Aim To investigate the protective effect of eriodictyol(ERD)on kidney damage in hypertensive mice and its possible mechanism.Methods Thirty C57BL/6J mice were randomly divided into five groups of six in each group.They were the control group(Ctrl),the hypertension model group(DOCA/Salt),the eriodictyol low-dose(DOCA/Salt+ERD-L),the high-dose(DOCA/Salt+ERD-H)and the positive drug perindopril group(DOCA/Salt+Perindopril).The classic hypertension model was induced by DOCA/Salt,and ERD was administered continuously for four weeks,and blood pressure,serum urea nitrogen,cre-atinine and other indicators were measured.Hematoxy-lin-eosin staining(HE)and Masson staining were used to observe the pathological changes of the kidney.Western blot was used to detect the expression of EMT marker proteins α-SMA,Vimentin,E-cadherin and FN in renal epithelial mesenchymal transition.Real-Time PCR was used to detect the expression of renal inflammatory cytokines Nlrp3,TNF-α,IL-1 β,IL-18,MCP-1 and NADPH oxidase(NOXs).Western blot was employed to detect the expression levels of TGF-β1,phosphorylated(p)-Smad2,TLR4 and NF-κB p65 proteins in mice.Results ERD intervention could delay the occurrence of hypertension,improve the pathological damage of renal tissue,reduce renal collagen deposition.It could also reduce the level of renal inflammation and oxidative stress,improve the level of EMT protein,and significantly reduce the pro-tein expression of TGF-β1,p-Smad2,TLR4 and NF-κB p65.Conclusions ERD is shown to have a signif-icant protective effect on DOCA/Salt hypertensive renal damage,and its mechanism may be related to the regu-lation of TGF-β1/Smad2,TLR4/NF-κB p65 and other signaling pathways.

Patients with severe trauma require an extremely timely treatment and transfusion plays an irreplaceable role in the emergency treatment of such patients. An increasing number of evidence-based medicinal evidences and clinical practices suggest that patients with severe traumatic bleeding benefit from early transfusion of low-titer group O whole blood or hemostatic resuscitation with red blood cells, plasma and platelet of a balanced ratio. However, the current domestic mode of blood supply cannot fully meet the requirements of timely and effective blood transfusion for emergency treatment of patients with severe trauma in clinical practice. In order to solve the key problems in blood supply and blood transfusion strategies for emergency treatment of severe trauma, Branch of Clinical Transfusion Medicine of Chinese Medical Association, Group for Trauma Emergency Care and Multiple Injuries of Trauma Branch of Chinese Medical Association, Young Scholar Group of Disaster Medicine Branch of Chinese Medical Association organized domestic experts of blood transfusion medicine and trauma treatment to jointly formulate Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients ( version 2024). Based on the evidence-based medical evidence and Delphi method of expert consultation and voting, 10 recommendations were put forward from two aspects of blood support mode and transfusion strategies, aiming to provide a reference for transfusion resuscitation in the emergency treatment of severe trauma and further improve the success rate of treatment of patients with severe trauma.

BACKGROUND: LY01005 (Goserelin acetate sustained-release microsphere injection) is a modified gonadotropin-releasing hormone (GnRH) agonist injected monthly. This phase III trial study aimed to evaluated the efficacy and safety of LY01005 in Chinese patients with prostate cancer. METHODS: We conducted a randomized controlled, open-label, non-inferiority trial across 49 sites in China. This study included 290 patients with prostate cancer who received either LY01005 or goserelin implants every 28 days for three injections. The primary efficacy endpoints were the percentage of patients with testosterone suppression ≤50 ng/dL at day 29 and the cumulative probability of testosterone ≤50 ng/dL from day 29 to 85. Non-inferiority was prespecified at a margin of -10%. Secondary endpoints included significant castration (≤20 ng/dL), testosterone surge within 72 h following repeated dosing, and changes in luteinizing hormone, follicle-stimulating hormone, and prostate specific antigen levels. RESULTS: On day 29, in the LY01005 and goserelin implant groups, testosterone concentrations fell below medical-castration levels in 99.3% (142/143) and 100% (140/140) of patients, respectively, with a difference of -0.7% (95% confidence interval [CI], -3.9% to 2.0%) between the two groups. The cumulative probabilities of maintaining castration from days 29 to 85 were 99.3% and 97.8%, respectively, with a between-group difference of 1.5% (95% CI, -1.3% to 4.4%). Both results met the criterion for non-inferiority. Secondary endpoints were similar between groups. Both treatments were well-tolerated. LY01005 was associated with fewer injection-site reactions than the goserelin implant (0% vs . 1.4% [2/145]). CONCLUSION: LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile. TRIAL REGISTRATION ClinicalTrials.gov, NCT04563936.
Humans ; Male ; Antineoplastic Agents, Hormonal/therapeutic use* ; East Asian People ; Gonadotropin-Releasing Hormone/agonists* ; Goserelin/therapeutic use* ; Prostate-Specific Antigen ; Prostatic Neoplasms/drug therapy* ; Testosterone

Ethical review runs through the whole process of drug clinical trials, and is a critical step to ensure the rights and interests of subjects. This paper analyzed and discussed the role and positioning of ethical review in new drug clinical trials, cleared the principles of ethical review, identified the responsibilities of ethical review, and clarified the authority of ethical review approval documents. The ethical review should primarily focus on the ethics of the clinical trials, not replace other professional institutions to review the clinical trials’ legality and scientific nature. Ethical approval is only one of the necessary conditions for conducting clinical trials, not the only factor. It is recommended to strengthen the publicity and popularization of scientific and technological ethics awareness, improve the clinical trial approval mechanism, and optimize the phrasing of ethical review approval documents. It is warranted to further optimize the quality of ethical review, improve the construction of ethical review system, ultimately achieve the unity of promoting innovation and preventing risks, so as to effectively realize the benign interaction between high-quality development of scientific and technological innovation and high-level safety.

Objective: To explore the related factors of negative conversion time (NCT) of nucleic acid in children with COVID-19. Methods: A retrospective cohort study was conducted. A total of 225 children who were diagnosed with COVID-19 and admitted to Changxing Branch of Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine from April 3^rd to May 31^st 2022 were enrolled in the study. The infection age, gender, viral load, basic disease, clinical symptoms and information of accompanying caregivers were retrospectively analyzed. According to age, the children were divided into<3 years of age group and 3-<18 years of age group. According to the viral nucleic acid test results, the children were divided into positive accompanying caregiver group and negative accompanying caregiver group. Comparisons between groups were performed using Mann-Whitney U test or Chi-square test. Multivariate Logistic regression analysis was used to analyze the related factors of NCT of nucleic acid in children with COVID-19. Results: Among the 225 patients (120 boys and 105 girls) of age 2.8 (1.3, 6.2) years, 119 children <3 years and 106 children 3-<18 years of age, 19 cases were diagnosed with moderate COVID-19, and the other 206 cases were diagnosed with mild COVID-19. There were 141 patients in the positive accompanying caregiver group and 84 patients in the negative accompanying caregiver group.Patients 3-<18 years of age had a shorter NCT (5 (3, 7) vs.7 (4, 9) d, Z=-4.17, P<0.001) compared with patients <3 years of age. Patients in the negative accompanying caregiver group had a shorter NCT (5 (3, 7) vs.6 (4, 9) d,Z=-2.89,P=0.004) compared with patients in the positive accompanying caregiver group. Multivariate Logistic regression analysis showed that anorexia was associated with NCT of nucleic acid (OR=3.74,95%CI 1.69-8.31, P=0.001). Conclusion: Accompanying caregiver with positive nucleic acid test may prolong NCT of nucleic acid, and decreased appetite may be associated with prolonged NCT of nucleic acid in children with COVID-19.
Adolescent ; Child ; Child, Preschool ; Female ; Humans ; Male ; Young Adult ; China/epidemiology* ; COVID-19/genetics* ; Nucleic Acids ; Retrospective Studies

Objective: To analyze the short-term efficacy of sleeve gastrectomy plus uncut jejunojejunostomy (SG+uncut JJB) for patients with obesity. Methods: This prospective study was conducted in the General Surgery Department of Beijing Chaoyang Hospital from January to December 2020 (NCT04534504). The inclusion criteria were patients with a body mass index (BMI) of >32.5 kg/m², type 2 diabetes mellitus (T2DM) or at least two comorbidities with a BMI of 27.5-32.5 kg/m², a waist circumference of >90 cm (male) or >85 cm (female), and those aged between 16 and 65 years. The exclusion criteria included patients who were pregnant, diagnosed with severe neurological or mental illnesses, long-term users of antidepressants and immunosuppressants, and diagnosed with severe gastroesophageal reflux disease or underwent revision surgery. Patients with incomplete follow-up data or insufficient follow-up time were also excluded. Patients were divided into SG-uncut JJB group and SG group according to doctor's recommendation and patients' wills. The primary endpoint was the percentage of excess weight loss (%EWL), and the secondary endpoints were the percentage of total weight loss (%TWL) and the T2DM remission rate. All patients were regularly followed up until the end of December 2020. Results: After excluding seven patients who did not meet the inclusion criteria, 47 eligible patients were finally identified, with 21 in the SG+uncut JJB group and 26 in the SG group. The operation time (140 [110-180] minutes vs. 90 [70-180] minutes, Z=-3.642, P=0.001) and total cost ([54,000 ± 6000] yuan vs. [49,000 ± 7000] yuan, t=2.590, P=0.013) were slightly higher in the SG+uncut JJB group than in the SG group (all P<0.05). However, no significant differences were observed in terms of postoperative hospital stay, operative blood loss, and postoperative complications between the two groups (all P>0.05). The incidence of nausea and vomiting was significantly lower in the SG+uncut JJB group than in the SG group (9.5% [2/21] vs. 46.2% [12/26], χ²=7.453, P=0.006}. The %EWL and %TWL in the SG+uncut JJB group tended to increase gradually with time. The same trend was also observed in the SG group during the first 6 months of follow-up. The 12-month %EWL and %TWL in the SG group were slightly lower compared with the 6-month %EWL and %TWL (P=0.001). The 12-month %EWL values in the SG+uncut JJB and SG groups were (72.4%±12.3%) and (63.6%±25.7%), respectively. However, no significant differences were observed between the two groups in terms of %EWL. Moreover, the 1-month ([11.1%±2.4%] vs. [8.2%±4.4%], P=0.011) and 12-month %TWL ([29.7%±6.9%] vs. [20.3%±7.2%], P=0.001) were significantly higher in the SG+uncut JJB group than in the SG group. No significant differences were observed in terms of T2DM and hypertension remission (all P>0.05). Conclusion: SG+uncut JJB might achieve a promising weight-loss effect similar to SG with a relatively lower incidence of postoperative nausea and vomiting, and it might be an effective and safe approach for obesity management.
Adolescent ; Adult ; Aged ; Female ; Humans ; Male ; Middle Aged ; Young Adult ; Diabetes Mellitus, Type 2/surgery* ; Gastrectomy ; Gastric Bypass ; Immunosuppressive Agents ; Laparoscopy ; Obesity/surgery* ; Obesity, Morbid/surgery* ; Prospective Studies ; Retrospective Studies ; Treatment Outcome ; Weight Loss

Objective: To compare the effects of three treatment options: emergency surgery, stent-surgery, and stent-neoadjuvant chemotherapy-surgery, on the pathological characteris- tics of surgically-resected specimens from patients with completely obstructive colorectal cancer. Methods: This was a retrospective cohort study analyzing clinicopathological data of patients with complete obstructive colorectal cancer who were admitted to the General Surgery Department of Beijing Chaoyang Hospital, Capital Medical University, between May 2012 and August 2020. The inclusion criteria were diagnosed with complete colorectal obstruction, pathologically confirmed as adenocarcinoma, resectable on imaging assessment, and without distant metastasis, combined with the patients' clinical manifestations and imaging examination findings. Patients with multiple colorectal cancers, refusal to undergo surgery, and concurrent peritonitis or intestinal perforation before stenting of the intestinal obstruction were excluded. Eighty-nine patients with completely obstructive colorectal cancer were enrolled in the study and were divided into emergency surgery group (n=30), stent-surgery group (n=34), and stent-neoadjuvant chemotherapy- surgery group (n=25) according to the treatment strategy. Differences in the pathological features (namely perineural infiltration, lymphovascular infiltration, tumor deposits, specimen intravascular necrosis, inflammatory infiltration, abscesses, mucus lake formation, foreign body giant cells, calcification, and tumor cell ratio) and biomolecular markers (namely cluster of differentiation (CD)34, Ki67, Bcl-2, matrix metalloproteinase-9, and hypoxia-inducible factor alpha) were recorded. Pathological evaluation was based on the presence or absence of qualitative evaluation of pathological features, such as peripheral nerve infiltration, vascular infiltration, and cancer nodules within the specimens. The evaluation criteria for the pathological features of the specimens were as follows: Semi-quantitative graded evaluation based on the proportion of tissue necrosis, inflammatory infiltrates, abscesses, mucus lake formation, foreign body giant cells, calcification, and tumor cells in the field of view within the specimen were classified as: grade 0: not seen within the specimen; grade 1: 0-25%; grade 2: 25%-50%; grade 3: 50%-75%; and grade 4: 75%-100%. The intensity of cellular immunity was classified as none (0 points), weak (1 point), moderate (2 points), and strong (3 points). The two evaluation scores were then multiplied to obtain a total score of 0-12. The immunohistochemical results were also evaluated comprehensively, and the results were defined as: negative (grade 0): 0 points; weakly positive (grade 1): 1-3 points; moderately positive (grade 2): 4-6 points; strongly positive (grade 3): 7-9 points; and very strong positive (grade 4): 10-12 points. Normally-distributed values were expressed as mean±standard deviation, and one-way analysis of variance was used to analyze the differences between the groups. Non-normally-distributed values were expressed as median (interquartile range: Q1, Q3). A nonparametric test (Kruskal-Wallis H test) was used for comparisons between groups. Results: The differences were not statistically significant when comparing the baseline data for age, gender, tumor site, American Society of Anesthesiologists score, tumor T-stage, N-stage, and degree of differentiation among the three groups (all P>0.05). The differences were not statistically significant when comparing the pathological characteristics of the resected tumor specimens, such as foreign body giant cells, inflammatory infiltration, and mucus lake formation among the three groups (all P>0.05). The rates of vascular infiltration were 56.6% (17/30), 41.2% (15/34), and 20.0% (5/25) in the emergency surgery, stent-surgery, and stent- neoadjuvant chemotherapy-surgery groups, respectively, with statistically significant differences between the groups (χ²=7.142, P=0.028). Additionally, the rate of vascular infiltration was significantly lower in the stent-neoadjuvant chemotherapy-surgery group than that in the emergency surgery group (P=0.038). Peripheral nerve infiltration rates were 55.3% (16/30), 41.2% (14/34), and 16.0% (4/25), in the emergency surgery, stent-surgery, and stent-neoadjuvant chemotherapy-surgery groups, respectively, with statistically significant differences (χ²=7.735, P=0.021). The infiltration peripheral nerve rates in the stent-neoadjuvant chemotherapy-surgery group were significantly lower than those in the emergency surgery group (P=0.032). The necrosis grade was 2 (1, 2), 2 (1, 3), and 2 (2, 3) in the emergency surgery, stent- surgery, and stent-neoadjuvant chemotherapy-surgery groups, respectively, with statistically significant differences (H=10.090, P=0.006). Post hoc comparison revealed that the necrosis grade was higher in the stent-surgery and stent-neoadjuvant chemotherapy-surgery groups compared with the emergency surgery group (both P<0.05). The abscess grade was 2 (1, 2), 3 (1, 3), and 2 (2, 3) in the emergency surgery, stent-surgery, and stent-neoadjuvant chemotherapy-surgery groups, respectively, with statistically significant differences (H=6.584, P=0.037). Post hoc comparison revealed that the abscess grade in the emergency surgery group was significantly lower than that in the stent-surgery group (P=0.037). The fibrosis grade was 2 (1, 3), 3 (2, 3), and 3 (2, 3), in the emergency surgery, stent-surgery, and stent-neoadjuvant chemotherapy-surgery groups, respectively, with statistically significant differences (H=11.078, P=0.004). Post hoc analysis revealed that the fibrosis degree was higher in both the stent-surgery group and the stent- neoadjuvant chemotherapy-surgery group compared with the emergency surgery group (both, P<0.05). The tumor cell ratio grades were 4 (3, 4), 4 (3, 4), and 3 (2, 4), in the emergency surgery, stent-surgery, and stent-neoadjuvant chemotherapy-surgery groups, respectively, with statistically significant differences (H=8.594, P=0.014). Post hoc analysis showed that the tumor cell ratio in the stent-neoadjuvant chemotherapy-surgery group was significantly lower than that in the emergency surgery group (P=0.012). The CD34 grades were 2 (2, 3), 3 (2, 4), and 3 (2, 3) in the emergency surgery, stent-surgery, and stent-neoadjuvant chemotherapy-surgery groups, respectively, and the difference was statistically significant (H=9.786, P=0.007). Post hoc analysis showed that the CD34 grades in the emergency surgery, stent-surgery, and stent-neoadjuvant chemotherapy-surgery groups were 2 (2, 3), 3 (2, 4), and 3 (2,3), respectively. Post hoc analysis revealed that the CD34 concentration was higher in the stent-surgery group than that in the emergency surgery group (P=0.005). Conclusion: Stenting may increase the risk of distant metastases in obstructive colorectal cancer. The stent-neoadjuvant chemotherapy-surgery treatment model promotes tumor cell necrosis and fibrosis and reduces the proportion of tumor cells, vascular infiltration, and peripheral nerve infiltration, which may help decrease local tumor infiltration and distant metastasis in completely obstructive colorectal cancer after stent placement.
Humans ; Neoadjuvant Therapy/methods* ; Abscess ; Retrospective Studies ; Intestinal Obstruction/etiology* ; Stents ; Colorectal Neoplasms/therapy* ; Necrosis

With the implementation of the national biomedical innovation strategy, new requirements for ethical review of clinical trials have been put forward, and more attention has been paid to the ethical pre-review. Based on the current situation of clinical trials and ethical review of new drugs in China, this paper discussed the concept, advantages and necessity of ethical pre-review, sorted out the problems and challenges in the implementation of ethical pre-review at this stage, and put forward the following suggestions on how to better implement ethical pre-review in clinical trials under the pharmaceutical innovation strategy: the complete definition of "ethical pre-review" should be made clearly; ethical review should be carried out on the basis of necessary reference; the scope of application of ethical pre-review should be clarified; after the ethical pre-review, the statement of the approval document should be standardized and accurate.

Objective:To explore the effect of empowerment education in patients with coronary heart disease after percutaneous coronary intervention (PCI) .Methods:From June 2020 to July 2021, convenience sampling was used to select 90 patients with coronary heart disease who received PCI in the Department of Cardiology of Qinhuai Medical District, Eastern Theater Command General Hospital as the research object. The 45 patients admitted from June to December 2020 were set as the control group, and the 45 patients admitted from January to July 2021 were set as the observation group. The control group received routine health education, and the observation group was given empowerment education on this basis. The physical activity level and aerobic exercise endurance of the two groups of patients were compared.Results:Repeated measures analysis of variance showed that there were between-group, time and interaction effects in the 6-minute walking distance between the two groups before intervention, one month and three months after intervention, and the differences were statistically significant ( P<0.05) . The physical activity levels of patients in the observation group were higher than those in the control group after one and three months of intervention, and the differences were statistically significant ( P<0.05) . Conclusions:Empowerment education can improve physical activity level and aerobic exercise endurance in patients with coronary heart disease after PCI.

Objective::To observe the clinical efficacy of modified Buyang Huanwu Tang combined with Sanrentang in treating early diabetic nephropathy(DN)with deficiency of spleen and kidney, damp-heat and blood stasis syndrome and its effect on glucose and lipid metabolism, oxidative stress and inflammatory factors, in order to explore its mechanism. Method::A total of 72 early DN atients were randomly divided into control group and treatment group, with 36 cases in each group. The control group was orally treated with losartan potassium tablets(50 mg every time, once/day), while the treatment group was treated with modified Buyang Huanwu Tang combined with Sanrentang orally in addition to the therapy of the control group(1 dose/day). Both groups were treated for 3 months. The changes in clinical efficacy and safety indicators were observed for both groups. The 24 h urine albumin excretion rate(UAER), serum creatinine(SCr), serum cystatin C(Cys C), urea nitrogen (BUN), fasting blood glucose (FBG), 2 h postprandial blood glucose (2 hPG), glycosylated hemoglobin (HbA1c), total cholesterol (TC), triglyceride(TG), low-density lipoprotein cholesterol(LDL-C), high-density lipoprotein cholesterol(HDL-C), malondialdehyde(MDA), superoxide dismutase(SOD), glutathione Peroxidase(GSH-Px), interleukin-2(IL-2), interleukin-4(IL-4), interleukin-8(IL-8), interleukin-10(IL-10), tumor necrosis factor-α(TNF-α)of patients in two groups were observed before and after treatment. Result::The total clinical effective rate was 88.9%in therapy group, which was higher than 61.1%in control group(P<0.05). After treatment, levels of UAER, SCr, Cys C and BUN were lower in both groups(P<0.05), and the levels in treatment group were all lower than those in control group(P<0.05). Levels of FBG, 2 hPG and HbA1c were lower in both groups(P<0.05). There was no significant difference in FBG, 2 hPG and HbA1c levels between two groups after treatment. The levels of HDL-C were higher in both groups(P<0.05), and the levels in treatment group were higher than that in control group(P<0.05). The levels of TC, TG and LDL-C were lower in both groups(P<0.05), and the levels in treatment group were all lower than those in control group(P<0.05). The level of MDA was lower in both groups(P<0.05), and the level in the treatment group was lower than that in control group(P<0.05). The levels of SOD and GSH-Px were higher in both groups(P<0.05), and the levels in the treatment group were all higher than those in the control group(P<0.05). Serum levels of IL-2, IL-8 and TNF-α were lower in both groups(P<0.05), and the levels in the treatment group were lower than those in control group(P<0.05). Serum levels of IL-4 and IL-10 were higher in both groups(P<0.05), and the levels in the treatment group was higher than those in control group(P<0.05). Conclusion::Modified Buyang Huanwu Tang combined with Sanrentang is effective and safe in the treatment of early DN with spleen and kidney deficiency, damp-heat and blood stasis syndrome. They can further improve renal function and lipid metabolism, inhibit oxidative stress reaction and regulate the secretion balance of inflammatory factors in early DN patients.