Mycophenolic acid (MPA), the active moiety of both mycophenolate mofetil (MMF) and enteric-coated mycophenolate sodium (EC-MPS), serves as a primary immunosuppressant for maintaining solid organ transplants. Therapeutic drug monitoring (TDM) enhances treatment outcomes through tailored approaches. This study aimed to develop an evidence-based guideline for MPA TDM, facilitating its rational application in clinical settings. The guideline plan was drawn from the Institute of Medicine and World Health Organization (WHO) guidelines. Using the Delphi method, clinical questions and outcome indicators were generated. Systematic reviews, Grading of Recommendations Assessment, Development, and Evaluation (GRADE) evidence quality evaluations, expert opinions, and patient values guided evidence-based suggestions for the guideline. External reviews further refined the recommendations. The guideline for the TDM of MPA (IPGRP-2020CN099) consists of four sections and 16 recommendations encompassing target populations, monitoring strategies, dosage regimens, and influencing factors. High-risk populations, timing of TDM, area under the curve (AUC) versus trough concentration (C₀), target concentration ranges, monitoring frequency, and analytical methods are addressed. Formulation-specific recommendations, initial dosage regimens, populations with unique considerations, pharmacokinetic-informed dosing, body weight factors, pharmacogenetics, and drug‍-‍drug interactions are covered. The evidence-based guideline offers a comprehensive recommendation for solid organ transplant recipients undergoing MPA therapy, promoting standardization of MPA TDM, and enhancing treatment efficacy and safety.
Mycophenolic Acid/administration & dosage* ; Drug Monitoring/methods* ; Humans ; Organ Transplantation ; Immunosuppressive Agents/administration & dosage* ; Delphi Technique

Objective Analyze and study the detection performance of single reagent reactivity results of human immunodeficiency virus antigen antibody enzyme-linked immunosorbent assay(HIV-ELISA)in unpaid blood donors,to provide reference for improving the laboratory's testing capabilities.Methods Detection of 7069 specimens from our station in February 2023 using the BR-HIV reagent,among them,there were 120 cases of BR-HIV single reagent reactivity,then,three different manufacturers of HIV-ELISA reagents were used for the single reagent reactivity sample,chemiluminescence immunoassay(CLIA),nucleic acid detection technology(NAT)and Western blot for detection,statistical analysis of the relationship between ELISA,CLIA,NAT and Western blot detection results.Results Phased BR-HIV single reagent reactivity increase is related to A virus A infection,the difference is statistically significant(χ2=4.058,P<0.05).Tracking the information of 120 specimens by phone,data analysis of BR-HIV single reagent reactive A virus A infected persons and uninfected persons S/CO value,infected individuals are significantly higher than uninfected individuals.Infected individuals are significantly higher than uninfected individuals,the difference is statistically significant(χ2=44.099,P<0.05).CLIA,NAT,and three other HIV-ELISA detection reagents have consistency(Kappa=1),with equivalence.The results of immunoblotting test(Western blot)were all negative.Conclusion The false positive rate of BR-HIV single reagent in the samples of unpaid blood donors who had been infected with A virus A increased,CLIA,NAT,and other enzyme exempt agents can be used instead of testing,reduce the scrapping of blood,improve the detection ability of blood.

Objective:To explore the effect of relaxation training in the treatment of patients with obsessive-compulsive disorder.Methods:From January 2017 to June 2018, 90 patients with obsessive-compulsive disorder were admitted to the fourth ward of the Mental Health Center of Shanghai Jiaotong University School of Medicine. According to the random number table method, they were divided into the control group and the intervention group with 45 cases each. The control group was given medication, and the intervention group used relaxation training on the basis of the control group. The obsessive-compulsive disorder scores, quality of life, depression, and anxiety of the two groups were compared before and after treatment.Results:The obsessive thinking and compulsive behavior scores of the control group after treatment were (14.02±3.12) and (15.01±2.45) points; the intervention group was (11.91±3.01) and (12.23±2.34) points after treatment, and lower than the control group ( t values were 3.265, 5.504, P<0.05 or 0.01). The quality of life score of the control group after treatment was (283.64±51.28) points; the intervention group was (305.67±49.28) points after treatment, and the intervention group was higher than the control group after treatment (t value was -2.078, P<0.05). After treatment, the scores of the depression scale and anxiety scale of the control group were (12.35±2.89) and (15.35±4.03) points; the intervention group was (8.05±1.72) and (10.35±3.65) points after treatment, and the intervention group after treatment all lower than the control group ( t values were 8.577, 6.169, P<0.01). Conclusion:Using relaxation training combined with conventional drugs to treat patients with obsessive-compulsive disorder can improve obsessive-compulsive symptoms, improve quality of life, and relieve negative emotions.

Objective: To investigate the effect of pituitrin-water separation on hemoglobin and ovarian function in laparoscopic ovarian chocolate cyst removal. Methods: From February 2018 to February 2019, 82 patients with ovarian chocolate cyst removed by laparoscopy were selected from the Second Affiliated Hospital of Wenzhou Medical University.They were randomly divided into observation group and control group according to the digital table, with 41 cases in each group.The control group underwent traditional laparoscopic tear-and-tear ovarian cyst removal, while the observation group underwent pituitrin-water separation.The changes of perioperative indicators, the decrease of hemoglobin (Hb) before and after operation, the positive rate of normal ovarian tissue on cyst wall and the number of normal follicles attached to cyst wall, the changes of serum hormone levels before and after operation were compared between the two groups. Results: The amount of bleeding during operation in the observation group [(58.97±8.74)mL] was less than that in the control group [(118.93±24.21)mL], and the operation time in the observation group[(57.46±8.27)min] was shorter than that in the control group [(87.38±10.19)min] , the differences were ststistically significant between the two group(t=14.916, 14.598, all P<0.05). There was no statistically significant difference in the time of anal exhaust between the two groups (P>0.05). The decrease of Hb in the observation group [(0.71±0.16)g/L] was lower than that in the control group [(1.27±0.35)g/L] (t=9.318, P<0.05). The positive rate of normal ovarian tissue on cyst wall in the observation group (21.95%) was lower than that in the control group (56.10%), the number of normal follicles attached to the cyst wall in the observation group (2.65±0.49) was less than that in the control group (4.86±1.24) , the differences were ststistically significant between the two group(χ²=10.045, t=10.613, all P<0.05). The serum level of E₂ [(398.21±17.84)pmol/L] in the observation group was higher than that in the control group [(367.83±15.21)pmol/L], while FSH [(6.72±0.28)mIU/mL] and LH [(5.23±0.38)mIU/mL] levels in the observation group were lower than those in the control group [(7.19±0.35)mIU/mL and (5.69±0.31)mIU/mL], the differences were ststistically significant between the two group (t=8.298, 6.714, 6.006, all P<0.05). Conclusion The method of pituitrin-water separation is effective in laparoscopic ovarian chocolate cyst removal, which can reduce the injury during operation, has little effect on hemoglobin and improve the ovarian reserve function of patients.

Objective: To investigate the genetic characteristics of human norovirus (NoV) among infants under 5 years of age with diarrhea in Chaoyang District, Beijing from 2011 to 2017. Methods: NoV-positive stool samples were collected from 2011 to 2017 in this region. The partial RdRp and VP1 genes were amplified and sequenced. Multi-sequence alignment was performed and phylogenetic tree was constructed using Mega software. Results: A total of 151 samples were sequenced and analyzed. The ratio of male and female was 2.28∶1 with mean age of 1.72 years. Fourteen NoV subtypes were detected, including GII.Pe/GII.4 (47.68%), GII.P12/GII.3 (20.53%), GII.P4/GII.4 (17.22%), GII.P16/GII.2 (3.31%), GII.P12/GII.12 (1.99%), GII.P17/GII.17 (1.99%), GII.P16/GII.13 (1.32%), GII.P7/GII.7 (1.32%), GII.P7/GII.6 (1.32%), GII.P2/GII.2 (0.66%), GII.P21/GII.21 (0.66%), GII.Pg/GII.12 (0.66%), GI.Pa/GI.3 (0.66%) and GI.P6/GI.6 (0.66%). Conclusions NoV genetic diversity was found among infants under 5 with diarrhea in Chaoyang district, Beijing. The subtypes from surveillance and those from epidemics occurred in chronological order. The surveillance should be strengthened for early detection of new subtype for monitoring the epidemic and vaccine design.

OBJECTIVE:To provide evidence-based basis for the continuous improvement of antibacterial use surveillance in China.METHODS:Retrieving from 3 biomedical literature databases as Medline,Embase,Cochrane Library,48 health administrative departments and academic institutions,relevant literatures on antibacterial surveillance networks/ projects were acquired and extracted,including basic information,data collection,analysis and reporting methods,etc.Descriptive analysis method was adopted to analyze the status quo of global antibacterial surveillance networks/projects.RESULTS:A total of 21 literatures were included,involving 16 antibacterial surveillance networks/projects.Among them,there were 3 international projects and 13 national projects,mainly in European (countries) (56.25％,9/16).Sixteen antibacterial surveillance networks/projects were established to monitor and compare the use of antibacterials,analyze the antibacterial use trend and its correlation with bacterial resistance,and evaluate implementation effect of antibacterial management policy.The responsible agencies were mainly the health administrative departments,and the funding agencies were mainly related government departments.Hospital and community were main surveillance objects.There were 2 surveillance networks/projects for antibacterial use in children,and 6 surveillance networks/projects contained medication data of children.Only Strama in Sweden alone analyzed medication data in children.Fourteen surveillance networks/projects promulgated data collection methods or contents;data collection was mainly based on active reporting and involved the data of drug use/consumption and population/ patient.Except for ESAC-Net,ARPEC,NAUSP,data validation method was not mentioned in other surveillance networks/projects.Data analysis was most common in medical institutions and antibacterial categories,and defined daily dose was the most commonly used statistical indicators of antibacterial consumption.Ten surveillance networks/projects promulgated surveillance reports which were mostly published annually.CONCLUSIONS:Antibacterial surveillance have been widely operated worldwide.But there is a lack of monitoring and analysis of antibacterial use in special population including children.In addition,data validation is the weak link of antibacterial surveillance,so the quality of data collection still need to be improved.

OBJECTIVE: To evaluate evidence-based guidelines of current global pediatric idiopathic thrombocytopenic purpura (ITP) drug therapy, and to provide evidence-based reference for pediatric ITP diagnosis and treatment, the formulation of guideline in China. METHODS: Retrieved from PubMed, Embase, National Guideline Clearinghouse, Guidelines International Network, TRIP medical database, CBM, CJFD, VIP and WANFANG DATA, etc., the evidence-based treatment guideline involving pediatric ITP were included, and methodological quality of the guideline was evaluated by using AGREE Ⅱ tool. The similarities and differences of the guidelines were analyzed and compared. RESULTS: A total of 7 pediatric ITP evidence-based guidelines were included, among which 2 came from US, 2 came from Italy, 2 came from British and another one came from Malaysia. The quality of 7 guidelines were not good, among which 6 guidelines were recommended as grade B and 1 guideline was recommended as grade C; only one GRADE evidence-based guideline was found. The score of included guideline in the field of AGREE Ⅱ was in descending order as scope and purpose, clarity, rigor of development, stakeholder involvement, applicability, editorial independence. The main recommended drugs of these guidelines were: glucocorticoids, intravenous immunoglobulin, anti-D-immunoglobulin, while some guidelines recommend platelet, rituximab and combined medication. CONCLUSIONS: The quality of evidence-based guidelines of ITP for children is in low level and should be improved. There is no evidence-based guideline of ITP for children in China. It is suggested to develop high quality evidence-based guideline for ITP children in China based on AGREE Ⅱ items.

OBJECTIVE:To review therapeutic efficacy of N-acetylcysteine (NAC) for idiopathic pulmonary fibrosis (IPF),and to provide evidence-based reference.METHODS:Retrieved from Central database,PubMed,EMBase,CBM,CJFD,Wanfang database and VIP,randomized controlled trials or semi-randomized controlled trials about NAC (unlimited single drug or combination) vs.placebo/blank control in the treatment of IPF were collected.Meta-analysis was performed by using Rev Man 5.3 statistical software after data extraction and quality evaluation with Cochrane collaboration's bias risk assessment tool(2014 edition).RESULTS:A total of 10 studies were included(2 RCT,8 qRCT),involving 742 patients.Results of Meta-analysis showed that compared to placebo/blank control,NAC couldn't reduce the mortality of IPF patients [OR=1.14,95％ CI(0.50,2.62),P=0.76],but could significantly improve subjective symptom remission rate[OR=3.17,95％ CI (1.98,5.07),P＜0.001] and dyspnea score [SMD =-2.54,95 ％ CI (-5.02,-0.06),P=0.04].CONCLUSIONS:For IPF,NAC can't decrease the mortality of patients,but can relieve main symptoms and dyspnea.

Objective To investigate the effects of different tidal volume mechanical ventilation on pulmonary function and inflammatory factors in gynecologic laparoscopic surgery.Methods 45 patients undergoing gynecological laparoscopic surgery without lung disease,ASA Ⅰ-Ⅱ,aged 20-45 years old,weight 45-65 kg,operation time 2-3 hours,were randomly divided into A,B,C three groups,15 cases in each group.Mechanical ventilation with different tidal volume of the three groups,A group,B group and C group were 8mL/kg,9mL/kg,10mL/kg.Blood gas analysis was performed before anesthesia (T0),30 minutes (T1),(T2),PA-aDO2 (60 minutes) (T3),and 120 min (T4),respectively,and the peak airway pressure and mean pressure were recorded.IL-6,TNF-α and IL-10 levels in plasma by radial artery blood sampling were simnultaneously determined.Results Comnpared with A group,the concentrations of Ppeak and Pmean were increased in B group at T1-T4 (t =5.13,4.78,6.54,5.32 and t =7.54,4.88,5.37,4.95;all P ＜ 0.05),the concentration of Ppeak and Pmean in C group at T1-T4 increased (t =7.76,8.87,7.23,8.99 and t =6.42,7.38,7.62,9.86;all P ＜ 0.05).Compared with B group,the concentrations of Ppeak and Pmean were increased in C group at T1-T4 (t =4.76,5.87,4.23,3.99 and t =4.76,3.99,6.06,4.52;all P ＜ 0.05).Compared with A group,the A-aDO2 values of B group and C group were increased at T1,T2,T3 and T4 (t =5.32,5.48,4.88,5.69 and t =7.85,7.32,8.45,6.67;all P ＜ 0.05).Compared with B group at the same time point,the A-aDO2 value of C group increased at four times of T1-T4 (t =5.62,4.38,6.94,4.22,P ＜0.05).Compared with group A,the concentration of A-aDO2 in C group was higher than that in B group at the same time point (t =4.45,4.87,5.32,4.79 and t =7.68,7.59,7.44,8.38;all P ＜ 0.05).The levels of IL-6 and TNF-α in C group were significantly higher than those in the control group (t =4.78,5.56,7.62,8.03 and t =3.98,4.52,5.46,6.23;all P ＜ 0.05).Compared with T0,IL-6 and TNF-α concentrations AT T2-T4 in A group had no statistically significant differences (all P ＞ 0.05).Compared with B group,the levels of IL-6 and TNF-α in C group were significantly higher (t =4.58,4.99,6.53,4.77 and t =5.62,7.89,6.43,4.52;all P ＜ 0.05).Compared with T0,IL-6 and TNF-α concentrations at T2-T4 in A group had no statistically significant differences (all P ＞0.05).There was no significant difference in IL-10 concentration among the thrce groups.Conclusion Laparoscopic surgery according to the end tidal carbon dioxide partial pressure (PetCO2) ventilation frequency,8 mL/kg tidal volume mechanical ventilation has no effect on the IL-6,TNF-alpha,IL-10 and other inflammatory factors,mechanical ventilation tidal volume is more appropriate.

OBJECTIVE:To systematically evaluate the monitoring system for global short drugs,and provide evidence-based reference and policy recommendations for developing the short drug monitoring in China. METHODS:Relevant literatures pub-lished in PubMed,Embase,CNKI,Wanfang,VIP database from building to Apr. 3rd in 2017 were retrieved by using"Drugs (cheap drugs,essential medicines,emergency drugs) storage""Short drugs""Insufficient supply of drugs""Drug shortage"as Chinese keywords,and"Drug storage""Out-of-stock drug""Stortage of medicine""Stock out of medicine"as English keywords. Literatures about monitoring system for short drugs in Baidu,Google and national or regional health administration websites were collected,and general information,data collection,data validation,data reporting method,feedback and improvement measures of monitoring system were extracted. RESULTS & CONCLUSIONS:Totally 25 literatures were included,20 national or regional health administration websites were retrieved. 11 countries and European Union had established monitoring system for short drugs. The main reporting agencies in each country were different,which were production enterprises,business enterprises and medical in-stitutions. It was mainly reported by network. Data validation was mainly conducted by specialized departments or groups for short drugs in each country. The monitoring reporting included information of short drugs and discontinued drugs. Countermeasures in each country mainly included looking for alternative drugs,encouraging production,temporary import,looking for new or other sources of raw materials and speeding up the approval of short drugs. Besides, precautions included implementation relevant laws and guidelines for short drugs,and increasing the cooper-ation with non-government departments,etc. Monitoring sys-tem for short drugs needs to be further improved in China. Itis suggested to establish monitoring and early warning platform for short drugs,and hierarchical intervention mechanism,improv-ing relevant laws and developing guidelines on managing short drugs.