最新刊期
卷 34 ， 期 7 ， 2023
- 摘要：OBJECTIVETo analyze the situation and causes of the shortage of drugs in centralized volume-based procurement， and to put forward countermeasures and suggestions for optimizing centralized procurement rules and improving the drug shortage supply guarantee system.METHODSThe shortage data of the first five batches of centralized purchasing drugs during January 2019 and December 2021 were collected from the Shortage Database of Chinese medicine economic information； descriptive statistical analysis was performed for shortage frequency， varieties and reasons. RESULTS &CONCLUSIONSAfter the first five batches of centralized volumetric procurement policy landed， the frequency of drug shortage reported for selected specifications and selected enterprises increased significantly， mainly drug shortage of selected enterprises. The shortage of some varieties from selected enterprises in the short term was obvious， and most of them were commonly used clinical drugs. The occurrence of drug shortages was affected by various links such as the production， circulation and use， and the main reasons were shortage or monopoly of raw materials. In order to ensure the drugs supply， the government should scientifically assess the risk of production interruption of enterprises， further optimize centralized procurement rules， improve the reporting system for drug shortages， and attach importance to the supply of key drugs； in addition， hospitals should take a variety of measures within the scopes of policies to flexibly respond to drug shortages so as to avoid delaying the treatment of patients.关键词：national centralized volume-based procurement;centralized purchasing drugs;supply support
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发布时间：2024-02-19 - 摘要：OBJECTIVETo mine the focus and emotional attitude of the public on rare diseases， and to provide decision-making reference for relevant departments to formulate and implement relevant policies， systems and strategies for medical security of rare diseases.METHODSLatent Dirichlet allocation （LDA） topic model and sentiment analysis method were used to analyze the comment text of short videos related to the “nosinasine” medical insurance admission event on the Bilibili video website， mine the theme and sentiment tendency of the text， and put forward relevant strategy suggestions.RESULTSA total of 8 videos with tens of thousands of playback and 7 109 text data were obtained. According to the LDA analysis， online public paid attention to 9 topics related to rare diseases （the price of rare disease drugs， the inclusion of rare disease drugs in medical insurance， the status quo of research and development of rare disease drugs， the scope of medical insurance and the medical security system， the plight of rare disease patients， the prevention and screening of rare diseases， the value of rare disease drugs in medical insurance， the Chinese and western medical methods of rare diseases， and the supply and demand status of rare disease drugs）， which could be summarized into 4 categories according to the objects of concern （rare disease drugs， rare disease medical insurance， rare disease medical and health services and rare disease patient groups）. On the whole， the emotional tendency of the Internet public towards each topic showed a low positive and high negative tendency.CONCLUSIONSThe public paid more attention to the price， research and development， supply and demand of rare disease drugs， and was deeply worried about the current medical status of rare diseases in China. To strengthen and improve the medical security for patients with rare diseases， such as actively carrying out public health services for rare diseases， strengthening cooperation in the diagnosis and treatment of rare diseases， and researching rare disease drugs， etc. Chinese medical and health departments can make concerted efforts in medical and health services， drug supply security， medical security and other social security.关键词：latent Dirichlet allocation topic model;sentiment analysis;nosinasine;medical security
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发布时间：2024-02-19 - 摘要：China produces about 15 000 tons of expired drugs every year. Standardized destruction of expired drugs consumes a large number of secondary costs， causing huge economic losses. Improper handling will also lead to serious environmental pollution， endanger national health and even endanger public safety. This paper analyzes the hazards， sources and disposal methods， and research status of expired drugs， introduces the Shelf-Life Extension Program of United States， and put forward feasible measures for the recovery， integration and reuse of expired drugs. It is suggested to construct a scientific and reasonable recovery and disposal system of expired drugs in combination with the actual situation in China， explore the strategy of extending the expiration of drugs， and greatly reduce the waste of drug resources.关键词：expiration;extending strategy;disposal;resource
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发布时间：2024-02-19 - 摘要：OBJECTIVETo study the improvement effects and its mechanism of catalpol on testicular lesions in KK-Ay spontaneous diabetic mice on the basis of glycolysis process mediated by advanced glycation end products （AGEs） and their receptors （RAGE）.METHODSKK-Ay spontaneous diabetic mice fed with high-fat diet were used as diabetic model， and then randomly divided into model group， catalpol group （100 mg/kg）， aminoguanidine group （AGEs inhibitor， 100 mg/kg） and FPS-ZM1 group （RAGE inhibitor， 1 mg/kg）， and C57BL/6J mice fed in the same period were set as normal group， with 6 mice in each group. The catalpol group and aminoguanidine group mice were given relevant medicine intragastrically， normal group and model group mice were given constant volume of normal saline intragastrically， and FPS-ZM1 group mice were given relevant medicine 1 mL/g intraperitoneally， for consecutive 8 weeks. After the last administration， the body mass， fasting blood glucose， 24-hour food intake， water consumption， urine volume， testicular organ coefficient， and sperm motility of the mice were measured； pathological morphology and ultrastructural structure of testicular tissue were observed； the levels of reduced glutathione （GSH）， superoxide dismutase （SOD）， lactate dehydrogenase （LDH） and sugar metabolites in testicular tissue of mice were detected； pathway enrichment analysis was performed； the level of AGEs in serum and testicular tissue， protein expressions of RAGE， B-cell lymphoma-2 （Bcl-2） and Bcl-2-associated X protein （Bax）， and mRNA expressions of key rate-limiting enzymes [hexokinase （HK）， phosphofructose kinase （PFK）， pyruvate kinase （PK）， LDH] in testicular tissue were all detected.RESULTSCatalpol could significantly improve the general symptoms， testicular organ coefficients and motility of sperm in KK-Ay spontaneous diabetic mice （P＜0.05 or P＜0.01）. The morphology and ultrastructure of spermatogenic cells in each layer of the seminiferous tubules were all improved. The levels of GSH， SOD and LDH in testicular tissue，the levels of the metabolic product glucose fructose-1，6-diphosphate， 3-phosphate glycerate， 3-phosphate glyceraldehyde， lactic acid and pyruvate， the expressions of HK， PFK， PK and LDH mRNA were all significantly increased（P＜0.05 or P＜0.01）； the levels of AGEs in serum and testicular tissue， the expression of RAGE protein and the ratio of Bax to Bcl-2 in testicular tissue were significantly decreased（P＜0.05 or P＜0.01）. Aminoguanidine and FPS-ZM1 could significantly improve the levels of most of above indicators in mice（P＜0.05 or P＜0.01）.CONCLUSIONSCatalpol shows significant improvement effects on testicular lesions of KK-Ay spontaneous diabetic mice， and its mechanism of action was associated with upregulation of AGEs/RAGE signaling pathway-mediated glycolysis.关键词：glycolysis;diabetes;testicular lesions;advanced glycation end products;the receptor of advanced glycation end products
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发布时间：2024-02-19 - 摘要：OBJECTIVETo investigate the effects and mechanism of Danshen decoction influencing platelet physiological characteristics and function in hyperlipidemia model rats based on platelet membrane glycoprotein 4 （CD36）/phosphatidylinositol 3-kinase （PI3K）/protein kinase B （Akt） signaling pathway.METHODSThe hyperlipidemia model rats were induced by feeding high-fat diet， and then randomly divided into model group， simvastatin group （0.004 g/kg）， Danshen decoction high-dose and low-dose groups （3.6， 0.9 g/kg）， and blank group （fed with basic feed）， with 10 rats in each group. Rats in each administration group were intragastrically administered with corresponding drugs every day， and the other groups were intragastrically administered with equal volume of normal saline for 4 weeks. After the last administration， the contents of blood lipid biochemical indexes [total cholesterol （TC）， triglyceride （TG）， high-density lipoprotein cholesterol （HDL-C）， low-density lipoprotein cholesterol （LDL-C）]， whole blood viscosity， plasma viscosity and fibrinogen （FIB） content in plasma， platelet-related parameters [platelet count （PLT）， platelet distribution width （PDW） and mean platelet volume （MPV）] were detected. The levels of platelet physiological characteristics and function-related factors [von Willebrand factor （vWF）， fibronectin （Fn）， phospholipase A2 （PLA2）， thromboxane B2 （TXB2）， 6-keto-prostaglandin F1α （6-keto-PGF1α）， thromboxane A2 （TXA2）， prostaglandin I2 （PGI2）， cyclic adenosine monophosphate （cAMP）， cyclic guanosine monophosphate （cGMP）， β-thromboglobulin （β-TG）]， platelet aggregation rate （maximum aggregation rate， 60 s aggregation rate， 180 s aggregation rate） and fibrinolytic system-related factors [tissue plasminogen activator （t-PA）， plasminogen activator inhibitor 1 （PAI-1）] and the expressions of CD36/PI3K/Akt signaling pathway-related proteins [CD36， focal adhesion kinase （FAK）， phosphatidylinositol 4-phosphate 5-kinase （PIP5K）， PI3K， phosphorylated Akt （p-Akt）， p-Akt1/2/3] in platelet were all determined.RESULTSCompared with blank group， the contents of TC， TG and LDL-C in plasma， whole blood viscosity， plasma viscosity， the plasma levels of FIB， PLT， MPV， vWF， Fn， PLA2， TXB2， TXA2， cGMP and β-TG， maximum platelet aggregation rate， 60 s aggregation rate， the expressions of PAI-1 in plasma， protein expressions of CD36， FAK， PIP5K， PI3K， p-Akt and p-Akt1/2/3 were significantly increased in the model group （P＜0.05）. The content of HDL-C and the levels of 6-keto-PGF1α， PGI2 and t-PA were significantly decreased （P＜0.05）. After the intervention of Danshen decoction， most of the above indexes were significantly reversed （P＜0.05）.CONCLUSIONSDanshen decoction can improve the physiological characteristics and function of platelets in hyperlipidemia model rats， and its mechanism may be related to the down-regulation of CD36/PI3K/Akt signaling pathway activity and the reduction of platelet activation.关键词：Danshen decoction;platelet activation;platelet membrane glycoprotein 4/phosphatidylinositol 3-kinase/protein kinase B signaling pathway
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发布时间：2024-02-19 - 摘要：OBJECTIVETo identify the chemical components of Changtong oral liquid （CTOL），and to provide reference for the basic research and secondary development of its pharmacological substances.METHODSUHPLC-Orbitrap HRMS technique was adopted. CTOL sample was separated on a Hypersil Gold column with mobile phase consisted of 0.1% formic acid （containing 5 mmol/L ammonium formate）-acetonitrile （gradient elution）. The eluent was detected in positive and negative ion modes using an electrospray ionization source. The data was processed by Xcalibur 4.3 and Compound Discoverer 3.3 software. The primary and secondary mass spectra data of each compound were collected. The unknown compounds were identified according to the mass spectrometry library of the instrument and the network databases mzCloud，mzVault，etc. Through matching with the pharmacology database and analysis platform of the traditional Chinese medicine system，the chemical components could be attributed to the traditional Chinese medicine.RESULTSFifty-three chemical components were identified and analyzed from CTOL，such as 24 flavonoids，8 quinones，5 phenylpropanoids，4 sugars and glycosides，5 organic acids，3 amino acids，1 alkaloid，1 phenolic and 2 other compounds. Among them，12 components were derived from Salvia miltiorrhiza，9 from Citrus aurantium，7 from Rheum palmatum，4 from Angelica sinensis，1 from Magnolia officinalis，16 from Glycyrrhiza uralensis，and 4 from many kinds of medicinal materials.CONCLUSIONSCTOL mainly contains flavonoids，quinones and phenylpropanoid compounds，and its chemical components mainly come from G. uralensis，S. miltiorrhiza and C. aurantium.关键词：UHPLC-Orbitrap HRMS;chemical components;identification
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发布时间：2024-02-19 - 摘要：OBJECTIVETo establish comprehensive quality evaluation method based on multi-index components combined with multivariate statistical analysis， and to comprehensively evaluate the quality of Periploca forrestii.METHODSTaking 11 batches of P. forrestii medicinal materials from different areas in Guizhou as samples， the contents of neochlorogenic acid， cryptochlorogenic acid， chlorogenic acid， procyanidin A2， isochlorogenic acid A and isochlorogenic acid C were determined by HPLC. Clustering heat map analysis， grey correlation analysis（GRA） and technique for order preference by similarity to ideal solution（TOPSIS） were used to evaluate the quality of P. forrestii.RESULTSThe results of methodological investigation of content determination were in accordance with the relevant regulations， and the linear relationship and accuracy of each component were good in their respective sampling range. The contents of chlorogenic acid， cryptochlorogenic acid， neochlorogenic acid， procyanidin A2， isochlorogenic acid A and isochlorogenic acid C in 11 batches of samples were 3.650-7.302， 0.888-2.575， 1.371-2.386， 0.947-1.469， 0.084-0.169 and 0.725-1.067 mg/g， respectively. The content of each component was significantly different， with the highest content of chlorogenic acid and the lowest content of isochlorogenic acid A. The comprehensive results of cluster heat map， GRA and TOPSIS analysis showed that the comprehensive quality of S5 and S10 was relatively good.CONCLUSIONSThe established method is accurate， stable and simple. Combined with multivariate statistical analysis method， it can be used for quality evaluation of P. forrestii. The quality of samples from Jiuzhou Town and Caiguan Town of Xixiu District in Anshun City of Guizhou Province are relatively good among 11 different origin samples.关键词：content determination;multi-index component;multivariate statistical analysis;quality evaluation
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发布时间：2024-02-19 - 摘要：OBJECTIVETo investigate the effects and mechanism of luteolin on osteogenic repair of bone defects.METHODSThe targets and potential pathways of luteolin in the treatment of bone defects were screened by network pharmacology method， and then the top 2 targets were selected by Hub gene screening for molecular docking verification， with binding energy as the evaluation standard. In vitro experiments were conducted on rat bone mesenchymal stem cells （BMSC） and rat umbilical vein endothelial cells （RUVEC）. Phenotypic validation was performed using alkaline phosphatase staining， alizarin red S staining， and in vitro angiogenesis experiments. Western blot assay was used to detect the protein expressions of phosphatidylinositol 3 kinase （PI3K） and protein kinase 1 （Akt1）， so as to validate the mechanism of luteolin on osteogenic differentiation of BMSC and angiogenesis of RUVEC in vitro.RESULTSThe results of network pharmacology showed that the effects of luteolin on vascular formation and bone repair in bone defects were mainly related to Akt1， SRC， estrogen receptor 1， epidermal growth factor receptor， cyclooxygenase 2， matrix metalloproteinase 9 targets， and were closely related to PI3K-Akt signaling pathway. The results of molecular docking showed that luteolin binding to Akt1 and SRC proteins was stable. The results of in vitro experiments showed that luteolin could significantly improve the expressions and activities of alkaline phosphatase in BMSC， increased the number of calcium salt deposits and calcified nodules， and promoted calcification of BMSC. Compared with luteolin 0 μmol/L group， the angiogenesis ability of RUVEC was enhanced significantly in luteolin 1， 10 μmol/L groups， the length of blood vessels and the protein expressions of PI3K and Akt1 were significantly increased （P＜0.05 or P＜0.01）； the higher the concentration， the better the effect.CONCLUSIONSLuteolin may play a role in promoting angiogenesis and bone repair at the fracture site by activating PI3K/Akt signaling pathway and promoting the protein expressions of PI3K and Akt1.关键词：bone defect;osteogenic repair;angiogenesis;network pharmacology;molecular docking
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发布时间：2024-02-19 - 摘要：OBJECTIVETo investigate the anti-inflammatory effects and mechanism of Zhuang medicine Tongfeng li’an capsules on gouty arthritis in combination with in vivo and in vitro experiments.METHODSSixty rats were randomly divided into normal group， model group， positive control group （27 mg/kg allopurinol+0.27 mg/kg colchicine）， Tongfeng li’an capsules low-dose， medium-dose and high-dose groups （2.2， 4.5， 9.0 g/kg）， with 10 rats in each group. Except for normal group， gouty arthritis model of rats was induced in other groups. Rats in each administration group were given corresponding drugs intragastrically， and rats in the normal group and model group were given equal volume of water intragastrically for 14 consecutive days. The degree of ankle joint swelling， serum level of interleukin-1β （IL-1β） and protein expressions of nuclear factor kappa-B （NF-κB） in synovial tissue were detected， and the histopathological changes of synovium tissue in the ankle joint of rats were observed. The inflammation model was established by stimulating RAW264.7 cells with lipopolysaccharide. After Tongfeng li’an capsules （62.5， 125， 250 μg/mL） were given， the levels of nitric oxide （NO）， reactive oxygen species （ROS） and IL-1β in the cells and protein expression of NF-κB were detected， and NF-κB localization in the cells was also determined.RESULTSResults of in vivo experiment showed that compared with normal group， the swelling degree of the ankle joint， serum IL-1β level and protein expression of NF-κB in synovium tissue were all increased significantly in model group （P＜0.05）； pathological changes such as synovial hyperplasia， edema， vascular congestion， capillary hyperplasia， and increased inflammatory cells were observed. Compared with model group， the levels of above indexes were all decreased significantly in Tongfeng li’an capsules high-dose group （P＜0.05）， and most of the above indexes were significantly reduced in Tongfeng li’an capsules medium-dose and low-dose groups （P＜0.05）； synovial hyperplasia of the ankle joint improved， and the infiltration of inflammatory cells decreased. Results of in vitro experiment showed that Tongfeng li’an capsule could significantly reduce the levels of NO， ROS and IL-1β and protein expression of NF-κB（P＜0.01）， and inhibit NF-κB nucleation.CONCLUSIONSTongfeng li’an capsules have good anti-inflammatory effect on gouty arthritis， and its mechanism may be related to the inhibition of NF-κB signaling pathway activity.关键词：Tongfeng li’an capsule;gouty arthritis;anti-inflammatory effect;NF-κB signaling pathway
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发布时间：2024-02-19 - 摘要：OBJECTIVETo study the improvement effects and mechanism of rhein on immunoglobulin A nephropathy （IgAN） model rat based on signal transducer and activator of transcription 3 （STAT3） signaling pathway.METHODSRats were randomly divided into normal control group， IgAN model group and rhein treatment group， with 10 rats in each group. IgAN model group and rhein treatment group were given combination of bovine serum albumin+lipopolysaccharide+carbon tetrachloride to induce IgAN model. Since the 7th week， rhein treatment group rats were intragastrically given relevant medicine， and normal control group and model group rats were given equal amount of normal saline intragastrically， for consecutive 4 weeks. After the last administration， the count of urine sediment erythrocyte， 24 h-urine total protein （UTP）， the levels of immunoglobulin A （IgA） in serum and secretory immunoglobulin A （sIgA） in intestinal mucosa were detected. The pathological changes of Peyer’s patch in renal cortex and intestinal mucosa and IgA deposition in renal cortex were observed. The expressions of interleukin-17 （IL-17）， IL-6 and transforming growth factor β （TGF-β） in Peyer’s patch of intestinal mucosa in rats were detected. The expressions of STAT3 and related orphan receptor γt （RORγt） mRNA in Peyer’s patch were detected. The expressions of p-STAT3 and RORγt proteins in Peyer’s patch were detected.RESULTSCompared with normal control group， the count of urine sediment erythrocyte， 24 h-UTP， the levels of IgA in serum and sIgA in intestinal mucosa were increased significantly in IgAN model group （P＜0.01）； enlarged renal corpuscles， dilated renal sacs， obvious intratubular mesangial hyperplasia and fibrosis were observed in renal cortex； the volume and germinal center of Peyer’s patch in intestinal mucosa increased； IgA deposition of renal cortex was obvious； the expressions of IL-17， IL-6 and TGF-β in Peyer’s patch， mRNA expressions of STAT3 and RORγt， protein expressions of p-STAT3 and RORγt were increased significantly （P＜0.01）. Compared with IgAN model group， above indexes were decreased significantly in rhein treatment group （P＜0.01）， pathological damage of renal cortex was improved， the volume of Peyer’s patch and germinal center of intestinal mucosa were reduced， and IgA deposition in renal cortex was weakened.CONCLUSIONSRhein can improve IgAN model rats， the mechanism of which may be associated with inhibiting STAT3 signaling pathway and regulating immune function of Peyer’s patch in intestinal mucosa.关键词：immunoglobulin A nephropathy;intestinal mucosa;Peyer’s patch;signal transducer and activator of transcription 3 signaling pathway
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发布时间：2024-02-19 - 摘要：OBJECTIVETo explore whether diterpenoid 12-deoxyphorbol-13-palmitate （DP） from Euphorbia fischeriana can exert anti-leukemia effects through the phosphatidylinositol 3-kinase （PI3K）/protein kinase B （Akt） signal pathway， and to provide experimental evidence for developing it into a new anti-leukemia drug.METHODSUsing LY294002 （PI3K specific inhibitor） as tool drug， the effects of 24 h DP treatment on the proliferation and apoptosis of human myeloid leukemia HL60 cells were detected by MTT method， Annexin Ⅴ-FITC/PI staining and AO-EB staining. ELISA method was used to detect lactic dehydrogenase （LDH） release and the activities of cysteinyl aspartate specific proteinase 3 （caspase-3） and caspase-9. The transcriptional level of caspase-3， caspase-9， forkhead box O3a （FoxO3a） and B cell lymphoma 2 interacting mediator of cell death （Bim） mRNA were detected by real-time quantitative polymerase chain reaction （qRT-PCR）. The protein expression of phosphorylated FoxO3a （p-FoxO3a） and phosphorylated Akt （p-Akt） were detected by Western blot method. The nuclear translocation of FoxO3a protein was detected by immunostaining combined with laser confocal microscopy.RESULTS10 μmol/L DP and 10 μmol/L DP+LY294002 could inhibit the proliferation and induce the apoptosis of HL60 cells （P＜0.01）. After treatment of 5， 10， 20 μmol/L DP， HL60 cells showed typical morphological characteristics of apoptosis； DP could significantly increase the levels of LDH release and the activities of caspase-3 and caspase-9 （P＜0.05 or P＜0.01）， in dose-dependent manner. After treatment of 10 μmol/L DP and 10 μmol/L DP+LY294002， the transcriptional levels of caspase-3， caspase-9 and Bim mRNA were increased significantly （P＜0.05 or P＜0.01）， and transcriptional level of FoxO3a mRNA and protein expressions of p-FoxO3a and p-Akt were decreased significantly （P＜0.05 or P＜0.01）. Nuclear translocation changes were observed in FoxO3a protein in 10 μmol/L DP+LY294002 group， and the change was more significant than that of LY294002 group.CONCLUSIONSDP can inhibit the proliferation and induce the apoptosis of HL60 cells via inhibiting PI3K/Akt signaling pathway.关键词：12-deoxyphorbol-13-palmitate;human myeloid leukemia HL60 cells;phosphoinositide 3-kinase/protein kinase B signaling pathway
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发布时间：2024-02-19 -
Content determination of 3 alkaloids in different origins of Tibetan
Corydalis pallida by UPLC-MS/MS摘要：OBJECTIVETo establish and apply a method for simultaneous determination of the contents of dicentrine， protopine and coptisine in Tibetan Corydalis pallida of different origins， and to provide reference for origin determination and quality control of the kind of medicinal materials.METHODSUltra performance liquid chromatography-tandem quadrupole mass spectrometry method was used. The determination was performed on Agilent EC-C18 column （100 mm×2.1 mm， 2.7 μm） with mobile phase consisted of acetonitrile-0.1% formic acid by gradient elution. The flow rate was 0.2 mL/min， and the column temperature was set at 35 ℃. MS detection was carried out by electrospray ionization in positive modes， multiple reaction monitoring mode was used for quantitative analysis.RESULTSThe injection mass concentrations of dicentrine， protopine， coptisine ranged from 5.88 to 117.60， 53.70 to 1 074.00， and 4.85 to 97.00 ng/mL， respectively， showing a good linear relationship with their respective peak areas （r＝0.998 2， 0.991 9， and 0.999 6， respectively）. The limits of quantitation were 2.35， 1.07 and 1.46 ng/mL； the limits of detection were 1.17， 0.54， 0.49 ng/mL， respectively. RSDs of precision， stability （24 h） and repeatability tests were all lower than 2.0％. The average recovery rates were 97.41%， 98.89% and 105.44% （all RSDs＜5.0％，n＝6）.CONCLUSIONSThe established method has good selectivity and high accuracy， and is suitable for the rapid analysis of dicentrine， protopine and coptisine in Corydalis. The total contents of three alkaloids in different original medicinal materials are from high to low in order of C. chrysosphaera， C. mucronifera， C. pygmaea， C. hendersonii and C. conspersa. The alkaloid contents in C. chrysosphaera and C. mucronifera are relatively similar， but no dicentrine has been detected in C. conspersa and C. hendersonii.关键词：ultra performance liquid chromatography-tandem quadrupole mass spectrometry method;dicentrine;protopine;coptisine;content determination- 14
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发布时间：2024-02-19 - 摘要：OBJECTIVETo evaluate the cost-effectiveness of clopidogrel versus aspirin monotherapy regimens for secondary prevention of ischemic stroke and to provide economic evidence and reference for clinical medication and decision-making.METHODSBased on the CAPRIE trial， a Markov model was constructed； the probabilities of risk events， health utility values， and costs of risk event management were obtained from relevant literature. The cycle length was 6 months， and the time horizon was 10 years. A discount rate of 5% per year was applied. The primary outcomes were total costs， quality-adjusted life-years （QALYs）， and incremental cost-effectiveness ratio （ICER）. Cost-utility analysis was performed for above 2 regimens by using TreeAge Pro software. The one-way sensitivity analysis， probabilistic sensitivity analysis and scenario analysis were conducted to validate the robustness of the analyses.RESULTSCompared with the aspirin regimen （325 mg/d of CAPRIE trial dose）， the ICER values of clopidogrel regimen for secondary stroke prevention for 10 years， 20 years and 30 years were 4 284.06， 4 201.20 and 3 986.78 yuan/QALY， respectively， which were all less than the willing-to-pay （WTP） threshold of one time China’s per capita gross domestic product （GDP） in 2021. Compared with the aspirin regimen （clinically recommended dose in China， 100 mg/d）， the ICER values of clopidogrel regimen for stroke secondary prevention for 10 years， 20 years and 30 years were 58 238.27， 42 164.72 and 36 164.77 yuan/QALY， respectively， which were all less than WTP threshold. When comparing with aspirin regimen of 325 mg/d， results of one-way sensitivity analysis showed that the cost of clopidogrel and aspirin， probability of the first recurrence of ischemic stroke were sensitive factors of model. Results of probabilistic sensitivity analysis showed that when WTP was set at one time GDP per capita in China in 2021， clopidogrel had a probability of being cost-effective of about 66.5%. Results of scenario analysis showed that neither changing the time horizon to 10， 20 or 30 years nor using different doses of aspirin （50， 100， 150， 200 or 250 mg/d） would not alter any conclusions.CONCLUSIONSCompared with aspirin monotherapy， clopidogrel monotherapy is more cost-effective for secondary prevention of ischemic stroke.关键词：aspirin;antiplatelet agents;ischemic stroke;secondary prevention;pharmacoeconomic evaluation;cost-utility analysis
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发布时间：2024-02-19 - 摘要：OBJECTIVETo compare the safety of high-dose methotrexate （HD-MTX） via peripherally inserted central catheter （PICC） and totally implantable venous access port （TIVAP） in pediatric patients with malignant brain tumors.METHODSPatients with malignant brain tumors who received HD-MTX via PICCs or TIVAPs in our hospital from July 2018 to April 2022 were retrospectively analyzed. Clinical data were collected to compare differences in blood concentration of methotrexate （MTX），the incidence of adverse events （including adverse drug reactions and catheter-related complications） and length of stay in hospital. Multivariate linear regression was applied to analyze the factors that influenced the blood concentration of MTX.RESULTSA total of 107 patients were included in the study，with 65 patients in the PICC group and 42 patients in the TIVAP group. Blood concentration of MTX at 24 h （C24 h） in TIVAP group was significantly higher than PICC group [（126.87±61.99） μmol/L vs. （102.45±48.77） μmol/L，P＜0.05）. There was no significant difference in blood concentration of MTX at 42 h （C42 h），compared with PICC group （P＞0.05）. Results of multivariate linear regression analysis showed that TIVAP was associated with the increase of C24 h（P＜0.05）. No significant differences were observed in the incidence of adverse events and the length of stay in the hospital between 2 groups （P＞0.05）.CONCLUSIONSRisk of adverse events is not increased，although the MTX C24 h level is elevated after administration of TIVAP. TIVAP is a safe choice for HD-MTX therapy with implementing therapeutic drug monitoring.关键词：totally implantable venous access port;peripherally inserted central catheter;malignant brain tumor;therapeutic drug monitoring;blood concentration;adverse event
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发布时间：2024-02-19 - 摘要：OBJECTIVETo investigate the clinical efficacy and safety of rituximab （RTX） followed by belimumab （BLM） in patients with severe systemic lupus erythematosus（SSLE）.METHODSNine SSLE patients， who were treated with RTX followed by BLM for more than 6 months in the Department of Rheumatology and Immunology of the First Affiliated Hospital of Zhengzhou University from October 2020 to June 2021， were enrolled. Baseline clinical data of patients， laboratory examination results and basic treatment status at weeks 0， 4， 12， and 24 of medication were collected retrospectively. The patients’ systemic lupus erythematosus disease activity index （SLEDAI） score， glucocorticoid dosage and serological indicators （complement C3， complement C4， serum albumin， and 24-hour urine protein quantification） level were analyzed. At the same time， the occurrence of adverse drug reaction was collected.RESULTSAll 9 patients completed more than 24 weeks of RTX followed by BLM therapy. All patients suffered from renal impairment， of which 7 （77.8%） had renal pathology support， 3（33.3%） had blood system damage and 2 （22.2%） had nervous system damage. During treatment， with the prolongation of treatment time， the SLEDAI score， 24-hour urinary protein quantification， and glucocorticoid dosage of patients showed a significant downward trend， and ultimately decreased to the normal index level （P＜0.05）； serum albumin， complement C3 and complement C4 all showed a significant upward trend， eventually rose to the normal index level （P＜0.05）. During treatment and follow-up， 1 patient developed herpes zoster， 1 patient developed upper respiratory tract virus infection， and 1 patient developed urinary system bacterial infection. All patients recovered after symptomatic treatment.CONCLUSIONSIn sequential use of RTX followed by BLM for SSLE， early administration of RTX can quickly stabilize the condition， significantly alleviate clinical symptoms， and gradually normalize specific serological indicators； subsequent administration of BLM can reduce the type and dosage of basic treatment drugs； there is no increase in the incidence of adverse drug reactions.关键词：rituximab;severe systemic lupus erythematosus;clinical efficacy;safety
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发布时间：2024-02-19 - 摘要：OBJECTIVETo analyze the clinical manifestations and characteristics of adverse drug reactions （ADR） induced by dronedarone，and to provide reference for clinically safe drug use.METHODSRetrieved from PubMed database， Wanfang database，CNKI and VIP （up to August 31st， 2022），ADR cases of dronedarone were analyzed retrospectively in respect of patient’s age，gender，nationality，usage and dosage of dronedarone，and occurrence time，clinical manifestations，treatment measures and outcome of ADR，etc.RESULTSA total of 26 case reports were included，with a total of 27 patients. The age of the patients was 41-86 years old，with an average age of 68.8 years. The proportion of patients aged 60-79 was the largest （20 cases，74.1%）. There was no significant difference in the number of males （14 cases） and females （13 cases）. The patients came from 6 countries，of which the United States was the largest （16 cases，59.3%）. The dosage of 14 patients was 400 mg bid；one patient was 200 mg bid；the dosage for 12 patients was not specified. The most ADR cases （16 cases，59.3%） occurred within 1 month，of which 11 cases（40.7%） occurred within 1 week，and there were no ADR reports with medication more than 12 months. Organs/systems involved in ADRs were mainly liver and biliary diseases （7 case times，23.3%），skin and subcutaneous tissue diseases （6 case times，20.0%），respiratory tract，thoracic and mediastinal diseases （5 case times，16.7%）. In addition，ADR also occurred in heart diseases，kidney and urinary system diseases，vascular diseases，medical examinations and eye diseases. Among 27 patients，there were 3 cases of death，the ADR were bronchiolitis obliterans with organizing pneumonia，toxic epidermal necrolysis and hepatic failure，respectively. One patient underwent liver transplantation.CONCLUSIONSDronedarone can cause multiple organ system ADR. Before use，it is necessary to improve the examination including ECG，liver function，lung function，etc. and strengthen drug use monitoring within one month after the start of use，especially the ADR of hepatobiliary，skin and respiratory system. The occurrence of severe ADR has no obvious relationship with the duration of medication； even if it is taken safely for a long time，it still needs continuous pharmaceutical monitoring and follow-up to ensure the clinical medication safety of patients.关键词：adverse drug reaction;literature analysis;bronchiolitis obliterans with organizing pneumonia;toxic epidermal necrolysis;hepatic failure
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发布时间：2024-02-19 - 摘要：OBJECTIVETo investigate the causal association between ticagrelor and risk of infectionMETHODSTwo-sample Mendelian randomization was adopted. Genetic instrumental variables were selected based on the results of the largest genome-wide association analysis to in vivo exposure of ticagrelor and its major active metabolite AR-C124910XX. The causal associations of ticagrelor and its major active metabolite AR-C124910XX with drug indications （coronary artery disease， unstable angina pectoris， myocardial infarction， stroke and ischemic stroke）were analyzed by inverse variance weighted Mendelian randomization model as a positive control for genetic instrumental variables. The causal relationship between ticagrelor and bacterial infection， acute lower respiratory infection， bacterial pneumoniae， pneumoniae， acute upper respiratory infection and sepsis were further analyzed by using this method， and the robustness of the results was assessed by using heterogeneity tests and horizontal pleiotropy tests.RESULTSThe increase of area under the curve at steady state （AUCss） of the genetic surrogated ticagrelor significantly reduced the risk of coronary artery disease， myocardial infarction and unstable angina pectoris（P＜0.001）. AUCss genetic instrument variables of its main active metabolite AR-C124910XX failed to pass positive control. Further analysis showed that the increase of the genetic surrogated ticagrelor exposure suggestively reduced the risk of bacterial infection [OR（95%CI）＝0.80（0.65，0.99），P＝0.040] and sepsis [OR （95%CI）＝0.84（0.73， 0.98）， P＝0.023]. The results of the heterogeneity tests showed that there was no heterogeneity in the causal association of the genetic surrogated ticagrelor AUCss with bacterial infection and sepsis （P＞0.05）. The results of horizontal pleiotropy tests showed that the causal association of genetic surrogated ticagrelor AUCss with bacterial infection and sepsis had no effects on horizontal pleiotropy （P＞0.05）.CONCLUSIONSTicagrelor has a potential role in reducing the risk of sepsis and bacterial infections.关键词：infection;Mendelian randomization;genome-wide association analysis;causal inference;sepsis
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发布时间：2024-02-19 - 摘要：OBJECTIVETo investigate the clinical efficacy of Gushen antai pills combined with heparin sodium in the treatment of antiphospholipin antibody （ACA）-positive recurrent abortion.METHODSA total of 203 ACA-positive recurrent abortion patients were randomly divided into control group （n＝101） and combination treatment group （n＝102）. Control group was additionally treated with heparin sodium on basis of basic treatment， and combination treatment group was additionally treated with Gushen antai pills on the basis of control group. Serum samples were collected from patients， the levels of interleukin 6 （IL-6）， tumor necrosis factor α （TNF-α）， cyclooxygenase 2 （COX-2）， β-human chorionic gonadotropin （β-HCG） and ACA were detected by enzyme-linked immunosorbent assay. The antibody-negative conversion rate was calculated， the clinical efficacy of the patient was observed， and the occurrence of adverse drug reactions was recorded.RESULTSAfter treatment， the pregnancy success rate and antibody-negative conversion rate of combination treatment group were significantly higher than those in the control group （P＜0.05）， and the abortion rate was significantly lower than that in the control group （P＜0.05）. Compared with before treatment， serum levels of IL-6， TNF-α and ACA in 2 groups were decreased significantly （P＜0.05）， while the levels of COX-2 and β-HCG were increased significantly （P＜0.05）； the changes of above indexes in combination treatment group were more significant（P＜0.05）. There was no statistical significance in the incidence of adverse drug reactions between 2 groups（P＞0.05）.CONCLUSIONSGushen antai pills can maintain high expression of β-HCG， reduce the level of ACA and improve immune microenvironment in patients with ACA-positive recurrent abortion by increasing the serum level of COX-2 and decreasing the serum level of IL-6， so as to increase the success rate of pregnancy.关键词：Gushen antai pill;heparin sodium;anticardiolipin antibody;Clinical efficacy
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发布时间：2024-02-19 - 摘要：OBJECTIVETo mine adverse drug event （ADE） signals related to baloxavir marboxil， and to provide reference for clinically safe drug use.METHODSThe ADE signals related to baloxavir marboxil from January 1， 2018 to May 31， 2022 in the US FDA adverse event reporting system （FAERS） were mined using the proportional reporting odds ratio （PRR） method. ADE with report number≥3， PRR≥2 and χ2≥4 was defined as a positive signal， and PRR method was used to analyze the ADE signal.RESULTSA total of 1 424 ADE reports with baloxavir marboxil as the main suspected drug were collected， involving 460 ADE signals. The femininity and patient under 18 years old were reported more， the country with the highest number of reports was the United States， and the main indication of drug reported was influenza. A total of 37 ADE positive signals were obtained after PRR calculation and screening exclusion， the first three ADE signals in the list of the reported number were diarrhea， vomiting and immediate hypersensitivity， and the first three ADE signals in the list of PRR value were febrile delirium， ischaemic colitis and hemorrhagic cystitis. Compared with the instructions of baloxavir marboxil， 18 ADE signals had not yet been included， such as abnormal liver function， hematuria， hemorrhagic cystitis， etc. Five new SOCs were involved， such as kidney and urinary system diseases， hepatobiliary system diseases， investigations， nervous system disorders and musculoskeletal and connective tissue disorders.CONCLUSIONSWhen clinical application of baloxavir marboxil， in addition to the adverse drug reactions mentioned in the drug instructions， attention should be paid to abnormal liver function， hematuria， hemorrhagic cystitis， etc， so as to guarantee the safety of drug use.关键词：adverse drug event;pharmacovigilance;proportional reporting ratio;drug safe use
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发布时间：2024-02-19 - 摘要：OBJECTIVETo systematically evaluate the efficacy and safety of Shenfu injection combined with chemical medicine in the treatment of coronary heart disease combined with heart failure.METHODSRetrieved from CNKI， CBM， VIP， Wanfang， PubMed， Embase and the Cochrane Library， randomized controlled trials （RCTs） about Shenfu injection combined with chemical medicine （trial group） versus chemical medicine （control group） in the treatment of heart failure with coronary heart disease were collected during the inception to August 2022. After literature screening and data extraction， the qualities of included literature were evaluated and rated by using Cochrane manual and GRADE system. Meta-analysis and Egger’s were performed with RevMan 5.3 software， and TSA 0.9.5.10 Beta software was used for trial sequential analysis.RESULTSSeventeen studies were included， with a total sample of 1 355 patients. The quality grade evidence of GRADE was all low. Meta-analysis showed that cardiac function efficacy [RR＝1.23， 95%CI （1.16，1.30）， P＜0.000 01]， the decrease of brain natriuretic peptide [MD＝－96.06， 95%CI （－116.47， －75.64）， P＜0.000 01] and the increase of left ventricular ejection fraction [MD＝5.32， 95%CI （4.03，6.60）， P＜0.000 01] in trial group were significantly better than control group； there was no statistical significance in the incidence of ADR between 2 groups [RR＝0.52，95%CI（0.22，1.22），P＝0.13]. The results of sequential analysis showed that the sample size included in this study met the requirements of meta-analysis； the results of Egger’s test showed that the results were robust and publication bias had no significant effect on the results.CONCLUSIONSShenfu injection combined with chemical medicine in the treatment of coronary heart disease combined with heart failure can further improve the clinical symptoms and related indicators， and no serious adverse reaction is observed.关键词：coronary heart disease;heart failure;efficacy;meta-analysis;trial sequential analysis
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发布时间：2024-02-19 - 摘要：OBJECTIVETo evaluate the effect of “Cloud Pharmacy Service System” electronic management platform in medication therapy management （MTM） of chronic airway diseases.METHODSMTM module setting of “Cloud Pharmaceutical Service System” was introduced. Totally 371 patients with chronic airway disease admitted to our hospital from January 2021 to March 2022 were selected for MTM based on the “Cloud Pharmacy Service System”. The standardization of inhalation device mastery and compliance of patients before and after intervention were compared with self-made inhalation device evaluation scale and Morisky medication adherence scale-8 （MMAS-8）. The satisfaction of patients with pharmacist after intervention was investigated.RESULTS“Cloud Pharmaceutical Service System” is mainly divided into 4 modules， such as medication therapy review， pharmacist intervention， personal medication record and the medication-related action plan， other functions. Among 371 patients， there were 237 outpatients （142 cases of asthma， 95 cases of chronic obstructive pulmonary disease） and 134 inpatients （19 cases of asthma and 115 cases of chronic obstructive pulmonary disease）. The score of the patients using inhalation device increased from 74.76±24.71 before intervention to 99.45±2.12 after intervention （P＜0.05）. MMAS-8 score increased from 7.14±1.15 before intervention to 7.88±0.44 after intervention （P＜0.05）. The degree of patients’ satisfaction with pharmacists reached 100% after intervention.CONCLUSIONS“Cloud Pharmacy Service System” is helpful to improve the effects of pharmaceutical service for patients with chronic airway disease by providing whole-process， online， visual and immediate MTM.关键词：chronic airway diseases
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发布时间：2024-02-19 - 摘要：OBJECTIVETo construct the quantitative evaluation system of regional clinical pharmacists’ professional ability， and provide reference for the evaluation of regional clinical pharmacists’ professional ability.METHODSTwenty-one experts from 18 hospitals in Chongqing were consulted to construct a professional ability index system for clinical pharmacists. TOPSIS model was used to calculate and obtain the expert authority index （EI）， and the weighted averaging method was used to construct the judgment matrix. Analytic hierarchy process （AHP） was used to calculate the weights of all indicators for establishing a quantitative evaluation system of regional clinical pharmacists’ professional ability according to the weights of each item.RESULTSThe results of TOPSIS showed that the EI range was 0.010-0.100， and the relative authority of experts was distinguished and measured effectively. The results of AHP showed that the judgment matrix of the quantitative evaluation system met the requirements of consistency test （consistency test index CR＜0.1）. Finally， a quantitative evaluation system for regional clinical pharmacists’ professional ability was established， including 6 sub-objective items （basic ability， clinical practice ability， coordination and communication ability， publicity ability， scientific research and teaching ability， continuous improvement ability） and 25 index items （such as educational background， professional title， clinical pharmacy working years， daily theoretical skills assessment， information ability level， medication education， etc.）.CONCLUSIONSA quantitative evaluation system of regional clinical pharmacists’ professional ability has been established. Our study provides a theoretical reference for the quantitative evaluation and optimal management of regional clinical pharmacists.关键词：professional ability;evaluation system;analytic hierarchy process;TOPSIS;regional
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发布时间：2024-02-19 - 摘要：ilibinin is a kind of flavonoid extracted from the dried ripe fruit of Silybum marianum，a plant of compositae. It has a variety of pharmacological activities and can effectively prevent and treat diabetes and its complications. This paper reviews the research progress on the mechanism of silibinin in the prevention and treatment of diabetes and its complications. It is found that silibinin can prevent and treat diabetes by up-regulating the expression of estrogen receptor-α，activating the duodenum-brain-liver axis pathway and stabilizing the protein structure. It can prevent and cure the nervous system diseases of diabetes by activating glucagon-like peptide-1 receptor/protein kinase A signal pathway and inhibiting the hyperphosphorylation of tau protein. It can prevent and treat diabetic retinopathy by down-regulating the expression and activity of pro-inflammatory，pro-oxidative factors and histone deacetylase 6. It can prevent diabetic nephropathy by activating protein kinase B signal pathway and reducing the level of transforming growth factor-β1，and prevent and treat diabete’s obesity by inhibition of hepatobiliary transporter CD36 expression，and suppressing nuclear factor-κB pathway and its downstream expression of pro-inflammatory cytokines（tumor necrosis factor-α and interleukin-1β），etc.关键词：diabetes;complications of diabetes;pharmacological target;mechanism of action
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发布时间：2024-02-19 - 摘要：Rheumatoid arthritis （RA） is a systemic chronic auto-inflammatory disease， characterized by infiltration of inflammatory cells， pannus formation， articular cartilage destruction， and bone matrix destruction. Therefore， improving articular cartilage destruction has an important impact on the treatment of RA. Chinese medicine has a good application effect in improving cartilage destruction of RA due to its characteristics of multiple components， multiple targets， high activity and low side effects. Based on this， the author reviewed relevant literature to summarize the relevant research and mechanism of Chinese medicine and its active components in improving RA cartilage destruction. The results showed that Chinese medicine and its active components can improve RA cartilage destruction by regulating inflammatory factors， phosphatidylinositol 3-kinase/protein kinase B， Wnt/β- catenin， nuclear factor-κB， mitogen-activated protein kinase， Janus kinase 2/signal transduction and activator of transcription 3/vascular endothelial growth factor， microRNAs， fibroblastic synovial cells.关键词：cartilage destruction;Chinese medicine;active component;improvement
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发布时间：2024-02-19
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