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.Therapeutic effect of oral Xuefu Zhuyu Pill combined with intravitreal injection of Aflibercept in the treatment of retinal vein occlusion
Ran SHEN ; Hongying JI ; Hongyu CUI ; Lequan YANG ; Lixia GUO
International Eye Science 2025;25(9):1532-1536
AIM: To explore the therapeutic effect of oral Xuefu Zhuyu Pill combined with intravitreal injection of aflibercept in the treatment of retinal vein occlusion(RVO).METHODS: A total of 80 patients(80 eyes)with RVO admitted to our hospital from January 2021 to March 2024 were prospectively selected. According to the treatment method, they were divided into a control group of 40 patients treated with intravitreal injection of aflibercept, and an observation group of 40 patients treated with oral Xuefu Zhuyu Pill combined with intravitreal injection of aflibercept. The efficacy, TCM syndrome score, retinal microcirculation parameters, macular edema(ME), and adverse reactions were compared between the two groups of patients in the treatment of RVO.RESULTS: All patients have completed follow-up. The clinical effective rate of the observation group after treatment was 95%, obviously higher than that of the control group(80%; χ2=4.114, P=0.043). After treatment for 3 mo, the traditional Chinese medicine syndrome scores, foveal avascular area(FAZ)area, FAZ circumference, macular central retinal thickness, and neovascularization leakage area of both groups decreased, the overall blood flow density of the superficial capillary plexus(SCP)and deep capillary plexuses(DCP)increased, and the observation group showed better results than the control group(all P<0.05). There was no statistically significant difference in the occurrence of adverse reactions between the two groups during the treatment period(P>0.05).CONCLUSION: Oral administration of Xuefu Zhuyu Pill combined with intravitreal injection of aflibercept in the treatment of RVO can improve retinal microcirculation, enhance vision, restore ocular blood circulation, improve bleeding, promote ME absorption, and improve clinical efficacy.
3.Development of a prediction model for incidence of diabetic foot in patients with type 2 diabetes and its application based on a local health data platform
Yexian YU ; Meng ZHANG ; Xiaowei CHEN ; Lijia LIU ; Pei LI ; Houyu ZHAO ; Yexiang SUN ; Hongyu SUN ; Yumei SUN ; Xueyang LIU ; Hongbo LIN ; Peng SHEN ; Siyan ZHAN ; Feng SUN
Chinese Journal of Epidemiology 2024;45(7):997-1006
Objective:To construct a diabetes foot prediction model for adult patients with type 2 diabetes based on retrospective cohort study using data from a regional health data platform.Methods:Using Yinzhou Health Information Platform of Ningbo, adult patients with newly diagnosed type 2 diabetes from January 1, 2015 to December 31, 2022 were included in this study and divided randomly the train and test sets according to the ratio of 7∶3. LASSO regression model and bidirectional stepwise regression model were used to identify risk factors, and model comparisons were conducted with net reclassification index, integrated discrimination improvement and concordance index. Univariate and multivariate Cox proportional hazard regression models were constructed, and a nomogram plot was drawn. Area under the curve (AUC) was calculated as a discriminant evaluation indicator for model validation test its calibration ability, and calibration curves were drawn to test its calibration ability.Results:No significant difference existed between LASSO regression model and bidirectional stepwise regression model, but the better bidirectional stepwise regression model was selected as the final model. The risk factors included age of onset, gender, hemoglobin A1c, estimated glomerular filtration rate, taking angiotensin receptor blocker and smoking history. AUC values (95% CI) of risk outcome prediction at year 5 and 7 were 0.700 (0.650-0.749) and 0.715(0.668-0.762) for the train set and 0.738 (0.667-0.801) and 0.723 (0.663-0.783) for the test set, respectively. The calibration curves were close to the ideal curve, and the model discrimination and calibration powers were both good. Conclusions:This study established a convenient prediction model for diabetic foot and classified the risk levels. The model has strong interpretability, good discrimination power, and satisfactory calibration and can be used to predict the incidence of diabetes foot in adult patients with type 2 diabetes to provide a basis for self-assessment and clinical prediction of diabetic foot disease risk.
4.Development and application of a prediction model for incidence of diabetic retinopathy in newly diagnosed type 2 diabetic patients based on regional health data platform
Xiaowei CHEN ; Lijia LIU ; Yexian YU ; Meng ZHANG ; Pei LI ; Houyu ZHAO ; Yexiang SUN ; Hongyu SUN ; Yumei SUN ; Xueyang LIU ; Hongbo LIN ; Peng SHEN ; Siyan ZHAN ; Feng SUN
Chinese Journal of Epidemiology 2024;45(9):1283-1290
Objective:To develop a prediction model for the risk of diabetic retinopathy (DR) in patients with newly diagnosed type 2 diabetes mellitus (T2DM).Methods:Patients with new diagnosis of T2DM recorded in Yinzhou Regional Health Information Platform between January 1, 2015 and December 31, 2022 were included in the study. The predictor variables were selected by using Lasso-Cox proportional hazards regression model. Cox proportional hazards regression models were used to establish the prediction model for the risk of DR. Bootstrap method (500 resamples) was used for internal validation, and the performance of the model was assessed by C-index, the receiver operating characteristic curve and area under the curve (AUC), and calibration curve.Results:The predictor variables included in the final model were age of T2DM onset, education level, fasting plasma glucose, glycated hemoglobin A1c, urinary albumin, estimated glomerular filtration rate, and history of lipid-lowering agent and angiotensin converting enzyme inhibitor uses. The C-index of the final model was 0.622, and the mean corrected C-index was 0.623 (95% CI: 0.607-0.634). The AUC values for predicting the risk of DR after 3, 5, and 7 years were 0.631, 0.620, and 0.624, respectively, with a high degree of overlap of the calibration curves with the ideal curves. Conclusion:In this study, a simple and practical risk prediction model for DR risk prediction was developed, which could be used as a reference for individualized DR screening and intervention in newly diagnosed T2DM patients.
5.Development of a prediction model for the incidence of type 2 diabetic kidney disease and its application based on a regional health data platform
Lijia LIU ; Xiaowei CHEN ; Yexian YU ; Meng ZHANG ; Pei LI ; Houyu ZHAO ; Yexiang SUN ; Hongyu SUN ; Yumei SUN ; Xueyang LIU ; Hongbo LIN ; Peng SHEN ; Siyan ZHAN ; Feng SUN
Chinese Journal of Epidemiology 2024;45(10):1426-1432
Objective:To construct a risk prediction model for diabetes kidney disease (DKD).Methods:Patients newly diagnosed with type 2 diabetes mellitus (T2DM) between January 1, 2015, and December 31, 2022, were selected as study subjects from the Yinzhou Regional Health Information Platform in Ningbo City. The Lasso method was used to screen the risk factors, and the DKD risk prediction model was established using Cox proportional hazard regression models. Bootstrap 500 resampling was applied for internal validation.Results:The study included 49 706 subjects, with an median ( Q1, Q3) age of 60.00 (50.00, 68.00) years old, and 55% were male. A total of 4 405 subjects eventually developed DKD. Age at first diagnosis of T2DM, BMI, education level, fasting plasma glucose, glycated hemoglobin A1c, urinary albumin, past medical history (hyperuricemia, rheumatic diseases), triglycerides, and estimated glomerular filtration rate were included in the final model. The final model's C-index was 0.653, with an average of 0.654 after Bootstrap correction. The final model's area under the receiver operating characteristic curve for predicting 4-year, 5-year, and 6-year was 0.657, 0.659, and 0.664, respectively. The calibration curve was closely aligned with the ideal curve. Conclusions:This study constructed a DKD risk prediction model for newly diagnosed T2DM patients based on real-world data that is simple, easy to use, and highly practical. It provides a reliable basis for screening high-risk groups for DKD.
6.Clinical outcome of kidney transplantation from DBD donors complicated with acute kidney injury
Hongyu WANG ; Hong WANG ; Songying SHEN ; He ZHAO ; Xingsong QIN ; Wei QIN ; Xinling QIAN ; Huijun DONG ; Yunfeng ZHAO ; Yafang WANG ; Peiliang LI
Organ Transplantation 2024;15(4):622-629
Objective To evaluate the clinical outcome of kidney transplantation from donation after brain death(DBD)donors complicated with acute kidney injury(AKI).Methods Clinical data of 216 DBD donors were retrospectively analyzed,and they were divided into the AKI group(n=69)and control group(n=147)according to the Kidney Disease:Improving Global Outcomes(KDIGO)guidelines.Donors in the AKI group were further divided into the KDIGO stage 1 and stage 2-3 subgroups.One hundred and thirty-five recipients were assigned into the AKI group and 288 recipients in the control group.Postoperative recovery of renal function and clinical outcomes of the recipients were recorded.The risk factors of delayed graft function(DGF)were identified.Results The highest serum creatinine(Scr)level,Scr level before procurement,the highest blood sodium level and blood sodium level before procurement in the AKI group were higher than those in the control group.The application duration of vasopressors in the AKI group was longer than that in the control group.In the AKI group,the amount of fluid resuscitation within 48 h was higher,the HCO3-level at admission was lower,and the incidence of diabetes insipidus and hypotension was higher than those in the control group.The highest Scr level and the Scr level before procurement in KDIGO stage 2-3 donors were significantly higher than those in KDIGO stage 1 counterparts(all P<0.05).Compared with the control group,the incidence of DGF and acute rejection was higher,the proportion of continuous renal replacement therapy was higher,the Scr level within postoperative 90 d was higher,and the urine amount within postoperative 3 d was less than those of recipients in the AKI group.Compared with KDIGO stage 1 recipients,KDIGO stage 2-3 recipients had higher Scr levels at postoperative 3,4,5 and 15 d,and less urine amount at postoperative 2 d(all P<0.05).Univariate analysis showed that donor age,the highest Scr level,the highest blood sodium level and the amount of fluid resuscitation within 48 h were the risk factors for DGF in recipients after kidney transplantation.Multivariate analysis showed that donor age was the independent risk factor for DGF in recipients after kidney transplantation(all P<0.05).Conclusions For the application of DBD donors complicated with AKI,active organ maintenance should be performed to alleviate AKI.It exerts no effect upon graft function and survival rate at postoperative 6 months,which may achieve equivalent efficacy as non-AKI donors and may be used as a source of extended criteria donor kidneys.
7.A prospective cohort study of leisure activities and declining intrinsic capacity in older adults
Jie ZHANG ; Ji SHEN ; Yuting KANG ; Chi ZHANG ; Jing PANG ; Hongyu LI ; Hong SHI
Chinese Journal of Geriatrics 2024;43(6):739-744
Objective:To investigate the trajectories of intrinsic capacity in older adults and explore the impact of leisure activities on the decline of intrinsic capacity.Methods:This study is a prospective cohort study conducted in a community in Beijing, China.A convenience sampling method was used to select 284 cases of older adults from November to December 2020.The purpose of the study was to gather information on the general conditions, intrinsic abilities(including cognitive, vitality, motor, psychological, and sensory dimensions), and participation in leisure activities of older adults.A 2.5-year follow-up of the respondents was conducted.Results:A total of 243(85.6%, 243/284)respondents completed the 2.5-year follow-up.The follow-up intrinsic capacity score decreased from a baseline level of 4(3, 4)to 3(3, 4)( Z=-4.667, P<0.001).Among the respondents, 113(46.5%, 113/243)older adults showed a decrease in intrinsic capacity, with more significant decreases observed in the locomotor and psychometric dimensions( χ2=16.953, 23.510, both P<0.001).The number of declines in intrinsic ability was higher in the low group of leisure activities compared to the high group[62.2%(56/90) vs.37.3%(57/153), χ2=14.199, P<0.001].There was a positive correlation between leisure activity scores and the follow-up intrinsic capacity score( r=0.200, P=0.002), as well as with the value of change in the score of intrinsic capacity( r=0.146, P=0.023).The results of Logistic regression analysis indicated that leisure activities( OR=0.644, 95% CI: 0.507 to 0.818, P<0.001), physical leisure activities( OR=0.565, 95% CI: 0.395 to 0.809, P=0.002), and intellectual leisure activities( OR=0.742, 95% CI: 0.555 to 0.992, P=0.044)independently influenced the decline of intrinsic ability in the elderly, even after accounting for demographic information, number of diseases, and type of medicine taken. Conclusions:The decline in intrinsic abilities is a common occurrence among the elderly population.Engaging in leisure activities has been found to be effective in reducing this decline.It is important to emphasize the impact of leisure activities on the overall health of older individuals.
8.Investigating age-related characteristics of gait parameters in community-dwelling older adults during normal walking
Ji SHEN ; Yuting KANG ; Hongyu LI ; Jing PANG ; Jie ZHANG ; Chi ZHANG ; Xue MENG ; Guoqing FAN ; Hong SHI
Chinese Journal of Geriatrics 2024;43(11):1468-1474
Objective:To investigate age-related characteristics of gait parameters in the elderly.Methods:From February 2023 to August 2023, a convenient sampling method was used to investigate the elderly over 60 years old in communities in Beijing.General characteristics and anthropometric data were collected.Gait parameters of the subjects during normal speed walking were measured using a wearable gait analyzer.Comparisons were made of the basic characteristics, physical status and gait parameters in different age groups.Linear regression analysis was used to evaluate the changes of physical status and gait parameters with age, with the 60-69-year-old group as the baseline standard.Results:A total of 670 elderly people were included, including 324(48.4%)aged 60-69 years, 285(42.5%)aged 70-79 years, and 61(9.1%)aged ≥80 years.Linear regression analysis showed that after adjusting for confounding factors, with increasing age, skeletal muscle mass index(SMI)( β=-0.018, 95% CI: -0.029--0.007), calf circumference( β=-0.096, 95% CI: -0.142--0.051), upper limb flexibility( β=-0.200, 95%, 95% CI: -0.355--0.046), lower limb flexibility( β=-0.244, 95% CI: -0.377--0.111), grip strength( β=-0.397, 95% CI: -0.491--0.303), the Short Physical Performance Battery(SPPB)( β=-0.080, 95% CI: -0.100--0.060)decreased( P<0.05), and the gait parameter such as speed( β=-0.010, 95% CI: -0.014--0.007), cadence( β=-0.398, 95% CI: -0.634--0.162), step length/height( β=-0.002, 95% CI: -0.003--0.002), stride length( β=-0.009, 95% CI: -0.011--0.007), swing power( β=-0.009, 95% CI: -0.012--0.006), ground impact( β=-0.020, 95% CI: -0.026--0.014), foot fall( β=-0.050, 95% CI: -0.064--0.036), pre-swing angle( β=-0.545, 95% CI: -0.714--0.377)all decreased( P<0.05), while stride time( β=0.005, 95% CI: 0.001-0.009), single limb support time( β=1.566, 95% CI: 0.499-2.633), terminal double limb support time( β=0.609, 95% CI: 0.084-1.134), swing duration( β=1.288, 95% CI: 0.024-2.552), single step time( β=2.417, 95% CI: 0.462-4.372)and support phase time( β=1.935, 95% CI: 0.421-3.449)all increased( P<0.05). Conclusions:The walking ability tends to decline with age in older people in the community who walk at a normal walking speed.
9.Effects of cultured mycelium Cordyceps sinensis on carbon tetrachloride-induced liver fibrosis mice by regulating AMPK/SirT1 signaling pathway
Zhao YANG ; Ruanyu YAN ; Hongyu WU ; Kai HUANG ; Li SHEN ; Yanyan TAO ; Chenghai LIU ; Yuan PENG
Acta Laboratorium Animalis Scientia Sinica 2024;32(5):630-637
Objective To investigate the effects of cultured mycelium Cordyceps sinensis(CMCS)on the AMPK/SirT1 signaling pathway in carbon tetrachloride(CCl4)-induced liver fibrosis in mice.Methods Forty male SPF-grade C57BL/6 mice were divided randomly into a normal control group,CMCS control group(3.0 g/kg),model control group,CMCS1.5 g/kg group,and CMCS 3.0 g/kg group.Mice were injected intraperitoneally with 10%CCl4(2 mL/kg)to induce liver fibrosis.Two weeks later,serum levels of alanine transaminase(ALT),aspartate transaminase(AST),and total bilirubin(TBil)were measured.Inflammation and collagen deposition in liver tissue were observed by hematoxylin and eosin(HE)and Sirius red staining,respectively.The content of hydroxyproline in liver tissue was detected by Jamall's hydrochloric acid hydrolysis method.Levels of interleukin(IL)-6,monocyte chemoattractant protein-1(MCP-1),interferon,tumor necrosis factor(TNF),IL-10,and IL-12p70 in liver tissue were detected using a cytometric bead array analysis system.Collagen Ⅰ and SirT1 expression in liver tissue were detected by immunohisotochemistry,and Prkaa1,Prkaa2,Lkb1,and p53 gene expression were detected by real-time fluorescent quantitative reverse transcriptase-polymerase chain reaction.Results Serum levels of ALT,AST,and TBil were significantly increased in the model control group compared with those in the normal control group(P<0.05).HE and Sirius red staining showed extensive inflammatory cell infiltration and collagen deposition in the liver,respectively.Hydroxyproline content and expression levels of IL-6,MCP-1,and TNF in the liver were significantly increased(P<0.05),while IL-10 and IL-12p70 levels were significantly decreased(P<0.01).Immunohistochemical staining revealed an increase in Collagen Ⅰ expression and SirT1 staining was decreased in the hepatic sinusoidal space,while collagen deposition was increased.Prkaa1,Prkaa2,and Lkb1 gene expression levels were decreased and p53 was increased in liver tissue(P<0.05).CMCS significantly reduced serum ALT and AST levels,decreased IL-6,MCP-1,and TNF expression in liver tissue(P<0.05),up-regulated IL-10 and IL-12p70(P<0.05),alleviated liver inflammation,collagen deposition,and hydroxyproline content,up-regulated the expression of SirT1 in the hepatic sinusoidal space,enhanced Prkaa1,Prkaa2,and Lkb1 expression(P<0.05),and down-regulated Collagen Ⅰ and p53(P<0.05)in the liver.Compared with CMCS 1.5 g/kg,CMCS 3.0 g/kg significantly inhibited liver inflammation and collagen deposition and up-regulated AMPK/SirT1 expression(P<0.05).Conclusions CMCS could improve CCl4-induced liver fibrosis via up-regulation of the AMPK/SirT1 signaling pathway.
10.Research advances in the pathogenesis of abnormal copper metabolism in Parkinson's disease
Huijie YANG ; Rui LAN ; Manman WANG ; Weiwei WANG ; Hongyu LI ; Chen TANG ; Shuang LIU ; Jieli YANG ; Xiaoming SHEN
Chinese Journal of Comparative Medicine 2024;34(10):118-124
Parkinson's disease is a neurodegenerative disease associated with abnormal copper metabolism in the brain,which leads to misfolding and aggregation of α-synuclein-copper complexes,which is an important pathological sign of Parkinson's disease.Copper metabolism,i.e.,cellular metabolic processes involving copper ions,is closely related to the pathogenesis of α-synuclein aggregation,dopamine metabolism,mitochondrial dysfunction,oxidative stress,and ferroptosis in Parkinson's disease.In this review,we summarize the molecular metabolic mechanism of copper toxicity by studying the pathological role of copper metabolism in Parkinson's disease,to support our further understanding of the mechanism of action and drug development.

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