Objective: To establish the quality standards for Zhichuang capsules. Methods: Rhubarb, Mahonia, Angelica and Borneol in the formula were identified by TLC, the content of emodin and chrysophanol from Rhubarb in Zhichuang capsules were deter-mined by HPLC. Results: The qualitative identification was easy to operate with good specificity. The linearity was good ( r =0. 999 9) within the range of 25.8-516.0ng and the average recovery was 97.31%(RSD=0.69%,n=6)for emodin, the linearity was good (r=1.000 0) within the range of 51.1-1 022.0ng and the average recovery was 97.63%(RSD=0.72%,n=6)for Chry-sophanol. Conclusion:The method is reliable and accurate, which can be applied as a quality control method of Zhichuang capsules.

Objective:To explore the clinical application values of contrast-enhanced ultrasound in the diagnosis and classification of portal vein tumor thrombosis (PVTT)by comparing with enhanced CT.Methods:43 patients with PVTT confirmed by clinic and pathology were selected, and the accuracy rates of the diagnosis and clinic classification of contrast-enhanced ultrasound and enhanced CT were compared. Results:The characteristic of PVTT in contrast-enhanced ultrasound was“quick in fast out”;88.4% (38/43)of PVTT were hyper-enhancement in the arterial phase, 81.4% (35/43 ) of PVTT were hypo-enhancement in the vein phase, and all tumor thrombosis showed hypo-enhancement in the delay phase. The diagnostic accuracy rate of contrast-enhanced ultrasound in PVTT was 100%,and the accuracy rate of enhanced CT was 97.7% (42/43).The classification accuracy rate of contrast-enhanced ultrasonic was 95.3% (41/43),and the accuracy rate of enhanced CT was 93.0% (40/43 );there was no statistically significant difference between two methods (P > 0.05 ). Conclusion:Dynamiccontrast-enhanced ultrasonography can display the blood perfusion characteristics of PVTT, and displays the actual infiltrating tumor thrombosis. Ultrasonic imaging and enhanced CT in the qualitative diagnosis of PVTT and clinical classification have a good consistency.Contrast-enhanced ultrasound can be used as an important imaging method to evaluate the PVTT before treatment.

Objective To evaluate the effect of PTH gene polymorphisms on bone mineral density (BMD) at multiple skeletal sites in normal females.Methods PTH gene phenotype was determined by PCR-RFLP of restriction enzyme Bst BⅠin 596 females aged (46.3?13.7) years (20-80 years),and PCR products with or without enzymolytic site were considered as genotype B or genotype b respectively.BMDs of the anteropesterior spine (AP) and supine lateral spine (Lat) of lumbar vertebrae (L_1-L_4),femoral neck (FN),total hip (T-hip), Ward's triangle (Ward),Trochanter (Troch),forearm [radius+ulna ultradistal (RUUD) and total area of radius + ulna (RUT) ] were measured by DEXA (QDR4500A).Results (1) Hardy-Weinberg equilibrium was evident for PTH polymorphisms.The frequencies of genotype were BB 0.784,Bb 0.208,bb 0.008 and frequencies of alleles B,b were 0.888 and 0.112 respectively in 596 normal females.Frequencies of BB,Bb,bb genotypes were 0.781,0.210,and 0.009 respectively in 347 postmenopausal women and their frequencies of alleles B,b were 0.886,0.114.No significant difference was found between post- and premenopausal women in genotype frequen- cy.(2) Comparing their BMDs of AP,Lat,FN,T-hip,Ward,Troch,RUUD and RUT,there was no significant difference between BB and Bb genotypes of pre- and postmenopansal women groups.(3) Logistic regression analysis failed to show any statistical difference between normal and osteoporosis women with regard to PTH phenotype.Conclusion PTH gene polymorphism has little effect on BMD in normal females.

OBJECTIVETo study the relationship between the serum levels of adipocyte fatty acid-binding protein (A-FABP) level and type 2 diabetes mellitus in a community population.

METHODSA total of 255 residents (aged 45-85 years) were randomly selected from 4 communities in Guangzhou to examine the fasting plasma glucose (FPG), 2-hour postprandial blood glucose (2hPG), glycosylated hemoglobin (HbA1c), body mass index (BMI), waist circumference (WC), hip circumference (HC), waist-to-hip ratio (WHR), blood pressure (BP), triglyceride (TG), cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C). The insulin resistance index (HOMA-IR) was calculated and enzyme-linked immunosorbent assay (ELISA) was used to determine serum A-FABP and fasting insulin (FINs) levels. The cases were divided into 3 groups according to blood glucose level, namely the normal group (group A, n=90), impaired glucose tolerance group (group B, n=85), and diabetic group (group C, n=80), and the A-FABP levels were compared between them.

RESULTSCompared with group A, the subjects in groups B and C showed significantly increased FPG, 2hPGh, HbA1C, HOMA-IR, systolic blood pressure (SBP), and waist circumference (P=0.000) as well as FINs, WHR, diastolic blood pressure (DBP) , TG, and HDL-C (P=0.038, 0.047, 0.01, and 0.046, respectively). Compared with group B, group C showed significantly higher FPG, 2hPG, HbA1c, TG, and SBP (P=0.00), with also higher levels of FINs, BMI, WC, DBP, and HDL-C (P=0.012, 0.006, 0.03, 0.019, and 0.029, respectively). A-FABP increased significantly in the order of group A, B, and C (P=0.00), and this result was not affected by the differences in age between the 3 groups (P>0.05). A-FABP level was positively correlated to FPB, 2hPG, FINS, WHR, BMI, WC, SBP, and HOMA-IR, but inversely to TG and HDL-C (P=0.00).

CONCLUSIONElevated serum A-FABP is closely related to glucose metabolism disorder, and A-FABP may serve as a useful marker for the occurrence and development of type 2 diabetes in the community population.

Adipocytes ; chemistry ; Aged ; Aged, 80 and over ; Diabetes Mellitus, Type 2 ; blood ; etiology ; Fatty Acid-Binding Proteins ; blood ; Female ; Humans ; Male ; Middle Aged ; Serum ; metabolism

OBJECTIVEThis research aimed to explore the application of ARIMA model of time series analysis in predicting influenza incidence and early warning in Jiangsu province and to provide scientific evidence for the prevention and control of influenza epidemic.

METHODSThe database was created based on the data collected from monitoring sites in Jiangsu province from October 2005 to February 2010. The ARIMA model was constructed based on the number of weekly influenza-like illness (ILI) cases. Then the achieved ARIMA model was used to predict the number of influenza-like illness cases of March and April in 2010.

RESULTSThe ARIMA model of the influenza-like illness cases was (1 + 0.785B(2))(1-B) ln X(t) = (1 + 0.622B(2))ε(t). Here B stands for back shift operator, t stands for time, X(t) stands for the number of weekly ILI cases and ε(t) stands for random error. The residual error with 16 lags was white noise and the Ljung-Box test statistic for the model was 5.087, giving a P-value of 0.995. The model fitted the data well. True values of influenza-like illness cases from March 2010 to April 2010 were within 95%CI of predicted values obtained from present model.

CONCLUSIONThe ARIMA model fits the trend of influenza-like illness in Jiangsu province.

Humans ; Influenza, Human ; prevention & control ; Models, Statistical ; Time Factors

Purpose To investigate the expression of lipocalin-2 (LCN2) and plateled derived growth factor-BB (PDGF-BB) in serum,carcinoma and bone metastases of lung cancer patients. Methods Protein chip were used to screen the differential expression of cytokines in serum of 19 lung cancer patients (9 patients with bone metastasis and 10 patients freedistant metastasis) . Immunohistochemistry was performed to assess the differential expression of LCN2 and PDGF-BB cytokines in 12 cases of primary lung cancer without distant metastasis and 12 cases of primary lung cancer with only bone metastasis. Results Serum level of lipid transport factor (LCN2) and PDGFBB in non-small cell lung cancer patients with bone metastasis were significantly higher than that without distant metastasis(P< 0. 05) . There was no difference cytokines between small cell lung cancer patients with bone metastasis and without metastasis group (P > 0. 05) . The results of immunohistochemistry showed that high expression of LCN2 and PDGF-BB in bone metastasis tissues was significantly higher than that in primary lung cancer tissues. Conclusions High expression of LCN2 and PDGF-BB in serum and bone metastasis tissue of patients with non-small cell lung cancer might be involved in the occurrence,development of bone metastasis of lung cancer in the bone marrow,may be an important biomarker and potential therapeutic target for bone metastasis of lung cancer.

Chemical investigation on the rice culture of an endophytic fungus Colletotrichum fioriniae F18, inhabiting in the stems of the medicinal plant Mahonia fortunei, led to the isolation of nine compounds. They included a new indole alkaloid, makomotindoline B (1), and two known indole derivatives, 3-indoleacetic acid methyl ester (2) and N-acetyltryptamine (3), together with six known aromatic compounds, 2-(4-hydroxyphenyl) acetic acid (4), 4-(2-hydroxyethyl)phenol (5), 2-(4-methoxyphenyl)acetic acid (6), 4-hydroxyphenethyl 2-(4-hydroxyphenyl)acetate (7), regiolone (8) and N-phenethylacetamide (9). The structures of these compounds were elucidated based on the analysis of spectroscopic data including MS and NMR. The absolute configuretion of compound 1 was determined by electronic circular dichroism (ECD) calculation. Antibacterial activity assay indicated that compounds 1-9 had no antibacterial activities against Bacillus subtilis, Staphylococcus aureus, Escherichia coli, and Pseudomonas aeruginosa, as well as no quorum sensing inhibitory (QSI) activity for Chromobacterium violaceum.

OBJECTIVE: To select and define the clinical questions and outcomes of Guideline for the Emergency Treatment of Anaphylaxis. METHODS: A draft including clinical questions, which could be divided into foreground questions and background questions, and outcomes was drawn and revised by the secretary group for the guideline referring to the present guidelines with the guidance of a panel consisting of 7 experienced clinical medicine, pharmacy and nursing experts. Foreground questions and outcomes of the draft were voted into a final version after three rounds of counsels of 22 experienced medicine, pharmacy and nursing clinical experts using Delphi method including 3 rounds of inquiry. And the background questions were directly included in the guideline after the 22 experts' thorough revising. The research was carried out under the supervision of method ologists. Active coefficient, coefficient of variation and the frequencies of each score were calculated for quality control. RESULTS: The draft of 34 foreground questions, 6 background questions and 6 outcomes was finally drawn up after thorough selecting and consulting. The 6 background questions revised by the clinical experts were all included. After three rounds of Delphi method, 28 pivotal clinical questions covering the diagnosis, preparation for the treatment, treatment and administration after the treatment, and 6 outcomes were defined and included for the guideline. The rest of the foreground questions, 4 of which were recognized as essential and 2 as important, were excluded from the guideline and left for further revising or updating. As for the outcomes, 4 of them were recognized as critical and the rest as important. The experts contributing to the research were active as the active coefficient reached 100%, and the degree of consensus was fine as the frequencies of the feedback scoring equal to or greater than 4 for all the 28 foreground questions included were greater than 75% and the result was settled in the first round. And 2 outcomes, fatality rate and severity, reached a higher degree of consensus with coefficient of variation less than 15%. CONCLUSION After thorough and rigorous selecting, the clinical questions and outcomes to be included in the Guideline for the Emergency Treatment of Anaphylaxis were finally selected and defined via Delphi method, guiding the future development of the guidelines.
Anaphylaxis/therapy* ; Consensus ; Delphi Technique ; Emergency Treatment ; Humans ; Research Design

This study was designed to investigate the effect of Huangqin Tang (HQT) on gut microbiota of ulcerative colitis (UC) rats, and to explore the relationship between Huangqin Tang and ulcerative colitis and gut microbiota. Fifteen male Wistar rats were randomly divided into control group, trinitrobenzene sulfonic acid (TNBS) group and TNBS + HQT group. The model of UC rats with cell immunoreactivity was made established using the compound method (TNBS and ethanol). After 10 days of administration, 15 fecal samples were collected and total DNA was extracted from the samples to get total DNA. The primers were designed on bacterial 16S rRNA V3-V4 region sequences and Illumina Miseq platform was used for high-throughput sequencing. It was found that the principal component analysis (PCA), the principal co-ordinates analysis (PCoA) and the non-metric multidimensional scale analysis (NMDS) based on the Beta diversity distance showed that there were significant differences in the composition of the gut microbiota among the three groups (P < 0.05). Compared with the control group, the Lactobacillus of the TNBS group was significantly decreased (P < 0.05), and the Lachnospiraceae, Desulfovibrio, Roseburia, Ruminococcaceae were significantly increased (P < 0.05). Compared with the TNBS group, the Lactobacillus in the TNBS + HQT group was significantly increased (P < 0.01), and the Alistipes was significantly decreased (P < 0.05). The study suggests that the Huangqin Tang plays a role in the treatment of ulcerative colitis partially through regulating the structure of the gut microbiota.

BACKGROUND: Innovative coronavirus disease 2019 (COVID-19) vaccines, with elevated global manufacturing capacity, enhanced safety and efficacy, simplified dosing regimens, and distribution that is less cold chain-dependent, are still global imperatives for tackling the ongoing pandemic. A previous phase I trial indicated that the recombinant COVID-19 vaccine (V-01), which contains a fusion protein (IFN-PADRE-RBD-Fc dimer) as its antigen, is safe and well tolerated, capable of inducing rapid and robust immune responses, and warranted further testing in additional clinical trials. Herein, we aimed to assess the immunogenicity and safety of V-01, providing rationales of appropriate dose regimen for further efficacy study. METHODS: A randomized, double-blind, placebo-controlled phase II clinical trial was initiated at the Gaozhou Municipal Centre for Disease Control and Prevention (Guangdong, China) in March 2021. Both younger (n = 440; 18-59 years of age) and older (n = 440; ≥60 years of age) adult participants in this trial were sequentially recruited into two distinct groups: two-dose regimen group in which participants were randomized either to follow a 10 or 25 μg of V-01 or placebo given intramuscularly 21 days apart (allocation ratio, 3:3:1, n = 120, 120, 40 for each regimen, respectively), or one-dose regimen groups in which participants were randomized either to receive a single injection of 50 μg of V-01 or placebo (allocation ratio, 3:1, n = 120, 40, respectively). The primary immunogenicity endpoints were the geometric mean titers of neutralizing antibodies against live severe acute respiratory syndrome coronavirus 2, and specific binding antibodies to the receptor binding domain (RBD). The primary safety endpoint evaluation was the frequencies and percentages of overall adverse events (AEs) within 30 days after full immunization. RESULTS: V-01 provoked substantial immune responses in the two-dose group, achieving encouragingly high titers of neutralizing antibody and anti-RBD immunoglobulin, which peaked at day 35 (161.9 [95% confidence interval [CI]: 133.3-196.7] and 149.3 [95%CI: 123.9-179.9] in 10 and 25 μg V-01 group of younger adults, respectively; 111.6 [95%CI: 89.6-139.1] and 111.1 [95%CI: 89.2-138.4] in 10 and 25 μg V-01 group of older adults, respectively), and remained high at day 49 after a day-21 second dose; these levels significantly exceed those in convalescent serum from symptomatic COVID-19 patients (53.6, 95%CI: 31.3-91.7). Our preliminary data show that V-01 is safe and well tolerated, with reactogenicity predominantly being absent or mild in severity and only one vaccine-related grade 3 or worse AE being observed within 30 days. The older adult participants demonstrated a more favorable safety profile compared with those in the younger adult group: with AEs percentages of 19.2%, 25.8%, 17.5% in older adults vs. 34.2%, 23.3%, 26.7% in younger adults at the 10, 25 μg V-01 two-dose group, and 50 μg V-01 one-dose group, respectively. CONCLUSIONS: The vaccine candidate V-01 appears to be safe and immunogenic. The preliminary findings support the advancement of the two-dose, 10 μg V-01 regimen to a phase III trial for a large-scale population-based evaluation of safety and efficacy. TRIAL REGISTRATION http://www.chictr.org.cn/index.aspx (No. ChiCTR2100045107, http://www.chictr.org.cn/showproj.aspx?proj=124702).
Aged ; Antibodies, Viral ; COVID-19/therapy* ; COVID-19 Vaccines ; Double-Blind Method ; Humans ; Immunization, Passive ; Recombinant Fusion Proteins ; SARS-CoV-2