最新刊期
      卷 32 ， 期 23 ， 2021
      • LIU Wen,ZHU Jiong,WANG Chong,HU Zengyao
        Vol. 32, Issue 23, (2021)
        摘要：OBJECTIVE：To provide reference for further improving the national drug quality disclosure system. METHODS ： The national drug quality disclosure system was analyzed in respects of general information ，implementation procedure ， implementation situation and effects ，and existing problems. The improvement suggestions were put forward. RESULTS & CONCLUSIONS：The national drug quality disclosure system had gone through the bulletin stage ，notice stage and announcement stage. At present ，it had become drug regulatory measure with timely release ，rigorous procedures and sanctions. The process of national drug quality disclosure included five steps ，ie. informing the sampling enterprises of the fact that the drugs were unqualified，controlling the risk of unqualified drugs ，providing legal relief to the notified units ，preparing the contents of the national drug quality notice ，and releasing the national drug quality notice to the public. In recent years ，National Medical Products Administration had made greater efforts to release the national drug quality notice. The release of the national drug quality notice has played an important role on forcing drug manufacturers to improve drug quality and enhance the credibility of drug regulatory departments. However ，there are also some problems ，such as the non-conforming report is not delivered in time ，the tracing time for suspected counterfeit TCM pieces is too long ，and the provincial drug regulatory bureau does not strictly control the first trial of complaints. It is suggested that National Medical Products Administration strengthen the training ，review and punishment of provincial drug regulatory departments ；at the same time ，provincial drug regulatory departments also need to strengthen responsibility and business capacity-building ，pay attention to relevant work and strengthen daily supervision.  
        关键词：National drug quality disclosure system;Drug quality;Drug administration   
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        发布时间：2022-06-21
      • ZHANG Chen,FAN Xin,JIN Qiuchen,CHEN Yongfa
        Vol. 32, Issue 23, (2021)
        摘要：OBJECTIVE：To learn from pedia tric drug pricing and price incentive policy in Japan ，and to provide reference for the improvement of pediatric drug price system in China. METHODS ：The drug pricing strategy of Japan was analyzed ，and price incentive policy of pediatric drugs in Japan and its implementation status and effect were summarized. The suggestions of perfecting the price system of pediatric drugs in China were put forward . RESULTS & CONCLUSIONS ：The pricing strategy of medical insurance drugs in Japan included two types ，such as access pricing of medical insurance list and price adjustment of drugs in medical insurance list. Among them ，price incentive policy for pediatric drugs mainly included the premium for initial pricing of new pediatric drugs ，the premium for drugs with newly added pediatric indication included in medical insurance list and other measures（such as eligible drugs could obtain indirect price compensation ，and children ’s factors could be considered in health technology assessment ）. Overall ，these measures accelerated the R&D and marketing of Japanese pediatric drugs ，and effectively promoted the development of pediatric drugs in Japan. The author suggests that our country should carry out health technology assessment which reflects the particularity of pediatric drugs ，give appropriate direct price incentives to the payment price of pediatric drugs ，and reasonably set the price of drug specification suitable for children and give price incentives so as to promote the development of pediatric drugs in China.  
        关键词：Pediatric drugs;Pricing mechanism;Price incentive policy;Premium;Japan   
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        发布时间：2022-06-21
      • XIAO Xiao,ZHOU Yasi,PENG Chuyin,DENG Jinqing,WANG Laiyou,ZHU Wenbo
        Vol. 32, Issue 23, (2021)
        摘要：OBJECTIVE：To study the effects and mechanism of oncolytic virus M 1（called M 1 virus for short ）inducing the apoptosis of cervical cancer C-33A cells. METHODS ：MTT assay was used to detect survival rate of C- 33A cells that were treated with different titers （0，0.001，0.01，0.1，1，10 PFU/cell）of M 1 virus. C- 33A cells were divided into control group （0 PFU/cell）， low-dose，medium-dose and high-dose groups of M 1 virus（0.001，0.01，0.1 PFU/cell）. After treated with corresponding titers of M1 virus for 48 h，flow cytometry was used to detect the apoptotic rate and infection rate of cells；Western blot was performed to detect the protein expression of C/EBP homologous proteins （CHOP），caspase-12，caspase-3 and cleaved-caspase- 3. RESULTS ： After treated with different titers of M 1 virus，the survival rate of C- 33A cells decreased significantly （P＜0.01），and showed a dose-dependent tr end. Compared with control group ，the apoptotic rate and infection rate of cells in M 1 virus groups as well as the protein expression of CHOP ，caspase-12 and cleaved-caspase- 3（except for medium-dose group ）in M 1 virus medium-dose and high-dose groups were increased significantly （P＜0.01）. CONCLUSIONS ：M1 virus can induce the apoptosis of cervical cancer C-33A cells ，and its mechanism may be related to the activation of endoplasmic reticulum stress pathway.  
        关键词：Oncolytic virus M 1;Cervical cancer;C-33A cells;Endoplasmic reticulum stress;Cell apoptosis   
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        发布时间：2022-06-21
      • YAN Yuxin,ZHANG Chunyan,GAO Xiaoyang,MA Yuehong
        Vol. 32, Issue 23, (2021)
        摘要：OBJECTIVE：To study the improv ement effects of Mongolian medici ne eligen- 7 on hepatic fibrosis （HF）and its mechanism. METHODS ：Taking rat hepatic stellate cells HSC-T 6 as research object ，the cells were divided into model group （blank serum ）and low-dose ，medium-dose and high-dose groups of eligen- 7 containing serum （10％，15％ and 20％ eligen-7 containing serum ）. Transforming growth factor β solution（0.2 mg/mL）was added into the cells for 48 h to induce liver fibrosis model，and then added into the corresponding blank or drug-contained serum. The optical density （OD）of cells in each group was measured and inhibition rate of cell proliferation was calculated （after treated for 24，48 and 72 h）. The apoptotic rate and cycle distribution of cells were detected ；mRNA and protein expression of type Ⅰ collagen（Collagen Ⅰ），α-smooth muscle actin （α-SMA），phosphatidylinositol-3-kinase and protein-serine-threonine kinase （PI3K/Akt）signaling pathway related factors （PI3K， Akt，PTEN）were also detected （after treated for 24 h）. Wistar rats were further divided into blank group ，model group and low-dose，medium-dose and high-dose groups of eligen- 7（135，270，405 mg/kg），with 10 rats in each group. Blank group and model group were given 0.5％ sodium carboxymethyl cellulose solution intragastrically ；other groups were given relevant medicine intragastrically，once a day ，for consecutive 10 weeks. After last intragastric administration ，the pathomorphological changes of liver tissue were observed ；mRNA and protein expression of Collagen Ⅰ，α-SMA，PI3K，Akt and PTEN were detected in liver tissue. RESULTS ：Compared with model group ，OD value （except for medium-dose and high-dose groups of eligen- 7 containing serum）and the proportion of cells at S phase in administration groups were decreased significantly （P＜0.01）；late apoptotic rate ， early apoptotic rate （except for low-dose group ），total apoptotic rate and the proportion of cells at G 2/M phase increased significantly（P＜0.01）；mRNA and protein expression of Collagen Ⅰ，α-SMA，PI3K and Akt in cells and liver tissue were decreased significantly （P＜0.05 or P＜0.01），those of PTEN were increased significantly （P＜0.05 or P＜0.01）. CONCLUSIONS ： Eligen-7 shows the effect of anti-hepatic fibrosis ， themechanism of which may be related to regulating the activity of PI 3K/Akt signaling pathway and promoting the apoptosis of hepatic stellate cells.  
          
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        发布时间：2022-06-21
      • JIA Mengnan,ZHU Mingjun,WANG Yongxia,LI Bin,HAO Xuanxuan,WANG Xinlu,YU Rui,CHANG Xindi,LI Jiewei
        Vol. 32, Issue 23, (2021)
        摘要：OBJECTIVE：To in vestigate the effects of quercetin （Que）on the expressio n of angiotensin Ⅱ（AngⅡ）-induced myocardial contractile proteins of primary rats through angiotensin-converting enzyme 2-angiotensin-（1-7）-Mas （ACE2-Ang- （1-7）-Mas）axis. METHODS ：Cardiac tissue of rats aged 1-2 d were collected ，and primary cardiomyocytes were isolated and cultured. The gene silencing model of cardiomyocytes ACE2 was constructed. Experiments were divided into 12 groups. Among them，AngⅡ group，AngⅡ+ small interference RNA （siRNA）group，and Ang Ⅱ+ A 779 group were the model groups ；AngⅡ+ losartan group was positive control group ；AngⅡ+Que40 group，AngⅡ+Que80 group，AngⅡ+siRNA+Que40 group，AngⅡ+ siRNA+Que80 group，AngⅡ+A779+Que40 group and Ang Ⅱ+A779+Que80 group were the experimental groups ；blank group and siRNA group were set up. Ang Ⅱ concentration was 1×10－6 mol/L；siRNA final concentration was 50 nmol/L；Que concentration was 40 and 80 μmol/L；A779（Mas receptor inhibitor ）concentration was 1 μmol/L；losartan concentration was 1×10－4 mol/L. mRNA and protein expression of ACE 2，Ang-（1-7） and Mas in primary cardiomyocytes were detected ；the expressions of myocardial contractile proteins were also determined ，such as Na +/Ca2+ exchange channel （NCX），calcium pump （SERCA2a）， phosphoprotein （PLB）. RESULTS ：Compared with Ang Ⅱ group，mRNA expression of Mas was increased significantly in Ang Ⅱ + Que 80 group （P＜0.05）；mRNA expression of ACE2 and Mas were increased significantly in Ang Ⅱ + CZ0210-01） losartan group （P＜0.05）. Compared with Ang Ⅱ group，the 851136165@qq.com protein expression of ACE 2 and Ang- （1-7） were increased significantly in Ang Ⅱ+ Que 40 group（P＜0.05）；compared with Ang Ⅱ + siRNA group ，the protein expression of Ang-（1-7）were increased significantly in Ang Ⅱ+ siRNA+Que 40 group（P＜0.05）；compared with Ang Ⅱ+A779 group，the protein expression of Ang- （1-7）were increased significantly in Ang Ⅱ+A779+ Que 40 group（P＜0.05）. Compared with Ang Ⅱ group，the protein expression of NCX was decreased in Ang Ⅱ+Que40 group（P＜0.05），protein expression of NCX was reduced in Ang Ⅱ+ losartan group （P＜0.05）；compared with Ang Ⅱ+A779 group，the protein expression of NCX was decreased in Ang Ⅱ+A779+ Que80 group （P＜0.05）. CONCLUSIONS ：Que improves the expression of Ang Ⅱ -induced ACE 2-Ang-（1-7）-Mas axis in cardiomyocyte model to some extent ，so as to regulate myocardial contractile protein.  
        关键词：Quercetin;ACE2-Ang-（1-7）-Mas axis;Cardiomyocytes;Angiotensin Ⅱ;Myocardial contractile protein   
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        发布时间：2022-06-21
      • LI Shanshan,TIAN Chunyu,ZHANG Guowei,MA Leilei,LI Ji ’an,LIU Jiaxuan,LIU Ying,LI Shuang,LI Xiaolong,SHEN Jiahuan
        Vol. 32, Issue 23, (2021)
        摘要：OBJECTIVE：To study the improvement effects of paeon iflorin（PF）on myocardial injury in type 2 diabetes mellitus（T2DM）model rats and its mechanism. METHODS ：The experiment was set up in the normal group ，model group ， positive control group （metformin 90 mg/kg），PF high-dose ，medium-dose and low-dose groups （90，60，30 mg/kg），with 8 rats in each group. Except for normal group ，other groups were given high-glucose and high-fat diet and intraperitoneal injection of streptozotocin （30 mg/kg） to induce T 2DM model. After modeling ， administration groups were given relevant medicine intragastrically，normal group and model group were given constant volume of normal saline intragastrically ，once a day ，for consecutive 4 weeks. The body weight ，fasting blood glucose and oral glucose tolerance were measured ；serum levels of glycosylated serum protein （GSP），total cholesterol （TC），triacylglycerol（TG），glutathione peroxidase （GSH-Px），superoxide dismutase（SOD），malondialdehyde（MDA），creatine kinase isoenzyme-MB （CK-MB） and troponin Ⅰ （cTn Ⅰ） were determined. The pathomorphological changes of myocardium were observed. The apoptosis index of rat cardiomyocytes was （ detected. The protein expression of B-cell lymphoma 2 （Bcl-2），Bcl-2 related X protein （Bax）and caspase- 3 in rat myocardium were detected by immunohistochemistry and Western blot. RE SULTS：Compared with normal group ，the body weight ，serum levels of GSH-Px and SOD ，protein expression of Bcl- 2 in myocardium were decreased significantly in model group（P＜0.01）；while fasting blood glucose ，area under blood glucose curve ，serum levels of biochemical indexes （GSP，TC， TG，MDA，CK-MB，cTnⅠ），cardiomyocyte apoptosis index ，protein expression of Bax and caspase- 3 in myocardium were increased significantly （P＜0.05 or P＜0.01）. The arrangement of myocardium was relatively irregular ，and some muscle fibers were broken. Compared with model group ，except for body weight ，serum levels of SOD and MDA ，the protein expression of Bax in myocardium in PF low-dose group ， above indexes of PF groups were reversed significantly （P＜0.05 or P＜0.01）. CONCLUSIONS：PF can regulate glycolipid metabolism ，enhance antioxidant ability ，inhibit cardiomyocyte apoptosis and improve myocardial injury in T 2DM model rats ；the mechanism may be associated with increasing the protein expression of Bcl- 2 and down-regulating the protein expression of Bax and caspase- 3 in myocardium.  
        关键词：Paeoniflorin;Type 2 diabetes mellitus;Myocardial injury;Apoptosis   
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        发布时间：2022-06-21
      • ZHANG Zhisi,CHENG Wanqiu,JIANG Tao,SHEN Zhibin,CHEN Yanfen,CHEN Cong,SITU Ying,TANG Chunping
        Vol. 32, Issue 23, (2021)
        摘要：OBJECTIVE：To study the toxicity mechanism of yunacotine-induced arrhythmia in rats. METHODS ：Totally 32 rats were randomly divided by random number table method into normal control group ，yunacotine low-dose and high-dose groups （0.09，0.14 mg/kg），aconitine group （positive control ，0.88 mg/kg），with 8 rats in each group. Administration groups were given the corresponding drugs once a day ，and normal control group was given the constant volume of normal saline ，for consecutive 7 d. After last intragastric administration ，the changes of electrocardiogram （ECG） were observed. The contents of adenosine triphosphate（ATP）in myocardial tissue and Ca 2+ in myocardial cells ，the activities of Na +-K+-ATPase and Ca 2+-Mg2+-ATPase as well as the protein expression of ranolidine receptor 2（RyR2）and Ca 2+-ATPase（SERCA2）in myocardial tissue were determined. RESULTS：Compared with normal control group ，time limit of QRS wave and QTc intervals of rats were prolonged significantly in yunaconitine low-dose group （P＜0.01）. The content of Ca 2 + in myocardial cells ， the ATP contents ， the activities of Ca2+-Mg2+-ATPase and Na +-K+-ATPase as well as the protein expression of SERCA 2 in myocardial tissue were reduced significantly （P＜0.05 or P＜0.01）. The heart rate of rats in yunaconitine high-dose group and aconitine group were increased significantly （P＜ 0.05 or P＜0.01），and time limit of QRS wave and QTc intervals were significantly prolonged （P＜0.01）；the content of Ca 2+ in myocardial cells was increased significantly （P＜0.01）；ATP content ，the activities of Ca 2+-Mg2+-ATPase and Na +-K+-ATPase，and protein expression of RyR 2 and SERCA 2 in myocardial tissue were decreased significantly （P＜0.01）. CONCLUSIONS ： Yunaconitine can induce arrhythmia in rats ，the mechanism of which may be associated with Ca 2+ overload that resulted from reducing the activities of Na +-K+-ATPase and Ca 2+-Mg2+-ATPase and down-regulating the expression of related calcium transporter RyR2 and SERCA 2.  
          
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        发布时间：2022-06-21
      • XING Xin,ZHAO Daqing,WANG Siming,YU Shiting,LI Yixuan,LIU Meichen
        Vol. 32, Issue 23, (2021)
        摘要：OBJECTIVE：To study the potential mechanism of yam protein （DOT） in the prevention and treatment of diabetes-induced erectile dysfunction （DIED）. METHODS ：DIED model was induced by high-glucose and high-fat diet and intraperitoneal injection of streptozotocin （40 mg/kg）. The experiment was set up in the normal control group （normal saline ）， model group （normal saline ），DOT low-dose ，medium-dose and high-dose groups （0.3，0.6，0.9 mg/kg），sildenafil group （positive control ，4.4 mg/kg），with 9 rats in each group. In the stage of successful establishment of diabetes model and initiation of inducing DIED ，rats in each group were given relevant solution intragastrically ，once a day ，for consecutive 11 weeks. Body weight，fasting plasma glucose （FPG），the times and rate of penile erection ，fasting insulin （FINS），insulin resistance index （IR），the contents of endothelial nitric oxide synthase （eNOS）and cyclic guanosine monophosphate （cGMP）in penile cavernous tissue were determined so as to evaluate the intervention effects of DOT on DIED model rats. High-glucose damaged mice cavernous endothelial cells （MCECs）model was induced by 30 mmol/L glucose for 48 h，and then give DOT 125，250，500 μg/mL. The cell viability was detected so as to evaluate the effects of DOT on high-glucose damaged MCECs model. RNA-Seq mail：xingxin0902@163.com technology was adopted to screen the differentially expressed genes between normal MCECs and high-glucose damaged MCECs，high-glucose damaged MCECs and MCECs treated with 250 μg/mL DOT. Gene ontology（GO）function enrichment analysis and KEGG pathway enrichme nt analysis were performed for differentially expressed genes. The common differentially expressed genes between 2 groups were analyzed ，and mRNA expressions of six key genes were validated. RESULTS ：Different doses of DOT could reverse the reduction of body weight ，the increase of FINS and IR ，the reduction of the times and rate of penile erection ，the decrease of eNOS and cGMP contents in penile cavernous tissue of DIED model rats ；above indexes of DIED model rats were reversed significantly after treated with high-dose of DOT（P＜0.05 or P＜0.01）. 125，250，500 μg/L DOT could significantly improve the activity of high-glucose damaged MCECs （P＜0.05 or P＜0.01）. RNA-Seq technology showed that compared with normal MCECs ，a total of 48 differentially expressed genes were found in high-glucose damaged MCECs. Compared with high-glucose damaged MCECs ，a total of 779 differentially expressed genes were found in MCECs treated with DOT. The differentially expressed genes of 2 groups were mainly cellular process in biological process annotation ，cellular part in cell component annotation and binding molecular function in molecular function annotation ，which were mainly enriched in extracellular matrix receptor interaction pathway ，mismatch repair pathway ， phosphatidylinositol 3 kinase-protein kinase B （PI3K-Akt）signal pathway and so on. Among differentially expressed genes of 2 groups，13 common differentially expressed genes such as Aldh1a1，Abcc5，Tac1 were found. DOT could significantly reverse the expression of the above common differentially expressed genes in high-glucose damaged MCECs. After validation ，DOT could significantly reverse the mRNA expression of TGF-β3，Txnip，Aldh1a1，Loxl1，Mt1 and Mt2 in high-glucose damaged MCECs. CONCLUSIONS：DOT could improve the symptom of DIED model rats ，the mechanism of which may be related to biological pathway of inhibiting fibrosis and reducing oxidative stress ，so as to improve the endothelial function of cavernous body.  
          
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        发布时间：2022-06-21
      • LI Xiaoming,WANG Wenbao,GUO Lina,SONG Bo,DONG Wei,XU Tianjiao,WANG Xiaoli
        Vol. 32, Issue 23, (2021)
        摘要：OBJECTIVE：To study the improvement eff ects and p otential mechanism of chelidonine on CCl 4-induced hepatic fibrosis model rats. METHODS ：According to the random number table method ，a total of 48 rats were randomly divided into normal control group ，model group ，chelidonine low-dose ，middle-dose and high-dose groups （0.125，0.25，0.50 mg/kg），positive control group （Liver-protecting tablet ，0.42 g/kg），with 8 rats in each group. Except for normal control group ，other groups were given CCl 4-olive oil solution intraperitoneally for 8 weeks to induce hepatic fibrosis model. From the fifth week of modeling ， normal control group and model group were given water intragastrically ；administration groups were given relevant medicine intragastrically，once a day ，for consecutive 10 weeks. After last intragastric administration ，hepatic index of rats was calculated. The levels of aspartate aminotransferase （AST），alanine aminotransferase （ALT）and hyaluronic acid （HA）in serum and the level of hydroxyproline （Hyp）in liver tissue were determined. The staining of collagen fibrin in rat liver was observed. The protein expression of α-smooth muscle actin （α-SMA），microtubule-associated protein 1 light chain 3（LC3）and p 62 as well as the phosphorylation level of phosphoinositide 3 kinase（PI3K），protein kinase B （Akt）and mammalian target of rapamycin （mTOR）in liver tissue were determined ；mRNA expression corresponding to above protein were also determined. RESULTS ：Compared with normal control group ，the hepatic index ，the serum levels of AST ，ALT，HA and Hyp ，the percentage of positive staining area for collagen fibrin ，the mRNA and protein expression of α-SMA and LC 3- Ⅱ were increased significantly （P＜0.05）. Protein expression of p 62，phosphorylation levels of PI 3K，Akt and mTOR as well as mRNA expression of p 62，PI3K，Akt and mTOR were significantly down-regulated （P＜0.05）. Compared with model group ，phosphorylation levels of PI 3K and mTOR were decreased significantly in chelidonine low-dose group （P＜0.05）. The changes of above indexes in chelidonine middle-dose and high-dose groups （except for liver index ， HA level in middle-dose group ） were reversed significantly （P＜0.05）. CONCLUSIONS：Chelidonine can attenuate CCl 4-induced liver fibrosis in rats ；the mechanism of it may be associated with activating PI 3K/Akt/mTOR signaling pathway and inhibiting autophagy.  
        关键词：Chelidonine;Hepatic fibrosis;PI3K/Akt/mTOR signaling path way;Autophagy   
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      • FENG Lei,YANG Jianmin,YANG Ran,SUN Li,DONG Lili,ZHANG Qingwei
        Vol. 32, Issue 23, (2021)
        摘要：OBJECTIVE：To study the reversal effect of quercetin on human cervical squamous carcinoma cisplatin-resistant cell line SiHa/DDP. METHODS ：The drug resistance index of cisplatin to SiHa/DDP cells ，and the reversal resistance multiple of quercetin to SiHa/DDP cells were determined. The effects of quercetin （0.005 μg/mL），cisplatin（2.5 μg/mL），cisplatin combined with quercetin （2.5 μg/mL cisplatin+0.005 μg/mL quercetin），quercetin combined with pathway inhibitor（0.005 μg/mL quercetin+ 20 nmol/L rapamycin ）on the apoptotic rate of SiHa/DDP cells were investigated ，as well as its effects on the expression of phosphatidylinositol 3-kinase （PI3K）/protein kinase B （Akt）/mammalian rapamycin target protein （mTOR） signaling pathway related proteins （PI3K，Akt，mTOR，P-gp，p70S6K）. RESULTS ：The resistance index of cisplatin to SiHa/DDP cells was 5.19， and reversal resistance multiple of quercetin to SiHa/DDP cells was 4.00. Compared with cisplatin alone and quercetin alone ， cisplatin combined with quercetin ，quercetin combined with rapamycin could significantly increase the apoptotic rate of SiHa/DDP cells（P＜0.05），while decreased the phosphorylation of Akt ，mTOR and p 70S6K protein as well as the expression of P-gp protein （P＜0.05）. CONCLUSIONS ：Quercetin can effectively reverse drug resistance of SiHa/DDP cells to cisplatin ，which may be associated with inhibiting the expression of the protein related to PI 3K/Akt/mTOR signaling pathway.  
          
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        发布时间：2022-06-21
      • REN Yu,GUAN Xin,ZHANG Yao,MA Aixia
        Vol. 32, Issue 23, (2021)
        摘要：OBJECTIVE：To evaluate the pharmacoec onomics of Enalapril folic acid tablet and Enalapril tablet for stroke prevention in patients with hypertension. METHODS ：Markov model was constructed by using Excel 2016 software. Patients with essential hypertension were selected as the research object with 1 year cycle and 20 years horizon. From the perspective of health system，the pharmacoeconomics of Enalapril folic acid tablets versus Enalapril tablets for stroke prevention in patients with hypertension was compared by cost-effectiveness analysis ，and the stability of the research results was verified by sensitivity analysis. RESULTS ：Compared with Enalapril tablet ，the incremental cost-effectiveness ratio of Enalapril folic acid tablet was 221 323 yuan/QALY，which was higher than three times of China ’s per capita GDP in 2020（217 341.04 yuan）. The results of single factor sensitivity analysis and probabilistic sensitivity analysis were consistent with that of basic analysis. CONCLUSIONS ： Compared with Enalapril tablet ，Enalapril folic acid tablet doesn ’t have a better economy for patients with hypertension.  
        关键词：Prevention;Stroke;Pharmacoeconomics;Enalapril folic acid tablet;Enalapril tablet;Hypertension;Health system   
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        发布时间：2022-06-21
      • LYU Fengjun,LI Si,SUN Fengjun,FAN Jishan
        Vol. 32, Issue 23, (2021)
        摘要：OBJECTIVE：To investigate the consistency and difference of f luorescence immunochromatographic and liquid chromatography-tandem mass spectrometry （LC-MS/MS）and enzyme multiplied immunoassay technique （EMIT）in the blood concentration monitoring of mycophenolic acid. METHODS ：Fluorescence immunochromatography ，LC-MS/MS and EMIT were used to detect the blood concentration of mycophenolic acid in 61 blood samples of children treated with mycophenolate mofetil ester orally at different time points. Kolmogorov-Smirnov method ，Wilcoxon pairing test ，Passing-Bablok regression ，Cusum method，Spearman correlation analysis ，Bland-Altman scatter diagram were adopted for statistical analysis. RESULTS ：Blood concentrations of mycophenolic acid ，which were determined by fluorescence immunochromatography ，LC-MS/MS and EMIT ， showed non-normal distribution. Passing-Bablok regression analysis showed that regression equation of fluorescence immunochromatography and LC-MS/MS ，fluorescence immunochromatographic method and EMIT were CFI=0.928 3CLC-MS/MS+0.961 7 and CFI＝0.880 7CEMIT－0.488 2（FI means fluorescence immunochromatographic ）. Spearman correlation analysis showed that the correlation coefficients between fluorescence immunochromatography and LC-MS/MS ，fluorescence immunochromatography and EMIT were 0.968 and 0.929， respectively （P＜0.000 1）. Bland Altman scatter plot analysis showed that 3.28％ of the 358341451@qq.com difference between fluorescence immunochromatography and LC-MS/MS was outside the consistency limit （±1.96SD）， and 1.64％ of the difference between fluorescence immuno- chromatography and EMIT was outside the consistency limit （± 1.96SD）. Wilcoxon pairing test showed that the results of fluorescence immunochromatography were higher than those of LC-MS/MS （Z＝3.76，P＝0.000 2）and lower than those of EMIT （Z＝－5.96，P＜0.000 1）. CONCLUSIONS ：Fluorescence immunochromatography shows good consistency and correlation with LC-MS/MS and EMIT ；the blood concentrations of mycophenolic acid detected by fluorescence immunochromatography were higher than those by LC-MS/MS and lower than those by EMIT . It can be used for bedside rapid detection. When using the test results of different methods for clinical medication ，the differences of test methods need to be considered.  
          
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        发布时间：2022-06-21
      • LI Jinshuang,QI Ranran,WANG Wanhong,ZHOU Hao,CHEN Chunwang,ZHANG Ronglin
        Vol. 32, Issue 23, (2021)
        摘要：OBJECTIVE：To investigate the effec ts of angiotensin receptor neprilysin inhibitor （ARNI）sacubitril valsartan sodium（SVS）on the short-term prognosis of patients with acute anterior myocardial infarction （AAMI）complicated with acute cardiac insufficiency. METHODS ：A total of 80 patients with AAMI and Killip grade Ⅱ-Ⅳ of cardiac function ，who met the inclusion criteria ，were randomly divided into ARNI group and control group ，with 40 patients in each group. Both groups were given the same basic standardized drug treatment ，vital signs support treatment and percutaneous coronary intervention treatment at the same time. On this basis ，ARNI group was given SVS tablet orally ，with initial dose of 25 mg each time ，twice a day ； thereafter，gradually adjust the dose to 200 mg each time ，twice a day. Control group was given Enalapril maleate tablets orally ， with an initial dose of 5 mg each time ，twice a day ；thereafter，gradually adjust the dose to 10 mg each time ，twice a day. Both groups took medicine for a long time ，and were followed up after 1，3 and 6 months of medication to the clinic. The levels of N-terminal pro-B-type natriuretic peptide （NT-proBNP）， soluble growth stimulation expressed gene 2 protein （sST2） and echocardiography indexes were compared between 2 groups before and after medication. The 6-minute walking test （6MWT）and the incidence of cardiogenic readmission events were recorded in 2 groups after medication. RESULTS ：Compared with before treatment，the indexes of the two groups were significantly improved at 1，3 and 6 months after treatment （P＜0.05）. Compared with control group ，the levels of NT-proBNP and sST 2 in ARNI group decreased significantly （P＜0.05），the levels of left ventricular ejection fraction and 6MWT increased significantly（P＜0.05），and the left ventricular end systolic diameter and left ventricular end diastolic diameter decreased significantly，after 3 and 6 months of treatm ent（P＜0.05）. However ，there was no significant difference in the velocity ratio of peak E to peak A ，pulmonary artery pressure ，right ventricular end diastolic diameter and the incidence of cardiogenic readmission events between 2 groups（P＞0.05）. CONCLUSIONS ：For patients with AAMI complicated with acute cardiac insufficiency ， compared with enalapril ，SVS can significantly improve the cardiac function （especially the left ventricular systolic function ）， reduce the inflammatory reaction of cardiomyocytes ，protect cardiomyocytes ，so as to improve the short-term prognosis of patients.  
          
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        发布时间：2022-06-21
      • HU Zixin,XIE Jinping,WANG Wanru,SHAO Rong
        Vol. 32, Issue 23, (2021)
        摘要：OBJECTIVE：To eval uate the effectiveness ，safety and economy of chimeric antigen receptor T cells （CAR-T） therapy for the treatment of B-lymphoblastic hematologic malignancy ，and to provide evidence-based reference for clinical decision. METHODS：Rapid health technology assessment （HTA）was adopted. PubMed ，Embase，Cochrane Library ，CNKI，Wanfang databases and foreign HTA official websites were systematically searched during the inception-Mar. 20th，2021. After inclusion ， data extraction and quality evaluation of literatures according to the inclusion and exclusion criteria ，descriptive analysis was performed for the effectiveness ，safety and economy of CAR-T therapy for the treatment of B-lymphoblastic hematologic malignancy. RESULTS ：A total of 2 HTA reports ，5 systematic reviews/Meta-analysis ，and 5 economics studies were included. In terms of effectiveness ，CAR-T therapy showed good efficacy in the treatment of B-lymphoblastic hematologic malignancy ；overall remission rate （ORR）of CAR-T therapy in the treatment of acute lymphoblastic leukemia was more than 63.5％，and the complete remission rate （CR）was 77.1％（95％CI：62.8％-87.1％）；ORR of CAR-T therapy in the treatment of chronic lymphoblastic leukemia was 70.0％（95％CI：53.0％-80.0％），and the CR was 25.5％（95％CI：13.9％-42.1％）；ORR of CAR-T therapy in the treatment of B-cell lymphoma was more than 44.4％. In terms of safety ，the incidence of cytokine release syndrome was more than 20％ during the treatment of CAR-T therapy ，and 1/3 or more （9％ believed in some studies ）patients suffered from neurotoxicity ； the incidence of infection was 12.2％-33.3％，and the incidence of graft-versus-host disease was 23.4％（95％CI：8.6％-49.8％）. In terms of economy ，most of the included studies believed that CAR-T therapy possessed economic advantages ，which were the results of evaluation in developed countries such as the United States and Japan. CONCLUSIONS ：CAR-T，as a new product of treatment for hematological malignancy ，shows good effectiveness and low level of ADR ，which is basically controllable ；its economy needs to be further evaluated by relevant researches combined with domestic reality.  
        关键词：Chimeric antigen receptor T cells therapy;B-lymphoblastic hematologic malignancy;Rapid health technology   
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      • ZHAO Qiuling,XIAO Shenglong,ZHANG Longfeng,CHEN Ting,YANG Lin
        Vol. 32, Issue 23, (2021)
        摘要：OBJECTIVE：To explore the mode of pharmaceutical care for oral medication of tumor patients with dysphagia by clinical pharmacists ，so as to promote clinical rational and safe drug use. METHODS ：Based on typical cases ，the problems existing in the oral medication of tumor patients with dysphagia were analyzed ，and the medication guidance and pharmaceutical care given by clinical pharmacists were expounded. RESULTS ：Clinical pharmacists found that tumor patients with dysphagia had some problems during oral medication ，such as improper administration position ，tube feeding of slow-controlled release preparations after opening the capsule ，limited administration route ，biting cytotoxic drugs ，unknown solubility of targeted drugs ，interaction of multiple drugs. In view of the above problems ，clinical pharmacists assisted physicians and nursing staff to provide pharmaceutical care to patients in combination with the patient ’s disease characteristics ，pharmacy，pharmacokinetics，pharmacodynamics，drug solubility，drug interaction and other factors ，such as skillfully using appropriate drug delivery location and mode ，using local drug delivery mode ，selecting appropriate dosage form based on pharmaceutical knowledge （the characteristics of new dosage form ）， guiding patients to use drugs correctly by being familiar with the characteristics of cytotoxic drugs and targeted drugs ，paying attention to potential drug interactions and guiding nurses to use drugs correctly. The situation of improper medication was improved. CONCLUSIONS ：Clinical pharmacists should participate in clinical therapy actively ，and make appropriate interventions with professional knowledge of pharmacy so as to promote the correct use of oral medication for tumor patients with dysphagia.  
        关键词：Clinical pharmacist;Dysphagia;Tumor patients;Oral drugs;Rational drug use;Pharmaceutical care   
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      • LI Xiaoxia,XIONG Wei,LIU Yongping,CHEN Caiping,ZHANG Qixiang,LIN Nengming
        Vol. 32, Issue 23, (2021)
        摘要：OBJECTIVE：To realize refined management of tablets i n the inpatient pharmacy ，and to ensure the medication safety of patients. METHODS ：Based on intelligent pharmacy ，the dispensing and packaging process under the automated drug dispensing and packaging system （ADDPS）mode was optimized and modified ；PDA barcode scanning technology was applied in all links of taking ，dismantling and adding ，so as to realize the real-time tracking of batch number and inventory ，and improve the drug closed-loop management of tablets. The error rate ，staff consumption time and pharmacist/nurse satisfaction were compared before and after the process improvement. RESULTS ：After the process improvement ，the dispensing error rate was decreased from 1.637‰ before improvement to 0.082‰（P＜0.01）；the staff consumption time decreased from （7.52±0.33）h to （5.11±0.24）h （P＜0.01）；the pharmacist/nurse satisfaction increased from 66.5％ to 93.4％（P＜0.01）. CONCLUSIONS ：Based on ADDPS ，the application of PDA barcode scanning technology standardizes the tablets management of inpatient pharmacy ，supplements and improves the drug closed-loop information ，realizes batch number tracking and inventory management ，reduces the occurrence of tablet dispensing errors ，improves the work efficiency and satisfaction of pharmacists ，and ensures the safety of clinical medication.  
        关键词：Intelligent pharmacy;Refined management;PDA barcode scanning technology;Automated drug dispensing and   
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      • CHEN Ci,LI Zhuo,YANG Bo,WANG Shengfeng
        Vol. 32, Issue 23, (2021)
        摘要：OBJECTIVE：To investigate the pharmaceutical ca re for a child with refractory Stenotrophomonas maltophilia sepsis by clinical pharmacists ，and to provide reference for the treatment of children with this disease. METHODS ：Clinical pharmacist participated in drug therapy for a child with refractory S. maltophilia sepsis. Based on the pathophysiological characteristics of the child and the PK/PD characteristics of the antimicrobials ，clinical pharmacists suggested that the anti-infection regimen should be adjusted as cefoperazone sodium and sulbactam sodium 160 mg/（kg·d），every 8 hours combined with levofloxacin 10 mg/kg， every 12 hours. For clinical manifestations of severe inflammatory reaction ， the clinical pharmacist suggested receiving methylprednisolone sodium succinate 1 mg/kg additionally ，every 12 hours，for anti-inflammatory adjuvant therapy. At the same time， clinical pharmacist provided individualized pharmaceutical care （including the detection of blood concentration of cefoperazone sodium and sulbactam sodium ，the detection of ADR and medication education of oxygen atomization ）during the treatment，and followed up the child for one year. RESULTS ：The doctors adopted the suggestions of clinical pharmacists. The sepsis was controlled ，the child ’s condition were improved and then discharged. During the follow-up ，the child did not suffered from ADR ，such as cartilage and joint injury. CONCLUSIONS ：Hypoimmunity，long stay in intensive care unit ，endotracheal intubation and malignant tumor are the high risk factors of S. maltophilia infection. The monitoring of therapeutic drugs of cefoperazone sodium and sulbactam sodium is very necessary in the treatment of severe infection in children. After weighing the advantages and disadvantages and meeting certain conditions ，children can use quinolones for anti-infection ；based on the effective anti-infection treatment ，low-dose glucocorticoid can reduce the systemic inflammatory respense in patients with sepsis.  
        关键词：Children;Refractory;Stenotrophomonas maltophilia;Sepsis;Pharmaceutical care   
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        发布时间：2022-06-21
      • LI Yingchun,LU Zhuolin,GAO Yan,SUN Yanyan
        Vol. 32, Issue 23, (2021)
        摘要：OBJECTIVE：To standardize the use of children’s over-the-counter（OTC）drugs in China，control the risk of children’s self medication and ensure the safety of children’s medication. METHODS：The questionnaire was randomly distributed to pharmacy practitioners in retail pharmacies in 13/parents in 16 provinces and municipalities directly under the central government. The results of questionnaire survey were analyzed descriptively. The corresponding suggestions were put forward for the problems existing in the use of OTC drugs for children among pharmacy practitioners in retail pharmacies and parents.RESULTS：Totally 5 367 people filled the questionnaire at pharmacies，and 5 353 questionnaires were filled validly with effective rate of 99.74％；the number of consumers（parents）who filled the questionnaires was 6 111，and 5 094 questionnaires were filled validly with effective rate of 83.36％. The results of survey showed that 93.67％ of retail pharmacies were equipped with 1-2 licensed pharmacists；most of the employees in pharmacies had college degree（46.59％），and their professional knowledge was relatively weak，and only 30.00％ of them were very familiar with pharmaceutical professional knowledge. Pharmacy practitioners could provide basic pharmaceutical care，but they were not sensitive to the information of children’s age and weight；only 44.11％ of the practitioners would approve the dosage according to the age and weight of the children；98.09％ of pharmacies would regularly conduct OTC drugs knowledge training，but they did not pay attention to the knowledge of children related to drug use. About half of the pharmacy practitioners were very clear about the indications，usage and dosage，precautions of OTC drugs for children. About 70％ of parents did not fully understand the difference between prescription drugs，green OTC drugs and red OTC drugs，and did not know the risk of home OTC treatment；63.06％ of parents chose OTC drugs according to their previous experience， and 23.05％ of parents relied on drug advertisements to choose OTC drugs； 92.64％ of parents would read the drug instruction carefully before using OTC drugs， but they had blind spots in understanding many contents of the drug instruction. In the process of OTC drug use，46.21％ of parents had used adult OTC drugs for their children，and 41.54％ of parents did not convert the amount of children；52.89％ of parents said that their children suffered from adverse reactions after taking OTC drugs. CONCLUSIONS：The pharmacy practitioners have low education on the whole，professional level needs to be improved，their understanding of children’s OTC drugs is not comprehensive enough，and there is a lack of training on children’s medication knowledge. Parents have a poor awareness of children’s OTC drugs，and there are many problems in the process of using children’s OTC drugs，such as inaccurate dosage，using adult’s drugs. It is suggested that we should improve the access standard of pharmacy practitioners and increase the number of licensed pharmacists；organize special training on safe drug use for children to improve the pharmaceutical service ability of pharmacies；strengthen the supervision of retail pharmacies and formulate pharmaceutical care standards for the use of OTC drugs for children；strengthen the publicity and education on rational drug use for children and popularize the knowledge of safe drug use of OTC drugs for children；give full play to the guiding role of pharmacists and pay attention to the medication guidance of parents.  
        关键词：Pharmacy practitioners in retail pharmacies;Parents;Children;OTC drugs;Safe use of drugs   
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        发布时间：2022-06-21
      • TIAN Yuan,TANG Guiju,WANG Jiting,XU Yong,LI Yaling
        Vol. 32, Issue 23, (2021)
        摘要：OBJECTIVE：To improve the level of pharmaceutical care，enhance the professional value and social status of pharmacists by clarifying the development process of pharmaceutical care and summarizing the value of pharmacists in pharmaceutical care. METHODS：The development process of pharmaceutical care at home and abroad（service objects，service contents and service methods）was summarized；the current situation of pharmaceutical care in China was analyzed；the value of pharmaceutical care were defined in respects of rational drug use，humanistic value and medical resources. The development of pharmaceutical care in the future was prospected. RESULTS & CONCLUSIONS：The development of pharmaceutical care can be divided into three stages：“drug supply as the center”“promoting rational drug use as the center”and“patients as the center”，and the service objects，service contents and service methods in different stages are expanding and diversifying. Compared with developed countries，the overall level of pharmaceutical care in China lags behind，and there are differences in level of pharmaceutical care modes in hospitals at different levels. Pharmacists ensure the safety，effectiveness and economy of drug use through pharmaceutical care，and promote rational drug use；the compliance，quality of life and satisfaction of patients have been improved through pharmaceutical care；pharmacists participate in medical quality management to save medical and health resources through pharmaceutical care. Pharmaceutical care，as an important part of the medical and health system，plays an important and irreplaceable role in the medical process，which is suggested that the relevant government departments should fully understand the value of pharmaceutical care and further strengthen their support for pharmaceutical care；pharmaceutical staff should improve their self-cultivation and cooperate with other disciplines to achieve the sustainable development of hospital pharmacy in different regions and medical institutions.  
        关键词：Pharmacist;Pharmaceutical care;Development process;Value;Medical resources   
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