1.Development and evaluation of classification system for drug-related problems in China
Shuang ZOU ; Tingting LU ; Lei BAO ; Yun LIAO ; Ling LI ; Ping ZHANG
China Pharmacy 2026;37(3):371-376
OBJECTIVE To establish a Chinese drug-related problem (DRP) classification system applicable to pharmacist-led pharmaceutical care in China, providing pharmacists with an effective and practical tool for pharmaceutical care. METHODS A multi-stage process was employed to construct the DRP classification system, including literature review and analysis, comparison of existing classification systems, refinement of classification items and framework development, two rounds of standard case validation, expert discussion, and system revision. The Fleiss′ kappa test was used to calculate the consistency coefficient κ, assessing the reliability of pharmacists participating in evaluating the classification system. An electronic questionnaire comprising six items was employed to evaluate the system’s applicability. RESULTS The constructed Chinese DRP classification system comprised six sections [problem(including potential problems), DRP evaluation, cause (including possible causes of potential problems), intervention, acceptance of intervention and DRP status], with 24 primary codes and 96 secondary codes. In the first round of case validation, κ values exceeded 0.4 for all sections except “intervention” and “DRP status”. In the second round, κ values exceeded 0.4 for all sections. In the applicability evaluation of the classification system, positive ratings (“strongly agree” or “agree”) exceeded 85% for all items. Specifically, positive ratings for“the classification system can provide appropriate category selection”,“ the classification system is comprehensive”,“ the classification system is convenient to use” and “the classification system is highly satisfactory” exceeded 92%. CONCLUSIONS The Chinese DRP classification system developed demonstrates both high reliability and applicability, providing an effective and practical classification tool for pharmacists in China to conduct pharmaceutical care.
2.Perioperative immune dynamics and clinical outcomes in patients undergoing on-pump cardiac surgery
Zhiyuan CHENG ; Xinyi LIAO ; Juan WU ; Ping YANG ; Tingting WANG ; Qinjuan WU ; Wentong MENG ; Zongcheng TANG ; Jiayi SUN ; Jia TAN ; Jing LIN ; Dan LUO ; Hao WANG ; Chaonan LIU ; Jiyue XIONG ; Liqin LING ; Jing ZHOU ; Lei DU
Chinese Journal of Blood Transfusion 2026;39(1):31-43
Objective: To characterize perioperative dynamic changes in immune-cell phenotypes and inflammatory cytokines in patients undergoing CPB (cardiopulmonary bypass) cardiac surgery, and to explore their associations with postoperative outcomes. Methods: In this prospective cohort study, 120 adult patients who underwent elective cardiac surgery under CPB at West China Hospital from May 2022 to March 2023 were enrolled. Perioperative immune-cell phenotypes and concentrations of 40 inflammation-related cytokines were measured. The primary outcomes were the sequential organ failure assessment (SOFA) score at 24 h after surgery and ΔSOFA (the peak SOFA score within 48 h after surgery minus the preoperative SOFA score). Secondary outcomes included major adverse cardiovascular events (MACE), acute kidney injury (AKI), respiratory failure, severe liver injury, and infection. Results: The mean age of enrolled patients was 57±10 years. Of these, 52% (62/120) were male and 90% (108/120) underwent valve surgery. During the rewarming to the end of CPB, neutrophil counts rapidly increased (7.39×10
/L vs preoperative 3.07×10
/L, P<0.001), with significant upregulation of CD11b (7.30×10
/L vs preoperative 3.05×10
/L, P<0.001) and CD54 (7.15×10
/L vs preoperative 2.99×10
/L, P<0.001). Lymphocyte counts increased at the end of CPB (1.75×10
/L vs preoperative 1.12×10
/L, P<0.001) but decreased significantly at 24 h after surgery (0.59×10
/L vs preoperative 1.12×10
/L, P<0.001). Plasma analysis showed that multiple pro-inflammatory cytokines increased during CPB and remained elevated up to 24 h after surgery; five chemokines and the anti-inflammatory cytokine IL-10 peaked at the end of CPB. The SOFA score increased from 1 (1, 2) preoperatively to 7 (5, 10) at 24 h after surgery, with a ΔSOFA of 6 (4, 8). Within 30 days after surgery, 48 patients (40.0%) developed AKI, 17 (14.2%) developed infection, 4 (3.3%) developed severe liver injury, 3 (2.5%) developed respiratory failure, and 3 (2.5%) experienced MACE. During the 2-year follow-up, 8 patients (6.7%) experienced MACE and 5 (4.2%) died. Conclusion: Multi-organ dysfunction is common after cardiac surgery under CPB (median ΔSOFA, 6), accompanied by perioperative activation of multiple immune-cell subsets and upregulation of pro-inflammatory, anti-inflammatory, and chemotactic mediators. This study provides data-driven evidence and research clues for further investigation of the associations between CPB-related immune perturbations and postoperative organ dysfunction and clinical outcomes.
3.Clinical and epidemiological characteristics of human bocavirus in hospitalized children with acute lower respiratory tract infection at a hospital in Shanghai from 2021 to 2023
Shan ZHANG ; Yujuan HUANG ; Lei SHEN ; Li LIU ; Jie WANG ; Huilin ZHOU ; Leijun MENG ; Tingting CHEN
Shanghai Journal of Preventive Medicine 2026;38(3):193-198
ObjectiveTo investigate the epidemiological and clinical characteristics of human bocavirus (HBoV) in hospitalized children with acute lower respiratory tract infection (ALRTI) at a single-center children’s hospital in Shanghai, thereby providing evidence for the diagnosis, treatment, and prevention of HBoV infection. MethodsA retrospective study was conducted on 19 537 hospitalized children with ALRTI at Shanghai Children’s Hospital from January 2021 to December 2023. Multiplex polymerase chain reaction (PCR) combined with capillary electrophoresis was used to detect HBoV and 12 other common respiratory viruses /atypical pathogens. The positive detection rate, demographic characteristics (sex, age), temporal distribution (year, season) of HBoV, as well as the clinical characteristics of severe and non-severe pneumonia were analyzed. ResultsThe overall HBoV-positive rate was 2.57% (503/19 537), with 59.44% (299/503) being single infections and 40.56% (204/503) being co-infections. The positive detection rate was significantly higher in boys than that in girls (2.78% vs 2.33%, χ²=3.88, P=0.049). The highest infection rate was observed in toddlers, followed by infants (χ²=379.57, P<0.001). The positive rate peaked in 2021 and reached its lowest point in 2023 (χ²=45.49, P<0.001), with epidemics mainly prevalent in summer and autumn. The main clinical symptoms were cough (90.06%, 453/503), fever (75.94%, 382/503), and wheezing (39.96%, 201/503). Children with severe pneumonia showed a higher incidence of wheezing compared with the non-severe group (P<0.001), while underlying diseases and co-infections had no significant association with disease severity (P>0.05). ConclusionHBoV was an important pathogen of ALRTI in children, predominantly affecting infants and toddlers, with higher susceptibility in boys and seasonal peaks in autumn and summer. The main clinical manifestations included cough, fever, and wheezing, with wheezing being more prevalent in children with severe pneumonia.
4.Confirmation and re-examination of reactive anti-TP screening in blood donors
Qin YU ; Tingting XU ; Bangrui CHEN ; Lei ZHAO
Chinese Journal of Blood Transfusion 2026;39(7):928-933
Objective: To confirm the reactive anti-TP ELISA screening results in blood donor samples, and analyze implementaion of re-examination among reactive donors, so as to provide data support for effectively formulating re-examination strategies. Methods: Confirmation tests were performed on 331 samples (including 224 cases with dual-reagent reactivity and 107 cases with single-reagent reactivity) using treponema pallidum particle agglutination assays (TPPA). A total of 136 blood samples were collected from blood donors who have previously tested for anti-TP ELISA with single-reagent reactivity and voluntarily applied for re-examination from 2020 to 2024. Infectious disease indicators were detected in accordance with the "Technical Operating Procedures of Blood Stations (2019 Edition)". Among them, anti-TP screening was performed using ELISA reagents from two different manufacturers, and HBV/HCV/HIV nucleic acid testing was conducted using an individual donation nucleic acid testing (ID-NAT) mode. Supplementary tests (WB or TPPA) were conducted on samples with anti-TP ELISA single-reagent reactivity. A two-sided Pearson's chi-squared test or Fisher's exact test was used to evaluate the differences of the positive rates of anti-TP among different groups or reagents. Results: Among the 331 samples, the confirmed positive rate was 93.75% (210/224) for dual-reagent reactive samples, and 2.8% (3/107) for single-reagent reactive samples. The confirmed positive rates of double reagent reactive samples with different reagent combinations were 91.7% (95% CI: 85.6%-95.5%), 95.6% (95% CI: 85.2%-98.8%), 96.6% (95% CI: 86.2%-97.3%) respectively, with no statistically significant difference (χ
=1.597, P=0.463). From 2020 to 2024, 994 donors showed anti-TP ELISA single-reagent reactive results. Among them, 136 (136/994, 13.68%) donors voluntarily applied for re-examination. After the first round of re-examination, 88 (88/136, 64.71%) donors passed the re-examination, and 18 donors were permanently deffered (18/136, 13.24%). Among the permanently quarantined donors, 12 donors remained anti-TP ELISA single-reagent reactive, including 8 confirmed positive for TP-specific antobodies and 4 with indeterminate results. The remaining 6 donors converted to dual-reagent reactive. Conclusion: The dual-reagent reactive results in anti-TP ELISA has a high true positive rate, and the corresponding blood donors can be directly deffered. The majority of single-reagent reactive anti TP-ELISA results are false positives. Timely confirmation or supplementary testing allows prompt notification of evaluation results to blood donors, and reduces unnecessary follow-up examinations. This helps improve the quality of blood donor services and management efficiency, as well as prevent blood donor attrition.
5.Quality evaluation of methodological and reporting quality of clinical practice guidelines and expert consensuses on blood transfusion and blood utilization in china
Yumei YANG ; Yuting WU ; Yu TIAN ; Weifeng DING ; Jiaying WANG ; Lei YANG ; Aiyuan DU ; Xiaofeng PAN ; Xiaoshan LI ; Rong GAO ; Tingting WANG
Chinese Journal of Blood Transfusion 2026;39(7):952-962
Objective: To evaluate the methodological quality and reporting quality of clinical practice guidelines or expert consensus on blood transfusion and blood use (BTBU) in China (hereinafter referred to as "guidelines/consensus"), providing reference for the development and updating of future BTBU guidelines/consensus. Methods: A systematic search was conducted in Chinese databases such as China National Knowledge Infrastructure (CNKI), Wanfang Data, VIP Data-base, relevant guideline release platforms, and professional association websites. BTBU-related guidelines/consensus published between January 2006 and December 2025 were included. According to the inclusion and exclusion criteria, after completing literature screening and data extraction, three evaluators independently assessed the quality of the included literature using the Scientificity, Transparency, and Applicability of Guidelines Rating Tool (STAR), the Appraisal of Guidelines for Research and Evaluation Ⅱ (AGREE Ⅱ), and the International Practice Guideline Reporting Standards (RIGHT). Results: A total of 29 documents were included, including 5 guidelines, 22 consensus statements, and 2 protocols. The results of the STAR assessment showed that the total score was (21.7±8.8)%. The domain score ratios for registration, research protocol, funding, working group, conflict of interest, clinical question, evidence, consensus method, recommendation, accessibility and other domains were (2.2±12.1)%, 0, (36.7±25.1)%, (18.3±7.6)%, (19.2±15.3)%, (16.6±23.1)%, (15.1±6.3)%, (9.6±21.2)%, (54.3±18.4)%, (31.7±10.4)% and (10.3±31.0)%, respectively. For the AGREE Ⅱ assessment, the methodological quality of 26 articles was rated Grade B and 3 articles Grade C. The results of the RIGHT assessment indicated that the overall reporting rate of all guidelines/consensuses was (65.3±4.0)%. Conclusion: The methodological and reporting quality of current expert guidelines/consensus on BTBU in China still need improvement, and guidelines and consensus should be strictly formulated and standardized according to the standards of STAR, AGREE II and RIGHT.
6.Overview of the amendments and revisions to the General Technical Requirements adopted by the Volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition
ZHANG Jun ; NING Baoming ; WEI Shifeng ; SHEN Haoyu ; SHANG Yue ; ZHU Ran ; XU Xinyi ; CHEN Lei ; LIU Tingting ; MA Shuangcheng
Drug Standards of China 2025;26(1):034-044
To introduce the general thinking, guidelines, work objectives and elaboration process of the general technical requirements adopted by volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition, and to summarize and figure out the main characteristics on dosage forms, physico-chemical testing, microbial and biological testing, reference standards and guidelines The newly revised general chapters of pharmacopoeia give full play to the normative and guiding role of the Chinese Pharmacopoeia standard, track the frontier dynamics of international drug regulatory science and the elaboration of monographs, expand the application of state-of-the-art technologies, and steadily promote the harmonization and unification with the ICH guidelines; further enhance the overall capacity of TCM quality control, actively implement the 3 R principles on animal experiments, and practice the concept of environmental-friendly; replace and/or reduce the use of toxic and hazardous reagents, strengthen the requirements of drug safety control This paper aims to provide a full-view perspective for the comprehensive, correct understanding and accurate implementation of general technical requirements included in the Chinese Pharmacopoeia 2025 Edition.
7.Seroprevalence characteristics of hepatitis E virus among blood donors infected with hepatitis B virus
Qin YU ; Tingting XU ; Hao YANG ; Lei ZHAO
Chinese Journal of Blood Transfusion 2025;38(1):1-6
[Objective] To investigate the seroprevalence characteristics of hepatitis E virus (HEV) among blood donors with hepatitis B virus (HBV) infection, so as to provide data support for the monitoring, prevention and treatment of HEV. [Methods] From January to December 2022, 219 samples positive for hepatitis B surface antigen (HBsAg), 142 occult hepatitis B virus infection (OBI) samples (HBV group) and 873 samples tested negative (control group) were collected. 361 samples were further tested with viral load assay and serological testing for five serological markers (HBsAg, HBsAb, HBeAg, HBeAb and HBcAb), and the DNA load was measured using real time fluorescence quantitative PCR. Commercially available enzyme-linked immunosorbent assays (ELISA) were used for the detection of anti-HEV IgG, anti-HEV IgM and HEV antigen (Ag). The Chi-square test or Fisher's exact test was used to assess the differences in the reactivity rates of anti-HEV IgG and anti-HEV IgM among different blood donor populations and different variables. Multivariable logistic regression was used to examine potential risk factors associated with anti-HEV IgG seroprevalence. [Results] In the HBV group, HBsAg positive donors exhibited low expression of antigen. The HBV DNA load of OBI infected donors ranged from 1 to 131.43 IU/mL (median 11.24 IU/mL). The prevalence of anti-HEV IgG and IgM antibody in the HBV group were 34.63% and 1.11%, respectively. Among them, the prevalence of anti-HEV IgG and anti-HEV IgM in the HBV group was 34.63% and 0, respectively (P<0.05), while in the OBI donors, they were 41.55% and 2.82%, respectively. In the normal donors, the reactivity rates for anti-HEV IgG and anti-HEV IgM were 18.67% and 1.49%, respectively. Statistical analysis showed that there was a difference in the reactivity rate of anti-HEV IgG between the HBV-infected donors and the normal donors (34.63% vs 18.67%, P<0.05), but no difference in the reactivity rate of anti-HEV IgM (1.11% vs 1.49%, P>0.05). No HEV Ag was detected in either group of blood donors. Multivariate logistic regression analysis indicated that age was an independent risk factor for anti-HEV IgG reactivity in both groups of blood donors. [Conclusion] The reactivity rate of anti-HEV IgG among HBV-infected blood donors was significantly higher than that in the normal donors in Wuhan, with age being an independent risk factor. Therefore, for HBV-infected donors, it is essential to strengthen and prioritize the prevention and treatment of HEV to reduce the spread of HEV.
8.Characteristics of influenza and changes of innate immune cells among Children at a hospital in Shanghai from 2019 to 2023
Yuxia SHI ; Lin ZHOU ; Bin CAI ; Lu ZHANG ; Tingting WANG ; Lei LEI
Academic Journal of Naval Medical University 2025;46(7):874-880
Objective To analyze the characteristics of influenza incidence and the changes of innate immune cells among children who visited the pediatric outpatient or emergency department of a hospital in Shanghai from Jan.2019 to Dec.2023,so as to provide references for the prevention of influenza in children.Methods Influenza-like illness(ILI)children who first visited the pediatric outpatient or emergency department of The First Affiliated Hospital of Naval Medical University from Jan.2019 to Dec.2023,and underwent influenza virus antigen or nucleic acid testing were enrolled.Their clinical and laboratory data were collected for retrospective analysis.With a month as the basic monitoring unit,a line chart was used to describe the changes in the number of influenza cases and the positive rate.Then,these cases were assigned to pre-coronavirus disease 2019(COVID-19)group(Jan.2019 to Dec.2019),mid-COVID-19 group(Jan.2020 to Dec.2022),or post-COVID-19 group(Jan.2023 to Dec.2023),and the influenza positive rates among these groups were compared.To further observe the changes of the innate immune cells of children with influenza A after non-pharmacological intervention(NPI)measures,considering the development characteristics of children's white blood cells,children with influenza A were assigned to 2 subgroups according to age:0-6 years or 7-16 years.Within each subgroup,they were assigned to pre-NPI group or post-NPI group according to time.A ratio of 1∶1 matching was carried out according to gender and age using propensity score matching,and the blood routine parameters were compared between the 2 groups.Results A total of 41 028 ILI children were enrolled.During the COVID-19 period from Jan.2020 to Dec.2022,the influenza positive rates decreased significantly(P<0.001),and almost no influenza virus was detected.The peak of influenza reappeared in Mar.2023,with a lag in the peak period,but higher than previous years'peak,and the speed of reaching the peak was faster.In each subgroup,the white blood cell count and lymphocyte ratio of children with influenza A in the post-NPI group were lower than those in the pre-NPI group(all P<0.001),and the monocyte ratio was higher than that in the pre-NPI group(both P<0.001).Conclusion The implementation of NPI measures during COVID-19 leads to disruption of influenza transmission route and changes in the epidemic trend of influenza.The influenza virus causes serious public health problems after COVID-19 period,and children with influenza A experience more serious immune response.It is recommended to strengthen the vaccination of influenza vaccine before the flu season.
9.Expert consensus on infection prevention and control of Creutzfeldt-Jakob disease in medical institutions
Tianxiang GE ; Yangyang JIA ; Chunhui LI ; Jianrong HUANG ; Xiujuan MENG ; Xiaodong GAO ; Jingping ZHANG ; Fu QIAO ; Lijuan XIONG ; Hui LIANG ; Wei LI ; Haiyan LOU ; Wenjuan WU ; Tianxin XIANG ; Jiansen CHEN ; Biao ZHU ; Kaijin XU ; Zhihui ZHOU ; Hongliu CAI ; Meihong YU ; Yan ZHANG ; Yanwan SHANGGUAN ; Haiting FENG ; Hangping YAO ; Lei GUO ; Tieer GAN ; Weihong ZHANG ; Jimin SUN ; Ye LU ; Qun LU ; Meng CAI ; Jin SHEN ; Yunsong YU ; Anhua WU ; Liu-yi LI ; Tingting QU
Chinese Journal of Infection Control 2025;24(4):437-450
Creutzfeldt-Jakob disease(CJD)is a rapidly progressive and fatal neurodegenerative disorder caused by prions,with certain infectivity and iatrogenic transmission risks.With the rapid progress and application of new dia-gnostic biomarkers and detection methods,as well as the construction and improvement of surveillance and reporting systems,the detection of CJD in patients domestically and internationally has shown an increasing trend year by year.Due to its long incubation period and heterogeneity of early symptoms,early identification and diagnosis of the disease is difficult,increasing the risk of transmission within medical institutions.Currently,there is a lack of con-sensus on the infection prevention and control of CJD.In order to timely identify and diagnose CJD as well as effec-tively block its transmission in medical institutions,this consensus summarizes 15 clinical concerns and formulates 24 specific recommendations based on the latest domestic and international research findings and clinical evidence,as well as combines with clinical practice,aiming to standardize healthcare-associated infection prevention and control measures for CJD and reduce its transmission risk in medical institutions.
10.Correlation between vitamin D level and immune dysfunction in children with recurrent respiratory tract infection
Ying ZHU ; Nan NAN ; Tingting LI ; Liqiong WEI ; Lei HUANG
Chinese Journal of Immunology 2025;41(3):668-674,679
Objective:To investigate the characteristics of vitamin D levels in children in Gansu Province,and to analyze the correlation between vitamin D levels and immune disorders in children with recurrent respiratory tract infections(RRTIs).Methods:From January 2020 to December 2021,9 790 cases of children aged 0~6 years who received vitamin D detection in pediatric depart-ment of maternal and Child health care hospitals and tertiary general hospitals in 6 cities and prefectures of Gansu Province were retro-spectively selected,characteristics of vitamin D in 5 000 children were analyzed.Ninty children with RRTIs in 5 000 children were taken as study group,and 80 healthy children were taken as control group.Correlation between vitamin D levels and immune function indexes(IgA,IgG,IgM,complement C3 and complement C4)between the two groups was compared to analyze the diagnostic value of vitamin D for children RRTIs.Results:After analyzing vitamin D data of 5 000 children in Gansu Province,it was found that vita-min D deficiency rate,deficiency rate and adequate rate were 11.58%,41.38%and 47.04%respectively,and no vitamin D overdose or poisoning were found.Vitamin D level of children was affected by age and season.Vitamin D deficiency of children aged 3 to 4 years was more serious,and vitamin D level of children in winter was the lowest,and vitamin D level was related to the growth and develop-ment of children and disease.25(OH)D level and immune function indexes in study group were lower than those in control group(P<0.05).Level of 25(OH)D was related to the age,allergic history,passive tobacco exposure and susceptible season of RRTIs(P<0.05).Immune function indexes of children with adequate vitamin D were higher than children with insufficient and deficient vitamin D(P<0.05).Level of vitamin D in children with RRTIs was positively correlated with their immune function(P<0.05).Low birth weight,premature delivery,preference for food,daily amount of fruits and vegetables,outdoor activity time,calcium,iron,zinc,25(OH)D,IgA,IgG,IgM,complement C3 and C4 were all independent risk factors for RRTIs in children(P<0.05).Vitamin D had a high diagnostic value for RRTIs in children(P<0.05).Conclusion:Vitamin D level of children in Gansu Province is related to age and season.Lower vitamin D level in children's RRTIs is related to the immune disorders of children,which can be used for the diag-nosis of this disease.

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