In the process of exploring standardized and efficient ethical review models for multi-center drug clinical trials, the ethical review alliance emerged as the times require. Compared with mature ethics committees, higher requirements have been put forward for the "young" ethics committees. By analyzing problems existing in review work of "young" ethics committees in the ethics review alliance, this paper discussed the measures to improve the review quality of "young" ethics committees and promote the standardized and efficient operation of the alliance, and put forward countermeasures and suggestions for improving the homogenization of ethics review and accelerating the clinical research process of innovative drugs.

Objective:To understand the clinical characteristics of novel coronavirus reinfection and explore the risk factors of novel coronavirus reinfection.Methods:The clinical data of 340 patients with novel coronavirus infection who were admitted to the Fever Clinic of Beijing Traditional Chinese Medicine, Capital Medical University from December 2022 to January 2023 were included. The general characteristics, basic diseases, clinical symptoms, and examination results of the first and second infections in the non repeated infection group, the repeated infection group, and the repeated infection group were compared. Binary logistic multivariate analysis was used to explore the risk factors of novel coronavirus reinfection.Results:In this study, 340 patients with novel coronavirus infection were included, 180 of whom were repeatedly infected. There was no statistically significant difference (all P>0.05) in terms of gender, age, body mass index (BMI), exercise, smoking, daily routine, and underlying disease between the recurrent infection group and the non recurrent infection group. However, the vaccination rate of the recurrent infection group was lower than that of the non recurrent infection group [80.0%(144/180) vs 88.0%(142/169), P<0.05]; In the repeated infection group, 157 cases (87.2%) were accompanied by overall discomfort (including headache, fatigue, muscle and joint pain), which was significantly higher than 122 cases (76.2%) in the non repeated infection group. The proportion of pneumonia occurring during the first infection was higher than that in the non repeated infection group [15.6%(28/180)], and the difference was statistically significant ( P<0.05). The interval between the first and second infections in the repeated infection group was (166.2±8.3)days. Cough and phlegm were the main clinical manifestations of two infections; The duration of re infection was shorter than that of the first infection [(7.03±2.30)days vs (8.94±3.02)days, t=6.739, P<0.001]; Secondary infections had less incidence of pneumonia [5.0%(9/180) vs 15.6%(28/180), χ 2=10.874, P=0.001]; 153 patients (85.0%) reported milder secondary infections. The results of binary logistic regression showed that cough, expectoration, body discomfort and pneumonia during the first infection were risk factors for repeated infection of novel coronavirus ( OR=2.710, 2.293, 2.808, P<0.05), and vaccination was a protective factor to avoid repeated infection ( OR=0.470, P=0.019). Conclusions:The symptoms of novel coronavirus reinfection are generally mild and the course of disease is relatively short. For vulnerable people, novel coronavirus vaccine should be actively inoculated to strengthen protection.

Objective:To explore the expression and clinical significance of heme oxygenase-1 (HO-1) and quinone oxidoreductase (NQO-1) in children with different severity levels of mycoplasma pneumoniae (MP) infection.Methods:A total of 140 children with MP infection who were treated at the Affiliated Hospital of Jining Medical University from January to June 2022 were selected as the observation group, while 100 healthy children who underwent physical examination were selected as the control group. The serum levels of interleukin-2 (IL-2), IL-6, IL-10, IL-1β, tumor necrosis factor α (TNF-α), interferon γ (IFN-γ), HO-1, and relative expression of NQO-1 protein were compared between the control group and the observation group, as well as between children with different degrees of MP infection, Forced vital capacity (FVC), maximum expiratory volume in the first second (FEV 1), peak expiratory flow rate (PEF), 50% forced expiratory flow rate and maximum mid expiratory flow rate (MEF 25-70), 50% forced expiratory flow rate (MEF 50), and 25% forced expiratory flow rate (MEF 25). Pearson correlation method was used to analyze the correlation between the expression of HO-1 and NQO-1 with inflammatory factors and lung function indicators. The receiver operating characteristic (ROC) curve was used to analyze the value of HO-1 and NQO-1 expression in predicting severe MP. Results:The serum levels of IL-2, IL-6, IL-10, IL-1β, TNF-α, IFN-γ, and HO-1 in the observation group were significantly higher than those in the control group (all P<0.05), while the relative expression level of NQO-1 protein was significantly lower than that in the control group ( P<0.05). The FVC, FEV 1, PEF, MEF 25-70, MEF 50, and MEF 25 in the observation group were significantly lower than those in the control group (all P<0.05). The serum levels of IL-2, IL-6, IL-10, IL-1β, TNF-α, IFN-γ, and HO-1 in the observation group of severe children were significantly higher than those in mild children (all P<0.05), while the relative expression of NQO-1 protein, FVC, FEV 1, PEF, MEF 25-70, MEF 50, and MEF 25 were significantly lower than those in mild children (all P<0.05). HO-1 in children with MP infection is positively correlated with IL-6, IL-1β, and IFN-γ, while the relative expression level of NQO-1 protein is negatively correlated with IL-6, IL-1β, and IFN-γ (all P<0.05); HO-1 was negatively correlated with MEF 50 and MEF 25, while the relative expression level of NQO-1 protein was positively correlated with MEF 50 (all P<0.05). The area under the ROC curve for predicting the relative expression levels of HO-1 and NQO-1 proteins in severe MP was 0.871 and 0.934, respectively (all P<0.05). Conclusions:The expression of serum HO-1 and NQO-1 in children with MP infection is correlated with cytokines and lung function indicators, and has certain application value in predicting severe illness.

Objective:To compare the effects of glenosphere offset positions on the impingement-free range of motion (ROM) in reverse total shoulder arthroplasty (RTSA).Methods:Shoulder joint models were reconstructed using shoulder CT scans of 6 patients with primary osteoarthritis. RTSA was performed virtually according to standard surgical procedures, and shoulder movements were simulated. Reverse shoulder models were constructed with 2 lateral offsets (0 and 4 mm) and 6 positional offsets (center, inferior, posterior, anterior, anterior-inferior, and posterior-inferior). The impingement-free ROM and impingement sites for abduction-adduction, flexion-extension, total rotation (sum of internal and external rotation), and total ROM (sum of ROM in all movement modes) were evaluated.Results:All the 12 combinations of different glenosphere offsets achieved 50% of the original shoulder ROM in all movements. In the abduction-adduction motion with 0 and 4 mm lateral offsets, the anterior-inferior offset provided the largest ROM (94.4°±8.7° and 105.3°±6.9°, respectively), but there was no significant difference between the positions ( P>0.05). In the flexion-extension motion with 0 and 4 mm lateral offsets, the posterior-inferior offset showed the largest ROM (194.1°±6.9° and 196.9°±9.7°, respectively), but there was no significant difference between the positions ( P>0.05). In the total rotation motion with 0 and 4 mm lateral offsets, the anterior-inferior offset had the largest ROM (141.5°±5.9° and 160.6°±8.5°, respectively), showing significant advantages over the center, anterior, and posterior offsets ( P<0.05), but insignificant advantages over the inferior and posterior-inferior offsets ( P>0.05). In total ROM, the anterior-inferior offset provided the largest ROM. When the lateral offset was 0 mm, the anterior-inferior offset provided a ROM of 421.8°±16.4°, showing significant advantages over the center and posterior offsets ( P<0.05). Compared with the lateral glenosphere offset of 0 mm, the lateral glenosphere offset of 4 mm significantly improved total shoulder ROM (122.8°±10.6° versus 145.8°±4.8°) and total ROM (390.9°±11.6° versus 428.4°±19.8°) ( P<0.05). Conclusions:The anterior-inferior, inferior, and posterior-inferior glenosphere offsets can improve ROM in all movement patterns. The position and lateral offset of the glenosphere significantly affect the total rotation and total ROM of the shoulder joint. Specifically, the anterior-inferior and inferior offsets show significant advantages over the center position in total rotation and total ROM of the shoulder joint.

Polysaccharides, predominantly extracted from traditional Chinese medicinal herbs such as Lycium barbarum, Angelica sinensis, Astragalus membranaceus, Dendrobium officinale, Ganoderma lucidum, and Poria cocos, represent principal bioactive constituents extensively utilized in Chinese medicine. These compounds have demonstrated significant anti-inflammatory capabilities, especially anti-liver injury activities, while exhibiting minimal adverse effects. This review summarized recent studies to elucidate the hepatoprotective efficacy and underlying molecular mechanisms of these herbal polysaccharides. It underscored the role of these polysaccharides in regulating hepatic function, enhancing immunological responses, and improving antioxidant capacities, thus contributing to the attenuation of hepatocyte apoptosis and liver protection. Analyses of molecular pathways in these studies revealed the intricate and indispensable functions of traditional Chinese herbal polysaccharides in liver injury management. Therefore, this review provides a thorough examination of the hepatoprotective attributes and molecular mechanisms of these medicinal polysaccharides, thereby offering valuable insights for the advancement of polysaccharide-based therapeutic research and their potential clinical applications in liver disease treatment.
Humans ; Drugs, Chinese Herbal/pharmacology* ; Liver Diseases/drug therapy* ; Antioxidants ; Polysaccharides/therapeutic use* ; Medicine, Chinese Traditional

Objective To explore the efficacy and safety of recombinant human anti-severe acute respiratory syn-drome coronavirus 2(anti-SARS-CoV-2)monoclonal antibody injection(F61 injection)in the treatment of patients with coronavirus disease 2019(COVID-19)combined with renal damage.Methods Patients with COVID-19 and renal damage who visited the PLA General Hospital from January to February 2023 were selected.Subjects were randomly divided into two groups.Control group was treated with conventional anti-COVID-19 therapy,while trial group was treated with conventional anti-COVID-19 therapy combined with F61 injection.A 15-day follow-up was conducted after drug administration.Clinical symptoms,laboratory tests,electrocardiogram,and chest CT of pa-tients were performed to analyze the efficacy and safety of F61 injection.Results Twelve subjects(7 in trial group and 5 in control group)were included in study.Neither group had any clinical progression or death cases.The ave-rage time for negative conversion of nucleic acid of SARS-CoV-2 in control group and trial group were 3.2 days and 1.57 days(P=0.046),respectively.The scores of COVID-19 related target symptom in the trial group on the 3rd and 5th day after medication were both lower than those of the control group(both P＜0.05).According to the clinical staging and World Health Organization 10-point graded disease progression scale,both groups of subjects improved but didn't show statistical differences(P＞0.05).For safety,trial group didn't present any infusion-re-lated adverse event.Subjects in both groups demonstrated varying degrees of elevated blood glucose,elevated urine glucose,elevated urobilinogen,positive urine casts,and cardiac arrhythmia,but the differences were not statistica-lly significant(all P＞0.05).Conclusion F61 injection has initially demonstrated safety and clinical benefit in trea-ting patients with COVID-19 combined with renal damage.As the domestically produced drug,it has good clinical accessibility and may provide more options for clinical practice.

Uncovering the risk factors of pulmonary hypertension and its mechanisms is crucial for the prevention and treatment of the disease.In the current study,we showed that experimental periodontitis,which was established by ligation of molars followed by orally smearing subgingival plaques from patients with periodontitis,exacerbated hypoxia-induced pulmonary hypertension in mice.Mechanistically,periodontitis dysregulated the pulmonary microbiota by promoting ectopic colonization and enrichment of oral bacteria in the lungs,contributing to pulmonary infiltration of interferon gamma positive(IFNγ+)T cells and aggravating the progression of pulmonary hypertension.In addition,we identified Prevotella zoogleoformans as the critical periodontitis-associated bacterium driving the exacerbation of pulmonary hypertension by periodontitis,and the exacerbation was potently ameliorated by both cervical lymph node excision and IFNγ neutralizing antibodies.Our study suggests a proof of concept that the combined prevention and treatment of periodontitis and pulmonary hypertension are necessary.

Artificial chord is a mature mitral valve repair technique, especially in adult mitral valve repair. It is still challenging to repair mitral valve in children with artificial chords because the quality of mitral valve is soft and immature. There are some differences in the methods of suture, the choice of suture size and the number of artificial chords. Although the artificial chords could not grow naturally, we found through the long-term research that most children did not have mitral valve restriction or even chords rupture due to itself can compensate through the growth of the flap and papillary muscle. This article summarizes the recent research progress on the treatment of mitral valve insufficiency in children with artificial chords, providing reference for clinical treatment.

Objective To investigate the key genes associated with ferroptosis in peri-implantitis and explore the potential mecha-nisms regulating peri-implantitis.Methods Several datasets were obtained from the GEO database.Differential expressed genes were screened,and GO and KEGG analyses were performed.A PPI network was constructed using the STRING website.Key genes were val-idated using a test set,and the diagnostic value of key genes was determined.The content and proportion of 22 immune cells in peri-im-plantitis tissues were obtained through immune infiltration analysis.Key genes were validated by qRT-PCR and Western Blot(WB).Results There were 1 138 differential genes between peri-implantitis tissues and normal gingival tissues,of which 29 were related to ferroptosis.The gene expression in peri-implantitis tissues mainly involved processes such as immune response activation.Five key genes in the ferroptosis-related differential genes,namely SOX2,GJA1,IL1B,GPX2 and CHAC1,were differentially expressed in peri-implantitis tissues and had high diagnostic value.Immune infiltration analysis showed significant changes in immune cells such as memory B cells and plasma cells in peri-implantitis tissues.qRT-PCR and WB confirmed significant differential expression of mRNA and the protein transcribed by key genes.Conclusion Differential genes between peri-implantitis and ferroptosis are screened using bioinformatics analysis and biological validation,providing new insights into the study on peri-implantitis.

To study the correlation between the level of Bordetella pertussis nucleic acid and clinical features of the disease in infants and young children and to investigate the risk factors for the development of severe pertussis. Using retrospective research methods, children aged 1 month-3 years who came to Hunan Children′s Hospital from August 2023 to February 2024 and were diagnosed with pertussis for analysis. According to the logarithmic value of BP-DNA (log 10 copies/ml), 35 cases were divided into the low load group, 78 cases were divided into the medium load group and 94 cases were divided into the high load group; 54 cases were divided into the severe whooping cough group and 153 cases were divided into the general group according to the severity of the disease; the clinical characteristics and laboratory data of the groups were compared, and the risk factors for the occurrence of severe whooping cough were analyzed at the same time. The ROC was used to evaluate the predictive efficacy of BP-DNA and WBC count for the development of severe pertussis. The results showed that in the high-dose group, the WBC count(22.59×10 9/L), L/N ratio(3.31), and hospitalization days(9.0 d) were significantly higher than those in the medium-dose group and low-dose group ( F=6.309, 2.825, 15.149, all P<0.05). The hospitalization rate (100%), combined infection rate (64.96%), incidence of severe whooping cough (31.9%), pyrexia rate (29.8%), and corticosteroid use rate (57.4%) were also significantly higher than the other two groups ( χ2=25.977, 9.163, 9.371, 8.299, 20.332, all P<0.05), and the complete immunity rate (9.6%) was significantly lower than the other two groups ( χ2=11.632, P<0.05). Compared with the group of common whooping cough, the proportion of children under 1 year old (100%, χ2=9.581), the BP-DNA load (6.56 log 10 copies/ml, Z=4.004), the WBC count(31.34×10 9/L, t=7.513), the PCT level(0.07 ng/ml, Z=2.626), the IL-6 level (6.65 ng/ml, Z=4.336), the combined infection rate (88.9%, χ2=36.536), the incidence of wheezing or dyspnea (55.6%, χ2=42.972), the rate of no improvement of symptoms with macrolides prior to the visit (77.8%, χ2=26.266), and the incidence of fever (55.6%, χ2=42.972) were all significantly higher;the complete immunity rate was significantly lower (5.6%, χ2=9.581) in the severe whooping cough group, the differences were all statistically significant(all P<0.05).The result of logistic regression analysis showed severe elevation of BP-DNA, high leukocyte count, co-infection, wheezing or shortness of breath, pyrexia and no improvement of symptoms with macrolides before the treatment were the risk factors for the development of severe pertussis and the logistic regressive model predicts a sensitivity and specificity of 0.83 and 0.90 for severe whooping cough, respectively. The sensitivity of BP-DNA>1.91×10 6 copies/ml, WBC count >19.97×10 9/L and the binominal combined test to predict the occurrence of severe pertussis were 0.87, 0.61 and 0.80, and the specificity were 0.43, 0.86 and 0.73, respectively. In conclusion, nucleic acid load in infants with pertussis correlated with clinical characteristics such as the active immunity status, fever, co-infections and hospitalisation and days in hospital. Children with high nucleic acid load, high white blood cell counts, co-infections, fever and no improvement of symptoms with macrolides prior to seeing a doctor were more likely to develop the severe pertussis. When BP-DNA >1.91×10 6 copies/ml or WBC counts>19.97×10 9/L, they have the highest predictive efficacy for severe pertussis respectively, and combined detection is better.