1.Current Status and Optimization Strategies for Investigator Initiated Trial on Traditional Chinese Medicine in the Treatment of Malignant Tumors Conducted by Western Medicine Institutions
Xuechen GENG ; Yanmei LIU ; Qianqian BU ; Qinchang ZHANG ; Dong ZHANG ; Yuquan TAO ; Liu LI ; Ling LI ; Haibo CHENG
Journal of Traditional Chinese Medicine 2025;66(9):878-882
Investigator initiated trial (IIT) represents a primary format for clinical research in traditional Chinese medicine (TCM). As key implementation sites for TCM-based IIT targeting malignant tumors, western medicine institutions often face unique challenges in conducting such studies, which limit their feasibility and standardization. This paper reviews the registration status of TCM-based IIT for malignancies conducted in western medical institutions and analyzes key difficulties, including complex project initiation and management processes, limited TCM knowledge and skills among western medicine physicians, and relatively low patient acceptance of TCM. From a practical perspective, the study proposes several optimization strategies. These include improving the review and management mechanisms of TCM-related IIT within western medical institutions, establishing multidisciplinary clinical research teams that integrate TCM and western medicine, and enhancing investigators' training in TCM theory and clinical skills. Additionally, the study suggests standardizing IIT operational procedures, objectifying the collection of TCM diagnostic information, refining subject recruitment methods, and increasing TCM involvement in patient follow-up and management. These investigator-oriented, TCM-featured, and operable strategies aim to promote the high-quality development of TCM-based IIT in western medicine institutions and enhance the clinical application of TCM.
2.Analysis on current status of registered clinical trials of TCM prevention and treatment for malignant tumors
Qianqian BU ; Xuechen GENG ; Changshun ZHOU ; Guannan ZHANG ; Liu LI ; Yanmei LIU ; Ling LI ; Haibo CHENG
International Journal of Traditional Chinese Medicine 2025;47(7):985-991
Objective:To analyze the current status of clinical research registration on TCM prevention and treatment of malignant tumors in the Chinese Clinical Trail Registry (ChiCTR); To summarize its characteristics and shortcomings.Methods:Clinical studies on the TCM prevention and treatment for malignant tumors registered from the establishment of ChiCTR database to July 15, 2024 were retrieved. Excel 2019 software was used to sort out the data, including basic research information (registration time, registration number status, registration title, test organizer, research implementation location, etc.), design scheme (disease type, research type, intervention measures, sample size, blind method, etc.), research funding or material sources, as well as other information such as human specimen collection and recruitment of research objects. SPSS 27.0 software was used for frequency statistics.Results:A total of 891 registered studies were included, including 783 interventional studies and 108 observational studies; the areas with a large number of registrations were mainly Shanghai, Beijing, Guangdong Province, etc. ; the research funds mainly came from local finance; a total of 46 tumor diseases were involved in the study, with the largest number of lung cancer (209 items), followed by tumor-related syndromes (155 items), colorectal cancer (148 items), and breast cancer (136 items); the type of research design was mainly random parallel control; the main intervention measures were TCM decoction or herbal decoction pieces (373 items), and the dosage form was mostly decoction (216 items), followed by granules (94 items); single-blind or double-blind design was used in 217 registered trials; 663 registration trials involved the collection of human samples.Conclusions:The number of clinical research registrations on the TCM prevention and treatment for malignant tumors is increasing day by day. The shortcomings such as insufficient standardization of research design and lack of research transparency still exists. In the future, TCM researchers need to strengthen cooperation with international traditional medicine clinical trial registry, giving full play to the leading role of standardization of TCM trials, and using registration as a starting point to improve the quality of clinical research.
3.Correlation of corneal α angle and κ angle with lens tilt angle using swept-source optical biometry
Zi-Suo LI ; Zi-Han HE ; Jie ZHOU ; Jian-Feng ZHAO ; Xiao-Ling LUO ; Ya-Li FENG ; Chen YANG ; Yu GENG
Medical Journal of Chinese People's Liberation Army 2025;50(9):1083-1088
Objective To investigate the correlation of corneal α angle and κ angle with lens tilt in normal human eyes using a new swept-source optical biometer.Methods A cross-sectional study was conducted,involving 303 healthy eyes(148 right eyes and 155 left eyes)of patients who visited the First Affiliated Hospital of Kunming Medical University from June to August 2024.ZW-30 swept-source optical biometer was used to collect the lens tilt angle,κ angle(distance from the corneal light reflex to the pupil center),and α angle(distance from corneal light reflex to the corneal geometric center,which is the midpoint of the horizontal white to white(WTW)diameter).The degrees(°)and directions of κ angle and α angle were calculated by the ratio of the above measurements to the anterior chamber depth(ACD)respectively.Spearman correlation analysis and linear regression analysis were employed to evaluate the correlations between the magnitude and direction of corneal α angle,κ angle and lens tilt angle.Results The magnitude and direction of corneal α angle,κ angle,and lens tilt angle in the right eye were as follows respectively:(0.54±0.19)mm(7.81°±3.88°),194.43°±39.75°;(0.27±0.23)mm(4.72°±3.90°),181.07°±79.59°;5.52°±1.67°,188.21°±25.73°.For the left eye,the corresponding values were:(0.47±0.27)mm(8.12°±5.26°),336.04°±46.64°;(0.26±0.27)mm(4.45°±4.80°),322.86°±107.79°;5.50°±1.61°,340.65°±32.84°.Spearman's correlation analysis showed that the correlation coefficients between corneal α angle and lens tilt angle in the right eye were 0.609(distance correlation)and 0.625(angle correlation),while those for κ angle were 0.559(distance correlation)and 0.578(angle correlation).In the left eye,the correlation coefficients between corneal α angle and lens tilt angle were 0.545(distance correlation)and 0.552(angle correlation),and those for κ angle were 0.377(distance correlation)and 0.395(angle correlation).In addition,the correlation coefficient between the direction of corneal α angle and the direction of lens tilt angle in the right eye was 0.343,and that for κ angle direction was 0.284;in the left eye,the correlation coefficients were 0.216(α angle direction)and 0.198(κ angle direction),all with statistical significance(P<0.05).Univariate linear regression analysis showed that lens tilt was positively correlated with both corneal α angle and Kappa angle(P<0.05).Conclusions Corneal α angle and κ angle are highly correlated with lens tilt angle in both eyes,and the correlation of corneal α angle is stronger than that of κ angle in both left and right eyes.The correlation expressed by degree(°)is better than that by distance(mm).It is recommended to refer to the corneal α angle and κ angle expressed in degrees during preoperative evaluation.
4.Recommendations for the clinical use of anti-amyloid-β monoclonal antibody for Alzheimer's disease(2025)
Nan ZHI ; Jinwen XIAO ; Rujing REN ; Binyin LI ; Jintao WANG ; Jieli GENG ; Wenwei CAO ; Yaying SONG ; Hualong WANG ; Shuguang CHU ; Guoping PENG ; Jun LIU ; Xiaoyun LIU ; Fang YUAN ; Wen WANG ; Ronghua DOU ; Xia LI ; Ling YUE ; Wenshi WEI ; Xiaoling PAN ; Xiangyang ZHU ; Dian HE ; Weinü FAN ; Jingping SHI ; Nan ZHANG ; Hui ZHAO ; Qin CHEN ; Cuibai WEI ; Xiaochun CHEN ; Gang WANG
Journal of Chongqing Medical University 2025;50(9):1133-1140
In recent years,significant breakthroughs have been achieved in the immunotherapy for Alzheimer's disease.In line with global advancements,two anti-amyloid-β monoclonal antibodies have been approved and successfully launched in China for clinical use.Lecanemab and Donanemab were officially used in June 2024 and April 2025 in China,respectively.In order to standardize the rational and safe application of anti-amyloid-β monoclonal antibodies for Alzheimer's disease in China,this article integrates recom-mendations from the clinical trials and real-world experience from the author's team and domestic peers to further update the recom-mendations for the clinical use of anti-amyloid-β monoclonal antibody based on the 2024 version.It includes indications for therapy,pre-treatment evaluation and preparation,administration protocols and safety measures during treatment,and post-treatment monitor-ing strategies.
5.Effect of ginsenoside Rg3 on polycystic ovary syndrome in rats via regulation of the Nrf2/HO-1-mediated endoplasmic reticulum stress pathway
Wei GUO ; Hui WANG ; Ling GENG
Chinese Journal of Endocrinology and Metabolism 2025;41(8):681-690
Objective:To investigate the effect of ginsenoside Rg3(G-Rg3) on ovarian injury in polycystic ovary syndrome(PCOS) rats and its mechanism.Methods:(1)SD rats were divided into Control group, PCOS group, G-Rg3 low-dose group(G-Rg3-L, 5 mg/kg), G-Rg3 high-dose group(G-Rg3-H, 20 mg/kg), and positive control metformin group(Met, 100 mg/kg), with 12 rats per group.(2)SD rats were divided into Control group, PCOS group, G-Rg3-H group, Nrf2 inhibitor group(ML385, 30 mg/kg), G-Rg3-H+ Nrf2 inhibitor group(G-Rg3-H+ ML385), with 12 rats per group. Except the Control group, other groups were established as PCOS models using letrozole gavage. After successful model establishment, rats received the respective interventions once daily for 21 consecutive days. The body weight, uterine weight, ovarian weight, fasting blood glucose(FBG) and fasting insulin(FINS) levels in rats were measured. Serum levels of follicle stimulating hormone(FSH), luteinizing hormone(LH), progesterone(P), testosterone(T), estradiol(E 2), as well as inflammatory cytokines IL-17, IL-6, TNF-α, IL-18 levels were detected by ELISA method. HE staining observed ovarian histopathological changes. The ultrastructural changes of ovarian tissue were observed by transmission electron microscopy. Western blot and immunohistochemistry were used to detect endoplasmic reticulum stress-related proteins and Nrf2/HO-1 pathway proteins expression. Results:Compared with Control group, PCOS group showed abnormal estrous cycles, increased body weight, ovarian weight, FBG and FINS levels, decreased uterine weight, marked histopathological damage in the ovaries, decreased FSH, E 2, P, increased LH, T, IL-17, IL-6, TNF-α, IL-18, elevated GRP78, CHOP, p-IRE1α and p-eIF2α proteins expression, and decreased Nrf2 and HO-1 proteins expression. Compared with the PCOS group, all medication-treated groups showed significant improvement in the aforementioned parameter alterations, while the ML385 group showed further deterioration in these parameters. In contrast to the G-Rg3-H group, G-Rg3-H+ ML385 combination treatment was found to inhibit the activation of the Nrf2/HO-1 pathway and reverse the protective effects of G-Rg3 on ovarian histopathological damage in PCOS rats. Conclusion:G-Rg3 alleviates ovarian injury in PCOS rats by activating the Nrf2/HO-1 pathway, suppressing endoplasmic reticulum stress, reducing inflammation, and modulating hormone secretion.
6.Clinical analysis of pediatric renal abscess
Jinshan SUN ; Chaoying CHEN ; Juan TU ; Haiyun GENG ; Huarong LI ; Ling WAN ; Yuchun YAN
Chinese Journal of Pediatrics 2025;63(5):524-528
Objective:To analyze the clinical characteristics of renal abscess in children and provide suggestions for early diagnosis and treatment.Methods:The clinical data including general information, laboratory data, imaging results, treatment and prognosis of 20 pediatric patients with renal abscess admitted to the Department of Nephrology, Capital Center for Children's Health Capital Medical University were analyzed retrospectively.Results:A total of 8 males and 12 females were enrolled. The age of onset was 3.0 (0.8, 9.0) years. All cases had fever. Six cases presented with abdominal pain, 6 cases had poor appetite, 5 cases had vomiting and 5 cases urinary tract irritation symptoms. Laboratory data showed elevated white blood cells 20.4 (17.4,26.3)×10 9/L, C-reactive protein 126 (77, 154)mg/L, erythrocyte sedimentation rate 60 (41,73) mm/1 h in 20 cases and procalcitonin 4.7 (1.2,33.5)μg/L in 10 cases. Totally 18 cases had pyuria. Urine culture was positive in 8 cases. Enterococcus faecium and Pseudomonas aeruginosa was detected in 2 cases. Klebsiella pneumoniae was found in 1 case after performing blood culture. Renal abscess was confirmed in all cases by doing contrast-enhanced CT scan, while only 9 cases with abscesses were identified by using renal ultrasound. There were 14 cases with renal abscess formation confirmed at onset by performing magnetic resonance imaging. Nine cases were accompanied with congenital anomalies of the kidney and urinary tract. All cases received conservative medical treatment. Intravenous broad-spectrum antibiotics were administered for 23 (14, 39) d initially, while the medication in 11 cases were upgraded to meropenem or imipenem. Oral antibiotics were continued for 23 (14, 28) d after discharge in all cases. Within 1 year of follow-up, except for 1 case of recurrence, the others had a favorable prognosis. Conclusions:Renal abscess should be suspected for children presenting with unexplained fever, vomiting, abdominal pain, elevated white blood cell count, C-reactive protein, erythrocyte sedimentation rate and pyuria. Ultrasonography is suitable for screening and follow-up, while CT or magnetic resonance imaging can be used to confirm the diagnosis. Conservative management with broad-spectrum antibiotics is effective and can be considered the first-line therapy for pediatric renal abscess.
7.Analysis of the characteristics of patients with road traffic accident injuries treated by pre-hospital emergency services in Beijing
Guifang DENG ; Ling GENG ; Tao SUN ; Yujie SHEN ; Min ZHAO ; Jingjing LI ; Hui CHEN
China Modern Doctor 2025;63(31):27-30
Objective To understand the epidemiological characteristics of road traffic accident injuries in Beijing can provide a theoretical basis for improving the pre-hospital emergency service capabilities and levels,and increasing patient survival rates while reducing disability,mortality rates.Methods A retrospective analysis was conducted on the medical records of 9207 patients who made pre-hospital emergency calls due to road traffic accident injuries at the Beijing Emergency Medical Center in 2023 to understand the patients' age,gender,injury time,injury location,injury degree and other characteristics.Results Traumatic diseases ranked first in the classification of emergency medical conditions in Beijing.Among them,road traffic accidents account for 37%.The ratio of male to female patients was 1.32∶1.The largest number of patients were aged 31-40,accounting for nearly 25%.The proportion of underage patients and those aged 71 and above was 12.16%.The differences in gender and age distribution were statistically significant,while the differences in gender distribution among different age groups were not statistically significant.Road traffic accident injuries occured most frequently in September and least in January.There were more cases in summer and autumn,and fewer in winter and spring.The most common injury sites in road traffic accidents were limbs/skin and head and neck,accounting for 81.06%.The patients with moderate severity of injuries were the most numerous,accounting for 85.29%.Conclusion To avoid road traffic accidents,prevention should be the priority.It is necessary to strengthen the joint governance of multiple departments and minimize the occurrence of road traffic accident from the source.Pre-hospital emergency care must focus on key populations and key seasons,strengthen professional skills training and resource allocation,ensure efficient and smooth connection between pre-hospital and in-hospital care.Popularize and publicize the importance of self-rescue and mutual rescue,promote first aid knowledge and skills training for the public,and create a social atmosphere where"rescue is right beside us".
8.A study on the characteristics of body temperature among Chinese elderly and their correlationwith health status
Wei LING ; Yangfu OU ; Lijun GENG ; Yanhong PAN ; Xinnan SONG
Chinese Journal of Geriatrics 2025;44(9):1277-1283
Objective:This study aims to explore the characteristics of body temperature(BT)of the elderly population in China and the relationship with health status.Methods:This is a cross-sectional study.The data were derived from the China Health and Nutrition Study(CHNS)in 2015.A total of 4 176 elderly people over 60 years old were enrolled for analysis(1968 males, and 2208 females). The participants were divided into three groups according to their BT values: hypothermia group(BT<36.5℃), moderate BT group(36.5℃≤BT<37.0℃), and hyperthermia group(37.0℃≤BT<37.5℃). The differences in health status among each group were compared based on the disease conditions(four-week prevalence rate)in the past four weeks.Multivariate logistic regression analysis was performed to explore the relationships between BT and the four-week prevalence rate.Results:Among the elderly population included in the analysis, the average age was 68.4 ± 6.9 years(ranging from 60 to 99 years). The average BT of the elderly was 36.40 ± 0.37℃(males: 36.42 ± 0.37℃; females: 36.38 ± 0.37℃).3 348 study subjects were aged between 60-74 years old, while 828 study subjects were aged between75-99 years old.The older the age, the lower the body temperature.Of the participants, 2 212(53.0%)elderly people belonged to the hypothermia group, 1 656(39.6%)belonged to the moderate BT group, and 308(7.4%)belonged to the hyperthemia group.Among 4 176 elderly people, a total of 1368 had suffered from disease in the past four weeks(31.3%)The four-week prevalence rates of each group were as follows: the hypothermia group(33.1%), the moderate BT group(29.8%); hyperthemia group(26.6%)( χ2=8.403, P=0.015). Multivariable logistic regression analysis indicated that for every 1℃ increases in BT among the elderly, the four-week prevalence rate decreased by 22%( OR=0.78, 95% CI=0.65-0.94, P=0.01). Conclusions:The BT of the elderly is generally lower than the current standard, and the lower the BT, the higher the four-week prevalence rate.Raising the BT of the elderly may help them improve their physical condition.
9.Research progress on the role and mechanism of PANoptosis in lung diseases.
Yumei KANG ; Tao YANG ; Ling DING ; Lei WANG ; Licheng GENG ; Jiangang XU
Chinese Critical Care Medicine 2025;37(7):688-692
PANoptosis is a newly defined type of programmed cell death (PCD), which is triggered by a variety of stimuli and covers three known forms of PCD: apoptosis, pyroptosis and necroptosis. In physiological state, cell death plays an important protective role against pathogen invasion, but its over-activation may aggravate inflammatory response and cause tissue damage. Studies have shown that the occurrence and progression of acute lung injury/acute respiratory distress syndrome (ALI/ARDS), asthma, chronic obstructive pulmonary disease (COPD) and other lung diseases are closely related to PANoptosis. The purpose of this review is to deeply explore the molecular mechanism of PANoptosis and its regulatory factors in lung diseases, in order to discover potential therapeutic targets and provide new targets and innovative ideas for clinical treatment for lung diseases.
Humans
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Lung Diseases
;
Apoptosis
;
Pyroptosis
;
Pulmonary Disease, Chronic Obstructive
;
Necroptosis
;
Acute Lung Injury
10.Lumbar Spondylolysis in Chinese Adults: Prevalence and Musculoskeletal Conditions.
Dong YAN ; Yan Dong LIU ; Ling WANG ; Kai LI ; Wen Shuang ZHANG ; Yi YUAN ; Jian GENG ; Kang Kang MA ; Feng Yun ZHOU ; Zi Tong CHENG ; Xiao Guang CHENG
Biomedical and Environmental Sciences 2025;38(5):598-606
OBJECTIVE:
To determine the prevalence of lumbar spondylolysis (LS) and the proportion of spondylolytic spondylolisthesis (SS) in China, and to evaluate the musculoskeletal status of patients with LS and SS.
METHODS:
Spine Computed Tomography (CT) images were collected from community populations aged 40 and above in a nationwide multi-center project. LS was diagnosed, and SS was graded by an experienced radiologist. Bone mineral density (BMD) and paraspinal muscle parameters were quantified based on CT images.
RESULTS:
One hundred and seventeen patients of a total of 3,317 individuals were diagnosed with LS, corresponding to a prevalence rate of 3.53%. 63 of the 1,214 males (5.18%) and 54 of the 2,103 females (2.57%) were diagnosed with LS. SS occurred in 64/121 vertebrae (52.89%). BMD was not associated with LS ( P = 0.341). The L5 extensor paraspinal muscle density was higher in the LS group than in the non-LS group. In the LS group, patients with SS had a smaller L5 paraspinal extensor muscle cross-sectional area than those without SS ( P = 0.003).
CONCLUSION
The prevalence of LS in Chinese adults was 3.53%, with prevalence rates of 5.18% in males and 2.57% in females. Patients with LS have higher muscle density, whereas those with SS have smaller muscle cross-sectional areas at the L5 level.
Humans
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Male
;
Female
;
Middle Aged
;
China/epidemiology*
;
Prevalence
;
Adult
;
Lumbar Vertebrae/diagnostic imaging*
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Spondylolysis/diagnostic imaging*
;
Aged
;
Bone Density
;
Tomography, X-Ray Computed
;
Aged, 80 and over
;
Spondylolisthesis/epidemiology*
;
East Asian People

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