最新刊期
卷 33 ， 期 24 ， 2022
- 摘要：OBJECTIVETo provide reference and suggestions for dynamic adjustment of classification management lists for clinical use of antibiotics and the promotion of rational use of antibiotics.METHODSThe latest version of provincial classification management lists for clinical use of antibiotics were aggregated into the “national list”， which was compared with 2021 WHO AWaRe classification list of antibiotics （hereinafter referred as to “AWaRe classification list”） to make a descriptive statistical analysis about the number of different classes of antibiotics in the two lists and their differences.RESULTSBased on the different classification principles， 262 kinds of antibiotic preparations in the national list were classified into non-restricted （84）， restricted （83） and highly-restricted classes （95）， and 258 kinds in the AWaRe classification list were classified into access （87）， watch （142） and reserve classes （29）； 182 kinds of antibiotic preparations were both included in the two lists. In the national list， among the non-restricted antibiotic preparations， 36 kinds belonged to access class， 30 belonged to watch class and 1 belonged to reserve class； among restricted antibiotic preparations， 7 belonged to access class， 46 kinds belonged to watch class and 3 belonged to reserve class； among highly-restricted antibiotic preparations， 9 belonged to access class， 35 belonged to watch class and 15 kinds belonged to reserve class. Among them， 91 kinds of antibiotic preparations were not recommended by WHO （20 kinds） or not included in the AWaRe classification list （71 kinds）.CONCLUSIONSThe classification methods of two lists are different in classification principles and grading of some similar drugs. The classification management list of antibiotics is one of the key points of antibiotics management， more research is needed in the future to provide sufficient evidence for optimizing antibiotics classification management.关键词：classification management;AWaRe classification list;China;World Health Organization
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发布时间：2023-02-22 - 摘要：OBJECTIVETo explore the impact of the adjustment of the national reimbursement drug list on rare disease drugs in hospitals， and to provide reference for improving the drug security of patients with rare diseases in China.METHODSThe monthly procurement data of rare disease drugs from 789 medical institutions that continuously reported data from January 2016 to December 2018 were extracted from the Chinese Medicine Economic Information. The single-group interrupted time series model was used to compare drug varieties， procurement amount， average defined daily cost （DDDc） and defined daily doses （DDDs） of rare disease drugs before and after the adjustment of national reimbursement drug list.RESULTSIn 2017， a total of 9 rare disease drugs were newly included in the national reimbursement drug list， including pirfenidone， carbidopa/levodopa， riluzole， ropinirole， droxidopa， ezetimibe， everolimus， coagulation factor Ⅸ human recombinant and coagulation factor Ⅶa human recombinant. After the adjustment of the national reimbursement drug list， the average DDDc of 9 rare disease drugs was significantly decreased， the upward trend of DDDs and the procurement amount was significantly increased （P＜0.001）.CONCLUSIONSThe number of newly included rare disease drugs in national reimbursement drug list keeps increasing， the coverage of medical security keeps expanding， the price of rare disease drugs is significantly decreased， the economic burden of patients is further decreased， and the consumption of rare disease drugs is significantly increased， benefiting more patients with rare diseases； but at the same time， it also increases the procurement amount of rare disease drugs in hospitals. National medical security departments need to fully consider how to balance the affordability of medical insurance funds with the demand for rare disease drug coverage.关键词：rare disease;interrupted time series analysis;defined daily dose cost;defined daily doses
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发布时间：2023-02-22 - 摘要：OBJECTIVETo study the tissue distribution and pharmacokinetic characteristics of polyethylene glycol-（polylactic acid-hydroxyacetic acid） -polyethylene glycol triblock copolymer （PELGE） -crebanine nanoparticles （PELGE-Cre-NPS） in rats.METHODSThe SD rats were divided into 9 groups （1 group at each time point）， with 6 rats in each group，half male and half female. After PELGE-Cre-NPs（5 mg/kg） was injected into tail vein of rats， appropriate amounts of heart， liver， spleen， lung， kidney and brain tissues were taken at 5， 15， 30， 60， 90， 120， 180， 240 and 300 min， respectively. With verapamil hydrochloride as internal standard， the content of crebanine （Cre） in each tissue was determined by HPLC， and the main pharmacokinetic parameters such as area under the drug-time curve （AUC0－t） and mean retention time （MRT0－t） were calculated.RESULTSAt 5-90 min after medication， the content of Cre in each tissue of rats from large to small was lung， kidney， spleen， liver， brain and heart； at 120-300 min after medication， the sequence was lung， spleen， kidney， liver， brain and heart. AUC0－t of Cre in heart， liver， spleen， lung， kidney and brain were （18.86±1.66）， （43.36±4.99）， （51.36±5.34）， （81.86±12.34）， （53.31±3.19） and （27.73±4.76） mg·h/L， respectively. MRT0－t of Cre were （1.94±0.12）， （1.97±1.02）， （1.98±1.23）， （1.89±0.21）， （1.88±0.06）， （1.85±0.19） h， respectively.CONCLUSIONSPELGE-Cre-NPs mainly distribute in lung tissue， but less in heart tissue， and the elimination of PELGE-Cre-NPs in heart， lung and liver tissue is slow.关键词：crebanine;nanoparticles;tissue distribution;pharmacokinetics
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发布时间：2023-02-22 - 摘要：OBJECTIVETo investigate the effect and potential mechanism of safflower polysaccharide on apoptosis and autophagy of human hepatocellular carcinoma cells.METHODSHuman hepatocellular carcinoma HepG2， SMMC-7721 and Huh-7 cells were selected as subjects， and safflower polysaccharide was used as intervention drug to screen sensitive cells， intervention concentration and intervention time. The sensitive cells were selected as the object and intervened with different concentrations of safflower polysaccharide； the apoptosis， migration， clone formation， morphology and autophagy of human hepatocellular carcinoma cells were observed； the expressions of apoptosis， autophagy and phosphatidyl inositol-3-kinase （PI3K）/protein kinase B （Akt）/mammals rapamycin target protein （mTOR） signaling pathway related protein were detected.RESULTSsafflower polysaccharide could inhibit the proliferation of 3 kinds of human hepatocellular carcinoma cells， and the half inhibition concentration of it to SMMC-7721 cells was significantly lower than to other two kinds of cells （P＜0.05）. After 48 h intervened with low， medium and high concentrations of safflower polysaccharide （20， 40， 80 μmol/L）， the apoptosis of SMMC-7721 cells was increased compared with the control group， and cell migration rates at 24 and 48 h （except for safflower polysaccharide low-dose group at 24 h） and clone formation rate at 24 h were significantly decreased compared with the control group （P＜0.05 or P＜0.01）. Compared with the control group， cell number in safflower polysaccharide groups was significantly decreased， and autophagy levels were improved to some extent； the relative expressions of cleaved caspase-3， caspase-9， Bax and beclin-1 protein and ratio of LC3Ⅱ/LC3Ⅰ were significantly increased， and the relative protein expressions of Bcl-2， p62， PI3K， mTOR and Akt were significantly decreased （P＜0.05 or P＜0.01）.CONCLUSIONSSafflower polysaccharide could effectively inhibit the proliferation and induce apoptosis and autophagy of human hepatocellular carcinoma SMMC-7721 cells，the mechanism of which may be related to the inhibition of PI3K/Akt/mTOR signaling pathway.关键词：human hepatocellular carcinoma cells;SMMC-7721;apoptosis;autophagy;phosphatidyl inositol-3-kinase/protein kinase B/mammals rapamycin target protein signaling pathways
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发布时间：2023-02-22 - 摘要：OBJECTIVETo explore the effect and mechanism of limonin on liver fibrosis in rats.METHODSForty-two SD male rats were randomly divided into normal group， model group， positive control group （colchicine， 0.1 mg/kg）， low-dose group of limonin （12.5 mg/kg） and high-dose group of limonin （50 mg/kg）， with 9 rats in normal group and model group， and 8 rats in other groups. Except for normal group， the model of liver fibrosis was established by carbon tetrachloride. After modeling， normal group and model group were given distilled water intragastrically， and administration groups were given relevant medicine intragastrically，once a day，for consecutive 4 weeks. After the last medication， the serum contents of alanine aminotransferase （ALT）， aspartate aminotransferase （AST）， hyaluronic acid （HA） and laminin （LN） in rats were detected by enzyme-linked immunosorbent assay （ELISA） method. HE and Masson staining were used to observe the pathological changes and fibrotic change of liver tissue. Western blot assay was used to detect the protein expressions of protein kinase B （Akt）， phosphorylated-protein kinase B （p-Akt）， E-cadherin and vimentin in liver tissue； ratio of p-Akt/Akt was calculated.RESULTSCompared normal group， the serum contents of ALT， AST， HA and LN in rats were all increased significantly in model group （P＜0.01）； HE and Masson staining showed that a large number of fibrous tissue hyperplasia， protein expressions of Akt， p-Akt and vimentin as well as p-Akt/Akt ratio in liver tissue were significantly increased （P＜0.01）， while E-cadherin protein expression was significantly decreased （P＜0.01）. Compared with model group， the degree of fibrosis hyperplasia in liver tissue was relieved in high-dose group and low-dose group of limonin， and other indexes were all reversed significantly except for LN and E-cadherin in the low-dose group of limonin （P＜0.01 or P＜0.05）.CONCLUSIONSLimonin can improve liver fibrosis in rats， the mechanism of which may be related to the inhibition of Akt phosphorylation and reversal of epithelial-mesenchymal transition process.关键词：liver fibrosis;epithelial-mesenchymal transition;rat
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发布时间：2023-02-22 - 摘要：OBJECTIVETo qualitatively analyze the chemical constituents from Tianzhi granules and their constituents absorbed into blood， and to provide reference for elucidating pharmacodynamic material basis of Tianzhi granules.METHODSUPLC-ESI-Q-TOF-MS/MS was adopted. The analysis was performed on an Agilent Eclipse Plus C18 column with mobile phase consisted of 0.5% formic acid solution-acetonitrile （gradient elution） at the flow rate of 0.3 mL/min； the column temperature was 40 ℃；the injection volume was 10 μL. Mass spectrometry was applied for the qualitative analysis under positive ionization mode and ESI ion source. Data were collected with MS-DIAL4.60， and then chemical constituents of the extract from Tianzhi granule （by 0.5% methanol） were analyzed by comparing with relevant literature， SciFinder， PubChem， MassBank， TCMSP， TCM-ID and other databases. The blank serum， administered serum and Tianzhi granule extract were compared to analyze the constituents absorbed into the blood.RESULTSOne hundred compounds were preliminarily identified from Tianzhi granules， including 46 flavonoids， 8 organic acids， 8 alkaloids， 6 terpenes， 6 coumarins， 2 quinones， 1 steroids， 7 glycosides and 16 others. Based on it， 10 prototype constituents absorbed into blood were identified preliminarily， including genistein， melatonin A， chrysin-7-O- β-glucuronide， apigenin-7-O-glucuronide， wogonin， 6-O-methylbaicalin are flavonoids， 2-hydroxyquinoline and isonacolline are alkaloids， 7-hydroxycoumarin is coumarins，1-indanol is others.CONCLUSIONS2-hydroxyquinoline， 7-hydroxycoumarin， genistein， melatonin A， isonocolline， chrysin-7-O-β-glucuronide， apigenin-7-O-glucuronide， wogonin and 6-O-methylbaicalin may be the pharmacodynamic material basis of Tianzhi granules.关键词：chemical constituent;constituent absorbed into blood;flavonoids;alkaloids;UPLC-Q-TOF-MS/MS
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发布时间：2023-02-22 - 摘要：OBJECTIVETo investigate the improvement effect of Dihuang yinzi on neurological function of APP/PS1 double transgenic positive mice and its possible mechanism.METHODSAPP/PS1 double transgenic positive mice were randomly divided into APP/PS1 positive model group， Dihuang yinzi low-dose， medium-dose and high-dose groups （12， 24， 48 g/kg，by the amount of crude drug）， western medicine group （donepezil hydrochloride 0.8 mg/kg）； APP/PS1 transgenic negative mice were included in as APP/PS1 negative normal group， with 6 mice in each group. Administration groups were given relevant medicine intragastrically； APP/PS1 positive model group and APP/PS1 negative normal group were given constant volume of normal saline intragastrically， once a day， for consecutive 28 d. After the last medication， the ability of learning and memory， intestinal flora diversity （only medium-dose group of Dihuang yinzi）， pathological changes of neural cells in hippocampus， and the expressions of Bcl-2， Bax and brain-derived neurotrophic factor （BDNF） in mice of each group were investigated.RESULTSCompared with APP/PS1 positive model group， escape latency of mice was shortened significantly in Dihuang yinzi medium-dose and high-dose groups， while the times of crossing the platform significantly increased （P＜0.05）. Compared with APP/PS1 positive model group， Chao1 index of Dihuang yinzi medium-dose group was lower， while Shannon index was higher （P＜0.05）； OTU abundance of microbial flora was decreased to some extent； dominant flora was Clostridia o_ Clostridia_ vadinBB60_ Group， verruca G_ UCG_005. Compared with the APP/PS1 positive model group， the pathological changes of the nerve cells in the hippocampal CA1 area of mice were improved in the medium-dose and high-dose groups of Dihuang yinzi； the protein expressions of Bcl-2 and BDNF in the hippocampal tissue were significantly increased， while the protein expression of Bax was significantly decreased （P＜0.05）.CONCLUSIONSDihuang yinzi can enhance the diversity of flora， change the type of dominant flora， and can inhibit the apoptosis of brain neurons， and increase the level of BDNF； its mechanism may be to protect nerve cells by means of gut-brain axis， thereby improving the learning and memory ability of APP/PS1 positive model mice.关键词：gut-brain axis;neurological function;learning and memory ability;APP/PS1 double transgenic positive mice
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发布时间：2023-02-22 - 摘要：OBJECTIVETo evaluate the quality of Angelica dahurica decoction pieces processed by different drying methods.METHODSAdobe Photoshop 2020 software was used to determine the red green degree （a）， yellow blue degree （b） and brightness （L） values of A. dahurica decoction pieces processed by 3 drying methods as steamed-cut and fresh-cut-dried， and semi-fresh-cut-dried. The contents of nine coumarins such as umbelliferone in A. dahurica decoction pieces processed by 3 drying methods were determined by HPLC. SPSS 26.00 software and SIMCA14.0 software were used to conduct principal component analysis and partial least squares-discriminant analysis on the content of coumarin in 32 batches of A. dahurica decoction pieces. Gray correlation analysis was conducted on the color of the powder and the coumarins contents in A. dahurica decoction pieces.RESULTSThe a， b and L were 0-2.4， 6.0-20.3 and 35.6-51.1 in 32 batches of A. dahurica decoction pieces. The contents of umbelliferone， byakangelicin， psoralen， xanthotoxin， bergapten， oxypeucedanin， imperatorin， phellopterin and isoimperatorin were 0.026-0.324， 0.051-0.549， 0-0.113， 0-0.398， 0.256-1.115， 1.434-6.014， 1.866-4.039， 0.742-1.455 and 0.789-2.642 mg/g， respectively. And the total content ranged 6.442-13.382 mg/g， respectively. The results of principal component analysis showed that the comprehensive scores of BZ-27-BZ-30 and BZ-32 batches of semi-fresh-cut-dried decoction pieces were in the top order， and the internal quality of the other two kinds of decoction pieces was quite different. The results of partial least squares discriminant analysis showed that semi-fresh-cut-dried decoction pieces were clustered into one category， poor separation was observed in steamed-cut and fresh-cut-dried decoction pieces. Results of gray correlation analysis showed that the correlation coefficients of L and b with bergapten， oxypeucedanin， imperatorin， phellopterin， isoimperatorin and b with psoralen were all greater than 0.8， a had a low correlation with all components.CONCLUSIONSThe appearance traits of A. dahurica decoction pieces have strong correlation with the contents of coumarins. The quality of the decoction pieces can be roughly judged by the color， i.e. the whiter the color of the decoction pieces， the better the quality. The quality of sample obtained by semi-fresh-cut-dried is better than steamed-cut and fresh-cut-dried decoction pieces.关键词：drying method;appearance traits;coumarins;HPLC;quality evaluation
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发布时间：2023-02-22 - 摘要：OBJECTIVETo determine the protein binding rates of main effective components in Houpu paiqi mixture as magnolol and honokiol in animal plasma of different species， and compare the differences among species.METHODSThe plasma of bovine， rabbit and rat （internal dialysate） was placed in 4.5， 9.0 and 13.5 μg/mL （according to the weight of the decoction pieces of Houpu paiqi mixture） dialysate containing drug for 24 h by equilibrium dialysate method. The concentrations of magnolol and honokiol in dialysis internal and external fluids were determined by ultra-performance liquid chromatography-tandem triple quadrupole mass spectrometry， and the plasma protein binding rates were calculated and compared.RESULTSAt the concentrations of 4.5， 9.0 and 13.5 μg/mL， the protein binding rates of magnolol were （68.13±4.52）%， （74.34±1.12）% and （86.22±0.50）% in bovine plasma， （59.55±4.62） %， （72.81±4.56）% and （86.40±1.91）% in rabbit plasma， and （56.63±2.87）%， （77.81±1.83）% and （83.18±0.65）% in rat plasma， respectively. The protein binding rates of honokiol were （34.82±1.67）%， （40.29±3.28）% and （63.57±0.59）% in bovine plasma， （34.25±5.62）%， （62.12±7.36）% and （80.86±4.01）% in rabbit plasma， and （37.06±3.28）%， （52.61±1.69）% and （79.83±7.38）% in rat plasma， respectively. There was generally statistical significance among those groups （P＜0.05 or P＜0.01）.CONCLUSIONSThere are significant species differences in plasma protein binding rates of magnolol and honokiol， the main effective components of Houpu paiqi mixture， in a certain concentration-dependent trend.关键词：magnolol;honokiol;plasma protein binding rate;equilibrium dialysis;bovine plasma;rabbit plasma;rat plasma
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发布时间：2023-02-22 - 摘要：OBJECTIVETo evaluate the quality of Prunella vulgaris by entropy weight method combined with grey correlation degree analysis method by determining the contents of rosmarinic acid， total flavonoids， water and water-soluble extract.METHODSThe content of rosmarinic acid was determined by HPLC； the content of total flavonoids was determined by UV spectrophotometry； the contents of water and water-soluble extract were determined according to the general rules of Chinese Pharmacopoeia （part Ⅳ）. The weight coefficients of four indexes as rosmarinic acid were calculated by entropy weight method， and the relative correlation degree of each index was analyzed by grey correlation degree analysis method， and the quality of 117 batches of P. vulgaris was ranked.RESULTSThe contents of rosmarinic acid， total flavonoids， water and water-soluble extractive were 0.237 1%-0.943 0%， 2.923 6%-6.400 7%， 8.736 7%-12.446 3%， 11.638 8%-19.166 2%， respectively. The weight coefficients were 0.297 1， 0.277 5， 0.163 7 and 0.261 6， respectively. The relative correlation degrees were 0.159 3-0.616 3， and the correlation degree of S24 batch of samples was the highest （0.616 3）； that of P. vulgaris from Nanjing of Jiangsu Province ranged from 0.500 9 to 0.616 3， ranking the first.CONCLUSIONSUsing the contents of rosmarinic acid， total flavonoids， water and water-soluble extract as indexes， entropy weight method and grey correlation degree analysis method can be used to evaluate the quality of P. vulgaris. The quality of different batches of P. vulgaris are different， and the quality of P. vulgaris produced in Nanjing of Jiangsu Province is the best.关键词：content determination;entropy weight method;grey correlation degree;quality evaluation
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发布时间：2023-02-22 - 摘要：OBJECTIVETo investigate the effect and mechanism of Pinggan huoxue powder on cerebral ischemia-reperfusion injury （CIRI） in rats.METHODSCIRI model was induced by suture-occluded method. SD rats were divided into sham operation group， model group， positive control group （Tongxinluo capsule 0.325 g/kg）， Pinggan huoxue powder low-dose， medium-dose and high-dose groups （3.02， 6.04， 12.08 g/kg）， with 12 rats in each group. Each group was given constant volume of water or drug intragastrically， once a day， for consecutive 14 d. Longa score was used to evaluate neurological function of rats on the 1st， 7th and 14th day of intervention. After the last administration， the percentage of cerebral infarction volume in rats was measured， and neuronal injury （neuronal density） and neuronal apoptosis were observed； the protein expressions of p53， B cell lymphoma-2 （Bcl-2）， Bcl-2 associated X protein （Bax）， Caspase-3 and activated Caspase-3 （Cleaved caspase-3） in brain tissue were detected.RESULTSCompared with sham operation group， Longa score at the 1st， 7th and 14th day of intervention and the percentage of cerebral infarction volume in model group significantly increased （P＜0.05）， and the arrangement of cortical cells in ischemic side was disordered， Nissl bodies were absent and vacuolated， and a large number of cell apoptosis occurred. The neuronal density and protein expression of Bcl-2 at the lesion side were significantly decreased （P＜0.05）， while the protein expressions of p53， Bax， Caspase-3 and Cleaved Caspase-3 were significantly increased （P＜0.05 or P＜0.01）. Compared with model group， the expressions of Bcl-2 in cerebral ischemia cortex of rats in Pinggan huoxue powder high-dose group were significantly increased （P＜0.05）. Longa scores of rats in Pinggan huoxue powder medium-dose and high-dose groups on the 7th and 14th day of intervention were significantly decreased （P＜0.05）， and other indexes were also significantly reversed （P＜0.05 or P＜0.01）.CONCLUSIONSPinggan huoxue powder can protect cerebral nerves and inhibit apoptosis of CIRI model rats， the mechanism of which may be related to down-regulating the protein expressions of p53， Bax and Caspase-3 and up-regulating the protein expression of Bcl-2.关键词：cerebral ischemia-reperfusion injury;apoptosis;rat
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发布时间：2023-02-22 - 摘要：OBJECTIVETo evaluate the cost-effectiveness of dimethyl fumarate versus fingolimod in the treatment of relapsing multiple sclerosis （RMS）.METHODSThe cost-effectiveness of dimethyl fumarate versus fingolimod in the treatment of RMS was evaluated with cost-minimization analysis from the perspective of China’s health system. The research period of the model was 2 years， and the discount rate was 5%. Costs included drug costs， treatment monitoring costs and adverse reaction disposal costs. Relevant parameters were from published literature， government documents and expert interviews. A one-way sensitivity analysis of the results and a scenario analysis of the model duration were performed.RESULTSIn existing clinical studies， indirect meta-analysis results of different dimensions showed that dimethyl fumarate and fingolimod were similar in clinical efficacy. Within 2 years of the model simulation， total cost per patient using dimethyl fumarate was 91 756.3 yuan and that of using fingolimod was 163 761.5 yuan. The use of dimethyl fumarate was associated with savings of 72 005.2 yuan compared with fingolimod. When extending study horizon to 3 years， the cost savings with the use of dimethyl fumarate increased to 105 420.8 yuan， compared with fingolimod. The most influential factor on the results of the basic analysis was the drug treatment cost of fingolimod. Within the parameter fluctuation range of sensitivity analysis， the incremental costs were all negative， and the basic analysis results were robust.CONCLUSIONSBased on a health system perspective， dimethyl fumarate is more cost-effective than fingolimod in the treatment of RMS.关键词：fingolimod;relapsing multiple sclerosis;cost-minimization analysis
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发布时间：2023-02-22 - 摘要：OBJECTIVETo compare the efficacy and safety of weekly regimen versus intensive regimen of paclitaxel neoadjuvant chemotherapy for breast cancer.METHODSThe data of 249 patients with breast cancer admitted to Breast Cancer Prevention and Treatment Center of Peking University Cancer Hospital from January 2017 to December 2020 were retrospectively analyzed. After matching with the propensity score matching method， they were divided into single-week regimen group （91 cases） and intensive regimen group （91 cases） according to the different administration frequencies of paclitaxel. The patients in single-week regimen group were given Epirubicin hydrochloride for injection 90-100 mg/m2， intravenous bolus， d1+Cyclophosphamide for injection 600 mg/m2， intravenous bolus， d1， 14 days as a cycle； after four cycles， they were given sequential injection of Paclitaxel injection 80 mg/m2， intravenous drip， d1， once a week， for 12 weeks. The patients in intensive regimen group were given Epirubicin hydrochloride for injection （same usage and dosage as single-week regimen group）+Cyclophosphamide for injection （same usage and dosage as single-week regimen group）， after 4 cycles they were given sequential injection of Paclitaxel injection 175 mg/m2， intravenous drip， d1， 14 days as a cycle， a total of 4 cycles； they were also given Polyethylene glycol recombinant human granulocyte stimulating factor injection 6 mg 24 hours after chemotherapy or 0.3 mg on the 4th， 6th， 8th and 10th day after chemotherapy. The clinical efficacy， pathologic complete remission rate （pCR） and the occurrence of adverse drug reactions were compared between two groups.RESULTSThere were no significant difference in effective rate， ineffective rate and pCR between the two groups （P＞0.05）. The pCR of patients over 50 years old， menopause and negative for human epidermal growth factor receptor 2 in single-week regimen group was significantly higher than intensive regimen group （P＜0.05）. The incidence of neutropenia of grade 3 and above in intensive regimen group was significantly lower than single-week regimen group （P＜0.05）. There was no significant difference in the incidence of decreased hemoglobin， increased transaminase and peripheral neurotoxicity between the two groups （P＞0.05）.CONCLUSIONSAmong the breast cancer patients with negative for human epidermal growth factor receptor 2， over 50 years old and menopause， the pCR of single-week regimen of paclitaxel is high. However， because the chemotherapy interval of this scheme is short and the drugs that increase leukocytes are not used prophylactically， the incidence of neutropenia of grade 3 and above is high.关键词：breast cancer;paclitaxel;single regimen;intensive regimen;clinical efficacy;safety
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发布时间：2023-02-22 - 摘要：OBJECTIVETo excavate the risk signals of adverse events （AE） related to dipeptidyl peptidase-4 （DPP-4） inhibitors， and to provide reference for clinical safe use of these drugs.METHODSAE reports of five DPP-4 inhibitors （sitagliptin， saxagliptin， linagliptin， vildagliptin， anagliptin） reported in FAERS database from October 17th， 2006 to December 31st， 2021 were collected. The reporting odds ratio （ROR） method was used for data mining， and the systematic organ classification （SOC） and preferred terms （PT） in the drug ADR terminology set of the Medical Dictionary for Regulatory Activitios （24.0 edition） were used for classification statistics.RESULTSA total of 120 510 AE reports related to DPP-4 inhibitors were retrieved， with 1 707 risk signals， including sitagliptin （80 570 reports， 717 signals）， saxagliptin （10 009 reports， 173 signals）， linagliptin （18 214 reports， 317 signals）， vildagliptin （7 893 reports，375 signals） and anagliptin （3 824 reports，125 signals）. In these reports， women （47.27%） were more than men （44.61%）； the age of the patients mainly ranged from 61 to 75 years old （28.37%）. The United States had the largest number （56.17%）； there were 65 458 serious AE reports （54.32%）， mainly hospitalization or prolonged hospitalization time （36.28%）. Sitagliptin， saxagliptin and anagliptin mainly induced gastrointestinal diseases； sitagliptin mainly caused endocrine system diseases， kidney and urinary system diseases， various examinations； vildagliptin mainly resulted in endocrine system diseases， systemic diseases and various reactions at the administration site， nervous system diseases， etc. Among them， risk signals of sitagliptin and liggliptin mainly manifested as the increase of blood glucose， those of saxagliptin as the congestive heart failure and heart failure， and those of vildagliptin and anagliptin as pemphigoid and vomiting respectively. The results of PT analysis of two or more drugs showed that the increase of blood glucose and pancreatitis had the greatest correlation with sitagliptin； the weight loss had the greatest correlation with saxagliptin； renal failure had the greatest correlation with linagliptin； diabetic ketoacidosis had the greatest correlation with anagliptin. Hypoglycemia， acute kidney injury， increased glycated hemoglobin， pemphigoid and lactic acidosis were the most associated with vildagliptin.CONCLUSIONSWhen DPP-4 inhibitors were used clinically， the blood glucose level and other blood biochemical indexes of patients should be monitored， and skin condition， the pancreas and kidney function should be paid attention to. If related AE occurred， timely intervention measures should be taken to ensure the medication safety of patients.关键词：adverse event;signal excavation;type 2 diabetes
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发布时间：2023-02-22 - 摘要：OBJECTIVETo analyze the influential factors for dose-corrected trough concentration （C/D） of amisulpride， and to provide reference for rational use of it in clinic.METHODSThe results of the last serum concentration monitoring and relevant medical data of schizophrenic inpatients who were monitored for the treatment of amisulpride in the Mental Health Center of the First Hospital of Hebei Medical University from March to November 2021 were collected retrospectively and analyzed the effects of age， sex， body mass index （BMI）， serum creatinine level， and combined medication on the C/D value of amisulpride.RESULTSA total of 133 schizophrenic inpatients were included， and median dose of amisulpride was 600.00 mg/d， median serum concentration was 332.57 ng/mL， and median value of C/D was 0.61 ng·d/（mL·mg）. The serum concentration of 49 patients was within the recommended range of relevant guideline （100-320 ng/mL）， and 27 patients exceeded the laboratory warning concentration （640 ng/mL）. There was no statistical significance in drug dose， serum concentration or C/D value among the patients of different genders （P＞0.05）. The serum concentration of minor patients was significantly lower than that of adult patients （P＜0.05）， but there was no statistical significance in drug dose or C/D value between minor patients and adult patients （P＞0.05）. The C/D value of amisulpride in obese patients （BMI＞28 kg/m2） was significantly lower than that in normal patients （BMI 18.5-23.9 kg/m2）； the combination of olanzapine， sodium valproate and benzodiazepines did not affect the C/D value of amisulpride （P＞0.05）； the level of serum creatinine in patients was not related to the dose of amisulpride （r＝0.081， P＞0.05）， but was positively related to the C/D value of the drug （r＝0.285， P＜0.05）.CONCLUSIONSThe age， BMI and serum creatinine level of patients are closely related to the C/D value of amisulpride. In the clinical treatment of schizophrenia with amisulpride， we should fully consider the patient’s age， body mass， serum creatinine and other factors， and develop a personalized drug regimen for patients to ensure the safety and effectiveness of treatment.关键词：therapeutic drug monitoring;dose-corrected trough concentration;influential factor;drug combination
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发布时间：2023-02-22 - 摘要：OBJECTIVETo excavate the risk signals of adverse drug events （ADEs） of atezolizumab after marketing， so as to provide a reference for rational use of atezolizumab.METHODSUsing the FAERS database， the ADEs of atezolizumab were collected from marketing on May 18th 2016 to Mar. 31st 2022. The ADEs risk signals were mined by reported odds ratio （ROR） and medicines and Healthcare Products Regulatory Agency method （MHRA）， and then described and classified by preferred term （PT） and system organ classification （SOC） in the adverse drug reaction glossary of Medical Dictionary for Regulatory Activities （MedDRA） （23.0 edition）.RESULTSA total of 16 051 ADEs reports with atezolizumab as the primary suspected drug were collected， and 401 PT were mined， involving 17 SOC. In 16 051 ADEs reports， the majority of patients were male （51.64%）， with main age distribution of 19 to 64 years old and more than 65 years old. According to the number of reports， ADEs were mainly focusing on pyrexia， disease progression， interstitial lung disease， anaemia， pneumonia， etc. The involved SOC includes kidney and urinary system diseases， benign， malignant and unknown tumors （including cysts and polyps）， endocrine system diseases， etc. According to the signal intensity， the new ADEs not specified in the drug instructions were macular thickening，paraneoplastic neurological syndrome， reactive perforating collagenosis， paraneoplastic dermatomyositis， anti-erythrocyte antibody positive and liver sarcoidosis.CONCLUSIONSIn addition to the ADEs mentioned in the drug instructions，when using atezolizumab in clinic，attention should also be closely paid to ADEs of eyes， nervous and skin system， so as to ensure the safety of drug use in patients.关键词：adverse drug events;warning signal;data mining
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发布时间：2023-02-22 -
Establishment and application of a method for the determination of plasma concentration of delamanid
摘要：OBJECTIVETo establish and apply a method for the determination of plasma concentration of delamanid （DLM）.METHODSAfter plasma samples were treated with methanol precipitation， LC-MS/MS was adopted to determine the plasma concentration of DLM. The chromatographic column was Phenomenex SynergiTM Fusion-RP with mobile phase of methanol-0.1% formic acid solution （gradient elution）. The column temperature was 40 ℃， the flow rate was 0.3 mL/min， and the sample size was 1 μL. The ion source was electrospray ion source， and positive ion scanning was carried out in multi-reaction monitoring mode. The DLM ion pair used for quantitative analysis was m/z 535.0→352.0. The plasma concentration of DLM in 6 multidrug resistant tuberculosis （MDR-TB） patients were determined by the LC-MS/MS method.RESULTSThe linear range of DLM was 0.05-8 μg/mL （r＝0.999 5）， and the lowest limit of quantitation was 0.05 μg/mL. RSDs of intra-batch and inter-batch precision were all less than 10%. The accuracy ranged 92.7%-104.9%. Average matrix effect was 94.3%-107.5%. Average recoveries were 93.2%-98.1%. The plasma concentration of DLM in 6 MDR-TB patients ranged from 0.61-2.76 μg/mL， with an average of （1.67±0.74） μg/mL.CONCLUSIONSThe established LC-MS/MS analysis method has good specificity， high sensitivity， accuracy and precision， and can be used to determine DLM plasma concentration in MDR-TB patients.关键词：plasma concentration;multidrug resistant tuberculosis;LC-MS/MS- 5
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发布时间：2023-02-22 - 摘要：OBJECTIVETo compare the efficacy and safety of new oral anticoagulants （NOACs） and warfarin in the treatment of left ventricular thrombus （LVT）， and to provide evidenced-based reference for rational drug use in clinic.METHODSRetrieved from PubMed， Cochrane Library， Embase， Ovid Medline， CNKI， Wanfang and VIP during the inceptions to March 2022， after screening the literature and extracting data， the quality of randomized controlled trials （RCTs） was evaluated by using bias risk evaluation tool recommended by Cochrane systematic evaluator manual. Newcastle Ottawa Scale was used to evaluate the quality of cohort studies， and RevMan 5.3 software was used for meta-analysis and bias risk analysis.RESULTSA total of 13 studies were included in the analysis， including 2 RCTs， 11 cohort studies and 2 261 patients； results of meta-analysis showed that there was no statistical significance in the incidence of complete LVT resolution [OR＝1.05， 95%CI（0.81，1.37）， P＝0.71]， the incidence of stroke/systemic embolism [OR＝0.89， 95%CI（0.67，1.18）， P＝0.42]， the incidence of massive haemorrhage [OR＝0.61， 95%CI（0.19，1.97）， P＝0.41]， the incidence of rehospitalization [OR＝0.84， 95%CI（0.49，1.46）， P＝0.54] or all-cause mortality [OR＝0.93， 95%CI（0.56，1.56）， P＝0.79] between 2 groups. The incidence of any bleeding event in trial group was significantly lower than that control group[OR＝0.65， 95%CI（0.45，0.93）， P＝0.02]. Subgroup analysis showed that complete LVT resolution of patients with follow-up ≤6 months in trial group was significantly higher than control group， and the incidence of any bleeding event was significantly lower in patients with follow-up ＞6 months and in the European region than control group （P＜0.05）. There was no statistically significant difference in the rate of complete LVT resolution in patients with follow-up＞6 months， the incidence of any bleeding event in patients from Asia and America， or the incidence of any bleeding event in the two groups included in the RCT or the cohort study （P＞0.05）. The publication bias analysis showed that publication bias was less likely in the rate of complete LVT resolution but more likely in the incidence of any bleeding event.CONCLUSIONSNOACs can eliminate thrombus faster in the early stage， but with the prolongation of anticoagulation time， the efficacy of NOACs is comparable to warfarin， and the safety of NOACs in any bleeding event is better than warfarin.关键词：warfarin;new oral anticoagulants;efficacy;safety
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发布时间：2023-02-22 - 摘要：OBJECTIVETo evaluate the effectiveness， safety and economy of iron isomaltoside in the treatment of iron deficiency anemia using a rapid health technology assessment （HTA） method， and provide an evidence-based basis for clinical decision-making.METHODSPubMed， Embase， Cochrane Library， CNKI， Wanfang database and foreign HTA official websites were systematically searched， and the search time frame of the databases was from the establishment of the database to May 25th 2022. After data extraction and quality evaluation of the literature according to the inclusion and exclusion criteria， a descriptive analysis of the effectiveness， safety and economy of iron isomaltoside in the treatment of iron deficiency anemia was performed.RESULTS &CONCLUSIONSA total of 1 HTA report， 3 systematic reviews/meta-analysis and 5 economic studies were included. In terms of effectiveness， compared with ferric carboxymaltose， the hemoglobin level of patients using iron isomaltoside increased more， but there was no significant difference in the proportion of responding patients； compared with iron sucrose， it had non-inferiority in increasing and maintaining hemoglobin level， and there was no difference in the quality of life. In terms of safety， the incidence of adverse events of ferric carboxymaltose， iron sucrose and iron isomaltoside were 12.0%， 15.3% and 17.0%， respectively. Iron isomaltoside had a lower incidence of hypophosphatemia， compared with ferric carboxymaltose. There was no statistical difference in the incidence of hypophosphatemia among iron isomaltoside， iron sucrose， iron-dextrin and nanocrystalline iron oxide. The conclusion of the incidence of treatment-emergent adverse event， the incidence of serious adverse events and the withdrawal rate of patients due to adverse events was not clear. In terms of economy， the economy of iron isomaltoside is better than that of iron sucrose， and the economy of iron isomaltoside versus that of ferric carboxymaltose had not been finalized.关键词：iron deficiency anemia;rapid health technology assessment
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发布时间：2023-02-22 - 摘要：OBJECTIVETo provide reference for improving pharmacy service capabilities and management quality.METHODSBy interviewing clinical department， the problems in the drug dispensing process of inpatient pharmacy in our hospital were collected； combined with the internal self-inspection results of the inpatient pharmacy， the fishbone diagram for the cause analysis of the existing problems were drawn. PDCA management method was used to summarize the main factors from five perspectives of personnel， machines， environment， methods and drugs， and improve the intervenable main factors； relevant data were collected and the optimization results were evaluated from two dimensions of work efficiency and service satisfaction.RESULTSThe five processes of our hospital were optimized， such as dismounted oral drugs， temporary medical orders， narcotic and psychotropic drugs， long-term medical orders and drug withdrawal， and the function of prescription pre-review was newly added. Information functions such as “putting code for prescription” “positioning by scanning code” “reviewing by scanning code” “receiving by scanning code” “issuing by scanning code” “one-click dispensing” and “status visualization” had been added to the hospital information system using QR code technology， and long-term medical orders had been optimized from the previous dispensing by department to dispensing by drug category. Compared with before optimization， the printing time of dispensing lists， the time of long-term medical order dispensing， the time of drug withdrawal and the time of issuing anesthetic drug were shortened significantly； but the times of missed delivery or dispensing， the times of calling to inquire about drug dispensing by nurse were all decreased significantly； satisfaction rate of nurses and pharmacists increased by 26.32% and 37.50%， respectively.CONCLUSIONSThrough process sorting and informational optimization， the inpatient pharmacy dispensing processes of our hospital are further refined and standardized， achieving the double improvement of service quality and efficiency.关键词：information;dispensing process;service quality;work efficiency;QR code
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发布时间：2023-02-22 - 摘要：OBJECTIVETo provide reference for improving rational use of antibiotics in medical institutions.METHODSWith the help of information construction， strengthening personnel training and assessment， carrying out science popularization and education， optimizing drug catalogs， equipping full-time clinical pharmacists， optimizing assessment indicators and releasing pharmaceutical information in time， new fine management mode of antibiotics was constructed in our hospital. Through the hospital information system， the relevant data of our hospital in Jan.-Dec. 2020 （before the implementation） and Jan.-Dec. 2021 （after the implementation） were collected and compared， such as utilization rate of antibiotics， intensity of antimicrobial use， the incidence of hospital infection in the inpatients， the incidence of surgical site infection， the qualified rate of antibiotic medical order， and the proportion of antibiotics in the total outbound amount of Western medicine.RESULTSCompared with 2020， the utilization rate of antibiotics in hospitalized patients in 2021 decreased from 34.94% to 32.44%， intensity of antimicrobial use decreased from 39.07 DDDs （defined daily doses） to 30.77 DDDs， and the incidence of nosocomial infections among inpatients decreased from 2.64% to 1.91%； the incidence of surgical site infections decreased from 0.26% to 0.03%； the qualified rate of antibiotic medical orders increased from 93.82% to 97.75%； the proportion of antibiotics in the total outbound amount of Western medicine decreased from 14.86% to 12.51%.CONCLUSIONSThrough a series of fine management measures， our hospital has built a new fine management mode of antibiotics， which has improved the rationality of antibiotics use while ensuring the treatment effect.关键词：fine management;rational use of medicine
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发布时间：2023-02-22 - 摘要：OBJECTIVETo explore the establishment of standardized training system for medication direction provided by pediatric pharmacists.METHODSBased on the questionnaire， the current needs of pediatric pharmacists and parents of children for medication direction were investigated， and the standardized training content of pediatric medication direction was constructed as a whole with reference to the survey results， instructions， databases and other literature. The basic knowledge of medication direction was integrated and summarized from the basic information of drugs such as drug name， usage and dosage， as well as the course of treatment， order of medication and special precautions， so as to form the general introduction of training content. In accordance with the principle of “integrated drug classification based on diseases”， a standardized framework of medication direction for various common diseases in children was constructed to form various theories of training content. Concomitantly， the pilot training of pharmacists in Qingdao Women and Children’s Hospital of Qingdao University was carried out， and the training effect was preliminarily evaluated.RESULTSAfter standardized training， the daily examination scores of pharmacists in this hospital were significantly higher than those before training， and the situation of ‘0’ times of receiving patients’ thank-you letters in the window service was broken through； the effective satisfaction rate of window service showed an increasing trend； after the pharmacist explained the medication to the patient， the times of patient returning to consult the doctor on how to use the medicine showed downward trend.CONCLUSIONSThe establishment and implementation of a systematic standardized training system for pediatric-specialist pharmacists can help to further improve the professional skills and professionalism of pharmacists， strengthen the standardization of window medication direction and enhance patients’ sense of gain.关键词：medication direction;standardization system;training content;pilot training;performance evaluation
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发布时间：2023-02-22 - 摘要：OBJECTIVETo investigate the working pressure of return-working postpartum hospital pharmacists， analyze the influential factors， and find the suitable strategy to relieve the working pressure of postpartum pharmacists.METHODSBy the means of general information questionnaire， working pressure questionnaire and self-rating depression scale， the data of postpartum pharmacists were surveyed with sampling survey to investigate the working-pressure situation. The main influential factors of the postpartum working pressure were analyzed by multiple linear stepwise regression analysis.RESULTSA total of 281 valid questionnaires were collected from 84 different hospitals， with effective rate of 88.64%. The total score of working pressure for 281 postpartum pharmacists who were back to position was （79.80±23.06） （total score of 155）. However， 51.60% of return-working postpartum pharmacists showed depressive state （≥53）. The depression status was positively correlated with working pressure. Family support， frequency of physical exercise， and ideal personnel care were all negatively associated with working pressure.CONCLUSIONSThe working pressure of return-working postpartum pharmacists is at a moderate level. Depression， family support， ideal personnel care， and frequency of physical exercise are the main influential factors.关键词：return-working postpartum;working pressure;influential factors;depressive state
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发布时间：2023-02-22 - 摘要：With the aging of Chinese society and the deepening of the reform of the medical and health system， pharmaceutical professionals are committed to providing patient-centered， efficient and scientific pharmaceutical care. Continuous pharmaceutical care has become the focus of scholars in this field. In this paper， the concept， importance， dimensions and evaluation indicators of continuous pharmaceutical care， as well as the development status at home and abroad， are reviewed by literature research， and suggestions for development are put forward. The continuous pharmaceutical care has been relatively mature in some developed countries. But in China， due to its late development， it is urgent to explore and develop evaluation indicators suitable for China’s medical and health service system. The continuous pharmaceutical care in China is mainly based on the coordination between comprehensive medical institutions and primary medical institutions within the medical consortium， achieves orderly two-way referral between medical institutions according to the individual situation of patients， and provides individualized drug treatment management for patients during disease prevention， treatment and after treatment.It is suggested to homogenize the pharmaceutical care of medical institutions at different levels， promote the cooperation among the government， medical insurance， superior medical institutions， etc.， so as to improve the pharmaceutical care of primary medical institutions and accelerate the construction of a continuous pharmaceutical care system.关键词：medical consortium;present situation research
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发布时间：2023-02-22 - 摘要：Tea polyphenol （TP） is the main active constituent in tea， and epigallocatechin gallate （EGCG） is the main active constituent of TP that plays a biological role. Both of them can be used as immunomodulators in the treatment of tumor. In this paper， the anti-tumor mechanism of TP and EGCG was summarized from two aspects： enhancing immune effect and improving immune escape. The results showed that TP and EGCG could not only enhance the anti-tumor immune effect by promoting the activity of immune cells and the secretion of cytokines， but also improve tumor immune escape by regulating immunosuppressive cells， immune checkpoints， cytokines， immunomodulatory enzymes and JAK/STAT pathway， which has great potential in tumor immunotherapy.关键词：epigallocatechin gallate;immunoregulation;immune effect;immune escape;antitumor;mechanism
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发布时间：2023-02-22
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