最新刊期
卷 33 ， 期 2 ， 2022
- 摘要：Chinese patent medicine is an important part of pharmaceutical products in China. In order to speed up the establishment of an effective evaluation index system for the variety selection and clinical application of Chinese patent medicine in line with the characteristics of traditional Chinese medicine ，so as to scientifically select drugs and carry out the clinical application evaluation of Chinese patent medicine in a standardized and reasonable manner ，Jiangsu Society of Traditional Chinese Medicine and Traditional Chinese Medicine Special Committee of Nanjing Pharmaceutical Society have organized the formulation of this expert consensus. Consensus experts have used literature research method ，brainstorming method ，analytic hierarchy process ， Delphi method ，etc. to build an evaluation index system for the selection and clinical application of Chinese patent medicine ， including 24 secondary indicators and 102 tertiary indicators ，from the seven dimensions of safety ，effectiveness，economy， innovation，suitability，accessibility and clinical application （primary indicators ）. It is expected to provide decision-making basis for the variety selection and evaluation of Chinese patent medicine by the pharmaceutical management and pharmacotherapeutics committee（group）of medical institutions ，promote medical institutions at all levels to continuously optimize the medication catalogue and medication structure ，and accelerate the formation of the “1 + X ”（“1”for the essential medicine ，“X”for non-essential medicine ） medication model dominated by essential drugs ，promote medical institutions to use Chinese patent medicines scientifically ，reasonably and safely ，so as to improve the quality of pharmaceutical care ，control the irrational drug use and cost ，and better meet the drug use needs of the people.关键词：Chinese patent medicine;Selection;Clinical application;evaluation;Index system;Expert Consensus
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发布时间：2022-06-21 - 摘要：OBJECTIVE To provid e reference and sugge stions for improving the volume-based procurement of drugs and medical consumables （hereinafter referred to as “consumables”）in China. METHODS The relevant policy documents of centralized volume-based procurement of drugs and consumables published from November 2018 to November 2021 were retrieved ； the implementation status and problems of centralized volume-based procurement of drugs and consumables in China were analyzed by using the policy analysis method and referring to relevant research literatures. RESULTS & CONCLUSIONS National health department and healthcare security administration guaranted the rational use of selected products in medical institutions through incentive and supervision measures ；healthcare security administration should optimize the way of medical insurance payment ， promote the medical institutions to control the fees by themselves ，and conduct the credit evaluation of bidding and procurement ； medical products administration should evaluate the consistency of drugs and supervise the quality of selected products. With the normalization of centralized volume-based procurement of drugs and consumables organized by the state and trans-regional alliance ， the drug varieties and dosage forms included in centralized procurement were increasingly in line with the demand of Chinese pharmaceutical market. The price of most selected drugs decreased by more than 50％，and the decrease of consumables was significantly higher than that of drugs. The selected enterprises were mainly domestic generic drug enterprises ，and domestic consumables had gradually become the competitors and substitute of imported consumables. However ，there were still some problems such as repeated bidding and procurement in various alliances and provinces （autonomous regions and municipalities ）， unclear construction of compensation mechanism in medical institutions ，inconsistent bidding and procurement rules and quality evaluation standards for consumables ，low localization rate of some consumables ，low innovation level and profitability of pharmaceutical enterprises and consumables manufacturers. Local centralized volume-based procurement should be encouraged ，and the bidding and procurement rules and quality evaluation standards of “one product ，one policy ”should be gradually established. Great importance should be paid to the construction of compensation mechanism of medical institutions ，standardize zhangqiuyu739632@126.com the dynamic adjustment of medical serv ice prices ；pharma- ceutical enterprises and consumables manufacturers should increase research and development investment to transform into innovative and diversified enterprises ，so as to improve the competitiveness of domestic drugs and consumables.关键词：centralized volume-based procurement;Drugs;medical consumables;Status;suggestions;policy analysis
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发布时间：2022-06-21 - 摘要：OBJEC TIVE To provide reference for clinical comprehensive evaluation of pediatric drugs in China. METHODS Taking pediatric anti-allergic drugs as an example ，the clinical comprehensive evaluation methods of pediatric drugs in medical institutions were explored from the aspects of theme selection ，evaluation content and dimension ，evaluation index ，evaluation method and evaluation result report. RESULTS & CONCLUSIONS During the clinical comprehensive evaluation of pediatric drugs，under the guidance of relevant national guidelines for clinical comprehensive evaluation ，the evaluation topics could be selected according to the three principles of importance ，relevance and evaluability ，and then an appropriate evaluation index system could be developed around the six dimensions of safety ， effectiveness， economy， suitability，accessibility and innovativeness；qualitative and quantitative data integration analysis of the drugs to be evaluated were performed. In the evaluation ， it is necessary to focus on children ’s clinical basic drug use practice and decision-making needs ，normatively，scientifically and reasonably define the core index set and standard data set required by different dimensions of evidence ，standardize the collection and use of real-world data ，and effectively combine other types of evidence to truly play its advantageous role in the clinical comprehensive evaluation of pediatric drugs in China.关键词：pediatric drug;anti-allergic drug;clinical comprehensive evaluation
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发布时间：2022-06-21 - 摘要：OBJECTIVE To establish the fingerprints of c ultivated and wild Anemarrhena asphodeloides，and to identify their differential components. METHODS Using an evaporative light-scattering detector ， the high performance liquid chromatography combined with Similarity Evaluation System of TCM Chromatographic Fingerprint （2012 edition） were used to establish fingerprints of 14 batches of cultivated A. asphodeloides and 14 batches of wild medicinal materials ，and evaluate their similarity. The common peaks were identified by comparison with the chromatogram of the mixed control. At the same time ，the contents of components corresponding to common peaks in cultivated and wild A. asphodeloides were determined. The principal component analysis and orthogonal partial least squares discrimination analysis were adopted to identify differential components of them ，and compare the contents of them. RESULTS Among 28 batches of A. asphodeloides ，10 common peaks were found ，i.e. neomangiferin（peak 1），mangiferin（peak 2），isomangiferin（peak 3），timosaponin B Ⅱ（peak 7），timosaponin B Ⅲ（peak 8）， timosaponin Ⅰ（peak 9），timosaponin A Ⅲ（peak 10）. The similarities of fingerprints of samples with control fingerprint were no less than 0.963. The average total contents of seven components in cultivated and wild A. asphodeloides were 74.18 and 84.72 mg/g， respectively；there was statistical significance （P＜0.05）. The cultivated and wild A. asphodeloides could be divided into two categories. The differential components were neomangiferin ，mangiferin，timosaponin B Ⅱ and timosaponin A Ⅲ（VIP values were all higher than 1）. The content of neomangiferin in cultivated products was significantly higher than that in wild products （P＜ 0.05），and the contents of mangiferin ，timosaponin B Ⅱ and ti mosaponin A Ⅲ were significantly lower than those in wild products （P＜0.05）. CONCLUSIONS Fingerprint of A. asphodeloides is established ，and differential components of cultivated and wild A. asphodeloides are identified primarily.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To establish the infrared fingerprints of Achyranthes bidentata from different producing areas ，and to conduct multivariate statistical analysis. METHODS The infrared fingerprints of 61 batches of A. bidentata samples were established by Spectrum for Window 3.02 and OMNIC 9.2 software. Taking the relative peak height of common peaks of infrared fingerprint as the variable ，the normal distribution analysis was carried out by Excel 2016 software；SPSS 22.0 software was used for cluster analysis and principal component analysis ，and the comprehensive score was calculated ；the orthogonal partial least squares-discriminant analysis was carried out by SIMCA 14.1 software，and the marker wave numbers affecting the quality of A. bidentata were screened by taking the variable importance in projection （VIP）＞1 as the standard. RESULTS The correlation coefficients of infrared spectra of 61 batches of A. bidentata samples were 0.967 2-0.997 7；there were 13 common peaks. The results of normal distribution analysis showed that the normal distribution curve of relative peak height of common peaks for A. bidentata from Henan and Hebei did not cross ，and the normal distribution curve of A. bidentata from Henan and Inner Mongolia crossed. The results of cluster analysis showed that when the distance between groups was 15，61 batches of A. bidentata samples could be clustered into 3 categories，including N 1-N12 were clustered into one category ，N13-N45 were clustered into one category，and N 46-N61 were clustered into one category. The results of principal component analysis showed that the cumulative variance contribution rate of the first three principal components was 91.121％；comprehensive score of qq.com A. bidentata （number N 40） in Jiabu village ，Jiaozuo City ， Henan Province was the highest （2.39）， and that of A.bidentata（number N 4）in Xin ’an village ，Anguo City ，Hebei Province was the lowest （－2.89）. The results of orthogonal 163.com partial least squares-discriminant analysis showed that 61 batches of A. bidentata samples were divided into three categories ，including N 1-N12 were clustered into one category ，N13-N28 were clustered into one category and N 29-N61 were clustered into one category. Seven marker wave numbers affecting the quality were selected. The corresponding wave numbers of VIP from large to small were 1 059，927，2 933，813，1 732，1 128 and 3 367 cm－1，1 732 cm－1 was the characteristic obsorption peak of saponins ，1 059，1 128，927 cm－1 were the characteristic obsorption peaks of glycosides. CONCLUSIONS Infrared fingerprint combined with normal distribution analysis ，cluster analysis ，principal component analysis and orthogonal partial least squares-discriminant analysis can be used to identify A. bidentata from different producing areas.
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发布时间：2022-06-21 - 摘要：OBJE CTIVE To establish the finger prints for Yinhuang solution for inhalation and determine the contents of neochlorogenic acid ，chlorogenic acid and cryptochlorogenic acid simultaneously. METHODS Using baicalin as reference ，the fingerprints of Yinhuang solution for inhalation were established by high performance liquid chromatography （HPLC）. Relative correction factors of neochlorogenic acid and cryptochlorogenic acid were calculated by slope correction method ，using chlorogenic acid as reference ；the contents of them were calculated according to relative correction factor. The results of quantitative analysis of multi-components by single marker （QAMS）were compared with those of external standard method （ESM）. RESULTS There were 18 common peaks in the fingerprints of 10 batches of Yinhuang solution for inhalation ，and their similarities with reference fingerprint were higher than 0.90. A total of 7 common peaks were identified as baicalin ，neochlorogenic acid ，chlorogenic acid ， cryptochlorogenic acid ，isochlorogenic acid B ，3，5-di-O-caffeoylquinic acid and 4，5-di-O-caffeoylquinic acid. The linear range of neochlorogenic acid ，chlorogenic acid and cryptochlorogenic acid were 0.025 0-1.247 4 μg（r＝0.999 7），0.039 3-1.178 7 μg（r＝ 0.999 9），0.031 6-1.184 1 μg（r＝0.999 9），respectively. RSDs of precision ，reproducibility and stability tests （48 h）were all lower than 1.0％. The average recoveries were 93.92％（RSD＝1.32％ ，n＝6），94.46％（RSD＝1.45％，n＝6），93.93％（RSD＝ 1.57％，n＝6）. Relative correction factors of neochlorogenic acid and cryptochlorogenic acid were 1.068 and 1.233. The contents of neochlorogenic acid and cryptochlorogenic acid determined by QAMS method were 0.301 8-0.386 3 and 0.262 5-0.362 5 mg/mL， respectively. The contents of neochlorogenic acid ，chlorogenic acid and cryptochlorogenic acid by ESM were 0.302 6-0.387 2， 0.231 0- 0.334 0，0.261 6-0.361 3 mg/mL，respectively. The deviations of the content determination results of the two methods（except for chlorogenic acid ）were both not higher than 0.20％. CONCLUSIONS Established HPLC fingerprints are stable and feasible. Established QAMS method is accurate and rapid. HPLC fingerprint combined with QAMS can be used for the quality control for Yinhuang solution for inhalation ．
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发布时间：2022-06-21 - 摘要：O BJECTIVE To optimize stir-frying with saltwater technology of Citrus reticulata . METHODS Taking the contents of limonin ，nomilin and obacunone ，color difference value and free radical scavenging rate of 1，1-diphenyl-2-trinitrophenyl hydrazine （DPPH） as the indexes ，the entropy weight method was used for comprehensive evaluation. The stir-frying with saltwater technology of C. reticulata was optimized by central composite design-response surface method by using water-salt ratio ，stewing time，frying temperature and frying time as factors. RESULTS The optimal stir-frying with saltwater technology of C. reticulata included water-salt ratio of 8 ∶ 1（mL/g），stewing time of 22 min，frying time of 9 min and frying temperature of 158 ℃. After three times of validation tests ，the average comprehensive score of the optimized technology was 92.35（RSD＝2.19％），and its relative error with the predicted value （93.25）was 1.10％. CONCLUSIONS The optimal stir-frying with saltwater technology is stable and feasible.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To op timize the i ntegrated technology of producing area processing and decoction pieces processing of Curcuma longa （hereinafter refer to “integrated technology ”）. METHODS The content of ethanol-soluble extract in C. longa was determined by hot leaching method ；the contents of curcumin ，demethoxycurcumin and bisdemethoxycurcumin were determined by high performance liquid chromatography. On the basis of identification of producing area processing technology ， Using overall desirability （OD） value of the contents of ethanol-soluble extract ， curcumin， demethoxycurcumin and bisdemethoxycurcumin as evaluation indexes ，moisture content ，slice thickness and drying temperature as factors ，the integrated technology of C. longa was optimized by single factor tests combined with central composite design-response surface method ，and the validation tests were conducted. At the same time ，prepared product was compared with traditional decoction pieces prepared according to 2020 edition of Chinese Pharmacopoeia （part Ⅰ）. RESULTS The best integrated technology was that the fresh C. longa was boiled in boiling water for 5 min，dried at 50 ℃ to 40％ water content ，cut into 2 mm thin slices ，and dried at 50 ℃ until moisture content not exceeding 15.0％. After validation ，The deviation between the average OD value （0.811 3，RSD＝2.13％） and the predicted value （0.848 1）of the contents of ethanol-soluble extract ，curcumin，demethoxycurcumin and bisdemethoxycurcumin was 4.34％. OD value of the contents of ethanol-soluble extract ，curcumin，demethoxycurcumin and bisdemethoxycurcumin in decoction pieces prepared by integrated technology were all higher than those prepared by traditional technology. CONCLUSIONS The process optimized in this study is simple ，stable and feasible.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To optimize the e xtraction technology of Guizhi shaoyao zhimu decoction （GSZD）. METHODS The contents of 9 components in GSZD were determined by HPLC ，such as ephedrine hydrochloride ，pseudoephedrine hydrochloride ， mangiferin，paeoniflorin，liquiritin，5-O-methylvisammioside，glycyrrhizic acid ，cinnamic acid ，6-gingerol. On the basis of single factor experiment ，taking material-liquid ratio ，extraction times and extraction time as inspection factors ，taking the contents of above 9 components and the yield of dry extract as evaluation indicators ，the analytic hierarchy process and entropy weight method were used to determine the composite weight of each index and calculate the comprehensive score ；the extraction technology parameters of GSZD were optimized by Box-Behnken response surface method ，and the validation tests were conducted. RESULTS The composite weight of the contents of ephedrine hydrochloride ，pseudoephedrine hydrochloride ，mangiferin，paeoniflorin， glycyrrhizin，5-O-methylvisa- midol ，glycyrrhizinate，cinnamic acid ，6-gingerol and the yield of dry extract were respectively 0.12，0.10，0.05，0.12，0.14，0.06，0.13，0.15，0.10，0.03. The optimal extraction technology of GSZD is that the ratio of material to liquid is 1 ∶ 14（g/mL），extraction is 2 times，and the extraction time is 3.0 h；average comprehensive score of the 3 verification tests was 95.879，and RSD was 0.50％（n＝3），the deviation from the predicted comprehensive score （94.328）was 1.64％. CONCLUSIONS In this study ，the optimal extraction technology of GSZD is determined.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To establi sh the fingerprint of Cnidium monnieri and a method for the content determination of 4 kinds of coumarins. METHODS Ultra-high performance liquid chromatography （UPLC） method was adopted to establish the fingerprints of 21 batches of C. monnieri ； their similarities were evaluated with Similarity Evaluation System of TCM Chromatographic Fingerprint （2012 edition）；common peaks were identification by comparison with reference substance. Using 10 common peak areas as variables ，cluster analysis was performed for 21 batches of C. monnieri by the method of between groups. The relative correction factors of xanthotoxin ，bergapten and imperatorin were calculated by the same UPLC method with osthole as the internal reference. The contents of them were calculated by quantitative analysis of multi-components by single marker （QAMS），and compared with the results of external standard method. RESULTS Totally 10 common peaks were identified in the fingerprints of 21 batches of C. monnieri ；the similarities ranged from 0.997 to 1.000. Peak 4 was identified as xanthotoxin ，peak 8 as bergapten ，peak 9 as imperatorin and peak 10 as osthole. A total of 21 batches of samples were divided into 3 categories，of which S 7 was clustered into one category ，S14 was clustered into one category ，and the other 19 batches were clustered into one category. The relative deviations of the contents of xanthotoxin ，bergapten and imperatorin determined by QAMS and external standard method were in the range of 0.88％ -1.07％ ，2.22％ -2.29％ ，0.67％ -2.93％ ，respectively. CONCLUSIONS UPLC fingerprint of C. monnieri is successfully established ，and QAMS method for content determination of 4 coumarins is also established.关键词：Cnidium monnieri;ultra-high performance liquid chromatography;Fingerprint;Coumarins;quantitative analysis of
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发布时间：2022-06-21 - 摘要：OBJECTIVE To evalu ate the quality of crude drug and di fferent processed products of Eriobotryae Folium . METHODS Ten batches of Eriobotryae Folium were processed into honey-stir-baked Eriobotryae Folium ，ginger-juice-stir-baked Eriobotryae Folium ，ginger-juice-boiled Eriobotryae Folium ，licorice-juice-stir-baked Eriobotryae Folium ，licorice-juice-boiled Eriobotryae Folium ，stir-fried Eriobotryae Folium ，totally 70 batches of samples . The contents of alcohol-soluble extracts ，the contents of total triterpene acids （calculated by ursolic acid ）and five triterpene acids such as euscaphic acid were determined by hot-dipping method ，ultraviolet and visibe spectrophotometry and high performance liquid chromatography （HPLC），respectively. The fingerprints were established with HPLC and their similarity evaluation was conducted with Similarity Evaluation System of TCM Chromatographic Fingerprint （2004A）. Common peaks were identified by comparison with mixed control. Hierarchical clustering analysis ，principal component analysis and orthogonal partial least squares-discriminant analysis （OPLS-DA） were performed by using SPSS 22.0 software and SIMCA-P 14.1 software. RESULTS In Eriobotryae Folium ，honey-stir-baked Eriobotryae Folium ，ginger-juice-stir-baked Eriobotryae Folium ，ginger-juice-boiled Eriobotryae Folium ，licorice-juice-stir-baked Eriobotryae Folium ，licorice-juice-boiled Eriobotryae Folium ，stir-fried Eriobotryae Folium ，average contents of alcohol-soluble extracts were 25.90％，39.95％，27.44％，28.20％，28.38％，26.36％ and 29.26％；average contents of total triterpene acids were 40.62，49.33，52.56，46.38，52.17，55.06 and 53.41 mg/g；average contents of euscaphic acid ，crataegolic acid ，corosolic acid ， oleanolic acid ，ursolic acid and average total content were 1.966-4.808，1.459-2.824，4.525-8.172，1.294-1.817，6.294-8.470， 15.538-25.671 mg/g，respectively. There were 11 common peaks in 70 batches of samples ，and the peak 2，5，6，10 and 11 were identified as euscaphic acid ，crataegolic acid ，corosolic acid ， oleanolic acid and ursolic acid. The similarities of crude drug different processed products with crude drug fringer print were 0.919-1.000. Among 70 batches of samples ，10 batches of Eriobotryae Folium could be clustered into one category ，and 10 batches of ginger- juice-boiled Eriobotryae Folium could be clustered into one category ；other 50 batches of processed products of Eriobotryae Folium could be clustered into one category ； the cumulative variance contribution rate of the first two principal components was 80.682％；variable importance in projection （VIP）value was in descending order ，i.e. peak 2（euscaphic acid ）＞peak 5（crataegolic acid ）＞peak 6（corosolic acid ）＞peak 9 （unknown component ） ＞peak 11 （ursolic acid ）＞peak 10 （oleanolic acid ）， which of them were all higher than 1. CONCLUSIONS After processing ，the contents of alcohol-soluble extracts ，total triterpene acids and the total content of five triterpene acids （euscaphic acid ，crataegolic acid ，corosolic acid ，oleanolic acid and ursolic acid ）increased in varying degrees ， among which the content of alcohol-soluble extracts in honey-stir-baked Eriobotryae Folium was the highest ，the content of total triterpene acids in licorice-juice-boiled Eriobotryae Folium was the highest ，and total content of five triterpene acids in ginger- juice-boiled Eriobotryae Folium was the highest. Euscaphic acid ，crataegolic acid ，corosolic acid ，ursolic acid ，oleanolic acid and other components may be the differential components affecting the quality of raw and processed the leaves from Eriobotryae Folium .
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发布时间：2022-06-21 - 摘要：OBJECTIVE To provide re ference for accurate measurem ent of population health status ，pharmacoeconomic evaluation and guidance of health resource allocation. METHODS Using quota and convenient sampling ，five administrative villages were selected from the rural areas under the jurisdiction of Liuzhi special zone ，Qianxi city and Jianhe county of Guizhou province from July to September 2020. Based on the gender and age ratio quota of rural population in the results of the national census，330 respondents were selected for questionnaire survey. The contents of the questionnaire included the self-made scale containing sociodemographic characteristics and general health information ，five-level EuroQoL five-dimension questionnaire （EQ-5D-5L，hereinafter referred to as the “new dimension scale ”）with cognitive dimensions （including attention ，memory， computing ability and learning ability ）and mini-mental state examination （MMSE）. The effects of reliability ，validity and new dimensions of new dimension scale on respond ents’quality of life were investigate ，and its measurement characteristics were verified；the application value of it in pharmacoeconomic hy_cheer@126.com evaluation and guiding the allocation of health resources were explored. RESULTS A total of 330 questionnaires weredistributed，320 were recovered and 320 were effective. The recovery rate and effective rate were 96.97％ and 100％ respectively. The ceiling effect of new dimension scale was 13.44％，the split-half reliability was 0.821，and the overall Cronbach ’s α was 0.852. Exploratory factor analysis showed that the new dimension scale was loaded with physiological ，cognitive and psychological factors ，and the cumulative contribution rate was 69.35％. The correlation coefficient between the new dimension and the dimension of MMSE scale were 0.19-0.61，showing a moderate or medium to strong correlation （P＜0.01）. Compared with EQ- 5D-5L，after adding each dimension ，the interpretation ability of the regression model was improved by 5.00％-17.50％. CONCLUSIONS The new dimension scale has high feasibility ，good reliability and validity ，significantly reduces the ceiling effect of EQ- 5D-5L，has higher sensitivity to the evaluation of people ’s quality of life，and can better evaluate the quality of life of rural population. It is suggested that it can be applied for quality of life evaluation，intervention effect analysis and related economic evaluation.关键词：five-level EuroQoL five-dimensional questionnaire;Cognition;quality of life;rural population;Pharmacoeconomics
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发布时间：2022-06-21 - 摘要：OBJECT IVE To evaluate the efficacy ，safety and cost-effectiveness of Qili qiangxin capsule in the treatment of chronic heart failure ，and provide reference for drug selection and evaluation in relevant institutions. METHODS Meta-analysis was performed to investigate clinical efficacy and safety of Qili qiangxin capsule combined with routine treatment （combined treatment group）versus routine treatment （routine treatment group ）in the treatment of chronic heart failure. From the perspective of Chinese health care system ，a decision tree model was constructed. The time horizon of the model was 1 year. The effective rate obtained by meta-analysis was taken as the effect parameter ，and the total cost was calculated by drug cost and hospitalization cost ，to evaluate the cost-effectiveness of combined treatment versus routine treatment in the treatment of chronic heart failure. Subgroup analysis was carried out according to the course of treatment and literature quality ，and one-way sensitivity analysis and probability sensitivity analysis were adopted to check the robustness of basic analysis results. RESULTS Total of 72 literatures involving 9 575 patients were included in meta-analysis. Results of meta-analysis showed that effective rate ，left ventricular ejection fraction ， N-terminal fragment of the prohomone brain-type natriuretic peptide and 6 minute walking distance in combined treatment group were all better than those of routine treatment group ， while its safety was similar to routine therapy. The results of cost-effectiveness analysis showed that the cost of combined therapy was 1 867 yuan higher than that of routine therapy ，patients could get 0.016 QALYs more ，and the incremental cost-effectiveness ratio （ICER）was 117 861 yuan/QALY. If only high-quality literature were included for meta-analysis and the effectiveness parameters were obtained ，the ICERs of the combined therapy versus routine therapy were 102 162 yuan/QALY（based on all high-quality literature ）and 72 354 yuan/QALY（based on high-quality literature with treatment course of 24 weeks）. The results of the probability sensitivity analysis showed that taking twice China ’s per capita gross domestic product in 2020 as the willingness to pay threshold ，the probability of cost-effectiveness for Qili qiangxin capsule combined with routine therapy was 67.1％ . CONCLUSIONS Compared with routine therapy ，Qili qiangxin capsule combined with routine therapy has better clinical efficacy ，equivalent safety and cost-effective.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To establish t he method for determining the concentrations of fluoxetine ，norfluoxetine and sertraline in human placental perfusate method and their placental permeability. METHODS Using glyburide as internal standard ，the samples were pretreated by protein precipitation method and detected by ultra-fast liquid chromatograph-mass spectrometer/mass spectrometer （UFLC-MS/MS）. The determination was performed on Synergi TM Hydro-RP 80A LC column with mobile phase consisted of water （containing 0.1％ formic acid ）-acetonitrile（containing 0.1％ formic acid ）at the flow rate of 0.70 mL/min，with a gradient elution. The column temperature was set at 40 ℃，and sample size was 5 μL. Detection was performed with electrospray ionization source in multipl e reaction monitoring mode . The ion pairs for quantitative analysis we re m/z 309.9→148.1（fluoxetine），m/z 296.0→134.4 （-167）， （norfluoxetine），m/z 306.1→159.0 （sertraline），m/z 493.9→ No.2018FE001（-207），（internal standard ）. The perfusion model of singal placenta under bidrectional cardiopulmonary bypass was established. Fluoxetine （160 ng/mL），norfluoxetine（160 ng/mL）， sertraline（100 ng/mL）and antipyrine （positive control ，ng/mL）were added into the maternal perfusate. The concen- 65324888 trations of fluoxe tine， norfluoxetine and sertrali ne were measured by above UFLC-MS/MS at 0，10，20，30，45，60，90，120，150 and 180 min of circulation ，and the placental permeability was calculated. RESULTS The linear range of fluoxetine ，norfluoxetine and sertraline were 5.00-500 ng/mL（all r＞ 0.990），and the lower limits of quantification were all 5.00 ng/mL. The RSDs of intra-day and inter-day were all less than 14.0％， and relative error ranged －9.6％ to 14.7％. The relative error of stability test was －4.0％ to 11.0％；the residual effect ，extraction method and matrix effect did not affect the quantitative analysis of the substance to be tested. Totally 31 perfusion model of human placenta under cardiopulmonary bypass were successfully established ，including 15 fluoxetine and norfluoxetine perfusion ，10 sertraline perfusion and 6 antipyrine perfusion. After 3 hours of perfusion ，the average placental permeability of fluoxetine ， norfluoxetine and sertraline were （8.74 ± 1.67）％ ，（10.70 ± 4.81）％ ，（5.90 ± 1.25）％ ，respectively. CONCLUSIONS The established UPLC-MS/MS is simple ，sensitive and accurate. It can be used for determination of fluoxetine ，norfluoxetine and sertraline in human placental perfusate. Fluoxetine ，norfluoxetine and sertraline can pass through the placenta ，but sertraline has a lower placental permeability.
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发布时间：2022-06-21 - 摘要：OBJE CTIVE To mine and analyze t he cardiac adverse drug reaction （ADR）signals induced by febuxostat in post-marketing experience ，and to provide reference for rational drug use in clinic. METHODS Reporting odds ratio （ROR） method was used to mine the ADR signals induced by febuxostat from the FDA Adverse Event Reporting System during the first quarter of 2009 to the fourth quarter of 2020；the information of cardiac disease signals was counted and analyzed. RESULTS A total of 209 ADR signals were detected in 8 282 adverse drug event （ADE）reports with febuxostat as the primary suspected drug ， involving 27 cardiac signals and 754 ADE reports. The most reported signals were symptoms （262 reports），including dizziness ， oedema peripheral，chest pain ，palpitations and gravitational oedema and so on ，followed by coronary atherosclerotic heart disease signal，heart failure signal ，arrhythmia signal ，sudden cardiac death signal （233，157，90，12 reports，respectively）. More than half of the signals were mentioned in the drug instructions ，while the unmentioned signals were mainly kinds of cardiac failure ， arrhythmia and extrasystoles ，etc. The patients with cardiac ADEs who received febuxostat were more male than female ，and the age was 60 and over ；the drug dosage was mostly 40 mg/d or 80 mg/d as recommended in the drug instructions ，and cardiac ADEs mostly occurred within 1 month of medication. CONCLUSIONS Routine attention should be paid to the cardiac safety of febuxostat during medication ，further evaluation and validation of febuxostat-induced cardiac ADR signals are still needed.关键词：febuxostat;cardiac adverse event;ADR signal;Data mining
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发布时间：2022-06-21 - 摘要：OBJECTIVE To compare the anticoagulant effectiveness and safety of new oral anticoagulants （NOACs）and warfarin after heart valve replacement ，and to provide evidence-based reference for clinical drug use. METHODS Retrieved from PubMed，Cochrane Library ，Embase，Web of Science ，CNKI，Wanfang database and VIP ，clinical studies about the use of NOACs versus warfarin after heart valve replacement were collected during the inception to July 2021. After literature screening and data extrac tion，the quality of included randomized controlled trials （RCTs）were evaluat ed by bias risk assessment tool recommended by Cochrane system evaluator manual 5.2.0. After the quality of the included cohort studies was evaluated by Newcastle-Ottawa scale （NOS），RevMan 5.3 software was used for meta-analysis and sensitivity analysis. RESULTS A E-mail：carolmeng_0813@163.com total of 9 studies involving 4 962 patients were included ，of which 7 were RCTs and 2 were cohort studie s. Results of meta-analysis showed that after biological valve replacement/repair ，the incidence of stroke and systemic embolism （SSE）[OR＝0.71，95％CI（0.52，0.97），P＝0.03]，major bleeding [OR ＝0.40，95％CI （0.30，0.54），P＜0.000 01] and intracranial hemorrhage [OR ＝0.20，95％CI（0.04，0.95），P＝0.04] in trial group were significantly lower than warfarin group ；there was no significant difference in all-cause mortality between 2 groups [OR ＝1.25，95％CI（0.88， 1.79），P＝0.22]. After mechanical valve replacement/repair ，there were no significant difference in the incidence of SSE [OR ＝1.52， 95％CI（0.04，60.29），P＝0.82] or all-cause mortality [OR ＝0.26，95％CI（0.04，1.84），P＝0.18] between 2 groups. The results of subgroup analysis according to the follow-up time showed that after biological valve replacement/repair ，the incidence of SSE in trial group was significantly lower than that in control group when the follow-up time was ≤3 months [OR ＝0.20，95％CI（0.06， 0.74），P＝0.03]；but there was no significant difference in the incidence of major bleeding between 2 groups [OR ＝0.67，95％CI （0.19，2.38），P＝0.53]；when the follow-up time was longer than 3 months，there was no statistical significance in the incidence of SSE between 2 groups [OR ＝0.74，95％CI（0.54，1.02），P＝0.07]，while the incidence of major bleeding in trial group was significantly lower than control group [OR ＝0.39，95％CI（0.29，0.52），P＜0.001]. Subgroup analysis by study type showed that after biological valve replacement/repair ，the incidence of SSE in the RCT in trial group was significantly lower than that in control group [OR ＝0.51，95％CI（0.29，0.92），P＝0.03]，but there was no significant difference in the incidence of major bleeding between 2 groups[OR＝0.58，95％CI（0.33，1.03），P＝0.06]. In cohort study ，there was no significant difference in the incidence of SSE between 2 groups [OR ＝1.03，95％CI（0.40，2.66），P＝0.95]，while the incidence of major bleeding in trial group was significantly lower than control group [OR ＝0.20，95％CI（0.06，0.74），P＜0.001]. Sensitivity analysis results showed that the results of the above-mentioned meta-analysis were relatively robust. CONCLUSIONS For the patients underwent biological valve replacement/repair，the effectiveness and safety of NOACs are better than or similar to those of warfarin ；for the patients underwent mechanical valve replacement/repair ，there is no significant difference in the effectiveness and safety between NOACs and warfarin.
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发布时间：2022-06-21 - 摘要：OBJE CTIVE To inv estigate the antibiotic use and rationality for children in community health service institutions from Beijing ，and to provide reference for promoting rational use of antibiotics in primary healthcare institutions. METHODS All the prescriptions for children from primary healthcare institutions in 2019 were extracted from prescription review system of community health service institutions in Beijing. The use of antibiotics was described according to the related indicators of the World Health Organization/International Network for Rational Use of Drug （WHO/INRUD）. The structure of antibiotics use was analyzed according to the anatomical therapeutic chemical （ATC）classification as well as the WHO AWaRe classification and diagnosis. RESULTS A total of 288 primary healthcare institutions and 10 422 prescriptions for children were included. The number of institutions in high-income areas ，middle-income areas and low-income areas were 119，80 and 89 respectively，and the number of prescriptions involved were 2 430，2 163 and 5 829 respectively，including 1 447 prescriptions involving antibiotics （13.9％）. Among 1 447 prescriptions，the rate of prescriptions involving combined use of antibiotics was 1.4％（20 pieces）；the rate of prescriptions involving antibiotics injection was 9.7％（141 pieces）；4.8％ antibiotics prescriptions were rated as unreasonable （69 pieces）. The three most commonly used antibiotics were the macrolides （40.2％），the second-generation cephalosporins （26.5％） and the third-generati on cephalosporins （23.4％）. The proportion of antibioti cs prescriptions from groups of access ，caution， reserve and not recommended were 9.1％，92.1％，0.3％，and 0， respectively. The rate of antibiotics prescriptions fortonsillitis was the highest （31.9％ ）. Among 69 irrationalantibiotics prescriptions ，main of them were irrational drug use （56 pieces，81.2％）. CONCLUSIONS The rate of antibiotics prescriptions for children in primary healthcare institutions from Beijing is lower than the standard of WHO antibiotics prescription rate （20.0％-26.8％），but the use rate of antibiotics at caution grade is too high.关键词：primary healthcare institutions;Children;Antibiotics;prescription;Rational drug use;Beijing
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发布时间：2022-06-21 - 摘要：OBJECTIVE To provi de reference for scholars to carry out the research on the competency of pharmacists in pharmaceutical care and the human resource management of hospital pharmaceutical personnel. METHODS The questionnaire was designed with Pharmacist Pharmaceutical Service Competency Evaluation Standard （Trial）as the competency evaluation indexes. The convenient sampling method was used to investigate the pharmaceutical technicians from two third-class grade A hospitals in Harbin. Exploratory factor analysis was used to judge whether each dimension and item of competency index system needed to be adjusted；the final weight of each evaluation index was calculated by analytic hierarchy process ；fuzzy comprehensive evaluation method was used to evaluate the competency of pharmacists in pharmaceutical care. RESULTS Totally 152 questionnaires were collected and 142 valid questionnaires were collected ，with an effective recovery rate of 93.42％. In this study ，women accounted for 76.8％，those aged 40 and below accounted for 60.6％，those with bachelor ’s degree and above accounted for 84.5％，those with intermediate professional title accounted for 45.1％，and those with 10 years of work or below accounted for 60.6％. Four common factors were extracted in exploratory factor analysis ，and the cumulative variance contribution rate was 78.841％，which were named knowledge and skills ，motivation，personal literacy and professional ethics. The average score of the pharmacist ’s pharmaceutical care competency was （5.884±0.810），and the development of various dimensions of competency was not balance ； honesty and trustworthiness ，conscientiousness and responsibility and dedication scored higher ，while the scores of statistical knowledge，foreign language knowledge and drug treatment evaluation ability were lower. According to the evaluation method of fuzzy comprehensive evaluation ，the final comprehensive evaluation result was “consistent”. CONCLUSIONS The evaluation indexes of pharmacist competency have good reliability and validity in the competency evaluation of pharmacists in medical institutions. At the same time ，the basic knowledge of 32 hospital pharmacists and their ability to participate in clinical rational drug use need to be further improved.
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发布时间：2022-06-21 - 摘要：3-iodothyronamine（T1AM）is an endog enous derivative of thyroid hormone. It can also be used as exogenous drug. It can play pharmacological effects such as reducing cardiac output and coronary flow ，slowing heart rate ，promoting lipolysis ， reducing basic metabolism and improving learning and memory ability. Its regulatory effect on metabolism is similar to that of thyroxine，but regulatory effect on heart and thermogenic function is opposite to that of thyroxine. As a new chemical messenger ， T1AM can exert different pharmacological effects through a variety of receptors and signal pathways. This review summarizes the research progress of various pharmacological effects and mechanisms of exogenous T 1AM，in order to provide new therapeutic drugs of cardiovascular ，metabolic diseases and nervous system diseases.关键词：3-iodothyronamine;receptor;signal pathway;pharmacological effect
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发布时间：2022-06-21 - 摘要：In order to further consolidate the national essential medicine system and establish and improve the selection and adjustment mechanism of the national essential medicine list ，the Department of Drug Policy and Essential Medicine of the National Health Commission of the People ’s Republic of China recently has issued the Measures for the Administration of the National Essential Medicine List （Revised Draft ）. Under the background that China is in a critical period of improving the management procedures for the adjustment of the essential medicines list ，how to better design the adjustment procedure ，clarify the operation process and material requirements of each link ，ensure social participation and improve work transparency are important problems to be solved. By consulting the official websites of World Health Organization （WHO）and some typical countries with essential medicine system as well as related foreign literature ，the advanced practices of WHO and some typical countries in the adjustment procedures of the essential medicine list were summarized from 6 stages，such as start-up stage ，the material collection and summary stage ，the evaluation stage ，result publicity stage ，relief stage and application and promotion stage. It is suggested that China can learn from the relevant successful international experience ，scientifically set the adjustment cycle ，establish a normalized feedback mechanism with multi-agent participation ，design a standardized material collection process and a scientific and efficient evaluation process ，and improve the transparency and social identity of the publicity of the selection results of essential medicines ， so as to build a more scientific and perfect adjustment procedure of essential medicine list.关键词：essential medicines list;adjustment procedure;international experien ce
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发布时间：2022-06-21
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