最新刊期
卷 33 ， 期 23 ， 2022
- 摘要：Multiple drug use is very common in the elderly， which will significantly increase drug interactions and adverse drug reactions. Cardiovascular disease complicated with neuropsychiatric disease is the most common multi-disease comorbidity among the elderly， and it is also one of the disease combinations involving the most multiple drug use. In order to reduce the adverse clinical outcomes of the elderly in China， Chinese Society of Clinical Pharmacy of Chinese Medical Association organized relevant experts to develop Expert Consensus on Risk Prevention and Control of Multiple Drug Use in Elderly Patients with Cardiovascular Diseases and Neuropsychiatric Diseases in China by using foreign drug use risk assessment tools and combining relevant evidence-based results， and further promote its application in clinical disease treatment practice to reduce the adverse clinical outcomes of the elderly in China.关键词：multiple drug use;risk prevention and control;cardiovascular disease;neuropsychiatric disease
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发布时间：2023-02-22 - 摘要：Based on the current laws and regulations framework of China， combined with practical cases， this paper systematically and comprehensively analyzes the supervision attributes， clinical trial supervision model and existing problems of tumor neoantigen vaccine， aiming to provide reference for the construction of the supervision system of clinical trial of tumor neoantigen vaccine in China. The results showed that， at present， the clinical trials of tumor neoantigen vaccine in China adopt a dual-track supervision model： clinical trials initiated by pharmaceutical enterprises and clinical trials initiated by researchers. This supervision model lags behind the development speed of the industry， mainly in the following aspects： challenges brought by dual-track supervision； the clinical trial data initiated by researchers are not effectively connected with new drug research applications； the guiding principles of clinical trial supervision need to be improved. Relevant medical institutions， regulatory authorities and cooperative enterprises can help the development of the regulatory system for clinical trials of tumor neoantigen vaccine in China from the above aspects.关键词：clinical trial;supervision model;current status of supervision
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发布时间：2023-02-22 - 摘要：OBJECTIVETo investigate clinical situation and problems of oral iron supplements in pediatrics department of China， and to provide reference for rational application of oral iron supplements in children.METHODSThrough surveying the prescriptions of outpatient/emergency oral iron supplements （pediatric patients） in 8 children’s/maternity and children’s hospitals of third-grade class A from six administrative regions of China， the information of the prescriptions was analyzed statistically in terms of general information of children， the types of oral iron supplements， drug combination， clinical diagnosis， off-label drug use.RESULTSA total of 20 988 outpatient/emergency prescriptions were investigated， involving 12 kinds of oral iron supplements. Among them， the third generation of oral iron supplements ranked first（14 038 prescriptions，66.89%）， and the dosage form was mainly oral solution. Children aged 1-＜3 years old accounted for the largest proportion（8 532 prescriptions，40.65%）. Most of the drugs prescribed in combination with oral iron supplements were vitamins（5 577 prescriptions，26.57%）. More than half of the prescriptions（11 210 prescriptions，53.41%） were for diseases or symptoms other than iron deficiency/iron deficiency anemia. There were a total of 13 615 prescriptions（64.87%） of off-label drug use， mainly manifesting as super-indications （10 923 prescriptions，52.04%） and super-usage and dosage（6 393 prescriptions，30.46%）. There were 163 prescriptions beyond contraindications （0.78%）.CONCLUSIONSThe varieties and dosage forms of oral iron supplements in pediatrics are comparatively reasonable in children’s/maternity and children’s hospitals of third-grade class A in China，but the problem of off-label drug use still needs to be solved. The relevant departments and medical institutions should pay attention and take measures to promote the rational use of oral iron supplements in pediatrics.关键词：children;off-label drug use;prescription analysis
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发布时间：2023-02-22 - 摘要：OBJECTIVETo investigate the protective effect and potential mechanism of Arisaema Cum Bile on acute liver injury induced by carbon tetrachloride （CCl4） in mice.METHODSFifty mice were randomly divided into normal group， model group， positive control group （Biphenyl diester dropping pills， 150 mg/kg）， Arisaema Cum Bile low-dose and high-dose groups （0.78， 2.34 g/kg）， with 10 mice in each group. The mice in each group were given relevant medicine intragastrically， once a day， for 7 consecutive days. Two hours after the last administration， those groups were given intraperitoneal injection of 0.2% CCl4-olive oil solution to induce acute liver injury model except for normal group. Seventeen hours after intraperitoneal injection， the serum levels of alanine aminotransferase （ALT）， aspartate aminotransferase （AST）， interleukin-6 （IL-6）， tumor necrosis factor-α（TNF-α）， and malondialdehyde （MDA）， superoxide dismutase （SOD） in liver tissue were measured with kit method. The hepatic index was detected. The pathological changes of liver tissue were observed by HE staining， and the degree of liver injury was scored quantitatively. The mRNA expressions of TNF-α and IL-6 in liver tissue were detected by real-time fluorescence quantitative PCR； the protein expressions of Janus kinase 2 （JAK2）， signal transducer and activator of transcription protein 3 （STAT3） and nuclear factor-κB p65 （NF-κB p65） in liver tissue were detected by Western blot assay.RESULTSCompared with normal group， the levels of ALT， AST， IL-6， TNF-α and MDA， the hepatic index were increased significantly （P＜0.05）， while the level of SOD was decreased significantly （P＜0.05）； the mRNA expressions of IL-6 and TNF-α， and the protein expressions of JAK2， STAT3 and NF-κB p65 were up-regulated significantly （P＜0.05）； the pathological observation of liver tissue showed that the structure of hepatic cord was seriously disordered， there were many inflammatory cells infiltration of liver cells， and the liver injury score was significantly increased （P＜0.05）. Compared with model group， pathological changes and above indexes in mice were improved significantly in Arisaema Cum Bile low-dose and high-dose groups （P＜0.05）.CONCLUSIONSArisaema Cum Bile has a protective effect on CCl4-induced acute liver injury in mice， which may be related to the inhibition of inflammatory response mediated by JAK2/STAT3/NF-κB signal pathway and antioxidant stress.关键词：acute liver injury;inflammatory response;oxidative stress;nuclear factor-κB p65;signal transducer and activator of transcription protein 3;Janus kinase 2
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发布时间：2023-02-22 - 摘要：OBJECTIVETo investigate the mechanism of Fuke duanhongyin capsule in improving dysfunctional uterine bleeding （DUB） in rats.METHODSPregnant SD rats were randomly divided into blank control group （distilled water）， model control group （distilled water） and Fuke duanghongyin capsule group （1.296 g/kg）， with 6 rats in each group. Except for blank control group， DUB model was established in other groups. After modeling， they were given relevant medicine/distilled water 10 mL/kg intragastrically， once a day， for consecutive 14 d. After medication， uterine index， ovary index and hemorheology indexes （whole blood high shear relative index， whole blood low shear relative index， erythrocyte aggregation index， Carson viscosity） of rats were all determined. The pathological changes of uterus and ovary tissues were observed； mRNA relative expression levels of epidermal growth factor （EGF）， hypoxia-inducible factor 1α （HIF-1α）， epidermal growth factor receptor （EGFR） and serine/threonine-protein kinase 1（AKT1）， and protein relative expression levels of EGF and EGFR in uterine tissue were all measured.RESULTSCompared with model control group， the uterine index， ovary index， erythrocyte aggregation index were all decreased significantly in Fuke duanghongyin capsule group （P＜0.05 or P＜0.01）； whole blood high shear relative indexes， mRNA relative expression levels of EGF， HIF-1α and EGFR and protein relative expression levels of EGF and EGFR in uterine tissue were all increased significantly （P＜0.05 or P＜0.01）. The pathological changes of ovary and uterus were improved.CONCLUSIONSFuke duanhongyin capsule can improve DUB in rat， the mechanism of which may be related to the activation of EGF-EGFR signaling pathway.关键词：dysfunctional uterine bleeding;epidermal growth factor;epidermal growth factor receptor
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发布时间：2023-02-22 - 摘要：OBJECTIVETo investigate the pharmacological components and mechanism of Qingre huoxue decoction in improving myocardial ischemia-reperfusion injury（MIRI）.METHODSForty-two rats were randomly divided into sham operation group （normal saline）， model group （normal saline）， Qingre huoxue decoction low-dose， medium-dose and high-dose groups（4.94， 9.88， 19.79 g/kg），Qingre huoxue decoction drug-containing serum group （19.79 g/kg） and blank serum group （normal saline）， with 6 rats in each group. Each group was given corresponding drug/normal saline intragastrically， once a day， for consecutive 2 weeks. Twelve hours after last administration， except for serum groups， MIRI model was induced in other groups （only threading without ligation in sham operation group）. After modeling， cardiac histopathology was observed and apoptosis level was detected. UPLC-MS was used to analyze the samples in Qingre huoxue decoction drug-containing serum group and blank serum group. The main pharmacological components were screened with the help of relevant databases. Multivariate statistical methods were used to analyze the differential metabolites and related metabolic pathways. Validation test was performed based on oxidative stress indicators.RESULTSQingre huoxue decoction could improve the pathological injury of cardiac tissue and decrease apoptosis rate of cardiac cells in MIRI model rats （P＜0.05）. Qingre huoxue decoction drug-containing serum contained 20 main pharmacological components such as baicalin， succinic acid， baicalein， cryptotanshinone， isoferulic acid， protocatechuic aldehyde. Qingre huoxue decoction could significantly up-regulate the levels of 15 metabolites including L-arginine， L-arginine， citric acid， glutathione， β-D-glucose and L-carnitine， and down-regulated the levels of 14 metabolites including arachidonic acid， 3-phosphate-d-glycerol phosphate， linoleic acid， docosahexaenoic acid， phosphatidylcholine and lysophosphatidylcholine （P＜0.05）. These metabolites were mainly involved in energy metabolism， inflammatory injury， oxidative stress and autophagy. Results of validation tests showed that Qingre huoxue decoction could significantly reduce the levels of malondialdehyde， and increased the levels of superoxide dismutase （except for low-dose group） and glutathione peroxidase significantly （P＜0.05）.CONCLUSIONSQingre huoxue decoction can improve the injury of cardiac tissue in MIRI model rats. Its pharmacological components include baicalin， cryptotanshinone， isoferulic acid， protocatechualdehyde， etc. Furthermore， it may play a protective role in MIRI by improving myocardial energy metabolism， down-regulating oxidative stress， inhibiting inflammation infiltration.关键词：myocardial ischemia-reperfusion injury;pharmacological components;mechanism
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发布时间：2023-02-22 - 摘要：OBJECTIVETo establish an analytical method based on ultra-performance liquid chromatography-quadrupole-time-of-flight mass spectrometry （UPLC-Q-TOF/MS） combined with UNIFI platform for rapid identification of the chemical constituents in Abrus cantoniensis Hance.METHODSThe chromatographic separation was performed on ACQUITY PRM HSS T3 FIT column for gradient elution with the mobile phase consisted of 0.1% formic acid aqueous solution-acetonitrile. The flow rate was 0.3 mL/min， and injection volume was 2 μL. Electrospray ionization was used to collect the mass spectrometry data of the chemical constituents of A. cantoniensis Hance with full information tandem mass spectrometry technology in positive and negative ion modes. The chemical constituent database of A. cantoniensis Hance was established. Targeted and non-targeted analyses were conducted based on UNIFI platform， and chemical constituents were further identified in combination with accurate molecular mass， secondary fragment ion information and equivalence with reference substances and literature data， etc.RESULTSTotally 46 compounds of A. cantoniensis Hance were successfully identified， including 19 flavonoids， 8 triterpenoids， 3 alkaloids， 5 organic acids and 11 other components. Among them， 11 compounds were firstly found in A. cantoniensis Hance， and 9 compounds were confirmed by reference substance.CONCLUSIONSThe analytical method based on UPLC-Q-TOF/MS combined with UNIFI platform can quickly identify the chemical constituents of A. cantoniensis Hance. Flavonoids and triterpenes are the main components in A. cantoniensis Hance.关键词：chemical constituents;identification;UPLC-Q-TOF/MS;UNIFI platform
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发布时间：2023-02-22 - 摘要：OBJECTIVETo investigate the mechanism of Shilinqing granules preventing the formation of calcium oxalate kidney stones in rats.METHODSSixty rats were randomly divided into blank group， model group， Shilingqing granules low-dose， medium-dose and high-dose groups （6.5， 13， 26 g/kg）， SIRT3 inhibitor group （Shilingqing granules 26 g/kg+SIRT3 inhibitor 25 mg/kg）， with 10 rats in each group. Except for blank group， other groups were given 1% ethylene glycol solution instead of drinking water， and intragastrical administration of 2% ammonium chloride solution 2 mL， for 4 consecutive weeks， to induce kidney stones rat model； at the same time， administration groups were given relevant medicine intrgastrically， blank group and model group were given constant volume of normal saline intrgastrically. The 24 h urine volume， urine pH， urine contents of Ca2+ and oxalic acid （Ox）， serum contents of creatinine （Cr）， blood urea nitrogen （BUN） and Ca2+ were all determined； the renal histopathology， calcium oxalate crystallization and ultrastructure were observed； the levels of malondialdehyde （MDA）， superoxide dismutase （SOD）， reactive oxygen species （ROS） and osteopontin （OPN） in renal tissue of rats were determined； mRNA and protein expressions of SIRT3， FOXO3a， and SOD2 in renal tissue of rats were determined.RESULTSCompared with blank group， 24 h urine volume， urine pH， SOD level， mRNA and protein expressions of SIRT3， FOXO3a and SOD2 in renal tissue were decreased significantly in model group （P＜0.05 or P＜0.01）. The contents of urine Ca2+ and Ox， serum contents of Cr， BUN and Ca2+ and the levels of ROS， MDA and OPN in renal tissue were increased significantly （P＜0.01）. The pathological damage of renal tissue was severe， with a large number of diffuse black crystals， thickened glomerular basement membrane， and mitochondrial edema in podocytes and renal tubular epithelial cells. Compared with model group， the above indexes （except for serum content of Ca2+ in low-dose group） were significantly reversed in Shilinqing granules groups （P＜0.05 or P＜0.01）； pathological renal damage， calcium crystal， mitochondrial damage of glomerular podocyte and renal tubular epithelial cell were significantly improved； there was no statistical significance in the changes of above indexes in SIRT3 inhibitor group （P＞0.05）.CONCLUSIONSShilinqing granules can effectively inhibit the formation of calcium oxalate kidney stones in rats and improve renal damage， the mechanism of which may be related to the improvement of anti-oxidant effect and the activation of SIRT3/FOXO3a signaling pathway.关键词：calcium oxalate;kidney stones;renal damage;anti-oxidant;SIRT3/FOXO3a signaling pathway
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发布时间：2023-02-22 - 摘要：OBJECTIVETo study the effects of yunaconitine on myocardial injury in rats and its mechanism related to mitochondrial apoptosis pathway rats.METHODSForty SD rats were divided into normal group （normal saline）， yunaconitine high-dose and low-dose groups（0.14， 0.09 mg/kg）and aconitine group （positive control， 0.88 mg/kg） by random number method， with 10 rats in each group. They were given relevant medicine intragastrically， once a day， for consecutive 7 days. The levels of lactate dehydrogenase （LDH）， creatine kinase （CK）， creatine kinase isoenzyme （CK-MB）， superoxide dismutase （SOD） and malondialdehyde （MDA） in serum as well as the level of reactive oxygen species （ROS） in myocardial tissue were detected. The pathomorphological changes of myocardium and ultrastructural changes of myocardial mitochondria were all observed. The apoptosis of cardiomyocytes was determined. The protein relative expressions of B-cell lymphoma-2 （Bcl-2）， Bcl-2 associated X protein （Bax）， caspase-9， cleaved-caspase-9， caspase-3 and cleaved-caspase-3 were determined in myocardium of rats.RESULTSCompared with normal group， the serum levels of LDH， CK， CK-MB and MDA， the apoptotic numbers of cardiomyocytes， the level of ROS and protein expression of caspase-3 in myocardium were increased significantly in yunaconitine high-dose and low-dose groups （P＜0.05 or P＜0.01）； serum level of SOD and Bcl-2/Bax ratio in myocardium were all decreased significantly （P＜0.01）； the protein relative expressions of caspase-9， cleaved-caspase-9， caspase-3 and cleaved-caspase-3 in myocardium were significantly increased in yunaconitine high-dose group （P＜0.05）； some pathomorphological changes were found in 2 groups， such as myocardial fiber disorder， mitochondrial swelling.CONCLUSIONSYunacotine could cause myocardial injury in rats. Its mechanism might be related to destroying the integrity of cardiomyocyte membrane， causing oxidative stress of cardiomyocyte， and inducing the apoptosis of myocardial cells through mitochondrial pathway.关键词：cardiotoxicity;oxidative stress;apoptosis;mitochondrial pathway;myocardial injury
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发布时间：2023-02-22 - 摘要：OBJECTIVETo investigate the improvement effects of Jinkui shenqi pills on polycystic ovary syndrome （PCOS） model rats and the mechanism.METHODSTotally 40 rats were given letrozole suspension instragastrically （1 mg/kg， once a day， for consecutive 21 d） to induce PCOS model. Model rats were divided into model group， ethinylestradiol and cyproterone acetate tablets （short for diane-35）+metformin group （diane-35 0.2 mg/kg + metformin 230 mg/kg， as positive control）， Jinkui shenqi pills low-dose， medium-dose and high-dose groups （0.5， 1.0， 2.0 g/kg）， with 10 rats in each group. Other 10 healthy rats were included in normal group. Each group was given the corresponding drugs， once a day， for consecutive 30 d. Twelve hours after the last administration， serum levels of blood glucose， insulin， estrogen （E2）， testosterone （T）， gonadotropin-releasing hormone （GnRH）， follicle-stimulating hormone （FSH） and luteinizing hormone （LH） were measured. The insulin resistance indexes were calculated， and the ovary coefficients of rats were calculated. The pathological changes of ovary were observed. The protein and mRNA expressions of liver kinase B1 （LKB1） and AMP-activated protein kinase （AMPK） in ovary tissue were detected.RESULTSCompared with normal group， the levels of blood glucose， insulin， insulin resistance index， serum levels of T， GnRH and LH and ovarian indexes were significantly increased （P＜0.05）， while serum levels of E2 and FSH as well as protein and mRNA expressions of LKB1 and AMPK in ovary tissue were decreased significantly （P＜0.05）； collagenization of ovarian cortex， increased number of atresia follicles and cystic follicles without cumulus， and follicular cystic lesions could be seen. Compared with model group， most of above indexes of Jinkui shenqi pills groups were reversed significantly （P＜0.05）； the number of follicle at each level was increased and no follicular cystic lesion was found in Jinkui shenqi pills medium-dose and high-dose groups.CONCLUSIONSJinkui shenqi pills can significantly improve the abnormal level of sex hormones， insulin resistance and ovarian cystic changes， the mechanism of which may be related to up-regulating the activation of LKB1/AMPK signaling pathway.关键词：polycystic ovary syndrome;insulin resistance;LKB1/AMPK signaling pathway;rats
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发布时间：2023-02-22 - 摘要：OBJECTIVETo identify the chemical composition of Xiaoshi granules， and investigate its potential mechanism of action in the treatment of functional dyspepsia （FD）.METHODSFirstly， ultra-performance liquid chromatography tandem quadrupole time-of-flight mass spectrometry was used to analyze the composition of the Xiaoshi granules， and then network pharmacology was used to screen the potential targets of the Xiaoshi granules for the treatment of FD. Molecular docking of core components and targets was performed by using AutoDock Tools 1.5.6 software.RESULTSA total of 53 major chemical components， mainly flavonoids and organic acids， were identified from Xiaoshi granules. Network pharmacology screened core components such as quercetin， isorhamnetin， kaempferol and rutin， six core targets such as estrogen receptor （ESR1）， signal transducer and activator of transcription （STAT3）， androgen receptor（AR）， cellular tumor antigen （TP53）， hypoxia-inducible factor 1 subunit α in breast cancer tissue（HIF1A）， proto-oncogene tyrosine protein kinase （SRC）， and obtained major signaling pathways such as phosphatidylinositol 3-kinase （PI3K）-protein kinase B （Akt）， advanced glycosylation products （AGE）-receptor for advanced glycosylation end products （RAGE）， mitogen-activated protein kinase （MAPK）. The molecular docking results showed good docking activity between the core components and the core targets.CONCLUSIONSXiaoshi granules may act on STAT3， HIF1A， SRC and other targets through quercetin， isorhamnetin， kaempferol and other active ingredients to regulate PI3K-Akt， AGE-RAGE， MAPK and other signal pathways， thus exerting its therapeutic effect on FD.关键词：chemical composition;network pharmacology;molecular docking;mechanism of action
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发布时间：2023-02-22 - 摘要：OBJECTIVETo prepare lipid-coated mesoporous silica nanoparticles （CLMSNs） co-loaded with doxorubicin （DOX） and siRNA （CLMSNs-SS-NH2@DOX/siRNA），and to characterize it and study anti-multidrug-resistant tumor cells.METHODSMSNs-SS-NH2@DOX was prepared on the basis of mesoporous silica （MSNs），covered with cationic liposomes （CLs） to synthesize CLMSNs-SS-NH2@DOX，and then obtain CLMSNs-SS-NH2@DOX/siRNA by co-loading with siRNA. The particle size and Zeta potential of the preparation were determined，and its micromorphology was observed； differential scanning calorimetry，X-ray diffraction，infrared spectroscopy and physical adsorption analysis were conducted. The in vitro release of DOX from the preparation was determined under different pH conditions （pH5.0，pH7.4） and different glutathione concentrations （0，2，5，10 mmol/L）. The effects of this preparation on the uptake，migration，apoptosis，cycle and P-glycoprotein （P-gp） expression of MCF-7/ADR in DOX-resistant breast cancer cells were investigated.RESULTSCLMSNs-SS-NH2@DOX/siRNA had a clear core-shell structure，obvious lipid membrane layer，particle size of （197.63±3.75） nm，Zeta potential of （20.64±0.98） mV，and with good physical and chemical properties. In vitro release results showed that CLMSNs-SS-NH2@DOX/siRNA possessed good pH/reduction double-response. The results of cell experiment showed that after intervened with CLMSNs-SS-NH2@DOX/siRNA，the fluorescence intensity of MCF-7/ADR cells was significantly enhanced，the migration rate and P-gp expression level were significantly reduced，while total proportion of apoptosis and that of G0/G1 phase were significantly increased （P＜0.05）.CONCLUSIONSIn this study，DOX and siRNA co-loaded CLMSNs-SS-NH2@DOX/siRNA is prepared successfully， which has good physical and chemical properties， pH/reduction double-response properties. It can reverse the multidrug resistance of MCF-7/ADR cells by down-regulation of P-gp expression.关键词：siRNA;doxorubicin;anti-tumor;multidrug resistance
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发布时间：2023-02-22 - 摘要：OBJECTIVETo explore the effects of the expression of serum Sirtuin-1 （SIRT1） on therapeutic efficacy of sodium valproate （VPA） in the treatment of epilepsy patients.METHODSFifty-four epileptic patients were collected from the Affiliated Baiyun Hospital of Guizhou Medical University from Mar. to Oct. 2021 as the research objects， and fifty healthy people were also collected during corresponding period as baseline reference samples. The patients whose relative mRNA expression of SIRT1 was lower than the baseline were selected as SIRT1 low-expression treatment group， and the patients whose that expression was higher than the baseline as SIRT1 high-expression treatment group. All patients were treated with low dose （12 mg/kg or about 600 mg/day） of VPA for 3 months， and the clinical efficacy was evaluated. The dosage of VPA in patients with ineffective epilepsy control should be increased to 15 mg/kg or about 800 mg/day for another 3 months as SIRT1 high-expression intensive treatment group and SIRT1 low-expression intensive treatment group. Clinical efficacies were evaluated. The blood concentration and liver function indexes of the patients were detected after 3 months of treatment and 3 months of intensive treatment.RESULTSBefore treatment， among 54 epileptic patients， 31 epileptic patients had low expression of SIRT1， and 23 had high expression of SIRT1. After 3 months of low-dose VPA treatment， within effective blood concentration of VPA， effective control rate of patients in SIRT1 high-expression treatment group was significantly lower than SIRT1 low-expression treatment group （P＜0.05）. After 3 months of intensive treatment， the effective control rate of patients SIRT1 high-expression intensive treatment group was significantly higher than SIRT1 high expression treatment group （P＜0.05）. No abnormality was found in liver function indexes during VPA treatment.CONCLUSIONSEpilepsy in patients with high expression of serum SIRT1 may be more difficult to control when VPA is within the effective blood concentration range； when the VPA dose is effectively increased， the effective control rate of epilepsy can be improved.关键词：epilepsy;sodium valproate;blood concentration monitoring;liver function
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发布时间：2023-02-22 - 摘要：OBJECTIVETo analyze the risk factors of linezolid-induced hyponatremia， and establish nomogram model of linezolid-induced hyponatremia.METHODSThe clinical information of 142 patients who received linezolid therapy were collected from Zhongshan Hospital Affiliated to Fudan University from April 2019 to May 2021 including demographic characteristics， laboratory index， concomitant disease and drug combination. They were divided into hyponatremia group and non-hyponatremia group according to whether hyponatremia occurred； univariate analysis was used to compare the differences of variables between the two groups； the independent risk factors for linezolid-induced hyponatremia were analyzed by multivariate Logistic regression. The nomogram model was set up to identify the occurrence risk of linezolid-induced hyponatremia， receiver operating characteristic （ROC） curve and calibration curve， Hosmer-Lemeshow goodness-of-fit test were used to evaluate the predictive effectiveness of the model.RESULTSOf 142 patients， 30 patients suffered from hyponatremia， and 112 patients did not suffer， the incidence of adverse drug reaction was 21.1%. Univariate analysis showed that there was statistical significance in trough concentration of linezolid， baseline serum sodium， white blood cell count， total bilirubin， albumin， alanine aminotransferase， aspartate aminotransferase， combined use of spironolactone between hyponatremia group and non-hyponatremia group （P＜0.05）. Multivariate Logistic regression analysis showed that trough concentration of linezolid [OR＝1.128， 95%CI（1.028-1.239）]， baseline serum sodium [OR＝0.719， 95%CI（0.604-0.857）] and total bilirubin [OR＝1.007， 95%CI（1.002， 1.011）] were independent risk factors for linezolid-induced hyponatremia （P＜0.05）. The area under the ROC curve （95%CI） of the nomogram model was 0.874 （0.794-0.995）； the sensitivity and specificity were 88.4% and 76.7%. The average absolute error of calibration curve was 0.017. The results of Hosmer-Lemeshow goodness-of-fit test showed that there was no statistically significant difference between the predicted risk value and the measured value （χ 2＝4.941，P＝0.064）.CONCLUSIONSThe trough concentration of linezolid， baseline serum sodium and total bilirubin are independent risk factors for linezolid-induced hyponatremia. The established nomogram model shows well predictive performance to identify linezolid-induced hyponatremia.关键词：hyponatremia;risk factor;adverse drug reaction;nomogram model
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发布时间：2023-02-22 - 摘要：OBJECTIVETo systematically review the effects of body weight on the efficacy and safety of novel oral anticoagulants （NOACs） or aspirin for the prevention of venous thromboembolism （VTE） after total hip arthroplasty and total knee arthroplasty （hereinafter referred to as “hip and knee arthroplasty”）.METHODSRetrieved from PubMed， Embase and Cochrane library， randomized controlled trial （RCT） and non-RCT about the effectiveness and/or safety of NOACs， aspirin and low-molecular heparin by subgrouping according to body weight or body weight index [BMI 18.5-＜25 kg/m2 as normal body mass， BMI 25-30 kg/m2 as overweight， and BMI＞30 kg/m2 as obesity （of them， BMI＞40 kg/m2 as morbid obesity）] were collected from the inception to June 30， 2022. After literature screening and data extraction， the quality of RCT was evaluated with bias risk assessment tool RoB 2.0 recommended by Cochrane system evaluator manual. The Newcastle-Ottawa scale was used to evaluate the quality of non-RCT. Meta-analysis was performed by using RevMan 5.4 software.RESULTSA total of 6 literatures， containing 3 series of RCT pooled studies and 3 non-RCTs were included. The results of meta-analysis showed that among different BMI subgroups， there was no statistical significance in reducing major VTE and VTE-related mortality of patients with normal body mass patients [OR＝0.63， 95%CI（0.26，1.51），P＝0.30]， overweight patients [OR＝0.48，95%CI（0.22，1.04），P＝0.06] and obese patients [OR＝0.70，95%CI（0.40，1.25），P＝0.23] by NOACs， compared with enoxaparin. The safety of NOACs was comparable to that of enoxaparin in different BMI subgroups in terms of the incidence of major bleeding events and major+clinically relevant non-major bleeding events （P＞0.05）. There was no statistical significance in the incidences of total VTE [OR＝1.28， 95%CI （0.68，2.40）， P＝0.45]， symptomatic VTE and all-cause mortality [OR＝1.26， 95%CI （0.81，1.95）， P＝0.30] and major bleeding [OR＝0.79， 95%CI （0.58，1.08）， P＝0.14] in obese/morbidly obese patients using NOACs and aspirin， compared with normal/overweight patients.CONCLUSIONSThe impact of body weight on the efficacy and safety of NOACs and aspirin for the prevention of VTE after hip and knee arthroplasty is not significant， and this study supports that overweight and obese patients receive NOACs or aspirin for VTE prevention.关键词：arthroplasty;venous thromboembolism;novel oral anticoagulants;aspirin;meta-analysis
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发布时间：2023-02-22 - 摘要：OBJECTIVETo systematically evaluate the clinical efficacy and safety of pirfenidone and nintedanib in the treatment of idiopathic pulmonary fibrosis.METHODSRandomised controlled trials on pirfenidone and nintedanib in the treatment of idiopathic pulmonary fibrosis which were publicly published in Chinese and English were searched from CNKI， Wanfang， VIP， PubMed， Cochrane library and other databases. The search time was set from January 2000 to December 2021. The existing studies were combined with indirect meta-analysis to systematically evaluate the efficacy and safety of the two drugs in the treatment of idiopathic pulmonary fibrosis.RESULTSA total of 15 randomized controlled trials were included， involving 1 026 cases in trial group of pirfenidone and 845 cases in control group of pirfenidone， 1 846 cases in trial group of nintedanib and 1 848 cases in control group of nintedanib. Both control groups were placebo. The results of indirect meta-analysis showed that the two drugs were similar in the evaluation indicators of therapeutic efficacy as acute exacerbation rate， the incidence of forced vital capacity （FVC）% decrease ≥10% from baseline or the incidence of absolute value decrease ≥0.2 L （P values of indirect analysis results were all ＞0.01， and the difference was not statistically significant）； but in terms of disease progression rate， nintedanib 150 mg （bid） was superior to pirfenidone 800 mg （tid） （RR＝1.66， 95%CI＝1.06-2.63）； in terms of safety， the incidence of diarrhea induced by nintedanib 150 mg （bid） was higher than pirfenidone 800 mg （tid） （RR＝0.42， 95%CI＝0.33-0.53）.CONCLUSIONSCompared with pirfenidone， nintedanib has slightly superior efficacy in terms of disease progression control， but the incidence of adverse reactions is also increased.关键词：nintedanib;idiopathic pulmonary fibrosis;efficacy;safety;indirect meta-analysis
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发布时间：2023-02-22 - 摘要：OBJECTIVETo investigate the awareness of the patients receiving Sanjin tablets in knowledge-attitude-practice （KAP） aspect， and its influential factors.METHODSDemographic characteristics， medication knowledge， attitude and practice of outpatients and inpatients who used Sanjin tablets in the First Affiliated Hospital of Henan University of Traditional Chinese Medicine from June to December 2020 were investigated online and offline for questionnaire survey and scale scoring.Oneway variance analysis and multiple linear regression analysis were used to screen the influential factors for KAP of the patient receiving Sanjin tablets.RESULTSA total of 503 valid questionnaires （effective recovery rate of 99.60%） were collected in this survey. The drug use knowledge score of Sanjin tablet users was （26.74±6.82） points， the drug use attitude score was （7.82±3.75） points， and the drug use practice score was （21.72±5.56） points. The overall scores were good， excellent and good， respectively.The results of oneway variance analysis showed that there were significant differences in drug use knowledge and drug use practice scores among the patients receiving Sanjin tablets with different ages，occupations and medical insurance types （P＜0.05）； there were significant differences in drug use attitude scores among the patients receiving Sanjin tablets with different ages， occupations， education levels and medical insurance types （P＜0.05）. The results of multiple linear regression analysis showed that ages， occupations， education levels and medical insurance types were the main factors affecting the drug use knowledge and drug use attitude of the patients receiving Sanjin tablets （P＜0.05）； education levels and medical insurance types were the main factors affecting the drug use practice of the patients receiving Sanjin tablets （P＜0.05）.CONCLUSIONSMost of the patients receiving Sanjin tablets have a good attitude towards the acquisition of safe medication information， but the knowledge to drug use and the actual drug use practice still have certain hidden danger in security； it is necessary to strengthen drug use education and publicity for individual age groups， low-educational background groups and other people， carry out the drug education among the population with different vocational characteristics and medical insurance types in order to promote safe and rational drug use.关键词：KAP investigation;drug use risk;drug use safety;rational drug use
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发布时间：2023-02-22 - 摘要：OBJECTIVETo explore the effect of informationized closed-loop management in the consultation of over-dose narcotics.METHODSSince November 2021， the informationized consultation mode of over-dose narcotics had been established innovatively in our hospital on the basis of the previous process of over-dose narcotics use； the consultation mode of over-dose narcotics transformed from paper to information. The standardized rate of consultation for over-dose narcotics， the waiting time of consultation for patients using over-dose narcotics were compared before （from January to April 2021） and after the improvement （from November 2021 to February 2022）.RESULTSThe informationized closed-loop management of over-dose narcotics consultation in our hospital was realized by improving hospital information system （maintaining basic information， embedding relevant reminder and consultation modules， and establishing query and statistics functions） and introducing mobile terminal. After establishing the mode， the standardized rate of the consultation increased from 55.56% to 93.75%； the waiting time for consultation was shortened from （20.61±9.77） min to （5.87±2.45） min.CONCLUSIONSThe informationized closed-loop management can effectively improve the standardization rate of consultations for over-dose narcotics and reduce the waiting time for consultation for patients using over-dose narcotics.关键词：informationized;closed-loop management;consultation;rational drug use
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发布时间：2023-02-22 - 摘要：OBJECTIVETo establish the drug use evaluation criteria of human albumin （HA） in the treatment of liver cirrhosis based on weighted technique for order preference by similarity to ideal solution （TOPSIS） method， and to comprehensively evaluate the utilization of HA.METHODSThe drug use evaluation criteria of HA was established with reference to guidelines of liver cirrhosis treatment at home and abroad and HA prescription evaluation method， based on the HA instructions. The weighted TOPSIS method was used to evaluate the rationality of HA drug use in inpatients with liver cirrhosis diagnosed by the infection department of our hospital in 2020.RESULTSThe established drug use evaluation criteria for HA included 8 evaluation indicators， i.e. baseline examination， indication， contraindication， combined use of drugs， usage and dosage， and so on； the scoring weight was set by consulting experts. According to the evaluation of the closeness degree （Ci） between the HA drug use of 1 068 medical records and the optimal plan and the worst plan in our hospital， the result showed that 133 （12.45%） were evaluated as reasonable medical records （Ci≥0.8）， 576 （53.93%） as basically reasonable medical records （0.6≤Ci＜0.8）， and 359 （33.61%） as unreasonable medical records （Ci＜0.6）. The main unreasonable problems were the absence of baseline examination， non-indication medication， medication for contraindication， etc.CONCLUSIONSThe drug use evaluation criteria of HA based on the weighted TOPSIS method can be used to evaluate the rational use of the drug. The drug use of HA in patients with liver cirrhosis in our hospital is reasonable， and we should continue to strengthen the management to reduce or avoid unreasonable drug use.关键词：liver cirrhosis;weighted TOPSIS method;rational drug use
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发布时间：2023-02-22 - 摘要：Yuebawei refers to 8 kinds of genuine medicinal materials in south China area，namely Citri Grandis Exocarpium， Citrus reticulata， Amomum villosum， Pogostemon cablin， Morinda officinalis， Aquilaria sinensis， Citrus medica and Polygonum multiflorum. The results of this review show that， the pharmacological effects of Yuebawei are very extensive. It has significant effects in relieving cough and phlegm， anti-bacterial and anti-inflammatory， enhancing immunity， anti-oxidation， antidepressant， immune regulation and regulating gastrointestinal function. Its development and application prospects are broad， but most of the existing pharmacological studies stay on pharmacodynamic studies. In the aspect of the safety research of Yuebawei， there are few studies on the safety of other medicinal materials， except for the liver toxicity of P. multiflorum； at the same time， there are few comparative studies on the therapeutic advantages of Yuebawei and other local medicinal materials in clinical application. It is necessary to strengthen the research on the material basis of efficacy， pharmacological action mechanism， and safety and efficacy observation of clinical medication for Yuebawei， so as to provide scientific basis for the development of new drugs and clinical promotion and application of Yuebawei.关键词：Yuebawei;pharmacological effects;safety
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发布时间：2023-02-22 - 摘要：OBJECTIVETo explore the effects of Citrus medica before and after being steamed on blood metabolism and dryness indexes in rats.METHODSTwenty-four SD rats were randomly divided into blank group， C. medica group （2.4 g/kg）， processed C. medica group （2.4 g/kg）， Citrus aurantium group （positive control， 1.2 g/kg）， with 6 rats in each group. After 5 weeks of continuous administration， the body weight， food intake， water intake and urine volume were observed dynamically. The content of aquaporin 3 （AQP3） in serum was detected. The metabolic profile of rat serum samples was analyzed by liquid chromatography-mass spectrometry. Principal component analysis （PCA） and orthogonal partial least squares-discriminant analysis （OPLS-DA） were used to screen differential metabolites， and screened differential metabolites were mapped to the KEGG database for pathway analysis.RESULTSThe body weight of rats in each group increased slowly； the food intake and water intake of processed C. medica group tended to be higher than those in C. medica group and C. aurantium group， but there was no significant difference among those groups （P＞0.05）. On the 21st day of administration， compared with C. aurantium group， the urine volume of processed C. medica group was significantly increased （P＜0.05）， the serum AQP3 content of processed C. medica group was significantly decreased （P＜0.05）， and were close to those of blank group. According to the metabonomic study， C. medica mainly affected the lipids metabolism， and processed C. medica mainly affected the amino acid metabolism. The differential metabolites pathway between C. medica and processed C. medica involved the metabolism of cysteine and methionine， metabolism of glycine， serine and threonine， and metabolism of taurine and hypotaurine.CONCLUSIONSProcessed C. medica might relieve the dryness of C. medica by affecting adenosine phosphate-protein kinase A. The content of AQP3 in serum can be used as the evaluation index for the dryness of C. medica before and after processing. The effects of C. medica and processed C. medica on endogenous metabolites in rat serum are quite different， especially in the aspect of lipid metabolism.关键词：steaming;dryness;differential metabolites;metabonomics
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发布时间：2023-02-22 - 摘要：OBJECTIVETo investigate the pharmacodynamic effects of the Citri Grandis Exocarpium extract on anorexia model immature rats.METHODSTen immature rats were randomly selected as the control group and given regular diet， while anorexia model was induced in the remaining 50 immature rats using the etiological simulation method. The immature model rats were divided into the model group， Jianwei xiaoshi tablet group （0.65 g/kg）， Citri Grandis Exocarpium extract low-dose， medium-dose and high-dose groups （0.5， 1.0， 2.0 g/kg）. After 14 d of continuous intragastric administration， the body mass and food intake of rats in each group were observed， and the gastric acid concentration， pepsinase activity， serum levels of gastrin （GAS）， motilin （MTL） and gastric inhibitory peptide （GIP） were measured.The histopathological changes in the gastric tissue were observed.RESULTSCompared with control group， the food intake， gastric acid concentration， pepsin activity， the levels of GAS and MTL were significantly decreased and GIP level was significantly increased in the immature rats of model group （P＜0.05）； gastric histopathological examination showed significant gastric mucosal congestion and loosening and detachment of epithelial cells. Compared with model group， all administration groups showed different degrees of improvement in the above indexes and decreased gastric histopathological damage after drug intervention.CONCLUSIONSCitri Grandis Exocarpium extract improves gastric motility and protects gastric mucosa in the immature rats by regulating the concentration of gastric acid， pepsin activity， the levels of GAS， MTL and GIP， thus improving anorexia in immature rats.关键词：anorexia;pepase;gastrin;motilin;gastric inhibitory peptide
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发布时间：2023-02-22 - 摘要：OBJECTIVETo establish a method for the content determination of patulin in Citri Grandis Exocarpium.METHODSHigh-performance liquid chromatography-triple quadrupole mass spectrometer（HPLC-MS/MS）was used for the analysis. After water-soluble dispersion and pectinase enzymolysis， the Citri Grandis Exocarpium sample was extracted by acetonitrile with high-speed homogenated. The extracted solution was conducted dispersive solid phase extraction by mixing powder of MgSO4 and NaAC （4∶1，m/m），then purified on SHIMSEN 228 solid phase purification column. Water acetonitrile was used as mobile phase， and the Shim-pack XR-ODS column was used to separate the target compound. And it was detected by electrospray ionization in the negative mode under multiple reaction monitoring， and quantified by the external standard method with matrix-matched standard correction curves.RESULTSPatulin showed good linear correlation in the concentration from 5 to 200 ng/mL （r＝0.999 6）. RSDs of precision， reproducibility and stability tests （12 h） were all lower than 6％. The average recoveries at low， medium， high concentrations were 83.9%， 92.08%， 92.21%， respectively （RSDs were 11.09%， 5.53%， 1.75%， respectively）. The limit of quantitation was 6 μg/kg and limit of detection was 3 μg/kg. Patulin was not detected in 20 batches of samples.CONCLUSIONSEstablished method can be used for the rapid detection and accurate quantification of patulin in Citri Grandis Exocarpium， which can provide experimental basis and method for safety study and quality control of Citri Grandis Exocarpium.关键词：patulin;HPLC-MS/MS;content determination;safe drug use
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发布时间：2023-02-22 - 摘要：Moutan Cortex， a common bulk traditional Chinese medicine， has a long medicinal history of more than 2 000 years. This study systematically summarizes the research overview of Moutan Cortex in the term of harvest time and growth years， and peeling， heart pumping， cutting while fresh， sulfur fumigation， drying and storage involved in the processing in producing area， as well as commodity specifications and grades， quality control methods. The results show that it is suitable to harvest Moutan Cortex on sunny days in autumn after 5-6 years of planting. The overall quality of Moutan Cortex retained cork is better than that of Moutan Cortex removed cork. It is recommended that the processing of Moutan Cortex may be considered to retain cork but remove xylem. It is more suitable to cut Moutan Cortex when it is fresh， in order to avoid the loss of the active ingredients due to the long storage time in the middle circulation. The fresh-cut pieces of Moutan Cortex can be dried and stored by the appropriate methods such as far-infrared drying， avoiding light and vacuum packing， which can preserve the efficacy to the greatest extent. Sulfur fumigation treatment not only affects the quality of Moutan Cortex， but also easily leads to excessive sulfur dioxide. It is not recommended to use the method of sulfur fumigation in the processing of Moutan Cortex in the production area. Moutan Cortex can be divided into three specifications： Fengdan， Liandan and Guadan， which are divided into four grades according to their length and diameter. At present， many methods （HPLC， GC-MS） have been used for quality control of Moutan Cortex， but whether they can reflect the overall quality of Moutan Cortex needs further research and discussion. Whether the Moutan Cortex is scraped should be considered in combination with other relevant factors （such as clinical efficacy， pesticide residues and heavy metal content）， and the process parameters of fresh-cut Moutan Cortex still need to be further optimized.关键词：harvesting;processing;quality control
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发布时间：2023-02-22
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