1.Guideline for the workflow of clinical comprehensive evaluation of drugs
Zhengxiang LI ; Rong DUAN ; Luwen SHI ; Jinhui TIAN ; Xiaocong ZUO ; Yu ZHANG ; Lingli ZHANG ; Junhua ZHANG ; Hualin ZHENG ; Rongsheng ZHAO ; Wudong GUO ; Liyan MIAO ; Suodi ZHAI
China Pharmacy 2025;36(19):2353-2365
OBJECTIVE To standardize the main processes and related technical links of the clinical comprehensive evaluation of drugs, and provide guidance and reference for improving the quality of comprehensive evaluation evidence and its transformation and application value. METHODS The construction of Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs was based on the standard guideline formulation method of the World Health Organization (WHO), strictly followed the latest definition of guidelines by the Institute of Medicine of the National Academy of Sciences of the United States, and conformed to the six major areas of the Guideline Research and Evaluation Tool Ⅱ. Delphi method was adopted to construct the research questions; research evidence was established by applying the research methods of evidence-based medicine. The evidence quality classification system of the Chinese Evidence-Based Medicine Center was adopted for evidence classification and evaluation. The recommendation strength was determined by the recommendation strength classification standard formulated by the Oxford University Evidence-Based Medicine Center, and the recommendation opinions were formed through the expert consensus method. RESULTS & CONCLUSIONS The Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs covers 4 major categories of research questions, including topic selection, evaluation implementation, evidence evaluation, and application and transformation of results. The formulation of this guideline has standardized the technical links of the entire process of clinical comprehensive evaluation of drugs, which can effectively guide the high-quality and high-efficient development of this work, enhance the standardized output and transformation application value of evaluation evidence, and provide high-quality evidence support for the scientific decision-making of health and the rationalization of clinical medication.
2.Association between acupuncture and live birth rates after fresh embryo transfer: A cohort study based on different propensity score methods.
Xiao-Yan ZHENG ; Zi-Yi JIANG ; Yi-Ting LI ; Chao-Liang LI ; Hao ZHU ; Zheng YU ; Si-Yi YU ; Li-Li YANG ; Song-Yuan TANG ; Xing-Yu LÜ ; Fan-Rong LIANG ; Jie YANG
Journal of Integrative Medicine 2025;23(5):528-536
OBJECTIVE:
To explore the association between acupuncture during controlled ovarian hyperstimulation (COH) and the live birth rate (LBR) using different propensity score methods.
METHODS:
In this retrospective cohort study, eligible women who underwent a COH were divided into acupuncture and non-acupuncture groups. The primary outcome was LBR, as determined by propensity score matching (PSM). LBR was defined as the delivery of one or more living infants that reached a gestational age over 28 weeks after embryo transfer. The propensity score model encompassed 16 confounding variables. To validate the results, sensitivity analyses were conducted using three additional propensity score methods: propensity score adjustment, inverse probability weighting (IPW), and IPW with a "doubly robust" estimator.
RESULTS:
The primary cohort encompassed 9751 patients (1830 [18.76%] in the acupuncture group and 7921 [81.23%] in the non-acupuncture group). Following 1:1 PSM, a higher LBR was found in the acupuncture cohort (41.4% [755/1824] vs 36.4% [664/1824], with an odds ratio of 1.23 [95% confidence interval, 1.08-1.41]). Three additional propensity score methods produced essentially similar results. The risk of serious adverse events did not significantly differ between the two groups.
CONCLUSION
This retrospective study revealed an association between acupuncture and an increased LBR among patients undergoing COH, and that acupuncture is a safe and valuable treatment option. Please cite this article as: Zheng XY, Jiang ZY, Li YT, Li CL, Zhu H, Yu Z, Yu SY, Yang LL, Tang SY, Lü XY, Liang FR, Yang J. Association between acupuncture and live birth rates after fresh embryo transfer: A cohort study based on different propensity score methods. J Integr Med. 2025; 23(5):528-536.
Humans
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Female
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Propensity Score
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Embryo Transfer
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Adult
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Acupuncture Therapy
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Retrospective Studies
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Pregnancy
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Live Birth
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Birth Rate
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Cohort Studies
3.Novel araucarene diterpenes from Agathis dammara exert hypoglycemic activity by promoting pancreatic β cell regeneration and glucose uptake.
Zhewei YU ; Yi ZHANG ; Wenhui WANG ; XinYi WU ; Shunzhi LIU ; Yanlin BIN ; Hongsheng LI ; Bangping CAI ; Zheng WANG ; Meijuan FANG ; Rong QI ; Mingyu LI ; Yingkun QIU
Chinese Journal of Natural Medicines (English Ed.) 2025;23(4):492-503
In this study, araucarene diterpenes, characterized by a pimarene skeleton with a variably oxidized side chain at C-13, were investigated. A total of 16 araucarene diterpenoids and their derivatives were isolated from the woods of Agathis dammara, including 11 previously unreported compounds: dammaradione (1), dammarones D-G (2, 5, 14, 15), dammaric acids B-F (8-12), and dammarol (16). The structures of these new compounds were elucidated using high-resolution electrospray ionization mass spectroscopy (HR-ESI-MS) and one-dimensional/two-dimensional (1D/2D) nuclear magnetic resonance (NMR), while their absolute configurations were determined through the electronic circular dichroism (ECD) exciton chirality method and Snatzke's method. The hypoglycemic activity of all isolated compounds was evaluated using a transgenic zebrafish model, and a structure-activity relationship (SAR) analysis was conducted. Araucarone (3) and dammaric acid C (9), serving as representative compounds, demonstrated significant hypoglycemic effects on zebrafish. The primary mechanism involves the promotion of pancreatic β cell regeneration and glucose uptake. Specifically, these compounds enhance the differentiation of pancreatic endocrine precursor cells (PEP cells) into β cells in zebrafish.
Zebrafish
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Animals
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Diterpenes/isolation & purification*
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Insulin-Secreting Cells/cytology*
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Glucose/metabolism*
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Hypoglycemic Agents/isolation & purification*
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Molecular Structure
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Structure-Activity Relationship
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Plant Extracts/pharmacology*
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Regeneration/drug effects*
4.Glycemic Control and Diabetes Duration in Relation to Subsequent Myocardial Infarction among Patients with Coronary Heart Disease and Type 2 Diabetes.
Fu Rong LI ; Yan DOU ; Chun Bao MO ; Shuang WANG ; Jing ZHENG ; Dong Feng GU ; Feng Chao LIANG
Biomedical and Environmental Sciences 2025;38(1):27-36
OBJECTIVE:
This study aimed to investigate the impact of glycemic control and diabetes duration on subsequent myocardial infarction (MI) in patients with both coronary heart disease (CHD) and type 2 diabetes (T2D).
METHODS:
We conducted a retrospective cohort study of 33,238 patients with both CHD and T2D in Shenzhen, China. Patients were categorized into 6 groups based on baseline fasting plasma glucose (FPG) levels and diabetes duration (from the date of diabetes diagnosis to the baseline date) to examine their combined effects on subsequent MI. Cox proportional hazards regression models were used, with further stratification by age, sex, and comorbidities to assess potential interactions.
RESULTS:
Over a median follow-up of 2.4 years, 2,110 patients experienced MI. Compared to those with optimal glycemic control (FPG < 6.1 mmol/L) and shorter diabetes duration (< 10 years), the fully-adjusted hazard ratio ( HR) (95% Confidence Interval [95% CI]) for those with a diabetes duration of ≥ 10 years and FPG > 8.0 mmol/L was 1.93 (95% CI: 1.59, 2.36). The combined effects of FPG and diabetes duration on MI were largely similar across different age, sex, and comorbidity groups, although the excess risk of MI associated with long-term diabetes appeared to be more pronounced among those with atrial fibrillation.
CONCLUSION
Our study indicates that glycemic control and diabetes duration significant influence the subsequent occurrence of MI in patients with both CHD and T2D. Tailored management strategies emphasizing strict glycemic control may be particularly beneficial for patients with longer diabetes duration and atrial fibrillation.
Humans
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Diabetes Mellitus, Type 2/blood*
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Male
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Female
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Middle Aged
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Aged
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Coronary Disease/complications*
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Myocardial Infarction/etiology*
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Retrospective Studies
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China/epidemiology*
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Glycemic Control
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Blood Glucose
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Adult
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Risk Factors
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Time Factors
5.Efficacy and Safety of Systemic Thrombolysis in the Treatment of Lower Extremity Fracture Complicated With Distal Deep Vein Thrombosis.
Shi-Qiang LIAO ; Shu-Ming SHI ; Qiang ZHANG ; Chuan-Yong LI ; Guang-Feng ZHENG ; Zhi-Chang PAN ; Jian-Jie RONG
Acta Academiae Medicinae Sinicae 2025;47(2):237-243
Objective To evaluate the efficacy and safety of systemic thrombolysis(ST)and standard anticoagulation(SA)in the treatment of lower extremity fracture complicated with distal deep vein thrombosis(DDVT).Methods We retrospectively analyzed the clinical data of 60 patients with lower extremity fracture complicated with DDVT treated from January 2021 to December 2023.When the lower limb venography indicated a calf thrombus burden score ≥3 points,a retrievable inferior vena cava filter(IVCF)was successfully placed in the healthy femoral vein before orthopedic surgery.The patients who received further anticoagulant or thrombolytic therapy after surgery were allocated into a ST group(n=30,urokinase ST and SA)and a SA group(n=30,only SA).The two groups were compared in terms of calf thrombus burden score,thrombus dissolution rate,IVCF placement time,IVCF retrieval rate,intercepted thrombi,hemoglobin level,platelet count,D-dimer level,and complications.Results There was no statistically significant difference in the calf thrombus burden score between the two groups before treatment(P=0.431).However,after treatment,the scores in both groups decreased(both P<0.001),with the ST group showing lower score than the SA group(P=0.002).The thrombus dissolution rate in the ST group was higher than that in the SA group(P<0.001).There was no statistically significant difference in the IVCF placement time between the two groups(P=0.359),and the IVCF retrieval rate was 100% in both groups.The ST group had fewer intercepted thrombi than the SA group(P=0.002).There was no statistically significant difference in hemoglobin level(P=0.238),platelet count(P=0.914),or D-dimer level(P=0.756)between the two groups before treatment.However,after treatment,both groups showed an increase in platelet count(both P<0.001)and a decrease in D-dimer level(both P<0.001).There was no statistically significant difference in the occurrence of complications between the two groups(P=0.704).Conclusions Both SA and ST demonstrate safety and efficacy in the treatment of lower extremity fractures complicated with DDVT,serving as valuable options for clinical application.Compared with SA,ST not only enhances the thrombus dissolution in the calf but also mitigates the risk of thrombosis associated with IVCF.
Humans
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Venous Thrombosis/therapy*
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Retrospective Studies
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Thrombolytic Therapy/methods*
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Male
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Female
;
Middle Aged
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Fractures, Bone/complications*
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Lower Extremity/injuries*
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Anticoagulants/therapeutic use*
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Aged
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Treatment Outcome
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Adult
6.Efficacy and safety of glofitamab monotherapy in the treatment of relapsed/refractory diffuse large B-cell lymphoma
Yu WANG ; Rong XIAO ; Yan MAO ; Xuemei YE ; Boyue ZHENG ; Hui LI
Journal of Leukemia & Lymphoma 2025;34(10):601-605
Objective:To investigate the efficacy and safety of glofitamab in the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL).Methods:A retrospective case series study was performed. The clinical data of 11 patients with relapsed/refractory DLBCL who were treated with glofitamab in Sichuan Provincial People's Hospital from March 2024 to October 2024 were retrospectively analyzed. All patients received glofitamab monotherapy. Dose escalation was required in the first course, and glofitamab at a dose of 30 mg was administered from the second to the 12th course. The general data, clinical manifestations, laboratory examination results, Eastern Cooperative Oncology Group (ECOG) performance score, previous treatment history, therapeutic effect after medication and adverse reactions were collected.Results:Among 11 patients, there were 8 males and 3 females, with the median age [ M ( Q1, Q3)] of 60 (51, 76) years; 1 case was primary central nervous system DLBCL. The median number of prior treatment lines was 3 (2, 3) lines, and 6 cases received ≥3 lines of therapy; 1 case was double DLBCL and 3 cases was complicated with p53 mutations. The median follow-up time was 5 months (2-7 months). After treatment of the median number of glofitamab, 3 cases achieved complete remission, among which 1 case successfully bridged to autologous hematopoietic stem cell transplantation; 1 case had the stable disease and 7 cases achieved partial remission. Grade 1-2 adverse events included mild leukopenia in 3 patients, mild anemia in 4 patients, thrombocytopenia in 1 patient, and lymphopenia in 8 patients. Grade 3 hematologic adverse events included thrombocytopenia in 1 patient and severe lymphopenia in 1 patient. Non-hematological toxicities included mild rash in 1 patient, grade 1 liver dysfunction in 3 patients and inflammatory factor storm in 4 patients. No medication stop or deferral was found in patients due to severe adverse events. Conclusions:Glofitamab demonstrates a high response rate in the treatment of relapsed/refractory DLBCL, with manageable adverse events and a favorable safety.
7.Role of joint function screening and correction in preventing training injuries for new recruits:a randomized controlled trial
Enyu LEI ; Zhen CHEN ; Bing LI ; Ling ZHANG ; Honghui RONG ; Lu LU ; Chuanfen ZHENG ; Tao MENG ; Ji'an CHEN
Journal of Army Medical University 2025;47(9):1003-1009
Objective To investigate the effects of joint function screening and correction on intervention efficacy of prevention and assessment score of training injuries in new recruits.Methods A randomized controlled study was conducted on 265 new recruits subjected from two organizational units of an army unit with cluster sampling.Based on entire organizational unit,the participants were randomly divided into a control group(n=132)and an experimental group(n=133).The experimental group received joint function screening and corrective movement training,which was subsequently applied in the new recruit training,while the control group underwent training according to conventional methods.Joint function were collected before and after training.The demographic data,assessment score of training,and incidence of training injuries were collected through the participant's own organizational unit.Receiver operating characteristic(ROC)curve was plotted to evaluate the efficacy of joint function screening in predicting training injuries,and binary logistic regression and general linear regression analyses were applied to verify the correlation of joint function screening score with training injuries and assessment score of training.Results After new training,the score of joint function screening was significantly higher in the experimental group than the control group(16.62±1.87 vs 14.92±2.58,P<0.001).And the score was obviously increased in the experimental group(16.62±1.87 vs 12.82±1.98,P<0.001)and the control group(14.92±2.58 vs 12.95±1.81,P<0.001)when compared with the corresponding score before training.The area under the ROC curve(AUC)of joint function screening in predicting training injuries was 0.762(95%CI:0.694~0.830),indicating good predictive efficacy.During the new training process,the incidence of training injuries in the experimental group(13.53%)was significantly lower than that in the control group(24.24%,Chi-square=4.963,P=0.026).Binary logistic regression analysis showed that the pre-training assessment score of joint function screening was an important influencing factor for training injuries in new recruits(OR=0.552,95%CI:0.413~0.660,P<0.001).The experimental group obtained notably higher mean assessment score than the control group[733.00(716.00,752.75)vs 728.79(710.46,744.28),P=0.027].Linear regression analysis revealed a correlation between post-training score of joint function screening and the assessment score of newly trained personnel(P<0.001).Conclusion Joint function screening and correction for newly trained personnel can effectively prevent training-related injuries during the new training period,and correcting joint function through training can effectively improve the assessment score of newly trained personnel.
8.Exploring the Diagnosis and Treatment Strategy for Incomplete Endothelialization After Left Atrial Appendage Closure Based on the View of Qi Flourishment Promoting Tissue Regeneration
Huiqi ZHAI ; Bowen DENG ; Qiucen CHEN ; Zheng JIN ; Rong LI ; Xiaoxiong ZHOU ; Qingmin CHU
Journal of Guangzhou University of Traditional Chinese Medicine 2025;42(11):2877-2882
Left atrial appendage closure(LAAC)is an important intervention method for preventing thromboembolic events in patients with non-valvular atrial fibrillation(NVAF).However,incomplete endothelialization following the procedure can impact its long-term efficacy and safety.This article proposes the view of qi flourishment promoting tissue regeneration based on the traditional Chinese medicine(TCM)theory of qi and blood,and explores diagnostic and therapeutic strategies for post-LAAC incomplete endothelialization by examining the theoretical connotation of qi flourishment promoting tissue regeneration and the relationship between qi and vascular endothelial cells.It is proposed that the primary pathogenesis in patients after LAAC is due to qi deficiency.Guided by the view of qi flourishment promoting tissue regeneration,therapeutic approaches such as tonifying qi to promote granulation,supplementing qi to activate blood circulation,and harmonizing the viscera can be employed to address incomplete endothelialization in NVAF patients following LAAC.Clinically,the qi-supplementing and blood-activating classic formula Neituo Shengji San,mainly composed of Astragali Radix,Glycyrrhizae Radix et Rhizoma,Olibanum,Myrrha,Paeoniae Radix Alb,Trichosanthis Radix,Salviae Miltiorrhizae Radix et Rhizoma,etc.,is usually utilized for modified use.Depending on the specific symptom patterns or pathogenesis characteristics of patients with incomplete endothelialization,this basic formula may be used by combining with Shengmai San or augmented with qi-supplementing and blood-activating herbs such as Chuanxiong Rhizoma,Fici Simplicissimae Radix,and Notoginseng Radix et Rhizoma to promote endothelialization.Diagnosing and treating post-LAAC incomplete endothelialization in NVAF patients following the view of qi flourishment promoting tissue regeneration,it is expected to offer a novel TCM perspective and therapeutic strategy to enhance post-LAAC outcomes and address the challenge of incomplete endothelialization.This approach can further serve as a reference for TCM clinicians to manage endothelialization issues following implantation procedures.
9.Specific extraction and analysis of synthesized proteins from mesenchymal stem cells transplanted into the ischemic heart
Wan-Er LU ; Ying DAI ; Mu-Han TANG ; Kang WEI ; Shu-Jia CHEN ; Huai HUANG ; Jing LIN ; Hao-Rong PENG ; Li-Xuan ZHOU ; Dun-Zheng HAN
Medical Journal of Chinese People's Liberation Army 2025;50(8):991-998
Objective To specifically extract and analyze nascent proteins synthesized by bone marrow mesenchymal stem cells(BMSCs)after transplantation into ischemic hearts using a technique employing mutant methionyl-tRNA synthetase(MetRSL247G)for nascent protein labeling,in order to explore the potential mechanisms of action in BMSCs post-transplantation.Methods Point mutation at position 274 of the MetRS gene in BMSCs was induced via lentiviral infection to enable azidonorleucine(ANL)-mediated labeling of nascent proteins in BMSCs.The labeling efficiency was verified by means of fluorescent non-canonical amino-acid tagging(FUNCAT).Thirty healthy female C57BL/6J mice(8-10 weeks old)were divided into control and experimental groups,with 15 mice in each group.The acute myocardial infarction model was constructed by ligating the left anterior descending coronary artery in experimental group,while control mice underwent only thoracotomy without coronary ligation.After modeling,both groups received intramyocardial injections of MetRSL247G-modified BMSCs(MetRSL247G-BMSCs)at 3 different sites in the peri-infarct ischemic region.Mice were intraperitoneally injected with ANL every 6 hours for 4 times on postoperative days 0,2,and 6(n=5 for each time point)respectively,euthanized 24 h after the last injection,and cardiac tissues were isolated.The newly synthesized and labeled proteins produced by BMSCs after transplantation into the myocardium of experimental and control groups were collected,using an enrichment technique for ANL-tagged proteins and liquid chromatography-tandem mass spectrometry(LC-MS)analysis.Gene ontology(GO)analysis,Kyoto Encyclopedia of Genes and Genomes(KEGG)pathway analysis,protein-protein interaction(PPI)analysis,and heatmap visualization analysis were performed to identify differentially expressed proteins at the 3 time points and screen key pathways and genes.Results Under fluorescence microscopy,the MetRSL247G lentivirus-infected BMSCs were observed to be labelled with mCherry signals,confirming the successful construction of the MetRSL247G-BMSCs cell line.Green fluorescent signals were detected only in nascent proteins in culture medium containing both MetRSL247G-BMSCs and ANL,validating the sensitivity and specificity of the labeling method.GO analysis revealed that differentially expressed proteins were primarily involved in basic cellular biological processes such as extracellular exosome formation,extracellular matrix organization,and focal adhesion.KEGG and PPI analyses indicated that the differential proteins were mainly involved in complement and coagulation cascade pathway,actin cytoskeleton regulation pathway,and apoptosis pathway.Heatmap analysis showed significantly upregulated expression of anti-apoptosis and cell adhesion-related factors in experimental group on day 1(P<0.05),upregulated anti-apoptotic factors,pro-apoptotic factors,and cell adhesion-related factors on day 3(P<0.05),and upregulated anti-apoptotic factors,cell differentiation-related factors,and cell adhesion-related factors on day 7(P<0.05)compared with control group.Expression of apoptosis-inducing factor 1 was significantly downregulated on days 1 and 7(P<0.05).On day 3,most differentially expressed proteins,including anti-apoptosis factors(Protein S100-A11,Clusterin,Gelsolin),pro-apoptosis factor(Cathepsin B),cell differentiation-related factor(Transgelin-2),and cell adhesion-related factors(Cofilin-1,Periostin,Fibronectin)were significantly upregulated(P<0.05).Conclusions The MetRSL247G mutation enables BMSCs to incorporate ANL and synthesize labeled proteins,confirming the feasibility of this nascent protein labeling technique.Nascent proteins of BMSCs in ischemic myocardium primarily contribute to extracellular exosome secretion and extracellular matrix organization.BMSCs may adapt to and respond to ischemic and hypoxic environments by influencing complement and coagulation cascades,activating inflammatory factors,regulating actin cytoskeleton structure,and modulating apoptosis,thereby maintaining the survival of BMSCs.
10.Rapid rehabilitation nursing for one pediatric patient with pancreatic divisum undergoing en bloc pancreatoduodenectomy
Jinfeng ZHU ; Weishu HU ; Li TANG ; Lei CAI ; Rong HUANG ; Lechun HUANG ; Ruixin ZHENG ; Jing CAO
Journal of Clinical Medicine in Practice 2025;29(7):118-121
This article summarizes the rapid rehabilitation nursing experience for one pediatric pa-tient with pancreatic divisum who underwent en bloc pancreatoduodenectomy preserving the duodenum,common bile duct,and Oddi's sphincter(DCOPPHTR).The nursing care encompassed preoperative prehabilitation to enhance physical and psychological preparation,postoperative precise volume and dynamic blood glucose management,early mobilization to facilitate recovery,personalized nutritional support to improve nutritional status,psychological nursing to bolster confidence,and family involve-ment to enhance quality of life.The pediatric patient experienced rapid recovery and was discharged from the hospital.A six-month follow-up indicated a significant improvement in quality of life.

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