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OBJECTIVE To investigate the preferences of patients who underwent solid organ transplantation regarding therapeutic drug monitoring (TDM) of mycophenolic acid (MPA) and explore the factors influencing patients’ decision-making process, so as to provide support for the development of individualized medication guidelines for MPA and improvement of clinical decision-making. METHODS The cross-sectional study was used to design the questionnaire on the patients’ preferences to accept MPA TDM, and involved patients who underwent solid organ transplantation and received MPA treatment at two tertiary hospitals in Beijing from April 14, 2022, to June 27, 2022. The Likert 5-level scoring method was used to score the patients’ preferences to accept MPA TDM, the influencing factors and their correlation of the patients’ preferences to accept MPA TDM were analyzed by Pearson correlation analysis and binary Logistic regression analysis, and the nonparametric test and chi-square test were used to rank and analyze the consistency of the factors affecting patients’ preference decision. RESULTS A total of 140 questionnaires were collected, and the effective recovery rate was 77.35%. The average preference score of 140 patients to receive MPA TDM was (4.01±0.65), and the overall preference value was high. There were 116 (82.86%) patients agreed or strongly agreed with MPA TDM. Significant differences were observed in preference scores between patients who had previously undergone MPA TDM and those who had never undergone it ([ 4.30±0.53) scores vs. (3.80±0.65) scores, P<0.001]. Additionally, patients’ preference scores were significantly influenced by their understanding level and attention level (P<0.001). The ranking of factors contributing to decision-making exhibited consistency (P<0.001). The factors were ranked in descending order of clinical efficacy, safety, comfortability, economy and time cost. CONCLUSIONS The patients who underwent solid organ transplantation hold high preferences towards MPA TDM. The primary factors influencing their decisions are their prior experience, understanding level, and attention level.
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OBJECTIVE To explore suitable storage and transportation conditions for “internet plus drug delivery” under high- temperature conditions. METHODS A survey on high-temperature conditions in summer in Beijing was conducted; a retrospective analysis was conducted on “internet plus drug delivery” orders in our hospital from July 2021 to June 2022, summarizing the proportion and delivery range of drugs under different storage and transportation conditions. Additionally, simulation and validation experiments were performed to investigate optimal drug storage and transportation devices for “internet plus drug delivery” in Beijing under high-temperature conditions in summer. RESULTS The monthly average temperature in Beijing from June to August consistently exceeded 25.0 ℃ between 1991 and 2022. From July 2021 to June 2022, a total of 104 drugs were required to be stored below 25.0 ℃, accounting for 31.23% of the 333 drugs listed in our hospital’s “internet plus drug delivery” catalog in Beijing. These drugs were delivered 1 058 times, accounting for 19.63% of the total deliveries. Simulation and validation experiments demonstrated that the average maximum temperature during the next-day delivery process of “carton + foam box + composite aluminum film pearl cotton + 500 g ice bag×2 + gas column bag” was 9.6 ℃, the average minimum temperature was 2.7 ℃, and all the temperatures remained below 15.0 ℃, which could effectively ensure the quality of drugs. CONCLUSIONS Under the high-temperature conditions in summer in Beijing, the storage and transportation device of “carton + foam box + composite aluminum film pearl cotton + 500 g ice bag×2 + gas column bag” can meet the temperature requirements specified in the drug storage instructions for Beijing intra-city drug delivery.
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OBJECTIVE To build a standardized simulation teaching system for resident pharmacists and evaluate its effects, and to provide reference for improving the competency of resident pharmacists. METHODS The established simulation teaching system for pharmacy residents’ standardized training in the study included revising the simulation teaching syllabus, setting up simulation teaching courses, implementing the teaching method through “six types of simulations”, applying objective structured clinical examination (OSCE) for assessment, building a simulation teaching team and strengthening the simulation teaching management. The effect evaluation was perfermed with mixed research method, and qualitative and quantitative research methods were used to collect and analyze data and information. RESULTS &&CONCLUSIONS Compared with the traditional teaching system, the passing rate of graduation examination (71.4% vs. 100%) and the score of after-department examination ([ 76.2±7.8) vs. (90.4±4.9)] under the simulation teaching mode were higher; through questionnaire surveys and qualitative interviews, we found that resident pharmacists who went through simulation teaching gave positive feedback on the role and impact of this system. The simulation teaching system can be used with good generalizability for the standardized training of resident pharmacists, and can provide strong basis and support for the high-quality development of hospital pharmacy.
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OBJECTIVE To develop an individualized medication list for elderly patients by evidence-based pharmacy method, and to support clinical decisions on rational use of METHODS Firstly, drugs with risk genetic information were screened out by systematically reviewing evidence-based pharmacy information. Secondly, researchers investigated the included drugs in lists from different data E- sources. Drugs included in three or more data sources and drugs proposed by the expert committee were then included in the medication list. Thirdly, for the drugs included in two data sources, researchers designed questionnaires to investigate the necessity of drug-related gene testing. According to the scoring results of the expert questionnaire, drugs with higher scores were included in the list. Data sources included real-world data (list of high frequency medication in hospitals, high frequency medication for elderly outpatients and inpatients in National Health Care Claims Data, drugs related to frequent medication errors and so on) and evidence-based pharmacy evidence (the websites of Clinical Pharmacogenomics Implementation Consortium, Dutch Pharmacogenetics Working Group, Food and Drug Administration and so on). RESULTS The study obtain 68 drugs with risk genetic information which were included in three data sources. Combined with 23 drugs proposed by the expert committee, a list containing 74 drugs was preliminarily formed after de-duplication. A total of 37 drugs included in two databases with risk genetic information were scored through the questionnaire survey to form a supplementary list of 26 drugs. This is the final composition of the list of 100 drugs developed in this study. Among them, there are 43 drugs for the central nervous system, 15 drugs for the cardiovascular system, 12 anti-tumor drugs and so on. Twelve drugs were included in six or more data sources, which mainly consisted of drugs for digestive system, all proton pump inhibitors. CONCLUSION In this study, a list of 100 commonly used drugs which require individualized medication for the elderly was developed by evidence-based pharmacy method. The drug list will be updated in time as available evidence changes, and can provide guidance for rational use of medicines for elderly patients.
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OBJECTIVE To evaluate the effectiveness, safety, economy, innovation, suitability and accessibility of recombinant Mycobacterium tuberculosis fusion protein (EC), and to provide evidence for selecting skin detection methods for tuberculosis infection diagnosis and auxiliary diagnosis of tuberculosis. METHODS The effectiveness and safety of EC compared with purified protein derivative of tuberculin (TB-PPD) were analyzed by the method of systematic review. Cost minimization analysis, cost-effectiveness analysis and cost-utility analysis were used to evaluate the short-term economy of EC compared with TB-PPD, and cost-utility analysis was used to evaluate the long-term economy. The evaluation dimensions of innovation, suitability and accessibility were determined by systematic review and improved Delphi expert consultation, and the comprehensive score of EC and TB-PPD in each dimension were calculated by the weight of each indicator. RESULTS The scores of effectiveness, safety, economy, innovation and suitability of EC were all higher than those of TB-PPD. The affordability scores of the two drugs were consistent, while the availability score of EC was lower than those of TB-PPD. After considering dimensions and index weight, the scores of effectiveness, safety, economy, innovation, suitability, accessibility and the comprehensive score of EC were all higher than those of TB-PPD. CONCLUSIONS Compared with TB-PPD, EC performs better in all dimensions of effectiveness, safety, economy, innovation, suitability and accessibility. However, it is worth noting that EC should further improve its availability in the dimension of accessibility.
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OBJECTIVE To mine the signals of adverse dr ug events (ADE)for tolvaptan based on FAERS database ,and to provide reference for safe use of drugs in clinic. METHODS The data of tolvaptan-induced ADE were collected from FAERS database during the first quarter of 2004 to the third quarter of 2020;the reporting odds ratio (ROR)method and the proportional reporting ratio (PRR)method of disproportional method were used for data mining. RESULTS A total of 4 744 ADE reports of the target drug tolvaptan were extracted ,involving 1 279 ADEs. The reporting countries were mainly the United States and Japan ,etc. A total of 199 ADE signals were obtained ,involving 21 system organ classes (SOCs),which mainly focused on various examinations(n=56),hepatobiliary disorders (n=17),renal and urinary disorders (n=14),etc. Among them ,80 signals were not mentioned in existing instructions for tolvaptan in China ,such as decreased glomerular filtration rate ,positional vertigo , rupture of renal cyst ,renal cyst infection ,pulmonary malignant tumor. CONCLUSIONS Before using tolvaptan ,drug evaluation should be performed well ,especially the patients with basic diseases such as heart failure ,liver insufficiency and renal insufficiency. During treatment ,the indexes of liver function and renal function should be closely monitored ;timely intervention measures should be taken to avoid related injury and disease deterioration caused by ADE when ADE or disease progression occurs.
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Evidence-based Practice Guideline of Medication Therapy of High-dose Methotrexate in China was published in the British Journal of Clinical Pharmacology in February 2022. The guideline followed the latest definition of clinical practice guideline and the methodology specification for the guideline development of WHO. The Grading of Recommendations Assessment , Development,and Evaluation (GRADE)approach was applied to rate the quality of evidence and determine the strength of recommendations. Finally ,this guideline presents 28 recommendations covering the whole process of clinical medication of high-dose methotrexate ,involving evaluation prior to administration (liver and renal function ,pleural effusion and ascites , comedication,genetic testing ),pre-treatment and routine dosing regimen (pretreatment of hydration and alkalization ,urine alkalization,routine dosing regimen ),therapeutic drug monitoring (necessity,method,timing,target concentration ),leucovorin rescue(rescue timing ,rescue regimen ,rescue dose optimization ),and management of toxicities (liver and kidney function monitoring,supportive treatment ,blood purification treatment ). This article aims to summarize and interpret the recommendations of this guideline ,so as to promote the better promotion and implementation of this guideline and provide comprehensive technical support and suggestions for whole-course individualized administration of high-dose methotrexate in China.
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OBJECTIVE:To compare the effectiveness and safety of int ensified dose and standard dose of mycophenolic acids (MPA)for kidney transplant recipients ,and to provide evidence-based reference for clinical use of drugs. METHODS :Retrieved from Embase ,PubMed,Cochrane library ,Clinical trials ,CNKI,Wanfang database and CBM ,randomized controlled trial (RCT) and cohort study about intensified dose and standard dose of clinical commonly used Mycophenotate mofetil (MMF) and Mycophenolate sodium enteric-coated tablet (EC-MPS)for adult kidney transplant recipients were collected during the inception to Mar. 2020. After literature screening and data extraction ,the quality of RCTs were evaluated with bias risk evaluation tool recommended by Cochrane system evaluator manual 5.0. The quality of cohort study was evaluated by NOS scale. Meta-analysis was performed by using Rev Man 5.3 software,and sensitivity analysis was conducted. RESULTS :A total of 8 studies were included,involving 6 RCTs,2 cohort studies ,with 1 637 patients involved. Meta-analysis results showed that ,the incidence of biopsy-proven acute rejection (BPAR)[RR=0.65,95%CI(0.48,0.89),P=0.007] and cytomegalovirus (CMV)infection [RR = 0.39,95%CI(0.17,0.91),P=0.03] in intensified dose groupwere significantly lower than control group. Subgroup analysis by drug showed that the incidence of BPAR in MMF intensive dose group [RR =0.72,95%CI(0.53,0.99),P=0.04] and EC-MPS intensive dose group [RR =0.19,95% CI (0.04, 0.81),P=0.03] was significantly lower than that in standard zhaorongsheng@bjmu.edu.cn dose group ; there was n o statistical significance in the incidence of CMV infection in MMF intensive dose group [RR =0.16,95%CI(0.02,1.33),P=0.09] and EC-MPS intensive dose group [RR =0.51,95%CI(0.20,1.30),P=0.16],compared with standard dose group (P>0.05). There was no significant difference in the incidence of rejection,treatment failure ,graft loss ,termination of treatment ,death,overall adverse events , infection(overall),BK virus infection ,urinary tract infection ,hematological adverse events (overall),leucopenia,anemia, thrombocytopenia,gastrointestinal adverse events (overall),nausea,vomiting or diarrhea between 2 groups(P>0.05). Sensitivity analysis showed that the incidence of rejection ,CMV infection and leukopenia were generally stable. CONCLUSIONS :The efficacy and safety of early intensive dose of MPA in adult renal transplant recipients were similar to those of standard dose ,but the incidence of rejection ,CMV infection and leucopenia should be carefully interpreted.
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OBJECTIVE:To explore refined management mode of outpatient pharmacy ,and to improve the efficiency and quality of outpatient pharmacy service. METHODS :From the hospital information and big data center of our hospital ,the outpatient pharmacy prescription data under the traditional management mode were collected ;fish bone analysis was used to find out the factors that may affect the waiting time of patients ,the work efficiency and quality of pharmacy ;4M1E method was adopted to improve the related problems and implement refined management. The prescription data of 10 working days before improvement,stage 1 and stage 2 of refined management were selected. The work efficiency of pharmacists ,average waiting time of patients ,dispensing errors and inventory errors before and after the improvement were compared and analyzed to evaluate the effects of refined management. RESULTS :By fishbone diagram ,the factors influencing the waiting time of patients ,the work efficiency and quality of outpatient pharmacy service in our hospital included personnel factors ,machine factors ,material factors , method factors ,environmental factors ,such as the number of personel and time alloction was unreasonable ,the machine was aging,etc. After the implementation of refined management ,the outpatient pharmacy of our hospital had taken a variety of measures,such as adjusting the staff working time and refining the performance rew ard scheme ,maintaining the automatic dispensing machine and updating the prescription scanning equipment,setting up temporary drug containers and opti- mizing the location number ,strengthening drug management and relevant personnel training , openning the window ofcharacteristic single variety dispensing. The statistical results com showed that in the first stage of fine management ,the number of dispensing prescriptions and the number of p rescription items in the outpatient pharmacy of our hospital increased slightly in 10 working days. Due to the decrease of the number of on-the-job staff and the change of the number and time of open windows ,the cumulative working hours of on-the-job staff decreased from 1 680 hours to 1 440 hours;the number of dispensing prescriptions and prescription items per hour per capita increased from 52.0 pieces,58.7 to 65.1 pieces,69.6(P<0.05);the number of dispensing errors decreased from 30 to 5;there was no significant change in waiting time of patients and inventory errors. In the second stage of fine management ,when the amount of dispensing prescriptions in outpatient pharmacy of our hospital was similar ,the number of dispensing prescriptions and the number of prescription items per hour per capita increased from 52.0 pieces,58.7 to 59.9 pieces,67.3,respectively(P<0.05);the average waiting time of patients decreased from 9.30 min to 7.32 min(P<0.05). After further refining the error data collection method and adjusting the performance incentive scheme ,the number of dispensing errors in outpatient pharmacy increased to 75,and the number of inventory errors decreased from 5 to 0. CONCLUSIONS :By 4M1E method,outpatient pharmacy of our hospital carry out refined management ,to achieve the improvement of work efficiency and quality,shorten the waiting time of patients
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OBJECTIVE:To systematically evaluat e the efficacy and safety of different regimens in the treatment of refractory Kawasaki disease ,and to provide evidence-based reference for clinical treatment. METHODS :Retrieved from PubMed ,Embase, Cochrane Library , CNKI, VIP, Wanfang database ,randomized controlled trials (RCTs)and cohort studies about different therapeutic regimens in the treatment of refractory 84206032。E-mail:liuyingzryy@163.com Kawasaki disease were collected during the inception to March 2021. After selecting the literature and extracting the data ,the quality of RCT was evaluated by modified Jadad scale ,and the quality of cohort st udy was evaluated by NOS scale. Network Meta-analysis was performed by using Stata 16.0 software. RESULTS :A total of 29 literatures were included ,involving 15 RCTs and 14 cohort studies. A total of 3 112 patients and 12 therapeutic regimens were involved ,including twice IVIG ,twice IVIG+hormone,twice IVIG+ulinastatin ,first IVIG ,first time IVIG+hormone ,first time IVIG+cyclosporine ,first time IVIG+ etanercept,hormone,hormone+ulinastatin,ulinastatin,infliximab and placebo. The results of network Meta-analysis showed that in terms of the incidence of coronary artery injury (CAL),twice IVIG+hormone was significant lower than hormone ,and first time IVIG +etanercept was significant lower than first time IVIG (P<0.05). The sorting results of network Meta-analysis showed that area under cumulative ranking curve of CAL incidence in ascending order was hormone <ulinastatin<twice IVIG <first time IVIG<first IVIG+hormone <twice IVIG+hormone <infliximab<first time IVIG+cyclosporin <first time IVIG+etanercept. In terms of the incidence of ADR ,compared with twice IVIG+ hormone and hormone ,twice IVIG and first time IVIG+etanercept were decreased significantly ;infliximab was significantly lower than hormone (P<0.05). The sorting results of network Meta-analysis showed that area under cumulative ranking curve of ADR incidence in ascending order was hormone <twice IVIG+hormone <first time IVIG+hormone <first time IVIG+cyclosporin <first time IVIG <twice IVIG <first time IVIG+etanercept <infliximab. In terms of the serum level of CRP ,compared with twice IVIG ,twice IVIG+hormone ,twice IVIG+ulinastatin and hormone were decreased significantly;twice IVIG+hormone was significantly lower than first time IVIG ;twice IVIG+ulinastatin were all significantly lower than twice IVIG+hormone ,hormone,hormone+ulinastatin,first time IVIG ,first time IVIG+hormone and ulinastatin (P<0.05). The sorting results of network Meta-analysis showed that area under cumulative ranking curve of serum CRP level in ascending order was first time IVIG <first time IVIG+hormone <twice IVIG <hormone+ulinastatin<ulinastatin<infliximab<hormone<twice IVIG+hormone<twice IVIG+ulinastatin. In terms of improving persistent fever duration ,there was no statistical difference between pairwise treatment measures (P>0.05). The sorting results of network Meta-analysis showed area under cumulative ranking curve of persistent fever time in ascending order was first time IVIG <placebo<first time IVIG+cyclosporine <hormone<twice IVIG+ hormone<twice IVIG <ulinastatin<infamliximab. CONCLUSIONS :The first time IVIG+etanercept has the best effect in reducing the incidence of CAL. Infliximab possesses a relatively low incidence of ADR and the best antipyretic effect. Twice IVIG + ulinastatin has the best anti-inflammatory effect.
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OBJECTIVE:To interpret the key points in local standard Specification for Pharmacy Intravenous Centralized Admixture(DB11/T 1701-2019)(Beijing Local Standard for short )in Beijing ,and to provide guidance and reference for managers of medical institutions and staff of PIVAS to deeply understand the standard and further improve the quality of PIVAS in medical institutions. METHODS :The background and main content of Beijing Local Standard were interpreted in detail ,and then compared with Quality Specification of Pharmacy Intravenous Admixture (National Specification for short )promulgated by Chinese National Ministry of Public Health and Quality Specification of Pharmacy Intravenous Admixture Services of Guangdong Provincial (Trial)(Specification of Guangdong Province for short )promulgated by Guangdong Pharmaceutical Association. RESULTS & CONCLUSIONS:Beijing Local Standard had been promulgated and implemented by Beijing Municipal Administration for Market Regulation on April 1st,2020. The text of Beijing Local Standard is divided into 7 parts,mainly including the scope of application,normative references ,terms and definitions ,basic requirement ,environmental requirements (design,location, layout),equipment and facilities (ventilation system and console ,operation and maintenance ),and admixture requirements. Beijing Local Standard further refines the relevant contents on the basis of following the requirements of National Specification . Like Specification of Guangdong Province ,the applicability and operability of the standard are enhanced by combining their local characteristics and practice status. As the first local standard in this domain ,the local standard is expected to promote the improvement of the working quality of PIVAS in Beijing ,enable the PIVAS of proposed construction ,under construction and operation maintenance to meet uniform standards and reduce the failure of acceptance or reconstruction after completion.
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OBJECTIVE:To provid e reference for pharmaceutical workers to better understand Novel Coronavirus Infection : Expert Consensus on Guidance and Prevention Strategies for Hospital Pharmacists and the Pharmacy Workforce (hereinafter referred to as “expert consensus ”),and to apply and practice in specific work ,so as to give full play to the role of pharmacists to help fight the epidemic.METHODS :The background of the formulation and revision of the expert consensus were introduced ,and its main contents and viewpoints were interpreted. RESULTS & CONCLUSIONS :The text of expert consensus is divided into 8 parts,mainly including disease diagnosis and treatment [SARS-CoV- 2 infection related background ,clinical manifestations and diagnosis, treatment],hospital pharmacy (prevention and control strategy ,work guidance ),drug and facility support management(key drug/facility/equipment support ,management and use of the drug in special circumstances ),information sources and related resources ,etc.,which comprehensively and detailedly provide information ,guidance and strategies for coronavirus SARS-CoV-2 infection prevention and control to play the role of pharmacists in hospital pharmacy well ,do well in the protection of staff in different pharmaceutical posts ,drug security work in response to epidemic situation ,and develop pharmaceutical care. So far,the understanding of SARS-CoV- 2 in the pharmaceutical industry is relatively limited. Based on the accumulated experience and progress in epidemic prevention and control ,the expert consensus will be updated and improved continuously ,so as to provide guidance and help for hospital pharmaceutical personnel.
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OBJECTIVE: To provide reference for improving emergency capacity of the hospital pharmacy department in response to the novel coronavirus pneumonia (COVID-19) epidemic. METHODS :According to the related regulations and requirements of Law of the People ’s Republic of China on the Prevention and Control of Infectious Diseases ,combined with the situation of COVID- 19 epidemic prevention and control ,and management experience of relevant hospitals ,on the basis of in-depth analysis of drug supply and quality assurance ,drug dispensing management ,provision of clinical pharmaceutical services and other related material support of hospital pharmacy department,integrated emergency management model was constructed for COVID- 19 epidemic prevention and control ,and the precautions and response measures of each link were sorted out. RESULTS :Integruted emergency management mode for COVID-19 epidemic prevention and control in hospital pharmacy department included but was not limited to human resource management,drug and disinfection products supply management (mainly including key treatment drugs and disinfection product list formulation,control,inventory increase ,etc.);drug dispensing management (mainly including prescription ,pharmacy window , planning quantitative reserve , drug return , etc.);clinical pharmaceutical care management (mainly including providing pharmaceutical information support ,online pharmaceutical service ,monitoring drug safety ,etc.);personnel protection and disinfection (mainly including personnel protection ,environment and window ,equipment and container ,paper prescription disinfection,etc.);special management of donated drugs ;prevention and control knowledge training ;pharmaceutical education and scientific research management ,etc. CONCLUSIONS :The integrated emergency management model for epidemic prevention and control is helpful for hospital pharmacy to manage public health emergencies. During the outbreak of COVID- 19,hospital pharmacy department should start integrated emergency management mode for epidemic prevention and control ,strengthen the risk control of each link ,and play a good role in the key functional departments in the special period.
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OBJECTIVE:To provide drug ,material supp ly and emergency management reference for novel coronavirus (SARS-CoV-2)infection in pharmacy staff in hospital. METHODS :The method of 5M1E was used to analyze the six main factors,including man ,machine,material,method,environment and measurement of drug ,material supply and emergency management. The relevant prevention and control strategies were put forward. RESULTS & CONCLUSIONS :In the drug ,material supply and emergency management of epidemic prevention and control ,the man factors were involved ,such as mainly pharmacists from pharmacy departments of medical institutions. At the same time ,the management also involved machine factors such as drug storage,cleaning and disinfection ;material factors such as emergency drugs ,disinfection products ,in vitro diagnostic reagents , the guarantee of medicine materials for medical team ,investigational products ;methods factors such as relevant management measures;environmental factors such as storage environment and facilities ;measurement factors such as drug use ,drug and substance reserve. In view of the above factors ,it is suggested to strengthen the professional knowledge and communication skills training of pharmacists ,and strengthen humanistic care ,so as to improve their post competency ,communication in emergency response and psychological tolerance. Equipment and materials management shall be strengthened ,and equipment maintenance and disinfection shall be done well to ensure normal use of equipment. According to the evidence-based method ,the emergency drug list should be established. According to the disinfection protection requirements ,the disinfection products should be reasonably selected and their quality and sufficient inventory should be ensured. The qualified in vitro diagnostic reagents should be purchased in time. The investigational products should be managed reasonably according to the relevant requirements of clinical trials ,to ensure the drug and material supply of medical team members. Emergency plans and standard operating procedures shall be formulated,the principle of sympathetic drug use shall be followed ,and the management of off-label drug use and early warning of drug and material shortage shall be done well. Reasonable storage space should be reserved to strengthen environmental monitoring and disinfection. We should strengthen the monitoring and reporting of daily data ,strengthen the quality monitoring , and accept the independent audit of the third party. Above strategies are helpful to improve the ability of drug supply risk identification and response ability ,and cooperate with the medical team to timely rescue patients.
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OBJECTIVE:To pro vide reference for exposure protection countermeasures for Novel coronavirus (SARS-CoV-2) infection in hospital pharmaceutical staff. METHODS :According to the recommendations of related medical staff protection guideline,combined with the characteristics and prevention and control requirements of novel coronavirus pneumonia (COVID- 19),based on the basic principle of exposure protection ,actual exposure risk of infections for hospital pharmaceutical staff were evaluated,and the countermeasures for exposure protection were constructed under the epidemic condition of COVID- 19. RESULTS:According to the standard prevention principle and the risk evaluation of infection exposure ,most of the pharmaceutical posts in the hospital belonged to low-risk exposure posts ,and only a few posts belonged to medium-and high-risk exposure posts. Personal protective equipment should be provided according to the exposure risk level of different pharmaceutical posts and work demand. At the same time ,infection protection training should be strengthened ;environment and facilities in pharmacy should be cleaned and disinfected. CONCLUSIONS :Standard prevention principle should be followed by hospital pharmaceutical staff during epidemic period. Based on the characteristics and exposure risks of pharmacy posts ,and according to the regulations of the hospital,personal protection for hospital pharmaceutical staff should be conducted according to the exposure risk level determined by the pharmaceutical department and relevant management regulations to avoid over-protection or inadequate protection ,so as to ensure the smooth and safe development of pharmaceutical care.
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OBJECTIVE:To p rovide reference for related pharmacy work for developing evidence-based pharmacy information support to respond for novel coronavirus pneumonia (COVID-19) epidemic. METHODS :The PubMed,CNKI and Wanfang database were consulted to obtain treatment progress of COVID-19,prohibited for use with lopinavir/ritonavir and adverse drug reactionas until February 12,2020;so were package insert and UpToDate at the same time. Those information were summarized and evaluated. RESULTS & CONCLUSIONS :Totally 14 literatures introduced chemical drugs for COVID- 19,involving 7 categories, 20 kinds of chemical drugs as antiviral drugs (interferon α/interferon α-2 β , lopinavir/litonavir, etc.), immunomodulatory agents (such as glucocorticoid ,gamma globulin ),antimalarial drugs (such as chloroquine phosphate ). The existing evidence of drug treatment mainly comes from in vitro cell test or currently progressing RCT ,with low-level evidence and recommendation intensity (Oxford evidence level is level 5,recommendation intensity is level D ). For lopinavir/ritonavir that recommended in the diagnosis and treatment recommendations for COVID- 19 published by the National Health Commission ,it is a CYP3A inhibitor ,which resulted in increased plasma concentrations of some medications such as antiarrhythmic drugs ,antitumor targeted drugs and antibacterial drugs ,and should not be used in combination with drugs such as afzosin ,ivabradine,amiodarone, etc. Its common adverse reactions mainly involved igestive system (diarrhea,taste disorders ,vomiting,etc.),respiratory system (upper respiratory tract infection ),endocrine and metabolic system (hypercholesterolemia,etc.),skin and its appendents (skin rash),which should be monitored clinically.
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OBJECTIVE:To provide re ference f or hospital pharmacy prevention and control management during novel coronavirus(SARS-CoV-2)infection epidemic period. METHODS :Based on 5M1E analysis method ,according to the needs of epidemic prevention and control ,it is necessary to analyze the risks of 5 aspects as personnel ,equipment and materials ,methods, environment,monitoring of the pharmacy work in hospital ,and establish the prevention and control strategy of hospital pharmacy infection in response to the epidemic situation of novel coronavirus pneumonia (COVID-19)according to the corresponding risks. RESULTS & CONCLUSIONS :Personnel management strategies include carrying out pharmacist prevention and control training , focusing on physical and mental health of pharmacists during infection prevention and control ;equipment and materials management strategies include strengthening equipment disinfection management and strengthening the management of materials for infection prevention and control ;method management strategies include developing emergency plans for infection prevention and control,standardizing individual infection prevention and control method ;environment management strategies include environment cleaning and disinfection management ,infection exposure management of related medical material ,medical waste management ; monitoring management strategies include strengthening pharmacists infection monitoring and evaluating pharmacists ’prevention and control effect. By establishing the strategy for COVID- 19 epidemic prevention and control ,it can effectively guiding pharmacists to carry out epidemic prevention and control.
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OBJECTIVE:To systematically evaluate the c orrelation of methylenetetra hydrofolate reductase (MTHFR)C677T and A 1298C gene polymorphisms with blood system adverse events induced by high-dose of methotrexate (HDMTX). METHODS : Retrieved from Medline ,Embase,Clinical Trials.gov ,CNKI,Wanfang database ,CBM,cohort studies about MTHFR gene polymorphism in hematological neoplasm treated by HDMTX were collected from inceptions to March 2018. After data extraction of included literatures ,quality evaluation with Newcastle Ottawa scale ,Meta-analysis was performed for adverse events of blood system induced by HDMTX in different genetic models with Rev Man 5.3 software. RESULTS :Totally 25 cohort studies were included,23 studies of which were related to MTHFR C677T site (including 1 858 patients)and 16 studies related to MTHFR A1298C site (including 1 088 patients). Results of Meta-analysis showed that MTHFR C677T mutation type significantly increased the risk of hematotoxicity [TT/CT vs. CC :OR=1.57,95%CI(1.12,2.20),P=0.009;TT vs. CT/CC :OR=2.19,95%CI(1.49, 3.23),P<0.001;T vs. C :OR=1.34,95%CI(1.03,1.74), P=0.03] and severe hematotoxicity [TT/CT vs. CC :OR=m 2.33,95%CI(1.43,3.81),P<0.001],including leukopenia [TT/CT vs. CC :OR=1.37,95%CI(1.02,1.82),P=0.03], severe leukopenia [TT/CT vs. CC :OR=1.63,95%CI(1.03, 010-82265810。E-mail:zhao_rongsheng@163.com 2.56),P=0.04],severe gra nulopenia [TT/CT vs. CC :OR= ·2.26,95%CI(1.50,3.39),P<0.001]. The mutation genotypes of MTHFR A1298C significantly decreased the risk of severe hematotoxicity [CC/AC vs. AA :OR=0.17,95%CI(0.04,0.76),P=0.02],including leukopenia [CC/AC vs. AA :OR=0.68, 95%CI(0.48,0.97),P=0.03;CC vs. AC/AA :OR=0.28,95%CI(0.14,0.59),P<0.001] and severe leukopenia [CC/AC vs. AA:OR=0.43,95%CI(0.19,0.97),P=0.04]. CONCLUSIONS :Among patients with hematological neoplasms ,MTHFR C677T mutation may significantly increase the risk of hematotoxicity by HDMTX including the risk of leukopenia and granulopenia ;while MTHFR A1298C may reduce the risk of hematotoxicity by HDMTX ,including the risk of leukopenia.
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OBJECTIVE: To systematically evaluate the effects of MTHFR, RFC1 and MDR1 gene polymorphisms on high- dose methotrexate-induced ADR in osteosarcoma patients, and to provide evidence-based reference for individual medication of high-dose of methotrexate. METHODS: Retrieved from Medline, Embase, clinical trials.gov, CNKI, Wanfang database and CBM, cohort studies about the association of MTHFR C677T/A1298C, RFC1 G80A, MDR1 C3435T gene polymorphisms with high-dose methotrexate-induced ADR were collected. After data extraction of clinical studies met inclusion criteria, and quality evaluation with the Newcastle-Ottawa Scale, Meta-analysis and descriptive analysis were performed for outcome indexes as the incidence of high-dose methotrexate-induced ADR (hematotoxicity and myelosuppression, hepatotoxicity, nephrotoxicity, oral mucositis, digestive tract toxicity and overall adverse events) with Rev Man 5.3 and Microsoft Excel 2016 software. RESULTS: Totally 8 cohort studies involving 608 patients were included; 6, 5, 4 and 2 studies reported outcome indexes related to MTHFR C677T/A1298C, RFC1 G80A and MDR1 C3435T gene polymorphisms respectively. Meta-analysis and descriptive analysis showed that MTHFR C677T gene polymorphism was significantly associated with the risk of G3-4 renal toxicity [TT/CT vs. CC: OR=12.35, 95%CI=(3.28,46.42), P<0.001], G3-4 oral mucositis [T vs. C: OR=2.04, 95%CI=(1.06,3.93), P=0.03], oral mucositis [(TT vs. CT/CC: OR=2.27, 95%CI=(1.20,4.27), P=0.01] and renal toxicity (P<0.05); MTHFR A1298C gene polymorphism was associated with G3-4 hepatotoxicity, G3-4 nephrotoxicity and G3-4 oral mucositis, without statistical significance (P>0.05). There was no significant correlation between RFC1 G80A polymorphism and hemotoxicity, hepatotoxicity, nephrotoxicity and digestive tract toxicity (P>0.05). MDR1 C3435T polymorphism was significantly correlated with oral mucositis (P<0.05), but not with hematotoxicity and hepatotoxicity (P>0.05). CONCLUSIONS: MTHFR C677T mutation can increase the risk of high-dose methotrexate-induced ADR. There is no significant association between MTHFR A1298C polymorphism and high-dose methotrexate-induced ADR. There are few studies on RFC1 G80A or MDR1 C3435T polymorphism and high-dose methotrexate-induced ADR, and their association is unclear.
ABSTRACT
OBJECTIVE: To systematically evaluate the efficacy and safety for different infusion schemes of large-dose (>500 mg/m2) of methotrexate in the treatment of osteosarcoma, and to provide evidence-based reference for clinical treatment. METHODS: Retrieved from Medline, Embase, clinicaltrials.gov, CJFD, Wanfang database and CBM database, observational studies and randomized/non-randomized controlled trials about therapeutic efficacy and safety for different infusion schemes (different doses and infusion time) of large-dose of methotrexate in the treatment of osteosarcoma were included during the establishment of the database to Mar. 2018. After data extraction and quality evaluation with methodological evaluation index of the Newcastle-Ottawa scale, Cochrane 5.1.0 bias risk evaluation tool and non-randomized controlled trials, Meta-analysis or descriptive analysis for blood drug concentration (c), related toxicity (e.g. incidence of hepatotoxicity, incidence of hemotoxicity) were performed by using Rev Man 5.3 software. RESULTS: Totally 5 studies were included, involving 310 cases. Results of Meta-analyses indicated c0 h [MD=-240.11, 95%CI(-271.47, -208.75), P<0.001], c24 h [MD=-0.09, 95%CI (-0.11, 0.08), P<0.001], c48 h [MD=-0.07, 95%CI (-0.10, -0.05), P<0.001], c72 h [MD=-0.05, 95%CI (-0.06, -0.03), P<0.001] and the incidence of liver toxicity [OR=0.26, 95%CI (0.10, 0.67), P<0.005] in 8 g/m2 group were significantly lower than 10 g/m2 group. Results of descriptive analysis showed that when both groups were given 8 g/m2, c24 h of patients with 2 and 4 h infusion time was significantly lower than that of patients with 6 h infusion time. The incidence of leukopenia and thrombo- cytopenia in 8 g/m2 group was significantly lower than 10 g/m2 group. CONCLUSIONS: In the treatment of osteosarcoma with high-dose of methotrexate, appropriate dosage reduction (e.g. 8 g/m2) and appropriate prolongation of infusion time (e.g. 6 h) may lead to a better efficacy and safety.