1.Review and reflection on the practice of pre-ethical review for drug clinical trials
Min HOU ; Xiaoyuan SHI ; Rongguo SUN ; Fang LIU ; Lei CHEN ; Zejin ZUO
Chinese Medical Ethics 2026;39(5):594-600
ObjectiveTo sort out the pre-ethical review status of drug clinical trials in a tertiary A hospital, summarize practical experience, and provide references for pre-ethical review. MethodA retrospective analysis was conducted on the ethical review of pre-ethical projects in a tertiary A hospital from 2018 to 2023. ResultsFrom 2018 to 2023, a total of 285 pre-ethical projects were reviewed in this tertiary hospital, including 79 projects where it served as the leading unit. Among these, 279 clinical trials ultimately received approval of the ethical review committee, while 6 projects were not approved due to sponsors’ refusal to modify study protocols. In terms of trial phases, phase III clinical trials constituted the largest proportion, and the oncology center was the department with the highest number of projects. In 2023, the average time for pre-ethical review projects from submission to approval was 43 calendar days, 3 days longer than for other project types. In 2023, this hospital reviewed 75 pre-ethical review projects, including 58 where it served as a participating unit. Among these, 42 projects received approval later than the leading unit, while 9 projects were approved earlier than the leading unit’s ethical approval date. Among the pre-ethical review projects applied in 2023, 70 projects obtained drug clinical trial notifications from the National Medical Products Administration, while 5 projects had unknown notification status due to the lack of ethical approval or discontinuation. Of the projects receiving approval notifications, 16 were annotated with matters requiring enhanced attention during clinical trials, and 7 necessitated protocol improvements. ConclusionThis tertiary A hospital has implemented multiple measures to optimize the management of pre-ethical review. This ethical review model does not compromise the quality of ethical review and contributes to accelerating the initiation of clinical trials. Notably, it is crucial to construct a patient-centered drug development system. Clinical trials guided by this concept align with ethical values, laying the foundation for the smooth conduct of clinical trials, assisting in the drug development process, and safeguarding patients’ medication needs.
2.Research strategy for key quality attributes of traditional Chinese medicine based on systems biology and chemical biology
HOU Yuanyuan ; ZHANG Man ; JIANG Min ; ZHANG Tiejun ; BAI Gang
Drug Standards of China 2026;27(1):0015-0020
Currently, the quality control of traditional Chinese medicine (TCM) encounters substantial technical challenges, necessitating the urgent development of innovative evaluation methods for key quality attributes. This study proposes the construction of a quality assurance system centered on key quality attributes, with systems biology and chemical biology serving as its core components: utilizing multi-omics technologies to systematically analyze the core functional modules of TCM, integrating pharmacological approaches to precisely identify key bioactive components; applying chemical biology to elucidate the interaction mechanisms between components and their targets, while screening for quality markers associated with specific functions and clinical indications; establishing an integrated quality control system based on quality markers and biological potency to ensure comprehensive quality management from raw herb materials through to finished products. Additionally, it emphasizes the formulation of compatibility rules grounded in TCM theory, integrates clinical practice and multi-dimensional value assessments, and establishes a novel quality evaluation model with distinct TCM characteristics.This offers a comprehensive and systematic approach to ensuring the safety and efficacy of TCM while facilitating the high-quality development of the TCM industry.
3.Immunotherapy for Lung Cancer
Pei-Yang LI ; Feng-Qi LI ; Xiao-Jun HOU ; Xue-Ren LI ; Xin MU ; Hui-Min LIU ; Shou-Chun PENG
Progress in Biochemistry and Biophysics 2025;52(8):1998-2017
Lung cancer is the most common malignant tumor worldwide, ranking first in both incidence and mortality rates. According to the latest statistics from the International Agency for Research on Cancer (IARC), approximately 2.5 million new cases and around 1.8 million deaths from lung cancer occurred in 2022, placing a tremendous burden on global healthcare systems. The high mortality rate of lung cancer is closely linked to its subtle early symptoms, which often lead to diagnosis at advanced stages. This not only complicates treatment but also results in substantial economic losses. Current treatment options for lung cancer include surgery, radiotherapy, chemotherapy, targeted drug therapy, and immunotherapy. Among these, immunotherapy has emerged as the most groundbreaking advancement in recent years, owing to its unique antitumor mechanisms and impressive clinical benefits. Unlike traditional therapies such as radiotherapy and chemotherapy, immunotherapy activates or enhances the patient’s immune system to recognize and eliminate tumor cells. It offers advantages such as more durable therapeutic effects and relatively fewer toxic side effects. The main approaches to lung cancer immunotherapy include immune checkpoint inhibitors, tumor-specific antigen-targeted therapies, adoptive cell therapies, cancer vaccines, and oncolytic virus therapies. Among these, immune checkpoint inhibitors and tumor-specific antigen-targeted therapies have received approval from the U.S. Food and Drug Administration (FDA) for clinical use in lung cancer, significantly improving outcomes for patients with advanced non-small cell lung cancer. Although other immunotherapy strategies are still in clinical trials, they show great potential in improving treatment precision and efficacy. This article systematically reviews the latest research progress in lung cancer immunotherapy, including the development of novel immune checkpoint molecules, optimization of treatment strategies, identification of predictive biomarkers, and findings from recent clinical trials. It also discusses the current challenges in the field and outlines future directions, such as the development of next-generation immunotherapeutic agents, exploration of more effective combination regimens, and the establishment of precise efficacy prediction systems. The aim is to provide a valuable reference for the continued advancement of lung cancer immunotherapy.
4.Correlation between level of support needs and post-traumatic stress disorder among fathers of preterm infants in neonatal intensive care unit
Xiaoyan ZHAO ; Min JIN ; Feixiang HOU
Journal of Clinical Medicine in Practice 2025;29(16):96-102
Objective To investigate relationship between the level of support needs and post-traumatic stress disorder(PTSD)among fathers of preterm infants in neonatal intensivecare unit(NICU).Methods A total of 209 fathers of preterm infants admitted to NICU were selected as survey subjects.The basic information questionnaire for preterm infants,the basic information questionnaire for fathers,the NICU Newborn Father Support Scale,and the civilian version of the Post-traumatic Stress Disorder Checklist were used to survey their conditions.Results The score of support needs among fathers of preterm infants was(88.69±11.04).Gestational age,cesarean section,length of stay in the NICU,father's educational level,monthly per-capita family income,and spouse's health status were all significant influencing factors of father's support needs(P<0.05).The score of PTSD among fathers of preterm infants was(32.27±5.96).Gestational age,birth weight,birth way,fa-ther's age,whether the father had received prenatal health education,and support needs were all in-fluencing factors of PTSD occurrence among fathers of preterm infants(P<0.05).There was a sig-nificant negative correlation between father's support needs and PTSD.Conclusion The level of support needs among fathers of preterm infants in the NICU is negatively correlated with PTSD.Medi-cal staff should pay attention to the level of support needs among fathers of preterm infants to reduce the occurrence of their PTSD.
5.Efficacy of enzymatic debridement combined with traditional chinese medicine fumigation-washing in postoperative perianal abscess
Shuna HOU ; Min NIE ; Chunyu LI
Journal of Clinical Medicine in Practice 2025;29(17):95-99
Objective To explore and analyze the application effect of enzymatic debridement combined with traditional Chinese medicine fumigation-sitting bath therapy on postoperative wounds of perianal abscess.Methods Eighty patients with simple perianal abscess were randomly divided into observation group(enzymatic debridement+traditional Chinese medicine fumigation-washing)and control group(potassium permanganate sitting bath+conventional debridement),with 40 cases in each group.The white blood cell(WBC)count,C-reactive protein(CRP)levels,wound healing rate,Visual Analogue Scale(VAS)pain score,and wound-related symptoms were observed in both groups after surgery.Results WBC and CRP levels in the observation group were lower than those in the control group.The observation group showed superior results compared to the control group in terms of wound pain,edema,exudation,and wound healing rate.Additionally,the improvement in wound area,healing time,and longitudinal wound diameter in the observation group was significantly better than that in the control group(P<0.05).Conclusion Enzymatic debridement combined with traditional Chinese medicine fumigation-washing can accelerate wound healing,alleviate pain and inflammatory responses after perianal abscess surgery,showing superior efficacy compared to traditional methods.
6.Preparation of MXene-Carbon Nanotube Microspheres and Its Application in Electrochemical Detection of Nitroaromatic Compounds
Yu LIU ; Hou-Shen LI ; Qing-Shuang YAO ; Pei-Yao LI ; Yi-Min SUN
Chinese Journal of Analytical Chemistry 2025;53(3):407-417
The MXene/MF microspheres were prepared by coating MXene nanosheets on melamine formaldehyde(MF)resin microspheres.Co(NO3)2 was adsorbed on the surface of the microspheres by impregnation,and then calcined at high temperature in an argon atmosphere.MF pyrolysis generated reducing gases such as CO and NH3,reducing Co2+to elemental Co,which was then used as a catalyst for in situ growth of carbon nanotube(CNT)through chemical vapor deposition(CVD),forming MXene-Co-CNT microspheres(MXene-Co-CNT MS).During this process,the pyrolysis of MF microspheres had dual effects.On one hand,the template was sacrificed to produce an internal hollow structure,and on the other hand,the generated gas worked as carbon source to generate CNT,forming an external sea urchin-like structure.Both of them promoted the formation of a novel structure,which combined the advantages of large specific surface area and good conductivity,thus possessing excellent electrocatalytic activity.The MXene-Co-CNT MS was modified on glassy carbon electrode(GCE)and further used in highly sensitive detection of nitroaromatic compounds(NACs).The detection limits of MXene-Co-CNT MS/GCE for 2,4,6-trinitrotoluene(TNT),1,3,5-nitrobenzamide(TNB),2,4-dinitrotoluene(DNT),1,3-dinitrobenzene(DNB),1-Cl-2,4-dinitrotoluene(Cl-DNB),and 4-nitrophenol(4-NP)were 26.84,31.60,35.03,54.14,43.86 and 28.67 nmol/L,respectively.It also had excellent anti-interference ability,and was used to detect NACs in environmental water samples accurately.
7.Pathophysiological mechanisms of secondary white matter injury after ischemic stroke
Min LIU ; Chao HOU ; Zhenqian HUANG ; Wusheng ZHU ; Ruidong YE
International Journal of Cerebrovascular Diseases 2025;33(6):468-472
Secondary white matter injury after ischemic stroke refers to the secondary changes in the white matter structure outside the infarct site that are not directly damaged after stroke, often involving key connecting areas such as the corpus callosum and contralateral internal capsule. This injury is closely associated with post-stroke cognitive impairment, motor dysfunction, and language disorders, which affects the long-term outcome. Its pathophysiological mechanisms mainly include immune and inflammatory imbalance, excitotoxicity and mitochondrial dysfunction, blood-brain barrier damage, axonal injury, and remyelination disorder. Exploring these mechanisms in depth can help promote early diagnosis and intervention of secondary white matter damage after ischemic stroke, provide theoretical basis for the development of targeted treatment strategies, and promote functional recovery in patients with stroke.
8.Research and Application of Scalp Surface Laplacian Technique
Rui-Xin LUO ; Si-Ying GUO ; Xin-Yi LI ; Yu-He ZHAO ; Chun-Hou ZHENG ; Min-Peng XU ; Dong MING
Progress in Biochemistry and Biophysics 2025;52(2):425-438
Electroencephalogram (EEG) is a non-invasive, high temporal-resolution technique for monitoring brain activity. However, affected by the volume conduction effect, EEG has a low spatial resolution and is difficult to locate brain neuronal activity precisely. The surface Laplacian (SL) technique obtains the Laplacian EEG (LEEG) by estimating the second-order spatial derivative of the scalp potential. LEEG can reflect the radial current activity under the scalp, with positive values indicating current flow from the brain to the scalp (“source”) and negative values indicating current flow from the scalp to the brain (“sink”). It attenuates signals from volume conduction, effectively improving the spatial resolution of EEG, and is expected to contribute to breakthroughs in neural engineering. This paper provides a systematic overview of the principles and development of SL technology. Currently, there are two implementation paths for SL technology: current source density algorithms (CSD) and concentric ring electrodes (CRE). CSD performs the Laplace transform of the EEG signals acquired by conventional disc electrodes to indirectly estimate the LEEG. It can be mainly classified into local methods, global methods, and realistic Laplacian methods. The global method is the most commonly used approach in CSD, which can achieve more accurate estimation compared with the local method, and it does not require additional imaging equipment compared with the realistic Laplacian method. CRE employs new concentric ring electrodes instead of the traditional disc electrodes, and measures the LEEG directly by differential acquisition of the multi-ring signals. Depending on the structure, it can be divided into bipolar CRE, quasi-bipolar CRE, tripolar CRE, and multi-pole CRE. The tripolar CRE is widely used due to its optimal detection performance. While ensuring the quality of signal acquisition, the complexity of its preamplifier is relatively acceptable. Here, this paper introduces the study of the SL technique in resting rhythms, visual-related potentials, movement-related potentials, and sensorimotor rhythms. These studies demonstrate that SL technology can improve signal quality and enhance signal characteristics, confirming its potential applications in neuroscientific research, disease diagnosis, visual pathway detection, and brain-computer interfaces. CSD is frequently utilized in applications such as neuroscientific research and disease detection, where high-precision estimation of LEEG is required. And CRE tends to be used in brain-computer interfaces, that have stringent requirements for real-time data processing. Finally, this paper summarizes the strengths and weaknesses of SL technology and envisages its future development. SL technology boasts advantages such as reference independence, high spatial resolution, high temporal resolution, enhanced source connectivity analysis, and noise suppression. However, it also has shortcomings that can be further improved. Theoretically, simulation experiments should be conducted to investigate the theoretical characteristics of SL technology. For CSD methods, the algorithm needs to be optimized to improve the precision of LEEG estimation, reduce dependence on the number of channels, and decrease computational complexity and time consumption. For CRE methods, the electrodes need to be designed with appropriate structures and sizes, and the low-noise, high common-mode rejection ratio preamplifier should be developed. We hope that this paper can promote the in-depth research and wide application of SL technology.
9.Effect of target characteristics on prospective memory in patients with depressive disorder
Min CHEN ; Dongsheng LYU ; Zheng WANG ; You HOU
Sichuan Mental Health 2025;38(1):14-21
BackgroundMany studies have shown that patients with depressive disorder show impairments in prospective memory, while it is deemed necessary for facilitating their social reintegration, and the current research findings are inconsistent regarding the factors affecting prospective memory of patients with depressive disorder. ObjectiveTo explore the impact of target characteristics (emotional valence and salience) on prospective memory in patients with depressive disorder, so as to provide references for the training and recovery of prospective memory function in these patients. MethodsFrom January to December 2022, 53 patients with depressive disorder were recruited from the outpatient department of Inner Mongolia Autonomous Mental Health Center. Meanwhile, 45 healthy individuals were concurrently recruited from surrounding communities as control group. An experiment with a 2 (participant type: depressive disorder, healthy control) ×2 (target salience: salient, non-salient) ×3 (emotional valence: positive, neutral, negative) factorial design was conducted. The positive/neutral/negative emotional pictures from Chinese Affective Picture System (CAPS) were used for emotional stimulation. A dual-task experimental paradigm was adopted, and the response time and accuracy in prospective memory task and ongoing task were recorded for participants with different target characteristics. Results①In the prospective memory task, the main effect of participant type was statistically significant, with the depressive group showing lower accuracy (F=14.892, P<0.01) and longer response time (F=10.642, P=0.002) compared with control group. ② The main effect of target emotional valence on accuracy (F=7.575, P=0.001) and response time (F=3.196, P=0.044) in the prospective memory task was statistically significant. Simple effect analysis revealed that depressive group yielded a shorter response time and higher accuracy rate under negative conditions compared with positive and neutral conditions (P<0.05 or 0.01). ③ The main effect of target salience on accuracy (F=6.659, P=0.012) and response time (F=10.106, P=0.002) in the prospective memory task was also statistically significant, with higher accuracy and shorter response time for salient targets compared with non-salient targets. ConclusionPatients with depressive disorder demonstrate preferential attention to and processing of negative stimuli in prospective memory tasks, while increasing target salience may facilitate spontaneous processing of prospective memory task in patients with depressive disorder. [Funded by Inner Mongolia Health Commission Medical Health Science and Technology Project (number, 202202104)]
10.Current status and influencing factors of insufficient hyperopia reserve in preschool children
Xiaofang HU ; Yan HAN ; Min ZHANG ; Jialu HOU ; Qiaoqian WANG ; Yanyan LUO
International Eye Science 2025;25(6):1026-1032
AIM: To analyze the current status and influencing factors for insufficient hyperopia reserve in preschool children from Changzhi City, Shanxi Province, and to provide reference and basis for myopia prevention and control in this district.METHODS: A stratified cluster random sampling strategy was used to select 2 854 preschool children(5 708 eyes)from 29 child-care centers in Changzhi City between January and May 2024. Hyperopia reserve was assessed through measurements and questionnaire surveys. Totally 2 820 cases(5 640 eyes)were finally included, with 34 cases excluded(32 cases of uncooperativeness and 2 cases of distractibility). The univariate analysis and multivariate Logistic regression were performed to analyze the associated influencing factors of insufficient hyperopia reserve.RESULTS: A total of 580 preschool children with insufficient hyperopia reserve were detected, with an incidence of 20.57%. Logistic regression analysis revealed that male(OR=1.723, 95% CI: 1.419-2.093), maternal myopia(OR=2.210, 95% CI: 1.681-2.906), paternal myopia(OR=1.426, 95% CI: 1.059-1.921), myopia in both parents(OR=2.761, 95% CI: 2.110-3.612), preterm infants(OR=1.740, 95% CI: 1.294-2.342), the mean daily sleep duration <10 h(OR=1.272, 95% CI: 1.024-1.579), and the mean daily outdoor activity time <2 h(OR=1.222, 95% CI: 1.005-1.485)were risk factors for insufficient hyperopia reserve(all P<0.05). Conversely, using blackout curtains during the day and turning off lights at night(OR=0.598, 95% CI: 0.405-0.883)were identified to be protective factors(P<0.05).CONCLUSION: Sex, genetics, gestational age, sleep duration and environmental conditions, and outdoor activity time are potentially associated with insufficient hyperopia reserve in preschool children. Caregivers should prioritize the management of these risk factors to prevent the occurrence of myopia.

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