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.Expert consensus on the diagnosis and treatment of cemental tear.
Ye LIANG ; Hongrui LIU ; Chengjia XIE ; Yang YU ; Jinlong SHAO ; Chunxu LV ; Wenyan KANG ; Fuhua YAN ; Yaping PAN ; Faming CHEN ; Yan XU ; Zuomin WANG ; Yao SUN ; Ang LI ; Lili CHEN ; Qingxian LUAN ; Chuanjiang ZHAO ; Zhengguo CAO ; Yi LIU ; Jiang SUN ; Zhongchen SONG ; Lei ZHAO ; Li LIN ; Peihui DING ; Weilian SUN ; Jun WANG ; Jiang LIN ; Guangxun ZHU ; Qi ZHANG ; Lijun LUO ; Jiayin DENG ; Yihuai PAN ; Jin ZHAO ; Aimei SONG ; Hongmei GUO ; Jin ZHANG ; Pingping CUI ; Song GE ; Rui ZHANG ; Xiuyun REN ; Shengbin HUANG ; Xi WEI ; Lihong QIU ; Jing DENG ; Keqing PAN ; Dandan MA ; Hongyu ZHAO ; Dong CHEN ; Liangjun ZHONG ; Gang DING ; Wu CHEN ; Quanchen XU ; Xiaoyu SUN ; Lingqian DU ; Ling LI ; Yijia WANG ; Xiaoyuan LI ; Qiang CHEN ; Hui WANG ; Zheng ZHANG ; Mengmeng LIU ; Chengfei ZHANG ; Xuedong ZHOU ; Shaohua GE
International Journal of Oral Science 2025;17(1):61-61
Cemental tear is a rare and indetectable condition unless obvious clinical signs present with the involvement of surrounding periodontal and periapical tissues. Due to its clinical manifestations similar to common dental issues, such as vertical root fracture, primary endodontic diseases, and periodontal diseases, as well as the low awareness of cemental tear for clinicians, misdiagnosis often occurs. The critical principle for cemental tear treatment is to remove torn fragments, and overlooking fragments leads to futile therapy, which could deteriorate the conditions of the affected teeth. Therefore, accurate diagnosis and subsequent appropriate interventions are vital for managing cemental tear. Novel diagnostic tools, including cone-beam computed tomography (CBCT), microscopes, and enamel matrix derivatives, have improved early detection and management, enhancing tooth retention. The implementation of standardized diagnostic criteria and treatment protocols, combined with improved clinical awareness among dental professionals, serves to mitigate risks of diagnostic errors and suboptimal therapeutic interventions. This expert consensus reviewed the epidemiology, pathogenesis, potential predisposing factors, clinical manifestations, diagnosis, differential diagnosis, treatment, and prognosis of cemental tear, aiming to provide a clinical guideline and facilitate clinicians to have a better understanding of cemental tear.
Humans
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Dental Cementum/injuries*
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Consensus
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Diagnosis, Differential
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Cone-Beam Computed Tomography
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Tooth Fractures/therapy*
3.Accuracy of multivariate discriminant analysis versus fibrosis-4 in evaluating the liver fibrosis degree in patients with chronic HBV infection
Hongyu LIU ; Xiaoting LI ; Jianning JIANG ; Chao JIN ; Cailian CAI ; Keshan WANG ; Fangpeng LING ; Bingling FAN ; Minghua SU
Journal of Clinical Hepatology 2025;41(4):677-683
ObjectiveTo investigate the accuracy of multiple discriminant analysis (MDA) versus fibrosis-4 (FIB-4) in assessing liver fibrosis degree in patients with HBV infection, as well as the possibility of MDA as an indicator for disease progression. MethodsA total of 263 patients with HBV infection who underwent liver biopsy in The First Affiliated Hospital of Guangxi Medical University from April 2010 to April 2024 were included, and their clinical data were collected. According to the results of pathological examination, they were divided into non-significant fibrosis group (F<2) with 126 patients and significant fibrosis group (F≥2) with 137 patients. The correlation of MDA and FIB-4 with liver fibrosis degree was analyzed, and MDA and FIB-4 were compared in terms of their accuracy in assessing significant liver fibrosis. A total of 62 patients completed follow-up, and according to the presence or absence of progression to liver cirrhosis at the last follow-up visit, they were divided into progressive group with 21 patients and non-progressive group with 41 patients; the efficacy of MDA and FIB-4 in diagnosing disease progression was analyzed and compared. The independent-samples t test was used for comparison of normally distributed continuous data between groups, and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between groups; the Kruskal-Wallis H test was used for comparison between multiple groups, and the Bonferroni method was used for further comparison between two groups. The chi-square test was used for comparison of categorical data. The Spearman’s correlation coefficient was used for correlation analysis. The Wilcoxon signed rank sum test was used for the analysis of baseline data and data at the end of follow-up, and the binary Logistic regression analysis was used to investigate the influencing factors for progression to liver cirrhosis. The receiver operating characteristic (ROC) curve was used to investigate the diagnostic efficacy of indicators, the Z-test was used for comparison of the area under the ROC curve (AUC), and the paired chi-square test was used for comparison of the sensitivity, specificity, and accuracy of the two indicators. ResultsThe correlation coefficient between FIB-4 and liver fibrosis degree was 0.378, while the correlation coefficient between MDA and liver fibrosis degree was -0.325 (both P<0.001). FIB-4 had an AUC of 0.688, a sensitivity of 64.96%, a specificity of 68.87%, a positive predictive value of 67.42%, a negative predictive value of 63.36%, an accuracy of 65.40%, and a cut-off value of 1.01, while MDA had an AUC of 0.653, a sensitivity of 52.55%, a specificity of 78.57%, a positive predictive value of 72.73%, a negative predictive value of 60.37%, an accuracy of 65.02%, and a cut-off value of 0.29, suggesting that compared with FIB-4, MDA had a lower sensitivity (P=0.004) and a higher specificity (P=0.001). The progressive group had a significantly higher age than the non-progressive group at baseline (t=2.611, P=0.011). For the progressive group, there was an increase in FIB-4 and a reduction in MDA from baseline to the end of follow-up (both P<0.001), while the non-progressive group showed no significant changes (both P>0.05). The multivariate Logistic regression analysis showed that aspartate aminotransferase (odds ratio [OR]=0.940, 95% confidence interval [CI]: 0.885 — 0.998, P<0.05) and MDA (OR=0.445, 95%CI: 0.279 — 0.710, P<0.001) were independent influencing factors for disease progression. MDA had an AUC of 0.893 and an optimal cut-off value of -0.01 in diagnosing the disease progression of liver cirrhosis. ConclusionMDA has a comparable accuracy to FIB-4 in the diagnosis of significant liver fibrosis, and MDA<-0.01 has a high accuracy in diagnosing the progression of liver fibrosis to liver cirrhosis, which can help to reduce the need for liver biopsy in clinical practice.
4.The anti-hyperuricemia potential of bioactive natural products and extracts derived from traditional Chinese medicines: A review and perspective.
Yaolei LI ; Zhijian LIN ; Hongyu JIN ; Feng WEI ; Shuangcheng MA ; Bing ZHANG
Journal of Pharmaceutical Analysis 2025;15(7):101183-101183
Hyperuricemia (HUA) and gout became typical metabolic disorders characterized by multiple pathogenic factors. Their incidence increased annually, affecting younger populations. Given that uric acid (UA) and inflammation were the primary disease mechanisms, the search for effective and low-side-effect UA-lowering and anti-inflammatory drugs became a pressing scientific priority. Traditional Chinese medicine (TCM) encompassed a rich array of theoretical and practical experience, along with a diverse range of chemical substances, making herbs or their components potential sources for therapeutic drugs. Despite the significant role that modern herbal medicines played in treating HUA and gout, the existing research literature remained fragmented, lacking comprehensive and systematic reviews. In this review, we focused on the regulation of UA and summarized the discovery of UA-lowering pharmacodynamic components or ingredients derived from herbs and formulas, as well as their multi-targeted mechanisms of action. Emphasizing this focus, we proposed that, compared to acute inflammation, low-grade inflammation may play a relatively "unnoticed" role in the disease process. In contrast to Western medicine, we discussed the risks and benefits of herbal medicines and their ingredients for treatment, drawing from theoretical insights and clinical practice. This review offered comprehensive perspectives on the research into anti-HUA and gout treatments using herbal medicines and their natural products. Additionally, it provided a forward-looking view on natural product discovery, the exploration of therapeutic strategies, and new drug research in this field.
5.Biological exposure and health risks of arsenic species from medicinal leeches at major exposure points in humans.
Yaolei LI ; Jing FAN ; Hailiang LI ; Xianlong CHENG ; Hongyu JIN ; Feng WEI ; Shuangcheng MA
Journal of Pharmaceutical Analysis 2025;15(7):101177-101177
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6.Erianin alleviates atopic dermatitis by regulating the HMGB1/RAGE-RhoA/ROCK1 signaling pathway
Kexin XU ; Dandan WANG ; Hongyu JIN ; Yue DU ; Li LI ; Yilan SONG ; Guanghai YAN ; Liangchang LI
Chinese Journal of Comparative Medicine 2025;35(4):11-20
Objective To explore the role of Erianin in atopic dermatitis(AD)and its regulatory mechanism involving the high-mobility group box 1(HMGB1)/receptor for advanced glycation end products(RAGE)-Ras homolog gene family member A(RhoA)/Rho-associated protein kinase 1(ROCK1)signaling pathway.Methods An AD model was induced in BALB/c mice using 1-chloro-2,4-dinitrobenzene(DNCB).Skin thickness and spleen and lymph node weight were measured and pathological changes in the back skin and ears were detected using methylamine blue and hematoxylin and eosin staining.Inflammatory factors were detected by enzyme-linked immunosorbent assay.An in vitro model of AD was established in HaCaT cells stimulated by tumor necrosis factor(TNF)-α.Cellular reactive oxygen species(ROS)were detected by flow cytometry and mitochondrial ROS(mtROS)were detected by immunofluorescence assay.Cell apoptosis was detected by terminal deoxynucleotidyl transferase dUTP nick-end labeling.HMGB1,RAGE,RhoA,and ROCK1 proteins were detected by Western blot.Results Erianin inhibited the increase in skin thickness,reduced the spleen and lymph node weights,improved the infiltration of inflammatory cells and the degranulation of mast cells,and reduced the levels of inflammatory factors(P<0.05).Erianin also reduced the production of cellular ROS and mtROS induced by TNF-α in vitro(P<0.01),and decreased the protein expression of HMGB1,RAGE,RhoA,and ROCK1(P<0.01).Treatment of HMGB1-stimulated HaCaT cells with a RAGE-specific blocker(TFA)had no effect on HMGB1 expression,while expression levels of RAGE,RhoA,and ROCK1 were decreased(P<0.01).Cells treated with the Rho kinase inhibitor Y-27632+r-HMGB1 group showed similar result to the TFA+r-HMGB1 group,except for RAGE.Conclusions Erianin relieves AD by regulating the HMGB1/RAGE-RhoA/ROCK signaling pathway.
7.Research progress of sex hormone and allergic diseases
Xinyi SONG ; Hanye LIU ; Dandan WANG ; Hongyu JIN ; Guanghai YAN ; Liangchang LI
Chinese Journal of Immunology 2025;41(1):220-225
Nowadays,the incidence of allergic diseases is increasing worldwide,which seriously affects the quality of human life.Recent studies have shown that sex hormones are closely related to the occurrence of allergic diseases.Sex hormones can directly affect the function and development of immune cells,as well as the susceptibility to autoimmune cell responses,resulting in different prevalence and clinical manifestations of allergic diseases in men and women.This article reviews the different roles and potential mechanisms of sex hormones in the occurrence and development of common allergic diseases.In atopic dermatitis,the amount of dehy-droepiandrosterone sulfate into dehydroepiandrosterone sulfate is higher in females than in males.Therefore,females are more suscep-tible to the influence of dehydroepiandrosterone,which inhibits the proliferation of Th2,resulting in a series of clinical symptoms.In allergic asthma,estrogen can aggravate type 2 airway inflammation and androgens can reduce type 2 airway inflammation.Studies have found that there are estrogen and progesterone receptors in the nasal mucosa.When the estrogen concentration increases,the two re-ceptors are also up-regulated,resulting in clinical manifestations such as increased nasal secretions and nasal mucosal swelling.
8.A randomized,double-blind,placebo-controlled,multicenter clinical study of Shengxuebao Mixture in treating cancer-related anemia
Zhu LIU ; Xiangrong LI ; Xiaojun DAI ; Yanjun WANG ; Xiao LI ; Keqiong WANG ; Tao WU ; Miaowen ZHONG ; Hongjiang YU ; Ji FENG ; Zuowei HU ; Kainan LI ; Shaowei CHEN ; Chunhua LI ; Zhengchuan FU ; Rui ZHANG ; Yongfa CHEN ; Hongyu XU ; Tao REN ; Yibo YAO ; Jianxu JIN ; Pengyin WANG ; Zhijiang HE ; Jian SHEN ; Lei WANG ; Min LI ; Wenming CHANG ; Xinyi CHEN ; Li HOU
Journal of Beijing University of Traditional Chinese Medicine 2025;48(10):1447-1459
Objective We aimed to evaluate the efficacy and safety of Shengxuebao Mixture in the treatment of cancer-related anemia(CRA)presenting with syndrome of deficiency of liver and kidney combined with syndrome of deficiency of both qi and blood.Methods A randomized,double-blind,placebo-controlled,multicenter clinical trial was conducted.Eligible patients with malignant tumors meeting the inclusion and exclusion criteria were enrolled from 26 hospitals,including Dongzhimen Hospital,Beijing University of Chinese Medicine,Xiaogan Central Hospital,and Yangzhou Hospital of Traditional Chinese Medicine,from June 1,2022,to September 30,2024.Patients were allocated 1:1 to either the experimental group receiving Shengxuebao Mixture or the control group receiving its simulator(placebo)using a block randomization method under double-blind conditions.Both groups received 15 mL orally three times daily for 28 consecutive days.The primary efficacy indicators included the hemoglobin(Hb)improvement rate(RHb)and the traditional Chinese medicine(TCM)syndrome improvement rate(RTCM)at week 4 of treatment.The secondary efficacy indicators encompassed Hb and red blood cell(RBC)count,Karnofsky Performance Status(KPS)score,TCM syndrome score,individual TCM symptom scores,and changes in each of these indicators compared to the baseline period at weeks 2,4,and 6 of treatment.Safety evaluations were conducted at week 4 of treatment.Results A total of 239 patients were enrolled,with 225 cases included in the Full Analysis Set(FAS)(109 in the experimental group vs.116 control group),163 in the Per Protocol Set(PPS)(77 vs.86),and 225 in the Safety Set(SS)(109 vs.116).Baseline characteristics between groups showed no significant differences.Significant differences were observed between the experimental and control groups in RHb at week 4(FAS:49.51%vs.35.24%,P<0.05;PPS:53.25%vs.36.05%,P<0.05)and RTCM at week 4(FAS:61.54%vs.39.62%,P<0.01;PPS:64.94%vs.40.70%,P<0.01).At weeks 2,4,and 6,the experimental group showed greater improvements in Hb and RBC counts than the control group.Additionally,the TCM syndrome scores were lower in the experimental group than in the control group at these time points.Except for week 2 in PPS,the KPS improvement was better in the experimental group than in the control group(P<0.05).The experimental group also demonstrated a greater reduction in scores for individual TCM symptoms such as spiritlessness and weakness,poor appetite and reduced food intake at weeks 4 and 6 compared to the control group(P<0.05,P<0.01).Furthermore,the reduction in vertigo score was more pronounced in the experimental group at week 6(P<0.01).For the score of pale and lusterless complexion,only in the PPS was the reduction from baseline more significant in the experimental group than in the control group at weeks 4 and 6(P<0.05).No significant differences were observed between the experimental and control groups in the incidence of all adverse events or drug-related adverse reactions.Conclusion Shengxuebao Mixture demonstrates significant efficacy in patients with CRA presenting syndrome of deficiency of liver and kidney combined with syndrome of deficiency of both qi and blood,effectively increasing Hb levels,ameliorating TCM syndromes,alleviating clinical symptoms,and enhancing functional status,with no significant difference in adverse drug reactions compared to the placebo.
9.National clinical three-tiered surveillance and stratified precision detection report on respiratory infectious pathogens in 2024
Jingwen AI ; Jikui DENG ; Min DONG ; Xiaohong GAO ; Jiawei GENG ; Xiaoli HU ; Zhu JIN ; Hongyan LIU ; Yongzhong LI ; Xi LIU ; Yuanwang QIU ; Lihong QU ; Binhuang SUN ; Wei SONG ; Hongyu WANG ; Junping WANG ; Sen WANG ; Xiaoming XIONG ; Daokun YANG ; Liaoyun ZHANG ; Yanliang ZHANG ; Xianghong ZHOU ; Wenhong ZHANG
Chinese Journal of Infectious Diseases 2025;43(2):79-89
Objective:To analyze the epidemiological and clinical characteristics of respiratory pathogens in China.Methods:This study was a cross-sectional study, which encompassed 19 core units of the clinical pathogen network and established a three-tiered clinical pathogen surveillance system. Thirty respiratory samples were collected every two weeks from various units from January to December 2024, and the clinical and pathogen diagnostic information were gathered. A total of 11 864 samples were tested using this system. The tier-1 clinical pathogen surveillance system covered influenza A virus (Flu-A), influenza B virus (Flu-B), respiratory syncytial virus (RSV), and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The tier-2 clinical pathogen surveillance system focused on 18 key respiratory pathogens. The tier-3 clinical pathogen surveillance system further clarified whether any emerging infectious diseases had occurred.Results:The tier-1 clinical pathogen surveillance system showed Flu-A predominated in December, Flu-B predominated in January, SARS-CoV-2 peaked in March and August, whereas RSV circulated sporadically throughout the year. Geographic trends were broadly consistent across the seven major regions, although Flu-A detection in December was notably higher in Northeast China (48.1%(111/231)) and East China (36.2%(148/409)), and RSV detection was concentrated in the Northwest and South China from January to March. Data from the tier-2 clinical pathogen surveillance system indicated that Streptococcus pneumoniae, Mycoplasma pneumoniae, rhinovirus, and adenovirus were detected year-round, of these, Streptococcus pneumoniae and rhinovirus showed elevated positive detection rates from August to September, while adenovirus peaked in January. Legionella pneumophila was not detected throughout the year, and other pathogens fluctuated throughout the year without a consistent pattern. The predominant etiologic agents of pediatric pneumonia were Mycoplasma pneumoniae (35.0%(105/300)), rhinovirus (25.7%(77/300)), and adenovirus (17.3%(52/300)), whereas adult pneumonia was mainly caused by Streptococcus pneumoniae (10.5%(29/277)), Staphylococcus aureus (6.9%(19/277)), Mycoplasma pneumoniae (6.9%(19/277)), and Flu-A (6.1%(17/277)). The tier-3 clinical pathogen surveillance system did not identify any emerging respiratory pathogens. Conclusion:Respiratory pathogens in China in 2024 exhibit distinct temporal and spatial distribution patterns and vary among different populations.
10.The anti-hyperuricemia potential of bioactive natural products and extracts derived from traditional Chinese medicines:A review and perspective
Yaolei LI ; Zhijian LIN ; Hongyu JIN ; Feng WEI ; Shuangcheng MA ; Bing ZHANG
Journal of Pharmaceutical Analysis 2025;15(7):1497-1511
Hyperuricemia(HUA)and gout became typical metabolic disorders characterized by multiple pathogenic factors.Their incidence increased annually,affecting younger populations.Given that uric acid(UA)and inflammation were the primary disease mechanisms,the search for effective and low-side-effect UA-lowering and anti-inflammatory drugs became a pressing scientific priority.Traditional Chinese medi-cine(TCM)encompassed a rich array of theoretical and practical experience,along with a diverse range of chemical substances,making herbs or their components potential sources for therapeutic drugs.Despite the significant role that modern herbal medicines played in treating HUA and gout,the existing research literature remained fragmented,lacking comprehensive and systematic reviews.In this review,we focused on the regulation of UA and summarized the discovery of UA-lowering pharmacodynamic components or ingredients derived from herbs and formulas,as well as their multi-targeted mechanisms of action.Emphasizing this focus,we proposed that,compared to acute inflammation,low-grade inflammation may play a relatively"unnoticed"role in the disease process.In contrast to Western medicine,we discussed the risks and benefits of herbal medicines and their ingredients for treatment,drawing from theoretical insights and clinical practice.This review offered comprehensive perspectives on the research into anti-HUA and gout treatments using herbal medicines and their natural products.Additionally,it provided a forward-looking view on natural product discovery,the exploration of ther-apeutic strategies,and new drug research in this field.

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