1.Practical exploration of ethical review in decentralized drug clinical trials
Xu ZUO ; Yingshuo HUANG ; Yue LI ; Lihan XING ; Chunxiu YANG ; Yan CUI
Chinese Medical Ethics 2025;38(1):40-45
ObjectiveTo explore the process and guidelines for ethical review in decentralized drug clinical trials, promote clinical trial progress, and ensure drug development progress. MethodsThe key points of the ethical review were summarized by studying the relevant laws and regulations on decentralized drug clinical trials, analyzing the advantages and challenges of decentralized drug clinical trials, and combining the experience of the ethics committee of the institution in reviewing decentralized drug clinical trials. ResultsRelevant laws and regulations were the basis for the ethical review, and the ethics committee should adopt appropriate review methods based on regulations and hospital ethical standard operating procedures. The ethics committee should focus on the feasibility, applicability, and rationality, the adequacy of informed consent, the protection of rights and interests and privacy of subjects, as well as the qualification and standard operating procedures of electronic platforms for conducting decentralized drug clinical trials. ConclusionDecentralized drug clinical trials are in their early stages and urgently require guidance from relevant laws and regulations. Ethical review is also constantly being refined through exploration. It is necessary to supervise the implementation of responsibilities by all parties, pay attention to the rights and interests of subjects, and gradually promote the implementation of decentralized drug clinical trials.
2.Five new triterpenoid saponins from the kernels of Momordica cochinchinensis
Ru DING ; Jia-qi WANG ; Yi-yang LUO ; Yong-long HAN ; Xiao-bo LI ; Meng-yue WANG
Acta Pharmaceutica Sinica 2025;60(2):442-448
Five saponins were isolated from the kernels of
3.Pharmacodynamic Substances and Mechanisms of Da Chengqitang in Treating Stroke: A Review
Yizhi YAN ; Xinyi LIU ; Yang DUAN ; Miaoqing LONG ; Chaoya LI ; Qiang LI ; Yi'an CHEN ; Shasha YANG ; Yue ZHANG ; Peng ZENG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(9):297-306
Stroke is the main cause of death and disability among adults in China and is characterized by high incidence, disability, mortality, and recurrence rates. The combination of traditional Chinese and Western medicine has great potential in treating stroke and its sequelae. The classic traditional Chinese medicine prescription Da Chengqitang (DCQT) has a long history and proven efficacy in treating stroke. Clinically, DCQT is often used to treat stroke and its sequelae. However, the number and quality of clinical trials of DCQT in treating stroke need to be improved. Because of the insufficient basic research, the active ingredients and multi-target mechanism of action of DCQT remain unclear. Our research group has previously confirmed that DCQT can effectively reverse neurological damage, reduce iron deposition, and downregulate the levels of pro-inflammatory cytokines in the rat model of hemorrhagic stroke. The treatment mechanism is related to the nuclear factor erythroid 2-related factor 2 (Nrf2)-mediated signaling pathway and p38 mitogen-activated protein kinase (MAPK) signaling-mediated microglia activation. To clarify the pharmacodynamic basis and anti-stroke mechanism of DCQT, this article reviews the research progress in the treatment of stroke with DCQT in terms of clinical trials, pharmacodynamic material basis, safety evaluation, and mechanisms of absorbed components. This article summarizes 45 major phytochemical components of DCQT, 11 of which are currently confirmed absorbed components. Among them, emodin, rhein, chrysophanol, aloe-emodin, synephrine, hesperidin, naringin, magnolol, and honokiol can be used as quality markers (Q-markers) of DCQT. The mechanism of DCQT in treating stroke is complex, involving regulation of inflammatory responses, neuronal damage, oxidative stress, blood-brain barrier, brain-derived neurotrophic factor, and anti-platelet aggregation. This article helps to deeply understand the pharmacodynamic basis and mechanism of DCQT in treating stroke and provides a theoretical basis for the clinical application of DCQT in treating stroke and the development of stroke drugs.
4.Latent class analysis and influencing factor study of work-related musculoskeletal disorders among operating room nurses in tertiary hospitals
Xiaogui TANG ; Li LI ; Yue ZHAO ; Ningning HU ; Feng FU ; Boya LI ; Mengru YANG ; Yinglan LI
Journal of Environmental and Occupational Medicine 2025;42(3):293-301
Background Work-related musculoskeletal disorders (WMSDs), as one of the major occupational health issues worldwide, have shown an increasing positive rate year by year. Due to the unique demands of work, operating room nurses exhibit a higher positive rate of WMSDs compared to other occupational groups, necessitating active attention and intervention. Objective To estimate the prevalence of WMSDs among operating room nurses in tertiary hospitals, explore the characteristics and latent categories of WMSDs, and analyze the influencing factors associated with the occurrence of WMSDs. Method Using a randomized cluster sampling method, operating room nurses from nine tertiary hospitals in Urumqi were selected as study participants between December 2023 and January 2024. Data were collected through a general information questionnaire, an ergonomic questionnaire for operating room nurses, and the Chinese Musculoskeletal Disorders Questionnaire. Latent class analysis was employed to examine the patterns of WMSDs among the nurses, while chi-square test and multinomial logistic regression were utilized to analyze the influencing factors of WMSDs. Result A total of 411 valid questionnaires were collected in this survey. The positive rate of WMSDs among operating room nurses in the tertiary hospitals of Urumqi over the past year was 91.9%. The positive rates, ordered from highest to lowest by body region, were neck (79.1%), shoulders (70.3%), and lower back (68.1%). The operating room nurses were categorized into three distinct groups by latent class analysis: multi-site pain group, neck-shoulder-back pain group, and neck and lower back pain group. The results of the multinomial logistic regression models revealed that gender, job strain level, ergonomic load level in the operating room, and exposure to cold or drafty working conditions or not were significant influencing factors for reporting WMSDs among operating room nurses. Specifically, having less than 5 years of work experience, low ergonomic load level, low job strain, and moderate job strain were identified as protective factors against WMSDs. Conversely, exposure to cold or drafty working environments and being female were identified as risk factors for WMSDs. The logistic regression models also indicated that compared to the neck-lower back pain group, the neck-shoulder-back pain group had a higher probability of reporting low job strain (OR=0.168, 95%CI: 0.029, 0.968) and being female (OR=4.847, 95%CI: 2.506, 9.378). In contrast, when comparing to the neck-lower back pain group, the multi-site pain group had a higher probability of reporting, low-level ergonomic workload (OR=0.079, 95%CI: 0.015, 0.412), low job strain (OR=0.019, 95%CI: 0.002, 0.145), moderate job strain (OR=0.080, 95%CI: 0.016, 0.401), high job strain (OR=0.132, 95%CI: 0.027, 0.647), less than 5 years of work experience (OR=0.173, 95%CI: 0.044, 0.683), being female (OR=2.424, 95%CI: 1.130, 5.200), and exposure to cold or drafty working environments (OR=3.277, 95%CI: 1.657, 6.481). Conclusion The positive rate WMSDs among operating room nurses in tertiary hospitals is notably high in Urumqi, with distinct co-occurrence characteristics observed within the population. To mitigate the risk of WMSDs, it is essential to implement targeted health education and prevention training programs tailored to different patterns of WMSDs. Additionally, improving working conditions, optimizing human resource allocation , and other proactive measures should be undertaken. These efforts will effectively reduce the incidence of WMSDs among operating room nurses and safeguard their occupational health.
5.Structural and Spatial Analysis of The Recognition Relationship Between Influenza A Virus Neuraminidase Antigenic Epitopes and Antibodies
Zheng ZHU ; Zheng-Shan CHEN ; Guan-Ying ZHANG ; Ting FANG ; Pu FAN ; Lei BI ; Yue CUI ; Ze-Ya LI ; Chun-Yi SU ; Xiang-Yang CHI ; Chang-Ming YU
Progress in Biochemistry and Biophysics 2025;52(4):957-969
ObjectiveThis study leverages structural data from antigen-antibody complexes of the influenza A virus neuraminidase (NA) protein to investigate the spatial recognition relationship between the antigenic epitopes and antibody paratopes. MethodsStructural data on NA protein antigen-antibody complexes were comprehensively collected from the SAbDab database, and processed to obtain the amino acid sequences and spatial distribution information on antigenic epitopes and corresponding antibody paratopes. Statistical analysis was conducted on the antibody sequences, frequency of use of genes, amino acid preferences, and the lengths of complementarity determining regions (CDR). Epitope hotspots for antibody binding were analyzed, and the spatial structural similarity of antibody paratopes was calculated and subjected to clustering, which allowed for a comprehensively exploration of the spatial recognition relationship between antigenic epitopes and antibodies. The specificity of antibodies targeting different antigenic epitope clusters was further validated through bio-layer interferometry (BLI) experiments. ResultsThe collected data revealed that the antigen-antibody complex structure data of influenza A virus NA protein in SAbDab database were mainly from H3N2, H7N9 and H1N1 subtypes. The hotspot regions of antigen epitopes were primarily located around the catalytic active site. The antibodies used for structural analysis were primarily derived from human and murine sources. Among murine antibodies, the most frequently used V-J gene combination was IGHV1-12*01/IGHJ2*01, while for human antibodies, the most common combination was IGHV1-69*01/IGHJ6*01. There were significant differences in the lengths and usage preferences of heavy chain CDR amino acids between antibodies that bind within the catalytic active site and those that bind to regions outside the catalytic active site. The results revealed that structurally similar antibodies could recognize the same epitopes, indicating a specific spatial recognition between antibody and antigen epitopes. Structural overlap in the binding regions was observed for antibodies with similar paratope structures, and the competitive binding of these antibodies to the epitope was confirmed through BLI experiments. ConclusionThe antigen epitopes of NA protein mainly ditributed around the catalytic active site and its surrounding loops. Spatial complementarity and electrostatic interactions play crucial roles in the recognition and binding of antibodies to antigenic epitopes in the catalytic region. There existed a spatial recognition relationship between antigens and antibodies that was independent of the uniqueness of antibody sequences, which means that antibodies with different sequences could potentially form similar local spatial structures and recognize the same epitopes.
6.Randomized Controlled Clinical Observation on the Treatment of Lumbar Disc Herniation of Cold-Dampness Obstruction Type with Hot Ironing of Haitongpi Formula (海桐皮方) Combined with Three Movements Technique of Qinggong Spinal Manipulation
Fajie LI ; Yue ZHANG ; Tianhao WAN ; Manhong YANG ; Di XIA ; Qing ZHANG
Journal of Traditional Chinese Medicine 2025;66(10):1023-1030
ObjectiveTo observe the clinical efficacy and safety of hot ironing with Haitongpi Formula (海桐皮方, HF) in the treatment of lumbar disc herniation (LDH) of cold-dampness obstruction type. MethodsA total of 70 patients with cold-dampness obstruction type LDH were randomly divided into a treatment group and a control group, with 35 cases in each group. Both groups received three movements technique of Qinggong Spinal Manipulation (QSM) as the basis for treatment. In addition, the treatment group received hot ironing with HF, while the control group applied Diclofenac Sodium Gel externally. The treatment duration for both groups was 14 days. The clinical efficacy was compared between groups. Japanese Orthopedic Association (JOA) score, visual analog scale (VAS) for pain, pain pressure threshold (PPT) for lumbar positive response points, and traditional Chinese medicine (TCM) symptom scores were compared, on day 7, and day 14 of treatment, as well as on day 7 and day 14 of follow-up. The lumbar curvature index (LCI) was also compared before treatment and on day 14 of treatment. Adverse reactions during the study were recorded for both groups. ResultsA total of 35 patients in the treatment group and 34 patients in the control group were included for final analysis. The clinical total effective rate of the treatment group (91.43%, 32/35) was significantly higher than that of the control group (82.35%, 28/34, P<0.05). Both the JOA score and PPT of the two groups increased on day 7 and day 14 of treatment, and on day 7 and day 14 of follow-up. VAS scores and TCM symptom scores both decreased. The LCI of both groups increased on day 14 of treatment (P<0.01). Compared with the control group at the same time points, on day 14 of treatment and day 7 and day 14 of follow-up, the treatment group had higher JOA scores and PPT, and lower VAS scores and TCM symptom scores. The LCI of the treatment group increased on day 14 of treatment (P<0.05 or P<0.01). One case in the control group showed mild skin allergy, with no other adverse reactions observed in either group. ConclusionBased on three movements technique of QSM, hot ironing with HF shows better clinical efficacy than external Diclofenac Sodium Gel in the treatment of cold-dampness obstruction type LDH. It can significantly reduce lumbar pain, increase pain pressure threshold, improve clinical symptoms, lumbar function, and lumbar curvature, with good safety.
7.Effects of Modified Guomin Decoction (加味过敏煎) on Traditional Chinese Medicine Syndromes and Quality of Life in Patients with Mild to Moderate Atopic Dermatitis of Heart Fire and Spleen Deficiency Pattern:A Randomized,Double-Blind,Placebo-Controlled Trial
Jing NIE ; Rui PANG ; Lingjiao QIAN ; Hua SU ; Yuanwen LI ; Xinyuan WANG ; Jingxiao WANG ; Yi YANG ; Yunong WANG ; Yue LI ; Panpan ZHANG
Journal of Traditional Chinese Medicine 2025;66(10):1031-1037
ObjectiveTo observe the clinical efficacy and safety of Modified Guomin Decoction (加味过敏煎, MGD) in patients with mild to moderate atopic dermatitis (AD) of the traditional Chinese medicine (TCM) pattern of heart fire and spleen deficiency, and to explore its possible mechanisms. MethodsIn this randomized, double-blind, placebo-controlled study, 72 patients with mild to moderate AD and the TCM pattern of heart fire and spleen deficiency were randomly divided into a treatment group and a control group, with 36 cases in each group. The treatment group received oral MGD granules combined with topical vitamin E emulsion, while the control group received oral placebo granules combined with topical vitamin E treatment. Both groups were treated twice daily for 4 weeks. Clinical efficacy, TCM syndrome scores, Visual Analogue Scale (VAS) for pruritus, Dermatology Life Quality Index (DLQI) scores, Scoring Atopic Dermatitis (SCORAD) and serum biomarkers, including interleukin-33 (IL-33), interleukin-1β (IL-1β), immunoglobulin E (IgE), and tumor necrosis factor-α (TNF-α) were compared before and after treatment. Safety indexes was also assessed. ResultsThe total clinical effective rates were 77.78% (28/36) in the treatment group and 38.89% (14/36) in the control group, with cure rates of 19.44% (7/36) and 2.78% (1/36), respectively. The treatment group showed significantly better clinical outcomes compared to the control group (P<0.05). The treatment group exhibited significant reductions in total TCM syndrome scores, including erythema, edema, papules, scaling, lichenification, pruritus, irritability, insomnia, abdominal distension, and fatigue scores, as well as reductions in VAS, DLQI, SCORAD, and serum IgE and IL-33 levels (P<0.05 or P<0.01). Compared to the control group, the treatment group had significantly better improvements in all indicators except for insomnia (P<0.05). No adverse events occurred in either group. ConclusionMGD is effective and safe in treating mild to moderate AD patients with heart fire and spleen deficiency pattern. It significantly alleviates pruritus, improves TCM syndromes and quality of life, and enhances clinical efficacy, possibly through modulation of immune responses.
8.Preliminary Efficacy of Growth Hormone Therapy in Children With Congenital HeartDisease and Short Stature: A Six-case Report and Literature Review
Xi YANG ; Siyu LIANG ; Qianqian LI ; Hanze DU ; Shuaihua SONG ; Yue JIANG ; Huijuan MA ; Shi CHEN ; Hui PAN
Medical Journal of Peking Union Medical College Hospital 2025;16(3):641-646
Congenital heart disease (CHD) is a congenital malformation resulting from abnormal embryonic development of the heart and great vessels, accounting for approximately 25% of all congenital malformations. Children with CHD are often complicated by short stature. Although surgical treatment can improve their growth and development to a certain extent, some children still experience growth retardation after surgery. Recombinant human growth hormone (rhGH) is the main drug for treating short stature, but its efficacy and safety in the treatment of patients with concomitant CHD warrant further investigation. This article reports six cases of children with CHD and short stature who were treated with rhGH. Through a literature review, we summarize and discuss the therapeutic efficacy, follow-up experiences, and adverse reactions of rhGH treatment, aiming to provide references for clinicians in applying rhGH to treat patients with CHD and short stature.
9.Discriminating Tumor Deposits From Metastatic Lymph Nodes in Rectal Cancer: A Pilot Study Utilizing Dynamic Contrast-Enhanced MRI
Xue-han WU ; Yu-tao QUE ; Xin-yue YANG ; Zi-qiang WEN ; Yu-ru MA ; Zhi-wen ZHANG ; Quan-meng LIU ; Wen-jie FAN ; Li DING ; Yue-jiao LANG ; Yun-zhu WU ; Jian-peng YUAN ; Shen-ping YU ; Yi-yan LIU ; Yan CHEN
Korean Journal of Radiology 2025;26(5):400-410
Objective:
To evaluate the feasibility of dynamic contrast-enhanced MRI (DCE-MRI) in differentiating tumor deposits (TDs) from metastatic lymph nodes (MLNs) in rectal cancer.
Materials and Methods:
A retrospective analysis was conducted on 70 patients with rectal cancer, including 168 lesions (70 TDs and 98 MLNs confirmed by histopathology), who underwent pretreatment MRI and subsequent surgery between March 2019 and December 2022. The morphological characteristics of TDs and MLNs, along with quantitative parameters derived from DCE-MRI (K trans , kep, and v e) and DWI (ADCmin, ADCmax, and ADCmean), were analyzed and compared between the two groups.Multivariable binary logistic regression and receiver operating characteristic (ROC) curve analyses were performed to assess the diagnostic performance of significant individual quantitative parameters and combined parameters in distinguishing TDs from MLNs.
Results:
All morphological features, including size, shape, border, and signal intensity, as well as all DCE-MRI parameters showed significant differences between TDs and MLNs (all P < 0.05). However, ADC values did not demonstrate significant differences (all P > 0.05). Among the single quantitative parameters, v e had the highest diagnostic accuracy, with an area under the ROC curve (AUC) of 0.772 for distinguishing TDs from MLNs. A multivariable logistic regression model incorporating short axis, border, v e, and ADC mean improved diagnostic performance, achieving an AUC of 0.833 (P = 0.027).
Conclusion
The combination of morphological features, DCE-MRI parameters, and ADC values can effectively aid in the preoperative differentiation of TDs from MLNs in rectal cancer.
10.Research on the Correlation between Balance Function and Core Muscles in Patients With Adolescent Idiopathic Scoliosis
Si-Jia LI ; Qing YUE ; Qian-Jin LIU ; Yan-Hua LIANG ; Tian-Tian ZHOU ; Xiao-Song LI ; Tian-Yang FENG ; Tong ZHANG
Neurospine 2025;22(1):264-275
Objective:
This study aimed to explore the correlation between balance function and core muscle activation in patients with adolescent idiopathic scoliosis (AIS), compared to healthy individuals.
Methods:
A total of 24 AIS patients and 25 healthy controls were recruited. The limits of stability (LOS) test were conducted to assess balance function, while surface electromyography was used to measure the activity of core muscles, including the internal oblique, external oblique, and multifidus. Diaphragm thickness was measured using ultrasound during different postural tasks. Center of pressure (COP) displacement and trunk inclination distance were also recorded during the LOS test.
Results:
AIS patients showed significantly greater activation of superficial core muscles, such as the internal and external oblique muscles, compared to the control group (p < 0.05). Diaphragm activation was lower in AIS patients during balance tasks (p < 0.01). Although no significant difference was observed in COP displacement between the groups, trunk inclination was significantly greater in the AIS group during certain tasks (p < 0.05).
Conclusion
These findings suggest distinct postural control patterns in AIS patients, highlighting the importance of targeted interventions to improve balance and core muscle function in this population.

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