In recent years, with the development of big data application technology, the real-world data and the corresponding generated real-world evidence have attracted the attention of healthcare regulatory authorities around the world. Regulators recognize that real-world research with specific purposes using real-world data can provide important evidence for regulatory decisions. A total of 90 instances of publicly released on the application of real-world evidence to support regulatory decisions of U. S. Food and Drug Administration are explored, and the positioning and value of real-world evidence in U. S. Food and Drug Administration regulatory decisions are summarized and analyzed, providing references for the use of real-world data and real-world evidence to promote medical devices whole cycle regulation in China.
United States ; United States Food and Drug Administration ; Equipment and Supplies ; Device Approval ; China

AIM: To analyze the current status and influencing factors for insufficient hyperopia reserve in preschool children from Changzhi City, Shanxi Province, and to provide reference and basis for myopia prevention and control in this district.METHODS: A stratified cluster random sampling strategy was used to select 2 854 preschool children(5 708 eyes)from 29 child-care centers in Changzhi City between January and May 2024. Hyperopia reserve was assessed through measurements and questionnaire surveys. Totally 2 820 cases(5 640 eyes)were finally included, with 34 cases excluded(32 cases of uncooperativeness and 2 cases of distractibility). The univariate analysis and multivariate Logistic regression were performed to analyze the associated influencing factors of insufficient hyperopia reserve.RESULTS: A total of 580 preschool children with insufficient hyperopia reserve were detected, with an incidence of 20.57%. Logistic regression analysis revealed that male(OR=1.723, 95% CI: 1.419-2.093), maternal myopia(OR=2.210, 95% CI: 1.681-2.906), paternal myopia(OR=1.426, 95% CI: 1.059-1.921), myopia in both parents(OR=2.761, 95% CI: 2.110-3.612), preterm infants(OR=1.740, 95% CI: 1.294-2.342), the mean daily sleep duration <10 h(OR=1.272, 95% CI: 1.024-1.579), and the mean daily outdoor activity time <2 h(OR=1.222, 95% CI: 1.005-1.485)were risk factors for insufficient hyperopia reserve(all P<0.05). Conversely, using blackout curtains during the day and turning off lights at night(OR=0.598, 95% CI: 0.405-0.883)were identified to be protective factors(P<0.05).CONCLUSION: Sex, genetics, gestational age, sleep duration and environmental conditions, and outdoor activity time are potentially associated with insufficient hyperopia reserve in preschool children. Caregivers should prioritize the management of these risk factors to prevent the occurrence of myopia.

Objective:To investigate feedback on teaching effectiveness and optimization strategies for flipped classrooms in pediatric probation of eight-year clinical medicine programs, and to provide insights for enhancing the educational quality of pediatric probation.Methods:From June to September 2022, eight-year clinical medicine students from the class of 2018 undergoing pediatric probation were included in the study using purposive sampling. The subjects participated in one-on-one, offline, semi-structured, in-depth interviews to provide feedback on traditional lectures and flipped classroom teaching. The sample size was determined based on the principle of data saturation, with nine students participating in-depth interviews. NVivo 12 software was used for coding and classifying the interview data, which were then analyzed using thematic framework analysis to identify key themes.Results:Analysis of the interview data revealed three themes and ten sub-themes. Specifically, theme 1: The flipped classroom enhanced learning effectiveness but increased students' workload; theme 2: The current pediatric probation was scientifically designed but could be improved; theme 3: Several strategies exist for optimizing the flipped classroom teaching in pediatric probation.Conclusions:The flipped classroom in pediatric probation is in its early stages. While offering some benefits, further exploration and optimization are needed in curriculum design, student motivation, and supervision and evaluation methods.

Objective:To investigate feedback on teaching effectiveness and optimization strategies for flipped classrooms in pediatric probation of eight-year clinical medicine programs, and to provide insights for enhancing the educational quality of pediatric probation.Methods:From June to September 2022, eight-year clinical medicine students from the class of 2018 undergoing pediatric probation were included in the study using purposive sampling. The subjects participated in one-on-one, offline, semi-structured, in-depth interviews to provide feedback on traditional lectures and flipped classroom teaching. The sample size was determined based on the principle of data saturation, with nine students participating in-depth interviews. NVivo 12 software was used for coding and classifying the interview data, which were then analyzed using thematic framework analysis to identify key themes.Results:Analysis of the interview data revealed three themes and ten sub-themes. Specifically, theme 1: The flipped classroom enhanced learning effectiveness but increased students' workload; theme 2: The current pediatric probation was scientifically designed but could be improved; theme 3: Several strategies exist for optimizing the flipped classroom teaching in pediatric probation.Conclusions:The flipped classroom in pediatric probation is in its early stages. While offering some benefits, further exploration and optimization are needed in curriculum design, student motivation, and supervision and evaluation methods.

Objective To investigate the therapeutic effect of Yudantong decoction in mice with α-naphthyl isothiocyanate (ANIT)-induced cholestasis, as well as its targets and mechanism based on intestinal flora and intestinal barrier function. Methods A total of 24 C57BL/6 mice were randomly divided into control group, model group, Yudantong decoction group (YDTF group), and ursodeoxycholic acid (UDCA) group, with 6 mice in each group. The mice in the model group, the YDTF group, and the UDCA group were given ANIT 35 mg/kg/day by gavage on days 1, 4, 7, 10, and 13, and those in the YDTF group and the UDCA group were given Yudantong decoction or UDCA by gavage for 15 consecutive days; related samples were collected on day 16. Liver histopathology was observed, and liver function parameters were measured; immunohistochemistry was used to measure the protein expression levels of caspase-1, interleukin-1β (IL-1β), and FXR in the liver, and flow cytometry was used to measure the percentages of CD11b + , CD86 + , and CD45 + immune cells in the liver; 16S rDNA sequencing and information analysis were performed for fecal microorganisms; immunohistochemistry was used to measure the protein expression of the intestinal FXR/NLRP3 pathway, and immunofluorescence assay was used to measure the protein expression of intestinal E-cadherin and occludin. A one-way analysis of variance was used for comparison of continuous data with homogeneity of variance between multiple groups, and the least significant difference t -test was used for further comparison between two groups; the Welch test was used for comparison of data with heterogeneity of variance between multiple groups, and the Games-Howell test was used for further comparison between two groups. Results HE staining showed that the model group had partial hepatocyte fatty degeneration, massive necrosis of hepatocytes in hepatic lobules, damage of lobular structure, and massive inflammatory cell infiltration, and the YDTF group and the UDCA group had alleviation of hepatocyte fatty degeneration and hepatocyte necrosis in hepatic lobules, with a reduction in inflammatory cells. Compared with the control group, the model group had significantly higher serum levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (GGT), alkaline phosphatase (ALP), total bilirubin (TBil), direct bilirubin (DBil), and total bile acid (TBA) (all P < 0.05); compared with the model group, the YDTF group had significant reductions in the serum levels of ALT, AST, GGT, ALP, TBil, DBil, and TBA (all P < 0.05), and the UDCA group had significant reductions in the serum levels of GGT, TBil, DBil, and TBA (all P < 0.05). Compared with the control group, the model group had significant increases in the levels of caspase-1 and IL-1β and a significant reduction in the expression of FXR in the liver (all P < 0.05); compared with the model group, the YDTF group had significant reductions in the levels of caspase-1 and IL-1β in the liver and the UDCA group had a significant reduction in the level of IL-1β in the liver, and both the YDTF group and the UDCA group had a significant increase in the expression level of FXR in the liver (all P < 0.05). The model group had a significant change in the composition of intestinal flora compared with the control group ( P < 0.05); there was a significant difference in the structure of intestinal flora between the YDTF group and the model group ( P < 0.05), and there was also a significant difference in the composition of intestinal flora between the UDCA group and the control/model groups ( P < 0.05). Compared with the control group, the model group had a significant increase in the abundance of intestinal Akkermansia muciniphila and a significant reduction in the abundance of Lactobacillus johnsonii (both P < 0.05); compared with the model group, both the YDTF group and the UDCA group had a significant reduction in the abundance of intestinal Akkermansia muciniphila , and the YDTF group had a significant increase in the abundance of Lactobacillus murinus , while the UDCA group had significant increases in the abundance of Lactobacillus murinus and Bifidobacterium pseudolongum (all P < 0.05). Compared with the control group, the model group had a significant reduction in the protein expression of intestinal FXR, a significant increase in the protein expression of intestinal NLRP3, and significant reductions in the expression of intestinal E-cadherin and occludin (all P < 0.05); compared with the model group, both the YDTF group and the UDCA group had a significant increase in the protein expression of intestinal FXR, a significant reduction in the protein expression of intestinal NLRP3, and significant increases in the expression of intestinal E-cadherin and occludin (all P < 0.05). Conclusion Yudantong decoction can alleviate liver injury in mice with ANIT-induced cholestasis, possibly by improving intestinal flora and enhancing intestinal barrier function.

The rise of nanotechnology has opened new horizons for cancer immunotherapy. However, most nanovaccines fabricated with nanomaterials suffer from carrier-related concerns, including low drug loading capacity, unpredictable metabolism, and potential systemic toxicity, which bring obstacles for their clinical translation. Herein, we developed an antigen self-assembled nanovaccine, which was resulted from a simple acryloyl modification of the antigen to induce self-assembly. Furthermore, a dendritic cell targeting head mannose monomer and a mevalonate pathway inhibitor zoledronic acid (Zol) were integrated or absorbed onto the nanoparticles (denoted as MEAO-Z) to intensify the immune response. The synthesized nanovaccine with a diameter of around 70 nm showed successful lymph node transportation, high dendritic cell internalization, promoted costimulatory molecule expression, and preferable antigen cross-presentation. In virtue of the above superiorities, MEAO-Z induced remarkably higher titers of serum antibody, stronger cytotoxic T lymphocyte immune responses and IFN-γ secretion than free antigen and adjuvants. In vivo, MEAO-Z significantly suppressed EG7-OVA tumor growth and prolonged the survival time of tumor-bearing mice. These results indicated the translation promise of our self-assembled nanovaccine for immune potentiation and cancer immunotherapy.

Objective:To culture and identify dermal mesenchymal stem cells (DMSCs) in skin lesions of patients with psoriasis, and to determine the expression of hairy and enhancer of split-1 (HES1) and chemokine ligand 6 (CXCL6) in DMSCs.Methods:DMSCs were isolated from skin lesions of 15 patients with psoriasis and normal skin tissues of 18 healthy controls, and then subjected to culture. Cell phenotypes were identified by flow cytometry, and mRNA and protein expression of HES1 and CXCL6 was determined by real-time fluorescence-based quantitative PCR (RT-PCR) and Western blot analysis respectively. Comparisons were performed between 2 groups by using t test. Results:There was no difference in the morphology of DMSCs between the psoriasis group and control group. The mRNA expression of HES1 and CXCL6 in the psoriasis group was 3.56 and 3.44 times that in the control group respectively, and there was a significant difference between the two groups (both P < 0.05) . The protein expression of HES1 and CXCL6 in DMSCs was significantly higher in the psoriasis group than in the control group (both P < 0.05) . Conclusion:The high expression of HES1 and CXCL6 in DMSCs from lesions may be involved in the occurrence of psoriasis.

Objective: To understand the awareness, treatment, and control of hypertension in residents aged 35-75 years in eastern China, analyze the treatment mode for antihypertensive agents while identifying those factors affecting awareness, treatment and control. Methods: The data collected in eastern China from the China Patient-Centered Evaluative Assessment of Cardiac Events (PEACE) Million Persons Project were used to obtain the information about the awareness, treatment and control of hypertension in the residents and the antihypertensive medication treatment mode in this area. Multilevel mixed-effects model was used to explore the association of the demographic characteristics of hypertension patients with the rates of awareness, treatment and control of hypertension. Results: A total of 640 539 participants aged 35-75 years, mean age (56.9±9.6) years, were included in the analysis, women accounted for 59.7% and 318 741 (49.8%) of the participants suffered from hypertension. Among those hypertensive patients, 46.5% were aware of their condition, 38.1% were taking prescribed antihypertensive medications, and 11.1% had achieved the control of hypertension, the differences were significant among provinces, between urban area and rural area and among different demographical groups. Calcium-channel blockers was the most commonly used medication (45.1%), and 78 735 hypertension patients (86.2%) took only one type of medication. Older age, higher household income, higher level of education, and histories of myocardial infarction, stroke and diabetes were associated with higher awareness, treatment and control of hypertension (P<0.05). Conclusions The rates of awareness, treatment and control of hypertension were low in residents in eastern China. The differences in hypertension management were significant among provinces and between urban area and rural area. Further efforts are needed to enhance the system of hypertension prevention, screening, diagnosis and treatment.

Objective: To explore the role of a customized 3D printing guide in total hip arthroplasty (THA). Methods: A retrospective analysis was performed of the 60 patients who had been treated by THA for avascular necrosis of the femoral head at Department of Orthopaedics and Traumatology, Foshan Hospital of Traditional Chinese Medicine from January 2018 to May 2019. Half of them used the personalized 3D printing guide in THA and half did not. In the guide group there were 17 men and 13 women with an age of 53.4±8.9 years while in the conventional group 19 men and 11 women with an age of 54.7±9.4 years. The acetabular cups were orientated at an abduction angle of 40° and an anteversion angle of 15°. The intraoperative blood loss, operation time and acetabular abduction angle were compared between the 2 groups. Results: The 2 groups were comparable due to insignificant differences between them in gender, age, body mass, cause of disease or staging of avascular necrosis of the femoral head (P>0.05). The guide group had significantly less intraoperative blood loss (286.7±150.8 mL) and operation time (90.5±34.4 min) than the conventional group did (438.3±292.6 mL and 115.6±58.6 min) (P< 0.05). The acetabular cup abduction was 38.9°±4.2° in the guide group and 37.2°±5.5° in the conventional group, showing no significant difference(t=1.315, P=0.194). Conclusion Use of a personalized 3D printing guide in THA can shorten the time for installation of an acetabular prosthesis and reduce the amount of intraoperative blood loss, but it leads to insignificant difference in the postoperative acetabular cup abduction compared with no use of the guide.

In recent years, cases of illegal addition of chemical substances into the TCMs and health-care products happened regularly. Therefore, it is particularly important to develop fast, sensitive and accurate analysis methods for detection of the adulterated chemical substances. Through literature survey of relevant papers published in 2016-2017, this article summarizes the application of various analytical techniques for adulterated chemical substances to the TCMs and health-care products with useful information for the further development of new methods and technologies in this field.