Scutellarin is the main effective constituent of breviscapine, a flavonoid mixture isolated from the dried whole plant of Erigeron breviscapus (Vant.) Hand-Mazz, and valsartan is used as an antihypertensive drug. These two drugs have already been clinically used together to treat diabetic nephropathy (DN) in China, and the combined medications showed some enhanced protection against DN. The aim of this study is to investigate the potential pharmacokinetic interaction between scutellarin and valsartan in rats. Breviscapine injection (20 mg x kg(-1), i.v.) and valsartan (15 mg x kg-, i.g.), either alone or together were given to 18 male Sprague-Dawley rats. Concentrations of scutellarin and valsartan were quantified by HPLC, and pharmacokinetic parameters were calculated by non-compartmental methods. We found that the pharmacokinetic parameters of scutellarin altered significantly after co-administration of oral valsartan. The plasma clearance (CL(p)) and the bile clearance (CL(b)) of scutellarin were reduced significantly in the presence of valsartan. After oral administration of valsartan with or without intravenous scutellarin, however, the pharmacokinetic parameters of valsartan were comparable. In conclusion, our data suggests that the concurrent use of valsartan reduces the biliary excretion of scutellarin, and this may be due to the inhibitory effect of valsartan on the biliary excretion of scutellarin mediated by Mrp2 (Multidrug resistance-associated protein 2).

OBJECTIVE: To compare randomized controlled trial (RCT) study and observational study systematically, and to provide reference for selecting suitable study design types for clinical researchers. METHODS: RCT study and observational study were compared in respects of study design and study report paradigm. Relevant literatures were retrieved from PubMed database and Chinese Journal Full-text Database. The differences of literature publication of RCT study and observational study were compared at home and abroad. RESULTS: There were differences in design principles, objectives, subjects, interventions and validity between RCT study and observational study. The requirements of CONSORT statemtnt and STROBE statement to the topics, abstracts, introduction, results and discussions of report paradigm of two studies were basically consistent, and main difference of them were in aspects of methods and other information. The number of literatures about RCT study and observational study had little gap at abroad, but had great gap at home, especially in cohort study with high-level evidence of evidence-based medicine. CONCLUSIONS: The observational study has developed rapidly in recent years, but RCT study is still a "gold standard" to evaluate the causal effect of clinical study. The researchers should choose the appropriate type of design according to the actual situation.

Objective:To investigate the value of serum soluble programmed cell death protein 1 (sPD-1), soluble B7 homolog 5 (sB7-H5) and trefoil factor 2 (TFF2) in evaluating the severity of disease and the risk of death in patients with acute pancreatitis (AP).Methods:A prospective research method was adopted. Three hundred and twenty-eight patients with AP (AP group) from February 2020 to February 2021 in Xiangyang Central Hospital were selected, including 124 patients with mild AP (MAP), 106 patients with moderately severe AP (MSAP) and 98 patients with severe AP (SAP). The serum levels of sPD-1, sB7-H5 and TFF2 were measured by enzyme-linked immunosorbent assay and compared with 60 healthy people (healthy control group). The patients with AP were followed up for 90 d, 284 patients survived and 44 died. The amylase, C-reactive protein (CRP), procalcitonin (PCT), acute physiology and chronic health evaluation Ⅱ (APACHE Ⅱ), sequential organ failure assessment (SOFA), modified CT severity index (MCTSI), sPD-1, sB7-H5 and TFF2 were compared between the two groups. Pearson method was used for correlation analysis. Multivariate Logistic regression was used to analyze the independent risk factors of death in patients with AP. The efficacy of sPD-1, sB7-H5 and TFF2 in predicting the death in patients with AP was evaluated using the receiver operating characteristics (ROC) curve.Results:The sPD-1, sB7-H5 and TFF2 in AP group were significantly higher than those in healthy control group: (177.99 ± 17.81) ng/L vs. (50.20 ± 10.81) ng/L, (2.69 ± 0.72) μg/L vs. (1.40 ± 0.35) μg/L and (569.97 ± 38.91) μg/L vs. (94.59 ± 11.98) μg/L, and there were statistical differences ( P<0.01). The amylase, sPD-1, sB7-H5 and TFF2 in patients with MSAP and SAP were significantly higher than those in patients with MAP: (639.36 ± 91.67) and (835.24 ± 109.30) U/L vs. (575.24 ± 89.78) U/L, (180.13 ± 20.61) and (221.17 ± 15.70) ng/L vs. (142.03 ± 16.76) ng/L, (2.85 ± 0.74) and (3.34 ± 0.82) μg/L vs. (2.05 ± 0.52) μg/L, (539.66 ± 36.58) and (763.55 ± 40.08) μg/L vs. (442.90 ± 35.79) μg/L, the indexes in patients with SAP were significantly higher than those in patients with MSAP, and there were statistical differences ( P<0.01). Pearson correlation analysis result showed that sPD-1 was positively correlated with sB7-H5 and TFF2 in patients with AP ( r = 0.552 and 0.641, P<0.01), and the sB7-H5 was positively correlated with TFF2 ( r = 0.610, P<0.01). The amylase, CRP, PCT, APACHE Ⅱ, SOFA, MCTSI, sPD-1, sB7-H5 and TFF2 in the dead patients were significantly higher than those in the living patients: (1 098 ± 105) U/L vs. (641 ± 93) U/L, (235.60 ± 40.17) mg/L vs. (118.04 ± 32.90) mg/L, (4.32 ± 0.52) μg/L vs. (3.14 ± 0.44) μg/L, (19.39 ± 3.14) scores vs. (11.18 ± 2.53) scores, (12.13 ± 2.78) scores vs. (7.40 ± 2.15) scores, (7.12 ± 1.73) scores vs. (4.31 ± 1.52) scores, (222.23 ± 22.30) ng/L vs. (171.14 ± 18.50) ng/L, (3.37 ± 0.89) μg/L vs. (2.59 ± 0.59) μg/L and (629.27 ± 39.63) μg/L vs. (560.78 ± 30.45) μg/L, and there were statistical differences ( P<0.01). Multivariate Logistic regression analysis result showed that CRP, PCT, APACHE Ⅱ, SOFA, sPD-1, sB7-H5 and TFF2 were independent risk factors death of in patients with AP ( OR = 1.339, 1.416, 1.285, 1.327, 1.092, 1.171 and 1.080; 95% CI 1.145 to 1.566, 1.146 to 1.751, 1.132 to 1.460, 1.150 to 1.531, 1.024 to 1.164, 1.072 to 1.280 and 1.031 to 1.131; P<0.01). The ROC curve analysis result showed that the area under the curve of sPD-1, sB7-H5 and TFF2 combined detection to predict the death in patients with AP was larger than that of sPD-1, sB7-H5, and TFF2 alone detection (0.870 vs. 0.771, 0.734 and 0.685). Conclusions:The increase of serum sPD-1, sB7-H5 and TFF2 levels in patients with AP is related to the severity of disease of patients with AP. The combined detection of the indexes can assist in evaluating the risk of death in patients with AP.

Chinese herbal piece is an important component of the traditional Chinese medicine （TCM） system， and identifying their quality and grading can promote the development and utilization of Chinese herbal pieces. Utilizing deep learning for intelligent identification of Chinese herbal pieces can save time， effort， and cost， while also reasonably avoiding the constraints of human subjectivity， providing a guarantee for efficient identification of Chinese herbal pieces. In this study， a dataset containing 108 kinds of Chinese herbal pieces （14 058 images） was constructed，the basic YOLOv4 algorithm was employed to identify the 108 kinds of Chinese herbal pieces of our database The mean average precision （mAP） of the developed basic YOLOv4 model reached 85.3%. In addition， the receptive field block was introduced into the neck network of YOLOv4 algorithm， and the improved YOLOv4 algorithm was used to identify Chinese herbal pieces. The mAPof the improved YOLOv4 model achieved 88.7%， the average precision of 80 kinds of decoction pieces exceeded 80%， the average precision of 48 kinds of decoction pieces exceeded 90%. These results indicate that adding the receptive field module can help to some extent in the identification of Chinese herbal medicine pieces with different sizes and small volumes. Finally， the average precision of each kind of Chinese herbal medicine piece by the improved YOLOv4 model was further analyzed. Through in-depth analysis of the original images of Chinese herbal medicine pieces with low prediction average precision， it was clarified that the quantity and quality of original images of Chinese herbal medicine pieces are key to performing intelligent object detection. The improved YOLOv4 model constructed in this study can be used for the rapid identification of Chinese herbal pieces， and also provide reference guidance for the manual authentication of Chinese herbal medicine decoction pieces.

BACKGROUNDInsulin resistance (IR) plays an important pathophysiological role in the development of diabetes, dyslipidemia, hypertension, and cardiovascular disease. Moreover, IR can occur even in non-obese people without diabetes. However, direct detection of IR is complicated. In order to find a simple surrogate marker of IR early in non-obese people, we investigate the association of commonly-used biochemical markers (liver enzymes and lipid profiles) with IR in urban middle-aged and older non-obese Chinese without diabetes.

METHODSThis cross-sectional study included 1 987 subjects (1 473 women). Fasting blood samples were collected for measurement of glucose, insulin, liver enzymes, lipid profiles and creatinine. Subjects whose homeostasis model of assessment-IR (HOMA-IR) index values exceeded the 75th percentile (2.67 for women and 2.48 for men) of the population were considered to have IR. The area under the receiver operating characteristic curve (ROC) was used to compare the power of potential markers in identifying IR.

RESULTSTriglycerides (TG) and ratio of TG to high-density lipoprotein cholesterol (TG/HDL-C) discriminated IR better than other indexes for both sexes; areas under the receiver operating characteristic (ROC) curves (AUC) values were 0.770 (95% confidence interval 0.733-0.807) and 0.772 (0.736-0.809), respectively, for women and 0.754 (0.664-0.844) and 0.756 (0.672-0.840), respectively, for men. To identify IR, the optimal cut-offs for TG and TG/HDL-C ratio were 1.315 mmol/L (sensitivity 74.3%, specificity 71.0%) and 0.873 (sensitivity 70.1%, specificity 73.4%), respectively, for women, and 1.275 mmol/L (sensitivity 66.7%, specificity 74.4%) and 0.812 (sensitivity 75.8%, specificity 69.2%), respectively, for men.

CONCLUSIONTG and TG/HDL-C ratio could be used to identify IR in urban middle-aged and older non-obese Chinese without diabetes.

Aged ; Alanine Transaminase ; blood ; Aspartate Aminotransferases ; blood ; Cholesterol, HDL ; blood ; Cross-Sectional Studies ; Diabetes Mellitus ; blood ; Female ; Humans ; Insulin Resistance ; physiology ; Liver ; enzymology ; Male ; Middle Aged ; Triglycerides ; blood