最新刊期
卷 34 ， 期 22 ， 2023
- 摘要：OBJECTIVEIn order to analyze the current situation of policy tool allocation in China’s TCM formula granule industry， and provide a theoretical basis for the high-quality development of the industry.METHODSBased on the perspective of policy tools， “TCM formula granules” was used as the keyword to retrieve the official websites of departments directly under the State Council such as the National Medical Products Administration and the National Administration of Traditional Chinese Medicine， as well as provincial governments. The relevant clauses in the policy documents related to TCM formula granules in China from 1993 to 2022 were encoded， and then the application of policy tools was summarized and classified. RESULTS &CONCLUSIONSA total of 12 national documents and 77 provincial documents were ultimately selected， involving 556 relevant policy clauses. It was found that among the relevant policy tools， environmental policy tools had the highest degree of attention， accounting for 62.6%； the proportions of demand-oriented policy tools and supply-oriented policy tools were less， accounting for 17.8% and 19.6%， respectively. From the perspective of policy tools， the use of demand-oriented policy tools in current policy texts was relatively simple， and various policy tools were given low attention； from the perspective of policy objectives， the proportion of use of environmental， demand-oriented and supply-oriented policy tools were not balanced enough. It is suggested to increase the proportion of demand-oriented policy tools to meet international competition； emphasize the use of supply-oriented policy tools to strictly control product quality； consolidate the use of environmental policy tools to standardize quality standards. On this basis， we will coordinate the overall situation， balance the use of various policy tools and promote the development of TCM formula granule industry.关键词：policy tool;environmental;demand-oriented;supply-oriented
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发布时间：2023-11-25 - 摘要：OBJECTIVETo analyze the patents of new target oral drugs for type 2 diabetes mellitus （T2DM）， and to provide references for the research and development direction and patent layout of new domestic diabetes drugs.METHODSBased on global patent data in the HimmPat database， from multiple perspectives such as the number of patent applications and authorization， development trend， regional distribution and main applicants， statistics and analysis were performed for the patents related to 3 types of new target oral drugs for T2DM， such as glucokinase activator （GKA）， protein tyrosine phosphatase 1B inhibitor （PTP-1B-IN）， and 11β-hydroxysteroid dehydrogenase 1 inhibitor （11β-HSD1-IN）. RESULTS &CONCLUSIONSA total of 1 649 patents of GKA， 709 patents of PTP-1B-IN， 592 patents of 11β-HSD1-IN were obtained， the main applicants were well-known pharmaceutical companies， which possessed the core patents of pharmaceutical compounds. The research on GKA drugs was more mature， with a larger number of patent applications and a more comprehensive enterprise layout. Domestic enterprises， universities and research institutions had advantages in the field of PTP-1B-IN. Domestic enterprises and research institutions can leverage the advantages of traditional Chinese medicine and resources to enhance their research capabilities and improve technological competitiveness through core technology exploration， the exploration of process route， patent layout， industry-university-research cooperation and the establishment of patent pool.关键词：new target oral drugs;glucokinase activator;protein tyrosine phosphatase 1B inhibitor;11β-hydroxysteroid dehydrogenase 1 inhibitor;patent analysis
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发布时间：2023-11-25 - 摘要：OBJECTIVETo explore the improvement effect and potential mechanism of total flavonoids from Alpinia zerumbet on gastric mucosa injury induced by absolute ethanol through microRNA-146a-5p （miR-146a-5p）.METHODSUsing human gastric mucosa GES-1 cells as objects， the acute gastric ulcer model was established by absolute ethanol； based on the investigation of the effects of different concentrations of total flavonoids from A. zerumbet on cell activity and the selection of action concentration， the relative expression level of miR-146a-5p in GES-1 cells was detected， the protein expressions of tumor necrosis factor （TNF） receptor-associated factor 6（TRAF6）， nuclear factor-κB p65 （NF-κB p65） and TNF-α were detected， and the levels of interleukin-1β （IL-1β）， IL-6 and prostaglandin E2 （PGE2） in cell supernatant were determined. The targeting relationship between miR-146a-5p and TRAF6 was verified； the effects of overexpressed miR-146a-5p and TRAF6 knockdown on the levels of IL-1β， IL-6 and PEG2 in supernatant of model cells as well as the effects of miR-146a-5p knockdown on anti-gastric ulcer effect of total flavonoids from A. zerumbet were observed.RESULTSCompared with the blank group， the relative expression of miR-146a-5p in cells and the level of PGE2 in cell supernatant were decreased significantly in the model group （P＜0.01）， while the protein expressions of TRAF6， NF-κB p65 and TNF-α in cells and the levels of IL-1β and IL-6 in cell supernatant were increased significantly （P＜0.01）. Compared with the model group， the relative expression of miR-146a-5p in cells and the level of PGE2 in cell supernatant were increased significantly in model+A. zerumbet total flavonoids （60 mg/L） group （P＜0.01）， while the protein expressions of TRAF6， NF-κB p65 and TNF-α in cells and the levels of IL-1β and IL-6 in cell supernatant were decreased significantly （P＜0.05 or P＜0.01）. There was a targeted relationship and a negative correlation between miR-146a-5p and TRAF6. After overexpression of miR-146a-5p or TRAF6 knockdown， the levels of IL-1β and IL-6 were decreased significantly in cell supernatant， while the level of PGE2 was increased significantly （P＜0.05）. After miR-146a-5p knockdown， the levels of IL-1β and IL-6 in cell supernatant and the protein expression of TRAF6 in cells administered with total flavonoids of A. zerumbet were increased significantly， while the level of PGE2 was decreased significantly （P＜0.05）.CONCLUSIONSTotal flavonoids of A. zerumbet can improve the gastric mucosa injury induced by absolute ethanol. The mechanism may be related to up-regulating the expression of miR-146a-5p， inhibiting the expression of TRAF6， and further inhibiting the secretion of related inflammatory factors.关键词：gastric mucosa cell;microRNA-146a-5p;TNF receptor-associated factor 6;anti-gastric ulcer effect
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发布时间：2023-11-25 - 摘要：OBJECTIVETo explore the mechanism of Chonghe paste promoting the dissipation of swollen lesions.METHODSThe bacteriostatic effects of Chonghe paste against Staphylococcus aureus， Escherichia coli， Pseudomonas aeruginosa， Staphylococcus albus and Streptococcus pneumoniae were detected by punching method. The subcutaneous soft tissue infection model of rats was established by subcutaneous injection of S. aureus. The effects of 14 d intervention of Chonghe paste （Compound polymyxin B ointment as positive control） on the pathological changes of subcutaneous soft tissue， the protein expressions of type Ⅰ collagen， type Ⅲ collagen， matrix metalloproteinase-2 （MMP-2） and MMP-9 in subcutaneous soft tissue， and the contents of transforming growth factor-β （TGF-β） and basic fibroblast growth factor （bFGF） in serum were investigated.RESULTSChonghe paste had varying degrees of bacteriostatic effect on the above 4 bacteria （except for S. pneumoniae）， especially on S. aureus. Compared with the model group， on the 7th day of treatment， collagen fibers in the Chonghe paste group were arranged in an orderly manner， pus dissipated faster； the protein expressions of type Ⅰ and type Ⅲ collagen and the contents of TGF-β and bFGF were up-regulated significantly， while protein expressions of MMP-2 and MMP-9 were decreased significantly （P＜0.05）. On the 14th day of administration， collagen deposition was obvious in the Chonghe paste group， subcutaneous appendages gradually formed； the protein expressions of type Ⅰ and type Ⅲ collagen and the contents of TGF-β and bFGF were down-regulated significantly， while the protein expressions of MMP-2 and MMP-9 were increased significantly （P＜0.05）.CONCLUSIONSChonghe paste has the bacteriostatic effect and may play a role in promoting the dissipation of swollen lesions by regulating the formation and decomposition of fibrin and increasing the secretion of bFGF and TGF-β.关键词：swollen lesion;bacteriostasis;mechanism
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发布时间：2023-11-25 - 摘要：OBJECTIVETo establish the fingerprint of total saponins from Mussaenda pubescens， and to study the spectrum-effect relationship of its hepatoprotective activity.METHODSTen batches of total saponins from M. pubescens from different origins were prepared using 75% ethanol as solvent. High-performance liquid chromatography （HPLC） and the Similarity Evaluation System for Traditional Chinese Medicine Chromatographic Fingerprints （2012 edition） were used to draw the fingerprints of 10 batches of total saponins from M. pubescens. The similarity evaluation and identification of common peaks were conducted. The same HPLC method was adopted to determine the contents of five triterpenoid saponins （mussaendoside H， mussaendoside U， mussaglaoside C， mussaendoside G and mussaendoside O）. The hepatoprotective effect of total saponins from M. pubescens was investigated by establishing carbon tetrachloride-induced acute liver injury model mice， and the spectrum-effect relationship was studied by using grey correlation analysis.RESULTSThere were 11 common peaks in 10 batches of total saponins from M. pubescens， 5 of which were identified， i.e. mussaendoside H （peak 3）， mussaendoside U （peak 7）， mussaglaoside C （peak 8）， mussaendoside G （peak 9） and mussaendoside O （peak 11）； the similarities of 10 batches of samples ranged 0.940-0.991. Average contents of mussaendoside H， mussaendoside U， mussaglaoside C， mussaendoside G， mussaendoside O were 0.01-0.05， 0.10-0.21， 0.10-0.18， 0.03-0.08， 0.20-0.40 mg/g， respectively. Ten batches of total saponins from M. pubescens could generally reduce the contents of alanine aminotransferase （ALT） and aspartate aminotransferase （AST） in serum， and tumor necrosis factor-α （TNF-α）， interleukin-6 （IL-6） and IL-1β in liver tissue of model mice （P＜0.05 or P＜0.01）. The correlation between the common peak areas and the contents of ALT， AST， TNF-α， IL-6 and IL-1β were 0.602-0.757， 0.585-0.833， 0.593-0.795， 0.618-0.820， 0.607-0.804， respectively； the peaks with high correlation were peaks 11， 9 and 8 in order.CONCLUSIONSTen batches of total saponins from M. pubescens have similar components， and the average contents of mussaendoside H， mussaendoside U， mussaglaoside C， mussaendoside G and mussaendoside O are different. The batches of samples have a certain degree of hepatoprotective effect； mussaendoside O， mussaendoside G and mussaglaoside C may be its main active components.关键词：total saponins;fingerprint;content determination;hepatoprotective activity;spectrum-effect relationship
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发布时间：2023-11-25 - 摘要：OBJECTIVETo investigate the inhibitory effects of formononetin on lipopolysaccharide （LPS）-induced apoptosis and inflammatory response in alveolar epithelial cells through phosphoinositide 3-kinase （PI3K）/protein kinase B （Akt） signaling pathway.METHODSHuman lung cancer alveolar basal epithelial cells A549 were cultured in vitro and divided into control group （no intervention）， model group （1 μg/mL LPS）， different concentrations of formononetin groups （1 μg/mL LPS+6.25， 12.5， 25， 50 μmol/L formononetin）. The levels of inflammatory factors （interleukin-8， tumor necrosis factor-α） and cell viability were detected in each group. Another A549 cells were divided into control group， model group （1 μg/mL LPS）， LPS+25 group （1 μg/mL LPS+25 μmol/L formononetin）， inhibitor group （1 μg/mL LPS+20 μmol/L LY294002）， formononetin+inhibitor group （1 μg/mL LPS+25 μmol/L formononetin+20 μmol/L LY294002） and formononetin+activator group （1 μg/mL LPS+25 μmol/L formononetin+10 μmol/L SC79）. The secretion levels and mRNA expressions of inflammatory factors， cell apoptosis， and expressions of the key proteins of PI3K/Akt signaling pathway were detected in each group.RESULTSCompared with model group， the levels of inflammatory factors were decreased significantly after the intervention of 25 μmol/L of formononetin， and the cell viability was increased significantly （P＜0.05）. Compared with the control group， the secretion levels and mRNA expressions of inflammatory factors， apoptotic rate， and relative expressions of phosphorylated Akt and phosphorylated PI3K of the model group were increased significantly （P＜0.05）. Compared with the model group， the above indexes of the LPS+25 group and the inhibitor group were decreased significantly （P＜0.05）. Compared with the LPS+25 group， the above indicators of formononetin+inhibitor group were further decreased， while those of formononetin+activator group were increased significantly （P＜0.05）.CONCLUSIONSFormononetin can inhibit LPS-induced epithelial cell apoptosis and improve inflammatory response， and the mechanism may be related to the inhibition of the PI3K/Akt signaling pathway.关键词：alveolar epithelial cells;lipopolysaccharide;phosphoinositide 3-kinase/protein kinase B signaling pathway;apoptosis;inflammatory response
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发布时间：2023-11-25 - 摘要：OBJECTIVETo establish the fingerprint and multi-component content determination method of Crataegus pinnatifida leaves from different producing areas， and to evaluate the quality of C. pinnatifida leaves and screen the differential markers.METHODSSeventy-eight batches of C. pinnatifida leaves were collected from Chengde of Hebei Province， Huludao of Liaoning Province， Yuncheng of Shanxi Province and Linyi of Shandong Province. High-performance liquid chromatography （HPLC） and Similarity Evaluation System for Traditional Chinese Medicine Chromatographic Fingerprints （2012 edition） were used to draw the fingerprints and conduct similarity evaluation. Grey correlation analysis， cluster analysis （CA）， principal component analysis （PCA） and orthogonal partial least squares-discriminant analysis （OPLS-DA） were performed by using SPSS 19.0， MetaboAnalyst 5.0 and SIMCA 14.1 software. The differential markers affecting the quality of C. pinnatifida leaves were screened with variable importance in the projection （VIP） value greater than 1 and the error line not exceeding the origin as the criterion. Using vitexin rhamnoside as an internal reference， the contents of chlorogenic acid， glucosylvitexin， hypericin and isoquercetin in 78 batches of C. pinnatifida leaves were determined by the same HPLC combined with quantitative analysis of multi-components by single-marker （QAMS）， and the results were compared with external standard method.RESULTSEight common peaks were calibrated in the fingerprints for 78 batches of C. pinnatifida leaves from 4 producing areas. Five known components were identified， including chlorogenic acid （peak 1）， glucosylvitexin （peak 3）， vitexin rhamnoside （peak 4）， hypericin （peak 7） and isoquercetin （peak 8）； their similarities ranged from 0.871 to 0.998. Average relative correlations of samples from Chengde of Hebei Province， Huludao of Liaoning Province， Yuncheng of Shanxi Province and Linyi of Shandong Province were 0.538， 0.528， 0.462 and 0.435， respectively. CA and PCA showed that the samples from Chengde of Hebei Province and Huludao of Liaoning Province were roughly classified into one category， while the samples from Linyi of Shandong Province and Yuncheng of Shanxi Province were roughly classified into one category； VIP values of peak 1， 2， 3 and 5 were all greater than 1. By QAMS， the relative correction factors of chlorogenic acid， glucosylvitexin， hypericin and isoquercetin were 0.401， 0.993， 1.670 and 1.615 （RSD＜2%）. Compared with external standard method， except for isoquercetin in the two batches of samples （S39 and S41）， there was no significant difference in the content of each component in other batches of samples （the relative deviations≤5%）.CONCLUSIONSThe established fingerprint and QAMS method are simple to operate and can be used to evaluate the quality of C. pinnatifida leaves. The sample from Chengde of Hebei Province is relatively good in quality. Chlorogenic acid （peak 1）， glucosylvitexin （peak 3）， and the corresponding components of peaks 2 and 5 may be differential markers affecting the quality of C. pinnatifida leaves.关键词：fingerprints;quantitative analysis of multi-components by single-marker;chemical pattern recognition;differential marker
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发布时间：2023-11-25 - 摘要：OBJECTIVETo explore the effects and potential mechanism of veratramine （VTM） on the proliferation of human glioblastoma U251 cells.METHODSThe network pharmacology methods were adopted to screen the targets of ferroptosis related to the effects of VTM on glioblastoma， and to conduct gene ontology and Kyoto Encyclopedia of Genes and Genosomes enrichment analysis. Using U251 cells as the object， CCK-8 assay， the observation of cell morphological changes， DCFH-DA fluorescence probe method， FerroOrange fluorescence probe method and Western blot assay were used to validate the inhibitory effects of VTM on U251 cell proliferation and its possible mechanism.RESULTSTotally 462 targets of ferroptosis related to the effects of VTM on glioblastoma were screened out； they mainly enriched in biological processes such as oxidative stress and apoptosis， and cellular components such as cytoplasmic vesicles and mitochondrial membranes； they affected molecular functions such as iron ion （Fe2+） binding and DNA transcription processes， as well as iron death and phosphoinositide 3-kinase/protein kinase B signaling pathways. VTM with 40， 60， 80， 100， 120 and 140 μmol/L could significantly reduce the cell survival rate （P＜0.01）； VTM with 40， 80 and 120 μmol/L could cause cell atrophy and nuclear fragmentation， significantly inhibit the clone formation， increase the levels of intracellular reactive oxygen species （ROS） and Fe2+ levels， increase the expressions of nuclear factor-erythroid 2-related factor 2 （Nrf2） and heme oxygenase 1 （HO-1） protein to different extents， while down-regulate the expression of glutathione peroxidase 4 （GPX4） protein （P＜0.05 or P＜0.01）.CONCLUSIONSVTM can inhibit the proliferation of U251 cells， and promote the accumulation of intracellular ROS and Fe2+， thus inducing ferroptosis； its mechanism might be related to the regulation of the Nrf2/HO-1/GPX4 signaling pathway.关键词：glioblastoma;ferroptosis;Nrf2/HO-1/GPX4 signaling pathway
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发布时间：2023-11-25 - 摘要：OBJECTIVETo investigate the impacts of isorhynchophylline （IRN） on airway inflammation in asthmatic mice by regulating the monocyte chemotactic protein-1 （MCP-1）/CC chemokine receptor 2 （CCR2） signaling pathway.METHODSThe asthmatic mice model was established by injecting and inhaling ovalbumin. The successfully modeled mice were randomly grouped into asthma group， IRN low-dose group （IRN-L， intragastric administration of 10 mg/kg IRN）， IRN high-dose group （IRN-H， intragastric administration of 20 mg/kg IRN）， IRN-H+CCL2 group [intragastric administration of 20 mg/kg IRN+intraperitoneal injection of 7.5 ng CC chemokine ligand 2 （CCL2）] and positive control group （intraperitoneal injection of 2 mg/kg dexamethasone）. The mice injected and inhaled with sterile phosphate-buffered solution were included in the blank control group， with 10 mice in each group. The mice in administration groups were given relevant medicine once a day， for consecutive 2 weeks. The levels of airway hyperreactivity indexes such as enhanced pause （Penh） value， tumor necrosis factor-α （TNF-α）， interleukin-13 （IL-13） and IL-4 in serum， the number of eosinophil （EOS）， lymphocyte （LYM） and neutrophils （NEU） in alveolar lavage fluid and the protein expressions of MCP-1 and CCR2 in lung tissue were observed in each group； the pulmonary histopathological changes were observed， and inflammatory cell infiltration score was evaluated.RESULTSCompared with the blank control group， the infiltration of inflammatory cells in the lung tissue of mice was more significant in the asthma group， and there was swelling and shedding of cells； inflammatory infiltration score， Penh value， the levels of IL-4， IL-13 and TNF-α， the number of EOS， NEU and LYM， the protein expressions of MCP-1 and CCR2 were increased significantly （P＜0.05）. Compared with the asthma group， the pathological injuries of the IRN-L group， IRN-H group and positive control group were improved， and the above quantitative indexes were decreased significantly （P＜0.05）. Compared with the IRN-L group， the above quantitative indexes of the IRN-H group and positive control group were decreased significantly （P＜0.05）. There was no statistical significance in the above quantitative indexes between the IRN-H group and the positive control group （P＞0.05）. Compared with the IRN-H group， the above quantitative indexes of the IRN-H+CCL2 group were increased significantly （P＜0.05）. CCL2 reversed the protective effect of high-dose IRN on asthmatic mice.CONCLUSIONSIRN may reduce the release of airway inflammatory factors in asthmatic mice by inhibiting the activation of the MCP-1/CCR2 signaling pathway， so as to achieve the purpose of improving asthma.关键词：asthma;monocyte chemotactic protein-1/CC chemokine receptor 2 signaling pathway;airway inflammation
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发布时间：2023-11-25 - 摘要：OBJECTIVETo optimize the extraction process of polysaccharides from Dendrobium officinale， and preliminarily study its effect on acute lung injury （ALI） in mice.METHODSUsing D. officinale as raw material， the polysaccharides were extracted from D. officinale by ultrasonic-assisted hot water immersion. Using the extraction rate of D. officinale polysaccharides as response value， the single-factor experiments and Box-Behnken response surface method were used to optimize the ratio of material to liquid， extraction time and extraction temperature. ALI mice were induced by lipopolysaccharide. Using prednisone acetate （5 mg/kg） as the positive control， the effects on the mass ratio of wet and dry lung and pathological changes of lung tissue （HE staining and Masson staining） of low-dose， medium-dose and high-dose D. officinale polysaccharides （50，100，200 mg/kg） were investigated.RESULTSThe optimal extraction technology of D. officinale polysaccharides was as follows： the ratio of material to liquid was 1∶25 （g/mL）， the extracting time was 1 h， and the extracting temperature was 58 ℃. Under these conditions， the average extraction rate of D. officinale polysaccharides was 37.75% （RSD＝1.12%，n＝3）， the relative error of which with predicted value （38.63%） was 2.28%. Compared with the model group， the ratios of wet and dry lung in the positive control group and D. officinale polysaccharides groups were all decreased significantly （P＜0.05 or P＜0.01）， and the pathological changes in lung tissue （severe destruction of alveolar structure， significant widening of alveolar septa， extensive infiltration of inflammatory cells and proliferation of fibroblasts） were alleviated to varying degrees.CONCLUSIONSThe optimal extraction process of D. officinale polysaccharides is feasible； the obtained polysaccharide extract has a certain improvement effect on ALI in mice.关键词：extraction technology;Box-Behnken response surface method;lipopolysaccharide;acute lung injury
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发布时间：2023-11-25 - 摘要：OBJECTIVETo evaluate the cost-effectiveness of Ferric carboxymaltose injection in the treatment of iron deficiency anemia in adult Chinese patients.METHODSFrom the perspective of China’s health system， the partitioned survival model was constructed to simulate the treatment process and outcome of patients with iron deficiency anemia using ferric carboxymaltose and iron sucrose based on the ferric carboxymaltose phase Ⅲ clinical trial in China （NCT03591406）. The study period was 1 year. Total costs and quality-adjusted life years （QALYs） were calculated for both treatment regimens， and incremental cost-effectiveness ratios were calculated. Scenario analysis was performed with different assumptions for efficacy parameters between 9th week and the end of 1 year， and from the perspective of China’s health system and the entire society. The sensitivity analysis was also performed.RESULTSIn the basic analysis， compared with iron sucrose， incremental effectiveness of ferric carboxymaltose therapy was 0.007 QALYs， with an additional savings of 1 038 yuan per patient. Ferric carboxymaltose therapy was more effective and less costly， presenting an absolute advantage. The results of the scenario analysis and single-factor sensitivity analysis were consistent with the basic analysis. Probability sensitivity analysis showed that when the willingness-to-pay threshold was 1， 2， 3 times gross domestic product per capita in 2022， the probability of ferric carboxymaltose with a cost-effectiveness advantage was 88.2%，94.5% and 97.6%，respectively.CONCLUSIONSFor Chinese adults with iron deficiency anemia， ferric carboxymaltose is a cost-effective treatment for iron deficiency anemia， compared with iron sucrose.关键词：iron deficiency anemia;cost-effectiveness analysis;partitioned survival model
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发布时间：2023-11-25 - 摘要：OBJECTIVETo establish a method to detect the blood concentration of ibrutinib and apply it to the clinic.METHODSUsing zanubrutinib as internal standard， the concentration of ibrutinib was detected by high performance liquid chromatography （HPLC） after plasma samples were processed by solid-phase extraction. The separation was performed on an Agilent 5 TC-C18（2） column with acetonitrile-0.5% potassium dihydrogen phosphate solution （43∶57， V/V） as the mobile phase at a flow rate of 1 mL/min， a detection wavelength of 260 nm， a column temperature of 40 ℃， a sample size of 20 μL， and a run time of 25 min. The concentration of ibrutinib was measured in the plasma of 9 patients with non-Hodgkin’s lymphoma 2 h after drug administration on the 30th day by the above method.RESULTSThe linear range of the assayed mass concentration of ibrutinib was 10-500 ng/mL （R 2＝0.998 9）， the lower limit of quantification was 10 ng/mL， and the RSDs of the intra-batch and inter-batch precision tests were not higher than 12.77%. The recoveries of the extraction were 74.80% and 97.70%， with both RSDs＜2.90%， and the RSDs of the stability tests were not higher than 7.10%. The peak plasma concentrations of 9 patients were 15.341-279.628 ng/mL.CONCLUSIONSThe established HPLC method is simple and rapid， and can be used for the determination of ibrutinib concentration in plasma samples.关键词：blood concentration;non-Hodgkin’s lymphoma;high performance liquid chromatography
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发布时间：2023-11-25 - 摘要：OBJECTIVETo mine and analyze severe cutaneous adverse reaction signals of 5 commonly used immune checkpoint inhibitors （ICIs）， and to provide reference for clinically safe use of drugs.METHODSBased on the FDA adverse events reporting system （FAERS） database，adverse drug events （ADEs） reports about severe cutaneous adverse reactions related to ipilimumab， nivolumab， pembrolizumab， atezolizumab and durvalumab were collected from listing in the United States to the fourth quarter of 2022. The ADE signals were mined and analyzed with reporting odds ratio （ROR） and Bayesian confidence propagation neural network （BCPNN）.RESULTSA total of 5 726 reports of severe cutaneous adverse reactions were collected， including 3 037 reports for nivolumab，1 465 reports for pembrolizumab， 130 reports for durvalumab， 429 reports for atezolizumab and 665 reports for ipilimumab. All 5 kinds of ICIs caused positive signals， the correlation degree of which was as follows： pembrolizumab＞atezolizumab＞nivolumab＞ipilimumab＞durvalumab. Stevens-Johnson syndrome（SJS）and toxic epidermal necrolysis （TEN） have been reported for all 5 ICIs， and the association was the strongest with pembrolizumab.CONCLUSIONSAll 5 kinds of ICIs are associated with the risk of severe skin adverse reactions， and close attention should be paid to their clinical use， especially being cautious when using pembrolizumab. The combination of ICIs should be avoided as much as possible.关键词：severe cutaneous adverse reactions;adverse drug reactions;signal detection
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发布时间：2023-11-25 - 摘要：OBJECTIVETo analyze the effects of tigecycline on coagulation function in patients with severe renal insufficiency， and to provide a reference for safe clinical drug use.METHODSRetrospective analysis was performed for the clinical data of patients with severe renal dysfunction complicated with infection receiving tigecycline admitted to nephrology department of our hospital from January 2021 to October 2022. The levels of prothrombin time （PT）， activated partial thromboplastin time （APTT）， international normalized ratio （INR）， platelet （PLT） and fibrinogen （FIB） were compared 3 days before medication， with 1-5， 6-10， 11-15 and 16-20 days after medication， 5 days after withdrawal and/or after symptomatic treatment.RESULTSFinally， 14 patients were included， and 9 patients developed coagulopathy， with an incidence of 64.29%. Compared with 3 days after medication， the levels of FIB at 6-10 and 11-15 days after medication， and PLT at 1-5 ， 6-10 and 11-15 days after medication were decreased significantly， while the levels of PT at 1-5 and 6-10 days after medication， APTT at 1-5， 6-10 and 11-15 days after medication were significantly prolonged， and INR increased significantly at 1-5 and 6-10 days after medication （P＜0.05）. Compared with 3 days before medication， there were no statistically significant changes in FIB， PT， INR， APTT and PLT at 16-20 days after medication and 5 days after withdrawal and/or symptomatic treatment（P＞0.05）.CONCLUSIONSPatients with severe renal insufficiency should be cautious with tigecycline， which can lead to prolonged PT and APTT， increased INR， and decreased PLT and FIB. If medication time is over 14 days， dynamic monitoring of coagulation function indicators is recommended to reduce the risk of adverse reactions.关键词：coagulopathy;renal insufficiency;adverse reaction
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发布时间：2023-11-25 - 摘要：OBJECTIVETo explore the risk signal of ixazomib and provide a reference for clinically rational drug use.METHODSThe Open Vigil 2.1 online tool was used to extract the data of adverse drug events （ADE） reported by the database of FDA adverse event reporting system （FAERS） from the launch of ixazomib in America （November 20th， 2015） to the latest update of the Open Vigil website （March 31st， 2023）. The data were mined by using the proportional reporting ratio （PRR） and Bayesian confidence propagation neural network （BCPNN） of the proportional imbalance method. The signals were coded by system organ class （SOC） and preferred term （PT） according to MedDRA v25.1.RESULTSA total of 13 841 ADE reports with ixazomib as the “primary subject” were extracted， involving slightly more male patients （49.53%）， and most of them were 65 years old and above （72.48%）； the reports came from 57 countries/regions， mainly America （52.90%）. A total of 186 positive signals were excavated， with 51 high-intensity， 99 medium-intensity， and 36 low-intensity signals， involving 19 SOCs. The top 50 PT in frequency and signal intensity of PRR included neuropathy peripheral （414 cases， high-intensity signal）， platelet count decreased （379 cases， high-intensity signal）， thrombocytopenia （360 cases， high-intensity signal）， cytopenia （75 cases， high-intensity signal） and neurological symptoms （41 cases， high-intensity signal）. SOC involved included nervous system disorders， investigations， and blood and lymphatic system disorders. ADE occurred most frequently in gastrointestinal diseases （2 588 cases）， including diarrhea （1 077 cases， high-intensity signal）， nausea （737 cases， medium-intensity signal）， vomiting （459 cases， medium-intensity signal）， constipation （275 cases， medium-intensity signal）， and so on. The positive signals of infections and infestations contained the largest number of PTs， and most of them were not recorded in the drug instruction， including 12 high-intensity signals （1 030 cases） and 30 medium-intensity signals （627 cases）， which were mainly distributed in lung infection， upper respiratory infection， gastrointestinal infection， sepsis， herpes zoster and so on. The signals of cardiac amyloidosis （7 cases， high-intensity signal） and acute coronary syndrome （14 cases， high-intensity signal） of cardiac disorders and renal dysfunction （91 cases， medium-intensity signal） of renal and urinary disorders were all strong and had not been recorded in the drug instruction.CONCLUSIONSIn addition to routine attention to the common ADE of ixazomib in gastrointestinal diseases， nervous system disorders and blood and lymphatic system disorders， clinical attention should also be paid to various infections that may occur during the treatment of patients， and the occurrence of cardiovascular toxicity and renal dysfunction should be monitored.关键词：adverse drug event;FDA adverse event reporting system;signal mining
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发布时间：2023-11-25 - 摘要：OBJECTIVETo explore the efficacy， safety and economics of a dual therapy consisting of conventional dose of vonoprazan combined with conventional dose of amoxicillin in patients with primary treatment of Helicobacter pylori （HP） infection.METHODSUsing a prospective cohort study， the patients diagnosed with HP infection and receiving initial treatment in Chengdu Xinhua Hospital from July 2021 to July 2022 were collected according to inclusion and exclusion criteria. The patients were given vonoprazan/amoxicillin dual therapy （i.e. VA group， Vonoprazan fumarate tablets 20 mg， once a day+Amoxicillin capsules 1.0 g， twice a day， 14 days） and bismuth-containing quadruple therapy （i.e. LJAF group， Rabeprazole sodium enteric-coated tablets 20 mg， twice a day+Colloidal bismuth pectin capsules 200 mg， twice a day+Amoxicillin capsules 1.0 g， twice a day+Furazolidone tablets 100 mg， twice a day， for 14 days） according to the patient’s medication willingness. Four weeks after the end of the treatment， HP eradication rates of the two groups were compared by using intention-to-treat （ITT）， modified intention-to-treat （MITT） and per-protocol （PP） analysis. The occurrence of adverse drug reactions （ADR） was recorded， and an economic evaluation was performed for them.RESULTSAmong the 58 patients in VA group， 55 completed the trial， 2 were lost to follow-up and one withdrew due to rash； among the 62 patients in LJAF group， 57 completed the trial， 3 were lost to follow-up and 2 withdrew due to rash. Results of ITT， MITT and PP analysis showed that HP eradication rates of VA group were 86.2%， 89.3% and 90.9%， and those of LJAF group were 87.1%， 91.5% and 94.7%， respectively； there was no statistical significance among different groups （P＞0.05）. The incidences of ADR in VA group and LJAF group were 6.9% and 14.5%， which were not significantly different （P＞0.05）. The result of cost minimization analysis showed that the treatment cost of VA group was 340.9 yuan， which was lower than 373.5 yuan of LJAF group.CONCLUSIONSIn patients with primary treatment of HP infection， the efficacy and safety of dual therapy of conventional dose of vonoprazan combined with conventional dose of amoxicillin is equivalent to the bismuth-containing quadruplex therapy with low cost.关键词：amoxicillin;Helicobacter pylori;bismuth-containing quadruple therapy;efficacy;safety;cost minimization analysis
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发布时间：2023-11-25 - 摘要：OBJECTIVETo evaluate the efficacy and safety of different drug regimens in the treatment of children with Kawasaki disease， and to provide evidence-based reference for clinical treatment.METHODSRetrieved from the Cochrane Library， Medline， Embase， CINAHL， Web of Science， ProQuest， Google Scholar， CNKI， Wanfang Data， Baidu academic database， World Health Organization International Clinical Trials Registration Platform and ClinicalTrials.gov， randomized controlled trials （RCTs） about intravenous immunoglobulin （IVIG）+glucocorticoid or cyclosporine or tumor necrosis factor-alpha （TNF-α） blocker （trial group） versus standard IVIG therapy （control group） were collected from the establishment of the database to Feb. 28th， 2023. After screening the literature， extracting data， and evaluating the quality of the literature， Stata 14.2 software was used for network meta-analysis.RESULTSTen RCTs with a total of 1 323 participants involving six measures were included： standard IVIG therapy， glucocorticoid therapy， cyclosporine therapy， TNF-α blocker therapy， remedial glucocorticoid therapy and remedial TNF-α blocker therapy. Results of network meta-analysis showed that the incidence of coronary artery aneurysms （CAA） at 4-8 weeks was significantly lower in patients receiving glucocorticoid therapy than receiving standard IVIG therapy and TNF-α blocker therapy. The incidences of CAA at 4-8 weeks in children treated with remedial glucocorticoid therapy and remedial TNF-α blocker therapy were significantly higher than those treated with glucocorticoid therapy； there was no significant difference in the incidence of CAA at 4-8 weeks among other interventions （P＞0.05）； network meta-order of the incidence was glucocorticoid therapy＜cyclosporine therapy＜standard IVIG therapy＜remedial TNF-α blocker therapy＜remedial glucocorticoid therapy＜TNF-α blocker therapy. The incidence of initial IVIG resistance in children receiving cyclosporine therapy was significantly lower than those receiving standard IVIG therapy； there was no significant difference in the incidence of initial IVIG resistance among other interventions （P＞0.05）； network meta-order of the incidence was cyclosporine therapy＜glucocorticoid therapy＜TNF-α blocker therapy＜standard IVIG therapy. There was no significant difference in the incidence of ADR among different interventions （P＞0.05）； network meta-order of the incidence was remedial TNF-α blocker therapy＜TNF-α blocker therapy＜standard IVIG therapy＜glucocorticoid therapy＜cyclosporine therapy.CONCLUSIONSGlucocorticoid therapy at the initial treatment can significantly reduce the risk of CAA at 4-8 weeks in children with Kawasaki disease； cyclosporine has a significant effect on improving initial IVIG resistance， and the use of TNF-α blocker in the remedial stage may have the lowest incidence of adverse reactions.关键词：intravenous immunoglobulin resistance;glucocorticoid;cyclosporine;tumor necrosis factor-alpha blocker;network meta-analysis
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发布时间：2023-11-25 - 摘要：OBJECTIVETo evaluate the efficacy and safety of four cyclin-dependent kinase 4/6 （CDK4/6） inhibitors （dalpicilib， abemacilib， ribocilib， palbocilib） combined with endocrine drugs in the treatment of hormone receptor-positive/human epidermal growth factor receptor 2-negative （HR+/HER2－） breast cancer.METHODSComputer searches were conducted on PubMed， the Cochrane Library， Web of Science， Embase， CNKI， Wanfang data and VIP to collect randomized controlled trials （RCTs） about CDK4/6 inhibitors combined with endocrine drugs （trial group） versus endocrine drugs alone or combined with placebo （control group）. The search period was from the establishment of the database to April 2023. After literature screening， data extraction and quality evaluation， a meta-analysis was conducted by using RevMan 5.4.1 software.RESULTSA total of 22 articles were included， involving 15 RCTs with a total of 18 574 patients. The meta-analysis results showed that the progression free survival [HR＝0.77， 95%CI （0.74， 0.79）， P＜0.000 1]， overall survival [HR＝0.91， 95%CI （0.87， 0.94）， P＜0.000 01]， objective response rate [OR＝1.71， 95%CI （1.51， 1.93）， P＜0.000 01] and clinical benefit rate [OR＝1.73， 95%CI （1.52， 1.95）， P＜0.000 01] of the trial group were significantly better than control group. The incidence of adverse drug reactions≥3 levels [OR＝10.28，95%CI （6.97，15.17），P＜0.000 01]， neutropenia [OR＝65.09， 95%CI （36.43， 116.31）， P＜0.000 01]， leukopenia [OR＝22.90， 95%CI （15.40， 34.04）， P＜0.000 01]， anemia [OR＝5.71， 95%CI （4.51， 7.22）， P＜0.000 01]， diarrhea [OR＝3.00， 95%CI （1.19， 7.51）， P＜0.05] and nausea [OR＝1.99， 95%CI （1.52， 2.60）， P＜0.000 01] in the trial group was significantly higher than control group.CONCLUSIONSThe combination of CDK4/6 inhibitors and endocrine drugs has a significant effect on HR+/HER2－ breast cancer， with a high incidence of adverse reactions， especially hematotoxicity.关键词：endocrine drugs;hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer;efficacy;safety
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发布时间：2023-11-25 - 摘要：OBJECTIVETo evaluate the incidence of nephrotoxicity in patients with drug-resistant Gram-negative bacterial infections after the use of polymyxin， and to provide evidence-based reference for clinical rational drug use.METHODSPubMed， Embase， Web of Science， the Cochrane Library， Wanfang database， CNKI， VIP and SinoMed were searched to collect randomized controlled trials （RCTs） or cohort studies about the polymyxin （trial group） versus other antibiotics （control group） or polymyxin B （trial group） versus polymyxin E （control group）. After literature screening， data extraction and quality evaluation， RevMan 5.4.1 software was used for meta-analysis.RESULTSA total of 37 studies were included， including 4 RCTs and 33 cohort studies， with a total of 5 871 patients. The meta-analysis results showed that in RCT [RR＝2.64，95%CI （1.43，4.87），P＝0.002] and in cohort studies [RR＝1.59， 95%CI （1.27， 1.98）， P＜0.000 1]， the incidence of nephrotoxicity in the trial group was significantly higher than control group. The results of the subgroup analysis of cohort studies showed that the incidence of nephrotoxicity in the trial group （receiving polymyxin） was significantly higher than control group （receiving new β-lactam and β-lactamase inhibitors and tigecycline）； when Kidney Disease Improving Global Outcomes （KDIGO）， renal replacement therapy or 0.5 times increase in serum creatinine were used as the standard of nephrotoxicity， the incidence of nephrotoxicity in the trial group was significantly higher than the control group （P＜0.05）. The incidence of nephrotoxicity in patients receiving polymyxin E was significantly higher than those using polymyxin B [RR＝0.57， 95%CI （0.39，0.84）， P＝0.005].CONCLUSIONSIn the treatment of drug-resistant Gram-negative bacteria infections， the incidence of nephrotoxicity caused by polymyxin is relatively high. The incidence of nephrotoxicity caused by polymyxin E is higher than polymyxin B.关键词：nephrotoxicity;drug-resistant Gram- negative bacteria;infection
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发布时间：2023-11-25 - 摘要：OBJECTIVETo review the efficacy and safety of cabozantinib in the treatment of advanced thyroid cancer.METHODSRetrieved from PubMed， the Cochrane Library， Embase， ClinicalTrials.gov， Wanfang data， VIP， CNKI and China Clinical Trials Registry， randomized controlled trials （RCTs） about cabozantinib （trial group） versus placebo （control group） were collected from the inception to Nov. 2022. After literature screening， data extraction and quality evaluation， meta-analysis was performed by using RevMan 5.4 software.RESULTSA total of 4 RCTs were included involving 588 patients. The results of the meta-analysis showed that the progression free survival （PFS） [HR＝0.24， 95%CI （0.19，0.31）， P＜0.000 01]， objective response rate （ORR） [RR＝31.46， 95%CI （6.32，156.75）， P＜0.000 1]， the incidence of grade 3-4 adverse event （AE） [RR＝2.15，95%CI （1.76，2.61），P＜0.000 01]， severe adverse event [RR＝1.78，95%CI （1.11，2.83），P＝0.02]， diarrhea [RR＝3.29，95%CI（1.62，6.66），P＝0.001]， palmar-plantar erythrodysesthesia syndrome [RR＝28.19，95%CI （12.25，64.88），P＜0.000 01]， and hypertension [RR＝6.50，95%CI （3.90，10.83），P＜0.000 01] in trial group were significantly higher than control group； there was no statistical significance in overall survival （OS） [HR＝0.83，95%CI （0.67，1.02）， P＝0.07] or the incidence of fatigue [RR＝1.25，95%CI （0.78，1.98），P＝0.35] between the two groups. Subgroup analysis showed that PFS and ORR in patients with differentiated thyroid carcinoma （DTC） and medullary thyroid carcinoma （MTC） in the trial group were significantly higher than control group （P＜0.05）. There was no significant difference in OS of DTC and MTC patients in the trial group compared with the control group （P＞0.05）.CONCLUSIONSCabozantinib can prolong PFS and increase ORR in patients with advanced thyroid cancer， but the incidence of AE is high.关键词：thyroid cancer;efficacy;safety;meta-analysis
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发布时间：2023-11-25 - 摘要：OBJECTIVETo analyze the characteristics of levofloxacin-induced hypersensitivity reaction.METHODSClinical pharmacists participated in the treatment for a case of levofloxacin-induced hypersensitivity reaction， and adjudged the relationship of levofloxacin with hypersensitivity reaction according to relative standards. Retrieved from CNKI， VIP， Wanfang database， PubMed and Embase， relevant literature about levofloxacin-induced hypersensitivity reaction was collected and analyzed.RESULTSClinical pharmacists suggested checking the patient’s previous medication and allergy history based on symptoms such as fever and systemic rash， and determined that the drug hypersensitivity was “likely” or “highly likely” to be associated with levofloxacin. Clinicians provided symptomatic treatment to the patient based on the judgment of clinical pharmacists， and the patient improved after treatment. Results of the literature analysis showed that among 31 involved patients， there were 23 males and 8 females； 18 patients aged 50 and above； the incubation period of 24 patients was within 4 days after medication. The main adverse drug reactions were drug hypersensitivity syndrome， fixed drug eruption， erythema multiforme， etc. Most patients were improved after withdrawal and symptomatic treatment.CONCLUSIONSHypersensitivity reaction is the rare adverse drug reaction of levofloxacin， mostly occurring within 2.5 h to 4 days after administration， and it is more likely to occur in middle-aged and elderly patients. Before clinical use， patients should be asked about their drug allergy history in detail； when patients experience fever or rash without obvious causes， medication should be stopped promptly and symptomatic treatment should be taken to ensure the safety and effectiveness of the patients’ medication.关键词：hypersensitivity reaction;pharmaceutical care;literature analysis
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发布时间：2023-11-25 - 摘要：OBJECTIVEUlcerative colitis （UC）， as a common and refractory disease of the digestive system， has always been a hot and difficult point in medical research. Traditional Chinese medicine has the advantages of good efficacy， high safety and not easy to relapse after drug withdrawal in the treatment of UC， but the mechanism has not been fully elucidated. Metabonomics looks for potential biomarkers and metabolic pathways from the point of view of the endogenous dynamic metabolism of the whole body， which is helpful to evaluate the efficacy of drugs and explore related mechanisms. Metabolomics studies on the treatment of UC with traditional Chinese medicine have shown that traditional Chinese medicine formulas， single herbs and herbs monomers act on various related pathways such as amino acid metabolism， lipid metabolism and energy metabolism by regulating endogenous metabolites in the body， thereby inhibiting immune inflammatory reactions， improving oxidative stress， reducing intestinal sensitivity， regulating intestinal microbiota， repairing intestinal mucosal damage， and restoring normal metabolic activity in the body. However， further screening and validation of relevant metabolic markers are needed.关键词：ulcerative colitis;metabonomics;metabolite;metabolic pathway
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发布时间：2023-11-25
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