1.Study design and rationale of the TXL-CAP trial: a randomized, double-blind, placebo-controlled, multicenter clinical trial assessing the effect of Tongxinluo capsules on the stability of coronary atherosclerotic plaques.
Mei NI ; Yun TI ; Yan QI ; Meng ZHANG ; Dayue Darrel DUAN ; Chen YAO ; Zhen-Hua JIA ; Yun ZHANG ; Pei-Li BU
Journal of Geriatric Cardiology 2025;22(7):615-624
Recent clinical trials have demonstrated a protective effect in using traditional Chinese medicine Tongxinluo (TXL) capsule to treat atherosclerosis. However, clinical evidence of the effects of TXL treatment on coronary plaque vulnerability is unavailable. In response, we developed this study to investigate the hypothesis that on the basis of statin therapy, treatment with TXL capsule may stabilize coronary lesions in patients with acute coronary syndrome (ACS). The TXL-CAP study was an investigator-initiated, randomized, double-blind clinical trial conducted across 18 medical centers in China. Patients with ACS aging from 18 to 80 years old who had a non-intervened coronary target lesion with a fibrous cap thickness (FCT) < 100 μm and lipid arc > 90° as defined by optical coherence tomography (OCT) were recruited. A total of 220 patients who met the selection criteria but did not meet the exclusion criteria will be finally recruited and randomized to receive treatment with TXL (n = 110) or placebo (n = 110) for a duration of 12 months. The primary endpoint was the difference in the minimum FCT of the coronary target lesion between TXL and placebo groups at the end of the 12-month follow-up. Secondary endpoints included: (1) changes of the maximum lipid arc and length of the target plaque, and the percentage of lipid, fibrous, and calcified plaques at the end of the 12-month period; (2) the incidence of composite cardiovascular events and coronary revascularization within the 12 months; (3) changes in the grade and scores of the angina pectoris as assessed using the Canadian Cardiovascular Society (CCS) grading system and Seattle angina questionnaire (SAQ) score, respectively; and (4) changes in hs-CRP serum levels. The results of the TXL-CAP trial will provide additional clinical data for revealing whether TXL capsules stabilizes coronary vulnerable plaques in Chinese ACS patients.
2.Associations of Ureaplasma urealyticum infection with male infertility and intrauterine insemination outcomes.
Yang-Yang WAN ; Xiao-Yun SHI ; Wen-Jing LIU ; Shun BAI ; Xin CHEN ; Si-Yao LI ; Xiao-Hua JIANG ; Li-Min WU ; Xian-Sheng ZHANG ; Juan HUA
Asian Journal of Andrology 2025;27(2):219-224
Ureaplasma urealyticum (UU) is one of the most commonly occurring pathogens associated with genital tract infections in infertile males, but the impact of seminal UU infection in semen on intrauterine insemination (IUI) outcomes is poorly understood. We collected data from 245 infertile couples who underwent IUI at The First Affiliated Hospital of USTC (Hefei, China) between January 2021 and January 2023. The subjects were classified into two groups according to their UU infection status: the UU-positive group and the UU-negative group. We compared semen parameters, pregnancy outcomes, and neonatal birth outcomes to investigate the impact of UU infection on IUI outcomes. There were no significantly statistical differences in various semen parameters, including semen volume, sperm concentration, total and progressive motility, sperm morphology, leukocyte count, the presence of anti-sperm antibody, and sperm DNA fragmentation index (DFI), between the UU-positive and UU-negative groups of male infertile patients (all P > 0.05). However, the high DNA stainability (HDS) status of sperm differed between the UU-positive and UU-negative groups, suggesting that seminal UU infection may affect sperm nuclear maturation ( P = 0.04). Additionally, there were no significant differences in pregnancy or neonatal birth outcomes between the two groups (all P > 0.05). These results suggest that IUI remains a viable and cost-effective option for infertile couples with UU infection who are facing infertility issues.
Humans
;
Male
;
Ureaplasma Infections/complications*
;
Female
;
Infertility, Male/therapy*
;
Ureaplasma urealyticum/isolation & purification*
;
Pregnancy
;
Adult
;
Pregnancy Outcome
;
Semen Analysis
;
Insemination, Artificial
;
Semen/microbiology*
;
China
3.Genetic and clinical characteristics of children with RAS-mutated juvenile myelomonocytic leukemia.
Yun-Long CHEN ; Xing-Chen WANG ; Chen-Meng LIU ; Tian-Yuan HU ; Jing-Liao ZHANG ; Fang LIU ; Li ZHANG ; Xiao-Juan CHEN ; Ye GUO ; Yao ZOU ; Yu-Mei CHEN ; Ying-Chi ZHANG ; Xiao-Fan ZHU ; Wen-Yu YANG
Chinese Journal of Contemporary Pediatrics 2025;27(5):548-554
OBJECTIVES:
To investigate the genomic characteristics and prognostic factors of juvenile myelomonocytic leukemia (JMML) with RAS mutations.
METHODS:
A retrospective analysis was conducted on the clinical data of JMML children with RAS mutations treated at the Hematology Hospital of Chinese Academy of Medical Sciences, from January 2008 to November 2022.
RESULTS:
A total of 34 children were included, with 17 cases (50%) having isolated NRAS mutations, 9 cases (27%) having isolated KRAS mutations, and 8 cases (24%) having compound mutations. Compared to children with isolated NRAS mutations, those with NRAS compound mutations showed statistically significant differences in age at onset, platelet count, and fetal hemoglobin proportion (P<0.05). Cox proportional hazards regression model analysis revealed that hematopoietic stem cell transplantation (HSCT) and hepatomegaly (≥2 cm below the costal margin) were factors affecting the survival rate of JMML children with RAS mutations (P<0.05); hepatomegaly was a factor affecting survival in the non-HSCT group (P<0.05).
CONCLUSIONS
Children with NRAS compound mutations have a later onset age compared to those with isolated NRAS mutations. At initial diagnosis, children with NRAS compound mutations have poorer peripheral platelet and fetal hemoglobin levels than those with isolated NRAS mutations. Liver size at initial diagnosis is related to the prognosis of JMML children with RAS mutations. HSCT can improve the prognosis of JMML children with RAS mutations.
Humans
;
Leukemia, Myelomonocytic, Juvenile/therapy*
;
Mutation
;
Male
;
Female
;
Child, Preschool
;
Retrospective Studies
;
Child
;
Infant
;
GTP Phosphohydrolases/genetics*
;
Membrane Proteins/genetics*
;
Adolescent
;
Hematopoietic Stem Cell Transplantation
;
Proportional Hazards Models
;
Proto-Oncogene Proteins p21(ras)/genetics*
;
Prognosis
4.Cardiofaciocutaneous syndrome caused by microdeletion of chromosome 19p13.3: a case report and literature review.
Cui-Yun LI ; Ying XU ; Ru-En YAO ; Ying YU ; Xue-Ting CHEN ; Wei LI ; Hui ZENG ; Li-Ting CHEN
Chinese Journal of Contemporary Pediatrics 2025;27(7):854-858
This article reports a child with cardioaciocutaneous syndrome (CFCS) caused by a rare microdeletion of chromosome 19p13.3, and a literature review is conducted. The child had unusual facies, short stature, delayed mental and motor development, macrocephaly, and cardiac abnormalities. Whole-exome sequencing identified a 1 040 kb heterozygous deletion in the 19p13.3 region of the child, which was rated as a "pathogenic variant". This is the first case of CFCS caused by a loss-of-function mutation reported in China, which enriches the genotype characteristics of CFCS. It is imperative to enhance the understanding of CFCS in children. Early identification based on its clinical manifestations should be pursued, and genetic testing should be performed to facilitate diagnosis.
Humans
;
Chromosome Deletion
;
Chromosomes, Human, Pair 19/genetics*
;
Ectodermal Dysplasia/genetics*
;
Facies
;
Failure to Thrive/genetics*
;
Heart Defects, Congenital/genetics*
5.Key Factors and Improving Paths of Promoting Long-Acting Injections in Communities in Beijing.
Yu XIN ; Chen CHEN ; Yao DONG ; Jin-Qi ZHU ; Yun CHEN ; Qing-Zhi HUANG ; Jun-Li ZHU
Acta Academiae Medicinae Sinicae 2025;47(3):414-424
Objective To investigate the key factors influencing the implementation of long-acting injection-promoting policies and propose effective improving paths.Methods Qualitative interviews were carried out for stakeholders involved in the promotion of long-acting injections,based on the consolidated framework for implementation research.Additionally,countermeasures for identified barriers were proposed based on expert recommendations for implementation changes.Results A total of 46 health administrators,healthcare workers,and patients in Beijing were interviewed.The study identified several barriers in the strength and quality of evidence,adaptability,relative advantage,complexity and cost,patient needs and resources,external collaboration,external policies and incentives,organizational structural characteristics,and self-efficacy.Conclusions From the perspectives and experiences of stakeholders,the promotion of long-acting injections has shown initial success but still faces multiple obstacles.It is recommended that efforts should be made to coordinate and adapt policies,improve and incentivize relative organizations,and continuously strengthen the advocacy and education for individuals.
Humans
;
Beijing
;
Delayed-Action Preparations
;
Health Personnel
;
Health Policy
;
Injections
6.Electrochemical Sensor Based on Nitrogen-Doped Carbon Nanobowl-Modified Electrode for Nitrofurantoin Detection
Yao-Juan HU ; Rui-Ying GUO ; Hui-Ru TANG ; Hui-Lin LI ; Feng-Yun HE ; Chang-Li ZHANG ; Chang-Yun CHEN
Chinese Journal of Analytical Chemistry 2025;53(7):1127-1137
Nitrofurantoin(NFT)is a nitrofuran antibiotic commonly used as a veterinary drug to treat bacterial infections in animals.However,due to the low solubility and bioaccumulation properties,NFT is prone to leave excessive residues in animal-derived foods and water systems,posing serious threats to human health and ecosystems.Therefore,there is an urgent need to develop an efficient and rapid detection method for NFT.In this work,nitrogen-doped carbon nanomaterials with unique bowl-like structures(N-CNBs)were synthesized via a hydrothermal-carbonization method.The morphology,surface structure,and specific surface area of N-CNBs were characterized using transmission electron microscopy(TEM),scanning electron microscopy(SEM),and X-ray photoelectron spectroscopy(XPS).The N-CNB modified glassy carbon electrode(N-CNB/GCE)was prepared,and the electrochemical test revealed that the N-CNB/GCE exhibited higher conductivity and larger electrochemical active surface area compared to bare GCE and nitrogen-doped hollow carbon nanosphere-modified electrode(N-HCNS/GCE).Additionally,the N-CNB/GCE demonstrated superior electrocatalytic activity toward NFT.An NFT electrochemical sensor was constructed based on N-CNB/GCE.The detection conditions of the sensor were optimized,and differential pulse voltammetry(DPV)was employed for NFT detection under optimal experimental conditions.The established NFT electrochemical sensor had a wide linear range of 0.4-500 μmol/L,a low detection limit(S/N=3)of 0.015 μmol/L and high selectivity,with excellent stability and reproducibility.The practical feasibility of this sensor was confirmed by analysis of NFT in milk and tap water samples,with spiked recoveries ranging from 94.2%to 108.9%.
7.Research progress of nano drug delivery system based on metal-polyphenol network for the diagnosis and treatment of inflammatory diseases
Meng-jie ZHAO ; Xia-li ZHU ; Yi-jing LI ; Zi-ang WANG ; Yun-long ZHAO ; Gao-jian WEI ; Yu CHEN ; Sheng-nan HUANG
Acta Pharmaceutica Sinica 2025;60(2):323-336
Inflammatory diseases (IDs) are a general term of diseases characterized by chronic inflammation as the primary pathogenetic mechanism, which seriously affect the quality of patient′s life and cause significant social and medical burden. Current drugs for IDs include nonsteroidal anti-inflammatory drugs, corticosteroids, immunomodulators, biologics, and antioxidants, but these drugs may cause gastrointestinal side effects, induce or worsen infections, and cause non-response or intolerance. Given the outstanding performance of metal polyphenol network (MPN) in the fields of drug delivery, biomedical imaging, and catalytic therapy, its application in the diagnosis and treatment of IDs has attracted much attention and significant progress has been made. In this paper, we first provide an overview of the types of IDs and their generating mechanisms, then sort out and summarize the different forms of MPN in recent years, and finally discuss in detail the characteristics of MPN and their latest research progress in the diagnosis and treatment of IDs. This research may provide useful references for scientific research and clinical practice in the related fields.
8.Long-term outcomes after infliximab discontinuation in patients with Crohn's disease: a single-center retrospective observational study
Danping ZHENG ; Yun QIU ; Yingfan ZHANG ; Baili CHEN ; Yao HE ; Zhirong ZENG ; Minhu CHEN
Chinese Journal of Inflammatory Bowel Diseases 2025;09(4):297-302
Objective:To assess the long-term risk of relapse in patients with Crohn's disease (CD) who discontinued infliximab (IFX) monoclonal antibody and to identify risk factors associated with relapse.Methods:A single-center retrospective observational study was conducted from February 2006 to October 2016. The study included CD patients who were treated with scheduled IFX infusions at the First Affiliated Hospital of Sun Yat-sen University and assessed in corticosteroid-free clinical remission at the time of withdrawal were included. The primary outcome was clinical relapse. We evaluated the risk of relapse using Kaplan-Meier method. Factors associated with time to relapse was identified using the multiple Cox proportional hazards regression analysis.Results:We included 97 eligible patients, and 75 (77.3%) experienced a relapse after a median follow-up time of 124 months. Among them, 45 patients (46.4%) relapsed within 3 years after IFX withdrawal. The 1-, 2-, 3-, 5-, and 10-year relapse-free survival were 79.4%, 59.8%, 52.6%, 42.0% and 22.6%, respectively. Risk factors for relapse included age ≤ 16 ( HR = 2.62, 95% CI: 1.30-5.31; P = 0.007) and failure to achieve biological remission (CRP > 3 mg/L, HR = 2.37, 95% CI: 1.29-4.36; P = 0.006) at drug withdrawal. Induction with biologics or systemic steroids were both effective (89%-100% relieved) in relapsers. Conclusions:Nearly half of CD patients relapsed within 3 years after discontinuation of IFX treatment. Early age of discontinuation and failure to achieve serum biological remission at the time of discontinuation are independent predictors of clinical relapse.
9.Allogeneic hematopoietic stem cell transplantation for the treatment of BCR::ABL-negative neutrophilic myeloid neoplasms: a clinical analysis of 12 cases
Tingting HAN ; Yun HE ; Jing LIU ; Yao CHEN ; Fengrong WANG ; Jingzhi WANG ; Yuhong CHEN ; Haixia FU ; Lanping XU ; Xiaohui ZHANG ; Xiaojun HUANG ; Yu WANG
Chinese Journal of Hematology 2025;46(9):827-832
Objective:To investigate the efficacy and safety of allogeneic hematopoietic stem cell transplantation (allo-HSCT) for the treatment of BCR::ABL-negative chronic neutrophilic leukemia (CNL) and MDS/MPN with neutrophilia.Methods:This study retrospectively analyzed 12 cases of CNL and MDS/MPN with neutrophilia that underwent allo-HSCT from March 2017 to June 2024, comprising 7 males and 5 females with a median age of 48 ( IQR: 28, 59) years. The 2-year overall survival (OS), disease-free survival (DFS), cumulative incidence of relapse (CIR), and transplantation-related mortality (TRM) rates were analyzed. Complications were also assessed. Results:Of the 12 patients, 6 received matched sibling HSCT and 6 received haploidentical HSCT. All patients had successful engraftment, and the median times of neutrophil and platelet engraftment were 17 ( IQR: 11, 24) days and 15 ( IQR: 9, 28) days, respectively. Grade Ⅱ–Ⅳ acute graft versus host disease (GVHD) and chronic GVHD occurred in 2 and 4 cases, respectively. The 2-year OS, DFS, CIR, and TRM rates were (65.6 ± 16.4) %, (41.7 ± 16.6) %, (47.2 ±18.2) %, and (11.1 ± 11.4) %, respectively, after a median follow-up time of 637 ( IQR: 330, 943) days. One patient died from treatment-related complications due to respiratory failure caused by coronavirus disease 2019. Two patients died due to relapse. Conclusion:Allo-HSCT can be applied as a safe and effective approach to treat CNL and MDS/MPN with neutrophilia.
10.Clinical analysis of donor-purified CD34 + stem cell boost in 11 patients with poor hematopoietic reconstruction after haploid hematopoietic stem cell transplantation for aplastic anemia
Yun HE ; Zhengli XU ; Huan CHEN ; Yao CHEN ; Tingting HAN ; Yuanyuan ZHANG ; Meng LYU ; Xiaodong MO ; Chenhua YAN ; Yu WANG ; Yuqian SUN ; Xiaohui ZHANG ; Xiaojun HUANG ; Lanping XU
Chinese Journal of Hematology 2025;46(7):618-624
Objective:To evaluate the safety and efficacy of donor-purified CD34 + stem cell boosts in patients with poor hematopoietic reconstruction (PHR) after haploid hematopoietic stem cell transplantation (haplo-HSCT) for aplastic anemia (AA) . Method:A retrospective analysis was conducted on 11 patients with AA and PHR who underwent haplo-HSCT and received donor-purified CD34 + stem cell boosts at Peking University People’s Hospital. Recovery of blood cell counts, incidence of graft-versus-host disease (GVHD), and overall survival (OS) were assessed. Results:Of the 11 patients with PHR, two were diagnosed with prolonged isolated thrombocytopenia (PT), one was primary poor graft function (PGF), and eight were diagnosed with secondary PGF. The median time to PHR diagnosis was 110 days (range: 60-330 days), and the median interval from transplantation to purified CD34 + hematopoietic stem cell infusion was 194 days (range: 125-456 days). The two patients with PT achieved complete platelet recovery at 22 and 13 days after CD34 + stem cell infusion, respectively. Among the remaining nine patients with PGF, six achieved complete hematopoietic recovery, with a median absolute neutrophil count recovery time of 19 days (8-158 days), HGB recovery time of 32.5 days (range: 13-158 days), and platelet recovery time of 31.5 days (range: 7-171 days). The incidence of chronic GVHD after infusion was 18.2%, with no cases of acute GVHD observed. The OS rate was 90.9% (10/11) in the 11 patients, with a median follow-up of 614 days (range: 153-1 765 days) . Conclusion:Donor-purified CD34 + stem cell boost may be an effective therapeutic strategy for PHR in patients with AA after haplo-HSCT.

Result Analysis
Print
Save
E-mail