2.A practice guideline for therapeutic drug monitoring of mycophenolic acid for solid organ transplants.
Shuang LIU ; Hongsheng CHEN ; Zaiwei SONG ; Qi GUO ; Xianglin ZHANG ; Bingyi SHI ; Suodi ZHAI ; Lingli ZHANG ; Liyan MIAO ; Liyan CUI ; Xiao CHEN ; Yalin DONG ; Weihong GE ; Xiaofei HOU ; Ling JIANG ; Long LIU ; Lihong LIU ; Maobai LIU ; Tao LIN ; Xiaoyang LU ; Lulin MA ; Changxi WANG ; Jianyong WU ; Wei WANG ; Zhuo WANG ; Ting XU ; Wujun XUE ; Bikui ZHANG ; Guanren ZHAO ; Jun ZHANG ; Limei ZHAO ; Qingchun ZHAO ; Xiaojian ZHANG ; Yi ZHANG ; Yu ZHANG ; Rongsheng ZHAO
Journal of Zhejiang University. Science. B 2025;26(9):897-914
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
3.Application of palatopharyngeal arch staging system in assessing the severity of obstructive sleep apnea and airway collapse.
Zhenzhang LU ; Shuang WANG ; Xiaodan XU ; Wenqian ZHONG ; Jing TAO ; Guohui NIE ; Beiping MIAO
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2025;39(9):824-829
Objective:To investigate the relationship between the Palatopharyngeal Arch Staging System(PASS) and the severity of Obstructive Sleep Apnea(OSA), as well as the patterns of airway collapse, while further assessing its clinical applicability. Methods:A total of 98 patients diagnosed with OSA at the Department of Otorhinolaryngology Head and Neck Surgery, Shenzhen University Affiliated Shenzhen Hospital, were recruited for this study. Data collected included basic demographic information, oropharyngeal laryngoscopy videos, results from awake laryngoscopy Muller tests, and indicators from sleep respiratory monitoring. The distribution of each PASS stage among patients with varying severities of OSA was compared. Additionally, both objective and subjective sleep indicators along with occurrences of airway collapse in OSA patients across different PASS stages were analyzed. Results:In total, 98 patients participated in this study. Statistically significant differences were observed in neck circumference, weight, Body Mass Index(BMI), tongue position, and PASS stage when comparing mild-to-moderate OSA patients to those with severe OSA(P<0.05). Furthermore, there were statistically significant variations in Apnea-Hypopnea Index(AHI), minimum blood oxygen saturation levels, average blood oxygen saturation levels, oxygen desaturation index values, and total oxygen desaturation indices among OSA patients categorized by different PASS stages. Multiple comparisons revealed statistically significant differences in AHI as well as minimum and average blood oxygen saturation levels between patients at PASS 1 versus those at PASS 3(P<0.05). Additionally, notable differences regarding oropharyngeal collapse rates among OSA patients across various PASS stages were identified; specifically between those at PASS stage 1 and those at PASS stage 3. Conclusion:The proportion of PASS stages for OSA varies across different severity levels. The severity of OSA and the degree of airway collapse in patients with varying PASS stages also exhibit significant differences. Patients classified as PASS 3 demonstrate a more severe form of OSA compared to those at PASS 1, with stage 3 being more susceptible to oropharyngeal collapse than its stage 1 counterpart. This assessment system is anticipated to address the current limitations in evaluating the lateral pharyngeal wall within the oropharynx.
Humans
;
Sleep Apnea, Obstructive/pathology*
;
Male
;
Severity of Illness Index
;
Female
;
Middle Aged
;
Polysomnography
;
Adult
;
Pharynx/physiopathology*
;
Aged
4.Safety, dosimetry, and efficacy of an optimized long-acting somatostatin analog for peptide receptor radionuclide therapy in metastatic neuroendocrine tumors: From preclinical testing to first-in-human study.
Wei GUO ; Xuejun WEN ; Yuhang CHEN ; Tianzhi ZHAO ; Jia LIU ; Yucen TAO ; Hao FU ; Hongjian WANG ; Weizhi XU ; Yizhen PANG ; Liang ZHAO ; Jingxiong HUANG ; Pengfei XU ; Zhide GUO ; Weibing MIAO ; Jingjing ZHANG ; Xiaoyuan CHEN ; Haojun CHEN
Acta Pharmaceutica Sinica B 2025;15(2):707-721
Peptide receptor radionuclide therapy (PRRT) with radiolabeled SSTR2 agonists is a treatment option that is highly effective in controlling metastatic and progressive neuroendocrine tumors (NETs). Previous studies have shown that an SSTR2 agonist combined with albumin binding moiety Evans blue (denoted as 177Lu-EB-TATE) is characterized by a higher tumor uptake and residence time in preclinical models and in patients with metastatic NETs. This study aimed to enhance the in vivo stability, pharmacokinetics, and pharmacodynamics of 177Lu-EB-TATE by replacing the maleimide-thiol group with a polyethylene glycol chain, resulting in a novel EB conjugated SSTR2-targeting radiopharmaceutical, 177Lu-LNC1010, for PRRT. In preclinical studies, 177Lu-LNC1010 exhibited good stability and SSTR2-binding affinity in AR42J tumor cells and enhanced uptake and prolonged retention in AR42J tumor xenografts. Thereafter, we presented the first-in-human dose escalation study of 177Lu-LNC1010 in patients with advanced/metastatic NETs. 177Lu-LNC1010 was well-tolerated by all patients, with minor adverse effects, and exhibited significant uptake and prolonged retention in tumor lesions, with higher tumor radiation doses than those of 177Lu-EB-TATE. Preliminary PRRT efficacy results showed an 83% disease control rate and a 42% overall response rate after two 177Lu-LNC1010 treatment cycles. These encouraging findings warrant further investigations through multicenter, prospective, and randomized controlled trials.
5.Heme oxygenase 1 linked to inactivation of subchondral osteoclasts in osteoarthritis
CHU MIAO ; CHEN GUANGDONG ; CHEN KAI ; ZHU PENGFEI ; WANG ZHEN ; QIAN ZHONGLAI ; TAO HUAQIANG ; XU YAOZENG ; GENG DECHUN
Journal of Zhejiang University. Science. B 2024;25(6):513-528,中插3-中插9
Osteoarthritis(OA)is a chronic progressive osteoarthropathy in the elderly.Osteoclast activation plays a crucial role in the occurrence of subchondral bone loss in early OA.However,the specific mechanism of osteoclast differentiation in OA remains unclear.In our study,gene expression profiles related to OA disease progression and osteoclast activation were screened from the Gene Expression Omnibus(GEO)repository.GEO2R and Funrich analysis tools were employed to find differentially expressed genes(DEGs).Gene Ontology(GO)and Kyoto Encyclopedia of Genes and Genomes(KEGG)enrichment analyses demonstrated that chemical carcinogenesis,reactive oxygen species(ROS),and response to oxidative stress were mainly involved in osteoclast differentiation in OA subchondral bone.Furthermore,fourteen DEGs that are associated with oxidative stress were identified.The first ranked differential gene,heme oxygenase 1(HMOX1),was selected for further validation.Related results showed that osteoclast activation in the pathogenesis of OA subchondral bone is accompanied by the downregulation of HMOX1.Carnosol was revealed to inhibit osteoclastogenesis by targeting HMOX1 and upregulating the expression of antioxidant protein in vitro.Meanwhile,carnosol was found to alleviate the severity of OA by inhibiting the activation of subchondral osteoclasts in vivo.Our research indicated that the activation of osteoclasts due to subchondral bone redox dysplasia may serve as a significant pathway for the advancement of OA.Targeting HMOX1 in subchondral osteoclasts may offer novel insights for the treatment of early OA.
6.Graphical analysis of research hotspots about male nurses at home and abroad based on CiteSpace in recent 10 years
Jinhu MIAO ; Yuexi ZHU ; Shiyao YANG ; Jie CHEN ; Xie LIU ; Jingjing XU ; Feifei JIN ; Qunfen TAO
Modern Clinical Nursing 2024;23(8):62-70
Objective To investigate the research status and the research hotspots on male nurses at home and abroad in last decade,so as to provide references for further research in male nurses.Methods Literature between 2013 and 2024 on male nurses were retrieved from the Web of Science(WOS)and CNKI.CiteSpace 6.2.6 R7 software was used to analyse the volume of publication,keyword co-occurrence,keyword clustering and emergence.Results A total of 736 articles were included in the study.From 2013 to 2023,the number of published papers of male nurses in CNKI and WOS showed an increasing trend.The research was primarily affiliated with 263 institutions across 62 countries.The country with the highest volume of publication is China,followed by the United States,although there was a need to enhance collaboration with other nations.The institution with the most publications is the Hong Kong Polytechnic University.A comprehensive analysis of keyword co-occurrence,clustering,and emerging trends revealed that the research hotspots in the field of male nursing in CNKI mainly includes the advantages of male nurses,psychological capital,humanistic care,development,needs,professional identification.Whereas WOS focuses on the topics such as gender bias against male nurses,mental health,workplace violence,ambivalent sexism,motivational barriers,individual differences,societal prejudice and knowledge and attitucle.Both domestic and international research on male nurses primarily consist of cross-sectional surveys and qualitative studies,with fewer intervention studies.Currently,the researches regarding male nursing focus on the qualitative study of mental health of male nurses.Conclusion Focusing on the mental health and professional status of male nurses,domestic scholars need to increase the formulation and implementation of interventions in this field in order to address the practical issues faced by male nurses,therefore to promote the comprehensive development of the nursing profession,enhance the overall quality and service quality of the nursing team,and provide patients with higher quality in nursing services.
7.Trend Analysis on Incidence and Age at Diagnosis of Lymphoma in Cancer Registration Areas of Jiangsu Province from 2009 to 2019
Wenshu LUO ; Wenchao XU ; Mengmeng ZHOU ; Jinyi ZHOU ; Weigang MIAO ; Ran TAO ; Renqiang HAN
China Cancer 2024;33(12):999-1005
[Purpose]To analyze the trend of incidence and mean age at diagnosis of lymphoma in cancer registration areas of Jiangsu Province from 2009 to 2019.[Methods]Continuous and com-pleted data of cancer incidence from 2009 to 2019 were collected from 16 cancer registries in Jiangsu Province,and all indicators meeting the requirements.Joinpoint 4.7.0.0 software was used to analyze the trend of lymphoma incidence,the average annual percentage change(AAPC)and 95%confidence interval(CI)were calculated.A birth cohort was built from 1929 to 2019,to ana-lyze the change trend of lymphoma incidence rate among people born in different periods.[Re-sults]From 2009 to 2019,the AAPC of lymphoma incidence rate in cancer registration areas of Jiangsu Province was 5.74%,5.55%for men and 5.02%for women.The AAPC in urban areas was higher than that in rural areas(6.26%vs 4.90%).The age-standardized incidence rate(ASIR)of lymphoma increased by 3.40%annually on average.The rising amplitude of ASIR of women(3.16%)was higher than that of men(3.05%),and the rising amplitude of ASIR of lymphoma in urban areas(3.39%)was higher than that in rural areas(2.43%).The birth cohort analysis showed that the incidence rate of lymphoma fluctuated greatly before the age of 40,and there was no sig-nificant trend of change,while the incidence rate in age groups of 40 years old and above showed an overall upward trend.The average age at onset of lymphoma showed an upward trend from 2009 to 2019,with an average annual increase of 0.35 years old(P<0.001).The standardized average age at onset for lymphoma still showed a significant upward trend,with an average annual increase of 0.15 years old(P=0.016).Compared with 2009,the standardized age specific incidence of lym-phoma in 2019 showed an overall backward trend,while the standardized incidence in all age groups after 60 years old(except for the age group of 70~74 years old)increased.The proportion of lymphoma in people above 60 years old was 56.16%in 2019,which was higher than that in 2009(52.57%).[Conclusion]The incidence rate of lymphoma in Jiangsu Province was increasing year by year from 2009 to 2019.The age at onset tended to shift back,and the trend was more pronounced in male than female.
8.The Influence of Internet Use on the Health status of the Elderly: a Mediating Effect Analysis Based on Social Interaction
Mengyao REN ; Ruijia TAO ; Qiang GAO ; Miao XU ; Pengjun ZHANG ; Chen WANG
Chinese Journal of Geriatrics 2024;43(5):609-615
Objective:To investigate the mediating effect of social interaction on the relationship between internet use and the health status of the elderly.The findings of this research can potentially contribute new insights into improving the health status of the elderly population.Methods:Based on the data from the Chinese General Social Survey(CGSS)in 2021, a total of 2 675 elderly individuals aged 60 and above were included in the study.The researchers analyzed the linear regression relationship between Internet use, social interaction, and the health status of the elderly using a hierarchical regression model.Additionally, a mediation effect test was conducted using the Bootstrap test.Furthermore, heterogeneity analysis of the mediation effect was performed considering factors such as gender, place of residence, working conditions, and physical exercise among the elderly participants.Results:The total effect value was 0.170.The direct effect of Internet use on the health status of older adults was 0.160(95% CI: 0.078-0.240), accounting for 93.66% of the effect value.The indirect effect of social interaction was 0.011(95% CI: 0.003-0.021), accounting for 6.34% of the effect value.The mediating effect of social interaction on the health status of older adults varied among different groups.Among female elderly, rural elderly, elderly who are currently unemployed, and those who are physically active, the mediating effects were 5.16%, 7.86%, 10.18%, and 9.91%, respectively. Conclusions:The impact of internet use and social interaction on the health status of the elderly is notably positive.Additionally, social interaction partially mediates the relationship between internet use and the health status of the elderly.
9.Development of Sample Size Formulas for Least Square Regression-Based Consistency Evaluation of Quantitative Indicators
Feilong CHEN ; Miao YU ; Tao XU
Acta Academiae Medicinae Sinicae 2024;46(2):225-231
Objective To develop and verify the sample size formulas for quantitative data consistency e-valuation based on the least square regression method.Methods According to the principle of least square regres-sion-based quantitative consistency evaluation,statistical inference,and formula derivation,we developed the for-mulas for calculating sample size based on regression constant and regression coefficient.Furthermore,the accuracy of the formulas was verified by the data of three examples,and the results were compared with those of the sample size formula established based on the Bland-Altman(BA)method.Results The sample size formulas for regres-sion-based quantitative consistency evaluation were deduced,and the accuracy of the formulas was verified by three examples.In addition,the results obtained with this formula had differences compared with those of the sample size formula established based on the BA method.Furthermore,consistent conclusions could be obtained by regression analysis and BA analysis with the sample size calculated with the regression method.However,with the sample size calculated based on the BA method,the consistency conclusion of regression analysis and BA analysis was some-times not valid.Conclusion A sample size formula for quantitative consistency evaluation based on the regression method was proposed for the first time,which provided methodological support for the research in this field.
10.Efficacy and safety of decitabine combined with unrelated umbilical cord blood transplantation in the elderly patients with acute myeloid leukemia after achieving remission
Can CHEN ; Yong-Fen HUANG ; Ling-Ling WANG ; Ya-Nan MA ; Yue-Xin CHENG ; Hao XU ; Shan-Dong TAO ; Yu-Qing MIAO
Chinese Journal of Clinical Medicine 2023;30(6):981-987
Objective To compare the safety and efficacy of decitabine combined with unrelated umbilical cord blood transplantation and traditional regimen in the elderly patients with acute myeloid leukemia(AML)after achieving complete remission with induction therapy.Methods Fifty-two elderly AML patients who obtained complete remission(CR)after 1-2 cycles of induction therapy in the Department of Hematology of Yancheng First People's Hospital and the Huai'an First Hospital Affiliated to Nanjing Medical University from January 2019 to January 2022 were enrolled,and were divided into the observation group(n=24)and the control group(n=28).The observation group received decitabine combined with unrelated umbilical cord blood transplantation,and the control group received traditional consolidation therapy,including azacitidine+vinblastine,idarubicin+cytarabine(IA),or aclarubicin+cytarabine+granulocyte colony-stimulating factor,and so on.The hematopoietic recovery time,adverse reactions,relapse-free survival(RFS),and overall survival(OS)were compared between the two groups.Results The median recovery time of neutrophils was 12.54 d in the observation group and wes 18.64 d in the control group(P<0.001);the median recovery time of platelets was 12.67 d in the observation group and was 19.71 d in the control group(P<0.001).There was no difference in incidences of grade Ⅲ-Ⅳ myelosuppression and non-hematological toxicity between the two groups.There were statistical differences in the median RFS(33 months vs 11 months)and OS(36 months vs 24 months)between the observation group and the control group(P<0.05).Conclusions Compared with the traditional consolidation regimen,decitabine combined with unrelated umbilical cord blood transplantation for consolidation of AML after achieving remission is more effective in elderly patients,could prolong survival,and has similar safety.

Result Analysis
Print
Save
E-mail