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.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.
6.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.
7.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.
8.Attributable deaths caused by smoking among residents in Tianjin and its impact on life expectancy in 2019
Wei LI ; Xiaodan XUE ; Wenda SHEN ; Dandan LI ; Yi PAN ; Meiqiu XIE ; Ying ZHANG ; Dezheng WANG ; Guohong JIANG ; Wenlong ZHENG
Chinese Journal of Health Management 2024;18(7):500-505
Objective:Analyze the impact of smoking on the mortality and life expectancy of residents in Tianjin in 2019.Methods:Use mortality case-control study method to collect all cause of death cases of residents in Tianjin in 2019 for analysis. After adjusting for the 5-years-old age group, education level, and marital status, the smoking attributed deaths from different diseases of different genders, smoking attributed deaths in different age groups, and their impact on life expectancy were analyzed.Results:The total number of deaths in 2019 was 75 254, with 42 201 males (56.1%). Among male deaths, 3 215 (9.9%) were attributed to smoking, of which 2 157 (50.2%) lung cancer deaths were attributed to smoking; The risk of lung cancer death among smokers was 3.075 times higher than that of non-smokers (95% CI: 2.812-3.364); Among the 33 053 female deaths (43.9%), 1 396 (5.8%) were caused by smoking, with 744 (29.1%) lung cancer deaths attributed to smoking. The age group with the highest number of deaths attributed to smoking for women was the 75-<80 years old age group, followed by the 70-<75 and 80-<85 years old age groups. The age group with the highest proportion of deaths attributed to smoking for men was the 55-<60 years old age group. In addition, smoking accounts for more than 60% of deaths in the 60-<65, 45-<50, 55-<60, and 65-<70 years old age groups. In 2019, the loss of life expectancy attributed to smoking deaths among all residents in Tianjin was 1.13 years, with a loss of 1.15 years for males and 0.57 years for females. The expected life expectancy excluding deaths caused by smoking was 82.92 years, 80.77 years for males and 84.61 years for females. Conclusions:Smoking remains one of the important risk factors for death among residents. Promoting effective measures to reduce smoking rates is an effective way to increase life expectancy.
9.Status of coronary collateral circulation and its correlation with thrombus burden in patients with acute myocardial infarction
Dandan WANG ; Jiafei LI ; Tongtong SHEN
Chinese Journal of Geriatric Heart Brain and Vessel Diseases 2024;26(11):1267-1271
Objective To analyze the status of coronary collateral circulation(CCC)in patients with acute myocardial infarction(AMI)and explore its relationship with thrombus burden.Meth-ods Convenient sampling was used to select 161 AMI patients diagnosed and treated in Tongling People's Hospital from May 2022 to March 2024.Their CCC status was assessed by Rentrop clas-sification,and according to the results,they were divided into well-(grade 2~3,84 cases)and poorly-developed CCC groups(grade 0~1,77 cases).The general clinical data,cardiac function in-dicators and thrombus burden were compared between the two groups.Multivariate logistic re-gression was employed to identify the independent influencing factors for CCC status in AMI pa-tients,and ROC curve was plotted to analyze the relationship between CCC status and thrombus burden.Results In the 161 AMI patients,the incidence of adverse CCC was 47.83%(77/161).The poorly-developed CCC group had significantly lower Gensini score,and higher white blood cell count than the well-developed CCC group(P<0.01);There is a statistically significant differ-ence in proportion of infarct related blood vessels between two groups(P<0.01).The rate of high thrombus burden in the poorly-developed CCC group was obviously higher than that in the well-developed group(79.22%vs 26.19%,P<0.01).Multivariate logistic regression analysis showed that infarction-related vessels(left anterior descending coronary artery),white blood cell count and thrombus burden were independent risk factors for poor development of CCC,while Gensini score was independent protective factors(OR=2.051,95%CI:1.071-3.928;OR=1.647,95%CI:1.353-2.006;OR=6.418,95%CI:2.654-15.519;OR=0.973,95%CI:0.948-0.999).ROC curve analysis indicated that the AUC value of thrombus burden was 0.752(95%CI:0.678-0.817).Conclusion It is quite common of poorly developed CCC in AMI patients,which is associ-ated with the increase of thrombus burden.
10.Clinical observation of areola approach endoscopic thyroidectomy and gasless axillary approach endoscopic thyroidectomy in the treatment of patients with papillary thyroid carcinoma
Hongyan SHEN ; Dandan HU ; Lei ZHAO ; Peiyou REN ; Guanlei ZHOU ; Zhen XU
Chinese Journal of Endocrine Surgery 2024;18(1):51-56
Objective:To explore the clinical efficacy of areola approach endoscopic thyroidectomy (AET) and gasless axillary approach endoscopic thyroidectomy (GAET) in the treatment of papillary thyroid carcinoma (PTC) patients.Methods:A total of 96 PTC patients from the Thyroid Surgery Department of Linyi People’s Hospital from May. 2019 to May. 2022 were selected and randomly divided into 48 patients using a random number table method. The areola group received AET, while the armpit group received GAET. The surgical situation, postoperative recovery, relevant biochemical indicators [white blood cell count (WBC), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), parathyroid hormone (PTH), blood calcium] before and after surgery, postoperative pain level, discomfort level, neck function, and complications were compared between the two groups.Results:The surgical time and extubation time of the armpit group were (125.71±15.73) minutes and (3.12±0.53) days, respectively, which were shorter than those of the areola group (137.94±20.02) minutes and (3.48±0.46) days. The intraoperative bleeding volume was (14.19±4.16) mL, which was less than that of the areola group (22.65±7.39) mL, and the number of lymph nodes cleaned was 5.06±1.02, which was more than that of the areola group (4.23±1.14) ( P<0.05) ; there was no significant difference in postoperative drainage volume and hospital stay between the two groups ( P>0.05) ; Peripheral blood WBC in the armpit group on the 1st and 3rd day after surgery [ (5.69±0.15) ×10 9/L, (5.52±0.14) ] ×10 9/L, ESR [ (8.21±0.55) mm/h, (7.64±0.60) mm/h], CRP [ (10.06±1.78) ng/L, (8.93±1.33) ng/L] were lower than those in the areola group [ (5.83±0.21) ×10 9/L, (5.70±0.23) ×10 9/L, (8.87±0.74) mm/h, (8.19±0.68) mm/h, (12.45±1.90) ng/L, (10.45±1.50) ng/L] ( P<0.05). There was no significant difference in the levels of the above biochemical indicators 5 days after surgery ( P>0.05). There was no significant difference in peripheral blood PTH and calcium levels between the two groups on the 1st, 3rd, and 5th postoperative days ( P>0.05). The pain level [ (3.25±0.32) scores, (2.53±0.27) scores, (1.82±0.22) scores] and discomfort level [ (6.85±0.71) scores, (5.24±0.66) scores, (3.51±0.57) scores] in the axillary group were lower than those in the areola group [ (3.78±0.40) scores, (2.89±0.34) scores, (2.06±0.26) scores, (7.46±0.84) scores, (6.09±0.73) scores, (4.16±0.60) scores] on the 1st, 3rd, and 5th postoperative days ( P<0.05). The neck flexion, lateral flexion, and extension range of motion in the axillary group on the 3rd day after surgery were (33.16±3.09) °, (27.63±2.57) °, and (30.44 2.73) °, respectively, which were greater than those in the areola group[ (30.08±2.76) °, (25.14±2.30) °, and (27.98±2.54) °], and the swallowing disorder index was (30.16±4.97) points lower than the (34.83±4.13) points in the areola group ( P<0.05). The incidence of complications in the axillary group was 4.17% (2/48), lower than the 16.67% (8/48) in the areola group. Conclusion:GAET treatment for PTC patients can improve the effect of lymph node dissection, reduce the degree of surgical trauma, postoperative pain and discomfort, accelerate early postoperative recovery of neck function, and reduce complications.

Result Analysis
Print
Save
E-mail