1.Study on the difference in nucleoside composition of Bombyx Batryticatus and its processed products
Yunjing QIU ; Miaoli WU ; Peizhen TONG ; Liping DENG ; Li YANG ; Guowei LI
International Journal of Traditional Chinese Medicine 2025;47(2):213-220
Objective:To establish an HPLC characteristic chromatogram method to simultaneously determine the content of 6 components in Bombyx Batryticatus and its processed products; To provide a scientific means for quality evaluation.Methods:The HPLC analysis was performed on a Waters Xselect HSS T3 column (250 mm×4.6 mm, 5 μm), with a mobile phase consisting of acetonitrile and 5 mmol/L ammonium acetate solution (adjust pH to 4.5 with acetic acid) in gradient mode at a flow rate of 1.0 ml/min. The column temperature was 30 ℃. The detection wavelength was 260 nm. The injection volume was 10 μl. The SIMCA-P 14.0 software was used for cluster analysis and partial least squares discriminant analysis to evaluate the quality of Bombyx Batryticatus and its processed products.Results:Nine common peaks were identified in the HPLC characteristic spectra of Bombyx Batryticatus and its processed products, and seven common peaks were identified. Cluster analysis and partial least squares discriminant analysis can classify Bombyx Batryticatus and its processed products into two groups, with peak 4, peak 2, peak 1, peak 6, and peak 3 as their mass difference markers. Uric Acid, Hypoxanthine, Uridine, Adenine, Guanosine, and Adenosine showed good linearity ( R2≥0.999 9) within 43.95-879.04, 2.05-41.07, 2.35-47.09, 2.02-40.36, 2.32-46.43, 2.32-46.43 μg/ml, respectively. The precision, stability (24 h), repeatability relative standard deviation (RSD) were all <3.00%. The average spiked recoveries were all in the range of 94.57%-102.01%, and the RSDs were all in the range of 0.96%-3.32%. In 15 batches of Bombyx Batryticatus, the content of the above 6 components, was determined to be 11.51, 0.33, 0.38, 0.42, 0.35, 0.36 mg/g in the following order. And in 15 batches of fried Bombyx Batryticatus, the content of components was determined to be 12.06, 0.35, 0.36, 0.18, 0.21, 0.24 mg/g in the following order. Conclusions:The method established in this study is simple, rapid, and repeatable. PLS-DA can distinguish Bombyx Batryticatus and its processed products, which can provide a reference for the quality evaluation of Bombyx Batryticatus and its processed products.
2.Analysis on the current status of clinical trial registration of the TCM treatment for functional dyspepsia
Zhongyi ZHU ; Guowei PU ; Fengye JI ; Sujing LI ; Jing LI ; Yan YANG
International Journal of Traditional Chinese Medicine 2025;47(12):1752-1758
Objective:To analyze the registration status of clinical trials of TCM treatment for functional dyspepsia (FD); To provide references for relevant clinical trial registration and implementation.Methods:The clinical registration trials of TCM for the treatment of FD were retrieved from ChiCTR and clinicaltrials.gov until January 1st, 2025. Excel 2019 was used to extract and analyze study characteristics, including basic information (registration time, country/region, institution, funding source), study features and quality (study type, trial design, phase, number of centers, sample size, interventions, outcome measures, methodological quality, reporting quality), as well as recruitment status and ethical review.Results:A total of 89 registered studies were included. Registration began in 2008 with 3 studies, peaking in 2021 with 14 studies. The studies involved 6 countries, with domestic trials covering 18 provincial-level regions in China and 52 clinical trial institutions. Primary funding sources were national funding and pharmaceutical company support. Most studies were interventional with randomized parallel-controlled designs, commonly using simple randomization. Post-marketing drug trials were the most frequent phase, and single-center trials predominated, involving a total sample size of 19 776 cases. Common interventions included acupuncture/massage and Chinese patent medicines. Frequently used outcome measures were effectiveness rate, symptom evaluation, and quality of life assessment, though issues existed with non-standardized reporting and lack of TCM-specific indicators. Methodological quality needed further improvement.Conclusions:Although the number of registered clinical trials of TCM treatment for FD has increased, the overall quantity remains insufficient. Researchers should emphasize optimization of registration details and study protocols to further enhance registration quality.
3.Study on artificial intelligence-based ultrasound diagnosis and auxiliary decision-making for ovarian tumors
Chunli QIU ; Yanlin CHEN ; Yuanji ZHANG ; Haotian LIN ; Xiaoyi PAN ; Siying LIANG ; Xiang CONG ; Xin LIU ; Zhen MA ; Cai ZANG ; Xin YANG ; Dong NI ; Guowei TAO
Chinese Journal of Ultrasonography 2025;34(7):608-615
Objective:To apply artificial intelligence(AI)in classifying ovarian tumors on ultrasound images,and compare the diagnostic results of several sonographers with varying seniority levels.Methods:A total of 645 patients diagnosed with adnexal masses via gynecological ultrasound examination at Qilu Hospital of Shandong University from January 2021 to December 2024 were enrolled. Three deep learning architectures,i.e.,Alexnet,Densenet121,and Resnet50 were developed and used to internally test the classification effectiveness of ovarian tumors,while the optimal model was selected for external testing. Two junior sonographers and two senior sonographers were recruited to independently diagnose ovarian tumors in the external test dataset. Subsequently,the benign and malignant results of the model's predictions were disclosed to each sonographer,and their revised diagnoses on the same external test data in combination with the best AI model were recorded.Results:The optimal model achieved an accuracy of 0.941,sensitivity of 0.936,and specificity of 0.944 on the internal test dataset,and maintained robust performance on the external test dataset with accuracy of 0.891,sensitivity of 0.880,and specificity of 0.907. Compared to junior sonographers,the optimal model demonstrated significantly higher sensitivity in discriminating benign from malignant ovarian tumors(0.880 vs. 0.723,0.602;all P<0.05). No statistically significant difference was observed in diagnostic accuracy between the optimal model and senior sonographer 1( P=0.05). With assistance from the optimal model,junior sonographers achieved significant improvements in both sensitivity and specificity(sensitivity:0.723 vs. 0.843,0.602 vs. 0.819;specificity:0.778 vs. 0.833,0.685 vs. 0.741;all P<0.05). Conclusions:The optimal model achieves comparable performance to that of senior sonographers in ovarian tumor classification. With model assistance,the diagnostic performance of junior sonographers is significantly improved.
4.A preliminary study of mechanosensitive channels Piezo 1 and Piezo 2 promoting neurogenic bladder fibrosis in young rats
Lei LYU ; Yanping ZHANG ; Qi LI ; Junkui WANG ; Shuai YANG ; Zhaokai ZHOU ; Shuai LI ; Yibo WEN ; Yakai LIU ; Guowei SI ; Xingchen LIU ; Jianguo WEN
Journal of Modern Urology 2025;30(4):343-349
Objective: To explore the changes of mechanosensitive channels Piezos (Piezo 1 and Piezo 2) in neurogenic bladder (NB) of young rats and their effects,so as to provide reference for clinical search of new therapeutic targets. Methods: A total of 30 female young SD rats were divided into 5 groups based on random number table method:sham operation group (sham),2-week nerve transection group (NB-2W),6-week nerve transection group (NB-6W),2-week nerve transection + Piezos inhibitor group (NB-P-2W) and 6-week nerve transection + Piezos inhibitor group (NB-P-6W),with 6 rats in each group.The NB models were constructed by transecting the L6 and S1 spinal nerves of young rats.The NB-2W and NB-6W groups were not intervened after modeling,while the NB-P-2W and NB-P-6W groups were intraperitoneally injected with Piezos inhibitor GsMTx4 (10 mg/kg) every 2 days after modeling.Bladder cystometry and ultrasound were performed after 2 and 6 weeks of transection.The expressions of Piezos and fibrosis-related indexes (Collagen Ⅰ and α-smooth muscle actin) were detected in bladder tissues. Results: The results of bladder cystometry showed that the basal bladder pressure in NB-2W group was significantly increased,while it was slightly decreased but was still higher in NB-6W group than in the sham group (P<0.05).Basal bladder pressure was lower in NB-P-2W group than in NB-2W group,but was higher than that in the sham group; basal bladder pressure was lower in NB-P-6W group than in NB-6W group,but higher than that in the sham group (P<0.05).Compared with the sham group,the NB-2W and NB-6W groups had firstly increased and then decreased maximum cystometric capacity (MCC) (P<0.05).Compared with NB-2W group,NB-P-2W group had lower bladder leakage point pressure (BLPP),but higher MCC and bladder compliance (BC) (P<0.05).Compared with NB-6W group,NB-P-6W group had significantly lower BLPP but higher MCC and BC (P<0.05).HE and MASSON staining and ultrasound results showed that,with the extension of nerve transection time,bladder fibrosis gradually worsened,the bladder wall became rough and thickened,calculi were visible inside,and hydronephrosis gradually appeared; the degree of fibrosis in NB-P-2W and NB-P-6W groups was less than that in NB-2W and NB-6W groups,and no hydronephrosis was observed in the upper urinary tract.In addition,Western blotting and immunohistochemical results showed that NB-2W and NB-6W groups had significantly higher relative expression levels of Piezos,Collagen Ⅰ and α-SMA than the sham group (P<0.01),while NB-P-2W and NB-P-6W groups had lower relative expression levels of Piezos,Collagen Ⅰ and α-SMA than NB-2W and NB-6W groups (P<0.01). Conclusion: The increased expressions of mechanosensitive channels Piezos in NB young rats may be involved in the progression of bladder fibrosis,but its mechanism needs further study.
5.Clinical efficacy of percutaneous trans-hepatic choledochoscopic lithotripsy under ERAS mode
Feifei YIN ; Guowei YANG ; Liming SONG ; Fei DUAN ; Zhanqiang LIANG ; Jian GUO ; Lei SHI ; Xuemin LI ; Xibin DUAN
Chinese Journal of Hepatobiliary Surgery 2025;31(6):415-419
Objective:To investigate the efficacy and safety of percutaneous trans-hepatic choledochoscopic lithotripsy (PTCSL) in the treatment of recurrent hepatobiliary calculi under enhanced recovery after surgery (ERAS) mode.Methods:Clinical data of 88 patients with recurrent hepatobiliary calculi, who were treated with PTCSL at Zhengzhou Central Hospital Affiliated to Zhengzhou University and the First Affiliated Hospital of Xi'an Jiaotong University between June 2022 and June 2024 were retrospectively analyzed, including 34 males and 54 females, aged (52.0±13.8) years. The scheme includes preoperative education, prophylactic antibiotic application, ensuring the quality of surgery, early postoperative feeding and activity, etc. The operation can be divided into two fashions: percutaneous transhepatic cholangial drainage and PTCSL, which can be completed in one stage (one-stage expansion method) or in two stages (staged expansion method). Clinical data such as gender, age, operative time, intraoperative blood loss, residual stone, and surgical complications were recorded.Results:All 88 patients underwent PTCSL under ERAS mode successfully, including 52 cases using one-stage expansion method and 36 cases using staged expansion method. The operative time was (53±20) min, the intraoperative blood loss was (9.7±3.8) ml, the postoperative hospital stay was (3.6±1.7) d, and the hospitalization cost was (17 500±4 700) yuan. Sixty-nine patients (78.4%, 69/88) had one-time stone removal in the first PTCSL. A total of 19 cases of residual stones were managed again by percutaneous sinus soft choledochoscopy, of which 12 cases were managed by one-time choledochoscopy, five cases by two-time choledochoscopy, and two cases by three-time choledochoscopy. The rate of residual stone was significantly higher in one-stage expansion method compared to staged expansion method [28.8% (15/52) vs. 11.1% (4/36), P=0.040]. No death, conversion to open surgery, or severe complications such as intra-abdominal hemorrhage or bile leakage occurred in the patients. No residual stones or recurrence were found during the follow-ups of (7.5±2.1) months after discharge. Conclusion:PTCSL under ERAS mode is safe and effective in the treatment of recurrent hepatobiliary calculi.
6.Exploration on the Mechanism of Chaihu Longgu Muli Decoction in the Treatment of Generalized Anxiety Disorder Rats Based on the HPA Axis-MEK/ERK Signaling Pathway
Yiming HU ; Rui YANG ; Chunxin WEI ; Shiqi HUANG ; Guowei TAN ; Xiao LI ; Yaorong AN
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(6):105-111
Objective To observe the effects of Chaihu Longgu Muli Decoction on oxidative stress in hippocampus and hypothalamic-pituitary-adrenal(HPA)axis hormone levels of rats with generalized anxiety disorder(GAD);To explore its mechanism of alleviating anxiety in GAD rats.Methods A total of 72 Wistar rats were randomly divided into blank group(12 rats)and modeling group(60 rats).Chronic restraint stress was used to establish the GAD model.The successfully modeled rats were randomly divided into model group,diazepam group(1 mg/kg)and TCM low-,medium-and high-dosage groups(Chaihu Longgu Muli Decoction 6,12,24 g/kg).The administration groups were given corresponding drugs by gavage for 14 consecutive days.Open field experiment and elevated cross maze experiment were used to observe indexes in rat behavior,HE staining was used to observe the morphology of hippocampal tissue,ELISA was used to detect the contents of serum corticotropin releasing hormone(CRH),adrenocorticotropic hormone(ACTH)and corticosterone(CORT),biochemical kits were used to detect the contents of malondialdehyde(MDA),catalase(CAT)and superoxide dismutase(SOD)in hippocampal tissue,RT-PCR was used to detect the mRNA expressions of MEK,ERK,Bax and Bcl-2 in hippocampal tissue,Western blot was used to detect the protein expressions of MEK,p-MEK,ERK,p-ERK,Bax and Bcl-2 in hippocampal tissue.Results Compared with the blank group,the rats in the model group had a significantly slower growth rate of body msss,loose stool,dark hair,significant hair removal and extreme agitation;the activity time and distance in the central area were significantly reduced(P<0.01),the percentage of time,frequency and distance of entering the open arm were significantly reduced(P<0.01);with structural degeneration of hippocampal neurons,changes in cell morphology,disordered arrangement and edema of surrounding tissues;the contents of serum CRH,ACTH and CORT significantly increased(P<0.01);the MDA content in hippocampal tissue significantly increased(P<0.01),CAT and SOD contents significantly decreased(P<0.01),p-MEK and p-ERK protein expressions significantly decreased(P<0.01),Bax mRNA and protein expressions significantly increased(P<0.01),Bcl-2 mRNA and protein expressions significantly decreased(P<0.01).Compared with the model group,the body mass growth rate of diazepam group and each dosage of TCM group increased,and the symptoms of loose stool,hair removal,anxiety and huddling were improved;the activity time and distance in the central area of rats in the diazepam group and TCM medium-and high-dosage groups significantly increased(P<0.01),and the percentage of time,frequency and distance of entering the open arm significantly increased(P<0.05,P<0.01);the contents of serum CRH,ACTH and CORT significantly decreased(P<0.05,P<0.01);the MDA content in the hippocampal tissue in diazepam group and TCM high-dosage group significantly decreased(P<0.01),while the CAT and SOD contents significantly increased(P<0.05,P<0.01),the protein expressions of p-MEK and p-ERK in hippocampal tissue in diazepam group and TCM medium-and high-dosage group significantly decreased(P<0.01),Bax mRNA and protein expressions were significantly decreased(P<0.01),and Bcl-2 mRNA and protein expressions significantly increased(P<0.05,P<0.01).There was no statistical significance in the expressions of MEK,ERK mRNA and protein among the groups(P>0.05).Conclusion Chaihu Longgu Muli Decoction can alleviate anxiety in GAD rats by inhibiting HPA axis hormone release and MEK/ERK signaling pathway activation,improving neuroendocrine levels,and reducing hippocampal oxidative stress response.
7.Clinical efficacy of percutaneous trans-hepatic choledochoscopic lithotripsy under ERAS mode
Feifei YIN ; Guowei YANG ; Liming SONG ; Fei DUAN ; Zhanqiang LIANG ; Jian GUO ; Lei SHI ; Xuemin LI ; Xibin DUAN
Chinese Journal of Hepatobiliary Surgery 2025;31(6):415-419
Objective:To investigate the efficacy and safety of percutaneous trans-hepatic choledochoscopic lithotripsy (PTCSL) in the treatment of recurrent hepatobiliary calculi under enhanced recovery after surgery (ERAS) mode.Methods:Clinical data of 88 patients with recurrent hepatobiliary calculi, who were treated with PTCSL at Zhengzhou Central Hospital Affiliated to Zhengzhou University and the First Affiliated Hospital of Xi'an Jiaotong University between June 2022 and June 2024 were retrospectively analyzed, including 34 males and 54 females, aged (52.0±13.8) years. The scheme includes preoperative education, prophylactic antibiotic application, ensuring the quality of surgery, early postoperative feeding and activity, etc. The operation can be divided into two fashions: percutaneous transhepatic cholangial drainage and PTCSL, which can be completed in one stage (one-stage expansion method) or in two stages (staged expansion method). Clinical data such as gender, age, operative time, intraoperative blood loss, residual stone, and surgical complications were recorded.Results:All 88 patients underwent PTCSL under ERAS mode successfully, including 52 cases using one-stage expansion method and 36 cases using staged expansion method. The operative time was (53±20) min, the intraoperative blood loss was (9.7±3.8) ml, the postoperative hospital stay was (3.6±1.7) d, and the hospitalization cost was (17 500±4 700) yuan. Sixty-nine patients (78.4%, 69/88) had one-time stone removal in the first PTCSL. A total of 19 cases of residual stones were managed again by percutaneous sinus soft choledochoscopy, of which 12 cases were managed by one-time choledochoscopy, five cases by two-time choledochoscopy, and two cases by three-time choledochoscopy. The rate of residual stone was significantly higher in one-stage expansion method compared to staged expansion method [28.8% (15/52) vs. 11.1% (4/36), P=0.040]. No death, conversion to open surgery, or severe complications such as intra-abdominal hemorrhage or bile leakage occurred in the patients. No residual stones or recurrence were found during the follow-ups of (7.5±2.1) months after discharge. Conclusion:PTCSL under ERAS mode is safe and effective in the treatment of recurrent hepatobiliary calculi.
8.Exploration on the Mechanism of Chaihu Longgu Muli Decoction in the Treatment of Generalized Anxiety Disorder Rats Based on the HPA Axis-MEK/ERK Signaling Pathway
Yiming HU ; Rui YANG ; Chunxin WEI ; Shiqi HUANG ; Guowei TAN ; Xiao LI ; Yaorong AN
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(6):105-111
Objective To observe the effects of Chaihu Longgu Muli Decoction on oxidative stress in hippocampus and hypothalamic-pituitary-adrenal(HPA)axis hormone levels of rats with generalized anxiety disorder(GAD);To explore its mechanism of alleviating anxiety in GAD rats.Methods A total of 72 Wistar rats were randomly divided into blank group(12 rats)and modeling group(60 rats).Chronic restraint stress was used to establish the GAD model.The successfully modeled rats were randomly divided into model group,diazepam group(1 mg/kg)and TCM low-,medium-and high-dosage groups(Chaihu Longgu Muli Decoction 6,12,24 g/kg).The administration groups were given corresponding drugs by gavage for 14 consecutive days.Open field experiment and elevated cross maze experiment were used to observe indexes in rat behavior,HE staining was used to observe the morphology of hippocampal tissue,ELISA was used to detect the contents of serum corticotropin releasing hormone(CRH),adrenocorticotropic hormone(ACTH)and corticosterone(CORT),biochemical kits were used to detect the contents of malondialdehyde(MDA),catalase(CAT)and superoxide dismutase(SOD)in hippocampal tissue,RT-PCR was used to detect the mRNA expressions of MEK,ERK,Bax and Bcl-2 in hippocampal tissue,Western blot was used to detect the protein expressions of MEK,p-MEK,ERK,p-ERK,Bax and Bcl-2 in hippocampal tissue.Results Compared with the blank group,the rats in the model group had a significantly slower growth rate of body msss,loose stool,dark hair,significant hair removal and extreme agitation;the activity time and distance in the central area were significantly reduced(P<0.01),the percentage of time,frequency and distance of entering the open arm were significantly reduced(P<0.01);with structural degeneration of hippocampal neurons,changes in cell morphology,disordered arrangement and edema of surrounding tissues;the contents of serum CRH,ACTH and CORT significantly increased(P<0.01);the MDA content in hippocampal tissue significantly increased(P<0.01),CAT and SOD contents significantly decreased(P<0.01),p-MEK and p-ERK protein expressions significantly decreased(P<0.01),Bax mRNA and protein expressions significantly increased(P<0.01),Bcl-2 mRNA and protein expressions significantly decreased(P<0.01).Compared with the model group,the body mass growth rate of diazepam group and each dosage of TCM group increased,and the symptoms of loose stool,hair removal,anxiety and huddling were improved;the activity time and distance in the central area of rats in the diazepam group and TCM medium-and high-dosage groups significantly increased(P<0.01),and the percentage of time,frequency and distance of entering the open arm significantly increased(P<0.05,P<0.01);the contents of serum CRH,ACTH and CORT significantly decreased(P<0.05,P<0.01);the MDA content in the hippocampal tissue in diazepam group and TCM high-dosage group significantly decreased(P<0.01),while the CAT and SOD contents significantly increased(P<0.05,P<0.01),the protein expressions of p-MEK and p-ERK in hippocampal tissue in diazepam group and TCM medium-and high-dosage group significantly decreased(P<0.01),Bax mRNA and protein expressions were significantly decreased(P<0.01),and Bcl-2 mRNA and protein expressions significantly increased(P<0.05,P<0.01).There was no statistical significance in the expressions of MEK,ERK mRNA and protein among the groups(P>0.05).Conclusion Chaihu Longgu Muli Decoction can alleviate anxiety in GAD rats by inhibiting HPA axis hormone release and MEK/ERK signaling pathway activation,improving neuroendocrine levels,and reducing hippocampal oxidative stress response.
9.Study on artificial intelligence-based ultrasound diagnosis and auxiliary decision-making for ovarian tumors
Chunli QIU ; Yanlin CHEN ; Yuanji ZHANG ; Haotian LIN ; Xiaoyi PAN ; Siying LIANG ; Xiang CONG ; Xin LIU ; Zhen MA ; Cai ZANG ; Xin YANG ; Dong NI ; Guowei TAO
Chinese Journal of Ultrasonography 2025;34(7):608-615
Objective:To apply artificial intelligence(AI)in classifying ovarian tumors on ultrasound images,and compare the diagnostic results of several sonographers with varying seniority levels.Methods:A total of 645 patients diagnosed with adnexal masses via gynecological ultrasound examination at Qilu Hospital of Shandong University from January 2021 to December 2024 were enrolled. Three deep learning architectures,i.e.,Alexnet,Densenet121,and Resnet50 were developed and used to internally test the classification effectiveness of ovarian tumors,while the optimal model was selected for external testing. Two junior sonographers and two senior sonographers were recruited to independently diagnose ovarian tumors in the external test dataset. Subsequently,the benign and malignant results of the model's predictions were disclosed to each sonographer,and their revised diagnoses on the same external test data in combination with the best AI model were recorded.Results:The optimal model achieved an accuracy of 0.941,sensitivity of 0.936,and specificity of 0.944 on the internal test dataset,and maintained robust performance on the external test dataset with accuracy of 0.891,sensitivity of 0.880,and specificity of 0.907. Compared to junior sonographers,the optimal model demonstrated significantly higher sensitivity in discriminating benign from malignant ovarian tumors(0.880 vs. 0.723,0.602;all P<0.05). No statistically significant difference was observed in diagnostic accuracy between the optimal model and senior sonographer 1( P=0.05). With assistance from the optimal model,junior sonographers achieved significant improvements in both sensitivity and specificity(sensitivity:0.723 vs. 0.843,0.602 vs. 0.819;specificity:0.778 vs. 0.833,0.685 vs. 0.741;all P<0.05). Conclusions:The optimal model achieves comparable performance to that of senior sonographers in ovarian tumor classification. With model assistance,the diagnostic performance of junior sonographers is significantly improved.
10.Research Status of Nanomaterial Medical Device and Discussion on Biological Evaluation
Lingxiao SUN ; Min WAN ; Xiaoxia SUN ; Jia LIU ; Xiaoxiao GAI ; Guowei WANG ; Wenting RUAN ; Yang QIN ; Chenghu LIU
Chinese Journal of Medical Instrumentation 2024;48(1):88-93
In recent years,China has made great progress in basic nanomedicine,nanotoxicology and nanobiology research.Nanotechnology has been continuously applied in biomaterial and medical device,more and more medical devices applying nanomaterials are developed and manufactured.In order to gain more comprehension and accurate understanding of the research and industrial development in nanobiomaterial medical devices,this study reviewed the common nanomaterial in medical devices and the regulatory situation of nanomaterial medical devices at home and abroad,and discussed the current challenges in biological evaluation of nanomaterial medical devices,with a view to providing ideas for the safety evaluation and research of related products.

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