1.Effect of Zhinao Capsules on Mild and Moderate Sleep Disorders in Alzheimer's Disease Patients with Syndrome of Spleen-kidney Deficiency and Combined Phlegm and Stasis
Hu XI ; Wenming YANG ; Wenting XIE ; Yue YANG ; Shu ZHAI ; Hao LI ; Yulong YANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(20):171-180
ObjectiveTo observe the clinical efficacy and safety of Zhinao capsules in the treatment of mild and moderate sleep disorders in Alzheimer's disease patients with the syndrome of spleen-kidney deficiency and combined phlegm and stasis. MethodsA randomized, double-blind, placebo, controlled clinical trial design was adopted, and 60 Alzheimer's disease patients aged 50-85 years with mild and moderate sleep disorders due to spleen-kidney deficiency and combined phlegm and stasis were included. According to the randomized numble table method, the patients were assigned into a treatment group and a control group (30 in each group, with 29 patients in the treatment group and 28 patients in the control group finally completing the trial). The treatment group was treated with donepezil hydrochloride tablets combined with Zhinao capsules, and the control group was treated with donepezil hydrochloride tablets combined with the simulant of Zhinao capsules for 12 weeks. The Pittsburgh sleep quality index (PSQI), smart bracelet sleep monitoring, epworth sleeping scale (ESS), Mini-Mental State Examination (MMSE), Activities of Daily Living (ADL), and traditional Chinese medicine symptoms were scored. Furthermore, the brain-derived neurotrophic factor (BDNF) and gamma-aminobutyric acid (GABA) levels were measured. ResultsAfter 12 weeks of treatment, the total response rate of clinical efficacy assessment in the treatment group reached 89.7%, which was significantly higher than that (21.4%) in the control group (Z=-5.14, P<0.01). After treatment, the TCM symptom scores declined in both groups (P<0.01), and the scores in the treatment group were lower than those in the control group (P<0.01). After treatment, the treatment group showed decreased total score and seven component scores of the PSQI scale (P<0.05, P<0.01), and the scores in the treatment group were lower than those in the control group (P<0.05, P<0.01). After treatment, the treatment group showed increases in the duration of deep sleep, light sleep, rapid eye movement sleep, and total sleep at night and decreases in the time to fall asleep, the number of awakenings from sleep at night, and the time for sporadic daytime naps (P<0.01). The control group did not show significant changes in the duration of light sleep, time to fall asleep, and number of awakenings from sleep at night. Moreover, the treatment group outperformed the control group in terms of the indicators above (P<0.05, P<0.01). After treatment, the treatment group showed decreased scores of ESS, ADL and its subscales physical self-maintenance scale (PSMS), and Instrumental Activities of daily living scale (IADLs) and increased score of MMSE and levels of BDNF and GABA (P<0.05, P<0.01). There was no significant difference in PSMS between the two groups, and the treatment group was significantly better than the control group in terms of the rest of the above indicators (P<0.05, P<0.01). Patients in neither groups complained of uncomfortable symptoms. ConclusionZhinao capsules have significant clinical efficacy in treating patients with mild and moderate sleep disorders in Alzheimer's disease patients with the syndrome of spleen-kidney deficiency and combined phlegm and stasis. Zhinao capsules can significantly reduce PSQI, ESS, and ADL scores, increase the MMSE score and the expression of BDNF and GABA, effectively optimize the structure of sleep, improve the intelligence, and enhance the ability of daily life, without causing uncomfortable symptoms. The mechanism may be related to the increase in the expression of sleep/wake-related neurotransmitters.
2.Effect of Zhinao Capsules on Mild and Moderate Sleep Disorders in Alzheimer's Disease Patients with Syndrome of Spleen-kidney Deficiency and Combined Phlegm and Stasis
Hu XI ; Wenming YANG ; Wenting XIE ; Yue YANG ; Shu ZHAI ; Hao LI ; Yulong YANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(20):171-180
ObjectiveTo observe the clinical efficacy and safety of Zhinao capsules in the treatment of mild and moderate sleep disorders in Alzheimer's disease patients with the syndrome of spleen-kidney deficiency and combined phlegm and stasis. MethodsA randomized, double-blind, placebo, controlled clinical trial design was adopted, and 60 Alzheimer's disease patients aged 50-85 years with mild and moderate sleep disorders due to spleen-kidney deficiency and combined phlegm and stasis were included. According to the randomized numble table method, the patients were assigned into a treatment group and a control group (30 in each group, with 29 patients in the treatment group and 28 patients in the control group finally completing the trial). The treatment group was treated with donepezil hydrochloride tablets combined with Zhinao capsules, and the control group was treated with donepezil hydrochloride tablets combined with the simulant of Zhinao capsules for 12 weeks. The Pittsburgh sleep quality index (PSQI), smart bracelet sleep monitoring, epworth sleeping scale (ESS), Mini-Mental State Examination (MMSE), Activities of Daily Living (ADL), and traditional Chinese medicine symptoms were scored. Furthermore, the brain-derived neurotrophic factor (BDNF) and gamma-aminobutyric acid (GABA) levels were measured. ResultsAfter 12 weeks of treatment, the total response rate of clinical efficacy assessment in the treatment group reached 89.7%, which was significantly higher than that (21.4%) in the control group (Z=-5.14, P<0.01). After treatment, the TCM symptom scores declined in both groups (P<0.01), and the scores in the treatment group were lower than those in the control group (P<0.01). After treatment, the treatment group showed decreased total score and seven component scores of the PSQI scale (P<0.05, P<0.01), and the scores in the treatment group were lower than those in the control group (P<0.05, P<0.01). After treatment, the treatment group showed increases in the duration of deep sleep, light sleep, rapid eye movement sleep, and total sleep at night and decreases in the time to fall asleep, the number of awakenings from sleep at night, and the time for sporadic daytime naps (P<0.01). The control group did not show significant changes in the duration of light sleep, time to fall asleep, and number of awakenings from sleep at night. Moreover, the treatment group outperformed the control group in terms of the indicators above (P<0.05, P<0.01). After treatment, the treatment group showed decreased scores of ESS, ADL and its subscales physical self-maintenance scale (PSMS), and Instrumental Activities of daily living scale (IADLs) and increased score of MMSE and levels of BDNF and GABA (P<0.05, P<0.01). There was no significant difference in PSMS between the two groups, and the treatment group was significantly better than the control group in terms of the rest of the above indicators (P<0.05, P<0.01). Patients in neither groups complained of uncomfortable symptoms. ConclusionZhinao capsules have significant clinical efficacy in treating patients with mild and moderate sleep disorders in Alzheimer's disease patients with the syndrome of spleen-kidney deficiency and combined phlegm and stasis. Zhinao capsules can significantly reduce PSQI, ESS, and ADL scores, increase the MMSE score and the expression of BDNF and GABA, effectively optimize the structure of sleep, improve the intelligence, and enhance the ability of daily life, without causing uncomfortable symptoms. The mechanism may be related to the increase in the expression of sleep/wake-related neurotransmitters.
3.Microscopic Mechanism of Chronic Liver Disease and Novel Thinking of Medicine Management Based on Theory of "Yang Transforming Qi While Yin Constituting Form-sweat Pore"
Yuying XU ; Changpu ZHAO ; Rongzhi LI ; Yu ZHANG ; Fei WANG ; Chenyuan HAO ; Guangjie SHU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(4):244-255
The theory of "Yang transforming Qi while Yin constituting form" in the Huangdi's Internal Classic is derived from the application, transformation, movement, and balance of Tao. It is highly condensed, revealing the true meaning of Tao and guiding the changes and progress of all natural things, including diseases. Therefore, the appearance of various physical diseases is the manifestation of Yin-Yang Qi transformation. Sweat pore, formed by the Qi transformation of Yin and Yang, is the nourishing and regulating system. It serves as the hub and channel, assisting in the flow and transformation of Qi, facilitating the exchange of material, energy, and information with the outside world. With sweat pore as the hub and based on the macro-control and holistic thinking of "Yang transforming Qi while Yin constituting form", this paper explores the microscopic mechanisms underlying chronic liver disease. In combination with the roles of mitochondria, exosomes, and the ultraliver sieve structure in the formation and progression of chronic liver disease, this paper elucidates the close internal relationship between the disease's initial quality, symptom signs, and its physiological and pathological functions under the guidance of this theory. Modern studies have shown that autophagy, intestinal flora disorders, glucose and lipid metabolism disturbances, activation of inflammatory factors, ferroptosis, and other microscopic pathological mechanisms are involved in the occurrence and development of chronic liver disease. The common connotation of the Yin-Yang concept in traditional Chinese medicine (TCM) and the pathological mechanisms in modern medicine is deeply analyzed. The corresponding relevant microscopic mechanisms and the guiding role of the theory of "Yang transforming Qi while Yin constituting form-sweat pore" in the management of chronic liver disease are summarized. Wind medicine promotes growth and transformation through sweat pore. The combination of pungent and sweet medicines facilitates Yang and disperse Yin. The formulas, combining the characteristics of wind medicine and pungent and sweet medicines, fit the principle of "Yang transforming Qi while Yin constituting form-sweat pore". This paper combines both macro and micro perspectives to explain the scientific connotation and microscopic mechanisms of chronic liver disease based on the theory of "Yang transforming Qi while Yin constituting form-sweat pore", and explore the prevention and treatment of chronic liver disease through the principles, methods, prescriptions, and medicines featured by combination of pungent and sweet medicines, facilitating Yang, activating sweat pore, and dispersing Yin, providing new ideas and reference for the clinical treatment of chronic liver disease.
4.Selection preference and optimization strategy of health intervention in high-risk population of cardiovascular disease in rural area:Based on a Discrete Choice Experiment
Ju SUN ; Wen-jing HAN ; Hao-miao LI ; Shu-zhen ZHU
Chinese Journal of Health Policy 2025;18(6):41-50
Objective:To investigate the selection preference and heterogeneity of intervention measures for high-risk population of Cardiovascular Disease in rural areas,and to provide new empirical evidence and path reference for evidence-based CVD intervention strategies.Methods:Using cluster sampling method,a discrete choice experiment was designed to conduct an offline survey on 345 CVD high-risk subjects in one of the CVD high-risk screening sites in Hubei Province.Mixed logit model was used for data analysis.Results:The attributes of"Primary medical staff+County-level medical staff+Experts above county-level","Monthly or longer","Non-drug intervention","Drug intervention+non-drug intervention","One hour",all significantly increased the probability of high-risk population to choose the project,and"Online"mode and"Personalized service package"will significantly reduce the probability of respondents to choose a solution,there were significant differences in the selection preferences of high-risk population with different gender,age,education level,income level and health status.Conclusion:The rural CVD high-risk population obviously prefer the intervention model with high level of service subject,off-line implementation,low frequency,medium intensity,non-drug intervention or combined with drug intervention,and free basic service content.It is necessary to explore a more efficient and suitable intervention scheme for CVD in rural high-risk population according to the demand-side preference and its heterogeneity.
5.Application value and prospect of artificial intelligence in the diagnosis of gallbladder cancer
Ziming YIN ; Lijia PAN ; Shilei LIU ; Rongqin WANG ; Hao LI ; Zimeng LI ; Yijun SHU ; Wei GONG
Chinese Journal of Digestive Surgery 2025;24(7):862-867
Gallbladder cancer is a highly aggressive malignancy of the biliary system, often diagnosed at the advanced stage due to its insidious early symptoms, leading to poor overall progno-sis. In recent years, the rapid advancement of artificial intelligence (AI) technologies and their inte-gration into medicine have opened new avenues for the early diagnosis and precision treatment of gallbladder cancer. Currently, AI incorporating deep learning algorithm has significantly improved diagnostic sensitivity and specificity in ultrasound, computed tomography, and pathological analysis. However, clinical translation of AI models remains limited by challenges such as insufficient annota-ted data and limited model interpretability. Future research should focus on establishing multi-center data-sharing mechanisms, developing interpretability tools, and optimizing multimodal data integration strategies, thereby promoting the transformation of AI technologies from an auxiliary diagnostic tool to a core component of clinical decision-making.
6.Interpretation of Sectoral Standard Requirements and Test Methods for Orthopaedic Surgical Navigation Equipment Employing Robotic Technology
Qiaohong TANG ; Xiangfeng MENG ; Hao WANG ; Shu LI
Medical Journal of Peking Union Medical College Hospital 2025;16(4):908-915
In recent years,robot-assisted technology has become increasingly sophisticated in the field of orthopedic surgical navigation.To ensure surgical safety and protect patient rights,corresponding products must undergo rigorous and standardized pre-market quality evaluations.In 2023,the National Medical Products Administration issued the sectoral standard YY/T 1901-2023 Requirements and Test Methods for Orthopaedic Surgical Navigation Equipment Employing Robotic Technology.This standard specifies the performance require-ments for robotic orthopedic surgical navigation systems across ten key aspects:general requirements,robotic arm positioning device performance,tracking device performance,system performance,installation repeatability,protective functions,orthopedic powered surgical instruments,liquid cooling,positioning acces-sory requirements,and software requirements.Additionally,it standardizes quality evaluation methods,provi-ding significant guidance for advancing robotic technology,accelerating product market entry,and strengthe-ning regulatory oversight.This article analyzes the key components of the standard to facilitate better quality assessment of products and promote high-quality development within the industry.
7.Interpretation of Sectoral Standard Artificial Intelligence Medical Device—Specific Requirement for Datasets:Color Fundus Images of Diabetic Retinopathy
Yanli ZHANG ; Jing LI ; Xiangfeng MENG ; Shu LI ; Hao WANG
Medical Journal of Peking Union Medical College Hospital 2025;16(4):916-921
In recent years,with the rapid development of the artificial intelligence(AI)medical device industry,regulatory authorities have been continuously strengthening quality control over datasets.In 2024,the National Medical Products Administration(NMPA)issued the significant industry standard YY/T 1949-2024 Artificial Intelligence Medical Devices—Particular Requirements for Datasets:Color Fundus Photographs of Dia-betic Retinopathy,which is China's first specialized standard for evaluating dataset quality in AI medical devices targeting a specific disease area.Under the existing general standards framework for AI medical devices,this standard focuses specifically on diabetic retinopathy fundus photograph datasets,systematically proposing spe-cialized quality requirements and testing methods.Its implementation will provide clear technical guidance for dataset manufacturers,help improve the development quality of AI-assisted diagnostic software for diabetic retinopathy,and promote standardized industry advancement.
8.Application of Cuff Stent in Treatment of Immediate Type Ⅰa Endoleak During Endovascular Aneurysm Repair of Abdominal Aortic Aneurysm
Xiong ZHANG ; Hao HE ; Ming LI ; Quanming LI ; Chang SHU
Chinese Circulation Journal 2025;40(5):469-474
Objectives:To investigate the safety and efficacy of Cuffstent in the treatment of immediate type Ia endoleak during endovascular aneurysm repair(EVAR)of abdominal aortic aneurysm.Methods:The clinical data of 24 patients with immediate type Ia endoleak during EVAR treated with Cuffstent at the Second Xiangya Hospital of Central South University from January 2019 to December 2022 were retrospectively analyzed.There were 18 males and 6 females with a mean age of(70.3±7.1)years.Results:Of the 24 patients,22 underwent conventional proximal Cuffstent implantation,and 2 underwent fenestrated Cuffstent to preserve unilateral renal artery.Emergency EVAR was performed in 7 patients.The procedure was technically successful in all patients.Immediate disappearance of type Ia endoleak was achieved in 23 patients,whereas 1 patient exhibited mild persistent type Ia endoleak,which was managed conservatively with watchful follow-up.All the 24 patients finished an average of(39.0±15.1)months follow-up,and all patients were alive during the follow-up period.Two patients received aortic reintervention,and one patient received thoracic aortic stent graft implantation due to thoracic aortic penetrating ulcer,and one patient received abdominal aortic aneurysm resection and iliac artery stent implantation due to type II endoleak and iliac artery rupture,respectively.There were no other aorta-related complications and reintervention.Conclusions:Proximal addition of Cuffstent for the management of immediate type Ia endoleak during EVAR is safe and effective.
9.Isolation,identification,and biological characterization of enterotoxigenic Escherichia coli from a South China tiger
Jing-ru XU ; Zhi-hao ZHU ; Yu-qi LI ; Si-si FAN ; Ya-li KANG ; Yu-bin ZHUO ; Ling-shan HUANG ; Shu-qi QIU ; XUE-YUXI ; Xiao-ping WU ; Yu-ting LIAO ; Wei-ye LIN ; Xiao-ziyi XIAO ; Xue-jin LI ; Teng-teng CHEN ; Xi-pan LIN ; Kai-xiong LIN ; Ke-wei FAN
Chinese Journal of Zoonoses 2025;41(6):567-573
This study was aimed at identifying the pathogenic bacteria responsible for the death of a young tiger at the Fujian Meihua Mountain South China Tiger Breeding Research Institute.Tissue samples from the lungs,liver,and intestines of the deceased tiger were collected,and the bacteria were cultured inasterile environment.The bacterial strains were characterized according to their morphological and molecular biological properties,including assessment of virulence genes and antibiotic resistance genes,mouse lethality tests,and antibiotic susceptibility evaluations.A predominant bacterial strain isolated from the liver of the deceased tiger was identified as enterotoxigenic Escherichia coli(ETEC)strain Tiger22513F.Phylogenetic analysis of the 16S rRNA gene revealed that the Tiger22513F strain exhibited close genetic similarity to the reference strain ETEC(MF919609.1),with 99.9%nucleotide similarity,and resided on the same evolutionary branch.The Tiger22513F strain contained 11 antibiotic resistance genes(tetA,sul1,sul3,cmlA,floR,blaTEM,blaSHV,blaCMY-2,qnrA,qnrS,and qnrD)along with five virulence genes(VT1,fyuA,tsh,iucD,and ST).Mouse lethality tests indicated significant pathogenicity toward mice,affecting primarily the lungs,liver,and intestines.Antibiotic susceptibility testing demonstrated that this strain exhibited resistance to various classes of beta-lactam antibiotics,as well as quinolones and aminoglycosides.This investigation successfully isolated a multi-drug resistant enterotoxigenic Escherichia coli strain with pronounced pathogenicity from the liver of a deceased tiger;thus providing valuable scientific insights for clinical diagnosis,as well as prevention and control measures,against ETEC infections in South China tigers.
10.Updates and amendments of the Chinese Pharmacopoeia 2025 Edition (Volume Ⅰ)
LI Hao ; SHEN Mingrui ; ZHANG Pang ; ZHAI Weimin ; NI Long ; HAO Bo ; ZHAO Yuxin ; HE Yi ; MA Shuangcheng ; SHU Rong
Drug Standards of China 2025;26(1):017-022
The Chinese Pharmacopoeia is the legal technical standard which should be followed during the research, production, use, and administration of drugs. At present, the new edition of the Chinese Pharmacopoeia is planned to be promulgated and implemented. This article summarizes and analyzes the main characteristics and the content of updates and amendments of the Chinese Pharmacopoeia 2025 Edition(Volume Ⅰ), to provide a reference for the correct understanding and accurate implementation the new edition of the pharmacopoeia.

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