最新刊期

    34 24 2023
    • Vol. 34, Issue 24, Pages: 2945-2950(2023) DOI: 10.6039/j.issn.1001-0408.2023.24.01
      摘要:OBJECTIVETo interpret Teacher Training Syllabus for Clinical Pharmacist Training Program (2023 edition) (hereinafter referred as to the “new syllabus”), and to provide reference and guidance for promoting the implementation of the new syllabus and realizing the quality-improving goal of the reform of the clinical pharmacist teacher training program initiated by China Hospital Association.METHODSFrom the perspective of the management and based on the position of the designer, the new syllabus was interpreted from four aspects: the background of its compilation and release, the process of its compilation and its characteristics, the key improvements of the program and the points for attention about its subsequent implementation. RESULTS &CONCLUSIONSThe development and release of the new syllabus provide a “construction blueprint” for the reform of the clinical pharmacist teacher training program of the China Hospital Association. The whole process of compiling the new syllabus is characterized by four basic features: theory-led, goal-oriented, research-based, and synergistic. Compared with the previous syllabus, in addition to the adjustment of the text structure, the new syllabus presents more complete and clearer competence requirements for clinical teaching competence in terms of training objectives; in terms of training content, it further structures the group of task items, pays attention to the sequential planning and time arrangement of items, and puts forward both quantitative and qualitative refinement requirements for each specific training task;in terms of training methods, it emphasizes the interaction of lecturing, demonstrating and guiding, and the progression of observation, operation and reflection, with the intention of guiding teacher trainees to “learn how to teach by teaching”. In the subsequent implementation of the new syllabus, it is necessary for the teacher training bases to attach great importance to the guarantee of training conditions and process quality management, and to organize the teacher training team to do a good job in the two training programs of “clinical pharmacist training” and “clinical pharmacist teacher training”. Based on further improving the connection between the two training programs, the teacher training team should continue to explore the scientific model of clinical pharmacist teacher training oriented by clinical teaching competence.  
      关键词:teacher training;training syllabus;interpretation   
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      发布时间:2023-12-22
    • Pharmaceutical Administration Committee of Chongqing Hospital Association
      Vol. 34, Issue 24, Pages: 2951-2967(2023) DOI: 10.6039/j.issn.1001-0408.2023.24.02
      摘要:OBJECTIVETo further standardize the clinical application of anticoagulants and provide reference for improving the efficiency of prescription review of anticoagulants in medical institutions.METHODSInitiated by the Pharmaceutical Administration Committee of Chongqing Hospital Association and led by the Second Affiliated Hospital of Chongqing Medical University, in collaboration with experts in relevant fields from multiple provinces across the country, the prescription review rules, warning levels, and intervention measures for 12 kinds of common anticoagulants were established based on drug instructions. Regarding clinical drug use that was not covered by the basic review rules, based on reference to existing guidelines and expert consensus, 42 experts from 22 hospitals in 8 provinces across the country were consulted by letter to form a consensus.RESULTS&CONCLUSIONSThe basic prescription review rules of 12 kinds of anticoagulants, including unfractionated heparin, enoxaparin sodium, nadroparin calcium, dalteparin sodium, fondaparinux sodium, bivalirudin, argatroban, warfarin, dabigatran etexilate, rivaroxaban, apixaban and edoxaban, had been established according to drug instruction, as well as warning levels beyond the basic review rules and corresponding intervention measures. After two rounds of expert consultation, 17 recommendations for prescription review were formed regarding some clinical drug use that were not covered by the basic prescription review rules. With the progress of clinical research, this consensus will be further updated and adjusted; in addition, as this consensus does not cover all situations where anticoagulants are used in clinical practice, prescription reviewer must conduct personalized evaluations based on the specific situation of the patient.  
      关键词:prescription suitability;prescription review rules;clinical application;expert consensus   
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      发布时间:2023-12-22
    • LIN Limin,PENG Xiaoqing,TANG Rong,LIU Guodong,LIU Hong,YIN Jiayu
      Vol. 34, Issue 24, Pages: 2968-2974(2023) DOI: 10.6039/j.issn.1001-0408.2023.24.03
      摘要:OBJECTIVETo analyze the effects of the national centralized drug procurement (NCDP) policy on drug availability and the structure of drug use in public hospitals.METHODSUsing hypoglycemic, lipid-lowering, antiviral drugs, and psychiatric drugs for the treatment of mental illness and depression as objects, the interrupted time series model was used to quantitatively evaluate the changes in consumption sum of drugs, consumption amount and daily cost of the target drugs in national sample hospitals as well as the changes in per capita medication frequency, outpatient prescription amount, and medical insurance surplus of target drugs in a third grade class A hospital before and after the implementation of NCDP policy.RESULTSAfter the implementation of the NCDP policy, the volume for the four bid-winning drugs increased significantly (P<0.01 for the remaining three categories except for hypoglycemic drugs), but DDDc (P<0.01) and the amount of related drugs (P<0.001) decreased significantly. The volume for the non-winning drugs (except for lipid-lowering drugs) decreased significantly (P<0.05), and DDDc also decreased significantly (P<0.05 for other 3 categories except for psychiatric drugs); the volume (P<0.01) and DDDc (P<0.01 only for psychiatric drugs) for alternative drugs all increased except for antiviral drugs. The structure of drug use for different drugs was affected differently by the NCDP policy, and that of hypoglycemic drugs was affected obviously; the proportion of alternative drugs increased after centralized procurement. The outpatient prescription amount of each hospital significantly decreased after centralized procurement, and the decrease in the cost paid by the patients using lipid-lowering and antiviral drugs related to centralized procurement was greater than 0.60; the remaining medical insurance amount for bid-winning drugs was approximately 1.252 5 million yuan.CONCLUSIONSNCDP policy effectively alleviates the burden of medical expenditure and also drives the structure changes of drug use such as the substitution of generic drugs for original drugs, the growth of the volume of alternative drugs.  
      关键词:the structure of drug use;interrupted time series model;drug availability   
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      发布时间:2023-12-22
    • SUN Jiaying,LUO Jinping,ZHANG Qianwen,YIN Wenqiang,CHEN Zhongming,REN Qichao,MA Dongping
      Vol. 34, Issue 24, Pages: 2975-2981(2023) DOI: 10.6039/j.issn.1001-0408.2023.24.04
      摘要:OBJECTIVETo understand the current status of research on traditional Chinese medicine(TCM) human resources, and to provide a reference for expanding research ideas on TCM human resources and promoting the construction of TCM talents.METHODSFrom January 1, 2000 to December 31, 2022, literature related to TCM human resources was collected from the three major databases of CNKI, Wanfang and VIP. Using CiteSpace 5.8 R3 software, visualization analysis was performed for the literature in terms of publication time, journal sources, authors, institutions and areas, funding, research content, keywords, etc.RESULTSA total of 324 literature related to TCM human resources in China were included, and the number of literature issued showed an upward trend, with an annual average of 14.09 literature; 161 kinds of journals were involved, core journals accounted for 18.21% of the total publication volume; a total of 23 authors had published 2 or more literature, with a total of 55 literature published (16.98%); a total of 416 institutions were involved, mainly schools (66.83%); 60.49% of the literature were supported by the fund. The majorities of 324 literature were survey studies (170 literature), and most of them used self-designed questionnaires (55 literature); the high-frequency keywords included talent training, human resources, TCM, etc. The keywords were clustered into 7 categories, such as “human resources”“talent training”“TCM industry”“TCM services”“talent training models”“fairness” and “TCM talents”. The main problems described in the literature included insufficient talent, lack of reasonable distribution of regional structure, lack of reasonable plans for talent training, and insufficient professional knowledge and abilities. Continuously cultivating high-level talents and improving employment conditions in areas with severe human resource loss were the corresponding countermeasures proposed in the literature.CONCLUSIONSThe research on TCM human resources starts late but has developed rapidly overall, and the quality of research needs to be improved; the structure of research team is single and unevenly distributed geographically; there is a structural imbalance in the allocation of human resources, as well as problems such as a shortage of professional talents, low levels of education and training and incomplete development systems.  
      关键词:human resources;bibliometrics   
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      发布时间:2023-12-22
    • LIU Jungang,YANG Xingyi,HUANG Jieying,XU Wei
      Vol. 34, Issue 24, Pages: 2982-2986(2023) DOI: 10.6039/j.issn.1001-0408.2023.24.05
      摘要:OBJECTIVETo analyze the current situation of pediatric drug use under centralized drug procurement, and to provide reference for the subsequent design of pediatric drug centralized procurement rules.METHODSThe comparative analysis method was used to analyze the problems in the centralized procurement, clinical use and supply of pediatric drugs from the aspects of centralized procurement selection results and actual use of pediatric drugs, price difference and online prices of pediatric drugs. The solutions were put forward to optimize the centralized procurement and pricing rules of pediatric drugs. RESULTS &CONCLUSIONSThe demands for pediatric drugs in China were increasing, but the supply of marketed pediatric drugs was insufficient (including insufficient coverage of disease fields, insufficient varieties, insufficient suitable dosage forms for children, insufficient specifications for children, etc.), and the development of pediatric drugs was relatively difficult. After merging the dosage forms of centralized procurement according to the medical insurance list, some suitable dosage forms and specifications for children couldn’t be selected, resulting in a shortage of clinical pediatric medication. Relevant enterprises’ enthusiasm for developing and producing pediatric drugs and participating in online competitions had decreased. There was also the problem of underpricing of pediatric drugs under the drug price difference ratio rule. It is recommended that when conducting centralized drug procurement, special drugs for children should be grouped separately for centralized procurement based on attributes and the population covered by the indications. The specifications of suitable pediatric drugs that were not selected are converted into the agreed purchase quantity of medical institutions in a certain proportion. It is necessary to further optimize the pricing rules for pediatric specialized drugs, ensure a certain profit margin for such drugs, increase the willingness of production enterprises to research, develop and supply drugs, and thus ensure the use and supply of pediatric drugs.  
      关键词:pediatric drug;price difference ratio;pricing;shortage   
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      发布时间:2023-12-22
    • LI Yuexing,CHEN Boyang,LI Qian,CHEN Shuai,CHEN Yunzhi
      Vol. 34, Issue 24, Pages: 2987-2994(2023) DOI: 10.6039/j.issn.1001-0408.2023.24.06
      摘要:OBJECTIVETo investigate the intervention effects and potential mechanism of Miao medicine Toddalia asiatica on cardiovascular damage in rats with collagen-induced arthritis (CIA) based on vitamin D (VD) and neutrophil extracellular traps (NETs).METHODSSD rats were randomly divided into the normal group (9 rats) and the modeling group (61 rats). CIA model was prepared by multi-point injection of type Ⅱ bovine collagen+Fisher’s incomplete adjuvant; the model rats were randomly divided into the model group, methotrexate group (positive control, 1.5 mg/kg, twice a week), vitamin D group [pathway validation, 1 000 IU/(kg·d), once a day], T. asiatica low-dose, medium-dose and high-dose groups [0.54, 1.08, 2.16 g/(kg·d), calculated by crude drug, once a day], with 9 rats in each group; they were given relevant medicine intragastrically for 4 consecutive weeks. Arthritis index scoring was performed after modeling and before administration, and plantar thickness was measured before and after the last administration; the histopathological changes of ankle joint, heart and abdominal aorta were observed in rats; the serum contents of myeloperoxidase (MPO), interleukin-6 (IL-6) and 25-hydroxyvitamin D3 [25(OH)D3] were detected; the expressions of peptidylarginine deiminase 4 (PAD4), NETs markers [citrullinated histone H3(CitH3), MPO], VD-related indicators [vitamin D receptor (VDR), 25-hydroxyvitamin D-1α-hydroxylase (CYP27B1)] and IL-6 were determined in cardiac tissue.RESULTSCompared with the normal group, the plantar thickness of the arthritis index increased significantly in the model group (P<0.01). The obvious inflammatory cell infiltration and fibrous tissue hyperplasia were found in the ankle joint, the obvious myocardial fiber vacuoles and thickening of some surrounding blood vessel walls were found in the heart tissue, and the endothelial detachment was found in the abdominal aorta. The contents of MPO and IL-6 in serum increased significantly(P<0.01), while the level of 25(OH)D3 decreased significantly (P<0.01); the protein expressions of PAD4, CitH3, MPO and IL-6 in myocardial tissue up-regulated significantly (P<0.01), while protein expression of VDR and CYP27B1 changed to acertain extent without significance (P>0.05). Compared with the model group, the pathological changes of ankle joints and cardiac tissue in rats were significantly improved in administration groups, and the above indicators were generally reversed (P<0.05 or P<0.01).CONCLUSIONST. asiatica can improve rheumatoid arthritis symptoms and cardiovascular damage by inhibiting the formation of NETs and inflammatory response, the mechanism of which may be associated with the regulation of VD expression.  
      关键词:rheumatoid arthritis;cardiovascular damage;neutrophil extracellular trapping net;vitamin D   
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      发布时间:2023-12-22
    • CHEN Xiaomin,LIU Na,ZHANG Lina,LI Youjia
      Vol. 34, Issue 24, Pages: 2995-2999(2023) DOI: 10.6039/j.issn.1001-0408.2023.24.07
      摘要:OBJECTIVETo study the effects and potential mechanism of anaphylactoid reaction induced by nonapeptide IVQKIKHCF activating mast cells.METHODSUsing human mast cell line LAD2 as subject, and substance P as positive control, the activation effects of 25, 50 and 100 μmol/L IVQKIKHCF on mast cells were investigated by determining the release rate of β-aminohexosidase, histamine release, and the contents of inflammatory factors; using MrgprX2-knockdown LAD2 cells and Mas-related G protein-coupled receptor X2 (MRGPRX2) high-expression human embryonic kidney cell line HEK293 (MRGPRX2/HEK293 cells) as subject, the correlation between the activation effect of IVQKIKHCF and MRGPRX2 was investigated by determining the release rate of β-aminohexosidase, and intracellular calcium ion concentration.RESULTSIVQKIKHCF with 25, 50, 100 μmol/L could significantly increase the release rate of β-aminohexosidase and histamine release in LAD2 cells (P<0.05), and promote the release of tumor necrosis factor-α, interleukin-8, macrophage inflammatory protein-1β and monocyte chemotactic protein-1 to varying degrees (P<0.05). After knocking down MrgprX2, the effects of 25, 50, 100 μmol/L IVQKIKHCF promoting the release of β-aminohexosidase in LAD2 cells were reversed significantly (P<0.05), resulting in an increase of calcium ion concentration in MRGPRX2/HEK293 cells.CONCLUSIONSNonapeptide IVQKIKHCF can promote mast cells to release granular matter and inflammatory mediators by activating MRGPRX2 thus inducing anaphylactoid reaction.  
      关键词:IVQKIKHCF;mast cell;anaphylactoid reaction;Mas-related G protein-coupled receptor X2   
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      发布时间:2023-12-22
    • ZHANG Ru,DU Haitao,WANG Xiaoxue,WANG Yi,ZHOU Qian,LIU Shanxin,WANG Ping
      Vol. 34, Issue 24, Pages: 3000-3005(2023) DOI: 10.6039/j.issn.1001-0408.2023.24.08
      摘要:OBJECTIVETo study the effects of Dayuanyin decoction (DYY) on lung injury and gut microbiota in mice with RSV-Hanshi yufei syndrome.METHODSThirty-six BALB/c mice were divided into the normal group (NC group), model group (MC group), positive control group (LBM group, 57.59 mg/kg ribavirin), DYY low-dose, medium-dose and high-dose groups(LDYY,MDYY,HDYY groups,1.67,3.34,6.68 g/kg,calculated by crude drug), with 6 mice in each group. Except for NC group, RSV-Hanshi yufei syndrome model was induced by “Hanshi modeling+RSV infection”; after the second cold and wet stimulation, RSV solution was dripped into the nasal cavity at 50% tissue culture infectious dose, once a day, for 3 consecutive days; each administration group was given corresponding solution intragastrically 4 hours after each nasal drip, once a day, for 5 consecutive days. The levels of motilin (MTL) and gastrin (GAS) in serum, the levels of IL-6 and IL-1β in supernatant of lung tissue, and the percentage of peripheral blood lymphocytes were all determined. The pathological changes of lungs were observed, and the changes of gut microbiota were analyzed.RESULTSCompared with MC group, the levels of MTL in serum (except for HDYY group), and the levels of IL-6 and IL-1β in supernatant of lung tissue were all decreased significantly in DYY groups, while the level of GAS (except for HDYY group) in serum was increased significantly (P<0.05 or P<0.01). The pathology of lung tissue was improved, the percentage of T lymphocytes in LDYY group and the percentages of T lymphocyte and B lymphocyte in MDYY group were all increased significantly (P<0.05 or P<0.01). Compared with the NC group, Bacteroidetes, Actinobacteria, Bacteroides, Alistipes, Bacteroidota, Bacteroides acidfaciens and Alloprevotella were expressed in high abundance, while Firmicutes, Proteobacteria, Lachnospiraceae NK4A136 group, Kineothrix and Clostridiales unclassified were expressed in low abundance. After the intervention of medium-dose DYY, the relative abundance of each microbiota tended to be adjusted back, with different species including Lachnospiraceae_UCG-006, Ruminococcus, etc.CONCLUSIONSDayuanyin decoction can reduce the lung injury caused by RSV, the mechanism of which may be associated with relieving inflammation, regulating gastrointestinal hormone levels, the percentage of lymphocytes and the abundance of beneficial and harmful bacteria in the intestinal tract.  
      关键词:respiratory syncytial virus;Hanshi yufei syndrome;gut microbiota   
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      发布时间:2023-12-22
    • SUN Lijun,LI Jun,WANG Qiutong,XIA Huimin,WANG Yuewu,ZHANG Qian,ZHANG Huiwen,WANG Huanyun
      Vol. 34, Issue 24, Pages: 3006-3011(2023) DOI: 10.6039/j.issn.1001-0408.2023.24.09
      摘要:OBJECTIVETo establish the methods to identify the chemical components of Ixeris chinensis, and determine the contents of 7 components (chlorogenic acid, luteolin, quercetin, rutin, protocatechuic acid, isochlorogenic acid A, luteoloside).METHODSHPLC-Q-Exactive-MS was used to identify the chemical components of I. chinensis. The contents of 7 components in I. chinensis, including chlorogenic acid, were determined by HPLC-MS/MS.RESULTSA total of 45 components were identified in I. chinensis, including 20 organic acids, 13 flavonoids, 4 fatty acids, 4 amino acids, 3 nucleosides, and 1 coumarin. The linear range of chlorogenic acid, luteolin, quercetin, rutin, protocatechuic acid, isochlorogenic acid A and luteoloside were 503.00- 25 150.00, 42.00-2 100.00, 5.05-252.50, 20.05-1 002.50, 25.10-1 255.00, 750.00-37 500.00, 196.00-9 800.00 ng/mL (r≥0.999 2), respectively. RSDs of precision, stability and reproducibility tests were all less than 3.00% (n=6), and average recovery ranged from 96.72% to 105.84% (all RSD<4.00%, n=6). The contents of 7 components in 3 batches of I. chinensis were 1 145.77- 3 261.25, 23.75-97.90, 0.92-2.12, 1.06-23.18, 9.35-21.85, 833.25-1 045.58, 199.56-1 869.78 μg/g, respectively.CONCLUSIONSThe established methods for identification and content determination are rapid and simple, and can be used for the identification of chemical components and the content determination of 7 components in I. chinensis.  
      关键词:HPLC-Q-Exactive-MS;HPLC-MS/MS;component identification;content determination   
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      发布时间:2023-12-22
    • FENG Junchao,LI Shunping,FANG Yunhai,SHI Zhao
      Vol. 34, Issue 24, Pages: 3012-3019(2023) DOI: 10.6039/j.issn.1001-0408.2023.24.10
      摘要:OBJECTIVETo systematically sort out and evaluate the health state utility of hemophiliac patients, and to provide reliable parameters for conducting pharmacoeconomic evaluation and health technology assessment.METHODSRetrieved from CNKI, Wanfang data, VIP, CBM, PubMed, Embase, the Cochrane Library, Scopus and Web of Science databases, relevant literature about the measurement of health state utility in hemophiliac patients was collected from the inception to February 2023. After screening literature, extracting data and evaluating the quality of literature, meta-analysis was performed for health state utility with Stata 15.1 software.RESULTSThirty-eight papers were finally included, with the highest and lowest health utility values of 0.90 and 0.46, respectively. Those studies mostly adopted the EuroQol Five Dimensions Questionnaire (EQ-5D) (73.7%). Results of meta-analysis showed that health state utility of global hemophiliac patients was 0.69,95% confidence interval was 0.65-0.74; those of patients with mild, moderate and severe hemophilia were 0.79, 0.70, and 0.64, respectively; health state utility for patients with inhibitors (0.64) was lower than that of patients without inhibitors (0.69); health state utility for the Chinese patient population was 0.55, which was higher than that of Iranian patients (0.46), but lower than those of other developed countries.CONCLUSIONSThere is some heterogeneity in the results of the studies across countries/regions, with higher health state utility in developed countries than in developing countries. As the severity of hemophilia increases, the trend of decreasing health state utility is obvious.  
      关键词:hemophilia;health state utility;systematic evaluation;meta-analysis   
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      发布时间:2023-12-22
    • NIE Xiaojing,FU Haofei,BAI Hehe,LI Yaping,WANG Jinping
      Vol. 34, Issue 24, Pages: 3020-3024(2023) DOI: 10.6039/j.issn.1001-0408.2023.24.11
      摘要:OBJECTIVETo explore the grouping efficacy of diagnosis related group (DRG) and the influential factors of hospitalization cost in diabetes cases, and to provide theoretical support for improving DRG payment system, reducing medical cost and enhancing the efficiency of medical insurance funds.METHODSThe information of 4 368 diabetic patients who were hospitalized in a 3A hospital in Xi’an from January 1, 2021 to June 30, 2023 was retrospectively analyzed, and DRG grouping of them was summarized; the hospitalization costs of patients in different DRG groups were analyzed by using one way ANOVA and Bonferroni multiple comparison. Coefficient of variation (CV) was used for evaluation within the group, and the influential factors of hospitalization costs were analyzed by one-way linear regression analysis and multi-factor linear regression analysis.RESULTS&CONCLUSIONSThe CV values of the four DRG groups were all lower than 0.8, indicating good grouping results and good consistency within the group; the difference of hospitalization cost among the four groups was statistically significant (P<0.05), and the hospitalization cost of China Healthcare Security-DRG version 1.1 FW11 group was significantly higher than those of other three groups (P<0.05). Length of stay, drug cost, the number of other diagnoses, test cost and payment method have significant positive effects on the hospitalization cost of diabetic patients. Whether there is pharmacist intervention has a significant negative influence on the hospitalization cost of patients. Under the DRG payment method, medical institutions can consider multidisciplinary linkage and incorporate a variety of management and service tools, including pharmacist’s intervention, to develop refined management measures, to reduce the economic burden of patients’ families and society.  
      关键词:diabetes;hospitalization cost;influential factors   
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      发布时间:2023-12-22
    • DONG Lin,SHU Yishuo,DONG Zhonghua,YI Qiaoyan,LI Hongjuan,GU Yan,HAN Yan,DING Guoyu,ZHAO Yuqi,ZHANG Xiaoyue,LI Xue,LIN Ziyun,MU Kai,YANG Yilei,SHI Haiyan,WANG Hongmei
      Vol. 34, Issue 24, Pages: 3025-3029(2023) DOI: 10.6039/j.issn.1001-0408.2023.24.12
      摘要:OBJECTIVETo analyze the dose-adjusted concentrations of Posaconazole oral suspension in patients undergoing hematopoietic stem cell transplantation (HSCT) and their influential factors.METHODSData were collected from hospitalized HSCT patients admitted to the First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital) from January 2021 to April 2023 who took Posaconazole oral suspension for the prevention of invasive fungal disease (IFD) and received blood concentration of posaconazole. The rate of concentration attainment and clinical failure rate of posaconazole for the prevention of IFD were evaluated, and one-way and multiple linear regression analyses were performed for the influential factors of dose-adjusted concentrations (C0/D) of posaconazole.RESULTSA total of 44 patients were enrolled; the mean C0 of posaconazole in patients was (0.99±0.94) µg/mL, and 20 patients had a C0≥0.7 μg/mL, with a concentration attainment rate of 45.45% for the prevention of IFD; 13 cases were clinical failures, with a clinical failure rate of 29.55%. Of 24 patients who did not achieve C0/D of posaconazole for IFD prophylaxis, one patient was a clinical failure despite timely dose adjustment of posaconazole in seven patients; seven of the thirteen patients who did not undergo dose adjustment were clinical failures; and the remaining four patients were switched to other antifungal agents. The results of univariate analysis showed that gender, body mass index (BMI), renal function, combined use of sodium phenytoin, omeprazole and metoclopramide had a significant effect on the C0/D of posaconazole (P<0.05); the results of multivariate linear regression analysis showed that gender, BMI and combined use of sodium phenytoin were the independent factors affecting the C0/D of posaconazole (P<0.05).CONCLUSIONSSignificant individual differences are reflected in the blood concentration of Posaconazole oral suspension; gender, BMI and combined use of sodium phenytoin are independent factors affecting the C0/D of posaconazole.  
      关键词:dose-adjusted concentration;influential factor;hematopoietic stem cell transplantation;therapeutic drug monitoring   
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      发布时间:2023-12-22
    • MEI Ling,WANG Yueyuan,ZHOU Houfeng,DU Shan
      Vol. 34, Issue 24, Pages: 3030-3035(2023) DOI: 10.6039/j.issn.1001-0408.2023.24.13
      摘要:OBJECTIVETo analyze the characteristics of drug-induced autoimmune hepatitis (DIAIH) induced by tumor necrosis factor-α inhibitor (TNFi), and to provide reference for clinical drug treatment.METHODSRetrieved from PubMed, Embase, China Academic Journal full-text Database, VIP and Wanfang database, the case reports of TNFi-induced DIAIH were collected to conduct descriptive analysis.RESULTSA total of 33 case reports involving 44 patients were collected, including 31 females and 13 males, with an average age of (41.14±2.20) years old, mostly aged 30 to 60 years (77.27%). The primary diseases were Crohn disease (CD), ulcerative colitis (UC) and rheumatoid arthritis (RA) (68.18%). Of the 44 patients, 35 were treated with infliximab (IFX), 7 with adalimumab, and 2 with etanercept. The dosage of 37 patients was within the scope of the instructions, and 31 received other drugs additionally; DIAIH mainly occurred ≤24 weeks after medication (68.18%); 21 patients (47.73%) had no clinical manifestations; alanine aminotransferase and aspartate aminotransferase were abnormally elevated in all patients; anti-nuclear antibodies were positive in 38 patients. Except for 3 patients who required liver transplantation, all the other patients improved after drug withdrawal and/or symptomatic treatment such as glucocorticoid therapy.CONCLUSIONSTNFi-induced DIAIH is more common in female patients and can occur with conventional doses, with significant differences in occurrence time. However, the intervention measures are basically the same for DIAIH induced by different types of TNFi. Clinical use of TNFi, especially the use of IFX, requires close attention to the clinical manifestations, liver function and autoantibody level, and a detailed evaluation should be conducted to detect DIAIH as soon as possible. If liver function continues to not improve, it is necessary to stop taking medicine as soon as possible and receive symptomatic treatment to avoid developing acute or severe DIAIH or liver failure.  
      关键词:infliximab;adalimumab;etanercept;drug-induced autoimmune hepatitis   
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      发布时间:2023-12-22
    • ZOU Jing,CHU Yaojuan,DU Qiuzheng,YUE Heying,WANG Xiaobao,DU Shuzhang
      Vol. 34, Issue 24, Pages: 3036-3041(2023) DOI: 10.6039/j.issn.1001-0408.2023.24.14
      摘要:OBJECTIVETo analyze the research status, hotspot and development trend of tyrosine kinase inhibitors (TKIs) in the treatment of human epidermal growth factor receptor 2 (HER2) positive breast cancer.METHODSThe literature related to TKIs in the treatment of HER2 positive breast cancer were searched from the Web of Science core collection database; the author, country/region, institution, subject field, journal and keywords was visualized by CiteSpace 6.1.R3 software.RESULTSA total of 732 pieces of literature were included, and the number of literature published showed an increasing trend year by year. The number of literature published in the United States was the largest (center degree 0.10), and the number of literature published in China ranked second (center degree 0.05). The most published and cited authors were Crown from St. Vincent’s University Hospital in Australia and Slamon from University of California, Los Angeles in the United States; the institution with the highest number of literature was the University of Texas MD Anderson Cancer Center, and the journal with the highest number of literature was the Journal of Clinical Oncology. The research mainly focused on five aspects: HER2 positive breast cancer treatment drugs, TKIs receptor, TKIs mechanism of action, HER2 positive breast cancer brain metastasis, and TKIs clinical trials. The main frontier areas and development trends were the combination of TKIs with other drugs or therapies to enhance targeting and reduce toxic side effects.CONCLUSIONSThe study of TKIs in the treatment of HER2 positive breast cancer has attracted the attention of scholars at home and abroad. Chinese scholars and research teams need to strengthen cooperation and communication in the future, and cooperation with other countries should be strengthened in terms of the efficacy and safety of TKIs alone and combined with other drugs in the treatment of HER2 positive breast cancer.  
      关键词:human epidermal growth factor receptor-2 positive breast cancer;visual analysis   
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      发布时间:2023-12-22
    • ZENG Na,LI Jie,SUN Huajun
      Vol. 34, Issue 24, Pages: 3042-3045(2023) DOI: 10.6039/j.issn.1001-0408.2023.24.15
      摘要:OBJECTIVETo analyze the safety of omalizumab in the treatment of allergic diseases in children.METHODSClinical data of children with allergic diseases who were prescribed omalizumab therapy were collected from our hospital during February 2019 to July 2023, including the children’s basic conditions, allergen test results, serum levels of total immunoglobulin E(IgE), omalizumab application and the occurrence of adverse events. The information on telephone follow-up was collected among the children who had completed treatment 12th month after drug withdrawal. At the same time, the causal relationship between adverse events and omalizumab was also evaluated by using the Naranjo assessment scale.RESULTSA total of 30 children were enrolled and received subcutaneous injections of omalizumab 245 times, accumulating 473 times. Four children suffered from four times of immediate-type hypersensitivity reactions (degree Ⅰ and Ⅱ every two times), with an incidence of 13.3%; among them, two cases occurred after the first injection, one after the third injection, and one after the fifth injection; the results of the causality evaluation showed that two cases were “very likely” and two cases were “likely”. The telephone follow-up of 21 children showed that the children were in good health and there were no adverse events, such as malignant tumors, worm infections, serum disease-like reactions and arterial thromboembolism.CONCLUSIONSOmalizumab in children with allergic diseases is of good safety with a low incidence of adverse reactions, which are mainly mild immediate-type hypersensitivity reactions with a high long-term safety profile.  
      关键词:children;allergic diseases;adverse reaction   
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      发布时间:2023-12-22
    • CHEN Xu,DENG Yi,LI Qiang,WU Di
      Vol. 34, Issue 24, Pages: 3046-3050(2023) DOI: 10.6039/j.issn.1001-0408.2023.24.16
      摘要:OBJECTIVETo compare the efficacy of different enteral nutrition (EN) drugs for severe acute pancreatitis (SAP) and their gastrointestinal tolerance.METHODSA total of 118 SAP patients admitted to the Pancreatic Center of Jiangsu Provincial People’s Hospital from January 1, 2022 to June 30, 2023 were collected and divided into short-peptide EN drugs (SP) group (41 cases), dietary fiber-free intact protein EN drugs (TP-MCT) group (40 cases) and dietary fiber-containing intact protein EN drugs (TPF-DM) group (37 cases) according to the types of EN. All three groups of patients were given continuous pumps of EN drugs via nasal feeding for 24 hours, with a target energy dose of 25-30 kcal/kg. The blood nutritional indexes [albumin (ALB), total protein (TP), hemoglobin (Hb), globulin (GLB)], inflammation indexes [white blood cells (WBC), percentage of neutrophils (N%), procalcitonin (PCT), C-reactive protein (CRP), interleukin-6 (IL-6)], clinical outcomes indexes [time of stay in the intensive care unit (ICU), length of hospital stay, duration of resuming oral diet, the rate of cases without improvement, mortality rate] and the occurrence of gastrointestinal tolerance were collected from 3 groups before medication and 7 d after medication.RESULTSAfter treatment, ALB and TP in 3 groups were significantly higher than before treatment (P<0.05); CRP and N% of 3 groups, PCT of TP-MCT group and IL-6 of SP group were significantly lower than corresponding group before medication (P<0.05); PCT of TP-MCT group and IL-6 of SP group were significantly lower than those of other two groups at corresponding period (P<0.05). There were no statistical significances in ALB, TP, CRP or N% among the three groups after medication, and in Hb, GLB or WBC among the three groups before and after treatment (P>0.05). There was no significant difference in clinical outcome indexes among 3 groups (P>0.05). The incidence of gastrointestinal adverse reactions in the TP-MCT group was the lowest (32.50%), and significantly lower than those in the SP group (46.34%) and TPF-DM group (48.65%) (P<0.05).CONCLUSIONSDifferent EN preparations can improve the nutritional status and reduce the inflammatory response in SAP patients to different extents, among which SP and TP-MCT are more effective, and TP-MCT shows the better gastrointestinal tolerance.  
      关键词:severe acute pancreatitis;therapeutic efficacy;tolerance;adverse reaction   
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      发布时间:2023-12-22
    • LI Xiuying,CHEN Ying,CHEN Hong
      Vol. 34, Issue 24, Pages: 3051-3054(2023) DOI: 10.6039/j.issn.1001-0408.2023.24.17
      摘要:OBJECTIVETo investigate the efficacy and safety of domestic Paliperidone extended-release tablets as a substitute for original Paliperidone extended-release tablets in the treatment of stable schizophrenia.METHODSA total of 65 patients with schizophrenia, who were treated with single original Paliperidone extended-release release tablets for 2 months or more in the outpatient or inpatient department of Shandong Daizhuang Hospital from June 2021 to June 2022, were collected and randomly divided into the domestic group (33 cases) and the original group (32 cases). The domestic group was treated with the same dose of domestic Paliperidone extended-release tablets instead for 2 months, and the original group continued to use the previous dose of the original drug for 2 months. Positive and negative syndrome scale (PANSS) and treatment emergent symptom scale (TESS) were used to evaluate the two groups at the time of enrollment and the end of 1 week, 1 month and 2 months after enrollment. The incidence of ADR was calculated at the end of 2 months after enrollment. The fasting blood glucose, blood lipid indicators (triglyceride, total cholesterol, low-density lipoprotein, high-density lipoprotein, very-low-density lipoprotein), serum prolactin levels, and paliperidone blood concentration were determined after the intravenous blood sample was collected. The ratio of paliperidone blood concentration to dose (C/D value) was calculated, and an electrocardiogram was performed.RESULTSThere were 31 and 30 patients in the domestic group and the original group who completed the trial, respectively. There were no statistical significances in PANSS score, TESS score or C/D value at the time of enrollment and the end of 1 week, 1 month and 2 months after enrollment; there were no statistical significances in the levels of fasting blood glucose, blood lipid or serum prolactin at the time of enrollment and at the end of 2 months after enrollment (P>0.05). PANSS scores of both groups significantly decreased at the end of 1 month and 2 months after enrollment (P<0.01). The incidences of ADR were 25.81% in the domestic group and 30.00% in the original group, without significant difference (P>0.05), and there were no significant abnormalities in the electrocardiograms of the two groups.CONCLUSIONSDomestic Paliperidone extended-release tablets can directly replace the original tablets in the treatment of stable schizophrenia, and their clinical efficacy and safety are comparable.  
      关键词:schizo-phrenia;domestic preparation;original preparation;efficacy;safety   
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      发布时间:2023-12-22
    • LIAO Wen,CHEN Wei,CHEN Jiayi,YU Junxian
      Vol. 34, Issue 24, Pages: 3055-3059(2023) DOI: 10.6039/j.issn.1001-0408.2023.24.18
      摘要:OBJECTIVETo evaluate the efficacy of immune checkpoint inhibitors (ICIs) in the treatment of non-small cell lung cancer (NSCLC) with different KRAS genotypes.METHODSRetrieved from PubMed, the Cochrane Library, Web of Science, Embase, CNKI, Wanfang data and VIP, randomized controlled trials (RCTs) about ICIs alone, combined use of various ICIs or ICIs combined with traditional chemotherapy (trial group) versus traditional chemotherapy (control group) for NSCLC were collected from the inception of the databases to April 1, 2023. After screening literature, extracting data and evaluating quality, meta-analysis, sensitivity analysis and publication bias analysis were conducted by using RevMan 5.4 software.RESULTSA total of 7 RCTs involving 5 980 patients were included. The results of the meta-analysis showed that overall survival (OS) [HR=0.79, 95%CI (0.72, 0.87), P<0.000 01] and progression-free survival (PFS) [HR=0.63, 95%CI (0.50, 0.80), P=0.000 2] of trial group were significantly longer than those of control group; furthermore, the OS of KRAS mutant type [HR=0.63, 95%CI (0.53, 0.75), P<0.000 01] and KRAS wild type [HR=0.87, 95%CI (0.78, 0.98), P=0.02], PFS of KRAS mutant type [HR=0.58, 95%CI (0.43, 0.78), P=0.000 3] and KRAS wild type [HR=0.68, 95%CI (0.47, 0.99), P=0.04] in the trial group were all significantly longer than in the control group. Subgroup analysis by different treatment regimens showed that the OS of KRAS mutant type patients receiving first- and second-line treatment regimens, using ICIs alone and those receiving ICIs combined with traditional chemotherapy as well as PFS of KRAS mutant type and wild type patients receiving first-line treatment regimens in the trial group were all significantly longer than in the control group (P<0.05). Sensitivity analysis results indicated that the findings of this study were robust. Publication bias results showed that the possibility of publication bias in this study was small.CONCLUSIONSICIs show significant efficacy in NSCLC patients, and NSCLC patients benefit equally regardless of whether KRAS mutations occur.  
      关键词:non-small cell lung cancer;KRAS;efficacy   
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      发布时间:2023-12-22
    • WANG Yan,ZHU Shaohui,YANG Jianing,CHEN Xiaoshan,ZHOU Minhua
      Vol. 34, Issue 24, Pages: 3060-3063(2023) DOI: 10.6039/j.issn.1001-0408.2023.24.19
      摘要:OBJECTIVETo investigate the role of clinical pharmacists in the treatment of a patient with Epstein-Barr (EB) virus encephalitis.METHODSClinical pharmacist participated in drug diagnosis and therapy for a patient with EB virus encephalitis. According to the physiological characteristics of the disease and the pharmacokinetic-pharmacodynamic characteristics of antibiotics, clinical pharmacists suggested that the dose should be adjusted as ceftriaxone 2 g, q12 h+meropenem 2 g, q8 h. Based on the uncontrolled infection of the patient, pharmacists suggested that ceftriaxone should be stopped and vancomycin 1 million U and q12 h should be used as alternative therapy. According to the results of etiology, pharmacists suggested that acyclovir should be discontinued and replaced with ganciclovir 5 mg/kg, q12 h. The electrolyte disturbance of the patient may be adverse drug reactions caused by Mannitol injection, it was recommended to stop the drug.RESULTSThe clinician followed the advice of the clinical pharmacists. After treatment, the patient improved and was discharged.CONCLUSIONSClinical pharmacists can carry out pharmaceutical care for patients with EB virus encephalitis, assist physicians in optimizing the treatment plan of patients, and ensure the effectiveness and safety of drug treatment.  
      关键词:clinical pharmacist;pharmaceutical care   
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    • ZHENG Li,ZHANG Kaihua,SUN Xuelin
      Vol. 34, Issue 24, Pages: 3064-3067(2023) DOI: 10.6039/j.issn.1001-0408.2023.24.20
      摘要:Diffuse large B cell lymphoma (DLBCL) is a malignant tumor derived from mature B cells. Currently, chemotherapy is still the main clinical treatment. However, some patients experience recurrence or refractory conditions after treatment. On June 15, 2023, the FDA approved the marketing of glofitamab, a CD3/CD20 bispecific monoclonal antibody, to provide the new treatment plan for patients with recurrent or refractory DLBCL after receiving 2-line or above systemic treatment. This article reviews pharmacological effects, clinical studies, safety, usage and dosage of glofitamab. Glofitamab mainly plays a therapeutic role in DLBCL by promoting the activation and proliferation of T cells,activating T cells to release tumor cell-killing proteins, and mediating the lysis of B cells. Clinical studies have shown that glofitamab has a better complete and objective response rate for recurrent or refractory DLBCL. Common adverse reactions caused by glofitamab include mild/moderate cytokine release syndrome, musculoskeletal pain, rash, fatigue, and so on,without significant drug interactions.  
      关键词:diffuse large B cell lymphoma;CD3/CD20 bispecific monoclonal antibody;pharmacological effects;clinical study;safety   
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      发布时间:2023-12-22
    • ZHU Kouzhu,WANG Yan,MIAO Liyan
      Vol. 34, Issue 24, Pages: 3068-3072(2023) DOI: 10.6039/j.issn.1001-0408.2023.24.21
      摘要:Infliximab (IFX), tumor necrosis factor-α inhibitor, is widely used in clinical practice for treating Crohn disease (CD), but it is difficult to obtain the optimal therapeutic effect according to the conventional dose. It is recommended to perform therapeutic drug monitoring (TDM) for patients with poor therapeutic efficacy to guide clinical decisions. This paper reviews the pharmacokinetic characteristics of IFX, exposure-response relationship, the influencing factors of pharmacokinetic differences, and analytical methods in TDM. It is found that IFX doesn’t undergo liver or kidney metabolism, exhibits obvious exposure-response relationships in both the induction and maintenance phases of CD treatment; disease activity, albumin, antibodies to IFX (ATI) and other factors influence IFX’s exposure. It is recommended that trough concentration of IFX in the maintenance period should be kept above 3 μg/mL; the dose of IFX should be increased or medication interval should be shortened for patients with severe disease, low albumin levels and ATI formation, to promote therapeutic efficacy of IFX. It is suggested to use the same detection method for TDM of IFX in the same patient.  
      关键词:Crohn disease;therapeutic drug monitoring;exposure-response relationship;pharmacokinetic variation   
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      发布时间:2023-12-22
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