最新刊期
卷 34 ， 期 12 ， 2023
- 摘要：OBJECTIVETo analyze the implementation experience of France’s additional list system for innovative medical products， and to provide reference for China to support medical institutions to use innovative medical products.METHODSTaking France as a case study， using policy analysis method， this paper systematically studied the practice of establishing additional list system to compensate for innovative medical products in France under diagnosis-related group （DRG） payment， including the establishment background， selection procedure and implementation effect. The suggestions were provided on the medical insurance payment methods for innovative medical products in China. RESULTS &CONCLUSIONSThe additional list system established a compensation and payment system for innovative medical products with significant clinical efficacy but high treatment cost， covering four stages： application， evaluation， payment and adjustment， which effectively reduced the drug burden on medical institutions， promoted the use of innovative pharmaceutical products by medical institutions， and stimulated the innovation drive of the pharmaceutical industry， but at the same time brought payment pressure to the medical insurance fund. With the rapid spread of our DRG/diagnosis-intervention packet payment reform of China， some regions have also explored the establishment of a compensation and payment mechanism for innovative medical products， but there are still imperfections. We can refer to the implementation experience of the French additional list system and establish an effective compensation and payment system for innovative medical products starting from the establishment of selection criteria， the selection of compensation mode and the implementation of dynamic adjustment.关键词：additional list system;innovative pharmaceutical products;medical insurance payment policy;France
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发布时间：2023-06-26 - 摘要：OBJECTIVETo study the effects of the active component 17-hydroxy-jolkinolide B （HJB） of Euphorbia fischeriana on the proliferation and apoptosis of human triple-negative breast cancers （TNBC） MDA-MB-231 and MDA-MB-468 cells.METHODSMTT assay was adopted to detect the inhibitory rate of MDA-MB-231 and MDA-MB-468 cells proliferation after treated with 0 （blank control），5，10，20，40，80 μmol/L HJB for 24， 48 and 72 h. Laser confocal microscope and flow cytometry were adopted to detect the apoptosis， mitochondrial membrane potential（MMP） and reactive oxygen species （ROS） of above 2 kinds of cells after treated with 0 （blank control）， 10，20，40 μmol/L HJB for 24 h. Western blot assay was used to detect the expressions of B cell lymphoma-2 （Bcl-2）， Bcl-2-associated X protein （Bax）， cytochrome-C （Cyt-C）， caspase-3， cleaved caspase-3， caspase-9 and cleaved caspase-9.RESULTSCompared with blank control group， 5，10，20，40，80 μmol/L HJB could significantly increase the inhibitory rate of MDA-MB-231 and MDA-MB-468 cells proliferation （P＜0.05）， in dose- and time-dependent trend. After 24 h treatment of HJB （10，20，40 μmol/L）， the apoptosis of above 2 kinds of cells increased， and the total apoptotic rate increased significantly （P＜0.05）； the mitochondrial membrane potential decreased significantly （P＜0.05）； the level of ROS increased significantly （P＜0.05）； the protein expressions of Bcl-2， caspase-3 and caspase-9 were decreased significantly （P＜0.05）， while the protein expressions of Cyt-C， Bax， cleaved caspase-3 and cleaved caspase-9 were increased significantly （P＜0.05）.CONCLUSIONSHJB can inhibit the proliferation of MDA-MB-231 and MDA-MB-468 cells， and induce their apoptosis.关键词：triple-negative beast cancer;apoptosis;mitochondrial membrane potential;reactive oxygen species
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发布时间：2023-06-26 - 摘要：OBJECTIVETo screen the differential components of coumarins in Angelica dahurica from two origins （A. dahurica cv. ‘Hangbaizhi’； A. dahurica cv. ‘Qibaizhi’）.METHODSNon-targeted metabolomics technique of UPLC-Q-Exactive-MS/MS was used to analyze the coumarins in 6 batches of A. dahurica cv. ‘Hangbaizhi’ and 12 batches of A. dahurica cv. ‘Qibaizhi’. The differential components were screened by principal component analysis， partial least squares discriminant analysis and orthogonal partial least squares discriminant analysis. Cluster analysis was performed on differential components.RESULTSA total of 41 coumarins were identified in 18 batches of samples， in which 23 coumarins were differential components. Therein， 6 differential components were higher in content in A. dahurica cv. ‘Hangbaizhi’， while 17 differential components were higher in content in A. dahurica cv. ‘Qibaizhi’. The content of marmesin galactoside in A. dahurica cv. ‘Hangbaizhi’ was significantly higher than that in A. dahurica cv. ‘Qibaizhi’. Based on 23 differential components， A. dahurica cv. ‘Hangbaizhi’ and A. dahurica cv. ‘Qibaizhi’ could be grouped into one category， respectively.CONCLUSIONSThe screened differential components of coumarins can be used to distinguish A. dahurica cv. ‘Hangbaizhi’ from A. dahurica cv. ‘Qibaizhi’， especially marmesin galactoside contributed the most， which can be used to identify A. dahurica cv. ‘Hangbaizhi’ and A. dahurica cv. ‘Qibaizhi’.关键词：Non-targeted metabolomics technique;multivariate statistical analysis;coumarin;origin identification
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发布时间：2023-06-26 - 摘要：OBJECTIVETo study the immunomodulatory effect of Guipi pills on D-galactose（D-gal）-induced aging mice.METHODSThe immune-related targets and related pathways for Guipi pills to exert immune effects were screened by network pharmacology and verified through pharmacodynamic experiments. Totally 105 male ICR mice were randomly divided into blank control （CON） group， model control （MOD） group， positive control （POS） group， Guipi pills low-dose （GD） group and Guipi pills high-dose （GG） group. Except for the CON group， other groups were subcutaneously injected with 400 mg/kg D-gal to induce the aging model； CON group and MOD group were given distilled water， POS group was given 300 mg/kg pidotimod oral solution intragastrically， GD group and GG group were given Guipi pills 300， 600 mg/kg intragastrically， once a day， for 8 weeks. After medication， the serum and spleen were collected， and the contents of interleukin 2 （IL-2）， IL-4， IL-6 and tumor necrosis factor α （TNF-α）， and the contents of immunoglobulin G （IgG）， IgM and IgA were detected. The spleen index was calculated and the histopathological changes in the spleen were observed. The activities of superoxide dismutase （SOD）， glutathione peroxidase （GSH-Px） and malondialdehyde （MDA）， and the content of 8-hydroxy-2 deoxyguanosine （8-OHdG） in spleen were detected； the expression of TNF/phosphoinositide-3-kinase-threonine protein kinase （PI3k-Akt）-related proteins in spleen was detected except for POS group.RESULTSThe results of network pharmacology showed that TNF， IL-6 and Akt1 were core targets. The results of pharmacodynamic study showed that compared with MOD group， the contents of IL-2， IL-4， IgG， IgM and IgA were increased significantly in Guipi pills groups， while the contents of TNF-α and IL-6 were decreased significantly； the spleen index was increased significantly （P＜0.05 or P＜0.01）. The phenomenon of diffuse proliferation of lymphocytes was improved， the spleen cells were closely arranged， and the line between the white pulp and red pulp was clear. The activities of SOD and GSH-Px in spleen were increased significantly， while the activity of MDA， the content of 8-OHdG， and the protein expressions of TNF-α， PI3K and p-Akt were decreased significantly （P＜0.05 or P＜0.01）.CONCLUSIONSGuipi pills can regulate the immune function of D-gal-induced aging mice， which is related to regulating the TNF/PI3k-Akt pathway， thereby reducing oxidative stress damage in spleen tissue of mice， and regulating protein expressions of TNF-α， PI3K and p-Akt.关键词：immuno-modulatory;network phar-macology;pharmacodynamics;tumor necrosis factor;phosphoinositide-3-kinase;threonine protein kinase
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发布时间：2023-06-26 - 摘要：OBJECTIVETo explore the protective effect and possible mechanism of baicalein on hypoxia-induced cortical neuron injury in rats.METHODSThe cortical neurons of rats （RN-C cells） were studied and cultured under hypoxic conditions （5%CO2， 94% N2， 1%O2） for 24 hours； the effects of different concentrations of baicalein （0.01， 0.1， 1， 10， 100 μmol/L） on the survival rate of hypoxic RN-C cells were investigated； the effects of baicalein （0.1 μmol/L） on the activities of lactate dehydrogenase （LDH） and superoxide dismutase （SOD）， the content of malondialdehyde （MDA）， migration rate， apoptotic rate， cell cycle and the expressions of cleaved caspase-3， B-cell lymphoma-2 （Bcl-2） and Bcl-2 X protein （Bax） were all detected.RESULTSCompared with control group， the survival rate of cells in the hypoxia group was significantly reduced （P＜0.01）； 0.01， 0.1 and 1 μmol/L baicalein could reverse survival rate of hypoxia-induced cortical neurons （P＜0.05 or P＜0.01）. Scratch experiments showed that baicalein significantly increased the migration rate of hypoxic RN-C cells （P＜0.01）. Compared with control group， the activity of LDH in the supernatant and the content of MDA in the cells， apoptotic rate and the proportion of cells in G1 phase， were significantly increased in the hypoxia group， while SOD activity and the proportion of cells in G2+S phase was decreased significantly （P＜0.01）. The protein expressions of cleaved caspase-3 were increased significantly， while the ratio of Bcl-2/Bax in cells was significantly reduced （P＜0.05 or P＜0.01）. Compared with hypoxia group， the above indexes were all reversed significantly in baicalein group （P＜0.01）.CONCLUSIONSBaicalein can promote the proliferation and migration of cortical neurons， improve hypoxia-induced cell apoptosis and cell cycle distribution， decrease the activity of LDH in supernatant and the level of cellular lipid peroxidation， and improve antioxidant levels. Its mechanism may be related to regulating the caspase-3/Bax/Bcl-2 pathway.关键词：cortical neuron of rats;hypoxia;neuroprotection;caspase-3/Bax/Bcl-2
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发布时间：2023-06-26 - 摘要：OBJECTIVETo explore the antitumor effect and mechanism of total alkaloids of Gelsemium elegans （TA） and sempervirine （SPV） in vitro.METHODSThe effects of low， medium and high concentrations of TA （50， 100， 200 μg/mL） and SPV （10， 30， 50 μmol/L） on the morphology of human hepatoma cells （HepG2， Bel-7402）， human lung cancer cells （A549） and human colon cancer cells （HCT-8） were observed， and the toxicity of TA and SPV to four tumor cells was monitored. The effects of TA and SPV on the contents of caspase-3 and caspase-9 in the supernatant of HCT-8 cells， the protein expressions of phosphorylated protein kinase B （p-Akt） （Thr308， Ser473）， B-cell lymphoma 2 （Bcl-2）， Bcl-2-related X protein （Bax）， survivin， C/EBP-homologous protein （CHOP）， immunoglobulin binding protein （Bip） and microtubule-associated protein 1 light chain 3Ⅱ （LC3Ⅱ） in HCT-8 cells were detected.RESULTSAfter the intervention of TA and SPV， the volume reduction and nuclear shrinkage were founded in four tumor cells； the cell activity decreased to varying degrees， among which TA and SPV had the best inhibitory effect on HCT-8 cells. After the intervention of TA and SPV， the contents of caspase-3 and caspase-9 in the supernatant of HCT-8 cells， the protein expressions of Bax， CHOP， Bip and LC3Ⅱ all increased to different degrees， while the protein expressions of p-Akt （Thr308， Ser473）， Bcl-2 and survivin in HCT-8 cells all decreased to different degrees.CONCLUSIONSTA and SPV have inhibitory effects on the above four tumor cells， and the inhibitory effect on HCT-8 cells is the best. The mechanism of their action on HCT-8 cells may be related to promoting apoptosis， activating endoplasmic reticulum stress and autophagy.关键词：sempervirine;antitumor;apoptosis;endoplasmic reticulum stress;autophagy
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发布时间：2023-06-26 - 摘要：OBJECTIVETo study the content changes of 5 chemical compositions in water extract and ethanol precipitate of different processed products of Psoralea corylifolia， and to preliminarily evaluate its hepatotoxicity.METHODSThe water extracts from crude product of P. corylifolia and processed products by Leigong method， running water rinsing method， and salt stir-frying method were prepared， as well as the ethanol precipitates of processed products by Leigong method and salt stir-frying method were prepared. The contents of psoralenoside， isopsoralenoside， psoralen， isopsoralen and bakuchiol were determined by high-performance liquid chromatography and compared. The median lethal concentration （LC50） and maximum non-lethal concentration （MNLC） of each sample to wild-type zebrafish juveniles were calculated after 72 h of treatment with different concentrations of water extracts from raw product and processed products by running water rinsing method， Leigong method and salt stir-frying method， different concentrations of ethanol precipitates from processed products by Leigong method and salt stir-frying method， and the acetaminophen was used as the positive control. The basic morphology of wild-type zebrafish juveniles and the liver phenotype of transgenic zebrafish juveniles were observed after 72 h of treatment with the above samples （MNLC）. Pearson correlation analysis was used to evaluate the correlation between component content and hepatotoxicity.RESULTSCompared with the water extract of raw products， the contents of psoralenoside and isopsoralenoside in the water extract of different processed products were generally decreased （P＜0.05）， while the contents of psoralen， isopsoralen and bakuchiol in the ethanol precipitate of Leigong method and salt stir-frying products were significantly increased （P＜0.05）. The LC50 of water extracts of crude product and processed products by running water rinsing method， Leigong method， salt stir-frying method， and ethanol precipitates of processed products by Leigong method and salt stir-frying method were 2.45， 5.00， 5.38， 1.55， 2.36， 0.64 g/L （calculated by crude drug）， and MNLC were 2.21， 4.53， 5.02， 1.37， 2.13， 0.53 g/L （calculated by crude drug）. Compared with the blank control group， the zebrafish juveniles in each sample treatment group showed different degrees of deformity， the liver relative fluorescence intensity was significantly weakened （P＜0.05 or P＜0.01）. Fat-soluble components such as bakuchiol， isopsoralen and psoralen were highly correlated with liver fluorescence intensity （R 2＞0.7）.CONCLUSIONSThe processed products of P. corylifolia mainly compose of psoralenoside and isopsoralenoside after water extraction， the contents of psoralen， isopsoralen and bakuchiol increase after alcohol precipitation， and the hepatotoxicity is positively correlated with the contents of liposoluble compositions in P. corylifolia.关键词：processed products;water extract;ethanol precipitate;hepatotoxicity;component content
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发布时间：2023-06-26 - 摘要：OBJECTIVETo provide reference for the clinical application and further research and development of Shenling baizhu powder.METHODSUsing the methods of textual research and bibliometrics， the key information such as the composition， dose， processing and usage of Shenling baizhu powder in ancient and modern literature were systematically summarized and sorted out， and the number of publications， keywords， and other contents of modern literature were visually analyzed. RESULTS &CONCLUSIONSShenling baizhu powder was first collected in Taiping Huimin Hejiju Fang （abbreviated “Jufang”）， the composition of core drugs and most widely used dose ratio in previous generations were the same as those in Jufang， basically focusing on powder making and being taken after mixed with liquid； the dosage was concentrated on 2-3 qian； the function and application of it had been expanded to a certain extent compared with Jufang； its clinical application had gradually extended from internal medicine to surgery， gynecology， pediatrics， ophthalmology， dermatology， etc.， covering all aspects of the disease caused by spleen deficiency in general； the composition mechanism revolved around “strengthening the spleen， replenishing qi and removing dampness”； the recommended prescription drugs were all selected from the corresponding varieties in the pharmacopoeia. Modern research mainly focuses on clinical practice， with traditional Chinese medicine or traditional Chinese and Western medicine combined with this formula as the main modified treatment for various intestinal diseases， diarrhea diseases， and lung diseases. The efficacy and application are the frontier hot spots today， and the mechanism of action has begun to be explored. The usage in the literature and the inclusion in the pharmacopoeia are inconsistent， and further research is needed.关键词：strengthening the spleen;replenishing qi;removing dampness;medical registration and prescription;ulcerative colitis;textual research
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发布时间：2023-06-26 - 摘要：OBJECTIVETo investigate the effects of matrine （MT） on steatosis Chang Liver cell model induced by oleic acid （OA） and its possible mechanism.METHODSChang Liver cells were divided into blank group， model group and MT low-dose， medium-dose group and high-dose groups （0.1， 0.5， 1.0 mmol/L）. Except for blank group， the other groups were treated with 1.0 mmol/L OA for 24 h to establish steatosis model， and MT groups were given corresponding concentrations of drugs for 24 h. The activities of steatosis Chang Liver cells were observed； the morphologies of intracellular lipid droplets were observed and lipid content was also determined. The contents of liver function indexes [alanine transaminase （ALT）， aspartate transaminase （AST）， total bilirubin （TBIL）， alkaline phosphatase （ALP）]， as well as mRNA and protein expressions of farnesoid X receptor （FXR）， cytochrome P450 7A1 （CYP7A1） and fibroblast growth factor 19 （FGF19） were all detected.RESULTSOA and MT had no significant effect on the activity of Chang Liver cells. After OA treatment， orange lipid droplets formed in cytoplasm； compared with blank group， relative lipid content and the levels of liver function indexes were increased significantly， while the mRNA and protein expressions of FXR， CYP7A1 and FGF19 were down-regulated significantly （P＜0.05）. After treatment of low， medium and high concentrations of MT， above indexes were all reversed significantly （P＜0.05）.CONCLUSIONSMT could significantly improve the lipid content and liver function indexes of steatosis Chang Liver cells induced by OA though regulating FXR/CYP7A1/FGF19 signaling pathway.关键词：Chang Liver cells;lipid metabolism;nonalcoholic fatty liver disease
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发布时间：2023-06-26 - 摘要：OBJECTIVETo study the mechanism of interfering with long non-coding RNA nicotinamide nucleotide transhydrogenase-antisense RNA1 （LncRNA NNT-AS1） expressing to reduce paclitaxel （TAX） resistance in non-small cell lung cancer （NSCLC） cells.METHODSNSCLC TAX-resistant cell line （A549/TAX） was constructed， and the expressions of LncRNA NNT-AS1 in normal， parental， and drug-resistant cells were observed. The targeting relationship of microRNA-582-5p （miR-582-5p） with LncRNA NNT-AS1 and high mobility group box2 （HMGB2） was verified. A549/TAX cells were cultured in vitro to observe the effects of interfering with LncRNA NNT-AS1 alone or interfering with LncRNA NNT-AS1 and miR-582-5p on the expressions of LncRNA NNT-AS1 and miR-582-5p， the mRNA and protein expressions of HMGB2， cell viability， clone formation and apoptosis. The effects of interfering with LncRNA NNT-AS1 on tumor growth and the expression of miR-582-5p and the mRNA and protein expressions of HMGB2 in tumor tissue were observed in nude mice.RESULTSCompared with normal cells， LncRNA NNT-AS1 was highly expressed in parental and drug-resistant cells （P＜0.05）， showing an increasing trend. It was validated that miR-582-5p had a targeting relationship with LncRNA NNT-AS1 and HMGB2. After interfering with the expression of LncRNA NNT-AS1， the expression of LncRNA NNT-AS1 and the mRNA and protein expressions of HMGB2， cell viability and the number of cloned cells in A549/TAX cell， decreased significantly， while the expression of miR-582-5p and the apoptotic rate increased significantly （P＜0.05）； simultaneously interfering with the expression of miR-582-5p could reverse above changes （P＜0.05）. Interfering with the expression of LncRNA NNT-AS1 in tumor cell could significantly reduce tumor volume and tumor weight of nude mice bearing tumors； at the same time， the expression of miR-582-5p was up-regulated significantly and the mRNA and protein expressions of HMGB2 were down-regulated significantly （P＜0.05）.CONCLUSIONSInterfering with the expression of LncRNA NNT-AS1 may alleviate TAX chemotherapy resistance in NSCLC through targeted up-regulation of miR-582-5p and down-regulation of HMGB2.关键词：mRNA-582-5p;high mobility group box 2;chemotherapy resistance;paclitaxel;non-small cell lung cancer
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发布时间：2023-06-26 - 摘要：OBJECTIVETo study the correlation of novel organic cation transporter 2 （OCTN2） with the chemosensitivity of prostate cancer cells to oxaliplatin.METHODSTumor samples of patients receiving radical prostatectomy were collected， and OCTN2 protein was detected with immunohistochemistry； the primary cells of the specimen were cultivated to obtain prostate cancer cell line. Inductively coupled plasma mass spectrometry was used to detect the uptake of low concentration （0.1 μmol/L） of oxaliplatin by cancer cells. Real-time PCR and Western blot were used to detect the mRNA and protein expressions of OCTN2 in cancer cells； the prostate cancer cells with the highest and lowest expression of OCTN2 protein were selected， and IC50 of oxaliplatin to prostate cancer cells was analyzed by ATP-TCA method. The inhibitory rate of plasma peak concentration of oxaliplatin （50 μmol/L） to prostate cancer cells was detected by MTT assay. Spearman method was used to analyze the relationship of the uptake of oxaliplatin by prostate cancer cells with inhibitory rate of oxaliplatin to prostate cancer cells and mRNA expressions of OCTN2.RESULTSOCTN2 was located on the membrane of cancer cells， and the uptake of oxaliplatin by cancer cells was 0.283±0.264 （n＝12）. The mRNA and protein expression of OCTN2 varied significantly among different cancer cells. The sensitivity of cancer cells with high expression of OCTN2 to oxaliplatin （IC50 of 4.61 μmol/L） was higher than that of cancer cells with lower expression of OCTN2 （IC50 of 26.23 μmol/L）. The inhibitory rate of oxaliplatin to cancer cells was （25.4±10.8）% （n＝12）. There was a correlation between the uptake of oxaliplatin by prostate cancer cells and the inhibition rate of oxaliplatin to prostate cancer cells and mRNA expression of OCTN2 （P＜0.05）.CONCLUSIONSHigh-expressed OCTN2 may promote the uptake of oxaliplatin by prostate cancer cells， and its expression can serve as a reference for predicting the sensitivity of prostate cancer cells to oxaliplatin chemotherapy.关键词：oxaliplatin;prostate cancer cell;chemosensitivity
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发布时间：2023-06-26 - 摘要：OBJECTIVETo study the cost-utility threshold （WTP/Q） based on the preference of the population in Liaoning province with willingness-to-pay（WTP） survey method， and to provide reference for decision-making.METHODSUsing the method of questionnaire survey， quota sampling combined with snowball sampling were used to conduct telephone interviews with the general population in Liaoning province， collect data and analyze it. Probit regression combined with generalized linear model was used to analyze the relevant factors affecting WTP/Q.RESULTSA total of 755 general people were recruited. The WTP/Q of Liaoning population was 119 175 yuan，the average WTP/Q for improving the quality of life was 84 902 yuan， and the average WTP/Q for extending the survival period was 188 005 yuan. The analysis of influential factors showed that the older the age， the lower the probability of people purchasing medical interventions； the higher the education level and income， the greater the WTP/Q； at the same time， the physical feelings of the interviewee， such as pain and depression， could also affect the WTP/Q results； compared with the scenario of improving quality of life， the WTP/Q for the extended survival period was higher.CONCLUSIONSThe WTP/Q of Liaoning province based on the WTP survey method is about 2.07 times of the per capita gross domestic product of Liaoning province in the same period. The WTP/Q for extending survival period is about 2.21 times that of improving the quality of life. Therefore， interventions to improve quality of life and to extend the survival period need to be treated differently， in measurement or decision-making.关键词：cost-utility threshold;willingness-to-pay method;Liaoning province
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发布时间：2023-06-26 - 摘要：OBJECTIVETo evaluate the efficacy， safety and cost-effectiveness of polyisobutylene （PIB）-type Gutong plaster （called “PIB Gutong plaster” for short） versus non-steroidal anti-inflammatory drugs （NSAIDs） in the treatment of osteoarthritis in Chinese adults.METHODSBased on a real-world study， after propensity score matching， the decrease in pain visual simulation score， utility increase， time to pain resolution， time to return to normal range of motion and total adverse events of PIB Gutong plaster versus three NSAIDs （celecoxib， diclofenac sodium， and ibuprofen） were evaluated. Cost-utility analysis was used to calculate the incremental cost-effectiveness ratio （ICER） of patients using PIB Gutong plaster versus the three NSAIDs from the perspective of the whole society， and sensitivity analysis was carried out.RESULTSIn terms of effectiveness， the recovery time of joint activity in PIB Gutong plaster group was significantly longer than that in celecoxib group， the decrease in VAS score of PIB Gutong plaster was significantly higher than that of ibuprofen but significantly lower than that of diclofenac sodium； the time of pain disappearance was longer than that in diclofenac sodium group and ibuprofen group， and the increase in health utility was significantly lower than that in diclofenac sodium group （P＜0.05）. In terms of safety， there were no significant differences in the incidence and severity of adverse events of PIB Gutong plaster， compared with the three NSAIDs， without statistical significance （P＜0.05）. In terms of cost-effectiveness， compared with celecoxib and diclofenac sodium， PIB Gutong plaster was dominant. Compared with ibuprofen， the ICER value of PIB Gutong plaster was 178 611.58 yuan/QALY， indicating that at the current price， PIB Gutong plaster was cost-effective if the threshold was 3 times GDP per capita. The results of sensitivity analysis were consistent with those of basic analysis.CONCLUSIONSThe efficacy of PIB Gutong plaster was better than that of ibuprofen， similar to that of celecoxib， but worse than that of diclofenac sodium， the safety was consistent with the three NSAIDs， and the cost-effectiveness of PIB Gutong plaster needs to be improved.关键词：non-steroidal anti-inflamma-tory drugs;efficacy;safety;cost-utility;real world
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发布时间：2023-06-26 - 摘要：OBJECTIVETo analyze the clinical characteristics of liraglutide-induced pancreatitis， and to provide reference for clinical rational drug use.METHODSRetrieved from CNKI， VIP， Wanfang database， PubMed， Web of Science and Medline， case reports about liraglutide-induced pancreatitis were collected from the inception to December 31st， 2022. Demographic characteristics， drug use， clinical manifestations， intervention and outcome were analyzed using descriptive statistical method.RESULTSA total of 17 pieces of literature were collected and 17 patients were involved， including 7 males and 10 females. The patients aged from 25 to 75 years. All 17 patients had drug indications， including 14 cases of type 2 diabetes mellitus， 3 cases of obesity or overweight. Among 17 patients， liraglutide was used alone in 5 cases， and combined with other drugs in 12 cases. Time from liraglutide administration to pancreatitis occurrence ranged from 1 day to 11 months after medication in 17 patients， with 14 cases less than 6 months. The clinical manifestations mainly included abdominal pain， nausea and vomiting， etc. After the diagnosis of pancreatitis， liraglutide discontinuation occurred in 16 patients； 1 case did not receive any other interventions and the other 15 cases were managed with symptomatic supportive treatment； the symptoms of all 16 patients resolved； however， 2 patients suffered from second episode of severe pancreatitis several weeks after liraglutide discontinuation， pancreatitis recurred after liraglutide rechallenge in 1 case. The results of correlation evaluation showed that 1 case was “positive”， 4 cases were “possible”， and the remaining patients were “very likely”.CONCLUSIONSLiraglutide-induced pancreatitis mainly occurred within 6 months after drug administration. The majority of liraglutide-induced pancreatitis cases are mild to moderate， but there are also severe and even fatal cases. It is advisable to periodically monitor the level of pancreatic enzymes and closely observe patients’ clinical mani-festations. In case of suspected liraglutide-induced pancreatitis， drug withdrawal and symptomatic treatment should be taken immediately.关键词：pancreatitis;type 2 diabetes mellitus;glucagon-like peptide-1 receptor agonist;literature case analysis
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发布时间：2023-06-26 - 摘要：OBJECTIVETo explore the clinical efficacy and safety of Ruyi jinhuang powder for external application combined with immune checkpoint inhibitors （ICIs） in the treatment of patients with advanced liver cancer complicated with dampness and heat syndrome of liver and gallbladder.METHODSAll patients with advanced liver cancer complicated with dampness and heat syndrome of liver and gallbladder were admitted to our hospital from January 2018 to June 2022 and assigned into observation group and control group according to random number table method. Patients in the control group （n＝56） were treated with ICIs （Navulizumab injection/Sintilimab injection/Camrelizumab for injection） 200 mg， ivgtt， 21 days as a treatment cycle. Patients in the observation group （n＝56） were additionally treated with Ruyi jinhuang powder for external application， once a day， on the basis of control group. The therapeutic effects of 2 groups were compared after a treatment cycle. The levels of interleukin-6 （IL-6）， matrix metalloproteinase-9 （MMP-9）， cyclooxygenase-2 （COX-2）， prostaglandin E2 （PGE2）， carbohydrate antigen 199 （CA199）， alpha-fetoprotein （AFP） and vascular endothelial growth factor （VEGF） in serum were compared between 2 groups before and after treatment. Karnofsky functional status （KPS） score， digital rating scale （NRS） score， total symptom score of traditional Chinese medicine， and the occurrence of adverse reactions were recorded for both groups of patients.RESULTSAfter treatment， the levels of IL-6， MMP-9， COX-2， PGE2， CA199， AFP， VEGF， NRS score and total symptom score of traditional Chinese medicine in observation group were significantly lower than control group （P＜0.05）， KPS score was significantly higher than the control group （P＜0.05）. The total effective rate and remission rate of the observation group were 64.29% and 80.36%， those of control group were 60.71% and 73.21%. There was no statistical significance between two groups （P＞0.05）. The adverse drug reactions of both groups were mainly nausea and vomiting， liver function injury， fever and so on； the incidence of adverse reaction in observation group was significantly lower than that of control group （P＜0.05）.CONCLUSIONSIn patients with advanced liver cancer complicated with dampness and heat syndrome of liver and gallbladder， the combination of Ruyi jinhuang powder for external application and ICIs can help inhibit the secretion of pain mediators， regulate vascular endothelial function， reduce the inflammatory response， promote the recovery of cardiopulmonary function， improve clinical efficacy and has good safety.关键词：immune checkpoint inhibitors;advanced liver cancer;dampness and heat syndrome of liver and gallbladder
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发布时间：2023-06-26 - 摘要：OBJECTIVETo mine the adverse drug reaction （ADR） signals of melphalan， so as to provide reference for clinically safe drug use.METHODSUsing OpenVigil 2.1 data platform， relative ADR reports of melphalan from the first quarter of 2004 to the second quarter of 2022 in FAERS database were collected； data mining was conducted using the reported odds ratio （ROR） method and Medicines and Healthcare Products Regulatory Agency （MHRA） method of disproportional method. ADR reports were described and classified according to the system organ class （SOC） and preferred term （PT） in Medical Dictionary for Regulatory Activities （24.0 edition）.RESULTSA total of 17 046 ADR reports related to the target drug melphalan were retrieved， and the number of ADR reports showed a fluctuating upward trend； the majority of patients were male （43.28%）， and were concentrated between the ages of 50-＜75 （35.09%）， with the main reporting country being the United States （23.97%）； ADR report involved a total of 22 842 severe outcomes， mainly including hospitalization or extended hospitalization （24.45%）. Totally 403 ADR signals were detected， involving 23 SOC， mainly including blood and lymphatic system diseases （801 cases， 13.77%）， followed by eye organ diseases （755 cases， 12.97%） and infectious and invasive diseases （716 cases， 12.30%）. The ADR signals ranked high in the number of reported cases included febrile neutropenia， diarrhea， fever and mucositis and other PT； PT such as pneumonia， sepsis， vitreous hemorrhage， chorioretinal atrophy， myelodysplastic syndrome were not recorded in drug instructions. The ADR signals with high signal strength ranking included choroidal dystrophy， chorioretinal atrophy， eyeball atrophy and other PT， and above three types of PT were not included in the drug instructions.CONCLUSIONSADRs caused by melphalan mainly include blood and lymphatic system diseases， eye organ diseases， and infectious and invasive diseases； before using melphalan， it is necessary to evaluate the drug use of patients， and pay close attention to the patient’s blood indicators and eye toxicity reaction， so as to guarantee the safety of treatment.关键词：FAERS database;adverse drug reactions;data mining;disproportional method
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发布时间：2023-06-26 - 摘要：OBJECTIVETo evaluate the bioequivalence of a single oral administration of two palbociclib preparations in healthy subjects under fasting and fed conditions.METHODSTwenty-four healthy subjects （fasting test） and twenty healthy subjects （fed test） were enrolled and divided into two groups. A single-center， open-label， single-dose， two-formulation， two-period， two-sequence and crossover trial was designed. The subjects in the two groups were given the test preparation （domestic Palbociclib capsules） or the reference preparation （original Palbociclib capsules） orally under fasting or fed conditions respectively followed by a 14-day washout period. The blood samples were collected at different time points before and after treatment. After pretreatment， the mass concentration of palbociclib in vivo was determined by high-performance liquid chromatography-tandem mass spectrometry with palbociclib-d8 as the internal standard. SAS V9.4 software was used to calculate the pharmacokinetic parameters and evaluate the bioequivalence.RESULTSUnder fasting condition， the cmax of the test preparation and the reference preparation were （71.4±18.1） and （73.8±19.0） ng/mL； AUC0－t were （1 754±412） and （1 793±448） h·ng/mL； AUC0－∞ were （1 851±456） and （1 887±478） h·ng/mL， respectively. Under fed condition， the cmax of the test preparation and the reference preparation were （78.4±18.3） and （81.9±21.7） ng/mL； AUC0－t were （1 905±375） and （1 932±318） h·ng/mL； AUC0－∞ were （2 027±411） and （2 050±342） h·ng/mL， respectively. The 90%CI of the geometric mean ratio of the above parameters was within the acceptable range （80.00%-125.00%）. Under fasting and fed conditions， there were 20 and 16 adverse events in 9 and 8 subjects， respectively， but no serious adverse event was observed.CONCLUSIONSUnder the fasting and fed conditions， the test preparation and the reference preparation of Pibociclib capsules are bioequivalent and have comparable safety.关键词：bioequivalence;safety;administration time
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发布时间：2023-06-26 - 摘要：OBJECTIVETo evaluate the efficacy， safety and cost-effectiveness of semaglutide in the treatment of type 2 diabetes mellitus （T2DM）， and to provide reference for clinical drug use.METHODSRapid health technology assessment was adopted. Retrieved from PubMed， Embase， Cochrane Library， Web of Science， CNKI， Wanfang database， CBM， domestic and foreign HTA official websites， HTA reports， systematic evaluation/meta-analysis and pharmacoeconomic studies about semaglutide in the treatment of T2DM were collected during the inception to May 1st， 2022. After data extraction and quality evaluation， descriptive analysis was performed on the results of included studies.RESULTSA total of 22 pieces of literature were included， involving 7 meta-analyses and 15 pharmacoeconomic studies. In terms of efficacy and safety， semaglutide showed significant advantages in controlling glycated hemoglobin （HbA1c）， fasting blood glucose， postprandial mean glucose， body mass index and achieving a target of glycosylated hemoglobin level ＜7%； also， there was no increased risk of hypoglycaemia or the incidence of serious adverse effects， but the risk of gastrointestinal adverse effects was significantly higher than other interventions. In terms of cost-effectiveness， results of foreign studies showed that semaglutide was more cost-effective， compared with other glucagon-like peptide-1 receptor agonists， sodium-glucose transporter protein 2 inhibitors， dipeptidyl peptidase-4 inhibitors. Research based on the perspective of China’s health system showed that semaglutide had a clear cost-effectiveness advantage over dulaglutide when using GDP per capita in 2020 （72 477 yuan） as the payment threshold.CONCLUSIONSThe semaglutide has excellent efficacy and good safety for the treatment of T2DM， with cost-effectiveness advantages over a number of drugs， but attention should be paid to the occurrence of gastrointestinal adverse effects.关键词：type 2 diabetes mellitus;efficacy;safety;cost-effectiveness;rapid health technology assessment
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发布时间：2023-06-26 - 摘要：OBJECTIVETo evaluate the risk of hypoglycemia caused by sodium-glucose co-transporter protein 2 （SGLT-2） inhibitors in type 2 diabetes （T2DM） patients.METHODSRetrieved from PubMed， Web of Science， Cochrane Library， CNKI， VIP， Wanfang Data and CBM， randomized controlled trials （RCTs） about SGLT-2 inhibitors in the treatment of T2DM were collected from the inception to Oct. 15th， 2022. After literature screening， data extraction and quality evaluation of included literature with bias risk assessment tool recommended by the Cochrane system evaluator handbook 5.1.0， Stata 15.1 software was used for network meta-analysis and publication bias analysis.RESULTSA total of 22 RCTs were included， with a total of 18 734 patients. The results of meta-analysis showed that compared with ertugliflozin 15 mg [RR＝3.26， 95%CI （1.13， 8.11）， P＜0.05] and ertugliflozin 25 mg [RR＝3.08， 95%CI （1.12， 6.34）， P＜0.05]， the incidence of hypoglycemia was significantly increased in patients using canagliflozin 300 mg. Compared with ertugliflozin 15 mg [RR＝1.48， 95%CI （1.24， 6.93）， P＜0.05] and ertugliflozin 25 mg [RR＝6.74， 95%CI （1.33， 9.34）， P＜0.05]， the incidence of hypoglycemia in patients treated with canagliflozin 100 mg was significantly increased. There was no statistically significant difference between other groups （P＞0.05）. The ranking results of the network meta-analysis showed that the incidence of hypoglycemia was from low to high， ie. ertugliflozin 15 mg＞placebo＞ertugliflozin 25 mg＞empgaliflozin 25 mg＞empgaliflozin 10 mg＞empgaliflozin 1 mg＞dapagliflozin 5 mg＞dapagliflozin 10 mg＞dapagliflozin 2.5 mg＞canagliflozin 300 mg＞ertugliflozin 10 mg＞ertugliflozin 5 mg＞empgaliflozin 50 mg＞canagliflozin 200 mg＞canagliflozin 100 mg＞canag-liflozin 50 mg＞ertugliflozin 1 mg＞empgaliflozin 5 mg. Results of publication bias analysis showed that there was little possibility of publication bias in this study.CONCLUSIONSWhen SGLT-2 inhibitors are used in patients with T2DM， the incidence of hypoglycemia is the lowest when using ertugliflozin 15 mg， and the incidence of hypoglycemia is the highest when using empagliflozin 5 mg.关键词：hypoglycemia;type 2 diabetes;network meta-analysis
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发布时间：2023-06-26 - 摘要：OBJECTIVETo evaluate the mode of pharmacists’ participation in multi-disciplinary diagnosis and treatment （MDT）， as well as the effects of pharmacists’ participation.METHODSRetrieved from Cochrane Library， PubMed， Embase， CNKI， CBM and Wanfang database， experimental studies and observational studies on the effects of MDT with pharmacists on clinical outcomes of patients were collected. After data extraction and quality evaluation， the results of included studies were analyzed descriptively.RESULTSA total of 10 studies were included， among which 3 were randomized controlled trials （RCT）， 2 were non-RCT， 4 were cohort and 1 was case-control study； there were 2 422 patients in total. In terms of effectiveness， tumor progression-free survival， glycosylated hemoglobin， re-admission rate and length of stay and other indexes were all improved significantly after pharmacists participated in MDT. In terms of safety， the incidence of major bleeding events was significantly decreased after pharmacists participated in MDT. In terms of economy， hospitalization costs and total outpatient expenses were improved significantly after pharmacists participated in MDT， but medical cost was not improved significantly. In terms of humanistic outcomes， there was controversy over the conclusion of patient compliance after pharmacists participated in MDT.CONCLUSIONSPharmacists， based on their own pharmaceutical care skills and methods， actively participate in MDT throughout the process， improving the clinical outcomes of patients and enhancing the safety of medication. There are still controversies regarding economic and humanistic outcomes.关键词：multi-disciplinary treatment;systematic review;participation mode;effectiveness
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发布时间：2023-06-26 - 摘要：OBJECTIVETo analyze the effect of pharmaceutical practice of pediatric pharmacists providing internet medication consultation services.METHODSA total of 8 356 children’s medication cases through the “Our Pharmacists” online medication consultation platform （hereinafter referred to as “Our Pharmacists”） were collected from July 2020 to June 2022. The general information， disease type and irrational drug use were analyzed statistically.RESULTSAmong 8 356 cases， 4 234 were male and 4 122 were female； the age of children was mainly from 12 months to 3 years old； the consulting diseases were mainly respiratory diseases （46.56%）， followed by digestive system diseases （18.41%） and skin system diseases （12.71%）. Among respiratory diseases， the proportion of irrational drug use was 92.30%， mainly including the use of antibiotics without indication （83.59%）， inappropriate selection of Chinese patent medicines （61.14%） and compound cold medicines （49.77%）， etc. Among digestive system diseases， the proportion of irrational drug use was 71.15%， mainly including not using oral rehydration salts （48.85%）， inappropriate use of probiotics （31.19%）， the use of antibiotics without indication （26.89%）， etc. A total of 4 273 evaluations of pharmacist services were received from child guardians， with a five-star rating of 99.88%.CONCLUSIONSPharmacists provide pediatric medication consultation services through “Our Pharmacists”， providing individualized evidence-based medication suggestions， increasing the safety of drug use and satisfaction with pharmaceutical care， and ensuring the safety of children medication.关键词：medication consultation;network;pediatric drug use;pharmaceutical care;Our Pharmacists
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发布时间：2023-06-26 - 摘要：The injury of vascular endothelial cells is not only the initial condition to promote the occurrence of early atherosclerosis （AS） plaques， but also an important link in the pathogenesis of AS. The microRNA （miRNA）， as an important medium of intercellular communication and gene regulatory factor， can affect vascular endothelial function and participate in the development of AS. The molecular mechanism of miRNA’s multi-target intervention in vascular endothelial cell injury has become a hot topic in the research of cardiovascular diseases. Monomers of traditional Chinese medicines such as ginsenoside Rb2 and paeonol， as well as traditional Chinese medicine for resolving phlegm and removing blood stasis could regulate miRNA to improve endothelial cell inflammation； astragaloside Ⅳ， dihydromyricetin and notoginsenoside could target miRNA and inhibit vascular endothelial oxidative stress； Danhong injection， Jianpi qutan and huayu prescription and paeonol could affect endothelial autophagy through miRNA； resveratrol， Bushen huoxue formula and Bushen tongmai formula could inhibit vascular endothelial aging by miRNA； dendrobine played an active role in regulating miRNA and improving endoplasmic reticulum stress. In the future， more in-depth research is needed on the effectiveness， mechanism of action， diagnosis and treatment plans， and safety of targeted regulation of miRNA for AS therapy by traditional Chinese medicine.关键词：endothelial cell injury;atheroscle-rosis;traditional Chinese medicine;mechanism of action
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发布时间：2023-06-26 - 摘要：Deucravacitinib is a selective tyrosine kinase 2 inhibitor. It has shown certain therapeutic potential for various immune system diseases， and its use in systemic lupus erythematosus （SLE） is currently in the clinical trial stage. Deucavacitinib is easily absorbed by oral administration and can cause pharmacological effects within 24 hours. Compared with placebo， after 32 weeks of treatment， patients in the deucravacitinib group who meet the SLE response index 4 have a higher proportion， and a higher response rate in the British Isles Lupus Assessment Group’s comprehensive lupus assessment， cutaneous lupus erythematosus disease area and severity index of 50， low disease activity status， and activity， swelling， and tenderness joint counts. In terms of safety， the incidence of adverse events such as rash and acne is higher in the deucravacitinib group than placebo group， but further observation was still needed. At present， more studies are evaluating the cost-effectiveness and safety of deucravatinib in the treatment of SLE， with the expectation of more data validation of deucravatinib’s therapeutic potential.关键词：tyrosine kinase inhibitor;systemic lupus erythematosus
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发布时间：2023-06-26 - 摘要：Diabetic retinopathy （DR） is one of the most important microvascular complications of diabetes mellitus， which can lead to blindness in severe cases. Both traditional drug therapy and surgical treatment have certain limitations. Literature review indicates that the main pathogenesis of DR is related to inflammation and apoptosis induced by oxidative stress， and changes in growth factors， hormones， etc. Monomer of traditional Chinese medicine （chlorogenic acid）， single medicine （Panax notoginseng， Typha angustifolia， Pueraria montana root， Matrimony vine， etc.）， prescription （modified Buyang huanwu decoction and Liujunzi decoction， modified Xuefu zhuyu decoction， Simiaoyong’an decoction， etc.） and Chinese patent medicine （Ligustrazine injection， Furong tongmai capsule， Qiju dihuang pill， etc.） can provide beneficial supplement for the treatment of DR. Its mechanism of action mainly involves antioxidant， anti-inflammatory， anti-apoptosis， decreasing the expression of vascular endothelial growth factor， improving hormone levels and so on.关键词：traditional Chinese medicine;inflammation;oxidative stress;mechanism of action
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发布时间：2023-06-26
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