最新刊期

    32 13 2021
    • WANG Xiaoyun,SHAO Xin,YANG Yang,GUO Zhiming,ZHANG Ziyin,XI Chen,ZHANG Xiaogao,LIAN Junying,ZHANG Xiaojian,GAO Jianbo,LI Yuhong
      Vol. 32, Issue 13, (2021)
      摘要:OBJECTIVE:To provide reference for the c onstruction of subject diagnosis and treatment scheme in drug clinical trials. METHODS :The subject diagnosis and treatment module was developed and implemented in our hospital on the basis of CTMS,and its effects were evaluated. RESULTS :A subject diagnosis and treatment module was established in CTMS of our hospital. Within one year from the launch of the module in the middle of October ,2019,the overall number of subjects in the group showed an increasing trend ,and the overall mean dropout rate of subjects was 0.16%. The data interface of CTMS system , hospital information system (HIS),laboratory information management system ,medical imaging information system had been established,so as to realize the synchronization of subject information (displaying subject identification in HIS system )and the interaction of diagnosis and treatment information and billing data (patients and subjects were charged separately ). Since the launch of the module ,the amount of data generated by the interface had been increasing ,and the number of departments producing the subject diagnosis and treatment business had been increasing month by month. Compared with subject diagnosis and treatment project based on HIS system ,the number of subject diagnosis and treatment business based on CTMS system was increased significantly(P<0.05). CONCLUSIONS :The subject diagnosis and treatment module based on CTMS improves the efficiency of subject diagnosis and treatment project implementation and financial settlement ,and realizes the efficient implementation of drug clinical trial projects in large general hospitals.  
      关键词:Drug clinical tr ials;Clinical tr ial management system;Subject diagnosis and treatment module   
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      发布时间:2022-06-21
    • DING Ruilin,JIANG Rong,SHAO Rong
      Vol. 32, Issue 13, (2021)
      摘要:OBJECTIVE:To provide reference a nd ideas for improving the organizational system of continuing education and management system of teaching institutions for licensed pharmacists in China. METHODS :By introducing the general situation of pharmaceutical education , the legal basis and subject of continuing education organization and management of licensed pharmacists,and the situation of teaching institutions in the United States ,the existing problems in organizing continuing education institutions and managing teaching institutions for licensed pharmacists in China were analyzed ,and some suggestions were put forward. RESULTS & CONCLUSIONS :The continuing education for licensed pharmacists in the United States is supported and promoted by state laws ;the organizational system of continuing education is relatively clear ,the responsibilities of each management subject are clear and the relationship is coordinated ;the teaching institutions have a relatively complete management system and process. However ,the management subject of continuing education for licensed pharmacists in China is inconsistent. It is difficult to establish a unified supervision system ,and there is a lack of unified management standard. And because the qualifications of teaching institutions vary greatly ,the quality of education is difficult to guarantee. It is suggested that China should learn from the experience of the United States and use higher-level legal documents to ensure the clarity of the organization and system of continuing education for licensed pharmacists ;establish a scientific and complete management system and access standards for continuing education institutions ;choose the appropriate management mode of continuing education based on the national conditions.  
        
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      发布时间:2022-06-21
    • YAN Juanjuan,HU Anxia,PEI Zhongyang
      Vol. 32, Issue 13, (2021)
      摘要:OBJECTIVE:To study industry-university-resear ch cooperation model and network evolution characteristics of pharmaceutical manufacturing industry in China ,and to provide decision-making basis for pharmaceutical innovation cooperation. METHODS:Using social network analysis method ,based on industry-university-research cooperation patent data of pharmaceutical manufacturing industry during 1998-2019,the patent cooperation network of pharmaceutical manufacturing industry in China was established,and the structural parameters were calculated and evolution regularity of the network were analyzed. RESULTS : Industry-university-research cooperation patents in the pharmaceutical manufacturing industry were affected by drug innovation policies. The scale of innovation network in pharmaceutical manufacturing industry was expanding day by day ;the density of innovation network was decreasing gradually ;it was not characterized with typical small world features. CONCLUSIONS :It is suggested to strengthen the scientific and technological support to the core innovation subjects (universities and research institutions),and improve the cooperation with enterprises ;optimize the drug innovation policy environment ,encourage more innovation subjects to participate in the drug R&D process ;construct a platform for industry-university-research collaborative innovation,build drug R&D mechanism which can promote industry-university-research cooperation ,reduce the number of intermediaries in cooperation ,optimize the allocation of drug R&D resources and promote cooperative innovation of enterprises.  
      关键词:Pharmaceutical manufacturing industry;Industry-university-research;Innovation;Patent;Social network   
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      发布时间:2022-06-21
    • XIE Ling,TAO Han,ZHANG Xuejun,ZHANG Lingli,HE Yangjie,TIAN Yunxia,WU Qiaoling,JI Chun
      Vol. 32, Issue 13, (2021)
      摘要:OBJECTIVE:To optim ize the ultrafiltration technology of enzymatic hydrolysate from Eucommia ulmoides peel. METHODS:The single factor test was adopted to investigate the effects of molecular weight of ultrafiltration membrane ,liquid temperature,operating pressure ,operating frequency ,membrane filtration time ,liquid concentration and pH on transfer rates of aucubin,geniposide and chlorogenic acid as well as solid removal rate in enzymatic hydrolysate from E. ulmoides peel. Setting the molecular cut off of fixed ultrafiltration membrane of 100 000,liquid concentration of 7 g/L,and pH value of 7,the ultrafiltration technology was optimized by Box-Behnken design response-surface methodology and validated with liquid temperature ,operating pressure,operating frequency and membrane passing time as factors ,using comprehensive scores calculated from transfer rates of aucubin,geniposide and chlorogenic acid as well as solid removal rate as indexes. RESULTS :The optimal ultrafiltration technology of enzymatic hydrolysate from E. ulmoides peel was as follows as liquid temperature of 35 ℃,operating pressure of 0.5 MPa,operating frequency of 35 Hz and membrane passing time of 42 min. Results of validation tests showed that the comprehensive scores of the transfer rates of aucubin ,geniposide and chlorogenic acid as well as solid removal rate in enzymatic hydrolysate from E. ulmoides peel was 78.06%(RSD=1.43%,n=3),and its relative error with the predicted value (77.18%) was 1.14%. CONCLUSIONS :The optimized ultrafiltration technology is stable and reliable ,and can be used for the ultrafiltration purification of enzymatic hydrolysate from E. ulmoides peel.  
        
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      发布时间:2022-06-21
    • YIN Jinping,ZHUO Shaoyuan
      Vol. 32, Issue 13, (2021)
      摘要:OBJECTIVE:To study the effects of ferulic acid on t he proliferation ,invasion and apoptosis of HepG 2 hepatocelluar carcinoma cells. METHODS :CCK-8 assay was used to screen the concentration of ferulic acid. Western blot assay was adopted to screen the optimal concentration of interleukin 6(IL-6)to induce HepG 2 cell model with high expression of phosphorylated signal transduction protein and activator 3(p-STAT3)protein. HepG 2 cell were divided into blank control group , model group ,ferulic acid group (0.5 mmol/L)and positive control group (p-STAT3 inhibitor C 188-9,10 μmol/L). Except for blank control group ,model group treated with IL- 6,while administration groups were treated with IL- 6 and relevant drugs. Cell survival rate ,invasion and apoptosis rate in early and late stage were detected by CCK- 8 assay,Transwell assay and Annexin V-FITC/PI double staining ,respectively. Western blot assay was used to detect the expression of p-STAT 3,caspase-3,ZBP-89 and vimentin proteins in each group. On the basis of the PDB protein database ,using 1BG1,a highly similar crystal structure of STAT3,as docking template ,using the region around Tyr 705 as the putative binding pocket ,the docking analysis of ferulic acid with STAT 3 protein was carried out. RESULTS :It is selected to use 0.5 mmol/L ferulic acid intervention for 48 h as the follow-up experimental condition ;50 ng/mL IL- 6 was selected as the modeling condition. Compared with blank control group ,the number of cell invasion ,p-STAT3/STAT3 ratio and protein expression of vimentin were increased significantly in model group (P<0.05 or P<0.01),while late apoptosis rate and protein expression 20 of caspase- 3 were decreased significantly (P<0.05 or P< 0.01). Compared with model group ,cell survival rate ,the number of cell invasion ,p-STAT3/STAT3 ratio and protein expression of vimentin were d ecreased significantly in ferulic acid group and positive control group (P<0.05 or P<0.01);early apoptotic rate (except for ferulic acid group ),late apoptotic rate,the protein expression of caspase- 3 and ZBP- 89(except for positive control group )were increased significantly (P<0.05 or P<0.01). The results of molecular docking showed that the carboxylic groups of ferulic acid could interact with 1.9 Å hydrogen bond of Asn 581 and 2.0 Å hydrogen bond of Lys 591,with binding energy of -4.4 kcal/mol. CONCLUSIONS :Ferulic acid may inhibit the activity of p-STAT 3 by directly binding to the phosphorylation site of STAT 3;it may up-regulate the protein expression of caspase- 3 via STAT 3 dependent pathway ,or up-regulate the protein expression of ZBP- 89 via STAT 3 independent pathway and then down-regulate the protein expression of vimentin ,so as to inhibit the proliferation ,invasion and apoptosis of HepG 2 cells.  
      关键词:Ferulic acid;HepG2 hepatocellular carcinoma cell;STAT3;Caspase-3;Vimentin   
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      发布时间:2022-06-21
    • AN Yan,LI Yuxin,YAN Xiaojing
      Vol. 32, Issue 13, (2021)
      摘要:OBJECTIVE:To study the imp rovement effects of Polygonatum si biricum polysaccharides(PSP)on the myocardial injury of acute myocardial infarction (AMI)model rats. METHODS :The rats were randomly divided into blank control group , model group ,aspirin group (positive control ,25 mg/kg),PSP low-dose ,medium-dose and high-dose groups (0.5,1,2 g/kg), with 10 rats in each group. Except for blank control group ,AMI model was established by ligation of the anterior descending branch of the left coronary artery of rats in other groups. After modeling ,blank control group and model group were given normal saline intragastrically ,and administration groups were given relevant medicine intragastrically ,once a day ,for consecutive 28 days. After last medication ,left ventricular ejection fraction (LVEF)and left ventricular short axis shorting rate (LVFS)of rats were detected. The morphological changes of myocardial tissue were observed. The levels of oxidative stress indexes (SOD,MDA, ROS)in myocardial tissue of rats were detected by ELISA. The expression of apoptosis-related proteins (Bcl-2,Bax,caspase-3, caspase-8,caspase-9)and the Wnt/ β-catenin pathway-related proteins (Wnt1,β-catenin)in left ventricular anterior wall tissue of rats were detected by Western blot assay. RESULTS :Compared with model group ,the levels of LVEF and LVFS ,the levels of SOD in myocardial tissue and protein expression of Bcl- 2 in left ventricular anterior wall tissue were increased significantly in PSP medium-dose,high-dose groups and aspirin group (P<0.05);the levels of MDA and ROS in myocardial tissue ,the protein expression of Bax ,caspase-3,caspase-8,caspase-9,Wnt1 and β-catenin in left ventricular anterior wall tissue were decreased significantly(P<0.05);myocardial tissue structure disorder and inflammatory cell infiltration were reduced. CONCLUSIONS : PSP can relieve myocardial injury in AMI model rats ;its mechanism may be related to increasing SOD level in myocardial tissue ,decreasing MDA and ROS level ,regulating apoptosis-related proteins and Wnt/ β-catenin pathway-related proteins.  
      关键词:Polygonatum sibiricum polysaccharides;Acute myocardial infarction;Oxidative stress;Wnt/β-catenin pathway   
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      发布时间:2022-06-21
    • BAO Hailan,Terigele,Qimuge
      Vol. 32, Issue 13, (2021)
      摘要:OBJECTIVE:To study the improvement effects of saf flower yellow on lung function in chronic obstructive pulmonary disease (COPD)model rats. METHODS :SD rats were randomly divided into control group ,model group ,positive control group (dexamethasone,0.09 mg/kg),safflower yellow low-dose ,medium-dose and high-dose groups (5,10,20 mg/kg), with 10 rats in control group and 11 rats in other groups. Except for control group ,other groups were given lipopolysaccharide combined with fumigation to induce COPD model. After modeling ,control group and model group were given constant volume of normal saline intragastrically ,and administration groups were given relevant medicine intragastrically ,once a day ,for consecutive 12 weeks. After last medication ,the levels of TNF-α,IL-6 and IL- 8 were detected by ELISA. The levels of blood gas indexes (PaO2,SaO2 and PaCO 2)in whole blood were detected by blood gas analyzer. The levels of lung function indexes (FVC,FEV1, FEV1/FVC,PEF and MMEF )were detected by lung function analyzer. The expression of TLR 4,NF-κB and I κB-α protein were detected by Western blot. HE staining was used to observe the pathological changes of lung tissue. RESULTS :Compared with control group ,the serum levels of TNF-α,IL-6 and IL- 8,the level of PaCO 2 in whole blood as well as the protein expression of TLR4 and NF-κB in lung tissue were increased significantly in model group(P<0.01);the levels of PaO 2 and SaO 2 in whole blood,the levels of lung function as FVC ,FEV1,FEV1/ FVC,PEF and MMEF as well as the protein expression of IκBα in lung tissue were decreased significantly(P<0.01); there were obvious degeneration and necrosis in the epithelial cells of lung tissue ,and obvious inflammatory infiltration in the interstitial cells. Compared with model group ,the levels o f inflammatory factors in serum ,blood gas indexes in whole blood and lung function indexes as well as the expression of related protein in lung tissue (except for IκBα in low-dose group)were reversed significantly in safflower yellow groups (P<0.05 or P< 0.01);the necrosis ,exfoliation and inflammatory infiltration of epithelial cells in lung tissue were improved in varying degrees. CONCLUSIONS:Safflower yellow can significantly improve the lung function of COPD model rats ,and its mechanism may be related to inhibiting the expression of inflammatory factors and regulating the expression of TLR 4/NF-κB pathway-related proteins.  
      关键词:Safflower yellow;Chronic obstructive pulmonary disease;Inflammatory factors;TLR4;NF-κB   
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      发布时间:2022-06-21
    • ZHANG Yong,LI Chuanfeng,GAO Guihua,MA Yu,REN Qiang
      Vol. 32, Issue 13, (2021)
      摘要:OBJECTIVE:To establish the metho d for the content determination of 8 nucleosides in wild and cultivated Pinellia ternate,and to conduct the difference analysis. METHODS :The contents of uracil ,uridine,inosine,xanthine,adenine, guanosine,β-thymidine and adenosine in 20 batches of P. ternate (wild product YS 1-YS8,cultivated product ZP 1-ZP12)were determined by HPLC method. Based on the contents of the above 8 nucleosides,cluster analysis ,principal component analysis (PCA),partial least squares analysis (OPLS-DA)were used to comprehensively evaluate the wild and cultivated P. ternata . RESULTS:The contents of uracil ,uridine,inosine,xanthine,adenine,guanosine,β-thymidine and adenosine in 20 batches of P. ternate were 0.02-0.24,0.01-0.24,0.06-0.37,0.02-0.14,0.04-0.22,0.14-0.42,0.01-0.09,0-0.32 mg/g,respectively. Cluster analysis,PCA and OPLS-DA showed that 8 batches of wild P. ternate (YS1-YS8)were clustered into one category ,and 12 batches of cultivated P. ternate (ZP1-ZP12)were clustered into one category. Main characteristic markers of wild P. ternate were guanosine,uridine,adenosine and adenine ,while the main characteristic markers of cultivated P. ternate were urinine ,xanthine, inosine,and β-thymidine. CONCLUSIONS:The method for the content determination of 8 nucleosides in P. ternate is established. Nucleosides as quality markers can effectively distinguish wild and cultivated P. ternata ,and the quality of the wild P. ternate was better than that of cultivated P. ternate .  
      关键词:Pinellia ternata;Wild product;Cultivated product;Nucleoside;Content determination;Chemical pattern   
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      发布时间:2022-06-21
    • XIE Tanfang,ZHU Xiaoyong,HUANG Tianyan
      Vol. 32, Issue 13, (2021)
      摘要:OBJECTIVE:To study the effects of chitosan graphene oxide car rier(CS-GO)loaded with oridonin (CS-GO- oridonin)on the proliferation and apoptosis of human lung cancer A 549 cells. METHODS :Taking A 549 cells as objects ,the survival rate of cells were detected by CCK- 8 method after treated with different concentrations of CS-GO (3,6,12,24,48 μg/mL)and CS-GO-oridonin loaded with same mass of oridonin (3,6,12,24,48 μg/mL,by the weight of oridonin ,the same below). IC 50 of CS-GO-oridonin was calculated. The cell morphology were observed by microscope after treated with CS-GO and CS-GO-oridonin(both 32 μg/mL)for 2,4,10,24 h. The uptake of CS-GO ,oridonin,CS-GO-orionin(all 32 μg/mL)by cells was observed with fluorescence labeling method. The apoptosis of cells and the content of ROS were observed by flow cytometry after treated with different concentrations of CS-GO (16,32,64 μg/mL)and CS-GO-oridonin (16,32,64 μg/mL). The expression of anti-apoptosis related proteins (Mcl-1,Bax and Bak )were detected by Western blot. RESULTS :After treated with different concentrations of CS-GO ,the survival rate of cells was still above 90% ;after treated with different concentrations of CS-GO-oridonin,the survival rate of cells showed a downward trend ,and was significantly lower than that of CS-GO group (P< 0.01);IC50 of CS-GO-oridonin was 32.61 μg/mL. After CS-GO treatment,the cell morphology did not change significantly ;after CS-GO-oridonin treatment ,the cells shrunk and fell off in clusters ,and the suspended matter increased ;the fluorescence of oridonin and CS-GO-orionin taken up by cells was enhanced than CS-GO. Compared with blank group ,there was no significant change in the apoptosis rate ,the content of ROS and the expression of apoptosis-related protein in 16,32,64 μg/mL CS-GO groups(P>0.05);apoptosis rate ,the content of ROS ,the protein expression of Bax and Bak in 16,32,64 μg/mL CS- GO-oridonin groups were increased significantly ,while the protein expression of Mcl- 1 were decreased significantly. Above indexes were significantly high er or lower than the same concentration CS-GO group (P<0.05). CONCL USIONS:CS-GO dose not affect the proliferation and apoptosis of A 549 cells;CS-GO-oridonin has obvious inhibition and apoptosis promoting effect on cells ,which may be related to increasing ROS production and regulating the expression of apoptosis related proteins.  
      关键词:Chitosan graphene oxide carrier;Oridonin;A549 cells;Proliferation;Apoptosis   
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      发布时间:2022-06-21
    • JIA Ru,WEI Shijie,ZHANG Wenping,MAI Shuxia,JIANG Shaofei,DANG Hongwan
      Vol. 32, Issue 13, (2021)
      摘要:OBJECTIVE:To develop a metho d for determining the plasma concentration of sulfasalazine (SSZ)metabolite sulfapyridine(SP)in rats ,and to investigate the effects of esomeprazole (ESOM)on the pharmacokinetic behavior of SSZ in rats. METHODS:Male SD rats were randomly divided into SSZ group and SSZ+ESOM group ,with 6 rats in each group. SSZ+ESOM group were given Esomeprazole enteric-coated tablets [ 90 mg/(kg·d)] intragastrically for 14 days. On the 15th day ,the rats in 2 groups were given Sulfasalazine enteric coated tablets (90 mg/kg)intragastrically,and blood sample was collected from the inner canthus at 0.5,1,1.5,2,3,4,6,8,10,12,24,36,48,72 h after administration. After protein precipitation with methanol , using diazepam as internal standard ,Agilent XDR-C 18 column was adopted with methanol- 0.1% formic acid solution (gradient elution)as mobile phase. The concentration of SSZ metabolite SP in plasma was determined by LC-MS/MS. The pharmacokinetic parameters were calculated by using DAS 3.0.1 software and compared between 2 groups. RESULTS :The linear range of SP were 2-1 000 ng/mL. The methodology met the requirements of Chinese Pharmacopeia . There was no statistical significance in pharmacokinetic parameters of SP between 2 groups,such as AUC 0-t,tmax,t1/2z,cmax,MRT0-t(P>0.05). CONCLUSIONS :The established method is simple ,rapid and sensitive ;it can be used for the concentration determination of SSZ metabolite SP in plasma. ESOM has no significant effect on the pharmacokinetic behavior of SSZ in rats.  
      关键词:Sulfasalazine;Sulfapyridine;Esomeprazole;LC-MS/MS;Pharmacokinetic behavior   
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      发布时间:2022-06-21
    • ZHOU Dachuang,LUO Mengjie,TANG Wenxi
      Vol. 32, Issue 13, (2021)
      摘要:OBJECTIVE:To evaluate the co st-utility of bivalent human papilloma virus (HPV)vaccine for 12-year-old girls in China and provide economic evidence for health service decision makers. METHODS :The CERVIVAC model was used to simulate the population of 12-year-old girls in China for a long time until all the population entered a state of death (1 year as a cycle ). The cost and health output of the people in experimental group who received the bivalent HPV vaccine and the control group who did not receive the vaccine were calculated separately , and the economics was judged combined with willingness to pay threshold [WTP ,1 time of China ’s per capita gross domestic product (GDP)in 2019]. RESULTS :During the simulation period , the incremental cost-effectiveness ratio (ICER) of the experimental group compared with the control group was 28 660.56 yuan/QALY,which was less than WTP and had pharmacoeconomic advantages. The results of single-factor sensitivity analysis showed that the five parameters that had a greater impact on ICER were discount rate ,the proportion of HPV- 16/HPV-18-induced cervical cancer ,vaccine effective rate ,direct economic burden of early/in situ cancer each year and the direct economic burden of advanced/metastatic cancer each year. The results of probabilistic sensitivity analysis showed that the experimental group was more acceptable(74%)than the control group when using 1 time of China ’s per capita GDP in 2019 as WTP ;the experimental group had a greater cost-utility advantage when WTP was higher than 25 876 yuan/QALY. CONCLUSIONS :For the prevention of cervical cancer,the bivalent HPV vaccine for 12-year-old girls in China has more cost-utility advantages than no vaccine intervention.  
      关键词:Cervical cancer;HPV;Bivalent vaccine;CERVIVAC model;Cost-utility analysis   
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    • ZHAO Bing,WU Zhijiu,TANG Xuegui,KONG Pengfei,CHEN Taiyu,LIU Shihong
      Vol. 32, Issue 13, (2021)
      摘要:OBJECTIVE:To inves tigate the application effect and safety of modified compound polyethylene glycol electrolyte powder(SF-PEG)in intestinal preparation method for patients with constipation undergoing colonoscopy. METHODS :From Jan. 2020 to Aug. 2020,160 patients with constipation undergoing colonoscopy in anorectal department of the affiliated hospital of North Sichuan Medical College were randomly divided into observation group and control group ,with 80 cases in each group. The patients in the control group took 2 boxes of SF-PEG (mixed into 3 000 mL warm water )orally at 3:00 a.m. on the day of examination,and finished within 2 hours. The patients in the observation group took 1 box of SF-PEG (mixed into 1 500 mL warm water)at 20:00 the night before the examination and 5:00 in the morning of the day of examination ,and drank it within 1 hour;1 bottle of Dimethylsiloxane powder (mixed into 75 mL warm water )was taken orally at 7:00 a.m. on the inspection day. The satisfaction of intestinal preparation ,intestinal bubble score ,operation time of colonoscopy ,detection of polyps ,tolerance rate , acceptance rate of repeating intestinal preparation of patients and incidence of adverse reactions were compared between the two groups. RESULTS :The patients of 2 groups successfully completed bowel preparation and colonoscopy. The intestinal preparation total satisfaction rate ,intestinal bubble satisfaction rate ,polyp detection rate ,tolerance rate and repeating intestinal preparation acceptance rate of patients of observation group were significantly higher than control group (P<0.05),while the incidence of nausea and vomiting and total incidence of adverse reactions were significantly lower than control group (P<0.05),and the operation time of colonoscopy was significantly shorter than control group (P<0.05). CONCLUSIONS :Oral administration of SF-PEG in batches combined with Dimethylsiloxane powder for bowel preparation in patients with constipation before colonoscopy have the advantages of high satisfaction with bowel preparation ,less intestinal bubbles ,short operation time ,high detection rate of polyps,high tolerance rate of patients ,high acceptance rate of repeating intestinal preparation and less adverse reactions. It is a safe and effect method for intestinal preparation.  
      关键词:Compound polyethylene glycol electrolyte powder;Dimethylsiloxane powder;Constipation;Colonoscopy;Intestinal   
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    • JIANG Jiemei,WANG Yalu,YANG Chunlan,FENG Lijuan,CHEN Ruonan,CAO Xi,MEN Peng,YANG Yiheng,ZHAI Suodi,XIA Quan
      Vol. 32, Issue 13, (2021)
      摘要:OBJECTIVE:To evaluate th e effectiveness ,safety and economy of albu min-bound paclitaxel (nab-PTX)in the treatment of breast cancer by using rapid health technology assessment (HTA),and to provide evidence-based reference for drug selection. METHODS :Retrieved from PubMed ,the Cochrane Library ,CNKI,Wangfang database and other databases ,systematic evaluation/Meta-analysis,HTA and pharmacoeconomic studies about nab-PTX in the treatment of breast cancer were included ;the conclusions were classified and analyzed by using descriptive analysis. RESULTS :A total of 5 systematic reviews/Meta-analysis , 8 pharmacoeconomic studies were included in this study. Compared with conventional taxanes ,nab-PTX increased pathological complete response (pCR)rate [OR =1.39,95%CI(1.16,1.67),P<0.001] and event-free survival (EFS)[HR=0.69,95%CI(0.57, 0.85),P<0.001] in neoadjuvant chemotherapy (NAC)-treated breast cancer patients. However ,there were no significant differences in overall survival (OS),progression-free survival (PFS),objective response rate (ORR)and disease control rate (DCR)in metastatic breast cancer (MBC)patients between 2 groups. In the terms of safety ,nab-PTX increased the incidence of grade 3-4 sensory neuropathy [OR =1.89,95%CI(1.36,2.61),P<0.001] in MBC patients ,and increased the incidence of neutropenia [OR = 1.52,95%CI(1.23,1.88,P<0.001],sensory neuropathy [OR = 2.17,95%CI(1.38,3.40),P<0.001],rash [OR =1.46,95%CI mei1213@163.com (1.18,1.80),P<0.001] and fatigue [OR =1.28,95%CI(1.04, 1.56), P=0.02] in NAC -treated breast cancer patients.Pharmacoeconomic studies showed that nab-PTX could improve the quality adjusted lif e years of MBC patients compared with traditional taxanes ,and it was a economical option. CONCLUSIONS:Nab-PTX enhances pCR in NAC-treated breast cancer patients ,but has no significant advantage in the effectiveness of MBC patients ,and increases the occurrence of ADR. Nab-PTX may have a cost-utility advantage over conventional taxanes for MBC.  
      关键词:Albumin-bound paclitaxel;Breast cancer;Rapid health technology assessment;Effectiveness;Safety;Economics   
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    • LI Chunxiao,SUN Jingya,LING Xiao,LI Xuelin,ZHAO Ya,ZHANG Bo
      Vol. 32, Issue 13, (2021)
      摘要:OBJECTIVE:To investigate and study the problems in the items labeling of Chinese patent medicine instructions in National Essential Medicines List ,and to provide reference for rational drug use and instruction revision. METHODS :Totally 268 Chinese patent medicines contained in the 2018 edition of National Essential Medicines List ,including 465 instructions of different . An dard docetaxel as first-line therapy in patients with meta - economic evaluation of docetaxel and paclitaxel regimens in metastatic breast cancer in the UK[J]. Pharmacoeco - dosage forms ,were collected ,and the labeling rate and content problems of drug instructions were counted. RESULTS :Of the 465 instructions,86.88% were labeled with cautions. The labeling rates of ADR ,pharmacokinetics,contraindications,drug interactions , clinical trials ,pharmacological toxicology and pharmacological action were low ,being 20.64%,0.21%,30.1%,1.07%,2.36%, 8.81%,1.93%. All other items were labeled. Incomplete description of ingredients ,incomplete information of decoction pieces and excipients accounted for 2.15% and 48.81%,respectively;the expression of functional indications was varied ,and there were 12 expression methods ,among which 16.5% of indications lacked TCM indications ;specifications were not uniform ,and there were 5 expression methods ;usage and dosage were not clearly marked ,and 465 instructions did not mention the usage and dosage for the elderly or pregnant and lactating women. Drug interactions ,ADR,matters needing attention and contraindications were not fully described with no substantive content ;only 0.64% marked interaction with chemical medicine and 12.68% marked contraindication content. CONCLUSIONS :There are some problems in the description of Chinese patent medicine instructions in 2018 edition of National Essential Medicine List ,such as non-standard and incomplete. It is suggested to strengthen efforts to establish and improve the information collection and feedback mechanism of Chinese patent medicine ,and introduce policies to support enterprises to carry out basic and clinical research after listing ;and through actively carrying out basic and clinical research in line with the characteristics of traditional Chinese medicine ,guided by the theory of traditional Chinese medicine ,combined with the latest research results ,so as to further improve the contents of Chinese patent medicine instructions.  
      关键词:National Essential Medicine List;Chinese patent medicine instruction;Rational drug use;Medication for special   
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    • ZHAO Ting,ZHANG Weibin,TANG Yan,PU Chuan
      Vol. 32, Issue 13, (2021)
      摘要:OBJECTIVE:To investig ate the application and trend o f tranexamic acid in the orthopedic inpatient ,and to provide reference for rational drug use. METHODS :The consumption of tranexamic acid ,the distribution of orthopedics diseases using tranexamic acid and route of administration were analyzed in 3 sub-departments (joint surgery department ,spinal surgery department,orthopedic trauma department )from 4 third-grade class-A hospitals of Chongqing during 2017 to 2020. RESULTS : The total consumption of tranexamic acid used in orthopaedic department had increased year by year in the past 4 years,with increase of 6.2%-52.2%,and the consumption of tranexamic acid in various departments also increased year by year ;from 2017 to 􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂􀤂 书辅料标明情况及风险控制建议 [J].中国药师,2018,21 中华中医药杂志,2018,33(6):2225-2229. (18):2020-2022. [10] 孟菲,李学林.中成药说明书中规格项存在的问题与探 [ 7 ] 国家药典委员会.中华人民共和国药典:二部[S]. 2010年 讨[J].当代医学,2015,21(12):14-15. 版.北京:中国医药科技出版社,2010:1014. [11] 国家食品药品监督管理局 .中成药规格表述技术指导原 [ 8 ] 孟菲,李学林.中成药说明书中功能主治项表述方法的探 则:征求意见稿 [EB/OL].(2017-10-11)[2020-12-20]. 讨[J].中医药临床杂志,2015,27(1):111-112. https://www.nmpa.gov.cn/xxgk/zhqyj/zhqyjyp/20171011- [ 9 ] 田硕,郭晖,苗明三.中成药说明书完善的思考及实践[J]. 151401184.html. [12] 王裴芳.我国中成药说明书中老年人用药项的调查分 Δ基金项目:重庆市科技计划项目-技术预见与制度创新项目(No. 析[J].中国药房,2015,26(29):4055-4057. cstc2018jsyj-zdcxX0052);重庆市社会科学规划项目(No.2019QNGL31) [13] 林志健,周伟龙,张冰,等.中成药说明书中儿童用药信息 *硕士研究生 。研究方向 :社会医学 、卫生事业管理 。电话: 023-68485178。E-mail:351389583@qq.com 的修订完善思考 [J].药物流行病学杂志 ,2018,27(4): # 通信作者:教授,硕士生导师,硕士。研究方向:医事法学、卫生 244-248. 政策、卫生事业管理。电话:023-68485178。E-mail:puchuan68@sina. (收稿日期:2021-01-07 修回日期:2021-05-26) com (编辑:罗 瑞) ·1622· China Pharmacy 2021Vol. 32 No. 13 中国药房 2021年第32卷第13期 2019,joint surgery department accounted for the largest prop ortion(59.2% ,53.5% ,47.2%)to use tranexamic acid ,and orthopedic trauma department accounted for the largest proportion (39.2%)in 2020. On the whole ,top 4 orthopedic diseases in the list of the consumption of tranexamic acid were joint replacement (25.5%-29.6%),hip fracture (19.3%-23.6%),diaphysis fracture (13.5%-18.6%)and pelvic and acetabular fracture (8.2%-14.0%). The route of administration for tranexamic acid in spinal surgery department ,joint surgery department and orthopedic trauma department was mainly intravenous application every year (accounting for 55.1%-81.0%,46.9%-77.1%,49.3%-73.3%,44.9%-71.5%). CONCLUSIONS :The consumption of tranexamic acid in orthopedic inpatients is increased year by year ,and is dominated by joint surgery department and orthopedic trauma department. The route of tranexamic acid is still mainly intravenous administration ,which is safe and reliable.  
      关键词:Tranexamic;Orthopedic department;Sub-department;Consumption;Disease types;Route of administration   
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    • ZHAO Siqi,LIU Dongliang,XIA Yuqi,CHU Shuzhen
      Vol. 32, Issue 13, (2021)
      摘要:OBJECTIVE:To su mmarize the achievements and shortcomings of chronic disease management policies in China , and to provide reference for the formulation and improvement of the policy. METHODS :Totally 109 documents related to chronic disease management issued by the State Council and various ministries and commissions from 2009 to 2020 were processed by text mining method. PMC index evaluation model of chronic disease management policy was established. Sixteen typical chronic disease management policies were quantitatively evaluated and analyzed by 10 first-level indicators and 40 second-level indicators. RESULTS:Among the 16 policies,10 were of excellent level and 6 were of acceptable level. The average PMC score was 7.243, which was generally acceptable level but still had large room for improvement. By comparing two representative policies ,it was found that the main reasons for the policies with low scores were the lack of long-term development planning ,the absence of “Internet + chronic disease management ”new model and other contents ,and the lack of talent incentive and legal guarantee measures. CONCLUSIONS :Chronic disease management policy has been improved ,and it can be further improved from the aspects of policy prescription ,policy content and incentive mode.  
      关键词:Chronic disease management policy;PMC index model;Quantitative evaluation   
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