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.Research progress on financial incentives for improving medication adherence
Tiantian TAO ; Yi CAO ; Mengdie ZHANG ; Pingyu CHEN
China Pharmacy 2025;36(10):1266-1270
Financial incentives, as an intervention in behavioral therapy, have been proven to be beneficial in many health behaviors, such as drug addiction treatment, long-term antiviral therapy, and the prevention and treatment of chronic diseases. At present, typical financial incentive schemes mainly include commitment contracts and lottery-based models. Key factors in the design of such interventions include the adaptability of behavioral economic principles and medication behavior, the effectiveness and cost-effectiveness of design scheme, and the acceptability of intervention population. Although financial incentives have accumulated rich experience in health behavior interventions abroad, research on medication adherence remains limited, with existing intervention scheme design and mechanism constraints, and their effectiveness potentially varying across different cultural and social environments. China should explore practical models of financial incentives to enhance medication adherence, considering patients’ medication patterns and socio-cultural factors.
3.Consideration of countermeasures to promote family doctor contracting rate and first-return-visit rate in primary care institutions
Fei SHENG ; Ping LU ; Liqing ZHOU ; Bihua CHEN ; Chuntao YI ; Jiangen CHEN ; Fulai SHEN ; Tiantian DENG ; Dongjian XU ; Liling MAO
Chinese Journal of General Practitioners 2024;23(2):180-184
Based on the analysis of the existing problems and implementation dilemmas in family doctor contracting and first-return-visits faced by primary medical institutions in China, the authors propose countermeasures to provide reference for managers of primary health care institutions.
4.Introduction to Guidelines for public health protection against high temperature and heatwaves
Tiantian LI ; Chen CHEN ; Mengxue ZHANG ; Yanwen LIU ; Lijun PAN ; Qinghua SUN ; Yuanyuan LIU ; Yi ZHANG ; Lin WANG
Chinese Journal of Preventive Medicine 2024;58(5):588-591
In recent years, the high temperature and heatwaves have seriously affected the health of Chinese residents, and there is an important need for public health protection guidelines for high temperature and heatwaves in China. The National Bureau of Disease Control and Prevention has organized experts to fully investigate the evidence from epidemiological research on the health of populations in high temperature and heatwaves globally and in China, analyze the health hazards and protection needs of different populations, and put forward practical and effective individual protection measures and health recommendations. For this reason, the "Guideline for Public Health Protection against High Temperature and Heatwaves" (referred to as the "Guideline") was officially issued in June 2023. This article interprets the background and significance of the Guideline, the principles of compilation, the main considerations, the main contents, the implementations and promotions and other aspects, to improve the understanding of the content of the Guideline and strengthen the publicity and implementations.
5.Introduction to Guidelines for public health protection against high temperature and heatwaves
Tiantian LI ; Chen CHEN ; Mengxue ZHANG ; Yanwen LIU ; Lijun PAN ; Qinghua SUN ; Yuanyuan LIU ; Yi ZHANG ; Lin WANG
Chinese Journal of Preventive Medicine 2024;58(5):588-591
In recent years, the high temperature and heatwaves have seriously affected the health of Chinese residents, and there is an important need for public health protection guidelines for high temperature and heatwaves in China. The National Bureau of Disease Control and Prevention has organized experts to fully investigate the evidence from epidemiological research on the health of populations in high temperature and heatwaves globally and in China, analyze the health hazards and protection needs of different populations, and put forward practical and effective individual protection measures and health recommendations. For this reason, the "Guideline for Public Health Protection against High Temperature and Heatwaves" (referred to as the "Guideline") was officially issued in June 2023. This article interprets the background and significance of the Guideline, the principles of compilation, the main considerations, the main contents, the implementations and promotions and other aspects, to improve the understanding of the content of the Guideline and strengthen the publicity and implementations.
6.Correlation between plasma neurofilament light chain and subtypes of Parkinson disease
Xiaojing LIANG ; Hongyan YI ; Tiantian LI ; Fugui XU ; Lijun WANG ; Zhou OU ; Qiang TONG
Chinese Journal of Behavioral Medicine and Brain Science 2024;33(9):783-789
Objective:To investigate the correlation between plasma total α-synuclein (α-syn), phosphorylated α-synuclein (p-α-syn), neurofilament light chain(NfL) and subtypes of Parkinson disease(PD).Methods:A total of 62 PD patients admitted to the Department of Neurology, the Affiliated Huai 'an No. 1 People 's Hospital of Nanjing Medical University from September 2021 to January 2023 were selected and scored on the Hoehn-Yahr stage(H-Y), unified Parkinson's disease rating scale Ⅲ(UPDRS-Ⅲ), levodopa equivalent daily dosage(LEDD), mini-mental state examination(MMSE), Parkinson disease quality of life questionnaire(PDQ-39) and activities of daily living(ADL). During the same period, 25 healthy individuals matched in age and sex were enrolled as the control group (HC). Clinical characteristics and blood samples were collected. The plasma levels of α-syn, p-α-syn and NfL were detected by enzyme-linked immunosorbent assay(ELISA). PD patients were divided into tremor dominant type (TD, n=27) and akinetic-rigid dominant type (AR, n=35) based on UPDRS-Ⅲ scores. Multifactorial Logistic regression analysis was performed by SPSS 25.0 software to determine the influencing factors of subtypes of Parkinson disease. The receiver operating characteristic (ROC) curve was used to determine the optimal cut-off point of plasma NfL between the AR type and the TD type. Results:Plasma α-syn, p-α-syn, NfL levels in the PD group were significantly higher than those of the HC group ( Z=-2.537, -6.580, -7.101, all P<0.05). There were statistically significant differences between the AR type and the TD type in disease duration, H-Y stage, UPDRS-Ⅲ scores, LEDD and MMSE scores ( Z=-2.503, -3.021, -2.025, -2.086, -2.409, all P<0.05). While no significant difference was found in plasma α-syn and p-α-syn levels between the AR type and TD type ( Z=-0.341, -0.085, both P>0.05), the plasma NfL levels were notably higher in the AR type(92.79(16.84, 117.53) pg/mL) compared to the TD type (12.10(6.99, 100.17) pg/mL)( Z=-2.236, P<0.05). Plasma NfL levels were correlated with rigidity scores ( r=0.438, P<0.001), UPDRS-Ⅲ scores ( r=0.337, P<0.05) and motor subtypes ( r=0.286, P<0.05) in PD patients. Multivariate Logistic regression analysis showed that NfL was risk factor for AR( B=0.002, OR=1.002, 95% CI=1.001-1.003, P=0.017). The ROC curve analysis indicated that plasma NfL levels could predict different subtypes of PD with an AUC=0.667, optimal cutoff =26.527. Conclusion:There is a correlation between elevated plasma NfL levels and the occurrence of AR type of PD, suggesting that nerve injury is probably involved in the occurrence and progression of various motor subtypes of PD.
7.Comparative PET molecular imaging study of abdominal vulnerable atherosclerotic plaque with targeted TSPO molecular probes 18F-FDPA and 18F-LW223 in rabbit models
Quan LI ; Tiantian MOU ; Ying ZHANG ; Yi TIAN ; Mingkai YUN ; Biao HU ; Yehong ZHANG ; Xiaofen XIE ; Wei DONG ; Hongzhi MI
Chinese Journal of Nuclear Medicine and Molecular Imaging 2024;44(8):478-483
Objective:To compare the feasibility and efficacy of translocator protein (TSPO) molecular probes N, N-diethyl-2-(2-(4- 18F-fluorophenyl)-5, 7-dimethylpyrazolo[1, 5-a]pyrimidin-3-yl)acetamide ( 18F-FDPA) and 18F-(R)-( N-sec-butyl)-3-fluoromethyl- N-methyl-4-phenylquinoline-2-carboxamide (LW223) for the detection of abdominal vulnerable atherosclerotic plaques (VAP) in rabbit models. Methods:Nine healthy New Zealand white rabbits were divided into group A (control group, n=3), group B (VAP group, n=3) and group C (VAP treatment group, n=3) using completely randomized design. Animals were injected with 18F-FDPA and 18F-LW223 at the end of 12, 16 and 24 weeks. PET/CT and CT angiography (CTA) was performed 40-50 min post injection. All rabbits were sacrificed at the end of 24 weeks after imaging studies. All abdominal aortas were collected for pathological and immunofluorescence examination. Repeated measures analysis of variance (Bonferroni test) and paired t-test were used to analyze the data. Results:Target-to-background ratio (TBR; abdominal aortic lesion/left ventricular blood pool) values of 18F-FDPA in 3 groups at the end of 12, 16 and 24 weeks were significantly different ( F values: 68.09-144.88, all P<0.001). At the end of 12 weeks, there was no increased uptake of 18F-FDPA in the abdominal aorta region in 3 groups. The local 18F-FDPA uptake of the abdominal aorta in group B was significantly higher than the uptake in group C and that in group A at the end of 16 and 24 weeks( P<0.05 or P<0.001), and there were significant differences between group C and group A, with higher uptake in group C (both P<0.01). In 3 groups, there was no significant 18F-LW223 uptake in the abdominal aorta region at 3 time points of PET/CTA imaging. At the end of 12, 16 and 24 weeks, TBR values of 18F-FDPA and 18F-LW223 in 3 groups exhibited statistical differences ( t values: 2.88-36.79, all P<0.05). HE, immunofluorescent CD68 and TSPO staining showed more macrophage infiltration in group B than group C. Conclusion:18F-FDPA can be used to detect VAP in rabbits′ abdominal arteries at early time compared to 18F-LW223, and to evaluate the changes in the stability of vulnerable plaque after lipid-lowering drug intervention.
8.Correlation between plasma glial fibrillary acidic protein, α -synuclein and progression of Parkinson disease
Hongyan YI ; Xiaojing LIANG ; Fugui XU ; Tiantian LI ; Qiang TONG
Chinese Journal of Behavioral Medicine and Brain Science 2023;32(11):999-1004
Objective:To investigate the correlation between plasma glial fibrillary acidic protein (GFAP), total α-synuclein (α-syn), phosphorylated α-synuclein (p-α-syn) and the disease progression in patients with Parkinson disease(PD).Methods:Sixty-three patients with PD including the outpatients and inpatients from Department of Neurology of Huai'an First People's Hospital were continuously collected as a PD group, and 25 healthy people matched in age and sex were selected as a healthy control (HC) group at the same time. The plasma levels of GFAP, α-syn, and p-α-syn levels in the PD group and HC group were detected by ELISA. SPSS 25.0 software was used for statistical analysis. Mann-Whitney U test was performed to assess the differences of GFAP, α-syn and p-α-syn levels between the two groups, and the correlation between GFAP and α-syn and p-α-syn levels in PD group was examined by Spearman correlation analysis. The levels of GFAP, α-syn and p-α-syn in different Hoehn-Yahr(H-Y) stages of PD group were compared by Mann-Whitney U test and Spearman correlation analysis. Results:The levels of GFAP (0.80(0.62, 0.97)ng/mL, 0.54(0.27, 0.88)ng/mL, Z=-3.216, P=0.001), α-syn (3.93(3.16, 6.02)ng/mL, 2.67(1.74, 4.47)ng/mL, Z=-2.600, P=0.009), and p-α-syn (5.80(1.31, 15.62), 0.71(0.61, 0.83), Z=-6.607, P<0.001) in PD group were higher than those in HC group, and the difference was statistically significant. In PD group, there was a significant positive correlation between GFAP and α-syn ( r=0.442, P<0.001) and p-α-syn ( r=0.493, P<0.001). GFAP in the advanced PD group was higher than that in the early PD group, and the difference was statistically significant( P=0.039). There was no significant difference in α-syn and p-α-syn between different H-Y stages of PD patients( P>0.05). Plasma GFAP was positively correlated with H-Y stages ( r=0.277, P=0.018). Conclusion:The level of plasma GFAP in PD patients is positively correlated with disease progression, which can be used as a potential biomarker for PD disease assessment.
9.Efficacy of endoscopic stenting drainage for hilar biliary malignant obstruction caused by hepatocellular carcinoma
Jigang YUAN ; Mingxing XIA ; Yi ZHAO ; Xin YE ; Jun WU ; Daojian GAO ; Tiantian WANG ; Xianrong HU ; Cui CHEN ; Bing HU
Chinese Journal of Digestive Endoscopy 2023;40(9):719-723
Objective:To evaluate the efficacy of endoscopic stenting drainage for patients with malignant hilar biliary obstruction caused by unresectable hepatocellular carcinoma.Methods:Data of 106 patients with malignant hilar obstruction caused by unresectable hepatocellular carcinoma who received endoscopic stenting drainage in the Third Affiliated Hospital of Naval Medical University from January 2012 to January 2019 were retrospectively analyzed. According to the different stent types, they were divided into the metal stent group (30 cases) and the plastic stent group (76 cases). The observation indexes included clinical success rate, complication incidence, stent patency and overall survival time. The independent predictors for stent patency and overall survival of patients were analyzed by multivariate Cox regression model.Results:The overall clinical success rate was 67.9% (72/106) and the incidence of postoperative cholangitis was 29.2% (31/106). The clinical success rates were 93.3% (28/30) and 57.9% (44/76) ( χ2=12.40, P<0.001), and the incidences of postoperative cholangitis were 13.3% (4/30) and 35.5% (27/76) ( χ2=5.12, P=0.024) in the metal stent group and the plastic stent group, respectively. The median stent patency was 5.2 (95% CI:3.7-6.0) months, and the overall survival time was 3.0 (95% CI:2.5-3.7) months. Multivariate Cox regression analysis showed that hepatic drainage volume <30% was an independent predictor for stent patency ( HR=2.12, 95% CI:1.01-4.46, P=0.048). Bismuth type Ⅳ ( HR=2.06, 95% CI:1.12-3.77, P=0.020), Child-Pugh class C ( HR=4.09, 95% CI: 2.00-8.39, P<0.001) and plastic stent ( HR=1.87, 95% CI:1.21-2.90, P=0.005) were independent predictors for overall survival time. Conclusion:Hepatocellular carcinoma involving the hilar bile duct has a poor prognosis. Compared with plastic stents, metal stents show advantages in clinical success rate and incidence of postoperative cholangitis. Hepatic drainage volume <30% is an independent predictor for stent patency, and Bismuth type Ⅳ, Child-Pugh class C and plastic stent are independent predictors for overall survival time.
10.Effect of Zuoguiwan on Pancreatic Islet Function in Offspring of Maternal Rats with GDM
Beixi TAN ; Le ZHAO ; Yi FENG ; Tiantian WANG ; Chaoqun WANG ; Yonghui WANG
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(17):1-8
ObjectiveTo investigate the effect of Zuoguiwan on pancreatic islet function in offspring of gestational diabetes mellitus (GDM) maternal rat model and explore the mechanisms of Zuoguiwan in improving pancreatic islet function based on postpartum pancreatic regeneration. MethodHealthy female SD rats with normal blood glucose levels were paired with male rats in a 2∶1 ratio and housed together. Pregnancy was confirmed based on vaginal plugs or vaginal smears. The pregnant rats were divided into the following groups: normal group, model group, insulin group (insulin Detemir, 20 U·kg-1), low-dose Zuoguiwan group (1.89 g·kg-1), and high-dose Zuoguiwan group (3.78 g·kg-1). The GDM rat model was induced using streptozotocin in rats except for those in the normal group. The model was confirmed by blood glucose testing in the maternal rats. Except for the normal and model groups, the other groups received daily administration of corresponding treatments. At 21 days after birth, fasting blood glucose (FBG) and fasting serum insulin (FINS) levels were measured in 6 offspring from each group. The homeostasis model assessment of insulin resistance (HOMA-IR) was calculated, and an oral glucose tolerance test (OGTT) was performed on additional 12 offspring from each group. Blood samples were taken from the abdominal aorta of the offspring at postnatal day 22, and enzyme-linked immunosorbent assay (ELISA) was used to measure insulin, glucagon (GC), pancreatic polypeptide (PPY), and somatostatin (SS) levels in the serum. Hematoxylin-eosin (HE) staining was performed to observe pathological changes in the pancreatic tissue of the offspring. Immunofluorescence (IF) was used to observe the area and structure of the pancreatic islets. Western blot was used to detect the expression of key proteins involved in the development and functional expression of pancreatic β-cells, namely pancreatic and duodenal homeobox factor 1 (Pdx1), Nkx6.1, and Glucose transporter 2 (Glut2). ResultCompared with the normal group, the model group showed significant increases in FBG and FINS levels, and HOMA-IR (P<0.01). Compared with the model group, the insulin group showed significant decreases in FBG levels and HOMA-IR (P<0.01), the low-dose Zuoguiwan group showed a significant decrease in FBG levels (P<0.05), and the high-dose Zuoguiwan group showed significant decreases in FBG and FINS levels, and HOMA-IR (P<0.01). Compared with the normal group, the model group showed significant increases in OGTT 60-min blood glucose levels and AUC index (P<0.05, P<0.01). Compared with the model group, the high-dose Zuoguiwan group showed significant decreases in OGTT60-min blood glucose levels and area under the curve(AUC) index (P<0.05, P<0.01). HE staining of pancreatic tissue showed that compared with the normal group, the model group had a reduced number of islets and a loose arrangement of acinar cells. Compared with the model group, the groups with drug treatment showed increased number of islets and a compact arrangement of acinar cells. Compared with the normal group, the model group had significantly increased levels of insulin, GC, PPY, and SS in the serum (P<0.01). Compared with the model group, the low-dose and high-dose Zuoguiwan groups and the insulin group showed significantly decreased serum levels of insulin, GC, PPY, and SS (P<0.05, P<0.01). IF results showed that compared with the normal group, the model group had a significantly lower positive rate of insulin (P<0.05). Compared with the model group, the low-dose and high-dose Zuoguiwan groups showed a significant increase in the positive rate of insulin (P<0.05). There was no significant difference in the positive rate of GC among the groups. In terms of the proportion of insulin and GC in individual islets, compared with the normal group, the model group showed a significant decrease in the proportion of insulin (P<0.01) and a significant increase in the proportion of GC (P<0.01). Compared with the model group, the low-dose and high-dose Zuoguiwan groups showed significantly increased proportion of insulin (P<0.01) and significantly decreased proportion of GC (P<0.01). Compared with the normal group, the model group showed significantly decreased expression levels of Pdx1, Nkx6.1, and Glut2 proteins in the pancreatic tissue of GDM offspring (P<0.05). Compared with the model group, the insulin group and the low-dose Zuoguiwan group showed significant increases in the expression levels of Pdx1 and Nkx6.1 proteins in the pancreatic tissue of GDM offspring (P<0.05), and the low-dose and high-dose Zuoguiwan groups showed significant increases in the expression levels of Glut2 protein (P<0.05). ConclusionZuoguiwan can promote pancreatic islet development in offspring of GDM maternal rat model, improve pancreatic islet morphology and function, and alleviate insulin resistance. Its mechanism of action may be related to the regulation of Pdx1, Nkx6.1, and Glut2 protein expression in the pancreatic tissue of offspring.

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