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.Effect of exercise on cancer patients with anxiety and depression during chemotherapy: a meta-analysis
Yicheng YANG ; Dandan WANG ; Qunce SHEN ; Lei ZHANG ; Xueping WU
Chinese Journal of Rehabilitation Theory and Practice 2025;31(2):184-193
ObjectiveTo explore the effect of exercise on anxiety and depression in cancer patients during chemotherapy, as well as the optimal exercise dosage. MethodsA PICO framework was constructed, and randomized controlled trials (RCTs) on the effect of exercise on anxiety and depression in cancer patients during chemotherapy were retrieved from databases of PubMed, Web of Science, Cochrane Library, Embase, Medline, CNKI, VIP and Wanfang data, from the establishment to November, 2023. The quality of the literature was evaluated with Cochrane Risk of Bias Tool and Physiotherapy Evidence Database (PEDro) scale. Data were synthesized and analyzed using RevMan 5.3, and the risk of bias was evaluated using Stata 18.0. ResultsA total of 13 RCTs involving 1 340 subjects were included. The scores of PEDro scale were five to eight. Exercise interventions significantly improved anxiety (SMD = -0.70, 95%CI -1.18 to -0.22, P = 0.004) and depression (SMD = -0.89, 95%CI -1.43 to -0.34, P = 0.002) compared to the control group. Subgroup analyses showed that, the exercise effect on anxiety was less than 45 minutes a time (SMD = -0.26, 95%CI -0.46 to -0.05, P = 0.01), more than three times a week (SMD = -0.26, 95%CI -0.46 to -0.05, P = 0.01), and less than twelve weeks (SMD = -0.21, 95%CI -0.36 to -0.07, P = 0.005). For depression, it was less than 45 minutes a time (SMD = -0.69, 95%CI -1.29 to -0.08, P = 0.03), more than three times a week (SMD = -0.69, 95%CI -1.29 to -0.08, P = 0.03), and less than twelve weeks (SMD = -0.52, 95%CI -0.92 to -0.13, P = 0.01). Moderate to high-intensity exercise interventions significantly outperformed the control group in improving anxiety (SMD = -0.21, 95%CI -0.37 to -0.06, P = 0.007) and depression (SMD = -0.21, 95%CI -0.41 to -0.01, P = 0.04). ConclusionExercise interventions can effectively improve anxiety and depression in cancer patients during chemotherapy, and it suggests for high-intensity exercise, less than 45 minutes a time, more than three times a week, and less than twelve weeks.
3.Effect and mechanism of Jingangteng capsules in the treatment of non-alcoholic fatty liver disease based on gut microbiota and metabolomics
Shiyuan CHENG ; Yue XIONG ; Dandan ZHANG ; Jing LI ; Zhiying SUN ; Jiaying TIAN ; Li SHEN ; Yue SHEN ; Dan LIU ; Qiong WEI ; Xiaochuan YE
China Pharmacy 2025;36(11):1340-1347
OBJECTIVE To investigate the effect and mechanism of Jingangteng capsules in the treatment of non-alcoholic fatty liver disease (NAFLD). METHODS Thirty-two SD rats were randomly divided into normal group and modeling group. The modeling group was fed a high-fat diet to establish a NAFLD model. The successfully modeled rats were then randomly divided into model group, atorvastatin group[positive control, 2 mg/(kg·d)], and Jingangteng capsules low- and high-dose groups [0.63 and 2.52 mg/(kg·d)], with 6 rats in each group. The pathological changes of the liver were observed by hematoxylin-eosin staining and oil red O staining. Enzyme-linked immunosorbent assay was performed to determine the serum levels of triglycerides (TG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), alanine transaminase (ALT), aspartate transaminase (AST), tumour necrosis factor-α (TNF-α), interleukin-1β (IL-1β), IL-6, IL-18. 16S rDNA amplicon sequencing and metabolomics techniques were applied to explore the effects of Jingangteng capsules on gut microbiota and metabolisms in NAFLD rats. Based on the E-mail:591146765@qq.com metabolomics results, Western blot analysis was performed to detect proteins related to the nuclear factor kappa-B (NF-κB)/NOD-like receptor family protein 3 (NLRP3) signaling pathway in the livers of NAFLD rats. RESULTS The experimental results showed that Jingangteng capsules could significantly reduce the serum levels of TG, TC, LDL-C, AST, ALT, TNF-α, IL-1β, IL-6, IL-18, while increased the level of HDL-C, and alleviated the hepatic cellular steatosis and inflammatory infiltration in NAFLD rats. They could regulate the gut microbiota disorders in NAFLD rats, significantly increased the relative abundance of Romboutsia and Oscillospira, and significantly decreased the relative abundance of Blautia (P<0.05). They also regulated metabolic disorders primarily by affecting secondary bile acid biosynthesis, fatty acid degradation, O-antigen nucleotide sugar biosynthesis, etc. Results of Western blot assay showed that they significantly reduced the phosphorylation levels of NF-κB p65 and NF-κB inhibitor α, and the protein expression levels of NLRP3, caspase-1 and ASC (P<0.05 or P<0.01). CONCLUSIONS Jingangteng capsules could improve inflammation, lipid accumulation and liver injury in NAFLD rats, regulate the disorders of gut microbiota and metabolisms, and inhibit NF-κB/NLRP3 signaling pathway. Their therapeutic effects against NAFLD are mediated through the inhibition of the NF-κB/NLRP3 signaling pathway.
4.Severe Anti-HER2 Drug-induced Interstitial Lung Disease: A Report of Two Cases and Clinical Implications
Zhu SHEN ; Dandan FAN ; Lei CHEN ; Guangqiang CHEN ; Yanan WANG ; Zhanhong HU ; Jie PAN ; Zhou GENG
Medical Journal of Peking Union Medical College Hospital 2025;16(6):1419-1424
Human epidermal growth factor receptor 2 (HER2) is a key therapeutic target for breast cancer. With the wide application of anti-HER2 and HER2 antibody-drug conjugates such as trastuzumab, pertuzumab, trastuzumab emtansine, and trastuzumab deruxtecan, the survival of patients with advanced HER2-positive breast cancers have been significantly improved. However, the subsequent drug-induced interstitial lung disease (DILD) has gradually become an important complication affecting the therapeutic effect and safety. However, the clinical understanding of interstitial lung disease (ILD) caused by this type of drugs is still insufficient, the management lacks unified standards, and the molecular mechanism has not been fully clarified. This study, through two clinical cases of severe DILD, explores the pathogenesis, treatment strategies, risk factors and follow-up monitoring requirements of ILD caused by HER2-targeted drugs, providing a scientific basis for optimizing the clinical diagnosis and treatment plan.
5.Relationship between the expression of serum miR-488 and miR-184 and the occurrence of preeclampsia in patients with gestational hypertension
Dandan WANG ; Mengye DENG ; Hong SHEN ; Jinjin WANG
International Journal of Laboratory Medicine 2025;46(3):276-280,286
Objective To investigate the relationship between the expression of serum microRNA(miR)-488 and miR-184 and the occurrence of preeclampsia in patients with gestational hypertension.Methods A to-tal of 128 patients with gestational hypertension admitted to a hospital from June 2022 to March 2023 were se-lected and divided into the simple gestational hypertension group(55 cases)and the combined with pre-eclampsia group(73 cases)according to whether they developed preeclampsia.Another 46 healthy pregnant women in the same period were selected as the control group.Real-time fluorescence quantitative polymerase chain reaction was used to detect miR-488 and miR-184 expression in each group,and multiple Logistic regres-sion was used to analyze the influencing factors of the occurrence of preeclampsia in patients with gestational hypertension.Receiver operating characteristic(ROC)curve was used to analyze the predictive value of each influencing factor in the occurrence of preeclampsia in patients with gestational hypertension,and Pearson cor-relation was used to analyze the correlation between serum miR-488,miR-184 and placental growth factor.Re-sults Compared with the control group,the expressions of serum miR-488 and miR-184 were increased in the simple pregnancy hypertension group and the combined with preeclampsia group,and the differences were sta-tistically significant(P<0.05).Compared with mild preeclampsia group,serum miR-488 and miR-184 ex-pressions were increased in severe preeclampsia group,and the difference was statistically significant(P<0.05).There were significant differences in gravida and parity,systolic blood pressure,diastolic blood pres-sure,urinary protein quantity and placental growth factor levels between the combined with preeclampsia group and the simple pregnancy hypertension group(P<0.05).Multiple Logistic regression analysis showed that gravida and parity,systolic blood pressure,diastolic blood pressure,urinary protein quantity,miR-488 and miR-184 were risk factors for preeclampsia in patients with gestational hypertension(P<0.05),and placental growth factor was protective factor for preeclampsia in patients with gestational hypertension(P<0.05).ROC curve analysis showed that the prediction efficiency of miR-488+miR-184 was significantly better than that of serum miR-488(Z=2.530,P=0.011)and miR-184(Z=2.437,P=0.015)alone.Serum miR-488 and miR-184 were negatively correlated with placental growth factor(r=-4.361,-4.288,P<0.05).Con-clusion Serum miR-488 and miR-184 have predictive value in the occurrence of preeclampsia in patients with gestational hypertension.
6.Value of coronary CT angiography combined with serum IL-12p70,PC,and PS in diagnosing the degree of coronary artery stenosis in coronary heart disease
Zhuo LIU ; Jianxing XU ; Dandan SHEN
International Journal of Laboratory Medicine 2025;46(9):1025-1029
Objective To explore the value of coronary CT angiography(CCTA)combined with serum in-terleukin(IL)-12p70,protein C(PC)and protein S(PS)in the diagnosis of coronary artery stenosis in coro-nary heart disease.Methods A total of 186 patients with coronary artery disease admitted to Wujin Hospital Affiliated to Jiangsu University(Changzhou Wujin People's Hospital)from April 2022 to April 2024 were prospectively selected as the study group,and the patients were grouped into mild,moderate and severe groups according to Gensimi scores,and another 186 patients with healthy physical examination during the same peri-od were selected as the control group.Enzyme-linked immunosorbent assay(ELISA)was used to detect IL-12p70 levels.Automatic coagulation instrument was used to detect the levels of PC and PS.The influencing factors of severe coronary artery stenosis in coronary heart disease were analyzed by multivariate Logistic re-gression analysis.Receiver operating characteristic(ROC)curve was plotted to analyze the diagnostic value of CCTA parameters combined with serum IL-12p70,PC and PS in the diagnosis of severe coronary artery steno-sis in coronary heart disease.Results The serum level of IL-12p70 in the study group was greatly higher than that in the control group(P<0.05),and the levels of PC and PS were greatly lower than those in the control group(P<0.05).Minimum lumen diameter(MLD),minimum tubular neck area(MLA),serum PC,and PS levels were sequentially decreased in the mild,moderate,and severe groups(P<0.05),and percentage area stenosis(%AS),percentage diameter stenosis(%DS),and serum IL-12p70 levels were sequentially increased(P<0.05).According to multivariate Logistic regression analysis,IL-12p70 was a risk factor for severe coro-nary artery stenosis in coronary heart disease(P<0.05),and PC and PS were protective factors(P<0.05).According to the ROC curve,the area under the curve(AUC)of MLD,MLA,%AS,%DS,serum IL-12p70,PC,and PS for the diagnosis of severe coronary artery stenosis in coronary heart disease was 0.810,0.767,0.782,0.779,0.776,0.809,and 0.805.The AUC of combined diagnosis for severe coronary artery stenosis in coronary heart disease was 0.982,which was better than that of individual diagnosis(Zcombination vs.MLD=2.489,Zcombination vs.MLA=2.502,Zcombination vs.%AS=2.531,Zcombination vs.%DS=2.602,Zcombination vs.IL-12p70=2.643,Zcombination vs.PC=2.537,Zcombination vs.PS=2.546,all P<0.05).Conclusion Serum IL-12p70 is greatly increased in patients with coronary heart disease,PC and PS levels are greatly reduced.CCTA combined with serum IL-12p70,PC,and PS could effectively improve their value in diagnosing degree of coronary artery stenosis in cor-onary heart disease.
7.Advances in the application of targeted protein degradation technology for cancer treatment
Fuli YAO ; Zongying LI ; Liuling SHEN ; Dandan LI
International Journal of Laboratory Medicine 2025;46(21):2571-2578
Targeted protein degradation(TPD)technology is an emerging approach that utilizes intracellu-lar proteasome or lysosome systems to eliminate disease-causing proteins,providing novel strategies for dis-ease treatment.Compared with conventional therapies,TPD has advantages such as targeting"undruppable"proteins,overcoming drug resistance and high selectivity.Among them,proteolysis-targeting chimeras(PRO-TACs)and molecular gels are representative methods,which have achieved significant progress in E3 ligase expansion,linker design,and delivery systems,and are gradually entering clinical research.PROTACs and mo-lecular glues can not only target key oncoproteins and overcome resistance,but also modulate immune respon-ses for therapeutic purposes,demonstrating broad clinical application prospects.This article reviews the re-search progress of the two types of technologies and their current application status in cancer treatment,and discusses their potential and challenges in efficacy monitoring and individualized medication from the perspec-tive of laboratory medicine.
8.CT radiomics and clinical indicators combined model in early prediction the severity of acute pancreatitis
Dandan XU ; Aoqi XIAO ; Weisen YANG ; Yan GU ; Dan JIN ; Guojian YIN ; Hongkun YIN ; Guohua FAN ; Junkang SHEN ; Liang XU
Chinese Journal of Emergency Medicine 2024;33(10):1383-1389
Objective:To explore the value of the Nomogram model established by CT radiomics combined with clinical indicators for prediction of the severity of early acute pancreatitis (AP).Methods:From January 2016 to March 2023, the AP patients in the Second Affiliated Hospital of Soochow University were retrospectively collected. According to the revised Atlanta classification and definition of acute pancreatitis in 2012, all patients were divided into the severe group and the non-severe group. All patients were first diagnosed, and abdominal CT plain scan and enhanced scan were completed within 1 week. Patients were randomly (random number) divided into training and validation groups at a ratio of 7:3. The pancreatic parenchyma was delineated as the region of interest on each phase CT images, and the radiomics features were extracted by python software. LASSO regression and 10-fold cross-validation were used to reduce the dimension and select the optimal features to establish the radiomics signature. Multivariate Logistic regression was used to select the independent predictors of severe acute pancreatitis (SAP), and a clinical model was established. A Nomogram model was established by combining CT radiomics signature and clinical independent predictors. Receiver operating characteristic (ROC) curve and decision curve analysis (DCA) were used to evaluate the predictive efficacy of each model.Results:Total of 205 AP patients were included (59 cases in severe group, 146 cases in non-severe group). 3, 5, 5 and 5 optimal radiomics features were selected from the plain CT scan, arterial phase, venous phase and delayed phase images of all patients, and the radiomics models were established. Among them, the arterial phase radiomics model had relatively better performance in predicting SAP, with an area under curve (AUC) of 0.937 in the training group and 0.913 in the validation group. Multivariate Logistic regression showed that C-reactive protein (CRP) and lactate dehydrogenase (LDH) were independent predictors of SAP, and they were used to establish a clinical model. The AUC in the training and validation groups were 0.879 and 0.889, respectively. The Nomogram model based on arterial phase CT radiomics signature, CRP and LDH was established, and the AUC was 0.956 and 0.947 in the training group and validation group, respectively. DCA showed that the net benefit of Nomogram model was higher than that of clinical model or radiomics model alone.Conclusions:The Nomogram model established by CT radiomics combined with clinical indicators has high application value for early prediction of the severity of AP, which is conducive to the formulation of clinical treatment plans and prognosis evaluation.
9.Predictive value of spectral CTA parameters for infarct core in acute ischemic stroke
Yan GU ; Dai SHI ; Yeqing WANG ; Dandan XU ; Aoqi XIAO ; Dan JIN ; Kuan LU ; Wu CAI ; Guohua FAN ; Junkang SHEN ; Liang XU
Chinese Journal of Emergency Medicine 2024;33(11):1572-1579
Objective:To investigate the value of dual-detector spectral CTA in distinguishing infarct core from penumbra in patients with acute ischemic stroke(AIS), and to further explore the risk factors associated with infarct core and their predictive value.Methods:The imaging and clinical data of 163 patients with AIS who met the inclusion criteria admitted to the Second Affiliated Hospital of Soochow University from March 2022 to May 2023 were retrospectively analyzed. Patients from March 2022 to December 2022 were used as the training group, and patients from January 2023 to May 2023 were used as the validation group for internal validation. The head and neck spectral CTA and brain CT perfusion imaging with dual-layer detector spectral CT were all carried out on all patients. Using CTP as reference, the patients were divided into infarct core group and non-infarct core group according to whether an infarct core occurred in the hypoperfusion regions of brain tissue. Multivariate logistic regression analysis was used to screen predictors related to the infarct core. The receiver operating characteristic (ROC) curve was used to evaluate the predictive efficacy.Results:A total of 163 patients were included in the study, including 112 in the training group and 51 in the validation group. There were significant differences in iodine density, effective atomic number, hypertension, triglyceride and neutrophils between the two groups ( P< 0.05). The cutoff values for iodine density values and effective atomic number values were 0.215 mg/mL and 7.405, respectively. Multivariate logistic regression analysis showed that iodine density and hypertension were independent risk factors for infarct core in AIS, and triglyceride was an independent protective factor. The area under the ROC curve (AUC) of iodine density value was the largest (0.859), with a sensitivity of 70.27%, and a specificity of 90.67%, which had a good predictive value. The ROC curve analysis results for the validation group were consistent with the training group. Conclusions:Spectral CT parameters iodine density values and effective atomic number values have the potential to distinguish the infarct core area from the penumbra area in patients with AIS. Iodine density and hypertension were independent risk factors of infarct core in AIS, triglyceride was an independent protective factor, and iodine density values obtained by dual-layer spectral detector CT had a high predictive value.
10.Relationship among Serum TRIM22 and KLF2 Levels,Disease Condition and Clinical Outcome of Patients with Active Ulcerative Colitis
Journal of Modern Laboratory Medicine 2024;39(4):143-149
Objective To explore the relationship among serum tripartite motif protein 22(TRIM22)and Kruppel-like factor 2(KLF2)levels,conditions and clinical outcomes of patients with active ulcerative colitis(UC).Methods A total of 97 patients with active ulcerative colitis admitted to Chongming Hospital Affiliated to Shanghai University of Medical and Health Sciences from January 2020 to January 2023 were selected as active group,56 patients with remission(remission group)and 80 healthy volunteers(control group)as control subjects.The patients in active group were divided into mild group(n=46),moderate group(n=31)and severe group(n=20)according to severity of the disease,which also were divided into improved group(n=68)and non-improved group(n=29)according to the clinical outcome.Enzyme-linked immunosorbent assay(ELISA)was used to detect serum TRIM22 and KLF2 levels.Pearson product moment correlation analysis was used to analyze its association with modified Mayo score.Multi-factorial logistic regression analysis was used to analyze the influencing factors of failure to improve,and the ROC curve was used to assess the predictive value of serum TRIM22 and KLF2 on failure to improve.Results The levels of serum TRIM22(37.16±9.22 pg/ml,51.05±10.83 pg/ml,64.29±13.51pg/ml)in control group,remission group and active group were increased in turn,while the levels of serum KLF2(45.27±7.98 pg/ml,36.91±7.34pg/ml,27.03±6.25 pg/ml)in control group,remission group and active group were decreased in turn,and the differences were statistically significant(F=121.076,143.946,all P<0.05).The levels of serum TRIM22(56.07±11.18 pg/ml,67.29±13.04pg/ml,78.56±13.69 pg/ml)in mild group,moderate group and severe group were increased in turn,while the levels of serum KLF2(32.07±4.95 pg/ml,25.86±4.32 pg/ml,17.25±4.09 pg/ml)in control group,remission group and active group were decreased in turn,and the differences were statistically significant(F=24.541,74.141,all P<0.05).Serum TRIM22 was positively associated with modified Mayo score(r=0.692,P<0.05),while serum KLF2 was negatively associated with modified Mayo score(r=-0.716,P<0.05)and serum TRIM22(r=-0.659,P<0.05)in patients with active ulcerative colitis.Compared with mild patients,moderate and severe patients with active ulcerative colitis had an increased risk of failure to improve after clinical treatment(OR=1.232,2.298,all P<0.05).Elevated TRIM22 level was a risk factor for failure to improve after clinical treatment(OR=1.835,P<0.05)and elevated KLF2 level was a protective factor(OR=0.731,P<0.05).Serum TRIM22,KLF2 and two indicators combined had predictive value for failure to improve,with AUC of 0.806,0.803 and 0.907,respectively.The predictive value of the combination indicators was greater than that of single indicator(Z=2.049,2.053,all P<0.05).Conclusion Serum TRIM22 level was elevated and KLF2 was decreased in patients with active ulcerative colitis,which were related to disease severity and clinical outcome.Combined testing of two indicators can be used as the biochemical marker for early clinical prediction of failure to improve after clinical treatment.

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