最新刊期
卷 31 ， 期 23 ， 2020
- 摘要：OBJECTIVE：To provide refe rence for improving the moni toring system of simplified registration system of Chinese classical formulas. METHODS ：A comparative study was conducted on the simplified registration system of traditional herbal medicines in the European Union and Chinese classical formulas from the aspects of regulatory agencies ，regulatory systems ， simplified registration conditions ，simplified registration catalogs and registration data. On the basis of the experience of the simplified registration system of traditional herbal medicines in the European Union ，some suggestions were put forward to improve the simplified registration system of Chinese classical formulas. RESULTS & CONCLUSIONS ：The European Union establishes special committee on traditional herbal medicine for registration and supervision ；has established a complete regulatory system from directives to specific guidelines ；focuses on the history and conditions of the use of traditional herbal medicine ；has published the European Union monographs and European Union list ，which are used as a basis for safety and effectiveness to further reduce or exempt registration data. In China ，National Medical Products Administration and the National Administration of Traditional Chinese Medicine are jointly responsible for the registration and supervision of classical formulas. At present ，the relevant documents to simplify the registration and approval have been issued ，but there is no corresponding implementation rules and guidelines. China also attaches great importance to the clinical experience of classical formulas ，and emphasizes the consistency of preparation methods and dosage forms with ancient classics. Recently ，China has published the Catalogue of Ancient Classic Formula（the First Batch ），including 100 classical formulas ，and the classic formulas in the catalogue can be exempted from relevant registration materials when applying for registration. Our country can learn from the experience of the European Union and combine the actual situation of classic formulas supervision to establish an expert committee ，focus on quality control and risk control to improve registration and supervision system ，optimize the selection conditions of classic formulas ，and explore the classic formulas monographs ， to further stimulate the innovation vitality of traditional Chinese medicine industry.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To study the influential factors for green innovation in pharmaceutical enterprises based on grounded theory so as to provide reference for pharmaceutical enterprises to enhance their green innovation ability and the government to issue relevant green policies. METHODS ：The grounded theory research methods were used to select enterprise samples and follow-up research. Firstly ，56 staffs from 22 sample enterprises （all were pharmaceutical companies ）were interviewed in depth one-on-one and face-to-face on issues related to the influential factors for green innovation. Then ，open coding ，spindle coding and selective coding were carried out on the conversation record data ，and conduct theoretical saturation testing was conducted. Finally ， the influential factor model of green innovation in pharmaceutical enterprises was constructed ，and its main influential factors were analyzed. RESULTS & CONCLUSIONS ：The government demand ，social demand ，industry demand ，green innovation ability ， environmental awareness of leaders and overall vision of leaders have significant influence on the green innovation of pharmaceutical enterprises. Among them ，leadership decision （including leaders ’environmental awareness and leadership pattern ） is the internal decisive factor ，green innovation ability （including green innovation investment capacity ，green innovation research and development capacity ，green innovation transformation capacity and green innovation production capacity ）is the internal driving factor ，social system （including government needs ，social needs and industry needs ）is the external factor ；they are the main factors affecting the green innovation of pharmaceutical enterprises ，and they all have a positive effect on the green innovation of pharmaceutical companies.关键词：Green innovation;Grounded theory study;Pharmaceutical enterprises
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To prom ote the implementation of clinical comprehensive evaluation of drugs in China ，promote the return of drugs to clinical value ，improve the utilization efficiency of limited resources ，and provide reference for decision makers of health departments. METHODS ：By combing the relevant policy documents and literatures of clinical comprehensive evaluation of drugs，the evolution and research progress of relevant policies in China were introduced ；the advanced experiences （including evaluation subjects ，evaluation value dimensions ，evaluation methods ，evaluation procedures and results applications ）of Canada ，the United States ，the United Kingdom ，Australia，Europe，International Society for Pharmacoeconomics and Outcomes Research and other countries （regions/organizations）were analyzed and summarized ；relevant suggestions on the construction of China ’s clinical comprehensive evaluation mechanism for drugs were put forward. RESULTS & CONCLUSIONS ：It is suggested that the following measures should be taken to construct the clinical comprehensive evaluation mechanism of drugs in China including that the development goal and orientation of clinical comprehensive evaluation of drugs should be further clarified with the guidance of decision-making needs ；the government should play a leading role and strengthen inter departmental cooperation and policy coordination；the traceability quality control system of internal and external standards should be established ，adhere to openness ， fairness and fair ；at the same time ，it is suggested to give full play to the role of informatization and big data ，strengthen the exploration of evaluation methodology and standards ，strengthen the transformation and application of evaluation results ，and promote the service of evaluation results to policy decision-making.关键词：Clinical comprehensive evaluation of drugs;Multi-criteria decision analysis;Evaluation mechanism
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发布时间：2022-06-21 - 摘要：OBJECTIVE： To estab lish the method for simultaneous determination of the contents of cyperotundone ， nootkatone，α-cyperone and aristolone in the volatile oil of Cyperus rotundus ，compare the content differences of 4 components in C. rotundus samples from different origins ，and to provide reference for germplasm screening ，development and utilization of the medicinal material. METHODS ：The volatile oil was extracted from 46 batches of C. rotundus from 12 origins. The contents of cypermenone，nootkatone，α-cyperone and aristolone in volatile oil were determined by HPLC. The determination was performed on Kromasil C 18 column with mobile phase consisted of methanol-water （68∶32，V/V）at the flow rate of 1.0 mL/min；the column temperature was 30 ℃；the detection wavelength was set at 242 nm；the sample size was 20 μL. Using the contents of above 4 components as evaluation indexes ，radar image analysis ，cluster thermal map analysis and principal component analysis were performed for comparing the quality of C. rotundus from different origins. RESULTS ：The results of content determination methodology investigation met relevant requirements ；the total contents of 4 components in volatile oil from C. rotundus from different origins ranged from 136.986 4 to 538.832 1 mg/g，of which the total content of samples from Yunnan was the highest （the average value was 476.059 2 mg/g）. Radar image analysis results showed that the whole contour in the 4 origins of Guangdong ， Jiangxi，Guangxi and Yunnan was large relatively and better balanced ，among which the samples from Yunnan had the largest overall contour and the best balance. The cluster thermal map analysis results showed that the samples from 12 origins could be grouped into 2 categories，the first category was from Hubei ，Jiangxi，Yunnan，Sichuan，Guangdong，Shandong，Henan and Shaanxi；the second category was from Guangxi ，Shanxi，Anhui and Hainan ；the quality of samples from the first category were better than that of samples from the second category. The principal component analysis results showed that the cumulative contribution rate of the first three principal components was 96.1％，and the samples from 12 origins were mainly clustered into two categories ，which was consistent with the results of cluster thermal map analysis. CONCLUSIONS ：Established HPLC method can be used for simultaneous determination of cypermenone ，nootkatone，α-cyperone and aristolone in volatile oil of C. rotundus from different origins. Among the samples from 12 origins，the quality of medicinal material from Yunnan is better.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To establish a method for simultaneous determination of calycosin glucoside ，ononin，calycosin， formononetin，astragaloside Ⅳ，isoastragaloside Ⅱ，cycloastragenol and isoastragaloside Ⅰ in Astragalus membranaceus before and after bidirectional solid fermentation with Cordyceps kyushuensis ，and to investigate the effects of fermentation on the contents of above 8 components in A. membranaceus . METHODS ：HPLC-DAD-ELSD was adopted. The determination was performed on Agilent 5 TC-C18 column with mobile phase consisted of 0.1％ formic acid aqueous solution-acetonitrile （gradient elution ）at the flow rate of 1 mL/min. The column temperature was set at 30 ℃. DAD detection wavelength was set at 260 nm，ELSD evaporation tube temperature was 100 ℃，atomizer temperature was 80 ℃，carrier gas flow rate was 1.6 L/min；injection volume was 15 μL. RESULTS：The eight components had a good linear relationship within their respective ranges of concentration （all R2＞0.999 0）； RSDs of precision ，stability and repeatability tests were all less than 3％（n＝3 or n＝6）；the recoveries was 97.88％-101.32％， and RSDs were 1.22％-2.39％（n＝6）. Setting the content of components in unfermented A. membranaceus as 100％，after bidirectional solid fermentation with C. kyushuensis ，the change rates of 8 components were －98.51％，－96.41％，－94.74％， －96.40％，289.20％，20.25％，－75.05％，562.46％，respectively. CONCLUSIONS ：After fermentation with C. kyushuensis ，the contents of active components as astragaloside Ⅳ，isoastragaloside Ⅰ and isoastragaloside Ⅱ can be increased significantly in A. membranaceus .关键词：Astragalus membranaceus;Cordyceps kyushuensis;Bidirectional solid fermentation;HPLC-DAD-ELSD;Content
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To study the e ffects of stilbene glycoside c（TSG）on phosphorylation of Thr 205，Ser404 sites of Tau protein in Aizheimer ’s disease （AD）model mice ，and to investigate the potential anti-AD mechanism of TSG. METHODS ：APP/ PS1/Tau three transgenes （3×Tg-AD）mice were randomly divided into model group ，positive control group （huperzine，0.15 mg/kg），TSG low-dose ，medium-dose and high-dose groups （0.033，0.1，0.3 g/kg），with 6 mice in each group. In addition ，6 C57BL/6J mice were chosen as normal control group. Administration groups were given relevant medicine intragastrically. Model group and normal control group were given equal volume of normal saline intragastrically ，once a day ，for consecutive 60 days. After last medication ，immunofluorescence staining was used to detect Tau protein and phosphorylated Tau protein （Thr205， Ser404 sites） distribution and expression in brain tissue of mice in each group. Western blotting assay was used to detect phosphorylated Tau protein （Thr205，Ser404 sites）expression level in brain tissue of mice in each group. RESULTS ：Compared with normal control group ，the expression of Tau protein，phosphorylated Tau protein （Thr205，Ser404 sites）in 729011126@qq.com the brain tissue of mice were increased in model group ，which were easy to aggregate and distributed more widely ；theirrelative expression were increased significantly （P＜0.01）. Results of Western blotting assay showed that the expression levels of phosphorylat ed Tau protein （Thr205，Ser404 sites）were increased significantly （P＜0.01）. Compared with model group ，the expression of Tau protein ，phosphorylated Tau protein （Thr205，Ser404 sites） in the brain tissue of mice were decreased in positive control group and TSG groups ；aggregation decreased，distribution narrowed and their relative expression were decreased significantly （P＜0.01）. Results of Western blotting assay showed that the expression levels of phosphorylated Tau protein （Thr205，Ser404 sites）were decreased significantly （P＜ 0.01）. Compared with positive control group ，There was no significant difference in the distribution of Tau protein ，phosphorylated Tau protein （Thr205，Ser404 sites）in the brain tissue of mice in TSG groups ；the relative expression were not statistically significant（P＞0.05）；but Western blotting assay showed the expression levels of phosphorylated Tau protein （Thr205 site）in TSG medium-dose and high-dose groups as well as the expression levels of phosphorylated Tau protein （Ser404 site）in TSG groups were decreased significantly （P＜0.05 or P＜0.01）. CONCLUSIONS ：TSG can play an anti-AD effect on AD model mice by down-regulating the expression of phosphorylated Tau protein （Thr205，Ser404 sites）in brain tissue.关键词：Alzheimer’s disease;Stilbene glycoside;3×Tg-AD mice;Tau protein;Phosphorylation;Thr205 site;Ser404 site
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To provide refere nce f or the quality control and evaluation of rice-wine processed Coptidis Rhizoma decoction piece. METHODS ：Taking 17 batches of rice-wine processed Coptidis Rhizoma decoction piece from different manufacturers as samples ，HPLC method was adopted to determine the contents of 4 kinds of alkaloids as epiberberine ，coptisine， palmatine and berberine. The compound weights of epiberberine ，berberine，palmatine and berberine were calculated by the subjective and objective combination weighting method （AHP combined with variation coefficient ）. Then the quality evaluation method was used to evaluate the quality of decoction pieces combined with the appearance of decoction pieces and the contents of 4 alkaloids. The percent mass constant was calculated and the grade of rice-wine processed Coptidis Rhizoma decoction piece was classified. RESULTS ：According to the results of content determination of 4 kinds of alkaloids ，among 17 batches of samples ，a total of 13 batches of samples met the requirements of 2015 edition of Chinese Pharmacopoeia （part Ⅳ）. Mass constants of 13 batches of qualified samples were 10.03-26.96，and the percent mass constants were 37.20％-100％. If the percent mass constant ≥ 80％ of the sample was listed as the first-class product ，the sample with the percent mass constant between 50％-＜80％ was classified as the second-class product ，and the rest was listed as the third-class product ，therefore the quality constant of first-class product was ≥21.57，that of second-class product was 13.48-＜21.57，and that of third-class product was ＜13.48. According to the grading standard ，3 batches of 13 batches of qualified samples are classified as first-class products ，6 batches are classified as second-class products ，4 batches are classified as third-class products. CONCLUSIONS ：The established subjective and objective combination weighting method and quality constant method can more scientifically and reasonably classify rice-wine processed Coptidis Rhizoma decoction piece.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To study the effects of chrysophanol on the activa tion of microglia and the expression of inflammatory factors in cerebral ischemia model rats. METHODS ：SD rats were randomly divided into sham operation group ， model group and chrysophanol high ，medium，low dose groups [7.88，3.94，1.97 mg/（kg·d）]，with 20 rats in each group （the number was complemented in cases of death or unsuccessful modeling during modeling process ）. Except for sham operation group ， middle cerebral artery occlusion model was established in other groups by improved thread method. After 2 hours of ischemia ， sham operation group and model group were intraperitoneally injected with 1 mL normal saline ，and each administration group was intraperitoneally injected with 1 mL corresponding drug ，once a day ，for 7 consecutive days. After last medication ，the score of neurological impairment was recorded ；cerebral infarction of rats was observed by TTC staining ，and the percentage of cerebral infarction area was calculated. The expression of Iba- 1 positive cells in ischemic penumbra of rats was observed by immunofluorescence staining. The expression of Notch- 1，TNF-α and ICAM-1 in the ischemic penumbra of rats were detected by Western blotting assay. RESULTS ：In sham operation group ，there was no infarction area in the brain tissue ，and the Iba- 1 positive cells in the ischemic penumbra were few and branched. Compared with sham operation group ，the infarction area of cerebral tissue in rats was obvious in model group ； the 052）number of Iba- 1 positive cells in ischemic penumbra were 〔ZQ2017003〕） increased significantly ，and they were in amoeba or round shape；the neurological impairment score ，the percentage of cerebral infarction area ， relative expression of Notch- 1， TNF-α and ICAM-1 protein in ischemic penumbra were increased significantly （P＜0.05）. Compared with m odel rats ，the infarction area of cerebral tissue in each dose group of chrysophanol was reduced to different extent ；the number of Iba- 1 positive cells in ischemic penumbra was decreased ；neurological impairment score ，the percentage of cerebral infarction area ，relative expression of Notch- 1，TNF-α and ICAM-1 protein were significantly decreased （P＜0.05 or P＜0.01）. CONCLUSIONS ：Chrysophanol has a certain protective effect on the brain tissue of cerebral ischemia model rats ，and can relieve the nerve injury. Its mechanism may be associated with inhibiting the activation of microglia and expression of inflammatory factors mediated by Notch pathway.关键词：Cerebral ischemia;Chrysophanol;Microglia;Inflammation factor;Notch signaling pathway;Rats
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To investigate the anti-apoptotic effect of curcumin on H 2O2-induced H 9c2 cardiomyocyte injury and the regulation of NF-κB signaling pathway. METHODS：H9c2 cardiomyocyte were randomly divided into normal control group ， injury model group ，curcumin low-dose ，medium-dose and high-dose groups （25，50，100 μmol/L）. Normal control group didn ’t received any intervention. The cells in injury model group were induced with 50 μmol/L H2O2 for 12 h to establish the injury model. The cells in curcumin groups were treated with relevant concentration of drugs for 24 h，and then induced with 50 μmol/L H2O2 for 12 h. After cultured for 24 h，survival rate and apoptotic rate of cells were measured by MTT method and TUNEL method ；SOD activity and MDA content were determined by WTS- 8 assay and color test ；relative fluorescence intensity of LC 3 positive expression was detected by immunofluorescence method ；mRNA expression of NF-κB p65 in cells was detected by real-time PCR ； Western blotting assay was used to detect the protein expression of NF-κB p65 and p-NF-κB p65 in cells. RESULTS ：Compared with normal control group ，survival rate and SOD activity were decreased significantly in injury model group ，while apoptotic rate ， MDA content ，relative fluorescence intensity of LC 3 positive expression ，mRNA expression of NF-κB，protein expression of NF-κ B p 65 and p-NF-κB p65 as well as p-NF-κB/NF-κB were increased significantly（P＜0.05）. Compared with injury model group ， survival rates and SOD activities were increased significantly in curcumin groups ，while apoptotic rates ，MDA contents ，relative fluorescence intensities of LC 3 positive expression ，mRNA expression of LC 3 positive cells ，protein expression of NF-κB p65 and p-NF-κ B p65 as well as p-NF-κ B p65/NF-κ B p65 were decreased significantly （P＜0.05）. CONCLUSIONS ：Curcumin can increase the survival rate of H 2O2-induced H 9c2 cardiomyocyte injury ，decrease its apoptotic rate ，increase SOD activity and decrease MDA content in cardiomyocytes. Above effects may be related to the regulation of NF-κB signaling pathway.关键词：Curcumin;H9c2 cells;Cardiomyocyte injury;Anti-apoptotic effect;NF-κB signaling pathway
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To e stablish UPLC characteristics fingerprints of Lysimachia christinae ，and to simultaneously determine 3 effective components and to comprehensively evaluate the quality of L. christinae from different production areas. METHODS：UPLC method was adopted to establish characteristics fingerprint of the whole plant ，stem and leaves of 10 batches of L. christinae ，and determine the contents of kaemperfol- 3-O-rutinoside，quercetin，kaemperfol. The determination was performed on Waters CORTECS UPLC T 3 column with mobile phase consisted of acetonitrile- 0.2％ phosphoric acid aqueous solution （gradient elution ）at the flow rate of 0.2 mL/min. The detection wavelength was set at 364 nm，and column temperature was 30 ℃. The sample size was 1 µL. Similarity Evaluation System for TCM Chromatographic Fingerprint （2012 edition）was adopted to evaluate its similarity ， and common peaks were confirmed. Using the contents of kaemperfol- 3-O-rutinoside， quercetin， kaemperfol，total ash ，acid-insoluble ash and sulfur dioxide residue ，the ethanol-soluble extract as index ，entropy weight TOPSIS was used to evaluate the overall quality of L. christinae comprehensively. RESULTS ：There were 7 common peaks in the whole plant，stem and leaves of 10 batches of L. christinae ，among which 3 peaks were identified as kaemperfol- 3-O-rutinoside， quercetin and kaemperfol. The similarity of same part in the whole plant of L. christinae from different batches were not lower than 0.830. The similarity between stem and leaves of L. christinae in same batch was 0.504-0.859； the similarity between whole plant and stem was 0.593-0.904；the similarity between whole plant and leaves was 0.885-0.995. The linear ranges were 0.392 0-39.197 0 μg/mL for kaempferol-3-O-rutinoside， 0.397 0- 39.703 4 μg/mL for quercetin，0.380 9-38.093 0 μg/mL for kaempferol（r＞0.999 0）. RSDs of precision ，stability and repeatability tests were all lower than 2％. The recoveries were 96.43％（RSD＝0.63％，n＝9），100.32％（RSD＝0.46％，n＝9）， 101.80％（RSD＝0.32％，n＝9），respectively. The content range of above components in L. christinae were 0.006 3％-0.041 1％， 0.002 9％-0.008 6％，0.004 4％-0.017 5％（stem）；0.024 8％-0.290 5％，0.000 9％-0.009 0％，0.001 3％-0.012 4％（leaves）； 0.007 9％-0.118 0％，0.001 5％-0.008 8％，0.002 8％-0.012 5％（whole plant ）. There was no significant difference in the contents of 3 components in L. christinae among different producing areas （P＞0.05）. The order of the contents of kaempferol- 3-O- rutinoside in different parts of L. christinae was leaves ＞whole plant ＞stem. The contents of quercetin and kaempferol were high relatively in the stem. Results of entropy weight TOPSIS method showed that mean values of Ci for L. christinae from Zhongjiang county and Shuangliu county of Sichuan province ，Shizhu county of Chongqing city were 0.446，0.512，0.287. CONCLUSIONS ： Established fingerprint and content determination method are stable and feasible ，and multi-index evaluation model constructed by characteristic chromatogram combined with entropy weight TOPSIS analysis method can be used for comprehensive quality evaluation of L. christinae . The quality of L. christinae from Sichuan province is better.关键词：Lysimachia christinae;Different parts;UPLC;Content determination;Characteristic fingerprint;Entropy weight
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To compare the cost-effectiveness of insulin analogues and human insulin in the treatment of type 2 diabetes mellitus ，to reduce economic burden of patients ，and to provide new ideas for non-randomized pharmacoeconomic research. METHODS ：Retrospective data of a Third-grade Class-A hospital were adopted and 533 patients with type 2 diabetes were taken as object to balance the difference between groups through propensity score matching ，and construct net-benefit regression framework so as to analyze the cost-effectiveness of insulin analogues and human insulin in the treatment of type 2 diabetes mellitus. RESULTS ：There was a positive relationship between the efficacy and cost of the two therapeutic schemes ，i.e. insulin analogues were more effective than human insulin ，and the difference of total effective rate between the two schemes was 14.5％. The corresponding treatment cost of insulin analogues was higher than that of human insulin ，and the average total cost difference was 960.3 yuan. The cost of insulin analogues was 66.23 yuan more than that of human insulin for each additional unit of clinical effect （total effective rate ）. Results of net-benefit regression analysis showed that critical value of willingness to pay of therapy plan was 16 947.5 yuan. CONCLUSIONS ：When the willingness to pay is more than 16 947.5 yuan，the insulin analogue scheme is suitable ；on the contrary ，the human insulin analogue scheme is suitable. The propensity scoring technology used for the net-benefit regression analysis can broaden the source of avaliable data for non-randomized pharmacoeconomic evaluation.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To systematically evaluate the pharmacoeconomic research of the second-generation direct-acting antiviral agents （DAAs）in the treatment of hepatitis C ，and to provide methodological suggestions for economic research ，and to provide decision-making reference for the adjustment of medical insurance catalogues and market access. METHODS ：Retrieved from PubMed ，EMbase，the Cochrane library ，CNKI，Wanfang database and VIP ，the pharmacoeconomic researches of the second-generation DAAs for hepatitis C were collected during Jan. 2015-Jan. 2020. The quality of included studies were evaluated with the checklist about Consolidated Health Economics Evaluation Reporting Standards （CHEERS），and the data were extracted and analyzed quantitatively. RESULTS ：A total of 14 studies were included ，and the standard coincidence rate ranged from 79.2％ to 95.8％；the overall quality was relatively high. Thirteen （92.9％）studies had compared the economics of different treatment schemes from the perspective of the payer by using the Markov model and the lifetime study time limit. Compared with the second-generation DAAs treatment schemes based on sofosbuvir ，all the research results showed that Ombitasvir combined with Dasabuvir（3D），EBR/GZR and GLE/PIB were more economical in the target countries ；single factor sensitivity analysis showed that the research results were more sensitive to the three parameters of drug price ，drug SVR rate and health status utility value. CONCLUSIONS：Among the second-generation DAAs for hepatitis C ，the three regimens of 3D，EBR/GZR and GLE/PIB are more economical. It is recommended that future research on the economics of medicines for hepatitis C adopted dynamic model and the research perspective of the whole society to carry out direct high-quality economic research on a variety of DAAs ；at the same time，considered the effects of drug price ，drug SVR rate and health status utility value on the robustness of basic analysis results in sensitivity analysis in order to increase the credibility of the research results.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To provide reference for clinical empirical treatme nt of non-fermentative Gram-negative bacilli （NFGNB）infection. METHODS ：All kinds of clinical specimens were collected from Jan. 2010 to Dec. 2019 in a tertiary hospital from Hanzhong city of Shaanxi province ；the distribution and drug resistance of NFGNB were analyzed retrospectively. RESULTS ： A total of 26 386 strains of pathogenic bacteria were detected in the hospital during 2010-2019，including 4 077 strains of NFGNB （15.45％），mainly from patients ≥60 years old （1 836 strains，45.05％）. During the 10 years，the detection rate of NFGNB decreased from 20.14％ in 2010 to 15.36％ in 2019 （P＜0.001）. Acinetobacter baumannii （1 359 strains），Pseudomonas aeruginosa （1 269 strains），Stenotrophomonas maltophilia （447 strains） and Burkholderia cepacia （351 strains） were main pathogens. The detected NFGNB mainly came from hospitalized patients （4 001 strains），and most of them were found in ICU （17.05％），neurosurgery department （14.52％），respiratory department （12.41％），and respiratory tract （66.69％），secretion （7.80％）specimens. The detection rates of A. baumannii and P. aeruginosa in oncology department ，blood specimens and urine specimens showed an overall upward trend ，while the detection rates in ICU of the hospital showed a downward trend （P＜0.05）； the detection rate of P. aeruginosa in neurosurgery department showed an upward trend （P＜0.05），and that of A. baumannii in respiratory department showed an upward trend （P＜0.05）. The resistance rate of A. baumannii to carbapenems increased from about 10％ in 2010 to about 75％ in 2019，and the guyh3201@163.com resistance rate to cephalosporins exceeded 78％. The resistance rates of P. aeruginosa to imipenem and me ropenem were lower than 35％ and 30％ respectively，and the trend of drug resistance did not change significantly （P＞0.05）；the resistance rates to 12 kinds of clinically commonly used antibiotics as piperacillin and aztreonam were lower than 40％. The resistance rate of S. maltophilia to compound sulfamethoxazole showed a decreasing trend （P＜0.001），and the resistance rate to ceftazidime was high （54.70％-74.10％）. The resistance rates of B. cepacia to compound sulfamethoxazole，meropenem and ceftazidime showed a downward trend （P＜0.01），and were lower than 15％ after 2014. CONCLUSIONS：Although the detection rate of NFGNB in our hospital showed a downward trend ，the multi-drug resistance and pan-drug resistance of A. baumannii are serious ，and the resistance rate to carbapenems is increased. Sensitive drugs such as cefoperazone/sulbactam，amikacin，levofloxacin and ceftazidime should be selected for NFGNB infection according to the results of drug sensitivity tests.关键词：Non-fermentative Gram-negative bacilli;Drug resistance transition;Acinetobacter baumannii;Pseudomonas
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To systematically evaluate the effectiveness and safety of low-m olecular-weight heparin combined with progesterone in the treatment of repeated implant failure （RIF）in embryo transfer patients ，and to provide reference for clinical use of it. METHODS ：Retrieved from Cochrane library ，PubMed，Embase，CNKI and Wanfang database ，randomized controlled trail （RCT）or observational study about low-molecular-weight heparin combined with progesterone （trial group ）versus progesterone（control group ）for RIF patients were collected during the inception to Jul. 2020. After data extraction of studies met included criteria ，the Cochrane 5.1.0 bias risk assessment tool and the Newcastle-Ottawa Scale evaluation scale were used to evaluate the quality of RCTs and observational studies. Rev Man 5.3 software was used for Meta-analysis. RESULTS ：A total of 15 studies were included ，including 10 RCTs and 5 observational studies ，with a total of 2 353 patients. Results of Meta-analysis showed that the implantation rate [RR ＝1.41，95％CI（1.24，1.60），P＜0.01]，pregnancy rate [RR ＝1.38，95％CI（1.23，1.56）， P＜0.01]，live birth rate [RR ＝1.41，95％CI（1.19，1.67），P＜0.01] of trial group were significantly higher than those of control group，with statistical significance ；while the abortion rate [RR ＝0.54，95％ CI（0.33，0.86），P＝0.01] of trial group was significantly lower than that of control group ，with statistical significance. The results of subgroup analysis showed that the implantation rate [RR ＝2.38，95％CI（1.31，4.31），P＝0.004] and pregnancy rate [RR ＝2.58，95％CI（1.62，4.11），P＜0.001] of patients over 35 years old in trial group were higher than control group ，with statistical significance. The main ADR of 2 groups were a small amount of bleeding and ecchymosis at the injection site. No severe ADR was observed. CONCLUSIONS： Low-molecular-weight heparin combined with progesterone can improve the embry o implantation rate ， pregnancy rate and live birth rate of RIF patients ，reduce the abortion rate ，with good safety.关键词：Low-molecular-weight heparin;Embryo transfer;Repeated implantation failure;Effectiveness;Safety;Meta-
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发布时间：2022-06-21 -
Key Elements Analysis of Sustainable Development of Pharmacy Intravenous Admixture Services in China
摘要：OBJECTIVE：To explore the key factors affecting the sustainable development of pharmacy intravenous admixture service（PIVAS），and to provide theoretical basis for the healthy development of PIVAS. METHODS ：Retrieved from PubMed ， CNKI，Wanfang database and VIP ，literatures related to the development of PIVAS. Combining with the actual operation and development of PIVAS in China in recent 20 years，based on actual experience of PIVAS in our hospital in recent 10 years，the key factors affecting the sustainable development of PIVAS were analyzed by retrospective method from five aspects ，i.e. drug management，quality control ，pharmacists’professional quality improvement ，pharmaceutical care extension ，cost and benefit. RESULTS & CONCLUSIONS ：The key elements of PIVAS drug management included drug inventory ，expiration date ，daily inventory，high-warning drug ，drug damage ，slack demand of drug and drug shortage. The key elements of PIVAS quality control included personnel quality control ，environment quality control and quality control of finished infusion. Improving the professional ability and communication service ability of pharmacists were the key factors to improve the professional quality of pharmacists. The establishment and application of medication order review and accurate flushing database based on PIVAS prescription audit system，professional drug consultation and clinical education ，whole pharmaceutical care of cytotoxic drugs and PIVAS adverse drug reaction monitoring were the key elements of pharmaceutical service extension. It can promote the sustainable and healthy development of PIVAS to improve pharmacists ’professional ability and communication ability ，strictly drug management and quality control ，continously extend pharmaceutical care ，improve professional influence and expand social influence and formulate reasonable charging mechanism.关键词：PIVAS;Sustainable development;Influential factor;Rational drug use- 100
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To provide refe rence for inte lligent managemen t of central pharmacy. METHODS ：The construction experience of intelligent central pharmacy management mode were introduced ，including the use of information technology ，the introduction of automation equipment ，the rational layout of the central pharmacy ，as well as the optimization of work flow ，and the establishment of integrated management mode ，etc. The workload of intelligent central pharmacy in our hospital before construction（2016），during construction （2017-2018）and after operation （2019）were collected from our hospital information system（HIS），including the number of injection doctor ’s orders ，the number of doctor ’s orders reviewed ，the number of PIVAS deployment，the number of oral medical orders ，the number of medical orders discharged with medicine ，etc. The pharmacist scheduling before and after the operation of intelligent central pharmacy in our hospital was counted. The average daily quantity of injection prescription ，average dispensing speed ，timely delivery rate and dispensing errors were calculated. In addition ，the satisfaction of medical staff in 39 wards of our hospital were investigated every quarter to evaluate the implementation effect of intelligent central pharmacy management model. RESULTS ：From 2016 to 2019，the workload of the central pharmacy in our hospital showed an overall upward trend ，and the average daily prescription amount increased year by year ，and the average daily prescription amount in 2017-2019 was significantly more than that in 2016（P＜0.05）. Average dispensing speed ，timely delivery rate and dispensing errors of central pharmacy during 2018-2019 were significantly lower than 2016（P＜0.05）. The daily number of pharmacists in dispensing posts in the central pharmacy was reduced from 22 in 2016 to 18 in 2019，with 4 pharmacists saved. During the 4 years，867 questionnaires were distributed and 862 valid questionnaires were recovered. The effective recovery rate was above 99％. The average satisfaction of medical staff in the ward to the central pharmacy was high relatively ，being 96.8％， 98.4％ ，99.1％ and 99.1％ respectively from 2016 to 2019. CONCLUSIONS ：The integrated intelligent center pharmacy management mode established in our hospital has realized the information and automatic management of inpatient medication order dispensing；reasonable arrangement of the work contents of professional and technical personnel with different professional titles can not only save the labor cost ，but also increase the content 09304021） of pharmaceutical care ，broaden the work depth ，so as to improve the work efficiency and ensure the quality of 126.com pharmaceutical care.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To standardize and optim ize the clinical use of Trastuzumab for injection ，and to provide reference for rational use of drugs in the patients. METHODS ：The pharmacy intravenous admixture service （PIVAS）in our hospital took the lead in communication and coordination with financial ，information，medical insurance departments as well as clinicians and nurses，to set up dispensing ，charging and reimbursement mode by dose of trastuzumab. Under that ，doctors could give orders according to the clinical dosage of patients ；PIVAS dispenses drugs according to the actual dose ；the drugs were shared among patients；the charge and reimbursement of drugs are carried out according to the actual dose of patients. At the same time ，the questionnaire survey was conducted among 60 patients about the medical experience and cost savings before and after the implementation of the mode . RESULTS ：The questionnaire survey showed that in terms of solving the potential safety problems of trastuzumab and the inconvenience of patients ’medical treatment ，the solution rate of the mode was 100％；in terms of improving patients’feeling of seeking medical treatment and helping treatment ，the improvement rate was 100％；in terms of saving patients ’ treatment costs ，most（80％）of the patients thought that it could save less than 500 yuan each time ，and rest of the patients thought that it could save more than 500 yuan each time. CONCLUSIONS ：The mode of dispensing ，charging and reimbursement of Trastuzumab for injection in our hospital has solved the problems of drug waste ，occupational injury and inconvenient preservation in clinical use ，and has played a good role in drug safety ，cost saving and patient convenience.关键词：PIVAS;Trastuzumab;By dose;Dispensing;Charging;Reimbursement
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发布时间：2022-06-21
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