Objective To analyze the current situation,problems and countermeasures of quality control and post-market supervision of medical equipment in China,and provide a reference basis for improving the quality and safety level of medical equipment in China.Methods Through literature research and current situation analysis,the reasons why the clinical use risks of medical equipment in China have not been effectively controlled due to post-market supervision and quality control were discovered,and targeted countermeasures and suggestions were put forward.Results lt targets the problems in the management of medical devices.Specifically,there were issues such as the ineffective implementation of post-market supervision,the lack of overall planning at the national level,and the absence of corresponding regulatory documents and operation guidelines.To address these issues,we ap-proach from three aspects:strengthening supervision,conducting coordinated management,and formulating guide-lines.Specific policy recommendations were as follows:enhance post-market supervision of medical devices to im-prove the effectiveness of medical quality risk prevention and control;establish a national quality control center to comprehensively and coordinately manage the quality of medical devices and promote balanced development;and expedite the formulation of supporting technical standards and operation guidelines,and strengthen the post-mar-ket use evaluation of medical devices.Conclusion The situation of risk prevention and control for the quality and safe-ty of medical equipment is severe and should be given sufficient attention.lt is urgent to strengthen post-market su-pervision and coordinate the quality control of medical equipment to ensure medical quality and safety and promote the healthy development of the medical equipment industry.

Objective:To evaluate the performance of deep learning reconstruction (DLR) in visualizing lenticulostriate arteries (LSAs) on cerebral CT angiography (CTA).Methods:This cross-sectional study retrospectively analyzed cerebral CTA from 38 patients who underwent cerebral CTA at the Fourth Affiliated Hospital of Harbin Medical University between January and December 2023. Images were reconstructed using filtered back projection (FBP), three-dimensional adaptive iterative dose reduction (AIDR), and DLR-advanced inteuigent clear-IQ engine(AiCE) algorithms (FBP group, AIDR group, DLR-AiCE group). On axial images, the mean CT values, standard deviation (SD), signal-to-noise ratio (SNR), and contrast-to-noise ratio (CNR) were measured at the origin of LSAs, cerebrospinal fluid in lateral ventricles, temporal muscle, and head of the caudate nucleus. Subjective evaluations were performed for overall vascular visualization and LSAs delineation. Comparisons of subjective and objective evaluation indexes among the 3 groups were performed using the complex measurement ANOVA, Friedman test, or χ2 test. Results:The CT, SD, SNR and CNR values at the origin of LSAs, cerebrospinal fluid in lateral ventricles, temporal muscle, and head of the caudate nucleus demonstrated statistically significance among DLR-AiCE group, AIDR group and FBP group ( P<0.001), in which, except for the difference between the FBP group and the AIDR group in the CT value of the head of the caudate nucleus and the CT value of the cerebrospinal fluid of the lateral ventricle which was not statistically significant ( P>0.05), the remaining pairwise comparisons between the groups for each site measurements were statistically significant ( P<0.001). The difference in the overall comparison of the subjective scores of the overall vessels and LSAs in the images of the DLR-AiCE group, the AIDR group, and the FBP group was statistically significant ( P<0.001), and the two-by-two comparisons showed a statistically significant difference ( P<0.001) except for the difference in the subjective scores of LSAs between the FBP group and the AIDR group. Conclusion:The DLR-AiCE algorithm significantly reduces image noise and improves image quality, enabling superior visualization of LSAs, thereby enhancing diagnostic confidence.

Objective:To evaluate the performance of deep learning reconstruction (DLR) in visualizing lenticulostriate arteries (LSAs) on cerebral CT angiography (CTA).Methods:This cross-sectional study retrospectively analyzed cerebral CTA from 38 patients who underwent cerebral CTA at the Fourth Affiliated Hospital of Harbin Medical University between January and December 2023. Images were reconstructed using filtered back projection (FBP), three-dimensional adaptive iterative dose reduction (AIDR), and DLR-advanced inteuigent clear-IQ engine(AiCE) algorithms (FBP group, AIDR group, DLR-AiCE group). On axial images, the mean CT values, standard deviation (SD), signal-to-noise ratio (SNR), and contrast-to-noise ratio (CNR) were measured at the origin of LSAs, cerebrospinal fluid in lateral ventricles, temporal muscle, and head of the caudate nucleus. Subjective evaluations were performed for overall vascular visualization and LSAs delineation. Comparisons of subjective and objective evaluation indexes among the 3 groups were performed using the complex measurement ANOVA, Friedman test, or χ2 test. Results:The CT, SD, SNR and CNR values at the origin of LSAs, cerebrospinal fluid in lateral ventricles, temporal muscle, and head of the caudate nucleus demonstrated statistically significance among DLR-AiCE group, AIDR group and FBP group ( P<0.001), in which, except for the difference between the FBP group and the AIDR group in the CT value of the head of the caudate nucleus and the CT value of the cerebrospinal fluid of the lateral ventricle which was not statistically significant ( P>0.05), the remaining pairwise comparisons between the groups for each site measurements were statistically significant ( P<0.001). The difference in the overall comparison of the subjective scores of the overall vessels and LSAs in the images of the DLR-AiCE group, the AIDR group, and the FBP group was statistically significant ( P<0.001), and the two-by-two comparisons showed a statistically significant difference ( P<0.001) except for the difference in the subjective scores of LSAs between the FBP group and the AIDR group. Conclusion:The DLR-AiCE algorithm significantly reduces image noise and improves image quality, enabling superior visualization of LSAs, thereby enhancing diagnostic confidence.

Objective To analyze the current situation,problems and countermeasures of quality control and post-market supervision of medical equipment in China,and provide a reference basis for improving the quality and safety level of medical equipment in China.Methods Through literature research and current situation analysis,the reasons why the clinical use risks of medical equipment in China have not been effectively controlled due to post-market supervision and quality control were discovered,and targeted countermeasures and suggestions were put forward.Results lt targets the problems in the management of medical devices.Specifically,there were issues such as the ineffective implementation of post-market supervision,the lack of overall planning at the national level,and the absence of corresponding regulatory documents and operation guidelines.To address these issues,we ap-proach from three aspects:strengthening supervision,conducting coordinated management,and formulating guide-lines.Specific policy recommendations were as follows:enhance post-market supervision of medical devices to im-prove the effectiveness of medical quality risk prevention and control;establish a national quality control center to comprehensively and coordinately manage the quality of medical devices and promote balanced development;and expedite the formulation of supporting technical standards and operation guidelines,and strengthen the post-mar-ket use evaluation of medical devices.Conclusion The situation of risk prevention and control for the quality and safe-ty of medical equipment is severe and should be given sufficient attention.lt is urgent to strengthen post-market su-pervision and coordinate the quality control of medical equipment to ensure medical quality and safety and promote the healthy development of the medical equipment industry.

Objective:To construct a cognitive training program suitable for elderly patients with mild cognitive impairment based on horticultural therapy, so as to effectively slow down the cognitive decline of patients with mild cognitive impairment.Methods:Through searching the Chinese and English database literature of cognitive intervention from July 2000 to July 2020 and field visits to nursing homes, the draft intervention plan was formed. Two rounds of focus group interview were held to consult experts in cognitive impairment and geriatric care, etc., and to revise the intervention plan.Results:In the two rounds of focus group interview, the expert positive coefficient was 100%, the expert judgment basis was 0.84, the expert familiarity degree was 0.84, and the expert authority coefficient was 0.84. In the end, a 10-week cognitive intervention program targeting six cognitive domains -- "visuospatial/executive ability", "memory ability", "language ability", "attention ability", "abstract ability" and "naming ability" was formed, and the implementation steps of the program were improved.Conclusions:The construction process of cognitive training program for patients with mild cognitive impairment based on horticultural therapy theory is rigorous, scientific and feasible, and can be used to guide the cognitive training of patients with mild cognitive impairment.

Trauma registration is an important tool to record the process and timeline in the treatment of trauma patients. The operation of trauma database is of great significance for reducing the mortality of patients, promoting the construction of trauma treatment system, and providing reference for policy-making. Trauma registration system has been established in the United States, United Kingdom, Germany and other developed countries for many years. However, the domestic system is still at an initial stage, and there are problems like data deficiencies, data incoherence, no item of complications, no treatment data after discharge and limits of human and financial resources. Therefore, there is room for improvements in terms of personnel fixation, financial support and continuous data monitoring should be further improved. In this study, the authors summarize the traum registration system from aspects of basic situation both at home and abroad, data analysis, clinical value, operation mechanism and challenges so as to provide important data for clinical researches.

Breast cancer has become the most commonly diagnosed cancer type in the world. A combination of chemotherapy and photothermal therapy (PTT) has emerged as a promising strategy for breast cancer therapy. However, the intricacy of precise delivery and the ability to initiate drug release in specific tumor sites remains a challenging puzzle. Therefore, to ensure that the therapeutic agents are synchronously delivered to the tumor site for their synergistic effect, a multifunctional nanoparticle system (PCRHNs) is developed, which is grafted onto the prussian blue nanoparticles (PB NPs) by reduction-responsive camptothecin (CPT) prodrug copolymer, and then modified with tumor-targeting peptide cyclo(Asp-d-Phe-Lys-Arg-Gly) (cRGD) and hyaluronic acid (HA). PCRHNs exhibited nano-sized structure with good monodispersity, high load efficiency of CPT, triggered CPT release in response to reduction environment, and excellent photothermal conversion under laser irradiation. Furthermore, PCRHNs can act as a photoacoustic imaging contrast agent-guided PTT. In vivo studies indicate that PCRHNs exhibited excellent biocompatibility, prolonged blood circulation, enhanced tumor accumulation, allow tumor-specific chemo-photothermal therapy to achieve synergistic antitumor effects with reduced systemic toxicity. Moreover, hyperthermia-induced upregulation of heat shock protein 70 in the tumor cells could be inhibited by CPT. Collectively, PCRHNs may be a promising therapeutic way for breast cancer therapy.

Objective:To analyze and integrate the illness experience of female patients with systemic lupus erythematosus (SLE) .Methods:The qualitative studies on the illness experience in female SLE patients were searched in PubMed, Web of Science, CINAHL, the Cochrane Library, PsycINFO, China Biology Medicine disc, Wanfang Database, VIP, CNKI and other Chinese and English databases by computer. The retrieval period was from the database construction to April 30, 2021. The quality of the literature was evaluated using the Australian JBI Evidence-based Health Care Center (2017) Qualitative Research Quality Evaluation Standard, and the results were integrated and analyzed using the collection integration method.Results:A total of 9 literatures were included, which were classified into 13 categories and integrated into 4 integration results. First, the patients lacked disease knowledge, family and social support and they desired support. Second, the disease caused physical discomfort and impaired self-image to patients, and their daily life, work, and childbirth are restricted. Third, the disease brought a series of negative psychological experiences to patients. Fourth, patients learned to accept themselves and could actively adjust coping strategies.Conclusions:Over time, SLE patients can learn to accept themselves and coexist with the disease. It is recommended that medical staff give patients necessary guidance to help patients correctly understand the disease and provide individualized interventions to improve the quality of life of SLE patients.

Objective? To investigate the anxiety and depression of pregnant women with spontaneous abortion in the first trimester of pregnancy, and to explore the related influencing factors, so as to provide basis for clinical psychological intervention and treatment. Methods? During August 2015 to February 2016, a total of 70 pregnant women with spontaneous abortions experience and 70 primigravid women at the outpatient department of a ClassⅢ Grade A hospital in Beijing were selected by convenience sampling method. A general questionnaire, Self-rating Anxiety Scale (SAS) and Center for Epidemiologic Studies-Depression Scale (CES-D) were applied in the investigation. Results? There were 8 anxiety cases (11.43%) and 15 depression cases (21.43%) among the 70 pregnant women with spontaneous abortions experience. The scores of SAS and CES-D of the spontaneous abortions group were higher than those of the primigravid group, and the differences were statistically significant (t=2.95,2.51; P＜ 0.05). The age and education level of the pregnant women were positively correlated with scores SAS (P＜0.05). The age, times of spontaneous abortion were positively correlated with scores of CES-D (P＜ 0.05). Conclusions? There is prominent anxiety and depression in the first trimester of re-pregnancy women with spontaneous abortion experience, which may be related to the age, education level and the times of spontaneous abortions. The psychological status of pregnant women with spontaneous abortion should be assessed early and appropriate psychological intervention should be given when necessary.

Radiotherapy is one of the most important methods to treat malignant tumors. Due to the presence of radiation resistance, the effect of radiotherapy is not entirely satisfactory. To alleviate radiation resistance and improve the radiotherapy effect, radiosensitizers have emerged. As a newly discovered radiosensitizer, RRx-001 has a good clinical application prospect. This paper reviewed the research progress of RRx-001 in source, safety, radiotherapy sensitizing activity and related mechanisms.