OBJECTIVE To promote the standardization and integrity of the informed consent form for clinical trials of registered anti-tumor drugs， and to protect the legitimate rights and interests of the subjects. METHODS The ethical review resolutions of clinical trial projects of registered anti-tumor drugs that were initially reviewed by the Ethics Committee of our hospital from July 1st， 2020 to July 1st， 2022 were summarized to statistically analyze the problematic items according to the “Quality Analysis Form of Informed Consent” prepared by our hospital. RESULTS Of the 316 clinical trials of registered anti- tumor drugs that were initially reviewed， 257 （81.3%） had problems with the contents of informed consent form， mainly domestic multi-center trials and phase Ⅲ trials. The main problems included the vague notification of the test fee bearer （68.5%）， the incomplete notification of the test content （59.1%）， the insufficient notification of rights and interests and risks （58.4%）， the insufficient notification of personal information protection （56.0%）， and the nonstandard expression of the informed consent form （52.5%）. CONCLUSIONS There is still a gap between the informed consent form of the clinical trials of registered anti-tumor drugs in our hospital and the requirements of the new version of Good Clinical Practice for Drugs （GCP）. The parties involved in the test can take a number of measures to improve the standardization and integrity of the informed consent form， and the research team should design the informed consent form in strict accordance with the requirements of the new GCP and pay attention to the comprehensive notification about the test. The Ethics Committee can provide the sponsor and researcher with the template of informed consent form and the key points of writing， continue to strengthen the examination ability， improve the examination quality， and effectively protect the safety and interests of the subjects.

Objective: To analyze the clinical epidemiological characteristics including composition of pathogens , clinical characteristics, and disease prognosis acute bacterial meningitis (ABM) in Chinese children. Methods: A retrospective analysis was performed on the clinical and laboratory data of 1 610 children <15 years of age with ABM in 33 tertiary hospitals in China from January 2019 to December 2020. Patients were divided into different groups according to age,<28 days group, 28 days to <3 months group, 3 months to <1 year group, 1-<5 years of age group, 5-<15 years of age group; etiology confirmed group and clinically diagnosed group according to etiology diagnosis. Non-numeric variables were analyzed with the Chi-square test or Fisher's exact test, while non-normal distrituction numeric variables were compared with nonparametric test. Results: Among 1 610 children with ABM, 955 were male and 650 were female (5 cases were not provided with gender information), and the age of onset was 1.5 (0.5, 5.5) months. There were 588 cases age from <28 days, 462 cases age from 28 days to <3 months, 302 cases age from 3 months to <1 year of age group, 156 cases in the 1-<5 years of age and 101 cases in the 5-<15 years of age. The detection rates were 38.8% (95/245) and 31.5% (70/222) of Escherichia coli and 27.8% (68/245) and 35.1% (78/222) of Streptococcus agalactiae in infants younger than 28 days of age and 28 days to 3 months of age; the detection rates of Streptococcus pneumonia, Escherichia coli, and Streptococcus agalactiae were 34.3% (61/178), 14.0% (25/178) and 13.5% (24/178) in the 3 months of age to <1 year of age group; the dominant pathogens were Streptococcus pneumoniae and the detection rate were 67.9% (74/109) and 44.4% (16/36) in the 1-<5 years of age and 5-<15 years of age . There were 9.7% (19/195) strains of Escherichia coli producing ultra-broad-spectrum β-lactamases. The positive rates of cerebrospinal fluid (CSF) culture and blood culture were 32.2% (515/1 598) and 25.0% (400/1 598), while 38.2% (126/330)and 25.3% (21/83) in CSF metagenomics next generation sequencing and Streptococcus pneumoniae antigen detection. There were 4.3% (32/790) cases of which CSF white blood cell counts were normal in etiology confirmed group. Among 1 610 children with ABM, main intracranial imaging complications were subdural effusion and (or) empyema in 349 cases (21.7%), hydrocephalus in 233 cases (14.5%), brain abscess in 178 cases (11.1%), and other cerebrovascular diseases, including encephalomalacia, cerebral infarction, and encephalatrophy, in 174 cases (10.8%). Among the 166 cases (10.3%) with unfavorable outcome, 32 cases (2.0%) died among whom 24 cases died before 1 year of age, and 37 cases (2.3%) had recurrence among whom 25 cases had recurrence within 3 weeks. The incidences of subdural effusion and (or) empyema, brain abscess and ependymitis in the etiology confirmed group were significantly higher than those in the clinically diagnosed group (26.2% (207/790) vs. 17.3% (142/820), 13.0% (103/790) vs. 9.1% (75/820), 4.6% (36/790) vs. 2.7% (22/820), χ²=18.71, 6.20, 4.07, all P<0.05), but there was no significant difference in the unfavorable outcomes, mortility, and recurrence between these 2 groups (all P>0.05). Conclusions: The onset age of ABM in children is usually within 1 year of age, especially <3 months. The common pathogens in infants <3 months of age are Escherichia coli and Streptococcus agalactiae, and the dominant pathogen in infant ≥3 months is Streptococcus pneumoniae. Subdural effusion and (or) empyema and hydrocephalus are common complications. ABM should not be excluded even if CSF white blood cell counts is within normal range. Standardized bacteriological examination should be paid more attention to increase the pathogenic detection rate. Non-culture CSF detection methods may facilitate the pathogenic diagnosis.
Adolescent ; Brain Abscess ; Child ; Child, Preschool ; Escherichia coli ; Female ; Humans ; Hydrocephalus ; Infant ; Infant, Newborn ; Male ; Meningitis, Bacterial/epidemiology* ; Retrospective Studies ; Streptococcus agalactiae ; Streptococcus pneumoniae ; Subdural Effusion ; beta-Lactamases

Objective: The coronavirus disease 2019 (COVID-19) pandemic continues to present a major challenge to public health. Vaccine development requires an understanding of the kinetics of neutralizing antibody (NAb) responses to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Methods: In total, 605 serum samples from 125 COVID-19 patients (from January 1 to March 14, 2020) varying in age, sex, severity of symptoms, and presence of underlying diseases were collected, and antibody titers were measured using a micro-neutralization assay with wild-type SARS-CoV-2. Results: NAbs were detectable approximately 10 days post-onset (dpo) of symptoms and peaked at approximately 20 dpo. The NAb levels were slightly higher in young males and severe cases, while no significant difference was observed for the other classifications. In follow-up cases, the NAb titer had increased or stabilized in 18 cases, whereas it had decreased in 26 cases, and in one case NAbs were undetectable at the end of our observation. Although a decreasing trend in NAb titer was observed in many cases, the NAb level was generally still protective. Conclusion We demonstrated that NAb levels vary among all categories of COVID-19 patients. Long-term studies are needed to determine the longevity and protective efficiency of NAbs induced by SARS-CoV-2.
Adult ; Aged ; Aged, 80 and over ; Antibodies, Neutralizing/immunology* ; Antibodies, Viral/immunology* ; COVID-19/immunology* ; Female ; Humans ; Kinetics ; Male ; Middle Aged ; Neutralization Tests ; SARS-CoV-2

Objective: The relationship between serum uric acid (SUA) levels and glycemic indices, including plasma glucose (FPG), 2-hour postload glucose (2h-PG), and glycated hemoglobin (HbA1c), remains inconclusive. We aimed to explore the associations between glycemic indices and SUA levels in the general Chinese population. Methods: The current study was a cross-sectional analysis using the first follow-up survey data from The China Cardiometabolic Disease and Cancer Cohort Study. A total of 105,922 community-dwelling adults aged ≥ 40 years underwent the oral glucose tolerance test and uric acid assessment. The nonlinear relationships between glycemic indices and SUA levels were explored using generalized additive models. Results: A total of 30,941 men and 62,361 women were eligible for the current analysis. Generalized additive models verified the inverted U-shaped association between glycemic indices and SUA levels, but with different inflection points in men and women. The thresholds for FPG, 2h-PG, and HbA1c for men and women were 6.5/8.0 mmol/L, 11.0/14.0 mmol/L, and 6.1/6.5, respectively (SUA levels increased with increasing glycemic indices before the inflection points and then eventually decreased with further increases in the glycemic indices). Conclusion An inverted U-shaped association was observed between major glycemic indices and uric acid levels in both sexes, while the inflection points were reached earlier in men than in women.
Aged ; Asian Continental Ancestry Group ; Blood Glucose/analysis* ; China/epidemiology* ; Cohort Studies ; Diabetes Mellitus/blood* ; Female ; Glucose Tolerance Test ; Glycated Hemoglobin A/analysis* ; Glycemic Index ; Humans ; Male ; Middle Aged ; Uric Acid/blood*

OBJECTIVES: To develop a new Chinese medicine (CM)-based drug and to evaluate its safety and effect for suppressing acute respiratory distress syndrome (ARDS) in COVID-19 patients. METHODS: A putative ARDS-suppressing drug Keguan-1 was first developed and then evaluated by a randomized, controlled two-arm trial. The two arms of the trial consist of a control therapy (alpha interferon inhalation, 50 µg twice daily; and lopinavir/ritonavir, 400 and 100 mg twice daily, respectively) and a testing therapy (control therapy plus Keguan-1 19.4 g twice daily) by random number table at 1:1 ratio with 24 cases each group. After 2-week treatment, adverse events, time to fever resolution, ARDS development, and lung injury on newly diagnosed COVID-19 patients were assessed. RESULTS: An analysis of the data from the first 30 participants showed that the control arm and the testing arm did not exhibit any significant differences in terms of adverse events. Based on this result, the study was expanded to include a total of 48 participants (24 cases each arm). The results show that compared with the control arm, the testing arm exhibited a significant improvement in time to fever resolution (P=0.035), and a significant reduction in the development of ARDS (P=0.048). CONCLUSIONS Keguan-1-based integrative therapy was safe and superior to the standard therapy in suppressing the development of ARDS in COVID-19 patients. (Trial registration No. NCT04251871 at www.clinicaltrials.gov ).
Administration, Inhalation ; Adult ; China ; Coronavirus Infections ; diagnosis ; drug therapy ; mortality ; Dose-Response Relationship, Drug ; Drug Administration Schedule ; Drugs, Chinese Herbal ; administration & dosage ; Female ; Follow-Up Studies ; Humans ; Integrative Medicine ; Interferon-alpha ; administration & dosage ; Lopinavir ; administration & dosage ; Male ; Middle Aged ; Pandemics ; Pneumonia, Viral ; diagnosis ; drug therapy ; mortality ; Risk Assessment ; Severe Acute Respiratory Syndrome ; diagnosis ; drug therapy ; mortality ; Severity of Illness Index ; Survival Rate

The aim of this article is to study the regulatory feedback loop between β-catenin and IQ motif containing GTPase activating protein 1 (IQGAP1), as well as the effect of this regulation loop in colon cancer cell proliferation. Western blot was used to detect the expression of IQGAP1 and β-catenin after changing their expression respectively by transfection in SW1116 cells. CCK-8 cell proliferation assay was used to detect the effect of IQGAP1 involved in the proliferation of SW1116 cells promoted by β-catenin. The results of Western blot indicated that β-catenin could positively regulate IQGAP1, while IQGAP1 silencing could up-regulate β-catenin, forming a negative feedback loop. The results of CCK-8 showed that IQGAP1 silencing inhibited β-catenin-mediated proliferation in SW1116 cells. In conclusion, our research reveals a negative regulatory feedback loop between β-catenin and IQGAP1 which has a remarkable effect on the proliferation ability of colon cancer cells.

Objective To observe the clinical features of atrial fibrillation (AF) patients, and to explore the correlation between the routine detection index and the new-onset AF and to find out risk factors for new AF in critically ill patients. Methods A prospective observational study was conducted. The patients with AF admitted to intensive care unit (ICU) of the Affiliated Hospital of Guizhou Medical University from March 2016 to June 2017 were enrolled. The patients were divided into new-onset AF group and past-existed AF group according to their past history of AF (including persistent AF, paroxysmal AF or permanent AF). In addition, patients in ICU without history of AF and new-onset AF were selected as the control group (no AF group). The general epidemiological characteristics of patients in three groups, and the blood biochemical, coagulation and other related indicators at the time of AF occurred (new-onset AF group) or 48 hours after ICU admission (AF group and no AF group) were analyzed; the difference of laboratory indexes between patients in new-onset AF group with AF within 48 hours before occurred and patients in no AF group within 48 hours after admission to ICU was compared. The relationship between each index and new-onset AF were analyzed. Pearson or Spearman rank correlation was used for analysis. Risk factors of new-onset AF were analyzed by Logistic regression analysis. Results 1 673 patients were admitted to ICU, including 179 cases of AF (10.70%), and 106 males and 73 females, with an average age of (71.73±23.22) years. There was 75 new-onset AF (morbidity 4.48%), and had a 28-day mortality of 45.33% (34/75). There were differences in age, previous heart disease and heart failure (HF) among new-onset AF group (n = 75), past-existed AF group (n = 104) and no AF group (n = 75). Compared with other two groups, renal insufficiency rates, troponin, serum sodium, calcium and procalcitonin levels were higher, mechanical ventilation time and the length of ICU stay were significantly prolonged, ICU and hospitalization costs were higher in new-onset AF group. Compared with no AF group, new-onset AF patients with the higher percentage of septic shock, the accumulation of vascular contraction drugs within 24 hours after AF usage were higher, and used more anti-arrhythmic drugs, has higher brain natriuretic peptide (pro-BNP), serum creatinine, blood lactic acid levels, and lower albumin, oxygenation index, and serum potassium levels, sequential organ failure assessment (SOFA) score, acute physiology and chronic health evaluation Ⅱ(APACHE Ⅱ) score and 28-day mortality were higher. Correlation analysis showed that age, APACHE Ⅱ score, septic shock, HF, cardiovascular disease, renal insufficiency were positively correlated with new-onset AF (r values were 0.393, 0.270, 0.386, 0.251, 0.194, 0.170;P values were 0.000, 0.001, 0.000, 0.002, 0.017, 0.037, respectively). The age [odds ratio (OR) = 0.962, P = 0.046], basic oxygenation index (OR = 1.005, P = 0.028) and serum potassium levels (OR = 1.638, P = 0.022) were the risk factors for new-onset AF. Conclusions Critical patients with a high incidence of AF, new-onset AF significantly prolong the length of ICU stay; age, APACHE Ⅱ score, septic shock, cardiovascular disease, and renal insufficiency are related to new-onset AF; age, basic oxygenation index and serum potassium levels are risk factors for new-onset AF.

Objective To explore the influence factors of help-seeking behavior in people with subjective memory complaints (SMCs).Methods A total of 305 eligible SMCs people were recruited and investigated with illness perception questionnaire-memory (IPQ-M),GDS-15,Mini-mental State Examination (MMSE),auditory verbal learning test(AVLT).Subjects were comprised of two groups:help-seeking group(n=44) and non-help-seeking group(n=261).Results The ratio of SMCs people for help-seeking was very low,only accounted for 14.4％.The ratio for going to hospital to see a specialist memory clinic accounted for only 2.0％.Logistic regression analysis showed 6 related factors were prime motivators for help-seeking behavior,which were symptom (OR=1.455),treatment control (OR=2.456),emotional representation (OR=2.268),accepting dementia education (OR=1.576),lacking of blood supply to the brain(OR=1.115),not using brain(OR=2.079).Three causal attributions were obstructive factors for help-seeking behavior,which were loneliness (OR=0.253),aging (OR=0.450),and chance or bad luck (OR=0.374).Conclusion Illness perception-memory in subjects with SMCs had some prediction for help-seeking behavior.Community nurses should attach importance to illness perception-memory of SMCs people and help them promote help-seeking,so as to facilitate earlv screening,identification and prevention of dementia.

Objective:To investigate the role and molecular mechanism of Na+/Ca2+ exchanger 1 (NCX1) in the invasion and proliferation of hepatocellular carcinoma (HCC),and to provide new therapeutic targets for the clinical diagnosis and treatment of hepatocellular carcinoma.Methods:Quantitative real-time PCR (qRT-PCR) and Western blotting were used to detect NCX1 mRNA and protein expression in different HCC cell lines.Lentiviral vectors pGC-SIL-GFP-shRNA-NCX1 and pGC-FU-GFP-NCX1 were constructed and transfected into hepatoma cells.Cell migration and invasion experiments were used to observe the effect of NCX1 on the migration and invasion of HCC cells;cell proliferation assay was used to observe the effect of NCX1 on the proliferation of hepatoma cells;Western blotting and ELISA were used to detect the expressions of NCX1-related proteins.Results:The expression of NCX1 in high metastatic potential HCC cell lines (MHCC97H,HCCLM3) was higher than that of low metastatic potential HCC cell lines (HepG2,Huh7,SMMC-7721),and the difference was statistically significant (P＜0.05).After transfection of NCX1,the invasion and proliferation ability of HCC cells increased significantly (P＜0.05);the secretion of cytokines (TGF-β1,IL-6 and TNF-α) increased significantly (P＜0.05);the expressions of epithelial-mesenchymal transition (EMT) related proteins in HCC cells were significantly increased (P＜0.05).Conclusions:NCX1 can promote the growth,invasion and metastasis of hepatocellular carcinoma by increasing the expressions of EMT-related proteins in HCC cells,and it is a potential target for the diagnosis and treatment of liver cancer.

Objective To study on the anti-fatigue and hypoxia tolerance function of Jasmine leaves' water extract in mice.Methods Forty-eight normal male mice were averagely selected and divided into four groups by weight:blank control group,low concentration experimental group,medium concentration experimental group and high concentration experimental group.Jasmine leaves' water extract of different concentrations (0,200,400,600 mg· mL-1 respectively for the four groups) was given into the mice's stomach for a continuous 16 days,each mice was given 10 mL · kg-1 a day.Burdened swimming test and hypoxia tolerance test were conducted in the mice to determine their swimming time and death time.The liver weight coefficient was calculated.Results The burdened swimming time:Compared with blank control group 9.27 min,that were 9.41,15.42,10.63 min in low,medium,high concentrations experimental groups respectively while medium experimental group had significantly (P ＜ 0.05).The hypoxia tolerance time:Compared with blank control group (47.56 ± 5.61)min,that were (56.24 ± 10.99),(47.20 ± 4.51),(53.44 ± 7.56) min in low,medium,high concentrations experimental groups respectively while low experimental group had significantly (P ＜ 0.01).The liver weight coefficient:Compared with blank control group (4.84 ± 0.29) × 10-2,that were (5.20 ± 0.72) × 10-2,(5.43 ±0.39) × 10-2,(5.42 ± 0.57) × 10-2 in low,medium,high concentrations experimental groups respectively while medium,high experimental groups had significantly(all P ＜ 0.01).Conclusion Jasmine leaves' water extract is proved to have anti-fatigue and hypoxia tolerance function in mice.