1.Retrospective analysis of adverse events associated with traditional Chinese medicine formula granules and decoction pieces in hospitalized patients using the global trigger tool
Yaxiong LI ; Fusang WANG ; Mei ZHANG ; Jiawei LIN ; Wenge CHEN ; Min HUANG ; Junyan WU
China Pharmacy 2025;36(5):606-611
OBJECTIVE To provide technical support for improving recognition rate of adverse drug events (ADEs) related to traditional Chinese medicine (TCM) formula granules and decoction pieces among inpatient patients. METHODS By referencing the global trigger tool (GTT) whitepaper, literature on adverse reactions to TCM, and expert review opinions, ADE trigger items for TCM formula granules and decoction pieces used in the inpatients were established. GTT was applied to analyze ADEs in inpatients who had used TCM formula granules and decoction pieces in our hospital from August 2013 to August 2023, utilizing the Chinese Hospital Pharmacovigilance System. The effectiveness of GTT and the characteristics of these ADEs were analyzed. RESULTS A total of forty-eight triggers were established, including thirty-two laboratory test indexes, thirteen clinical symptoms, and three antidotes. Among the 1 682 patients included, GTT identified 652 potential ADEs, 284 true positive ADEs,with a trigger rate of 38.76% and a positive predictive value of 43.56%. After review by the auditor, 278 cases of ADEs were finally confirmed, with an incidence rate of 16.53%, significantly higher than the number of spontaneously reported ADEs during the same period (0). The 278 cases of ADEs were mostly grade 1 (223 cases), mainly involving hepatobiliary system, gastrointestinal system, blood- lymphatic system, etc;a total of 219 types of TCMs are involved,and the top five suspected TCMs used at a frequency higher than 1% were Poria cocos, Codonopsis pilosula, Atractylodes macrocephala, fried Glycyrrhiza uralensis, and Scutellaria baicalensis. CONCLUSIONS The established GTT can improve the recognition rate of ADEs for hospitalized patients using traditional Chinese medicine formula granules and decoction pieces.
2.Analysis of the management status and project undertaking of drug clinical trial institutions in Jiangxi Province after the implementation of the filing system
Min JIANG ; Li LIN ; Chenxi GAN ; Wenxiong SUN ; Qingsong XU ; Xiuli ZHAO
China Pharmacy 2025;36(3):275-279
OBJECTIVE To investigate and analyze the current management of drug clinical trial institutions in Jiangxi Province and the situation of undertaking drug clinical trials after the implementation of the filing system. METHODS A survey was conducted on 38 new institutions (obtained qualifications during the implementation of the filing system) and old institutions (obtained qualifications during the implementation of the recognition system) that had completed drug clinical trial institution qualification filing for more than one year in Jiangxi Province. The survey focused on the basic information of the institutions, the number of registered principal investigator (PI), institutional hardware and information construction, personnel allocation and training, and drug registration clinical trials undertaken by the institutions. RESULTS Of 38 institutions surveyed, there were 22 general hospitals and 16 specialized hospitals; there were 24 old institutions and 14 new institutions. Whether in general hospitals or specialized hospitals, the old institutions were better than the new institutions in the number of approved beds, the number of outpatients, the number of inpatients, the number of specialties, and the number of PI; both old and new institutions had separate offices; all new institutions were set up with GCP pharmacy. The adoption of clinical trial management system in new institutions is significantly less than in old institutions. In the general hospital, both the number of full-time managers and the number of quality controllers in old institutions were significantly more than in the new institutions, while the opposite was true at the level of specialized hospitals. In terms of centralized training on GCP, new institutions were all better than the old ones. Whether in general hospitals or specialized hospitals, the number of drug registration clinical trial projects undertaken by new institutions was significantly less than that of old ones. CONCLUSIONS The new institutions are worse than the old institutions in comprehensive strength and information construction of hospitals, and the number of clinical trials undertaken by new institutions is also less than old institutions.
3.Advances in oral distant targeted nanodelivery systems
Min SUN ; Chuan-sheng HUANG ; Li-ping WANG ; Xu-li RUAN ; Yun-li ZHAO ; Xin-chun WANG
Acta Pharmaceutica Sinica 2025;60(1):72-81
Due to patient compliance and convenience, oral medication is likely the most common and acceptable method of drug administration. However, traditional dosage forms such as tablets or capsules may lead to low drug bioavailability and poor therapeutic efficiency. Therefore, with advancements in material science and micro/nano manufacturing technology, various carriers have been developed to enhance drug absorption in the gastrointestinal tract. In this context, we initially discuss the key biological factors that hinder drug transport and absorption (including anatomical, physical, and biological factors). Building on this foundation, recent progress in both conventional and innovative oral drug delivery routes aimed at improving drug bioavailability and targeting is reviewed. Finally, we explore future prospects for oral drug delivery systems as well as potential challenges in clinical translation.
4.Design, synthesis and anti-Alzheimer's disease activity evaluation of cinnamyl triazole compounds
Wen-ju LEI ; Zhong-di CAI ; Lin-jie TAN ; Mi-min LIU ; Li ZENG ; Ting SUN ; Hong YI ; Rui LIU ; Zhuo-rong LI
Acta Pharmaceutica Sinica 2025;60(1):150-163
19 cinnamamide/ester-triazole compounds were designed, synthesized and evaluated for their anti-Alzheimer's disease (AD) activity. Among them, compound
5.The two-year follow up study on the association between new caries risk in school aged children and multi dimensional sleep indicators
LU Xiuzhen, HUANG Chuanlong, LI Yang, ZUO Min, SUN Ying, CHEN Xin
Chinese Journal of School Health 2025;46(4):579-583
Objective:
To explore the prospective association between multidimensional sleep indicators and the risk of newlyonset dental caries, providing a reference for childrens oral healthrelated sleep intervention.
Methods:
In October 2021, 1 417 students in grades 1 to 4 (aged 6 to 11) from two elementary schools in Bengbu, Anhui Province, were selected by cluster sampling method. Surveys and followup visits were conducted at baseline (T1), November 2022 (T2), May 2023 (T3), and November 2023 (T4), respectively, including parental questionnaires, oral health and physical examination. Bedtime, sleep duration, sleep midpoint, social jet lag, weekend catchup sleep, and sleep habits were collected and calculated. A multifactorial Cox proportional risk regression model was used to analyze the association between multidimensional sleep indicators and newlyonset caries in schoolaged children after 2 years.
Results:
The prevalence of dental caries in children was 65.1% at baseline, and the prevalence was 59.0% at the end of the 2year followup. Cox proportional risk regression model showed that for every 1point increase in the childrens bedtime resistance, nocturnal awakenings, parasomnias, and daytime sleepiness scores, the risk of newlyonset caries increased by 12% (HR=1.12, 95%CI=1.08-1.15), 22% (HR=1.22, 95%CI=1.15-1.29), 12% (HR=1.12, 95%CI=1.08-1.17), and 15% (HR=1.15, 95%CI=1.12-1.19), respectively; the risk of newlyonset caries increased by 23% for each 1 h increase in the length of weekend catchup sleep (HR=1.23, 95%CI=1.14 -1.33); compared with children who went to bed before 21:00 on school days, those who went to bed later than 22:00 had a 57% higher risk of newlyonset caries (HR=1.57, 95%CI=1.22-2.03). Compared to children who slept adequately (≥9 h/d), those with insufficient sleep had a 67% higher risk of new caries (HR=1.67, 95%CI=1.43-1.95) (P<0.01).
Conclusions
These findings suggest a significant association between sleep patterns/sleep disorders and the development of childhood dental caries. Incorporating sleep behavior optimization and sleep quality improvement into comprehensive caries prevention and oral health management protocols may represent a promising intervention strategy to enhance childrens oral health outcomes.
6.Pulmonary Function and Its Influencing Factors in Rural Elderly Adults in Guangzhou
Weifeng ZENG ; Bingqi YE ; Jialu YANG ; Jianhua LI ; Qianling XIONG ; Lele YUAN ; Min XIA
Journal of Sun Yat-sen University(Medical Sciences) 2025;46(5):851-860
ObjectiveTo investigate pulmonary function levels and associated influencing factors among rural elderly in Guangzhou, to identify high-risk populations for poor pulmonary function, and to reveal the relationship between the influencing factors of pulmonary function. MethodsWe recruited 1 500 residents aged 60 to 94 years from rural area of Conghua District, Guangzhou City using convenience sampling in 2023. Data on demographics, body measurements, medical history and lifestyle were collected via face-to-face questionnaires and physical examination. Meanwhile, expiratory function parameters including forced expiratory volume in one second (FEV1), forced vital capacity (FVC), FEV1/FVC, and the prevalence of airflow obstruction (AFO) were assessed using a portable spirometer. Age and sex distribution of pulmonary function in older adults at 5-year intervals was reported, and risk factors of AFO using multifactorial logistic regression models were analyzed. Furthermore, path analysis was further employed to explore the role of lifestyle in the association between other influencing factors and lung function. ResultsAmong the 1 500 participants, the median age was 71 years (67-75), and 44.2% were male. Subjects identified as AFOs were generally older, more likely male, less educated, and had lower rates of moderate to vigorous physical activity (<1 time/week) and lower lean body mass. Mean FEV1/FVC ratio was (82.0±16.4) %. FEV1/FVC was (79.80±17.58) % in men and (83.66±15.22) % in women. Older age, lower education, male sex and leanness were negatively associated with all pulmonary function outcomes (all P values<0.05). Path analysis identified that age, gender, marital status, occupation and income may influence pulmonary function indirectly through lifestyle. ConclusionRural elderly in Guangzhou exhibited lower pulmonary function levels, and male sex, non-married status, advanced age, lower education, smoking habits, insufficient engagement in moderate to vigorous physical activity, and lean body type were all associated with worse pulmonary function.
7.Investigation and analysis of the current status of transjugular intrahepatic portosystemic shunt treatment for portal hypertension in China
Haozhuo GUO ; Meng NIU ; Haibo SHAO ; Xinwei HAN ; Jianbo ZHAO ; Junhui SUN ; Zhuting FANG ; Bin XIONG ; Xiaoli ZHU ; Weixin REN ; Min YUAN ; Shiping YU ; Weifu LYU ; Xueqiang ZHANG ; Chunqing ZHANG ; Lei LI ; Xuefeng LUO ; Yusheng SONG ; Yilong MA ; Tong DANG ; Hua XIANG ; Yun JIN ; Hui XUE ; Guiyun JIN ; Xiao LI ; Jiarui LI ; Shi ZHOU ; Changlu YU ; Song HE ; Lei YU ; Hongmei ZU ; Jun MA ; Yanming LEI ; Ke XU ; Xiaolong QI
Chinese Journal of Radiology 2024;58(4):437-443
Objective:To investigate the current situation of the use of transjugular intrahepatic portosystemic shunt (TIPS) for portal hypertension, which should aid the development of TIPS in China.Methods:The China Portal Hypertension Alliance (CHESS) initiated this study that comprehensively investigated the basic situation of TIPS for portal hypertension in China through network research. The survey included the following: the number of surgical cases, main indications, the development of Early-TIPS, TIPS for portal vein cavernous transformation, collateral circulation embolization, intraoperative portal pressure gradient measurement, commonly used stent types, conventional anticoagulation and time, postoperative follow-up, obstacles, and the application of domestic instruments.Results:According to the survey, a total of 13 527 TIPS operations were carried out in 545 hospitals participating in the survey in 2021, and 94.1% of the hospital had the habit of routine follow-up after TIPS. Most hospitals believed that the main indications of TIPS were the control of acute bleeding (42.6%) and the prevention of rebleeding (40.7%). 48.1% of the teams carried out early or priority TIPS, 53.0% of the teams carried out TIPS for the cavernous transformation of the portal vein, and 81.0% chose routine embolization of collateral circulation during operation. Most of them used coils and biological glue as embolic materials, and 78.5% of the team routinely performed intraoperative portal pressure gradient measurements. In selecting TIPS stents, 57.1% of the hospitals woulel choose Viator-specific stents, 57.2% woulel choose conventional anticoagulation after TIPS, and the duration of anticoagulation was between 3-6 months (55.4%). The limitation of TIPS surgery was mainly due to cost (72.3%) and insufficient understanding of doctors in related departments (77.4%). Most teams accepted the domestic instruments used in TIPS (92.7%).Conclusions:This survey shows that TIPS treatment is an essential part of treating portal hypertension in China. The total number of TIPS cases is far from that of patients with portal hypertension. In the future, it is still necessary to popularize TIPS technology and further standardize surgical indications, routine operations, and instrument application.
8.Follow up study of the association between bedroom light at night exposure and body mass index in children
LI Qi, ZHOU Yi, DING Wenqin, ZUO Min, XU Yuxiang, TAO Fangbiao, SUN Ying
Chinese Journal of School Health 2024;45(4):475-478
Objective:
To explore the association between bedroom light at night (LAN) exposure and body mass index (BMI) in children at 1 year follow up, so as to provide new strategies for obesity prevention.
Methods:
From December 2021 to May 2022, cluster random sampling was conducted, involving 648 children from two primary schools in Tianchang, Chuzhou City, Anhui Province, China, to assess bedroom LAN exposure of children during sleep. A questionnaire survey and physical examination were carried out in May 2022. Multivariate linear regression was performed to analyze the correlation between bedroom LAN exposure and BMI variable quantity at 1 year follow up (May, 2023).
Results:
The median intensity of bedroom LAN exposure during the sleep episode was [1.11(0.35,3.24)lx] in children. The proportion of the sample exposed to an average light intensity of ≥3 lx was 27.5%, while 19.0% was exposed to a LAN intensity of ≥5 lx during the sleep episode. In the multivariable linear regression, after adjusting for covariates, including sex, baseline age, sleep duration, family monthly income, and maternal education level, exposure to a 1 h-average post bedtime LAN intensity of ≥3 lx ( β=0.25, 95%CI =0.05-0.44) and LAN≥5 lx ( β=0.34, 95% CI = 0.12-0.55) was associated with a gain of 0.25 and 0.34 kg/m 2, respectively, in the children s BMI at the 1 year follow up ( P < 0.05).
Conclusions
A positive correlation was found between bedroom LAN exposure and BMI variable quantity at 1 year follow up in children. Thus, reduced bedroom LAN exposure might be useful for interventions aimed at obesity prevention.
9.Association between visceral fat area measured with quantitative CT and fatty liver in normal weight population
Qi QIAO ; Yang ZHOU ; Yongbing SUN ; Xin QI ; Yawei DU ; Zhonglin LI ; Zhi ZOU ; Xiaoling WU ; Jing ZHOU ; Gong ZHANG ; Min QU ; Xiaolin ZHANG ; Yong WANG ; Shewei DOU ; Hongming LIU ; Fengshan YAN ; Jiadong ZHU ; Yongli LI
Chinese Journal of Health Management 2024;18(2):120-126
Objective:To analyze the association between visceral fat area (VFA) and fatty liver based on quantitative CT (QCT) in people receiving health examination with normal body mass index (BMI).Methods:A cross-sectional study. A total of 1 305 physical examiners who underwent chest CT and QCT examination in the Department of Health Management of Henan Provincial People′s Hospital from January to December 2021 were retrospectively selected as subjects. The physical components at the central level of the lumbar two cone were measured with QCT, including subcutaneous fat area (SFA), VFA and liver fat content (LFC). And the metabolic indexes, such as blood lipids and blood glucose, were collected. The t-test and χ2 test were used to analyze the correlation between the detection rate of fatty live and LFCr and age and gender. According to level of VFA (<100 cm 2, 100-150 cm 2 and≥150 cm 2), the subjects were divided into three groups, and one-way ANOVA and χ2 test were used in comparison between groups. Multiple linear regression was used to analyze the correlation between VFA and metabolic indexes and LFC. Results:Of the 1 305 subjects, there were 634 males and 671 females. The detection rate of fatty liver in normal BMI population was 65.67%, and it was 72.71% and 59.02% respectively in men and women ( χ2=27.12, P<0.001), and the detection rate of fatty liver and LFC increased with age (both P<0.05). With the increase of VFA, the age, BMI, SFA, LFC, total cholesterol (TC), triacylglycerol (TG), low-density lipoprotein cholesterol (LDL-C), fasting blood glucose (FBG), alanine aminotransferase (ALT), blood uric acid and prevalence of fatty liver increased (all P<0.05), and the low-density lipoprotein cholesterol (HDL-C) decreased ( P<0.001). Multiple linear regression analysis showed that after adjustment for age factors, regardless of male or female, LFC was independently positively related with VFA, BMI, and ALT (male β=0.206, 0.145, 0.174, female β=0.194, 0.150, 0.184; all P<0.05). FBG was positively correlated with male independently ( β=0.134; P<0.001). The indicators related to female independently were TC, TG, and blood uric acid ( β=-0.121, 0.145, 0.141, all P<0.05) Conclusion:In the population receiving health examination with normal BMI, the VFA measured by QCT technique is closely related to fatty liver.
10.Research progress of single-cell RNA sequencing in the immune microenvironment analysis of non-small cell lung cancer
Wenwen YANG ; Li HE ; Min ZHANG ; Shuo SUN ; Feng WANG ; Minjie MA ; Biao HAN
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2024;31(03):467-472
Non-small cell lung cancer (NSCLC) is one of the most common types of cancer in the world and is an important cause for cancer death. Although the application of immunotherapy in recent years has greatly improved the prognosis of NSCLC, there are still huge challenges in the treatment of NSCLC. The immune microenvironment plays an important role in the process of NSCLC development, infiltration and metastasis, and they can interact and influence each other, forming a vicious circle. Notably, single-cell RNA sequencing enables high-resolution analysis of individual cells and is of great value in revealing cell types, cell evolution trajectories, molecular mechanisms of cell differentiation, and intercellular regulation within the immune microenvironment. Single-cell RNA sequencing is expected to uncover more promising immunotherapies. This article reviews the important researches and latest achievements of single-cell RNA sequencing in the immune microenvironment of NSCLC, and aims to explore the significance of applying single-cell RNA sequencing to analyze the immune microenvironment of NSCLC.


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