1.Interpretation and thoughts on the formulation and revision of the standards for exogenous harmful residues in traditional Chinese medicinal materials in the Chinese Pharmacopoeia 2025 Edition
WANG Ying ; SHEN Mingrui ; LIU Yuanxi ; ZUO Tiantian ; WANG Dandan ; HE Yi ; CHENG Xianlong ; JIN Hongyu ; LIU Yongli ; WEI Feng ; MA Shuangcheng
Drug Standards of China 2025;26(1):083-092
As people’s attention to health continues to increase, the market demand for traditional Chinese medicine (TCM) is growing steadily. The quality and safety of Chinese medicinal materials have attracted unprecedented social attention. In particular, the issue of exogenous harmful residue pollution in TCM has become a hot topic of concern for both regulatory authorities and society. The Chinese Pharmacopoeia 2025 Edition further refines the detection methods and limit standards for exogenous harmful residues in TCM. This not only reflects China’s high-level emphasis on the quality and safety of TCM but also demonstrates the continuous progress made by China in the field of TCM safety supervision. Basis on this study, by systematically reviewing the development history of the detection standards for exogenous harmful residues in TCM and analyzing the revisions and updates of these detection standards in the Chinese Pharmacopoeia 2025 Edition, deeply explores the key points of the changes in the monitoring standards for exogenous harmful residues in TCM in the Chinese Pharmacopoeia 2025 Edition. Moreover, it interprets the future development directions of the detection of exogenous residues in TCM, aiming to provide a reference for the formulation of TCM safety supervision policies.
2.Preliminary development of Health Literacy Evaluation Scale for Chinese High School Students
GUO Shihao, ZHU Fan, ZHU Guiyin, QI Tiantian, YANG Shuang, HU Bin, WU Huiyun, JIANG He, MA Yinghua
Chinese Journal of School Health 2025;46(5):676-680
Objective:
To develop a health literacy evaluation scale for Chinese high school students, providing a tool for dynamic monitoring of health literacy among high school students and evaluating the effectiveness of health school construction.
Methods:
Through theoretical research, an evaluation index system for health literacy of Chinese high school students was constructed. Two rounds of Delphi expert consultations were conducted to quantitatively screen the items, and the item pool was revised based on expert opinions to compile the health literacy evaluation scale for Chinese students. Two focus group interviews were held to collect suggestions from health educators, high school teachers, and high school students regarding optimized scale length, question types, difficulty and wording of the scale. The scale was revised accordingly. A pilot survey was conducted in Beijing and Tianjin in November 2024, and the reliability and validity of the scale were evaluated based on the pilot survey data.
Results:
The response rate in both rounds of Delphi expert consultations was over 80%, and the expert authority coefficient was over 0.70. The expert opinions were highly concentrated, and the dispersion was small. The revised item pool based on expert opinions contained 39 items. The revised scale based on the suggestions and opinions collected from the focus group interviews had a moderate number of questions and difficulty level. The pilot survey obtained 800 valid responses, with the response rate of 89.39%. The Cronbach α coefficient of the scale was 0.911, χ 2/df =3.321, the root mean square error of approximation was 0.054, the adjusted goodness-of-fit index was 0.991 , and the factor loadings of some items were less than 0.40.
Conclusion
The health literacy evaluation scale for Chinese high school students demonstrates scientific rigor and practical applicability, with good internal consistency and structural validity.
3.Preliminary development with reliability and validity testing of health literacy assessment scale for junior high school students
QI Tiantian, ZHU Fan, ZHU Guiyin, GUO Shihao, YANG Shuang, WU Huiyun, HU Bin, JIANG He, MA Yinghua
Chinese Journal of School Health 2025;46(6):816-820
Objective:
To develop and validate a health literacy assessment scale for junior high school students, providing an effective tool for evaluating and monitoring health literacy among Chinese adolescents.
Methods:
Based on school health education policy documents, a health literacy assessment framework was constructed, comprising five horizontal and four vertical dimensions. From May to June and August to September in 2024, the framework was refined through Delphi expert consultations and focus group discussions, leading to the development of the Health Literacy Assessment Scale for Junior High School Students. In September 2024, a convenience sample of 625 students from three junior high schools in Beijing and Tianjin completed the questionnaire. Item analysis, reliability, and validity tests were conducted to evaluate the scale.
Results:
The recovery rate for two rounds of expert consultation questionnaires was 100%. The expert authority coefficients ( Cr ) were 0.86 and 0.87 respectively (both >0.70), with Kendall W values of 0.34 and 0.27 ( P <0.05). The focus group discussions followed a rigorous structure, and after multiple rounds of item screening and revision, the version 3.0 of the junior high school students health literacy assessment scale was developed, comprising 57 items. Three items that failed to meet the comprehensive screening criteria were preliminarily removed, and the final scale contained 54 items. The scale demonstrated excellent reliability, with an overall Cronbach s α coefficient of 0.92 and split half reliability of 0.93. Confirmatory factor analysis [ χ 2/df =2.094, root mean square error of approximation ( RMSEA )=0.042, comparative fit index ( CFI )=0.911, Tucker Lewis index ( TLI )=0.907] indicated good model fit indices.
Conclusions
The preliminary development of the health literacy assessment scale for junior high school students follows a rigorous item screening process with well designed dimensions, demonstrating good reliability and validity, thus serving as an appropriate evaluation tool for adolescent health literacy.
4.Trend in disease burden of interstitial lung disease in China from 1990 to 2021
SUN Yuefeng ; GUO Sijia ; WEI Yuan ; HE Tiantian ; GUO An ; ZENG Zhaolu ; SUN Luyan ; DOU Wenjing ; SUN Zengtao
Journal of Preventive Medicine 2025;37(11):1124-1128
Objective:
To investigate the trend in disease burden of interstitial lung disease (ILD) in China from 1990 to 2021, so as to provide a reference for formulating prevention and control strategies for chronic respiratory diseases.
Methods:
Based on the Global Burden of Disease 2021 database, data on the number of incident cases, incidence, standardized incidence, number of deaths, mortality, standardized mortality, number of disability-adjusted life years (DALY), DALY rate, and standardized DALY rate of ILD in China were collected. The incidence, mortality, and DALY rate were used to analyze the disease burden of ILD. The estimated annual percentage change (EAPC) was employed to assess the trend in standardized incidence, standardized mortality, and standardized DALY rate of ILD from 1990 to 2021. Rate decomposition analysis was applied to identify the main contributing factors affecting the trend in disease burden.
Results:
In 2021, China reported 48 514 cases, 7 674 deaths, and 222 288 person-years of DALY due to ILD, representing increases of 155.43%, 159.70%, and 97.34%, respectively, compared with 1990. From 1990 to 2021, the standardized incidence and standardized mortality of ILD in China showed upward trends (EAPC=1.106% and 0.239%, both P<0.05), while the standardized DALY rate showed a downward trend (EAPC=-0.230%, P<0.05). From 1990 to 2021, the standardized incidence and standardized mortality among males showed upward trends (EAPC=1.199% and 0.520%, both P<0.05), while the trend in the standardized DALY rate was not statistically significant (P>0.05). Among females, the standardized incidence of ILD showed an upward trend (EAPC=0.966%, P<0.05), while the standardized mortality and standardized DALY rate showed downward trends (EAPC=-0.306% and -0.760%, both P<0.05). In 2021, the incidence, mortality, and DALY rate of ILD in China increased with age, peaking in the group aged ≥95 years at 14.84/105, 13.90/105, and 124.71/105, respectively. Across all age groups aged ≥55 years, the incidence, mortality, and DALY rate of ILD were consistently higher in males than in females. The increase in the number of incident cases, deaths, and DALY due to ILD in China from 1990 to 2021 was primarily influenced by population aging, with contribution rates of 42.65%, 68.25%, and 69.79%, respectively.
Conclusions
From 1990 to 2021, the incidence and mortality risk of ILD in China showed upward trends, while the disability risk demonstrated a downward trend. Males bore a heavier disease burden of ILD, and aging was identified as the primary factor contributing to the increased burden of ILD in China.
5.Distribution and seasonal fluctuation of visceral leishmaniasis vectors sandflies in Henan Province in 2023
Zhiquan HE ; Dan WANG ; Yuanjing KOU ; Chengyun YANG ; Yiying SUN ; Penghui JI ; Tiantian JIANG ; Deling LU ; Dan QIAN ; Hongwei ZHANG ; Ying LIU
Chinese Journal of Schistosomiasis Control 2024;36(4):346-351
Objective To investigate the geographical distribution and seasonal fluctuations of visceral leishmaniasis vectors sandflies in Henan Province in 2023, so as to provide insights into the prevention and control of visceral leishmaniasis vectors. Methods A total of 23 counties (districts) were sampled from 18 cities of Henan Province from May to September, 2023 as sandfly surveillance sites, and sandflies were captured using human capture and light trapping methods. Following morphological identification, the changes in the sandfly density were calculated at different months and in different breeding habitats. Results A total of 406 light traps were set at sandfly surveillance sites in Henan Province from May to September, 2023, and a total of 3 137 female sandlies were captured, with an average density of 7.73 sandlies/(light·night). A total of 1 494 Phlebotomus chinensis sandflies were captured, including 1 222 female sandflies, with an average density of 3.01 sandflies/(light·night), and the highest density of P. chinensis was found in Gongyi City [17.00 sandflies/(light·night)]. A total of 5 544 sandflies were captured using the human capture method, including 230 P. chinensis, and the density of P. chinensis appeared a unimodal distribution, with a peak in early July [5.81 sandflies/(light·night)]. Among different breeding habitats, the highest P. chinensis density was detected in pigpens [4.50 sandflies/(light·night)]. Conclusions P. chinensis was predominantly distributed in hilly areas of northern and central-western Henan Province in 2023, and the sandfly density appeared a unimodal distribution. Intensified monitoring of visceral leishmaniasis vectors is recommended.
6.Expert consensus on the evaluation and management of dysphagia after oral and maxillofacial tumor surgery
Xiaoying LI ; Moyi SUN ; Wei GUO ; Guiqing LIAO ; Zhangui TANG ; Longjiang LI ; Wei RAN ; Guoxin REN ; Zhijun SUN ; Jian MENG ; Shaoyan LIU ; Wei SHANG ; Jie ZHANG ; Yue HE ; Chunjie LI ; Kai YANG ; Zhongcheng GONG ; Jichen LI ; Qing XI ; Gang LI ; Bing HAN ; Yanping CHEN ; Qun'an CHANG ; Yadong WU ; Huaming MAI ; Jie ZHANG ; Weidong LENG ; Lingyun XIA ; Wei WU ; Xiangming YANG ; Chunyi ZHANG ; Fan YANG ; Yanping WANG ; Tiantian CAO
Journal of Practical Stomatology 2024;40(1):5-14
Surgical operation is the main treatment of oral and maxillofacial tumors.Dysphagia is a common postoperative complication.Swal-lowing disorder can not only lead to mis-aspiration,malnutrition,aspiration pneumonia and other serious consequences,but also may cause psychological problems and social communication barriers,affecting the quality of life of the patients.At present,there is no systematic evalua-tion and rehabilitation management plan for the problem of swallowing disorder after oral and maxillofacial tumor surgery in China.Combining the characteristics of postoperative swallowing disorder in patients with oral and maxillofacial tumors,summarizing the clinical experience of ex-perts in the field of tumor and rehabilitation,reviewing and summarizing relevant literature at home and abroad,and through joint discussion and modification,a group of national experts reached this consensus including the core contents of the screening of swallowing disorders,the phased assessment of prognosis and complications,and the implementation plan of comprehensive management such as nutrition management,respiratory management,swallowing function recovery,psychology and nursing during rehabilitation treatment,in order to improve the evalua-tion and rehabilitation of swallowing disorder after oral and maxillofacial tumor surgery in clinic.
7.Efficacy and Safety of Enhanced Recovery After Surgery for Pregnant Women with Gestational Diabetes Mellitus Undergoing Elective Cesarean Delivery and Their Newborns
Jin ZHOU ; Peizhen ZHANG ; Zhangmin TAN ; Chuo LI ; Lin YAO ; Tiantian HE ; Yuzhu YIN
Journal of Sun Yat-sen University(Medical Sciences) 2024;45(6):930-940
[Objective]To explore if the enhanced recovery after surgery (ERAS) protocol for pregnant women with gestational diabetes mellitus (GDM) who are undergoing elective cesarean delivery could cause perioperative glycemic abnormalities and heighten the risk of neonatal hypoglycemia.[Methods]A retrospective analysis was conducted on a cohort of pregnant women with singleton pregnancies who underwent elective cesarean sections and received ERAS between May 1,2022,and October 31,2023,at the Third Affiliated Hospital of Sun Yat-sen University. A total of 150 patients were included in this study,comprising the GDM group (n=75) and the non-GDM group (n=75). The study included pregnant women with good glycemic control (GDM) and maternal age (18-30 years;30-35 years;35-40 years;>40 years),BMI (<18.5 kg/m2;18.5-24.9 kg/m2;25-30 kg/m2;>30 kg/m2),and gestational age (within 7 days). We used these criteria to match 1∶1 non-GDM women as the control group. After administering preoperative oral carbohydrates,we observed the trends of maternal glycemic changes,including hyperglycemia and hypoglycemia,at any time of the day. We also evaluated the incidence of hypoglycemic low Apgar scores in newborns,abnormal pH values in blood gases,and the rate of transfer to the pediatric unit immediately after delivery.[Results]No significant difference was observed in fasting blood glucose levels on the day of surgery between the two groups of pregnant women[(4.4±0.5) mmol/L vs. (4.3±0.5) mmol/L,t=1.395,P=0.165]. The blood glucose peak was reached 30 minutes after consuming 300 mL (42.6 g of low-dose carbohydrate) of a light drink[(7.2±0.9) mmol/L vs. (6.4±0.8) mmol/L,t=5.773,P<0.001],with a subsequent decline in blood glucose levels. At the 120-minute mark,blood glucose had returned to the pre-oral carbohydrate level. The blood glucose levels in GDM groups was significantly higher than those in the non-GDM group (P<0.005). Although the incidence of hyperglycemia was significantly higher in the GDM group than in the non-GDM group at the 30-minute peak blood glucose level after oral carbohydrate intake,and the difference was statistically significant (17.3% vs. 1.3%,x2=11.354,P<0.001),severe hyperglycemia (≥10 mmol/L) did not occur. The incidence of hypoglycemia was not significantly higher in neonates in the GDM group than in the non-GDM group (22.7% vs. 28%,x2=0.564,P=0.453). The incidence of neonatal hypoglycemia in the GDM group was not significantly elevated in comparison to the non-GDM group after adjusting for age and BMI (Model 1),primiparity and gestational week of delivery (Model 2),hypertensive disorders of pregnancy (Model 3),cesarean section indications,time of cesarean section,and intraoperative hemorrhage (Model 4),and neonatal weight (Model 5).[Conclusion]In GDM patients with excellent glycemic control,an ERAS regimen with a low oral dose of carbohydrates prior to elective cesarean section does not increase the risk of preoperative serious hyperglycemia in mothers,nor does it increase the incidence of neonatal hypoglycemia.
8.Establishment and validation of liver micronucleus assay in rats using 4%neutral formaldehyde-fixed tissues
Tiantian ZHAO ; Weiwei HE ; Changhui ZHOU ; Zehao ZHAO ; Zixuan YANG ; Yan CHANG
Chinese Journal of Pharmacology and Toxicology 2024;38(6):436-444
OBJECTIVE To establish and validate a rat liver micronucleus test(LMNT)method based on fixation of liver tissue with 4%neutral formaldehyde(HCHO fixation)for preparation of hepa-tocytes(HEPs).METHODS ①The LMNT based on neutral HCHO fixation(HCHO fixation-LMNT)was established using the liver micronucleus positive compound N-nitrosodiethylamine(DEN).SD rats were divided into female and male groups,and each group was randomly subdivided into the vehicle control group and DEN 12.5 mg·kg-1 group,with five rats in each.The rats were ig administered with normal saline and DEN once a day for 14 consecutive days,after which liver tissues were collected.Some of the tissue was digested with collagenase to prepare HEP suspension,and the remaining tissue was used to prepare HEP suspension with HCHO fixation.After staining with SYBR Gold,the number of micronucleated hepatocytes(MN-HEP)and the number of HEPs in the mitotic phase were counted under a microscope.The micronucleus rate of HEP(MN-HEP rate)and the mitotic index were calculated,and an MN-HEP rate>0.07%was considered positive.②Male SD rats were divided into the quinoline(30,60,120 mg·kg-1)group,N-nitrosoopyrrolidine(NPYR,25,50,100 mg·kg-1)group,vehicle control group(deionized water for NPYR,and corn oil for quinoline),and positive control DEN(12.5 mg·kg-1)group,with 5-6 rats per group,and were ig administrated for 15 consecutive days.Body mass was recorded daily,and at the end of the experiment,the liver was removed to record the total liver weight,and calculate the liver coefficient.Liver function-related serum biochemical indicators including glutamic-pyruvic transaminase(GPT),glutamic-oxaloacetic transaminase(GOT)activities,and levels of total bili-rubin(T-BIL)were measured and direct bilirubin(D-BIL)using an automatic biochemical analyzer.The MN-HEP rate was determined using the collagenase digestion and HCHO fixation methods,and the peripheral blood MN assay and hepatocellular carcinoma comet assay were conducted to evaluate the genotoxicity of quinoline and NPYR.RESULTS ① Compared with the corresponding vehicle control groups(0.069%and 0.030%),the MN-HEP rate of male rats treated with DEN by formalin-LMNT was 1.10%,and the MN-HEP rate of female ones was 0.82%,both significantly increased(P<0.05).Com-pared with corresponding vehicle control groups(0.060%and 0.030%),the MN-HEP rate of male rats treated with DEN by collagenase digestion-LMNT was 1.45%,and that of female rats was 0.46%,both significantly increased(P<0.05),which were considered positive.The MN-HEP rate of male rats was significantly higher than that of females with both methods(P<0.05).There was no significant differ-ence in mitotic indexes between the DEN groups by collagenase digestion-LMNT and HCHO fixation-LMNT in male and female rats compared to corresponding vehicle control groups.② Compared to the vehicle control group,the body mass of rats in the NPYR 50 and 100 mg·kg-1 groups was significantly reduced 7 to 14 days into the ig administration(P<0.01),and the DEN group showed a significant reduction at days 8 to 14(P<0.01).The body mass of rats in the quinoline 120 mg·kg-1 group was signifi-cantly reduced 4 to 14 days into the ig administration(P<0.01),and the DEN group showed a signifi-cant reduction at days 10 to 14(P<0.05).Compared to the vehicle control group,both the liver weight and liver coefficient were significantly reduced in the NPYR 100 mg·kg-1 group(P<0.01)and the DEN group(P<0.05).The liver weight(P<0.01)and liver coefficient(P<0.05)were significantly increased in the quinoline 60 and 120 mg·kg-1 groups.Compared to the vehicle control group,the serum T-BIL level was significantly increased in the DEN group(P<0.01),and the activities of GPT and GOT,as well as the levels of D-BIL and T-BIL,were significantly increased in the NPYR 100 mg·kg-1 group(P<0.01).There were no significant changes in the NPYR 25,50 mg·kg-1 groups or any of the dose groups of quinoline.The MN-HEP rate by HCHO fixation-LMNT for NPYR was slightly higher than that by collage-nase digestion-LMNT,both considered positive.Compared with corresponding control group,the MN-HEP rate by formalin-LMNT for NPYR and the MN-HEP rate by collagenase digestion for NPYR were both significantly increased(P<0.05).The MN-HEP rate by HCHO fixation-LMNT for quinoline was comparable to that by collagenase digestion-LMNT,both considered positive.Compared with corresponding vehicle control group,the MN-HEP rate by HCHO fixation-LMNT for quinoline and the MN-HEP rate by collagenase digestion-LMNT for quinoline were both significantly increased(P<0.05).The correlation between the MN-HEP rates based on HCHO fixation and collagenase digestion for NPYR and quinoline was good(R2=0.8614 and 0.9279,respectively).In the NPYR groups,the periph-eral blood micronucleus assay were negative,while the comet assay results were positive.In the quino-line group,both the peripheral blood micronucleus assay and the comet assay results were negative.CON-CLUSION The HCHO fixation-LMNT has been established and validated,and the sensitivity of the LMNT method based on HCHO fixation-LMNT for detection of hepatocarcinogens is higher than that of collagenase digestion-LMNT.
9.Prevention effect of ceftriaxone sodium combined with bundle management on early ventilator-associated pneumonia
Yin HE ; Tiantian GAI ; Zunhai HAN
China Pharmacist 2024;27(6):1028-1033
Objective To observe the preventive effect of ceftriaxone sodium(CRO)combined with bundle management(BM)on early ventilator-associated pneumonia(VAP)in the intensive care unit(ICU)patients with mechanical ventilation(MV).Methods A total of 138 ICU patients treated with MV at Beijing Tongren Hospital affiliated to Capital Medical University were selected from May 2022 to April 2023.According to whether CRO was used,they were divided into CRO group and non-CRO(NCRO)group,and BM was performed during hospitalization in both groups.The incidence of early VAP,mortality,duration of mechanical ventilation,ICU stay,and total hospital stay were observed and compared between the two groups.In addition,the changes in inflammatory indicators[C-reactive protein(CRP),procalcitonin(PCT),and white blood cell count(WBC)]were compared before and after the intervention(on day 7).Results The incidence of early VAP was lower in the CRO group than in the NCRO group(P<0.05).The mortality rate of patients in the CRO group was lower than that in the NCRO group,but the difference was not statistically significant(P>0.05).The duration of mechanical ventilation,length of ICU stay and total hospital stay in the CRO group were shorter than those in the NCRO group(P<0.05).Before treatment,the CRP levels,serum PCT levels,and WBC were not significantly different between the two groups(P>0.05).Compared with before treatment,serum CRP levels,PCT levels and WBC were significantly decreased in the CRO and NCRO groups(P<0.05).In addition,serum CRP,PCT and WBC of the CRO group were lower than the NCRO group on the seventh day,with a statistically significant difference(P<0.05).Conclusion CRO combined with BM can reduce the incidence of early VAP in ICU patients undergoing MV,shorten MV time,ICU stay and total hospital stay,and reduce the level of inflammatory response.
10.Exploration on the Biological Connotation of the Pathogenesis of "Earth Congestion and Wood Depression" of Atherosclerosis from "Intestinal Flora-Bile Acids" Pathway
Haoxian MENG ; Hua JIN ; Jinmeng XI ; Yanhu HE ; Meilong SI ; Luliang YE ; Tiantian HOU
Chinese Journal of Information on Traditional Chinese Medicine 2024;31(9):12-17
Intestinal flora and bile acid metabolism regulate and influence each other,and an imbalance in the"intestinal flora-bile acid"pathway is closely related to atherosclerosis.Based on TCM theory and clinical practice,it is found that"earth congestion and wood depression"is the key mechanism of atherosclerosis,but its biological connotation needs to be further elucidated.Combined with the results of modern research,it is believed that intestinal flora imbalance is an important foundation of"earth congestion",and bile acid metabolism abnormality is an important manifestation of"wood depression".In the process of atherosclerosis,the imbalance of the"intestinal flora-bile acid"pathway is closely related to the"earth congestion and wood depression"pathogenesis of TCM in atherosclerosis.Exploring the biological connotation of the pathogenesis of"earth congestion and wood depression"of atherosclerosis from the"intestinal flora-bile acids"pathway is of far-reaching significance for clarifying the scientific connotation of TCM theory and guiding the TCM prevention and treatment of atherosclerosis.


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