1.Exploration on Surrogate Outcome Measures in Clinical Trials of Traditional Chinese Medicine for Diabetic Kidney Disease
Can CAO ; Weiwei SUN ; Tong MA ; Yaoxian WANG
Journal of Traditional Chinese Medicine 2025;66(8):790-794
Traditional Chinese medicine (TCM) has unique advantages in alleviating the symptoms of diabetic kidney disease (DKD) and slowing its progression. However, traditional clinical trials often use the occurrence of end-stage renal disease as the end point, requiring long-term follow-up, which increases trial complexity and costs, thereby limiting the feasibility of TCM clinical studies. This paper suggested that in clinical trials of TCM for DKD, both the estimated glomerular filtration rate (eGFR) change rate (≥30%) and eGFR slope can serve as potential surrogate outcome measures. If the intervention course is short (<1 year), the eGFR change rate (≥30%) is recommended as a surrogate outcome measure, whereas in long-term interventional studies (≥1 year), the eGFR slope may be more appropriate. Furthermore, based on biochemical indicators such as eGFR slope and urinary albumin-to-creatinine ratio (UACR) change rate, integrating TCM symptom evaluation, TCM syndrome evaluation, and quality of life scales can help develop internationally recognized patient-reported outcome measures (PROMs) for TCM clinical trials, which will be a key step in enhancing the evaluation system for the effectiveness of TCM in treating DKD.
2.Variation Tendency and Prediction of Colorectal Cancer Burden Among Chinese Population from 1990 to 2021
Tongzhou WANG ; Juanfang ZHU ; Jin ZHOU ; Pan ZHANG ; Qin TANG
Cancer Research on Prevention and Treatment 2025;52(4):319-323
Objective To examine the current status and trends of colorectal cancer (CRC) burden among Chinese residents from 1990 to 2021. Methods Data on CRC burden in China, Asia, and the global population from 1990 to 2021 were retrieved from the Global Burden of Disease database for descriptive analysis. An age-period-cohort model was employed to estimate the effects of age, period, and cohort on CRC mortality and to forecast changes in disease burden. Results In 2021, China’s age-standardized mortality rate, prevalence rate, and DALY rate for CRC were higher than global and Asian averages. The estimated annual percentage changes (EAPC) from 1990 to 2021 were −0.49% (95%CI: −0.55% to −0.43%) for mortality, 3.17% (95%CI: 3.03%−3.31%) for prevalence, and −0.62% (95%CI: −0.71% to −0.54%) for DALYs. Areas with high and medium-high sociodemographic indexes (SDIs) showed significant decreases in standardized mortality and DALY rates, but these rates remained higher compared with other regions. CRC mortality increased with age in the Chinese population, more prominently in males than in females. Using the 2002–2006 period as a reference (RR=1), the period effect on CRC mortality risk for women was higher than that for men until 2004, after which it declined considerably. With the 1957 birth cohort as a reference (RR=1), CRC mortality risk generally decreased across subsequent birth cohorts. Predictions indicate that by 2035, the standardized prevalence rate will be 267.21 per 100 000, and the standardized mortality rate will be 12.29 per 100 000. Conclusion From 1990 to 2021, China’s age-standardized CRC mortality and DALY rates have decreased, while the standardized prevalence rate has increased. These findings suggest the government to establish a comprehensive multi-level CRC prevention network.
3.Exploration of Therapeutic Effect of Wujiwan on Inflammatory Bowel Disease in Rats Based on PPARγ Signaling Pathway and T-cell Immunoregulation
Shiyun GUO ; Yuxuan GUO ; Yi SUN ; Xiaoxin ZHU ; Yujie LI ; Ying CHEN ; Qing YANG ; Yajie WANG ; Qi LI ; Xiaogang WENG ; Zhihao DENG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(23):237-245
ObjectiveThis study explores the efficacy and pharmacological mechanism of Wujiwan in rats with inflammatory bowel disease (IBD) from the perspectives of the peroxisome proliferator-activated receptor γ (PPARγ) signaling pathway and T-cell immunity, providing reference for the treatment of IBD with traditional Chinese medicine. MethodThe study involved administering 2,4,6-trinitrobenzenesulfonic acid (TNBS) enemas to 35 rats to induce acute IBD. After 24 hours, the animals were divided into the following groups: normal group, model group, Wujiwan treatment group, and positive drug control group. Each group received gastric gavage for 8 consecutive days before the rats were dissected to compare the disease activity index (DAI) of the rat colon tissue, the colon mucosal damage index (CMDI), and the spleen index. Enzyme-linked immunosorbent assay (ELISA) was used to measure the levels of interleukin-1β (IL-1β), interleukin-10 (IL-10), and tumor necrosis factor-α (TNF-α) in the serum. Quantitative real-time polymerase chain reaction (Real-time PCR) was used to determine the mRNA expression levels of T-bet (T-box expressed in T cells) and Gata3 (Gata-binding protein-3) in the colon tissue. Western blot analysis was conducted to detect the protein expression levels of PPARγ, T-bet, and nuclear factor-κB p65 (NF-κB p65) in the rat colon. ResultThe rat model of IBD was successfully established. Compared with the model group, the Wujiwan treatment group showed reduced DAI, CMDI, and spleen index, decreased content of TNF-α in the serum(P<0.01), significantly increased content of IL-10(P<0.01), and elevated mRNA content of T-bet and Gata3(P<0.05) in the colon tissue. The expression of PPARγ protein was augmented(P<0.05), and the expression of T-bet and NF-κB p65 protein was decreased(P<0.05,P<0.01). ConclusionWujiwan activates or upregulates PPARγ expression in IBD rats to inhibit the generation of pro-inflammatory factors, participates in the inflammatory immune process, and alleviates inflammatory reactions. Its mechanism may involve regulating the NF-κB pathway through PPARγ, enhancing Th2 cell transcription expression, and reducing Th1 cell transcription.
4.A Review of Theoretical Research on Interpretation of Scientific Connotation of Compatibility of Traditional Chinese Medicine Compounds
Shiyun GUO ; Zhihao DENG ; Yan LI ; Yuxuan GUO ; Xiaoxin ZHU ; Yujie LI ; Ying CHEN ; Qing YANG ; Yi SUN ; Yajie WANG ; Qi LI ; Weiyan CAI ; Xiaogang WENG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(23):338-344
Traditional Chinese medicine (TCM) has a long history of application in China and has consistently played a vital role in treating diseases and saving lives. TCM prescriptions (compounds) constitute the primary form of clinical TCM treatment and significantly differ from western medicine (chemicals) due to the diverse composition and chemical constituents of TCM (compounds). Nevertheless, the potential multi-component, multi-target, and multi-pathway action characteristics of TCM prescriptions also demonstrate their possible (complementary) therapeutic advantages when compared with single-component chemical drugs. Therefore, driven by the development of modern science and technology and the demands of the modernization and internationalization of TCM, modern theories regarding the complexity of TCM prescription effects have been continuously proposed: Different from the abstract language of traditional prescription theory, the modern TCM prescription theory is more inclined to illustrate the connotation of prescription compatibility concretely and vividly from an experimental and scientific perspective. In this paper, new theories on the complexity of TCM prescriptions proposed in recent years are summarized to provide research references and ideas for the greater role of TCM prescriptions and a better scientific understanding.
5.Distribution characteristics of astigmatism in preschool children from Tongzhou District of Beijing and its effect on visual acuity
Shana WANG ; Xiaolan XIE ; Bidan ZHU
International Eye Science 2024;24(1):162-165
AIM: To explore the characteristics of astigmatism distribution among preschool children from Tongzhou District, Beijing, discuss its categorizations, severity, and the effect on preschoolers' vision, and clarify the influence of cycloplegic refraction on the detection of astigmatism.METHODS:In this cross-sectional study conducted from December 2021 to January 2022, a cluster random sampling method was utilized to assess 1 498 preschool children(2 996 eyes)from Tongzhou District, Beijing. The sample comprised 791 males and 707 females, with 222 children aged 3 to <4 years, 521 children aged 4 to <5 years, 647 children aged 5 to <6 years, and 108 children aged 6 to <7 years. Evaluations included visual acuity, anterior segment, computerized optometry, and cycloplegic refraction.RESULTS:Prior to cycloplegic refraction, the prevalence of astigmatism was found to be 61.88%(927/1498). For post-cycloplegic refraction, this percentage slightly increased to 64.02%(959/1498, P=0.095). Following cycloplegic refraction, the distribution of astigmatism severity was as follows: 51.87%(777/1498)had mild astigmatism, 9.41%(141/1498)had moderate astigmatism, and 2.74%(41/1498)had severe astigmatism. Astigmatism was predominantly with-the-rule across all age groups, with compound hyperopic astigmatism being the most frequent type. In cases of subnormal vision caused by astigmatism: low degree accounted for 9.38%, moderate degree accounted for 25.4%,and high degree accounted for 52.6%.CONCLUSION:The findings reveal a high incidence of astigmatism in preschool children, predominantly in a mild nature. Cycloplegic refraction was observed to have a negligible effect on the rate of astigmatism detection. Moreover, its impact on vision becomes more significant as the degree of astigmatism increases.
6.Effects of 5G mobile phone radiofrequency radiation exposure on male mouse fertility
Zhaowen ZHANG ; Guiqiang ZHOU ; Ling GUO ; Tongzhou QIN ; Xing WANG ; Guirong DING
Chinese Journal of Radiological Health 2024;33(2):135-141
Objective To clarify the effects of 5G mobile phone radiofrequency radiation exposure on male mouse fertility and to preliminarily explore the underlying mechanisms. Methods Healthy male C57BL/6 mice aged 7-8 weeks were randomly assigned to Sham group, 3.5 GHz radiofrequency radiation group, and 4.9 GHz radiofrequency radiation group, with 16 mice in each group. The mice were exposed to 3.5 GHz or 4.9 GHz mobile phone radiofrequency radiation for 42 consecutive days (1 h per day). The sperm quality was evaluated using sperm count, deformity rate, and motility. H&E staining was performed to assess testicular tissue structure by observing the morphology of spermatogenic cells at various development stages, the diameter of seminiferous tubules, and the thickness of seminiferous epithelium. The sperm mitochondrial function was assessed using sperm mitochondrial membrane potential and testicular ATP content. The fertility of mice was evaluated through fertility rate, litter size, and survival rate of offspring. The underlying mechanisms were explored by detecting the methylation of LRGUK gene and its mRNA and protein levels. Results Compared with the Sham group, there were no significant changes in sperm count in the 3.5 GHz and 4.9 GHz groups; however, the sperm abnormality rate significantly increased (P < 0.05) and sperm motility significantly decreased (P < 0.05). The structure of testicular tissue, the function of sperm mitochondria, and fertility of mice showed no significant changes as compared with the Sham group. The methylation level of LRGUK gene in the testes significantly increased, while the mRNA and protein expression levels significantly decreased. Conclusion Exposure to 3.5 GHz and 4.9 GHz mobile phone radiofrequency radiation for 42 consecutive days can lead to an increase in sperm deformity rate and a decrease in sperm motility in mice, but has no significant effect on fertility, which may be related to an increase in methylation level of the LRGUK gene in the testes.
7.Nested case-control study on the risk factors and interaction analysis of positive screening for infant motor development
Yue HU ; Zheng BAO ; Ronghuan WANG
Chinese Journal of Child Health Care 2024;32(5):502-506
【Objective】 To identify the influencing factors of infant motor development, and to explore the potential interactive factors, so as to provide scientific basis for early prediction and targeted prevention of infant motor developmental delay. 【Methods】 Data of infants receiving "0~1 motor development screening" at 21 community health service centers in Tongzhou District, from January 1st, 2020 to August 31st, 2021 were collected through the Beijing Maternal and Child Information System.Using the method of nested case-control study, 416 infants with positive screening results were selected as case group, 416 infants with negative screening result were selected into the control group by 1∶1 case-control matching of screening age.Chi-square test, Logistic regression analysis, and Exhaustive CHAID decision tree model were used to explore the influencing factors of infant motor development, the interaction effect was investigated by using the additive and multiplicative interaction models. 【Results】 Multivariate Logistic analysis showed that birth weight<2 500g (OR=3.28), cesarean section (OR=1.63), outdoor activity≤ 1h/d (OR=3.07), and no supplementation of vitamin D (OR=2.68) were risk factors for positive screening results of infant motor development (P<0.01).The Exhaustive CHAID decision tree showed that low birth weight was the primary risk factor for infant with positive screening results, followed by outdoor activity, vitamin D supplementation and delivery.The interaction analysis showed that there was a multiplicative interaction (OR=13.76, 95% CI:1.20 - 158.08) and an additive interaction (RERI=10.22, 95%CI:5.05 - 15.38) between non supplementation of vitamin D and low birth weight on infant motor development with positive screening results. 【Conclusions】 Attention should be paid to the early motor development of infants with low birth weight and those born by cesarean section, with emphasis on the dosage of vitamin D supplementation and outdoor activity duration.Moreover, the early screening and hierarchical management of infant motor development should also be strengthened.
8.Analysis of influencing factors of post-vaccination serologic testing in children exposed to hepatitis B virus in Tongzhou District, Beijing from 2020 to 2022
Ronghuan WANG ; Zheng BAO ; Yue HU
Shanghai Journal of Preventive Medicine 2024;36(5):423-428
ObjectiveTo explore the importance of post-vaccination serological testing (PVST) for children exposed to hepatitis B virus (HBV), and analyze the factors affecting the progress of PVST. MethodsThe study focused on hepatitis B surface antigen (HBsAg)-positive pregnant women and their newborns residing in Tongzhou District, Beijing, who delivered at various obstetric institutions from January 1, 2020 to March 31, 2022. The obstetric institutions and community health service centers conducted follow-up visits 1 to 2 months after the children had received three doses of the hepatitis B vaccine (HepB). ResultsThe vaccination rate of hepatitis B immunoglobulin (HBIg) was 100.00% (800/800), with a successful PVST follow-up rate of 85.88% (687/800) in Tongzhou District. The initial non-response rate to immunization was 0.29% (2/687), but successful immunization was achieved after re-immunization. The mother-to-infant transmission rate of hepatitis B was 0. Children who did not undergo PVST accounted for 14.13% (113/800), with the main reasons being delays due to the COVID-19 pandemic, parents’ reluctance to allow venous blood collection due to the young age of the children, and loss to follow-up because children moved back to their parents’ place of origin. Logistic regression analysis showed that the proportion of PVST was higher among high-risk children (OR=30.009,P=0.001), children with family residing in Beijing (OR=2.218,P=0.002), and children whose mothers were <35 years old (OR=1.687,P=0.020). ConclusionPVST is necessary for assessing the status of HBV immune response in newborns after vaccination with HepB. The COVID-19 pandemic impacted the implementation of PVST for children exposed to HBV. Strengthening the management of non-high-risk children, those living outside Beijing, and children with mothers aged ≥ 35 years old may increase the rate of PVST in Tongzhou District.
9.Association of maternal isolated thyroid peroxidase antibody positive in the first trimester with fetal growth.
Jin Hui XU ; Na HAN ; Tao SU ; Li Zi LIN ; Yue Long JI ; Shuang ZHOU ; He Ling BAO ; Zheng LIU ; Shu Sheng LUO ; Xiang Rong XU ; Hai Jun WANG
Journal of Peking University(Health Sciences) 2023;55(5):886-892
OBJECTIVE:
To investigate the association of isolated thyroid peroxidase antibody (TPOAb) positive in the first trimester with fetal growth.
METHODS:
A total of 16 446 pregnant women were included in the birth cohort study, whose last menstrual period was between May 2016 and April 2019 and with singleton pregnancy. Maternal serum samples were collected when they firstly came for prenatal care in the first trimester. The pregnant women were consecutively seen and followed in the hospital and the information of pregnant women was extracted from the electronic medical information system. The pregnant women were divided into isolated TPOAb positive group (n=1 654) and euthyroid group (n=14 792). Three fetal ultrasound examinations were scheduled during the routine prenatal visits at the hospital and were performed by trained sonographers. All fetal growth indicators were quantified as gestational age- and gender- adjusted standard deviation score (Z-score) using the generalized additive models for location, scale and shape (GAMLSS). Fetal growth indicators included estimated fetal weight (EFW), abdominal circumference (AC), biparietal diameter (BPD), femur length (FL) and head circumference (HC). Fetal growth restriction (FGR) was defined as AC or EFW Z-score<3rd centile based on clinical consensus. Generalized estimating equation (GEE) analysis was applied to assess the association of maternal isolated TPOAb positive with fetal growth. The generalized linear model was further used to analyze the association between isolated TPOAb positive and fetal growth indicator at different gestational ages when the fetal growth indicator was significantly associated with isolated TPOAb positive in the GEE mo-del.
RESULTS:
The median gestational age at three ultrasound measurements was 23.6 (23.3, 24.1), 30.3 (29.7, 30.9), 37.3 (37.0, 37.7) weeks, respectively. The BPD Z-score was higher in isolated TPOAb positive women, compared with the euthyroid pregnant women after adjustment (β=0.057, 95%CI: 0.014-0.100, P=0.009). The generalized linear model showed the BPD Z-score was higher in the isolated TPOAb positive women at the end of 21-25 weeks (β=0.052, 95%CI: 0.001-0.103, P=0.044), 29-32 weeks (β=0.055, 95%CI: 0.004-0.107, P=0.035) and 36-40 weeks (β=0.068, 95%CI: 0.011-0.125, P=0.020), compared with the euthyroid pregnant women. There was no difference in other fetal growth indicators (EFW, AC, FL and HC) and FGR between the isolated TPOAb positive and euthyroid pregnant women.
CONCLUSION
The BPD Z-score was slightly increased in the isolated TPOAb positive pregnant women in the first trimester, while other fetal growth indicators were not changed. The reproducibility and practical significance of this result need to be confirmed.
Pregnancy
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Female
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Humans
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Pregnancy Trimester, First
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Iodide Peroxidase
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Cohort Studies
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Reproducibility of Results
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Fetal Development
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Fetal Weight
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Fetal Growth Retardation
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Ultrasonography, Prenatal
10.Effect of radiofrequency radiation from 5G mobile phone on blood-brain barrier in mice
Guiqiang ZHOU ; Yizhe XUE ; Zhaowen ZHANG ; Tongzhou QIN ; Ling GUO ; Panpan LAI ; Peng GAO ; Xing WANG ; Zhifei HUANG ; Yuhang ZANG ; Yuntao JING ; Guirong DING
Chinese Journal of Radiological Medicine and Protection 2023;43(3):176-181
Objective:To investigate the effect of radiofrequency radiation (RF) from 5G mobile phone communication frequency bands (3.5 GHz and 4.9 GHz) on the permeability of the blood-brain barrier (BBB) in mice.Methods:A total of 24 healthy adult male C57BL/6 mice (6-8 weeks old) were randomly divided into Sham, 3.5 GHz RF and 4.9 GHz RF groups, and 8 mice in each group. Mice in the RF groups were systemically exposed to 5G cell phone radiation for consecutive 35 d(1 h/d) with 50 W/m 2 power density. The BBB permeability of mice was detected by Evans Blue (EB) fluorescence experiment. The expression levels of the BBB tight junction-related proteins (ZO-1, occludin and claudin-11) and the gap junction-related protein Connexin 43 were determined by Western blot. Results:The number of spots, fluorescence intensity and comprehensive score of EB were significantly increased in 3.5 GHz RF group and 4.9 GHz RF group compared with the Sham group ( t=12.98, 17.82, P<0.001). Compared with the Sham group, the content of S100B in mouse serum was significantly increased in 3.5 GHz RF group and 4.9 GHz RF group ( t=19.34, 14.68, P<0.001). The BBB permeability was increased in the RF group. The expression level of occludin protein was significantly reduced in the 3.5 GHz RF group ( t=-3.13, P<0.05), and this decrease was much profound in the 4.9 GHz RF group ( t=-6.55, P<0.01). But the protein levels of ZO-1, Claudin-11 and Connexin 43 in the cerebral cortex of the RF groups had no significantly difference in comparison with the Sham group( P>0.05). Conclusions:The continuous exposure of mobile phone RF at 3.5 GHz or 4.9 GHz for 35 d (1 h/d) induces an increase of BBB permeability in the mouse cerebral cortex, perhaps by reducing the expression of occludin protein.

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