0.893. Ferulic acid and calycosin 7-O-β-D-glucoside were identified as peak 13 and 15，respectively. Compared with the chromatogram of reference medicinal material，it could be found that peaks 1-3，7，8，10，12，13（ferulic acid ），17-19，27-29，32 and 33 belonged to Angelica sinensis，and peak 14，15（calycosin 7-O-β-D-glucoside），20-23，25 belonged to Astragalus membranaceus . The methodology of content determination met the requirements. The mean contents of ferulic acid ，calycosin 7-O-β-D-glucoside and astragaloside Ⅳ in 15 batches of samples were 0.050 1，0.402 6，0.913 4 mg/g. CONCLUSIONS In this study ，HPLC fingerprints of Danggui buxue pills and the method of HPLC quantitative analysis for three indicative constituents are established. Established methods are accurate，reliable and repeatable.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To systematic ally stu dy the chemic al components of ethanol extract from Sanzi san ，and to provide reference for clarifying the pharmacodynamic material basis of the formulation. METHODS HPLC-Q-Exactive-MS technology was adopted. The determination was performed on Shim-pack GIST-HP C 18 column with mobile phase consisted of acetonitrile- 0.1％ formic acid aqueous solution for gradient elution at the flow rate of 1 mL/min. The column temperature was 40 ℃，and sample size was 10 μL. Mass spectrometry conditions included the electrospray spray ion source was used for detection in positive and negative ion detection modes. Full MS/dd-MS 2 detection mode was adopted ，the resolution of Full MS was 70 000 and the resolution of dd-MS2 was 17 500. The scanning range was m/z 110-1 200. The ion peaks were identified by comparing with the information of control substances ，literature references and self-built database. RESULTS A total of 64 components were identified in the ethanol extract of Mongolian medicine Sanzi san ， including 9 flavonoids，13 iridoids，14 organic acids ，18 tannins，3 triterpenes，3 amino acids and 4 fatty acids. CONCLUSIONS The ethanol extract of Mongolian medicine Sanzi san mainly include iridoids ，tannins and flavonoids ，which might be the pharmacodynamic material basis of Sanzi san.
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发布时间：2022-06-21 - 摘要：OBJECT IVE To study the effects of ergosterol peroxide derivatives EP-3P on the proliferation ，migration and invasion of human tripe negative breast cancer cell MDA-MB- 231，and to provide reference for the development of breast cancer related drugs. METHODS MTT assay was adopted to detect the proliferation of MDA-MB- 231 cells after treated with 0（blank control），1.25，2.5，5，10，20，40 μmol/L EP-3P for 24，48 and 72 h. Wound healing assay and Transwell chamber method were adopted to detect the migration and invasion ability of MDA-MB- 231 cells after treated with 0（blank control ），5，10，20 EP-3P for 24 h. The apoptosis and cell cycle distribution were detected by flow cytometry. Western blot assay was used to detect the expressions of B-cell lympho ma-2（Bcl-2），Bcl-2 associated X protein （Bax），caspase-3，cleaved-caspase-3，cytochrome C （Cyt-C），matrix metalloproteinase- 2（MMP-2）and MMP- 9. RESULTS Compared with blank control group ，2.5，5，10，20，40 μmol/L EP-3P could significantly increase the inhibitory rate of cell proliferation （P＜0.05 or P＜0.01）in a dose and time- dependent manner. After 24 h treatment of EP- 3P（10，20 μmol/L），the rate of cell migration and the number of invasive cells were decreased significantly （P＜0.01），and cell was arrested at G 2/M stage （P＜0.05 or P＜0.01）；the apoptotic rate was increased significantly （P＜0.05）；the protein expressions of Bax ，Cyt-C and cleaved-caspase- 3 were upregulated significantly ， while those of Bcl- 2，caspase-3，MMP-2 and MMP- 9 were downregulated significantly （P＜0.01）. CONCLUSIONS EP-3P can inhibit the proliferation ，migration and invasion of human tripe negative breast cancer cells MDA-MB- 231 through mitochondrial mediated endogenous caspase pathway ，and induce the apoptosis of cells .
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发布时间：2022-06-21 - 摘要：OBJECTIVE To study the pharm acokinetics of venlafaxine（VEN）combined with vinpocetine （VIN）in rats ，and to investigate the interaction between them. METHODS Healthy male SD rats were randomly divided into VEN group （13.5 mg/kg）， VIN group （1.8 mg/kg） and VEN + VIN group （13.5 mg/kg VEN + 1.8 mg/kg VIN ），with 6 rats in each group. Before administration，rats in each group fasted but didn ’t deprived of water for 12 hours，and were given corresponding drugs intragastrically at one time. Blood was collected from rats in each group through orbital venous plexus at different time points after administration. After plasma sample was pretreated （domperidone as internal standard ），LC-MS/MS method was adopted to determine the concentration of VEN ，active metabolite O-desmethylvenlafaxine of VEN （ODV）and active metabolite apovinblastic acid of VIN （AVA）in plasma. DAS 2.0 software was used to calculate and compare the pharmacokinetic parameters of VEN ，ODV and AVA. RESULTS Compared with VEN group ，the pharmacokinetic parameters cmax，AUC0－t，AUC0－∞，MRT0－t（except for VEN），MRT0－∞（except for VEN ）of VEN and ODV in VEN+VIN group were increased significantly ，while CL/ F and Vz/F were decreased significantly （P＜0.05 or P＜0.01）. Compared with VIN group ，there was no statistical difference in the pharmacokinetic parameters of AVA in rat plasma of VEN+VIN group （P＞0.05）. CONCLUSIONS After the combination of VEN and VIN ，VIN can affect the metabolism of VEN by increasing the absorption of VEN and ODV and slowing down their elimination.关键词：venlafaxine;vinpocetine;pharmacokinetics;Drug interaction;Metabolism;Rat
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发布时间：2022-06-21 - 摘要：OBJECTIVE To systematically evaluate the economical efficiency of marketed a naplastic lymphoma kinase （ALK）-tyrosine kinase inhibitors （TKI）for the treatment of ALK-positive non-small cell lung cancer （NSCLC）in China ，and to provide a reference for the selection of China ’s medical insurance list and drug pricing. METHODS Computer searches of databases such as CNKI ，Wanfang database ，VIP，PubMed，Embase and the Cochrane Library were conducted to collect pharmacoeconomic evaluation studies of four marketed ALK-TKI （crizotinib，seretinib，aletinib and ensatinib ）in the treatment of ALK-positive NSCLC in China during the inception to July 2021. The qualities of the included literature were evaluated using CHEERS checklist ，and analyzed systematically in terms of both methodological and economic outcomes. RESULTS A total of 6 literatures were included ，with a compliance rate of 71％ to 83％ for the CHEERS list criteria ，and the overall quality of the literature was high. In terms of methodological analysis ，the pharmacoeconomic evaluation methods included in the study were mainly model-based （Markov or partitioned survival models ） and real-world data-based cost-utility analysis. Most research perspectives were health insurance payer and health system perspectives ；all cost types were direct medical costs. In terms of economical efficiency analysis ，compared with chemotherapy plan ，2 studies confirmed that ALK-TKI （crizotinib，seretinib）were not economic ，1 study confirmed ALK-TKI （crizotinib） showed economical efficiency. Seretinib showed relatively higher economical efficiency when compared to other ALK-TKIs. High drug prices were the main factor why ALK-TKI was not economically viable for treating ALK-positive NSCLC. CONCLUSIONS The second-generation ALK-TKI （seretinib， 163.com alectinib） have better economical efficiency than the first-generation ALK-TKI （crizotinib）. The economical efficiency of seretinib is the best among the second-generation · ALK-TKI. The economical efficiency of chemotherapy regimen is better than that of the second-generation ALK-TKI （seretinib）. Economic comparison between chemotherapy and first-generation ALK-TKI （crizotinib）remains controversial.关键词：anapastic lymphoma kinase;tyrosine kinase inhibitors;non-small cell lung cancer;Pharmacoeconomic;Systematic
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发布时间：2022-06-21 - 摘要：OBJECTIVE To evaluate the econ omical efficiency of daratumumab combined with lenalidomide and dexamethasone （D-Rd） regimen versus lenalidomide and dexamethasone （Rd） regimen alone in the treatment of transplant- ineligible newly diagnosed multiple myeloma （TNE-NDMM）. METHODS From the perspective of China ’s health system ，a partitioned survival model with three health states of progression free survival ，disease progression and death was established by using the published MAIA test data and relevant literature data. The model cycle was 28 days and the simulation time limit was 20 years. The incremental cost-effectiveness ratio （ICER）was calculated using quality-adjusted life years （QALY）as the output index. Sensitivity analysis was performed for key parameters. RESULTS The results of basic analysis showed that the ICER of D-Rd regimen versus Rd regimen was 2 719 038.08 yuan/QALY，far exceeding 3 times of GDP per capita in 2021（242 928 yuan）. The results of single factor sensitivity analysis showed that cost discount rate ，progression-free survival utility value ，utility discount rate，the cost of daratumumab and lenalidomide had a greater impact on ICER. Probabilistic sensitivity analysis suggested that the probability of economic advantage of D-Rd regimen was always 0 within the WTP range of 0-1 200 000 yuan. CONCLUSIONS Compared with Rd regimen ，D-Rd regimen has no cost-effectiveness advantage for the treatment of TNE-NDMM under the WTP of 3 times GDP per capita of China .关键词：daratumumab;multiple myeloma;partitioned survival model;Pharmacoeconomics
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发布时间：2022-06-21 - 摘要：OBJECTIVE To excavate and evaluate β-blockers associated with acute renal failure（ARF）signal. METHODS Using the report odds ratio （ROR）method and Bayesian confidence interval progressive neural network （BCPNN）method，signal detection and analysis were performed for 4 kinds of β-blockers（metoprolol，bisoprolol，atenolol，nebivolol）associated with ARF Δ 基金项目：重庆市临床药学重点专科建设项目 （No.渝卫办发 in FDA adverse event reporting system （FAERS）from the two 〔2020〕68号）；重庆医科大学未来医学青年创新团队发展支持计划项 dimensions of Standard International Dictionary of Medical 目（No.W0081） Terms （MedDRA） analysis query （SMQ） term set and ＊药师，硕士研究生。研究方向：药物警戒。电话：023-68485161。 preferred term （PT） level terms. When the two methods E-mail：2020121624@stu.cqmu.edu.cn detected positive signals at the same time ，it indicated that # 通信作者：主任药师，硕士生导师。研究方向：临床药学、药物警 suspicious signals were detected. RESULTS Totally 14 328 戒。电话：023-63625666。E-mail：jiayuntaomail@hospital.cqmu.edu.cn ARF reports of 4 kinds of β-blockers were retrieved within the ·1380· China Pharmacy 2022Vol. 33 No. 11 中国药房 2022年第33卷第11期 narrow sense of “acute renal failure ”in SMQ term set ，of which men （6 964）were more than women （6 206）. The age of patients was mainly concentrated in the middle-aged and elderly （≥45 years old ），and serious adverse events accounted for 77.23％. The results of signal retrieval based on SMQ term set showed that ROR values and 95％ confidence intervals of metoprolol ，bisoprolol， atenolol and nebivolol detected by ROR method were 2.58（2.51，2.65），5.30（5.14，5.47），2.80（2.69，2.91）and 3.28（3.04， 3.53）respectively. The signal components （IC）detected by BCPNN method and the lower limit of IC were 1.29（1.25），2.26 （2.22），1.42（1.36）and 1.64（1.53）respectively，suggesting suspicious signals were detected in these four kinds of β-blockers associated ARF. The results of signal detection based on PT level terms showed that 37 positive signals were detected by ROR method，38 positive signals were detected by BCPNN method ，and 36 suspicious signals were detected by the two methods at the same time. For each drug ，12 suspicious signals of metoprolol were detected at the same time ，9 suspicious signals of bisoprolol and atenolol were detected at the same time ，and 6 suspicious signals of nebivolol were detected at the same time ；the number and type of signals were different among the 4 kinds of drug. CONCLUSIONS Four kinds of β-blockers may cause ARF. Compared with metoprolol and atenolol ，bisoprolol and nebivolol have strong statistical correlation with ARF ，suggesting that medical personnel should pay attention to the possible renal related adverse reactions of these drugs in the process of clinical use.关键词：β-blockers;acute renal failure;Data mining;signal detection
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发布时间：2022-06-21 - 摘要：OBJECT IVE To develop a rapid health technology assessment （rHTA）methodology of drugs based on evidence integration and value judgment ，which is suitable for China ’s national conditions. METHODS The literature review was adopted to study health technology assessment （HTA）and multi-criteria decision analysis （MCDA），and then rHTA method based on China ’s condition was formulated preliminarily with anti-tumor drugs ；the method of rHTA was demonstrated by expert consultation ； finally，the feasibility of rHTA was preliminarily verified taking the drugs for the treatment of non-small cell lung cancer as an example. RESULTS Established rHTA method combined the theory and principles of HTA and MCDA ：HTA method was used to guide the collection and synthesis of literature and real-world evidence ，while MCDA made the value measurements of achievable evidences by various stakeholders from different views ；it established the working process ，evaluation dimensions ，evaluation indicators and scoring system of rHTA. The feasibility of this method was verified by the drug example of treating non-small cell lung cancer. CONCLUSIONS A set of drug-driven rHTA methodology guidance based on HTA and MCDA is established. It can quickly collect and integrate evidence ，and provide evidence support for decision makers in a short time.关键词：anti-tumor drug use;Rapid health technology assessment;Health technology assessment;multi-criteria decision
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发布时间：2022-06-21 - 摘要：OBJECTIVE To provide the suggestions and reference for the follow-up update of Guiding Principles of Clinical Application of Novel Anti -tumor Drugs （hereinafter referred to as “Guiding Principles ”）. METHODS The update of 2018-2021 editions of Guiding Principles were compared ；the changes of its style ，the variety and quantity of novel anti-tumor drugs ，the classification of indications ，the target ，the inclusion of medical insurance and other aspects were analyzed. Its change trend and possible problems were summarized. RESULTS There was a great change in the style of Guiding Principles in 2020 edition，i.e. deleting the item of “clinical application management ”and adding the item of “attached table ”. Totally 33 novel anti-tumor drugs were included in the 2018 edition of Guiding Principles ，and the number of novel anti-tumor varieties increased to 46，60 and 77 in 2019，2020 and 2021 editions，respectively. The time when the new varieties were included in Guiding Principles was the same year or one year after the domestic market time. Totally 26 varieties of national medical insurance negotiation were included in the 2018 edition of Guiding Principles ，and 8，10 and 12 varieties were added respectively in 2019，2020 and 2021 editions on the basis of the previous edition . Novel anti-tumor drug in the 2018 edition of Guiding Principles mainly focused on traditional targets such as EGFR，HRE2 and VEGFR. However ，since 2019，the number of new targets such as PD-1，PARP，ALK and CDK had been increasing，among which domestic original drugs accounted for a large proportion. CONCLUSIONS The revision of Guiding Principles aims to further guide the clinical application of novel anti-tumor drugs from the professional level of health technology. The new varieties and indications conform to the principles of scientificity and dynamics ；domestic original varieties have developed rapidly ，and innovative varieties to novel target have emerged. The follow-up update of Guiding Principles should refer to authoritative medical guidelines and high-quality evidence- based evidence. Attention should be paid to the types of tumors lacking therapeutic drugs and the clinical value of oushun- novel anti-tumor drugs.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To investigate the treatment plan for az treonam-resistant metallo- β-lactamase（MBL）-producing Enterobacteriaceae infection in pediatric solid organ transplant recipients. METHODS The clinical data of aztreonam-resistant MBL-producing Klebsiella pneumoniae caused intra-abdominal infection of an infant after liver transplantation were retrospectively analyzed. Abdominal infection occurred after operation. The pathogenic bacterium was MBL-producing K. pneumoniae . The drug sensitivity results showed that the infant was resistant to aztreonam. Based on the results of sensitivity test ，polymyxin B combined with tigecycline were selected as initial regimen. The treatment effect was poor ，with recurrent disease and shock spots. The clinical pharmacist assisted the clinician to formulate treatment regimen of ceftazidime avibactam 0.5 g，q8 h combined with aztreonam 0.18 g，q6 h. Relevant domestic and foreign literature were reviewed ，and the treatment plan of MBL-producing Enterobacteriaceae infection after solid organ transplantation was summarized. RESULTS & CONCLUSIONS The infant was finally cured and discharged with ceftazidime avibatan combined and aztreonam. Several foreign literature reported that ceftazidime avibactam combined with aztreonam could effectively treat the infection caused by aztreonam-resistant MBL-producing Enterobacteriaceae infection in patients with organ transplantation. It is expected to be an effective treatment for aztreonam-resistant MBL-producing Enterobacteriaceae infection in pediatric solid organ transplant recipients.
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发布时间：2022-06-21 - 摘要：Vinorelbine（NVB）is a semisynthetic vinca alkaloid and can play an anti-tumor role by inhibiting the synthesis of tubulin. Its oral preparation has been used in the treatment of a variety of tumors as its convenience and good clinical response. The blood concentration of NVB is closely related to its curative effect and toxicity. Small variations in blood concentration may reduce the curative effect and even produce serious toxicity. There are some risks in the clinical drug use due to limited clinical data and effective pharmacodynamic monitoring methods. By reviewing the relevant literature at home and abroad ，this paper summarizes the research progress of in vivo pharmacokinetics and toxicity of NVB ，fully understands the pharmacokinetic characteristics and influencing factors of NVB ，the influencing factors of toxicity ，and the application status of pharmacokinetics in the adjustment of administration scheme ，so as to provide reference for its clinical rational use.关键词：anti-tumor drug;vinorelbine;Pharmacokinetics;curative effect;toxicity;pharmacodynamic index
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发布时间：2022-06-21
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