1.Formulation and interpretation of the Guidelines for the Pharmacist-managed Clinics Service and Document Writing and Usage(Reference)
Lijuan YANG ; Quanzhi LI ; Kejing WANG ; Xiaofen YE ; Zining WANG ; Xuelian YAN ; Liang HUANG ; Juan LI ; Jiancun ZHEN
China Pharmacy 2025;36(11):1301-1305
The writing of pharmacist-managed clinics documents (hereinafter referred to as “outpatient medication record”) is a necessary part of pharmacist-managed clinics service. Outpatient medication record is an important carrier to reflect the quality of pharmacist-managed clinics service. The Chinese Hospital Association Pharmaceutical Specialized Committee was entrusted by the Pharmaceutical Administration Department of the National Health Commission to lead the formulation of the Guidelines for the Pharmacist-managed Clinics Service and Document Writing and Usage (Reference) (hereinafter referred to as Guidelines) according to the compilation method of group standards and the technical route of “documentation combing→framework establishment→draft writing→opinion collection→Guidelines formation”. The Guidelines standardizes the basic requirements of pharmacist-managed clinics record management and the basic content of record, and provides a general template and two specialized templates including pregnant and lactating pharmacist-managed clinics record template and cough and asthma pharmacist-managed clinics record template, which provides a reference for medical institutions to write pharmacist-managed clinics record. This paper introduces the formulation process of Guidelines and analyzes the key contents of Guidelines, which is helpful for the application practice of Guidelines and further improves the quality of pharmacist-managed clinics work.
2.Construction of a prediction efficacy model for PD-1 inhibitor in advanced esophageal squamous cell carcinoma
Shanshan WU ; Xiaojie HUANG ; Xiaochun XIE ; Shaokai HUANG ; Lina HUANG ; Xiaofen WANG
China Pharmacy 2025;36(17):2154-2159
OBJECTIVE To develop a prediction model for durable clinical benefit (DCB) in patients with advanced esophageal squamous cell carcinoma (ESCC) receiving programmed death-1 (PD-1) inhibitor. METHODS The clinical data of patients with advanced ESCC who received PD-1 inhibitor in Jieyang People’s Hospital were retrospectively collected between January 2020 to December 2023. Predictors were screened by least absolute shrinkage and selection operator (Lasso) regression, and a multivariable Logistic regression model was developed to predict DCB. A nomogram was constructed based on the model. Internal validation of the prediction model was performed by using the Bootstrap method, and the model was evaluated by the receiver operating characteristic (ROC) curve, calibration curve, and decision curve analysis. RESULTS A total of 91 patients with advanced ESCC were included. The results of Lasso regression combined with Logistic regression analysis indicated that the baseline lymphocyte monocyte ratio (LMR) [odds ratio (OR)=1.97, 95% confidence interval (CI): 1.15-3.36, P=0.013], albumin (ALB) content (OR=1.35, 95%CI: 1.13-1.60, P<0.001), body mass index (BMI) category 1 [normal vs. low: OR= 0.28, 95%CI (0.09-0.96), P=0.042], BMI category 2 [overweight-obesity vs. low: OR=0.08, 95%CI (0.01-0.59), P=0.013], and treatment regimen [monotherapy vs. monotherapy combination therapy: OR=0.07, 95%CI (0.01-0.50), P=0.008] were predictive factors for patients with advanced ESCC to achieve DCB when treated with PD-1 inhibitor. A prediction model was constructed based on the above indicators. Internal validation of the model using the Bootstrap method showed an area under the curve of 0.831 (95%CI: 0.746-0.904), with specificity of 74.4% and sensitivity of 75.0%. The Hosmer-Lemeshow test yielded χ2= 9.930, P=0.270, and the calibration curve slope was close to 1. The decision curve analysis demonstrated that the model exhibited good clinical utility within a threshold range of 0.1 to 1.0. CONCLUSIONS The prediction model based on baseline LMR, ALB content, BMI, and treatment regimen demonstrates robust predictive performance and clinical utility for assessing therapeutic efficacy of PD-1 inhibitor in the treatment of advanced ESCC.
3.Development and testing of validity and reliability in evidence-based health care related competence assessment scale for medical personnel
Shuang WANG ; Ning WANG ; Lin XIAO ; Jiayi ZHANG ; Xiaofen WU ; Lijie WANG ; Chen YANG ; Qinghong FANG ; Lili ZHANG
Chongqing Medicine 2025;54(2):352-359
Objective To develop the Evidence-Based Health Care Related Competence Assessment Scale for Health Professionals(hereinafter referred to as the Scale),and to test its validity and reliability.Methods Based on the JBI evidence-based health care model as the theoretical framework,the initial items of the Scale were formed by reviewing the literature.Through the discussion of the research group,two rounds of Delphi expert consultation and pre-inspection,the items of the Scale were optimized.The convenience sam-pling method was adopted to extract 928 health professionals as the research subjects.The Scale conducted the validity and reliability testing.Results The Scale included the four dimensions of evidence generation,evi-dence synthesis,evidence transfer and evidence implementation,including 47 entries in total.The cumulative variance contribution rate was 59.08%.The confirmatory factor analysis results indicated that the model had good fitness.The convergent validity of all dimensions reached the standard,and the distinguishing validity was good.Finally,the Cronbach's α coefficient of the Scale was 0.971,and the split-half reliability was 0.928.Conclusion The developed Scale possesses good reliability and validity,which can be used to evaluate the competence of health professionals carrying the evidence-based healthcare related link works.
4.Trim72 overexpression alleviates myocardial inflammation and apoptosis in mice with acute viral myocarditis
Junyi WANG ; Shanghua XU ; Yimin XUE ; Jun KE ; Jiuyun ZHANG ; Hui XIE ; Shan LI ; Xiaofen ZHOU
Chinese Journal of Emergency Medicine 2025;34(2):193-199
Objective:To investigate the role and possible mechanism of tripartite motif-containing protein 72 (Trim72) in acute viral myocarditis (AVMC) in mice.Methods:A mouse model of AVMC was established by intraperitoneal injection of Coxsackievirus B3 (CVB3, 2.0 × 10 5 PFU/mouse). Forty mice were randomly divided into the negative control (NC) + phosphate-buffered saline (PBS) group (NC+PBS group), Trim72 overexpression + PBS group (Trim72 + PBS group), NC + CVB3 group, and Trim72 + CVB3 group ( n = 10). Fourteen days before modeling, mice in each group were injected with adeno-associated virus type 9 vector (AAV9) encoding either negative control or Trim72 overexpression (5.0 × 10 11 VG/mouse) via tail vein. Subsequently, PBS or CVB3 was injected intraperitoneally in the PBS and CVB3 groups, respectively. After seven days, the surviving mice were euthanized, and the heart and serum samples were collected. HE and TUNEL staining were used to observe the cardiac pathological changes and cardiomyocyte apoptosis, respectively. The mRNA expression levels of Trim72 and pro-inflammatory cytokines TNF-α, IL-6, and IL-1β in myocardial tissues of each group were detected by RT-qPCR. The protein levels of cTnI, TNF-α, IL-6, and IL-1β in serum were detected by ELISA. The expression levels of Trim72, apoptosis-related proteins (Bax, Bcl-2, Cleaved caspase-3, Caspase-3), TLR4, p-p65, and p65 were detected by Western blot. Results:The protein and mRNA expression levels of Trim72 in myocardial tissues of mice in the NC+CVB3 group were significantly downregulated compared with those in the NC + PBS group ( P<0.05). Compared with the NC + CVB3 group, Trim72 overexpression significantly increased the protein and mRNA expression of Trim72 in myocardial tissues ( P<0.05), ameliorated myocardial inflammatory injury, decreased the apoptotic index of cardiomyocytes ( P<0.05), and reduced the levels of pro-inflammation cytokines TNF-α, IL-6, and IL-1β in the myocardium and serum ( P<0.05). Additionally, Trim72 overexpression also downregulated the protein expression of Bax, Cleaved caspase-3/Caspase-3, TLR4, and p-p65, and upregulated the protein expression of Bcl-2 in myocardial tissues ( P<0.05). There was no significant difference in the indexes of mice between the NC + PBS and Trim72 + PBS groups ( P>0.05). Conclusions:Trim72 overexpression attenuates AVMC in mice by inhibiting myocardial inflammatory injury and apoptotic imbalance, and the mechanism may be related to the negative regulation of the TLR4/NF-κB signaling pathway.
5.Screening threshold for congenital adrenal hyperplasia in preterm and full-term infants by an indirect method
Jing GUO ; Guoli TIAN ; Zhixing ZHU ; Zhuo ZHOU ; Wei JI ; Xiaofen ZHANG ; Yanmin WANG
Chinese Journal of Applied Clinical Pediatrics 2024;39(3):182-186
Objective:To analyze the difference and reliability of blood 17-hydroxyprogesterone (17-OHP), an indirect screening index for congenital adrenal hyperplasia (CAH), between preterm and full-term infants.Methods:In this retrospective cross-sectional study, a total of 210 285 newborns who underwent CAH screening at the Neonatal Screening Center of Shanghai Children′s Hospital from January 2019 to December 2022 were collected, including 14 312 premature infants and 195 973 full-term infants.The concentration of 17-OHP in dried blood spots on filter paper was determined by an automatic fluorescence analyzer.The distribution of 17-OHP levels in preterm and full-term infants and its statistical index were analyzed.The Kolmogorov-Smirnov test was used for normal distribution.The skewed distribution data was converted into approximately normal distribution using Box-Cox.Outliers were eliminated by the interquartile range method.The cumulative frequency distribution map was drawn by R language programming.The 99.5 th percentile value was used as the screening threshold and compared with the reference value given by the manufacturer or laboratory and with the reference change value (RCV). Results:According to the threshold provided by the laboratory, 26.76‰ of premature infants were tested positive in preliminary screening, and 4 were confirmed with an incidence of 1∶3 578, while 0.79‰ of full-term infants were tested positive in preliminary screening, and 11 were confirmed with an incidence of 1∶17 816.The thresholds for CAH screening established indirectly were 20.35 nmol/L in preterm infants and 10.78 nmol/L in full-term infants.The relative deviations between the indirect CAH screening thresholds and the manufacturer′s or laboratory′s CAH screening thresholds were higher than the RCV, respectively.According to the indirect CAH screening thresholds, the negative and positive coincidence rates of 65 samples in 13 batches from the Centers for Disease Control and Prevention interlaboratory quality assessment program in the United States reached 100%.A retrospective analysis of 210 285 neonates showed that 17-OHP concentration was higher than the screening threshold in all CAH-positive neonates.The application of this screening threshold reduced the false positive rate of preterm infants by 59.79%.Conclusions:It is feasible to establish the CAH screening thresholds for premature and full-term infants by an indirect method, which can improve the efficiency of screening and provide better diagnostic basis for clinical practice.
6.Therapeutic effect of mesenchymal stem cells on acute-on-chronic liver failure:A Meta-analysis
Hang DING ; Xiaofen LI ; Yan XIONG ; Yanyan LI ; Xiuji CHEN ; Xiaolin WANG
Journal of Clinical Hepatology 2024;40(8):1646-1652
Objective To systematically evaluate the efficacy and safety of mesenchymal stem cells(MSC)in the treatment of acute-on-chronic liver failure(ACLF).Methods This study was conducted according to PRISMA guidelines,with the PROSPERO registration number of CRD42024517851.PubMed,Embase,Wanfang Data,VIP,CNKI,CBM,and the Cochrane Library were searched for randomized controlled trials(RCT)and cohort studies on MSC in the treatment of ACLF published up to November 1,2023,and the articles were screened according to inclusion and exclusion criteria.After data extraction and quality assessment,RevMan 5.3 software was used to perform the Meta-analysis.Results A total of 11 articles involving 803 subjects were included in this meta-analysis.The results showed that for the patients with ACLF,MSC could improve 8-week survival rate(odds ratio[OR]=2.71,95%confidence interval[CI]:1.58-4.67,P=0.000 3),12-week survival rate(OR=2.24,95%CI:1.36-3.69,P=0.001),24-week survival rate(OR=2.09,95%CI:1.37-3.17,P=0.000 6),and 48-week survival rate(OR=2.09,95%CI:1.29-3.40,P=0.003)and reduce 12-week Model for End-Stage Liver Disease(MELD)score(mean difference[MD]=-3.27,95%CI:-6.07 to-0.48,P=0.02)and 24-week MELD score(MD=-2.24,95%CI:-3.16 to-1.33,P<0.000 01);it could also reduce the level of total bilirubin after 4 weeks of treatment(MD=-36.86,95%CI:-48.72 to-25.01,P<0.000 01)and increase 4-week albumin level(MD=2.11,95%CI:0.62-3.61,P=0.006)and 24-week albumin level(MD=3.54,95%CI:2.06-5.02,P<0.000 01).Adverse events were evaluated in 6 studies,with no serious adverse events.Conclusion MSC have a good safety in treatment and can improve the survival rate of patients and enhance liver function to some extent,and therefore,it holds promise for clinical application.
7.Clinical analysis and genetic diagnosis of three children with Isoleucine metabolic disorders due to variants of HSD17B10 and ACAT1 genes
Wei JI ; Guoli TIAN ; Xiaofen ZHANG ; Yanmin WANG ; Yongchen YANG ; Zhuo ZHOU ; Jing GUO
Chinese Journal of Medical Genetics 2024;41(5):540-545
Objective:To explore the clinical, biochemical and genetic characteristics of three children with Isoleucine metabolic disorders due to variants of HSD17B10 and ACAT1 genes. Methods:Two children with 17β hydroxysteroid dehydrogenase 10 (HSD17B10) deficiency and a child with β-ketothiolase deficiency (BKD) diagnosed at Shanghai Children′s Hospital between 2014 and 2021 were selected as the study subjects. Clinical data of the children were collected. The children were subjected to blood acylcarnitine, urinary organic acid and genetic testing, and candidate variants were analyzed with bioinformatic tools.Results:The main symptoms of the three children had included epilepsy, developmental delay, hypotonia and acidosis. Their blood acylcarnitine methylcrotonyl carnitine (C5: 1), 3-hydroxyisovalerylcarnitine (C5-OH) and 3-hydroxybutylcarnitine (C4OH) were increased to various extents, and urine organic acids including methyl crotonylglycine and 2-methyl-3-hydroxybutyric acid were significantly increased. Child 1 and child 2 were respectively found to harbor a c. 347G>A (p.R116Q) variant and a c. 274G>A (p.A92T) variant of the HSD17B10 gene, and child 3 was found to harbor compound heterozygous variants of the ACAT1 gene, namely c. 547G>A (p.G183R) and a c. 331G>C (p.A111P). Among these, the c. 274G>A (p.A92T) and c. 331G>C (p.A111P) variants were unreported previously. Based on the guidelines from the American College of Medical Genetics and Genomics (ACMG), they were respectively classified as variant of unknown significance (PP3_Strong+ PM2_supporting) and likely pathogenic (PM3+ PM2_Supporting+ PP3_Moderate+ PP4). Conclusion:Both the HSD17B10 deficiency and BKD can lead to Isoleucine metabolism disorders, which may be difficult to distinguish clinically. Genetic testing can further confirm the diagnosis. Discoveries of the HSD17B10: c. 274G>A (p.A92T) variant and the ACAT1: c. 331G>C (p.A111P) variant have enriched the mutational spectrum of the two diseases.
8.A randomized controlled trial on effects of brief mindfulness meditation training on negative emotions in patients with coronary heart disease after percutaneous coronary intervention
Xia YAN ; Xiaofen DONG ; Wei TAN ; Lingyun WANG ; Lihua HE ; Laimei LUO ; Yi CHENG
Chinese Mental Health Journal 2024;38(10):867-872
Objective:Evaluate the effects of brief mindfulness meditation training on improving negative e-motions,mindfulness attention awareness,and sleep quality in patients after percutaneous coronary intervention(PCI)for coronary heart disease.Methods:Eighty-four patients with coronary heart disease after PCI admitted to the cardiology department were selected.According to the principle of simple randomization,they were divided into an intervention group of 42 cases and a control group of 42 cases.The Self Rating Anxiety Scale/Self Rating De-pression Scale,Mindfulness Attention Awareness Scale,and Pittsburgh Sleep Quality Index Scale were used as eval-uation indicators before and after intervention.Results:The difference in total scores of anxiety,depression,and mindfulness attention awareness before and after intervention in the intervention group was higher than that in the control group(P<0.05).The difference in total sleep score,sleep quality,time to fall asleep,sleep duration,use of hypnotic drugs,daytime dysfunction,and total sleep score before and after intervention was higher than that of the control group(P<0.05).Conclusion:It suggests that brief mindfulness meditation training could alleviate negative emotions in patients with coronary heart disease after PCI,improve mindfulness awareness,and improve sleep quali-ty.
9.Establishment of ultra-performance liquid chromatography-tandem mass spectrometry method for assay of tobramycin in human serum and its use in a pharmacokinetic study of tobramycin inhalation in bronchiectasis patients
Yu WANG ; Xiaoyong XU ; Xiaolan HUANG ; Xiaofen LIU ; Yaxin FAN ; Jiali HU ; Hailan WU ; Jing ZHANG ; Beining GUO
Chinese Journal of Infection and Chemotherapy 2024;24(5):545-552
Objective To establish an ultra-performance liquid chromatography-tandem mass spectrometry(UPLC-MS/MS)method for determination of tobramycin in human serum,and examine the utility of the method in a clinical pharmacokinetic study of tobramycin inhalation.Methods Serum samples were pretreated by solid phase extraction with tobramycin-D12 as internal standard.Chromatographic separation was performed on a TitankHilic(2.1 mm × 100 mm,3 μm)column.The mobile phase consisted of0.1%formic acid-acetonitrile and 0.1%formic acid aqueous solution at a flow rate of 0.4 mL/min.Electrospray ionization source and multiple reaction monitoring(MRM)scanning were used for monitoring the quantitative ion pairs with m/z 468.3→m/z 163.3(tobramycin)and m/z 480.6→m/z 166.2(tobramycin-D12).The established method was investigated in terms of selectivity,interaction,concomitant medication,standard curve and lower limit of quantitation,precision and accuracy,recovery,matrix effect,and stability of tobramycinin.Results The linear range of tobramycin was 0.050 0-10.0 mg/L(R2=0.999 5).The intra-and inter-batch precision was satisfactory(coefficient of variation[CV]≤3.6%).The accuracy ranged from-0.4%to 6.0%.The matrix effect factor(MF)in human serum samples(including hemolysis and lipemia)ranged from 92.2%to 94.9%(CV≤2.7%).The recovery of tobramycinin was 79.5%-81.9%in serum samples,while the recovery of internal standard was 78.9%.The analyte was stable in serum samples for 72 h at room temperature and for 274 days at-20℃/-70℃.The pharmacokinetic study of tobramycin inhalation in bronchiectasis patients showed that after continuous administration of tobramycin 300 mg twice a day to 3 patients,the mean Cmax of tobramycin was(0.72±0.61)mg/L on Day 1 and(0.76±0.73)mg/L on Day 28,respectively.The corresponding Tmax was(1.83±0.61)h and(1.50±0.50)h,respectively.Conclusions The UPLC-MS/MS method established in this study is sensitive,accurate and rapid.It is successfully applied to the clinical pharmacokinetic study of tobramycin inhalation.The method may be suitable for therapeutic drug monitoring of tobramycin in clinical practice.
10.Predictive value of gated myocardial perfusion imaging for all-cause mortality risk in patients with familial hypercholesterolemia
Jian JIAO ; Luya WANG ; Wei DONG ; Tiantian MOU ; Ying ZHANG ; Zhi CHANG ; Xiaofen XIE ; Junqi LI ; Hongzhi MI
Chinese Journal of Nuclear Medicine and Molecular Imaging 2024;44(5):297-302
Objective:To evaluate the predictive value of stress+ rest gated myocardial perfusion imaging (G-MPI) in assessing all-cause mortality risk in patients with familial hypercholesterolemia (FH).Methods:From June 2010 to March 2022, 72 patients (39 males, 33 females; age (21.1±12.3) years) who diagnosed with FH clinically and genetically and underwent stress+ rest G-MPI in Beijing Anzhen Hospital, Capital Medical University were retrospectively followed up. Image analysis was performed using the 17-segment 5-point method to obtain left ventricular myocardial perfusion and functional parameters. Patients were followed for all-cause mortality events, and predictors associated with the risk of all-cause mortality were analyzed using Cox regression. The efficiencies of predictors were evaluated by ROC curve analysis, and the Kaplan-Meier method and log-rank test were used to compare the differences in the incidence of all-cause mortality in different groups of patients with FH. Independent-sample t test or Mann-Whitney U test was used to analyze the data. Results:The follow-up time of 72 patients was 7(4, 10) years, and all-cause death occurred in 16(22.2%) patients during the follow-up period. There were statistically significant differences in total cholesterol (TC), low density lipoprotein cholesterol (LDLC), summed stress score (SSS), summed rest score (SRS), summed difference score (SDS), stress end-systolic volume (SESV), stress ejection fraction (SEF), rest end-diastolic volume (REDV), rest end-systolic volume (RESV) and rest ejection fraction (REF) between the death group and the survival group ( t values: from -2.65 to 4.47, z values: from -3.43 to -1.98, all P<0.05). Cox regression analysis showed that SDS (hazard ratio ( HR)=1.337, 95% CI: 1.114-1.604, P=0.002), SESV ( HR=1.019, 95% CI: 1.008-1.030, P<0.001) and LDLC ( HR=1.355, 95% CI: 1.049-1.749, P=0.020) were independent predictors associated with the risk of all-cause mortality in patients with FH. The optimal cut-off value of SESV for predicting mortality in patients with FH determined by ROC curve analysis was 35.5 ml, with the AUC of 0.701 (95% CI: 0.517-0.885). The incidence of all-cause mortality in the group with SESV≥35.5 ml was significantly higher than that in the group with SESV<35.5 ml (28.6% vs 6.9%; χ2=5.15, P=0.023). Conclusion:Stress+ rest G-MPI is an important imaging method for all-cause mortality risk assessment in patients with FH, and SDS, SESV and LDLC are important factors in predicting mortality in patients with FH.

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