Objective:To investigate the implementation status of periodic risk evaluation reports(PRER)for medical devices in China,so as to provide references for adapting the development of vigilance system for medical device,and improving the PRER system.Methods:A questionnaire was self-designed,which was online distributed to registrants and filing persons for medical devices,domestic agent for imported medical devices,and the relevant persons of monitoring agencies for adverse events of medical device at all grades through monitoring agencies of each provincial grade in China,so as to understand the evaluation and suggestion of the relevant agencies of medical devices for the PRER work.Combined with review status and special inspection results of all monitoring agencies for PRER,and compared with guidelines of the European Union's Periodic Safety Update Reports(PSURs),the existing issues in the PRER for medical devices in China were analyzed at present.Results:A total of 4,377 valid questionnaires were returned,the respondents by 64.95%acknowledged that PRER can aid stakeholders to identify products'risks.Additionally,the respondents by 41.28%acknowledged that the medical devices of Class I and renewal registrations need be simplify in the PRER,and the respondents by 57.69%considered the frequency of writing and submitting reports should be adjusted.Conclusion:This article combined with the requirements of pilot work of vigilance for medical device,and recommended to strengthen risk analysis in PRER,and streamline reporting formats,and improve the top-level design of safety supervision after medical devices enter the market in China.These measures will promote the supervision and management system of China for medical device to integrate with international standards,and enhance the international competitiveness of the domestically medical device industry.

ObjectiveTo establish a method for the identification of Haliotidis Concha and its counterfeits， and to improve its quality evaluation method. MethodsA total of 17 batches of Haliotis discus hannai， 4 batches of H. ruber， 3 batches of H. laevigata， 3 batches of H. ovina， 3 batches of H. diversicolor， 3 batches of H. asinina， 3 batches of H. iris were collected. Ultra-high performance liquid chromatography-quadrupole/electrostatic field orbitrap high-resolution mass spectrometry（UPLC-Q-Exactive-Orbitrap-MS/MS） was used to analyze the hydrolysates of different original Haliotidis Concha and its counterfeits， and the potential characteristic ions of each species were screened by Venn diagram. UPLC-triple quadrupole tandem mass spectrometry（UPLC-QqQ-MS/MS） was used to validate the characteristic ions， and the specific detection method of the characteristic ions was established. ResultsA total of 1 182， 167， 47， 89， 104， 203， 424 potential characteristic ions were screened from H. discus hannai， H. ruber， H. laevigata， H. ovina， H. diversicolor， H. asinina and H. iris， respectively. And 9 characteristic ions were selected. The precision， stability and repeatability of the 9 characteristic ions in the established identification method met the requirements. Different original Haliotidis Concha and its counterfeits could detect their own characteristic ions， including m/z 631.83-886.48（double charge） and m/z 631.83-443.74（double charge） of H. discus hannai， m/z 699.28-232.11（double charge） and m/z 699.28-544.27（double charge） of H. ruber， m/z 535.76-752.37（double charge） and m/z 535.76-548.28（double charge） of H. laevigata， m/z 708.35-442.28（double charge） and m/z 708.35-215.14（double charge） of H. ovina， m/z 561.33-614.86（triple charge）， m/z 561.33-468.28（triple charge）， m/z 608.29-618.32（double charge） and m/z 608.29-390.21（double charge） of H. diversicolor， m/z 769.85-274.10（double charge）， m/z 769.85-532.75（double charge）， m/z 827.43-646.36（single charge）， m/z 827.43-257.12（single charge） of H. asinina， and m/z 468.24-576.29（double charge） and m/z 468.24-505.26（double charge） of H. iris. ConclusionIn this study， a total of 9 characteristic ions are screened from 6 kinds of original Haliotidis Concha and its counterfeits， and a specific identification method is established， which is helpful to solve the limitations of the existing quality evaluation methods of Haliotidis Concha， and provide a basis for the production， circulation and medication quality.

ObjectiveTo establish a method for the identification of Haliotidis Concha and its counterfeits， and to improve its quality evaluation method. MethodsA total of 17 batches of Haliotis discus hannai， 4 batches of H. ruber， 3 batches of H. laevigata， 3 batches of H. ovina， 3 batches of H. diversicolor， 3 batches of H. asinina， 3 batches of H. iris were collected. Ultra-high performance liquid chromatography-quadrupole/electrostatic field orbitrap high-resolution mass spectrometry（UPLC-Q-Exactive-Orbitrap-MS/MS） was used to analyze the hydrolysates of different original Haliotidis Concha and its counterfeits， and the potential characteristic ions of each species were screened by Venn diagram. UPLC-triple quadrupole tandem mass spectrometry（UPLC-QqQ-MS/MS） was used to validate the characteristic ions， and the specific detection method of the characteristic ions was established. ResultsA total of 1 182， 167， 47， 89， 104， 203， 424 potential characteristic ions were screened from H. discus hannai， H. ruber， H. laevigata， H. ovina， H. diversicolor， H. asinina and H. iris， respectively. And 9 characteristic ions were selected. The precision， stability and repeatability of the 9 characteristic ions in the established identification method met the requirements. Different original Haliotidis Concha and its counterfeits could detect their own characteristic ions， including m/z 631.83-886.48（double charge） and m/z 631.83-443.74（double charge） of H. discus hannai， m/z 699.28-232.11（double charge） and m/z 699.28-544.27（double charge） of H. ruber， m/z 535.76-752.37（double charge） and m/z 535.76-548.28（double charge） of H. laevigata， m/z 708.35-442.28（double charge） and m/z 708.35-215.14（double charge） of H. ovina， m/z 561.33-614.86（triple charge）， m/z 561.33-468.28（triple charge）， m/z 608.29-618.32（double charge） and m/z 608.29-390.21（double charge） of H. diversicolor， m/z 769.85-274.10（double charge）， m/z 769.85-532.75（double charge）， m/z 827.43-646.36（single charge）， m/z 827.43-257.12（single charge） of H. asinina， and m/z 468.24-576.29（double charge） and m/z 468.24-505.26（double charge） of H. iris. ConclusionIn this study， a total of 9 characteristic ions are screened from 6 kinds of original Haliotidis Concha and its counterfeits， and a specific identification method is established， which is helpful to solve the limitations of the existing quality evaluation methods of Haliotidis Concha， and provide a basis for the production， circulation and medication quality.

Objective:To establish a mass spectrometry method for the determination of characteristic peptides of Galli Gigerii Endothelium Corneum that can identify the authenticity of Galli Gigerii Endothelium Corneum as well as its preparations; To evaluate their quality.Methods:Ultra performance chromatography-electrospray tandem mass spectrometry (UPLC-MS/MS) with the mode of multiple reaction monitoring quantification (MRM) was employed to monitor the ion pairs of m/z 379.21(charge: +2)→571.36, m/z 379.21(charge: +2)→385.26, m/z 785.41(charge: +2)→941.51 and m/z 785.41(charge: +2)→245.08, in order to detect the Galli Gigerii Endothelium Corneum crude drug and its preparations. Results:Chicken specific peptide I and chicken specific peptide Ⅱ could be detected in the 18 batches of Galli Gigerii Endothelium Corneum from different regions, their corresponding extractions and 4 batches of prescription preparations, while the chicken specific peptides were not detected in the 8 batches of endothelium corneums from ducks, geese and pigeons.Conclusions:The method established in this study can effectively supplement the deficiencies in standards of Galli Gigerii Endothelium Corneum and its decoction pieces, improve the quality control standard, and provide a reference for the safety and effectiveness of Galli Gigerii Endothelium Corneum in clinical medication.

Objective To investigate the predictive value of serum microRNA(miRNA)-143-3p and miR-188-5p levels for poor prognosis in patients with acute cerebral infarction(ACI)after thrombolysis.Methods From February 2022 to February 2024,121 patients with acute cerebral infarction(ACI)who visited the hospital(all treated with thrombolysis)were selected as the study group.They were assigned into mild and moderate to severe groups based on the severity of their condition.They were into good prognosis group and poor prognosis group based on their postoperative condition.In addition,another 121 healthy individuals who underwent physical check ups during the same period were as the control group.The qRT-PCR method was applied to detect the expression levels of miR-143-3p and miR-188-5p.Pearson correlation was applied to analyze the correlation between serum miR-143-3p,miR-188-5p and NIHSS score.The influencing factors of poor prognosis in ACI patients after throm-bolysis were analyzed using multiple logistic regression.ROC curve was plotted to analyze the predictive value of serum miR-143-3p and miR-188-5p for poor prognosis after thrombolysis in ACI patients.Results The serum miR-143-3p level in the study group was higher than that in the control group(P<0.05),and the miR-188-5p level was lower than that in the control group(P<0.05);The serum miR-143-3p and NIHSS score in the mild,moderate and severe groups were increased in turn,and the level of miR-188-5p was decreased in turn(P<0.05);Serum miR-143-3p was negatively correlated with miR-188-5p(P<0.05);Diabetes,time from onset to throm-bolysis,NIHSS score at admission,miR-143-3p and miR-143-3p were the influencing factors of poor prognosis in ACI patients after thrombolysis;The AUC of the joint of serum miR-143-3p and miR-188-5p in predicting poor prognosis after thrombolysis in ACI patients was 0.871,and the joint of the two was better than their individual predictions(Z=2.683,2.703,P<0.05).Conclusions The level of serum miR-143-3p in ACI patients is significantly increased,and the level of serum miR-188-5p is significantly decreased,which is a poor prognostic factor for ACI patients after thrombolysis.The combination of the two has higher diagnostic value.

Objective:To investigate the implementation status of periodic risk evaluation reports(PRER)for medical devices in China,so as to provide references for adapting the development of vigilance system for medical device,and improving the PRER system.Methods:A questionnaire was self-designed,which was online distributed to registrants and filing persons for medical devices,domestic agent for imported medical devices,and the relevant persons of monitoring agencies for adverse events of medical device at all grades through monitoring agencies of each provincial grade in China,so as to understand the evaluation and suggestion of the relevant agencies of medical devices for the PRER work.Combined with review status and special inspection results of all monitoring agencies for PRER,and compared with guidelines of the European Union's Periodic Safety Update Reports(PSURs),the existing issues in the PRER for medical devices in China were analyzed at present.Results:A total of 4,377 valid questionnaires were returned,the respondents by 64.95%acknowledged that PRER can aid stakeholders to identify products'risks.Additionally,the respondents by 41.28%acknowledged that the medical devices of Class I and renewal registrations need be simplify in the PRER,and the respondents by 57.69%considered the frequency of writing and submitting reports should be adjusted.Conclusion:This article combined with the requirements of pilot work of vigilance for medical device,and recommended to strengthen risk analysis in PRER,and streamline reporting formats,and improve the top-level design of safety supervision after medical devices enter the market in China.These measures will promote the supervision and management system of China for medical device to integrate with international standards,and enhance the international competitiveness of the domestically medical device industry.

Objective To investigate the predictive value of serum microRNA(miRNA)-143-3p and miR-188-5p levels for poor prognosis in patients with acute cerebral infarction(ACI)after thrombolysis.Methods From February 2022 to February 2024,121 patients with acute cerebral infarction(ACI)who visited the hospital(all treated with thrombolysis)were selected as the study group.They were assigned into mild and moderate to severe groups based on the severity of their condition.They were into good prognosis group and poor prognosis group based on their postoperative condition.In addition,another 121 healthy individuals who underwent physical check ups during the same period were as the control group.The qRT-PCR method was applied to detect the expression levels of miR-143-3p and miR-188-5p.Pearson correlation was applied to analyze the correlation between serum miR-143-3p,miR-188-5p and NIHSS score.The influencing factors of poor prognosis in ACI patients after throm-bolysis were analyzed using multiple logistic regression.ROC curve was plotted to analyze the predictive value of serum miR-143-3p and miR-188-5p for poor prognosis after thrombolysis in ACI patients.Results The serum miR-143-3p level in the study group was higher than that in the control group(P<0.05),and the miR-188-5p level was lower than that in the control group(P<0.05);The serum miR-143-3p and NIHSS score in the mild,moderate and severe groups were increased in turn,and the level of miR-188-5p was decreased in turn(P<0.05);Serum miR-143-3p was negatively correlated with miR-188-5p(P<0.05);Diabetes,time from onset to throm-bolysis,NIHSS score at admission,miR-143-3p and miR-143-3p were the influencing factors of poor prognosis in ACI patients after thrombolysis;The AUC of the joint of serum miR-143-3p and miR-188-5p in predicting poor prognosis after thrombolysis in ACI patients was 0.871,and the joint of the two was better than their individual predictions(Z=2.683,2.703,P<0.05).Conclusions The level of serum miR-143-3p in ACI patients is significantly increased,and the level of serum miR-188-5p is significantly decreased,which is a poor prognostic factor for ACI patients after thrombolysis.The combination of the two has higher diagnostic value.

ObjectiveTo evaluate the clinical efficacy and safety of Tongluo Mingmu capsules in the treatment of diabetic retinopathy with blood stasis， collateral obstruction， and Qi and Yin deficiency syndrome. MethodA randomized， double-blind， positive-control， and multi-center clinical trial design method was used. 416 patients with diabetic retinopathy with blood stasis， collateral obstruction， and Qi and Yin deficiency syndrome in four test centers were included （the ratio of the treatment group to the control group was 3∶1）. On the basis of standardized hypoglycemic treatment， the treatment group was given both four Tongluo Mingmu capsules and two Calcium Dobesilate capsule agents three times a day， while the control group were given both two Calcium Dobesilate capsules and four Tongluo Mingmu capsule agents three times a day. The course of treatment was 12 weeks. The curative effect of Tongluo Mingmu capsules was evaluated by comparing the comprehensive curative effect of diabetic retinopathy， traditional Chinese medicine（TCM） syndrome score， corrected visual acuity， fundus changes， fundus fluorescence angiography， and other curative effect indexes before and after treatment in the two groups. At the same time， general examination， laboratory examination， and adverse events were performed to evaluate the safety of the drug. ResultThe baseline demographic data and disease characteristics of the treatment group and the control group were balanced and comparable， with the difference not statistically significant. After 12 weeks of treatment， the total effective rate of the comprehensive curative effect of diabetic retinopathy in the treatment group （61.0%， 189/310） was better than that in the control group （44.1%， 45/102）， and the difference was statistically significant （χ²=8.880， P<0.01）. The total effective rate of TCM syndromes in the treatment group （88.4%， 259/293） was better than that in the control group （69.9%， 65/93）， and the difference was statistically significant （χ²=17.927， P<0.01）. The disappearance rate of dry eyes （χ²=8.305）， dull complexion （χ²=4.053）， lassitude （χ²=10.267）， shortness of breath （χ²=8.494）， and dry stool （χ²=8.657） in the treatment group was higher than that in the control group， and the difference between the groups was statistically significant （P<0.05， P<0.01）. In terms of improving corrected visual acuity （χ²=8.382）， fundus changes （χ²=6.026） ， the treatment group was significantly better than the control group （P<0.05）. During the trial， the incidence of adverse events in the treatment group and the control group was 1.3% and 2.9%， respectively. There was no significant difference between the two groups. In addition， there were no serious adverse events and adverse events leading to withdrawal in both groups. ConclusionTongluo Mingmu capsules can improve the comprehensive curative effect of diabetic retinopathy and enhance the efficacy of TCM syndromes， visual acuity， fundus changes， and fundus fluorescein angiography， with great safety. Therefore， it can provide a new alternative therapeutic drug for patients with diabetic retinopathy.

Bone metastasis is a common complication of many advanced cancers,especially prostate cancer(85％),breast cancer(70％)and lung cancer(40％),which severely affects the quality of life of the pa-tients and increases its death risk.Macrophages are the essential immune cells in the human body that play a crucial role in the tumor microenvironment(TME),including phagocytosis or removal of cell debris,damaged or apoptotic cells.The phenotypic and functional transition of macrophages is a dynamic process.Under vari-ous stimulation conditions in TME,they can be transformed into two major subpopulations:M1 and M2.In TME,M1 macrophages exert anti-tumor effects and contribute to tumor immunity.M2 macrophages display a robust immunosuppressive phenotype,aiding in tumor cell proliferation and thereby promoting the occurrence of bone metastasis.This article reviews the interaction between macrophages and TME,and explores the role of macrophage polarization in bone metastasis of common cancers such as prostate cancer,breast cancer and lung cancer,and the influence in the occurrence and development of tumors.

The diagnosis of Parkinson's disease(PD)mainly relies on clinical appearance of patients,and the routine magnetic resonance scan has difficulty in finding the abnormality of that,which is not able to meet the requirement of early and precise quantification for the PD lesion area.Diffusion magnetic resonance imaging(dMRI)technique is a noninvasive method of examining the microstructure of living tissue.Diffusion weighted imaging(DWI)and diffusion tensor imaging(DTI)were the most widely used in clinical practice.However,the principles of them have limitation,which are not able to fully outline the microstructure of brain tissue.This paper discussed several new dMRI techniques that are able to make up conventional dMRI model,which included diffusion kurtosis imaging(DKI),neurite orientation dispersion and density imaging(NODDI)and diffusion tensor imaging index of perivascular space(DTI-ALPS).Moreover,this paper summarized the applications of above imaging technique in exploring the changes of the microstructure of brain tissue of PD patients,so as to provide more imaging information for the pathological changes of PD patients.