最新刊期

    33 14 2022
    • RONG Hongguo,LI Qi,DONG Yue,XIA Ruyu,FEI Yutong
      Vol. 33, Issue 14, (2022)
      摘要:OBJECTIVE To provide refere nce for the optimization and adjustment of the relevant policies in the field of pediatric drug in China. METHODS“Children”“pediatrics”and“drugs”were taken as the keywords to search the official websites of the State Council ,the National Health Commission ,the National Healthcare Security Administration ,the State Administration of Market Regulation and other relevant ministries and commissions ,and collect the relevant pediatric drug policies issued at the national level from January 1,2010 to December 31,2021. Content analysis method was used to summarize ,code and statistically analyze the policy tools used in the policy research documents. RESULTS A total of 39 policy documents and 327 policy tools were included in this study. According to statistics ,from 2011 to 2021,China issued national policy documents on pediatric drug use every year ,and in recent years ,the issuance of documents was relatively intensive. The main body of issuing pediatric drugs policy was the national health department and drug supervision and administration department (71.79%,28/39),and the number of documents issued by relevant ministries and commissions alone (76.92%,30/39)was significantly more than the number of documents jointly issued by multiple ministries and commissions (23.08%,9/39). The environmental policy tools were the most widely used (64.83%,212/327),followed by s upply-oriented policy tools (30.28%,99/327),and demand-oriented policy tools were the least used (4.89%,16/327). CONCLUSIONS The development of pediatric drug use in China is in its infancy. It is suggested that China should optimize supply-oriented policy tools,increase capital investment and the use of public health service tools ;adjust environmental policy tools ,accelerate the legislation of pediatric drugs ,and increase the proportion of incentive policy tool ;attach importance to demand-oriented policy tools ,strengthen international exchanges and the application of service outsourcing in the field of pediatric medication ;plan the use of various policy tools as a whole ,and coordinate the use proportion of three types of policy tool and their sub policy tools,so as to enhance the initiative of policy tools ,form policy synergy ,and jointly promote the development of pediatric drug use.  
      关键词:pediatric drug;Policy tool;policy analysis;content analysis method   
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      发布时间:2022-11-09
    • LI Zulan,ZHOU Geyao,MEI Yuhong,MAO Jia
      Vol. 33, Issue 14, (2022)
      摘要:OBJECTIVE To understan d the c urrent situation and feasibility of payment reform for TCM dominant diseases from the perspective of clinicians ,so as to provide reference for optimizing and improving the reform scheme. METHODS A questionnaire was designed by ourselves ,and a simple random sampling method was used to select clinicians from the pilot hospitals of payment reform for TCM dominant diseases in Guizhou province to conduct a face-to-face questionnaire survey. SPSS 20.0 software was used for statistical analysis. The single-factor analysis and ordered Logistic regression analysis of multi-factor were used to analyze the influential factors of reform feasibility. RESULTS A total of 420 questionnaires were distributed in this survey,and 413 valid questionnaires were recovered ,with an effective rate of 98.3%. Totally 86.0% of the clinicians thought that it was feasible for the reform to be carried out in their hospitals ,and 81.8% thought that the selected TCM dominant diseases in the pilot hospitals were reasonable. After the reform was carried out ,61.0% and 58.8% of clinicians indicated that the daily number of patients treated in their departments and their willingness to communicate with patients increased ,respectively;60.3% indicated that the difficulties and obstacles encountered in the reform were the complexity and diversity of TCM diseases ,for the treatment of patients with integrated traditional Chinese and Western medicine ,which was difficult to use a unified disease and surgery code to correctly code ;76.3% indicated that the greatest advantage of the reform implementation was the improvement of medical quality ,while 54.2% indicated that the greatest disadvantage was the excessive restriction of doctors ’autonomy. The results of multi-factor ordered Logistic regression analysis showed that changes in treatment services (changes in readmission rate of patient),the reasonableness of the selection of TCM dominant diseases ,and whether to reduce medical costs ,improve doctor-patient relationship , and promote hierarchical treatment were the influential factors of reform feasibility after the implementation of reform (P<0.05). CONCLUSIONS It is feasible to carry out payment reform for TCM dominant diseases in Guizhou province ,but it is still in the exploratery stage ,and there are many factors affecting the feasibility of the reform. It is suggested that in the future ,when promoting in the whole pr ovince and even the whole c ountry,we should pay attention to selecting more and more reasonable dominant diseases for payment reform , further standardize the diagnosis and treatment behavior of clinicians , control the unreasonablegrowth of medical expenses , strengthen communication between clinicians and patients, improve the accurate diagnosis rate of traditional Chinese medicine diseases ,implement hierarchical calculation of dominant diseases ,and promote hierarchical diagnosis and treatment of medical institutions.  
      关键词:TCM dominant diseases;payment reform;Feasibility;Influential factors;clinicians   
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      发布时间:2022-11-09
    • WU Hongyan,GU Yaqin,ZHOU Hongcheng,CHEN Xin,ZHANG Lihu
      Vol. 33, Issue 14, (2022)
      摘要:OBJECTIVE To study the effects of cy cloastragenol (CAG) on carbon tetrachloride (CCl4)-induced hepatic fibrosis(HF)and glycolysis in mice. METHODS Male ICR mice were randomly divided into blank group ,model group ,CAG low-dose,medium-dose and high-dose groups (60,120,240 mg/kg),with 6 mice in each group. Except that blank group was given olive oil intraperitoneally ,the mice in other groups were intraperitoneally injected with 10%CCl4-olive oil solution (5 mL/kg) three times a week for 8 weeks to induce HF model. From the 4th week after modeling ,mice in each drug group were given corresponding drug solution intragastrically (10 mL/kg),and mice in blank group and model group were given 0.5% sodium carboxymethyl cellulose solution intragastrically (10 mL/kg),once a day for 4 weeks. During the experiment ,the body weight of mice were weighted ;after last gastrogavage ,the liver weight was weighted and liver indexes of mice were calculated. The changes of hepatic injury indexes [aspartate aminotransferase (AST), alanine aminotransferase (ALT)], related indexes of HF [hematoxylin-eosin (HE)staining score ,Masson and Picrosirius red staining collagen volume fraction ,collagen Ⅰ,α-smooth muscle actin (α-SMA)] and related indexes of glycolysis [lactic acid (LD),hexokinase(HK),phosphofructokinase(PFK), pyruvate kinase (PK)] were all detected. RESULTS Compared with model group ,the collagen deposition and fibrosis of mice in each drug group were reduced ,and the body weights of mice (except for CAG low-dose group )were increased to some extent (P<0.05). Liver indexes ,serum levels of ALT and AST ,HE staining score of liver histopathology ,Masson and Picrosirius red staining collagen volume fraction ,protein expression of collagen Ⅰ and α-SMA,serum content of LD ,the levels of HK ,PFK and PK in serum and hepatic tissues (except for hepatic tissue of CAG low-dose group )were all decreased significantly (P<0.05). CONCLUSIONS CAG can improve HF in mice induced by CCl 4,and reduce the levels of key enzymes and products of glycolysis.  
      关键词:cycloastragenol;hepatic injury;Hepatic fibrosis;glycolysis;Mice   
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      发布时间:2022-11-09
    • YI Huan,PENG Fang,XIE Yuchen,GOU Xiaoling,DING Yin,FAN Gang
      Vol. 33, Issue 14, (2022)
      摘要:OBJECTIVE To esta blish the method for simultaneous determination of 25 components (such as berberine , magnoflorine and hydroxysafflor yellow A )in Bawei xiaobopi capsules. METHODS High-performance liquid chromatography- tandem triple quadrupole mass spectrometry (HPLC-QqQ-MS)method was adopted. The determination was performed on WondaSil C18-WR column with mobile phase consisted of 0.1% formic acid solution-methanol (gradient elution )at the flow rate of 0.5 mL/min. The column temperature was 25 ℃,and sample size was 5 μL. Electrospray ionization source was scanned in positive and negative ion mode at the same time ,with multiple reaction monitoring. The capillary voltage was 4 000 V(+)and 2 500 V(-). The drying gas flow rate was 11 L/min with the temperature of 300 ℃. The pressure was 15 psi. RESULTS Totally 25 components of Bawei xiaobopi capsules had good linear relationship within a certain range ,such as magnolflorine ,jatrorrhizine,berberine, palmatine,bufotenine,bufotenidine,piperine,glycyrrhizic acid ,ferulic acid ,ferulic acid 4-O-β-D-glucopyranoside,hydroxysafflor yellow A ,chlorogenic acid ,gallic acid ,chebulagic acid ,corilagin,ellagic acid ,liquiritigenin,liquiritin,rutin,quercetin, glycocholic acid ,cholic acid ,glycochenodeoxycholic acid ,glycodeoxycholic acid ,ursodeoxycholic acid (r≥0.999 0). The limits of quantitation were 0.62-554.50 ng/mL;the limits of detection were 0.18-166.30 ng/mL.RSDs of precision ,repeatability and stability(24 h)tests were all lower than 3.00%. The recovery rates were 80%-115%(all RSDs lower than 3.00%,n=6). The contents of above 25 components were 16.94-20.82,3.78-5.17,9.11-11.43,0.24-0.30,0.20-0.39,0.74-1.16,0.79-0.89,3.26-3.35, 0.48-0.66,11.96-13.35,2.30-3.12,0.19-0.21,6.07-8.83,10.42-10.48,1.43-1.64,4.17-4.76,0.14-0.15,0.46-0.52,0.04,0.01, 0.59-0.63,0.20-0.23,0.02,0.15-0.16,0.01 mg/g,respectively. CONCLUSIONS Established method is simple ,sensitive and stable,and can be used for content determination of 25 components in Bawei xiaobopi capsules simultaneously.  
        
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      发布时间:2022-11-09
    • HUANG Guangqiang,ZHENG Piaoxue,LIANG Jie,CHEN Kuikui,CAO Yupin,HU Jue,AN Shijia,LIANG Jingchun,LIU Xingchen,ZHU Xiaofeng
      Vol. 33, Issue 14, (2022)
      摘要:OBJECTI VE To optimize the extraction technology of the leaves of Dimocarpus longan according to flavonoids and phenolic acids. METHODS The contents of gallic acid ,protocatechuic acid ,ethyl gallate ,quercetin,luteolin and kaempferol in the leaves of D. longan were determined by HPLC. Based on single factor test ,with the ethanol volume fraction ,solid-liquid ratio and extraction time as factors ,using comprehensive scores of the contents of above six components as indexes ,the extraction technology of the leaves of D. longan was optimized by Box-Behnken response surface methodology. RESULTS The optimal extraction technology included ethanol volume fraction of 100%,solid-liquid ratio of l ∶ 7(g/mL),extraction time of 90 min, extraction temperature of 80 ℃. After 3 times of validation tests ,the average comprehensive score was 97.54(RSD=0.33%,n= 3),relative error of which with predicted score (99.05)was 1.55%. CONCLUSIONS Box-Behnken response surface methodology combined with multi-index comprehensive score can be used for the extraction technology of the leaves of D. longan ,and the optimized extraction technology is stable and feasible.  
        
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      发布时间:2022-11-09
    • ZHAO Junjie,ZHANG Jinjuan,ZHANG Chunlei,ZHU Qinfeng,LIAO Shanggao
      Vol. 33, Issue 14, (2022)
      摘要:OBJECTIVE To investigat e the effects of water extract (WCS)and ethanol extract (ECS)from the root of Caragana sinica on hyperuricemia (HUA)in mice. METHODS Kunming mice were randomly divided into normal control group , model group ,allopurinol group (positive control ,5 mg/kg),benzbromarone group (positive control ,7.8 mg/kg),WCS low-dose , medium-dose and high-dose groups (38,75,150 mg/kg),ECS low-dose ,medium-dose and high-dose groups (50,100,200 mg/kg), with 10 mice in each group. Except for the normal control group ,the other mice were given potassium oxazinate intraperitoneally and hypoxanthine intragastrically for consecutive 7 d to establish HUA model. On the third day of modeling ,mice in each administration group were given corresponding drugs intragastrically ,and normal control group and model group were given equal volume of normal saline once a day for 5 consecutive days.The body weight of mice were weighted during administration ;one hour after the last administration ,the organ indexes of liver ,kidney and spleen were calculated ;the contents of serum uric acid (SUA), blood urea nitrogen (BUN)and serum creatinine (SCR);the activity of xanthine oxidase (XOD)in serum and liver tissue were determined. Relative mRNA and protein expressions of XOD in liver tissue ,relative expre ssions of GLUT9,URAT1 and OAT 1 in renal tissue were all detected ;and the pathological changes of renal tissue were observed. RESULTS There were no significant differences in liver index and spleen index in each group (P>0.05). Compared with normal control group , except for allopurinol group , there were no significant differences in the body weight and the contents of BUN and SCR in mice of other administration groups (P>0.05);the renal index and SUA content of mice in the m odel group and allopurinol group were significantly increased (P<0.05);in the model group ,the XOD activity in serum and liver tissue ,the relative mRNA and protein expression of XOD in liver tissue ,the relative expressions of GLUT 9 and URAT 1 protein in renal tissue were significantly increased (P<0.05),and the relative expression of OAT 1 protein in renal tissue was significantly decreased (P< 0.05). Compared with model group ,renal indexes of mice were decreased significantly in WCS and ECS groups (P<0.05),and the pathological damage of renal tissue was significantly improved ;SUA content ,XOD activity in serum and liver tissue ,the relative mRNA and protein expression of XOD in liver tissue ,and the relative expression of URAT 1 protein in renal tissue were decreased significantly in administration groups (P<0.05). The relative expression of GLUT 9 protein in renal tissue of mice in benzbromarone group and ECS high-dose group decreased significantly (P<0.05);relative expression of OAT 1 protein in renal tissue of mice in benzbromarone group ,WCS low-dose and high-dose groups ,ECS low-dose group were increased significantly (P<0.05). CONCLUSIONS WCS and ECS can significantly decrease the contents of SUA in HUA model mice ,and improve pathological state of renal tissue ,the mechanism of which may be associated with inhibiting XOD activity and uric acid reabsorption,and down-regulating protein and mRNA expression of XOD.  
        
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      发布时间:2022-11-09
    • HE Ziji,WU Binxi,LI Yuxin,SHEN Zhibin,LIU Qiyue,WANG Qiuhong
      Vol. 33, Issue 14, (2022)
      摘要:OBJECTIV E To establish the method for evaluating the quality o f Plantago asi atica and fried P. asiatica . METHODS The fingerprints of 15 batches of P. asiatica and 15 batches of fried P. asiatica were established by HPLC. The common peaks were identified with the Similarity Evaluation System for Chromatographic Fingerprinting of TCM (2012 edition), and similarity evaluation was performed. Analysis of chemical pattern recognition was performed by using SPSS 25.0 and SIMCA-P 14.1 software(cluster analysis ,principal component analysis and orthogonal partial least squares regression analysis ). The markers which affected the difference in the quality between P. asiatica and fried P. asiatica were screened with variable importance projection(VIP)value greater than 1. RESULTS There were 18 common peaks in the fingerprints of 15 batches of P. asiatica and 13 common peaks in the fingerprints of 15 batches of fried P. asiatica . A total of 8 common peaks were found in both of them. Their similarities were greater than 0.920. Two common peaks were identified as geniposidic acid ,acteoside. The results of cluster analysis showed that when the spacing was 10,the 30 batches of samples could be clustered into three categories ,with S 1-S5 as one,S16-S20 as one ,S6-S15 and S 21-S30 as one . The results of the pri ncipal component analysis showed that the cumulative variance contribution rate of the first two principal components was 82.575% . The results of the orthogonal partial least squares regression analysis showed that the VIP values of the three common peaks were greater than 1,namely peak E(acteoside), peak D (geniposidic acid ) and peak G. CONCLUSIONS Established fingerprints are stable ,simple sina.com and rapid. It can be used for the quality evaluation of P. asiatica and fried P. asiatica ,by combining with analysis of chemical pattern recognition. Acteoside ,geniposidic acid and the component represented by peak G may be the markers affecting the difference in quality of P. asiatica and fried P. asiatica .  
      关键词:Plantago asiatica;fried Plantago asiatica;HPLC;Fingerprint;analysis of chemical pattern recognition;quality   
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      发布时间:2022-11-09
    • JI Liang,LEI Jingwei,ZHANG Weifang,JIA Hao,LI Yingying,WANG Xinle
      Vol. 33, Issue 14, (2022)
      摘要:OBJECTIVE To investigate the eff ects of different habitat processing methods on the quality of Cyperus rotundus , such as sun-drying after steaming ,sun-drying after boiling and direct sun-drying ,and to investigate the optimal habitat processing method of C. rotundus from the perspective of chemical component. METHODS The fingerprint of C. rotundus was established by high performance liquid chromatography (HPLC)combined with the Similarity Evaluation System for Chromatographic Fingerprint of TCM (2012 edition). The similarity evaluation was conducted to determine the common peak. Cluster analysis (CA)combined with principal component analysis (PCA)and partial least squares-discriminant analysis (PLS-DA)was used to differentiate and compare C. rotundus treated by different habitat processing methods. And the contents of cyperrenone ,α-cyperone,luteolin and ferulic acid in C. rotundus were determined by HPLC. RESULTS There were 22 common peaks in the HPLC fingerprints of C. rotundus reated by different habitat processing methods ;their similarities were higher than 0.9;common peak 16 and common peak 20 were cyperrenone and α-cyperone. CA results showed that C. rotundus boiled for 4,8 and 12 min were clustered into one category,the rest of the samples clustered into one category. PCA results showed that comprehensive score of C. rotundus steamed for 10 and 15 min and boiled for 2 min were the highest. The steaming treatment had small effect on comprehensive score of samples,while the boiling treatment had a great effect on the quality of the samples ;the overall score of samples decreased sharply after boiling for 2 min. Results of PLS-DA showed that variable importance projection (VIP)of peak 20(α-cyperone),peak 16 (cyperrenone),peak 22,peak 17 and peak 22 in HPLC fingerprints were all higher than 1. The results of content determination showed that there was significant difference in the contents of α-cyperone,cyperrenone and luteolin in samples treated by different habitat processing methods.With the increase of steaming and boiling time ,the contents of α-cyperone,cyperrenone and luteolin showed a significant downward trend ,and boiling had a great impact on them. CONCLUSIONS Too long boiling treatment greatly;2019 destroys the chemical composition of C. rotundus , andsteaming for 10,15 min or boiling for 2 min is the optimal processing method.  
        
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      发布时间:2022-11-09
    • GAN Zhiqiang,XIONG Shuangfeng,ZHONG Lu,LUO Qingfang,ZHANG Yi
      Vol. 33, Issue 14, (2022)
      摘要:OBJECTIVE To establish the fingerprint of Tibetan medicine Adhatoda vasica ,and determine the contents of vasicine and vasicinone ,so as to comprehensively evaluate its quality combined with chemical pattern recognition. METHODS Using vasicine as control ,HPLC fingerprints of 11 batches of A. vasica were established with Similarity Evaluation System for Chromatographic Fingerprints of TCM (2012 edition). The common peaks were identified and their similarities were evaluated. Cluster analysis (CA),principal component analysis (PCA)and orthogonal partial least squares-discriminant analysis (OPLS-DA) were performed by using SPSS 25 software and SIMCA 14.1 software. The variable importance in the projection (VIP)value>1.0 was used as the standard to screen the differential components affecting the quality of A. vasica ;the contents of vasicine and vasicinone were determined by HPLC simultaneously. RESULTS A total of 23 common peaks were found ,and peak 2 was identified as vasicine ,and peak 4 was identified as vasicinone. Their similarities ranged 0.920-0.994. The results of CA showed that 11 batches of samples were clustered into 3 categories(distance was 14):S1-S8 as one category (origin:Yunnan,Tibet),S9 as one category (origin:Yunnan),S10-S11 as one category (origin:Sichuan);the results of P CA and OPLS-DA showed that S 9 and S10-S11 were divided into one category respectively ,and S1-S8 were further divided into 2 categories:S1,S4 as one category,S2-S3,S5-S8 as one category ;the common peaks with VIP value >1.0 included peak 2,peak 16,peak 21,peak 17,peak 1 and peak 13. Among 11 batches of samples , contents of vasicine and vasicinone were 4.12-10.22 and 0.60-3.26 mg/g, respectively. CONCLUSIONS Established edu.cn HPLC fi ngerprint and content determination method are simple and accurate ,and can be used for the quality evaluation of Tibetan medicine A. vasica ,by combining with chemical pattern recognition. Vasicine and other components may be the differential components that affect the quality of the drug.  
        
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      发布时间:2022-11-09
    • LIANG Chaofeng,HAN Xiaoke,QIN Yadong,XU Bin,QI Jun,ZHOU Juanjuan
      Vol. 33, Issue 14, (2022)
      摘要:OBJECTIVE To establish the fingerp rint of decoction pi eces and dispensing granules of Gardenia jasminoides ,to determine the contents of 6 components,so as to evaluate its quality combined with chemical pattern recognition. METHODS High performance liquid chromatography (HPLC)was used. Using geniposide as the reference ,Similarity Evaluation System for Chromatographic Fingerprint of TCM (2012 edition)was used to draw the fingerprints of 20 batches of G. jasminoides decoction pieces and 10 batches of G. jasminoides dispensing granules. Similarity evaluation and common peaks identification were conducted. The same HPLC method was adopted to determine the contents of deacetyl asperulosidic acid methyl ester ,geniposide, picrocrocin,rutin,crocin-Ⅰ and crocin- Ⅱ. ORIGIN 9.1 software was used for hierarchical clustering analysis ,and SIMCA 16.0 software was used for principal component analysis (PCA) and partial least squares-discriminant analysis. The differential components affecting the quality of decoction pieces and dispensing granules were screened by taking the variable importance in projection(VIP)value>1 as the standard. RESULTS There were 24 common peaks for both 20 batches of G. jasminoides decoction piece and 10 batches of G. jasminoides dispensing granules ;a total of 22 common peaks were found in the fingerprints of 30 batches of samples ,and the similarity was not lower than 0.96;six common peaks were identified ,i.e. deacetyl asperulosidic acid methyl ester (peak 2),geniposide(peak 6),picrocrocin(peak 9),rutin(peak 11),crocin-Ⅰ(peak 15),crocin-Ⅱ(peak 17). Average contents of above 6 components in G. jasminoides decoction pieces were 1.04,57.00,1.30,1.03,9.63 and 0.99 mg/g, respectively;those of G. jasmin oides dispensing granules were 0.96,17.04,0.37,0.27,0.73 and 0.04 mg/g,respectively. PCA results showed that G. jasminoides decoction pieces and G. jasminoides dispensing granules were clustered into respective one category ,which was consistent with results of cluster analysis. There were 9 common peaks with VIP value >1, which were 16,14,3,17(crocin-Ⅱ),15(crocin-Ⅰ),18, 22, 2 (deacetyl asperulosidic acid methyl ester) and 21. CONCLUSIONS The estab lished fingerprint and content determination method are simple and reproducible. Combined with chemical pattern recognition ,it can be used to evaluate the quality of decoction pieces and dispensing granules of G. jasminoides . Nine corresponding components represented by peak 16 and so on are the differential components that affect the quality of them.  
        
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      发布时间:2022-11-09
    • LIU Yi,TAO Ting,LIU Yun,LI Yanli,HU Panpan,JIANG Yanjiao,SUN Zengxian
      Vol. 33, Issue 14, (2022)
      摘要:OBJECTIVE To estab lish the pre paration method of clopidogrel active thiol metabolite (CATM),and to provide reference for the synthesis of cis-CATM. METHODS CATM was prepared ,separated and purified with isolated rat liver perfusion and ChromCore 120 C18 preparative column ,using(S)-2-oxo-clopidogrel as substrate. The target compounds were identified by mass spectrometry and nuclear magnetic resonance spectroscopy. The retention time of the active configuration of CATM in the human body (cis-CATM)were compared to confirm the proportion of active configuration in the target product. RESULTS The conversion rate of the target product was 11.71%. The target products were identified as CATM by MS and 1H-NMR. Peak 2-peak 5 of CATM were four stereoisomers. The retention time of them were 21.3,22.3,26.5,27.3 min. The peak area ratios of them were 7.13%,7.23%,63.52%,14.97%,respectively. Based on that retention time of the active configuration of CATM in human body was 26.3 min,the active cis-stereoisomer in the target product CATM accounted for 63.52%. CONCLUSIONS This method is low-cost ,simple,and can prepare CATM with higher active configuration.  
      关键词:isolated rat liver perfusion;Clopidogrel;active thiol me tabolite;Preparation;Purification;(S)-2-oxo-clopidogrel   
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    • WAN Yunhui,CHEN Xiaoyong
      Vol. 33, Issue 14, (2022)
      摘要:OBJ ECTIVE To study the effect a nd mechanism of modified Yijing decoction on the decrease of ovarian reserve function(DOR)in rats. METHODS A total of 140 SPF female SD rats were randomly divided into control group ,model group , positive control group (Estradiol valerate tablets 0.09 mg/kg),inhibitor group [modified Yijing decoction 23.6 g/kg+transcriptional inhibitor for hypoxia inducible factor- 1α(HIF-1α)YC-1 2 mg/kg] and modified Yijing decoction low-dose ,medium-dose and high-dose groups (5.9,11.8,23.6 g/kg). Except for control group ,rats in other groups were given cyclophosphamide via femoral vein to induce DOR model ;after successful modeling for 2 h,rats in each group were given normal saline or relevant medicine intragastrically,once a day ,for 8 consecutive weeks.The estrous cycle of rats in each group was recorded ,and the ovarian index was calculated to observe the histopathological changes and autophagy in the ovary ;serum levels of follicle stimulating hormone (FSH),luteinizing hormone (LH),anti-Müllerian hormone (AMH)and estrogen (E2)were measured ;protein and mRNA levels of HIF-1α,B lymphoblastoma 2 gene/adenovirus E 1B interacting protein 3 recombinant protein (Bnip3)and yeast Atg 6 homolog of autophagy key molecule (Beclin1)in ovarian tissues of rats were all detected. RESULTS Compared with control group ,the ovarian indexes of model group and administration groups were decreased significantly (P<0.05). Model group possessed disturbed estrous cycle and the ovary tissues showed pathological morphology ,the autophagolysosomes appeared in ovary cells ,AMH and E 2 levels were significantly decreased (P<0.05);FSH and LH levels ,protein and mRNA expressions of HIF- 1α,Bnip3 and Beclin 1 were significantly increased (P<0.05). Compared with model group ,the estrous cycle of rats in positive control group and modified Yijing decoction groups gradually returned to normal ,the pat hological morphology of ovarian tissue and the autophagy of ovarian cells were improved ;the ovarian index ,AMH and E 2 levels were significantly increased (P<0.05);the levels of FSH and LH ,protein and mRNA expressions of HIF- 1 α , Bnip3 and Beclin 1(except for protein of HIF- 1α,protein and wanyunhui188@163.com mRNA of Bnip 3 in modified Yijing decoction low-dose group ) were decreased significantly (P<0.05). The protein expressions of H IF-1α,Bnip3 and Beclin 1,mRNA expressions of HIF- 1α and Beclin 1 were decreased significantly in the inhibitor group (P<0.05). CONCLUSIONS Modified Yijing decoction can improve ovarian function ,regulate the secretion of sex hormone ,and protect ovarian tissue in DOR model rats ,and the mechanism of which may be related to the inhibition of HIF- 1α/ Bnip3/Beclin1 pathway.  
      关键词:modified Yijing decoction;ovarian function;hypoxia inducible factor 1α;Autophagy;Rat   
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      发布时间:2022-11-09
    • LIAO Wanzhong,JIANG Weizhe,LIU Wei,ZHOU Xianqiang,LIU Xueping,FU Shujie
      Vol. 33, Issue 14, (2022)
      摘要:OBJEC TIVE To establish the qu ality standard of Hylocereus undatus ,and to provide reference for its quality control. METHODS The sample of H. undatus medicinal materials was collected for character observation ,powder microscopic identification and thin-layer chromatography (TLC)identification. Moisture content ,total ash ,acid-insoluble ash ,water-soluble extracts and alcohol-soluble extracts were determined according to the corresponding methods in the general provisions of the 2020 edition of Chinese Pharmacopoeia (part Ⅳ). The contents of kaempferol and isorhamnetin in H. undatus were determined by high performance liquid chromatography. RESULTS The medicinal materials of H. undatus were in brown or yellowish brown irregular long bundles ;the calyx tubes were twisted in bundles ;the scales on the outside of the flower were shrunken ,and many stamens were inserted on the inside. The powder was brown-green or brown-yellow ,and pollen grains ,ducts and non-glandular hairs were found.In the TLC diagram of test sample ,fluorescent spots of the same color were displayed on the corresponding position of the chromatogram of substance control (kaempferol, isorhamnetin) and reference material. The moisture content , total ash , acid-insoluble ash ,water-soluble extract and alcohol-soluble extract of the 15 batches of samples ranged from 10.70% to 12.23%, 7.48% to 11.29%,0.25% to 0.70%,30.34% to 49.91%,and 25.27% to 36.92%,respectively. The average values were 11.44%,9.51%,0.46%,40.13%,32.33%,respectively. The contents of kaempferol and isorhamnetin were 1.787-3.785 and 0.597-2.211 mg/g,respectively. CONCLUSIONS This study add microscopic identification ,TLC identification and inspection items such as moisture content ,ash and extract on the basis of the existing quality standards of H. undatus . It is preliminarily proposed that the moisture content in H. undatus shall not exceed 13.0% and total ash content shall not exceed 12.0%,and the water-soluble extract and alcohol-soluble extract shall not be less than 30.0% and 25.0% respectively;the contents of kaempferol and isorhamnetin shall not be less than 1.780 and 0.590 mg/g,respectively. The established quality standard can be used for quality control of H. undatus .  
        
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    • DU Guiping,GAO Shengnan,QI Ran,LIU Xuting,LIU Guoqiang
      Vol. 33, Issue 14, (2022)
      摘要:OBJECTIVE To evaluate the cost-effectiveness of denosumab and zoledronic acid in the treatment of postmenopausal osteoporosis ,and to provide reference for relevant decision-making. METHODS From the perspective of Chinese health system ,Excel 2003 software was used to establish Markov model ,and cost-utility analysis was used to evaluate the cost-effectiveness of denosumab or zoledronic acid combined with calcium carbonate D 3 in the treatment of postmenopausal osteoporosis. Pharmacotherapy effects were obtained from the network Meta-analysis ,and cost and health-utility value data were obtained from the published literature or network ,etc. The model cycle was 1 year,and the simulation time limit was the patient ’s lifetime. One-way sensitivity analysis and probabilistic sensitivity analysis were used to evaluate the impact of model parameter changes on the robustness of the results ;and the cost-effectiveness of changing the medication cycle of zoledronic acid were explored through scenario analysis. RESULTS Denosumab regimen was more effective than zoledronic acid regimen (12.77 QALYs vs. 11.98 QALYs),and its cost was also higher than zoledronic acid regimen (51 224.56 yuan vs. 49 221.67 yuan), and the incremental cost-effectiveness ratio was 2 544.14 yuan/QALY. One-way sensitivity analysis showed that the cost of Zoledronic acid injection and that of Denosumab injection had great impact on the results. The results of probabilistic sensitivity analysis showed that when using 3 times of per capita gross domestic product (GDP)in China in 2021 as the threshold of willingness to pay ,the probability of Denosumab regimen being cost-effective was 85.4%. The results of the scenario analysis showed that the Denosumab regimen was still more cost-effective when the dosing cycle of zoledronic acid was changed. CONCLUSIONS Under the threshold of 1-3 times of Chinese per capita GDP in 2021,denosumab combined with calcium carbonate D 3 is more cost-effective than zoledronic acid combined with calcium carbonate D 3 in the treatment of postmenopausal osteoporosis.  
        
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    • LU Yuqiong,DAI Zhanjing,LU Yun,CHANG Feng
      Vol. 33, Issue 14, (2022)
      摘要:OBJECTIVE To provide methodology re ference for conducting health state disutility estimation and calculating health output in pharmacoeconomic evaluation. METHODS Literatures about health state disutility estimation of malignant tumor drugs-related adverse events were retrieved from 3 Chinese databases such as CNKI ,Wanfang database and VIP and 3 English database such as PubMed ,Web of Science and the Cochrane Library from inception to July 2021. After 2 researchers independently screened the literature and extracted the data ,qualitative analysis was conducted. The modified decision-making technical support documents of the National Institute for Health and Care Excellence were used for quality evaluation. The practice and existing problems of health state disutility measurement were summarized to put forward some suggestions. RESULTS A total of 77 literatures were included. The first literature was published in 1991,and the number of publications increased in a fluctuating manner. 77 literatures involved 120 kinds of adverse events ,mainly utility studies (49,63.64%),only 3 (3.90%) were investigated in China. A total of 35 literatures(45.45%)had no statement of study design type ,48(62.34%)had no statement of health status development method ,52(67.53%)had no statement of health status verification method ,46(59.74%)set and explained the basic health status ,and 20(25.97%)were ranked for the health status . The utility measurement tools used were mainly the standard game method and the European five-dimensional health scale (23 literatures each ,accounting for 29.87%). The research objects of 45 literatures(58.44%)were patients ,and 63(81.82%)did not specify the representative test of the population. Utility report types included negative value ,non-negative value and non-negative value of consolidated basic status. A total of 45 literatures(58.44%)had no statement of statistical method of utility. Overall quality score of included studies was 0.683. CONCLUSIONS The current disutility estimation include 4 key links of basic study design , health status confirmation, utility estimation survey and survey data E-mail:luyuqiong96@foxmail.com statistics. The deficiencies of related studies are the lack of data based on the Chinese population ,the inconsistent type ofresult reporting ,and the incomplete report of measurement- related critical items. It is recommended to standardize the basic implementation path of disutility estimation ,formulate guidelines for health status utility value estimation ,and strengthen multidisciplinary cooperation so as to improve the quality of health status utility value estimation .  
      关键词:malignant tumor;drugs;adverse events;disutility;health state utility value;Systematic review   
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    • WEI Bin,ZHANG Chaoyong,DENG Yan,ZHONG Shiying,WEI Zhe,HUANG Kai
      Vol. 33, Issue 14, (2022)
      摘要:OBJECTIVE To observe th e efficacy and safety of intermittently repeated application of levosimendan in the treatment of right heart failure of pulmonary hypertension. METHODS A total of 70 cases of right heart failure of pulmonary hypertension were collected from the First Affiliated Hospital of Guangxi Medical University during Jan. 2019-May 2021,and then randomly divided into control group and observation group ,with 35 cases in each group.In control group ,the patients with moderate risk of classification of pulmonary hypertension were given Tadalafil tablets and Ambrisentan tablets ,while the patients with high risk were given Tadalafil tablets ,Ambrisentan tablets and Treprostinil injection ;both were given anti-right heart failure drugs at the same time. On the basis of treatment in the control group ,patients in the observation group were additionally intravenously pumped with levosimendan injection 12.5 mg,once a month ,at a rate of 0.05-0.1 μg/(kg·min),3 months in total. Response rate of therapy ,improvement of risk stratification of pulmonary hypertension after treatment ,and average pulmonary artery pressure ,six-minute walk distance (6MWD),serum level of N-terminal pro brain natriuretic peptide (NT-proBNP),right atrial pressure (RAP),oxygen saturation in mixed venous blood (SvO2),cardiac index (CI),right ventricular ejection fraction (RVEF),early diastolic tricuspid inflow velocity/early diastolic tricuspid annular velocity (E/Ea),tricuspid annular plane systolic excursion(TAPSE),right ventricular end-diastolic diameter (RVEDD),right ventricular end-systolic diameter (RVESD)before and after treatment ,and the occurrence of adverse reactions were observed in 2 groups. RESULTS The total response rate of observation group was significantly higher than control group after treatment (P<0.05). After treatment ,average pulmonary artery pressure,NT-proBNP level ,RAP,E/Ea,RVEDD and RVESD of 2 groups were significantly lower than before treatment ,while 6MWD,SvO2, CI, TAPSE and RVEF were significantly higher than before treatment ;NT-proBNP level and E/Ea of observation group were significantly lower than control group , while 6MWD,CI,TAPSE and RVEF were significantly higher than control group (P<0.05 or P<0.01). There was no significant difference in average pulmonary artery pressure , risk stratification improvement cases of pulmonary hypertension , RAP, SvO2, RVEDD, RVESD and the incidence of asymptomatic hypotension between 2 groups(P>0.05). CONCLUSIONS Intermittently repeated application of levosimendan can improve the function of right heart of pulmonary hypertension complicated with right heart failure and has good safety.  
      关键词:levosimendan;right heart failure;pulmonary hypertension;inotropic agent;intermittently repeated;Efficacy;Safety   
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    • QIU Shuijing,HU Zhansong,TU Ying,LIU Yu,ZHANG Yao,ZHU Mengchen,CHEN Lijuan
      Vol. 33, Issue 14, (2022)
      摘要:OBJECTIVE To investigate the eff ects of hypoalbuminemia and human albumin supplementation on patients with acute kidney injury (AKI)after off-pump coronary artery bypass grafting (OPCABG). METHODS From December 2018 to January 2020,clinical information of 484 patients with coronary atherosclerotic heart disease who underwent selective OPCABG in Tianjin Chest Hospital were analyzed retrospectively. The basic data ,American Society of Anesthesiologists (ASA)grading,the number of coronary artery bypass grafting ,amount of intraoperative bleeding ,use of artificial colloid ,minimum value of hemoglobin within 7 days after operation ,hypoalbuminemia occurred after operation ,monitoring time in postoperative intensive care unit ,drainage volume of thoracic catheterization ,perioperative blood transfusion ,amount of human albumin after operation were summarized. All patients were divided into non-AKI group (414 cases)and AKI group (70 cases)according to the occurrence of AKI. The differences of the above indexes between the two groups were compared. Multiple Logistic regression analysis was performed to analyze the risk factor of AKI when selecting the indexes with P<0.1. According to whether hypoalbuminemia occurred after operation ,all patients were divided into normal protein group (347 cases)and hypoalbuminemia group (137 cases). Hierarchical analysis was carried out to explore the correlation between human albumin supplementation and AKI. RESULTS The results of multiple Logistic regression analysis showed that there was no significant effect on AKI in postoperative hypoalbuminemia (P>0.05),but there were significant effect in body mass index and the dosage of postoperative human serum albumin (P<0.05). The risk of AKI would increase by 12.7% every time the body mass index increases by 1 unit;the risk of AKI increased by 17.3% for every 10 g increase in the dosage of human albumin. Stratified analysis showed that the risk of AKI would increased by 26.9% for every 10 g increase in postoperative human albumin supplementation in normal protein group and 14.0% for every 10 g increase in postoperative human albumin supplementation in hypoalbuminemia group. CONCLUSIONS Hypoalbuminemia is not a risk factor fo r the development of AKI after OPCABG ,but human albumin supplementation is a risk factor for AKI after OPCABG.  
        
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    • WANG Yi,REN Mengyue
      Vol. 33, Issue 14, (2022)
      摘要:Allergic contact dermatitis (ACD)is a common type Ⅳ allergic disease ,which has a wide range of patients ,and seriously affects the quality of patients ’lives. To understand the pharmacological mechanism of traditional Chinese medicine (TCM)in the treatment of ACD ,and to provide reference for clinical application and new drug research and development ,the relevant research literatures were reviewed from aspects of pathogenesis of ACD ,traditional Chinese medicine that can be used to treat ACD and its mechanism of action. TCM for the treatment of ACD mainly include heat-clearing medicines (Sophora flavescens,Dictamnus dasycarpus ),exterior-releasing medicines (Cinnamomum cassia ,Xanthium sibiricum ,Saposhnikovia divaricata),antirheumatic medicines (Tripterygium wilfordii ,Cynanchum paniculatum ),and damp-draining medicines (Plantago asiatica,Kochia scoparia ),etc. The main mechanisms include inhibition of IgE secretion ,regulation of Th 1/Th2 cell and Th 17/ Treg balance ,reduction of mast cells degranulation ratio ,inhibition of pERK 1/2/TLR4/NF-κ B pathway,AIM2/caspase-1 inflammasome signaling pathway ,Wnt/β-catenin pathway ,STAT3 pathway and MAPK pathway.  
      关键词:allergic contact dermatitis;traditional Chinese medicine;pharmacology;Mechanism   
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    • GAN Shuirong,OUYANG Hua,LYU Peiyu,CAI Hongfu
      Vol. 33, Issue 14, (2022)
      摘要:OBJECTIVE To system atically evaluate the efficacy and safety of immune checkpoint inhibitors (ICIs)versus routine second-line chemotherapy in the treatment of advanced esophageal cancer ,and to provide evidence-based reference for clinical medication. METHODS Randomized controlled trials (RCTs) about ICIs (trial group ) versus routine second-line chemotherapy (control group ) in the treatment of advanced esophageal cancer were searched from PubMed ,Embase,The Cochrane Library ,CNKI,Wanfang and VIP databases from the inception to August 1st,2021. After screening the literature and extracting data ,the risk of bias assessment tool recommended by Cochrane Systematic Evaluator Manual 5.1.0 was used to evaluate the quality of the included literature ,and RevMan 5.4.1 software was used for meta-analysis and sensitivity analysis. RESULTS A total of four studies were included ,involving 1 656 patients. Meta-analysis results showed that the overall survival of trial group was significantly longer than control group [HR =0.79,95%CI(0.71,0.88),P<0.000 1];the incidence of grade 3 or higher adverse events in trial group was significantly lower than control group [RR =0.42,95%CI(0.32,0.54),P<0.000 01]. But there was no significant difference in progression-free survival [HR =0.95,95% CI (0.75,1.21),P=0.70] or objective remission rate [RR =1.72,95%CI(0.95,3.13),P=0.07] between 2 groups. Results of subgroup analysis was performed according to the expression of programmed death ligand 1 showed that overall survival of patients with tumor proportion score (TPS)≥1% in trial group was significantly longer than control group [HR =0.64,95%CI(0.51,0.79),P<0.000 1];there was no significant difference in overall survival of patients with TPS <1% between 2 groups [HR =0.83,95%CI(0.67,1.02),P=0.07]. The results of sensitivity analysis showed that except for the objective remission rate ,the conclusions of other indicators were robust. CONCLUSIONS Compared with routine second-line treatment ,ICIs can prolong overall survival and has good safety ,but shows no advantage in ) terms of progression-free survival and objective response rates.  
        
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    • KONG Lingxi,WANG Hongmei,PENG Min,QIU Feng,YANG Jiadan,SHAN Xuefeng
      Vol. 33, Issue 14, (2022)
      摘要:OBJECTIVE To evalu ate relat ed researches about the cost- benefit of pharmaceutical care in medical institutions with cost- benefit analysis,in order to provide evidence-based basis for related policy decisions and provide methodological reference for the cost- benefit evaluation of pharmaceutical care in the future. METHODS Retrieved from PubMed ,Embase,the Cochrane Library ,CBM,Wanfang database ,VIP and CNKI ,cost-benefit analysis was used to evaluate the researches about the cost-benefit of pharmaceutical care in medical institutions. Two researchers independently screened the research and extracted data according to the “Consolidated Health Economic Evaluation Reporting Standards Checklist ”. The quality of included studies was scored and evaluated systematically. RESULTS A total of 46 studies from 17 countries were included. Most of them came from the United States (21.74%),China(19.57%)and France (8.70%). Average score of 46 literature was 14.30,of which 1 literature was excellent ,5 literature were good ,25 literature were qualified and 14 literature were unqualified. There were 25 research protocols of prospective study type ;the type of pharmaceutical care involved mostly was pharmaceutical monitoring (60.87%), followed by prescription review (23.91%),medication reconciliation (8.70%)and outpatient pharmacy (6.52%)were less. The median cost-benefit ratio of pharmaceutical care was 5.05 (3.08,11.28). CONCLUSIONS Pharmaceutical care shows good economic value ,and pharmacists have played an important role in saving medical resources ,but the design level and report quality of the existing studies need to be improved.  
      关键词:Pharmaceutical care;Cost;cost-benefit;economic evaluation;quality evaluation   
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    • CUI Hongyan,ZHOU Lu,SUN Wenxu,WU Fengbo
      Vol. 33, Issue 14, (2022)
      摘要:Augmented renal clearance (ARC)refers to the significant enhancement of patients ’renal function ,which is manifested by the significant increase of glomerular filtration rate ,which increases the clearance of drugs ,and the effective blood drug concentration cannot be achieved under the conventional dose. The efficacy of antibiotics is closely related to the concentration. The influence of renal dysfunction on drug metabolism is an important factor that clinicians should consider when determining the dosage. This article reviews the definition ,risk factors ,occurrence mechanism ,evaluation methods of ARC ,as well as its impact on the pharmacokinetics/pharmacodynamics of antibiotics and administration methods. It is found that ARC widely exists in critically ill patients ,and the risk factors include age (≤50 years old ),brain trauma ,sepsis,multiple trauma , etc. When using antibiotics in ARC patients ,the therapeutic effect of drugs can be improved by increasing the dosage ,prolonging the duration of administration and increasing the frequency of administration. However ,in order to prevent adverse reactions caused by high concentration accumulation of drugs ,it is recommended to try to combine treatment drug monitoring.  
        
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    • LIN Jing,MO Junqiao,ZHOU Xin,SONG Yan,LI Yongchang
      Vol. 33, Issue 14, (2022)
      摘要:Micheliolide is a kind of guaiacane sesquiterpene lactone from natural plants. It distributs in the root bark of Cephalantheropsis gracilis and Michelia compressa . Modern pharmacological studies show that ,micheliolide can play an anti-tumor role by inhibiting the proliferation of tumor cells ,regulating the apoptosis of tumor cells ,inducing autophagy of tumor cells ,and inhibiting invasion and metastasis of tumor cells. It can reduce the expression of inflammatory cytokines by regulating several related signaling pathways ,such as nuclear factor κB and phosphatidylinositol-3-hydroxykinase/protein kinase B ;it can play an immunomodulatory role by restoring the expression of immune-related factors in the body ;it can play a neuroprotective effect by reducing the accumulation of amyloid β-protein and inhibiting microglial activation ;it can play a liver protective role by reducing the inflammatory response and steatosis of hepatocytes ;its nephroprotective mechanism is related to the relief of the inflammatory response by regulating multiple pathways ;the mechanisms of its cardioprotective action include alleviating the inflammatory response and reducing the level of oxidative stress ,etc. In conclusion ,micheliolide is a compound of great development value.  
      关键词:micheliolide;pharmacological effects;Mechanism;Anti-tumor;anti-inflammatory;immune regulation;nerve   
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