1.Research on the standardization of “Indications”in package inserts for Chinese patent medicines
Meiwei ZHANG ; Keqian LI ; Keyu YAO ; Yan ZHU
China Pharmacy 2025;36(5):513-518
OBJECTIVE To promote the standardization of the “Indications” section in package inserts for Chinese patent medicines and ensure rational clinical and patient use. METHODS The “Function and Indications” information of package inserts for Chinese patent medicines was retrieved and collected from the 2020 edition of the Chinese Pharmacopoeia (Volume Ⅰ) and various national and regional standards. Identification criteria were established for syndrome, pathogenesis, disease name, and symptom terminology in the “Indications” section. Microsoft Office Access 2021 was utilized to create query tables for manual extraction of terminological elements, followed by the construction of a three-tier classification system for “Indications” descriptions. A standardized template for “Indications” was developed through quantitative analysis. RESULTS & CONCLUSIONS A total of 9 851 valid package inserts for Chinese patent medicines were included. Among these, the majority (7 991) contained symptom terminology, followed by disease names (5 867) and pathogenesis descriptions (5 167). Within disease name terminology, Western medical disease names predominated (4 446), followed by traditional Chinese medicine disease names (2 018). The “Function and Indications” content of 6 962 package inserts complied with existing requirements. Notably, the secondary classifications of “disease name”, as well as the tertiary classification of “disease name+symptoms” and “symptoms”, failed to meet established standards. Two standardized templates for “Indications” were formulated based on pathogenesis and syndrome:“pathogenesis+disease name+symptoms” and “disease name+syndrome+symptoms”. The “Indications”section should provide complete and accurate information, adhere to standardized formatting, and employ appropriate conjunctions and punctuation. For non-prescription patent medicines, package inserts should be categorized into professional and patient versions. These measures will facilitate the standardization of “Indications” descriptions and advance the overall package inserts for Chinese patent medicines documentation.
2.Global Status of Antimicrobial Resistance and Corresponding Therapeutic Strategies
Medical Journal of Peking Union Medical College Hospital 2025;16(5):1073-1081
With the widespread use of antimicrobial agents, the issue of microbial drug resistance has become increasingly severe, emerging as a major global public health challenge. Worldwide, there are significant differences in the types of drug-resistant bacteria, their epidemiological trends, and their resistance mechanisms. This article aims to review the current global status of microbial drug resistance, with a focus on the epidemiological trends, resistance mechanisms, and corresponding clinical treatment strategies for common drug-resistant bacteria and fungi, in order to provide a theoretical basis for promoting the rational use of antimicrobial agents.
3.Equivalence of SYN008 versus omalizumab in patients with refractory chronic spontaneous urticaria: A multicenter, randomized, double-blind, parallel-group, active-controlled phase III study.
Jingyi LI ; Yunsheng LIANG ; Wenli FENG ; Liehua DENG ; Hong FANG ; Chao JI ; Youkun LIN ; Furen ZHANG ; Rushan XIA ; Chunlei ZHANG ; Shuping GUO ; Mao LIN ; Yanling LI ; Shoumin ZHANG ; Xiaojing KANG ; Liuqing CHEN ; Zhiqiang SONG ; Xu YAO ; Chengxin LI ; Xiuping HAN ; Guoxiang GUO ; Qing GUO ; Xinsuo DUAN ; Jie LI ; Juan SU ; Shanshan LI ; Qing SUN ; Juan TAO ; Yangfeng DING ; Danqi DENG ; Fuqiu LI ; Haiyun SUO ; Shunquan WU ; Jingbo QIU ; Hongmei LUO ; Linfeng LI ; Ruoyu LI
Chinese Medical Journal 2025;138(16):2040-2042
4.Application progress on functional insoles in the prevention and treatment of diabetic foot.
Heng-Yu LIU ; Zhen-de JIANG ; Yao-Kuan RUAN ; Qiu-Ju LI ; Si-Yuan CHEN ; Shun-Yu WEI ; Nan MEI ; Chou WU ; Fei CHANG
China Journal of Orthopaedics and Traumatology 2025;38(9):969-975
Diabetic foot (DF) is one of the most serious chronic complications of diabetes. The incidence rate among global diabetes patients is as high as 15% to 25%, and about 50% of patients will develop contralateral foot ulcers within 5 years after the first unilateral ulcer. As a non-invasive prevention and control solution, the application progress of functional insoles is mainly reflected in the following aspects:(1) Material innovation. The application of new composite materials and smart materials has significantly enhanced the pressure reduction effect and comfort. (2) Structural optimization. The development of multi-layer design and local pressure reduction structure has achieved more precise pressure distribution regulation. (3) Manufacturing process. 3D printing and parametric design have enabled the personalized customization of functional insoles. (4) Intelligent monitoring. It integrates functions such as pressure sensing and temperature monitoring, achieving real-time monitoring and early warning of foot conditions. Clinical research has confirmed that personalized functional insoles could reduce the incidence of foot ulcers and shorten the healing time of ulcers. At present, the research hotspots mainly focus on the development of smart materials, the construction of multi-functional integration and remote monitoring systems. However, in-depth research is still needed in the aspects of biomechanical mechanisms, standardized evaluation systems and long-term efficacy assessment. The development of future functional insoles should focus on the coordinated advancement of "personalization-intelligence-standardization", with the aim of providing more effective solutions for the prevention and treatment of DF.
Humans
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Diabetic Foot/therapy*
;
Foot Orthoses
5.Air pollution and adult hospital admissions for ischemic stroke: a time-series analysis in Inner Mongolia, China.
Sen FENG ; Chunhua LI ; Yujing JIN ; Haibo WANG ; Ruying WANG ; Zakaria Ahmed MOHAMED ; Yulong ZHANG ; Yan YAO
Environmental Health and Preventive Medicine 2025;30():29-29
BACKGROUND:
Previous studies have demonstrated that short-term exposure to ambient particulate matter elevates the risk of ischemic stroke in major urban areas of various countries. However, there is a notable gap in research focusing on remote areas inhabited by ethnic minorities and the cumulative effects of air pollutants. Our study conducted in the area aims to explore the potential association between ischemic stroke and air pollutants and contribute to improving health outcomes among the community.
METHODS:
This retrospective observational study was conducted at the Xing'an League People's Hospital in Inner Mongolia. The medical records of 4,288 patients admitted for IS between November 1, 2019, and October 31, 2020, were reviewed. Data on demographics (age and sex), air pollutants (PM10, PM2.5, NO2, NO, CO, and O3), and meteorological factors (daily average temperature, daily average wind speed, and daily average atmosphere pressure) were collected and analyzed. The statistical analysis included descriptive statistics, Poisson distribution analysis to evaluate the adverse effects of atmospheric pollutants on daily hospitalizations, and subgroup analysis to determine whether gender and age could modify the impact on hospitalizations.
RESULTS:
A substantial correlation was revealed in single-day lags model. The peak delayed effects of PM10, PM2.5, SO2, and NO2 were observed at lag8 (PM10 (OR = 1.016, 95%CI 1.002, 1.030), PM2.5 (OR = 1.027, 95%CI 1.007, 1.048), SO2 (OR = 1.153, 95%CI 1.040, 279) and NO2 (OR = 1.054, 95%CI 1.005, 1.105)) while males exhibited a consistent trend from lag0 to lag8 (PM10 (OR = 1.035, 95%CI 1.018, 1.053), PM2.5 (OR = 1.056, 95%CI 1.030, 1.082), SO2 (OR = 1.220, 95%CI 1.072, 1.389), NO2 (OR = 1.126, 95%CI 1.061, 1.120), CO (OR = 10.059, 95%CI 1.697, 59.638) and O3 (OR = 0.972, 95%CI 0.946, 0.999)). When gender and age were considered, a positive impact was also observed after three days cumulative effect in males.
CONCLUSIONS
There is a significant cumulative effect of exposure to air pollution on IS hospital admissions, especially the males and patients under the age of 65. Our results also suggested that a notable association between CO and NO2 in two-pollutant models.
Humans
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Male
;
Female
;
Air Pollution/analysis*
;
China/epidemiology*
;
Retrospective Studies
;
Middle Aged
;
Air Pollutants/analysis*
;
Aged
;
Particulate Matter/analysis*
;
Hospitalization/statistics & numerical data*
;
Adult
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Ischemic Stroke/chemically induced*
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Environmental Exposure/adverse effects*
;
Aged, 80 and over
6.Advanced bioanalytical techniques for pharmacokinetic studies of nanocarrier drug delivery systems.
Xiangjun MENG ; Jiayi YAO ; Jingkai GU
Journal of Pharmaceutical Analysis 2025;15(1):101070-101070
Significant investment in nanocarrier drug delivery systems (Nano-DDSs) has yielded only a limited number of successfully marketed nanomedicines, highlighting a low rate of clinical translation. A primary contributing factor is the lack of foundational understanding of in vivo processes. Comprehensive knowledge of the pharmacokinetics of Nano-DDSs is essential for developing more efficacious nanomedicines and accurately evaluating their safety and associated risks. However, the complexity of Nano-DDSs has impeded thorough and systematic pharmacokinetic studies. Key components of pharmacokinetic investigations on Nano-DDSs include the analysis of the released drug, the encapsulated drug, and the nanomaterial, which present a higher level of complexity compared to traditional small-molecule drugs. Establishing an appropriate approach for monitoring the pharmacokinetics of Nano-DDSs is crucial for facilitating the clinical translation of nanomedicines. This review provides an overview of advanced bioanalytical methodologies employed in studying the pharmacokinetics of anticancer organic Nano-DDSs over the past five years. We hope that this review will enhance the understanding of the pharmacokinetics of Nano-DDSs and support the advancement of nanomedicines.
7.Xuefu Zhuyu Capsules Ameliorate Atherosclerosis in Mice by Regulating Sirt3/EPAC1 Signaling Pathway
Bo YAO ; Hengwen CHEN ; Jiyu GONG ; Xuanhui HE
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(21):31-41
ObjectiveTo observe the effects of Xuefu Zhuyu capsules (XFZY) on blood lipid levels and aortic plaques in the mouse model of atherosclerosis (AS) induced by a high-fat diet by regulating the silencing regulatory factor 2-like protein 3 (Sirt3)/exchange protein directly activated by cAMP 1 (EPAC1) signaling pathway and explore the mechanism of XFZY in ameliorating AS. MethodMice were assigned into normal, model, blank, rosuvastatin (0.05 g·kg-1·d-1), and low-, medium-, and high-dose (0.3, 0.6, 1.2 g·kg-1·d-1, respectively) XFZY groups. The normal group consisted of normal C57BL/6J mice, while the other groups consisted of ApoE-/- C57BL/6J mice. The normal group and blank group were fed routinely, and the rest groups were fed with a high-fat diet for 24 consecutive weeks for the modeling of AS. The drug intervention groups were administrated with corresponding drugs by gavage, and model group and blank group with an equal volume of deionized water for 6 consecutive weeks. The small animal B-ultrasound was used to evaluate the mouse heart function and aortic plaque condition. A fully automated biochemical analyzer was used to measure the levels of blood lipids such as total cholesterol (CHOL), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and extremely low-density lipoprotein (VLDL) in mice. Oil red O staining was employed to observe lipid deposition in the aorta. Hematoxylin-eosin staining and Masson staining were employed to observe the pathological changes and collagen deposition in mouse blood vessels. Transmission electron microscopy was employed to observe the mitochondrial damage in mouse aorta. The levels of adrenocorticotropic hormone (ACTH), adenosine triphosphate (ATP), and nicotinic choline receptor α1 (CHRNα1), and total superoxide dismutase (T-SOD) were measured by enzyme-linked immunosorbent assay (ELISA). Real-time fluorescence quantitative polymerase chain reaction (Real-time PCR) and Western blot were performed to determine the mRNA and protein levels, respectively, of Sirt3, EPAC1, Caspase-3, B-cell lymphoma-2 (Bcl-2), and Bcl-2-associated X protein (Bax) in the mouse aorta and heart. ResultMultiple AS plaques were observed in the aortic arch, indicating that the model was successfully established. Compared with the model group, the XFZY groups showed reduced and narrowed plaques. Compared with the normal group, the model group showed elevated CHOL level (P<0.01). Compared with the model group, rosuvastatin and low-dose XFZY lowered the CHOL and TG levels (P<0.01). Compared with the normal group, the model group presented a large number of protruding red lipid plaques on the aortic wall and increased percentage of AS plaque area to total tissue area (P<0.01). Compared with the model group, low-dose XFZY reduced the plaque load (P<0.05). Compared with the model group, XFZY at different doses reduced the lipid plaques and collagen deposition. Compared with the normal group, the model group showed decreased or disappeared mitochondrial cristae and presented severe damage of the membrane structure in endothelial cells. The mitochondria of endothelial cells in each treatment group approached the normal structure, with mitochondrial cristae faintly visible. Compared with the normal group, the model group showcased reduced myocardial mitochondrial ATP activity (P<0.01), which were rescored in the drug intervention groups (P<0.01). Compared with the normal group, the modeling inhibited the expression of Sirt3 (P<0.01) and promoted the expression of EPAC1 (P<0.01). Compared with the model group, low-dose XFZY increased the Sirt3 content (P<0.01) and medium-dose XFZY increased the EPAC1 content (P<0.01), which indicated that XFZY treatment upregulated the mRNA and protein levels of Sirt3 and downregulated the mRNA and protein levels of EPAC1. ConclusionXFZY can alleviate the aortic lipid deposition, reduce the AS plaque area, improve the mitochondrial morphology and functions in endothelial cells, increase the ATP activity, upregulate the expression of Sirt3, and downregulate the expression of EPAC1 in AS mice by regulating mitochondrial energy metabolism via the Sirt3/EPAC1 signaling pathway.
8.Association Between Ferroptosis and Central Nervous System Diseases and A Review of Traditional Chinese Medicine Intervention
Hao LIU ; Hanying XU ; Zhong SHI ; Fan YAO ; Ziyue TIAN ; Tianye LAN ; Weimin ZHAO
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(5):246-256
Central nervous system (CNS) is a sophisticated system subject to complex regulation, which dominates the high-level neural activities of the human body. Due to its complex physiological structure and refined regulatory mechanism covering a variety of diseases, CNS is the place where many chronic, refractory and rare diseases occur. Nerve cell is the basic unit of CNS, and its dysfunction and death is the root cause of CNS diseases. Ferroptosis is a new form of programmed cell death proposed in recent years, and has been proved to be closely related to the production and development of multiple CNS diseases. Traditional Chinese medicine (TCM), including Chinese herbs, acupuncture and moxibustion, and massage, has shown unique advantages in the treatment of CNS diseases for a long time. A large number of studies have demonstrated that TCM participates in the regulation of CNS diseases via regulating ferroptosis and shows a good research prospect. This paper summarized the characteristics of ferroptosis and discussed the association between ferroptosis and CNS diseases in pathological mechanism. We also reviewed the regulation of various CNS diseases by different TCM interventions through ferroptosis, providing references for TCM to participate in the treatment of CNS diseases properly in the future.
9.Effect of electroacupuncture at the acupoints for Tiaozang Xingshen on cerebral metabolism in the patients with type 2 diabetes mellitus-associated cognitive dysfunction.
Lin YAO ; Yan-Ze LIU ; Meng-Yuan LI ; Zi-Yang ZHANG ; Shuo YU ; Shu-Nan SUN ; Ming XU ; Hai-Zhu ZHENG ; Shi-Qi MA ; Zhen ZHONG ; Hong-Feng WANG
Chinese Acupuncture & Moxibustion 2023;43(12):1343-1350
OBJECTIVES:
To investigate the cerebral metabolism in the patients with type 2 diabetes mellitus-associated cognitive dysfunction (T2DACD) and explore the mechanism of electroacupuncture (EA) at the acupoints for Tiaozang Xingshen (adjusting zangfu function and rescuing the spirit) in treatment of T2DACD, using magnetic resonance spectroscopy.
METHODS:
Fifteen patients with T2DACD (observation group) and 22 healthy subjects (control group) were enrolled. In the observation group, the patients were treated with EA for Tiaozang Xingshen at Baihui (GV 20) and Shenting (GV 24), and bilateral Feishu (BL 13), Pishu (BL 20), Shenshu (BL 23), Zusanli (ST 36), Sanyinjiao (SP 6), Hegu (LI 4) and Taichong (LR 3). EA was operated with disperse-dense wave, 2 Hz/100 Hz in frequency and 0.1 mA to 1.0 mA in current intensity; 30 min each time, once daily. One course of EA consisted of 5 treatments, at the interval of 2 days and the intervention lasted 8 courses. Before treatment in the control group, before and after treatment in the observation group, the score of Montreal cognitive assessment scale (MoCA), the score of clinical dementia rating (CDR), Flanker paradigm, Stroop paradigm, Nback paradigm, the score of self-rating anxiety scale (SAS), the score of self-rating depression scale (SDS), and the score of Hamilton depression rating scale (HAMD) were evaluated separately; the glycolipid metabolic indexes (fasting plasma glucose [FPG], glycosylated hemoglobin type A1c [HbA1c], total cholesterol [TC], triacylglycerol [TG], high-density lipoprotein cholesterol [HDL-C] and low-density lipoprotein cholesterol [LDL-C]) were determined;with the magnetic resonance spectroscopy technique adopted, the metabolites in the basal ganglia area were detected. The correlation analysis was performed for the metabolite values with MoCA score, CDR score , Flanker paradigm, Stroop paradigm, and Nback paradigm.
RESULTS:
Before treatment, compared with the control group, in the observation group, MoCA score was lower (P<0.001), CDR score and the levels of FPG and HbA1c were higher (P<0.001); the reaction times of Flanker non-conflict, Flanker conflict, Stroop neutrality, Stroop congruence, Stroop conflict, and 1-back were prolonged (P<0.05, P<0.001), and the accuracy of Flanker conflict, Stroop conflict, and 1-back decreased (P<0.05, P<0.01); the ratio of N-acetyl aspartate (NAA) to creatine (Cr) in the left basal ganglia area was dropped (P<0.001), and that of myo-inositol (MI) to Cr in the right side increased (P<0.05). In the observation group after treatment, compared with the levels before treatment, MoCA score was higher (P<0.001), the scores of CDR, SAS and HAMD were reduced (P<0.01, P<0.05), the reaction times of Flanker conflict and Stroop conflict shortened (P<0.001, P<0.05), and the accuracy of Flanker conflict and 1-back increased (P<0.001, P<0.05); the ratio of NAA to Cr in the left basal ganglia area and that of the gamma-aminobutyric acid (GABA) to Cr in the right increased (P<0.05), that of MI to Cr in the right decreased (P<0.05). Before treatment, in the observation group, the ratio of MI to Cr in the right basal ganglia area was positively correlated with the reaction time of Stroop congruence (r=0.671, P=0.012) and this ratio was positively correlated with the reaction time of Stroop conflict (r=0.576, P=0.039).
CONCLUSIONS
Electroacupuncture for "adjusting zangfu function and rescuing the mind" improves the cognitive function of T2DACD patients, which may be related to the regulation of NAA, MI and GABA levels in the basal ganglia.
Humans
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Electroacupuncture
;
Acupuncture Therapy
;
Acupuncture Points
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Diabetes Mellitus, Type 2/therapy*
;
Glycated Hemoglobin
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Cognitive Dysfunction/therapy*
;
Cholesterol
;
gamma-Aminobutyric Acid
10.Integrated Chinese and Western Medicine for Tuberculosis and Severe Malnutrition with Coronavirus Disease 2019(Critical Type): A Case Report
Danni ZHOU ; Xiuyang LI ; Xuefei ZHAO ; Aibo DU ; Zezheng GAO ; Chensi YAO ; Chongxiang XUE ; Jun SUN ; Han WANG ; Chuantao ZHANG ; Linhua ZHAO ; Qiang WANG ; Peng WANG
Journal of Traditional Chinese Medicine 2023;64(22):2363-2367
We reported a case of a patient dignosed as tuberculosis and severe malnutrition with coronavirus disease 2019 (critical type) treated with a combination of Chinese medicine and Western medicine. Through the retrospective analysis of the diagnosis and treatment process of this patient, on the basis of Chinese medicine's understanding of the etiology and pathogenesis of “old state” and “deficient state”, the critical coronavirus pneumonia combined with pulmonary tuberculosis and severe malnutrition was mostly due to the physical condition and the invasion of epidemic toxin, resulting in dysfunctions of the internal organs such as the lungs, spleens, kidneys and other organs. Based on the understanding of the cause and mechanism of the coronavirus disease, the treatment combined Chinese and Western medical therapies was given. The western medicine was used with the main treatments of oxygen therapy, anti-viral, intestinal nutritional support, and anti-coagulation, while the Chinese medicine was used by tonifying qi, blood, yin, and yang, warming yang and dissipating cold, and clearing heat and dampness, then tonifying qi, nourishing yin and eliminating heat, in which tonifying middle and replenishing qi ran through the whole process. The integrated treatment eventually improved the patient's symptoms and accelerated the negative conversion of nucleic acid of the coronavirus.

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