Objective To systematically evaluate of the effect of autoimmune diseases(AIDs)on early spontaneous abortion(ESA).Methods Several databases such as Ovid and Web of Science were searched from January 2000 to May 2024 for retrospective analysis.Furthermore,subgroup analysis was conducted in terms of AIDs,continent and assisted reproduction.Results Total of 73 eligible studies were included in this study.There was a statistically significant difference in the risk of ESA between the population with AIDs and the population with normal pregnancy(OR=1.832,95％CI:1.619-2.073).When subgroup studies of AIDs were performed,the increased risk of ESA in patients with some AIDs was statistically significant:e.g.,thyroid autoimmunity,antiphospholipid syndrome,systemic lupus erythematosus,desiccation syndrome,antinuclear antibody positivity and rheumatoid arthritis.While the impact of some AIDs on ESA was still uncertain,e.g.inflammatory bowel disease,ulcerative colitis,Crohn's disease,autoimmune skin diseases,neuromyelitis optica spectrum disorders.In addition,patients with antiphospholipid syndrome who had underwent assisted reproductive technologies were at higher risk of ESA.Furthermore,compared to other continents,there is a difference in the risk of ESA in patients with AIDs in Africa.Conclusion AIDs are associated with the risk of ESA.

Objective To establish a stable,reliable,and clinically relevant porcine model of endotoxin-induced acute respiratory distress syndrome(ARDS).Methods Ten 8-month-old male Bama minipigs were deeply sedated,followed by invasive mechanical ventilation and electrocardiographic monitoring.Lipopolysaccharide(LPS)was intravenously pumped at 600 μg/(kg·h)for 3 hours,then maintained at 15 μg/(kg·h)thereafter.Dynamic monitoring was performed at five time points after LPS injection(LPS 0,1,3,5,and 8 h),including arterial blood gas analysis and chest computed tomography(CT)scans.Pathological examination of lung tissues obtained via bronchoscopic biopsy(HE staining and transmission electron microscopy)was conducted.These indicators were comprehensively used to evaluate the success of the animal model.Results At 5 hours after LPS administration,8 minipigs developed symptoms such as skin cyanosis,elevated body temperature,and respiratory distress.The oxygenation index decreased to<300 mmHg.Chest CT scans showed diffuse pulmonary infiltrates.Histopathology revealed alveolar edema and hyaline membrane formation.Transmission electron microscopy demonstrated disruption of pulmonary blood-air barrier,depletion of lamellar bodies in type Ⅱ pneumocytes,inflammatory cell infiltration,and exudation of plasma proteins and fibrin.Compared with LPS 0 h,at LPS 8 h,the oxygenation index and arterial blood pH were significantly decreased(P<0.001),while blood lactic acid and serum potassium were significantly increased(P<0.05);serum calcium and base excess were significantly decreased(P<0.05),and the lung injury score based on HE-stained lung sections was significantly increased(P<0.01).Conclusion The porcine ARDS model established by continuous LPS injection can dynamically simulate the pathophysiological characteristics and typical pathological manifestations of clinical septic ARDS,making it an effective tool to study the pathogenesis,prevention,and treatment strategies of septic ARDS.

Aim To study the effect of p-benzoyl sali-droside(pOBz)on angiogenesis after ischemic stroke and to explore the underlying mechanism.Methods The MCAO model was prepared by suture method.Rats were divided into four groups:sham,MCAO,pOBz administration,and edaravone positive control,treated for seven days.The mNSS was used to assess the neurological impairment.Western blotting was em-ployed to detect CD31,NICD,and Hes-1 protein ex-pression,while immunofluorescence staining was ap-plies to quantify CD31-positive cells in ischemic brain tissue.In vitro an OGD/R model was established in HUVECs.Following treatment with varying pOBz con-centrations(0.01,0.1,1 μmol·L-1),the CCK-8 as-say was uses to measure cell viability,and in vitro tube formation assay was utilized to evaluate angiogenesis.Western blotting was employed again to assess CD31,NICD and Hes-1 protein levels.To further elucidate the mechanism,HUVEC were treated with the Notch inhibitor DAPT prior to grouping and pOBz administra-tion,and the same parameters were evaluated.Results pOBz significantly reduced the mNSS score of MCAO rats,increased CD31-positive cell counts,and upregu-lated CD31,NICD,and Hes-1 protein expression(P＜0.01).In vitro results further showed that pOBz could dose-dependently increase the survival rate and angio-genesis ability of HUVEC induced by OGD/R,and promote CD31,NICD and Hes-1 proteins(P＜0.01),and Notch inhibitor DAPT could reverse the above effects of pOBz.Conclusion pOBz promotes angio-genesis in HUVEC,and its mechanism involves activa-tion of the Notch signaling pathway.

Objective:To develop a bacterial endotoxin detection method suitable for mRNA vaccines based on lipid nanoparticle（LNP）delivery system.Methods:The gel clot limit test outlined in the third section of the Chinese Pharmacopoeia（2020 edition）was utilized. Taking the human herpesvirus type 2 mRNA vaccine as the detection object，the optimal conditions for bacterial endotoxin detection were established by evaluating sample dilution factors，diluents，and other interfering elements. The results were validated using the recombinant C factor method. Finally，the applicability of the established method was validated through testing the respiratory syncytial virus mRNA vaccine and the shingles mRNA vaccine.Results:Increasing the sample dilution factor to 480 times with a magnesium-containing buffer and using 0.06 EU/ml tachypleus amebocyte lysate effectively mitigated the interference caused by LNP on the test results of the human herpesvirus type 2 mRNA vaccine，the respiratory syncytial virus mRNA vaccine，and the shingles mRNA vaccine. The results from recombinant C factor method and the gel clot limit method were consistent.Conclusion:A bacterial endotoxin gel clot limit detection method tailored for human herpesvirus type 2 mRNA vaccine，respiratory syncytial virus mRNA vaccine，and shingles mRNA vaccine is successfully developed based on existing protocols in the Chinese Pharmacopoeia（2020 edition）. This study offers insights for the detection of bacterial endotoxin in LNP-based biological products.

Objective:To explore the design and application effect of a home-based pulmonary rehabilitation checklist for postoperative lung cancer patients and to analyze the feasibility of this innovative rehabilitation approach.Methods:A prospective non-concurrent controlled study was conducted. Eighty postoperative lung cancer patients from the Department of Thoracic Surgery, Henan Provincial People's Hospital, were conveniently selected. According to the time of admission, postoperative lung cancer patients from April to June 2024 ( n=40) were assigned to the control group, while those postoperative lung cancer patients from August to October 2024 ( n=40) were assigned to the experimental group. The control group was given routine home-based pulmonary rehabilitation knowledge education upon discharge, while the experimental group was provided with the application of a home-based pulmonary rehabilitation checklist in addition to the routine home-based pulmonary rehabilitation knowledge education. Assessments were performed on the day of discharge and 1-month post-discharge using the Chinese version-Strategies Used by People to Promote Health (C-SUPPH), the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC-QLQ-C30), the six-minute walk test (6MWT) and the Brog score. Results:A total of 40 patients in each group completed this study. Among them, there were 26 males and 14 females in the control group, aged (51.25 ± 11.39) years, and 23 males and 17 females in the experimental group, aged (53.07 ± 12.21) years. One month after discharge, the scores of positive attitude, self-decision making and self-stress reduction on the C-SUPPH in the experimental group were (44.25 ± 10.29), (30.76 ± 8.31) and (9.51 ± 2.17) points, respectively. They were higher than those in the control group (37.02 ± 7.14), (26.61 ± 6.71) and (7.58 ± 1.09) points, and the differences were statistically significant ( t=-3.65, -2.46, -5.03, all P<0.05). The scores of somatic function, role function, cognitive function and emotional function on the EORTC-QLQ-C30 in the experimental group were (65.77 ± 6.41), (71.46 ± 7.21), (70.11 ± 5.61) and (69.59 ± 5.71) points, respectively. They were higher than those in the control group (57.71 ± 7.01), (64.27 ± 5.25), (62.79 ± 7.18), (61.11 ± 6.25) points, and the differences were statistically significant ( t values were -6.34 to -5.08, all P<0.05). The 6MWT distance in the experimental group was (411.31 ± 35.02) m, which was higher than (376.58 ± 30.26) m in the control group, and the difference was statistically significant ( t=-4.75, P<0.05). The Brog score in the experimental group was (2.12 ± 0.68) points, which was lower than (2.50 ± 0.65) points in the control group, and the difference was statistically significant ( t=2.56, P<0.05). Conclusions:The implementation of home pulmonary rehabilitation list can improve the self-management ability of patients after lung cancer surgery, improve the quality of life, and then enhance the exercise ability, which is worthy of clinical promotion.

To study the differences in transcript levels among different organs of Spatholobus suberectus and to explore the genes encoding enzymes related to the catechin biosynthesis pathway, this study utilized the genome and full-length transcriptome data of S. suberectus as references. Transcriptome sequencing and bioinformatics analysis were performed on five different organs of S. suberectus-roots, stems, leaves, flowers, and fruits-using the Illumina NovaSeq 6000 platform. A total of 115.28 Gb of clean data were obtained, with GC content values ranging from 45.19% to 47.54%, Q20 bases at 94.17% and above, and an overall comparison rate with the reference genome around 90%. In comparisons between the stem and root, stem and leaf, stem and flower, and stem and fruit, 10 666, 9 674, 9 320, and 5 896 differentially expressed genes(DEGs) were identified, respectively. The lowest number of DEGs was found in the stem and root comparison group. KEGG enrichment analysis revealed that the DEGs were mainly concentrated in the pathways of phytohormone signaling, phenylalanine biosynthesis, etc. A total of 39 genes were annotated in the catechin biosynthesis pathway, with at least one highly expressed gene found in all organs. Among these, PAL1, PAL2, C4H1, C4H3, 4CL1, 4CL2, and DFR2 showed high expression in the stems, suggesting that they may play important roles in the biosynthesis of flavonoids in S. suberectus. This study aims to provide important information for the in-depth exploration of the regulation of catechin biosynthesis in S. suberectus through transcriptome analysis of its different organs and to provide a reference for the further realization of S. suberectus varietal improvement and molecular breeding.
Catechin/biosynthesis* ; Gene Expression Profiling ; Gene Expression Regulation, Plant ; Plant Proteins/metabolism* ; Fabaceae/metabolism* ; Transcriptome ; Flowers/metabolism* ; Plant Stems/metabolism* ; Plant Leaves/metabolism* ; Plant Roots/metabolism* ; Fruit/metabolism*

Since the promulgation of the first Drug Administration Law of the People's Republic of China 40 years ago in 1984, China has undergone four main stages in the traditional Chinese medicine(TCM) regulation: the initial establishment of TCM regulation rules(1984-1997), the formation of a modern TCM regulatory system(1998-2014), the reform of the review and approval system for new TCM drugs(2015-2018), and the construction of a scientific regulation system for TCM(2019-2024). Over the past five years, a series of milestone achievements of TCM regulation in China have been achieved in the six aspects, including its strategic objectives and the establishment of a science-based regulatory system, the reform of the review and approval system for new TCM drugs, the optimization and improvement of the TCM standard system and its formation mechanism, comprehensive enhancement of regulatory capabilities for TCM safety, international harmonization of TCM regulation and its role in promoting innovation. Looking ahead, centered on advancing TCMRS to establish a sound regulatory framework tailored to the unique characteristics of TCM, TCM regulation will evolve into new reform patterns, advancing and extending across eight critical fronts, including the legal framework and policy architecture, the review and approval system for new TCM drugs, the quality standard and management system of TCM, the comprehensive quality & safety regulation and traceability system, the research and transformation system for TCMRS, AI-driven innovations in TCM regulation, the coordination between high-quality industrial development and high-level regulation, and the leadership in international cooperation and regulatory harmonization. In this way, a unique path for the development of modern TCM regulation with Chinese characteristics will be pioneered.
Humans ; China ; Drugs, Chinese Herbal/standards* ; History, 20th Century ; History, 21st Century ; Medicine, Chinese Traditional/trends*

OBJECTIVES: To evaluate the causal association between circulating levels of zinc, magnesium, and other minerals and autism spectrum disorder (ASD). METHODS: A two-sample Mendelian randomization (MR) analysis was performed using summary statistics from large-scale genome-wide association studies of European populations, including 18 382 ASD cases and 27 969 controls. Genetic data for iron, calcium, and magnesium were obtained from the UK Biobank, and data for zinc and selenium were sourced from an Australian-British cohort. A total of 351 genetic instrumental variables were selected. Causal inference was performed using inverse-variance weighting as the primary analysis method. Sensitivity analyses were performed by Cochran's Q test and MR-PRESSO global test to assess the robustness of the findings. RESULTS: No statistically significant causal effect was observed for circulating zinc, magnesium, calcium, selenium, or iron levels on ASD risk (all P>0.05). The odds ratios and 95% confidence intervals from the inverse-variance weighting analysis were 0.934 (0.869-1.003) for zinc, 1.315 (0.971-1.850) for magnesium, 1.055 (0.960-1.159) for calcium, 1.015 (0.953-1.080) for selenium, and 0.946 (0.687-1.303) for iron. Sensitivity analysis revealed significant heterogeneity in the causal association between circulating calcium and ASD (P=0.006), while the effect estimate remained stable after MR-PRESSO correction (P=0.487). The causal effect estimates for the remaining minerals demonstrated good robustness. CONCLUSIONS This study did not find significant evidence supporting a causal association between circulating zinc, magnesium, calcium, selenium, or iron levels and ASD risk, providing important clues for the etiology of ASD and precision nutritional interventions.
Humans ; Mendelian Randomization Analysis ; Autism Spectrum Disorder/genetics* ; Magnesium/blood* ; Zinc/blood* ; Minerals/blood* ; Genome-Wide Association Study ; Selenium/blood*

Aim To study the effect of p-benzoyl sali-droside(pOBz)on angiogenesis after ischemic stroke and to explore the underlying mechanism.Methods The MCAO model was prepared by suture method.Rats were divided into four groups:sham,MCAO,pOBz administration,and edaravone positive control,treated for seven days.The mNSS was used to assess the neurological impairment.Western blotting was em-ployed to detect CD31,NICD,and Hes-1 protein ex-pression,while immunofluorescence staining was ap-plies to quantify CD31-positive cells in ischemic brain tissue.In vitro an OGD/R model was established in HUVECs.Following treatment with varying pOBz con-centrations(0.01,0.1,1 μmol·L-1),the CCK-8 as-say was uses to measure cell viability,and in vitro tube formation assay was utilized to evaluate angiogenesis.Western blotting was employed again to assess CD31,NICD and Hes-1 protein levels.To further elucidate the mechanism,HUVEC were treated with the Notch inhibitor DAPT prior to grouping and pOBz administra-tion,and the same parameters were evaluated.Results pOBz significantly reduced the mNSS score of MCAO rats,increased CD31-positive cell counts,and upregu-lated CD31,NICD,and Hes-1 protein expression(P＜0.01).In vitro results further showed that pOBz could dose-dependently increase the survival rate and angio-genesis ability of HUVEC induced by OGD/R,and promote CD31,NICD and Hes-1 proteins(P＜0.01),and Notch inhibitor DAPT could reverse the above effects of pOBz.Conclusion pOBz promotes angio-genesis in HUVEC,and its mechanism involves activa-tion of the Notch signaling pathway.

Objective:To explore the design and application effect of a home-based pulmonary rehabilitation checklist for postoperative lung cancer patients and to analyze the feasibility of this innovative rehabilitation approach.Methods:A prospective non-concurrent controlled study was conducted. Eighty postoperative lung cancer patients from the Department of Thoracic Surgery, Henan Provincial People's Hospital, were conveniently selected. According to the time of admission, postoperative lung cancer patients from April to June 2024 ( n=40) were assigned to the control group, while those postoperative lung cancer patients from August to October 2024 ( n=40) were assigned to the experimental group. The control group was given routine home-based pulmonary rehabilitation knowledge education upon discharge, while the experimental group was provided with the application of a home-based pulmonary rehabilitation checklist in addition to the routine home-based pulmonary rehabilitation knowledge education. Assessments were performed on the day of discharge and 1-month post-discharge using the Chinese version-Strategies Used by People to Promote Health (C-SUPPH), the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC-QLQ-C30), the six-minute walk test (6MWT) and the Brog score. Results:A total of 40 patients in each group completed this study. Among them, there were 26 males and 14 females in the control group, aged (51.25 ± 11.39) years, and 23 males and 17 females in the experimental group, aged (53.07 ± 12.21) years. One month after discharge, the scores of positive attitude, self-decision making and self-stress reduction on the C-SUPPH in the experimental group were (44.25 ± 10.29), (30.76 ± 8.31) and (9.51 ± 2.17) points, respectively. They were higher than those in the control group (37.02 ± 7.14), (26.61 ± 6.71) and (7.58 ± 1.09) points, and the differences were statistically significant ( t=-3.65, -2.46, -5.03, all P<0.05). The scores of somatic function, role function, cognitive function and emotional function on the EORTC-QLQ-C30 in the experimental group were (65.77 ± 6.41), (71.46 ± 7.21), (70.11 ± 5.61) and (69.59 ± 5.71) points, respectively. They were higher than those in the control group (57.71 ± 7.01), (64.27 ± 5.25), (62.79 ± 7.18), (61.11 ± 6.25) points, and the differences were statistically significant ( t values were -6.34 to -5.08, all P<0.05). The 6MWT distance in the experimental group was (411.31 ± 35.02) m, which was higher than (376.58 ± 30.26) m in the control group, and the difference was statistically significant ( t=-4.75, P<0.05). The Brog score in the experimental group was (2.12 ± 0.68) points, which was lower than (2.50 ± 0.65) points in the control group, and the difference was statistically significant ( t=2.56, P<0.05). Conclusions:The implementation of home pulmonary rehabilitation list can improve the self-management ability of patients after lung cancer surgery, improve the quality of life, and then enhance the exercise ability, which is worthy of clinical promotion.