Post-marketing effectiveness evaluation of traditional Chinese medicine in paradigm based on "proving efficacy, conforming standard, and exploring mechanism":a case study of Danhong Injection / 中国中药杂志

At present, new concepts, new technologies, and new methods are emerging in the field of medical research, breaking through the inherent thinking patterns and research models, and promoting the transformation of the research paradigm of traditional Chinese medicine(TCM). This paper gave a case study of clinical research in Danhong Injection in the treatment of chronic stable angina, and based on the background of the study, index evaluation model, experimental design method, blind implementation of placebo, data management system, and exploration of clinical efficacy mechanism of traditional Chinese medicine compounds under the framework of modular pharmacology, the scientific idea of "proving efficacy, conforming standard, and exploring mechanism" was used as the guideline to discuss the research model of reevaluation of the effectiveness of post-marketing TCM varieties. This paper drew a target network map of Danhong Injection in the treatment of chronic stable angina for the first time, which was composed of targeted functional modules. By combining evidence-based clinical research with modular pharmacology framework, changes in the pharmacolo-gical mechanism were finally associated with changes in clinical efficacy, and the advantages of phenotypic correlation of efficacy were explored. This study is expected to provide references for the post-marketing effectiveness evaluation and new ideas for the phenotypic pharmacological mechanism study of multi-target TCM compounds and precise treatment, thereby promoting the innovative development of TCM.

Mechanism of Learning and Memory Impairment in Rats Exposed to Arsenic and/or Fluoride Based on Microbiome and Metabolome / 生物医学与环境科学（英文）

OBJECTIVE@#Arsenic (As) and fluoride (F) are two of the most common elements contaminating groundwater resources. A growing number of studies have found that As and F can cause neurotoxicity in infants and children, leading to cognitive, learning, and memory impairments. However, early biomarkers of learning and memory impairment induced by As and/or F remain unclear. In the present study, the mechanisms by which As and/or F cause learning memory impairment are explored at the multi-omics level (microbiome and metabolome).@*METHODS@#We stablished an SD rats model exposed to arsenic and/or fluoride from intrauterine to adult period.@*RESULTS@#Arsenic and/fluoride exposed groups showed reduced neurobehavioral performance and lesions in the hippocampal CA1 region. 16S rRNA gene sequencing revealed that As and/or F exposure significantly altered the composition and diversity of the gut microbiome，featuring the Lachnospiraceae_NK4A136_group, Ruminococcus_1, Prevotellaceae_NK3B31_group, [Eubacterium]_xylanophilum_group. Metabolome analysis showed that As and/or F-induced learning and memory impairment may be related to tryptophan, lipoic acid, glutamate, gamma-aminobutyric acidergic (GABAergic) synapse, and arachidonic acid (AA) metabolism. The gut microbiota, metabolites, and learning memory indicators were significantly correlated.@*CONCLUSION@#Learning memory impairment triggered by As and/or F exposure may be mediated by different gut microbes and their associated metabolites.

Dynamic Changes of ROS and Nrf2-Related Factors During Erythroid Development / 中国实验血液学杂志

OBJECTIVE@#To investigate the changes and roles of reactive oxygen species (ROS) and nuclear factor erythroid 2-related factor 2 (Nrf2) related antioxidases during erythroid development.@*METHODS@#Flow cytometry was used to detect the sensibility of peripheral red blood cells of wild-type mice to a strong oxidant hydrogen peroxide (H2O2). Erythroid cells from different developmental stages in bone marrow (BM) were obtained using fluorescence-activated cell sorter and the ROS levels were detected by flow cytometry. RT-qPCR was used to detect the changes of expression levels of Nrf2 and related antioxidases in erythroid cells from different developmental stages in BM. The ROS levels of the peripheral blood and BM nucleated erythrocytes in Nrf2 knockout mice were further examined. The expression level of Nrf2 in erythroid precursors isolated from 14.5 d embryonic liver of wild-type mice during differentiation and culture in vitro was detected.@*RESULTS@#In the peripheral blood of wild-type mice, the ROS level of reticulocytes and mature erythrocytes treated with H2O2 increased about 4 times and 7 times, respectively (P<0.01). In BM erythrocytes, the ROS level gradually decreased as the cells matured (r=0.85), while the expression level of Nrf2 and its related anti-oxidative genes increased (r=0.99). The ROS levels in peripheral blood erythrocytes and BM nucleated erythrocytes of Nrf2 knockout mice were significantly increased compared with wild-type mice (P<0.01). The expression of Nrf2 increased during the early erythroid development after embryonic liver cell sorting (P<0.01).@*CONCLUSION@#The expression levels of Nrf2 and its related factors vary during erythropoiesis. Nrf2 at physiological level plays an important antioxidant role during the erythroid development.

Expert consensus on core indicators for lifecycle value assessment of Chinese patent medicine / 中国中药杂志

The establishment of core indicators for assessment plays an important role in carrying out the lifecycle value assessment of Chinese patent medicine, which are developed based on the concepts such as clinical value oriented, paying attention to the human use experience, and whole process quality control. To this end, the Specialty Committee of Data Monitoring and Decision Making of the World Federation of Chinese Medicine Societies organized experts to draft the Expert Consensus on Core Indicators for Lifecycle Value Assessment of Chinese Patent Medicine based on the research including Chinese Medicine Registration Review Evidence System in Combination of Traditional Chinese Medicine Theory, Human Use Experience, and Clinical Trials(GZY-FJS-2022-206) by National Administration of Traditional Chinese Medicine. This consensus proposed 92 core indicators from four stages, including new drug R&D project approval, pre-clinical research, new drug marketing authorization, and post-marketing, combining the assessment purposes and needs of different stakeholders from different dimensions such as clinical needs, clinical positioning, human use experience, effectiveness, safety, quality control, innovation, accessibility, and suitability. This consensus also interpreted the indicators to clearly elucidate the core elements of the value assessment of Chinese patent medicine in different R&D stages and guided the stakeholders to identify, analyze, and assess the value of Chinese patent medicine in the R&D and use process based on the core indicators in a scientific, objective, and standardized approach. This consensus is expected to play an important role in the high-quality new drug development, drug pricing and compensation of Chinese patent medicine, the development of clinical pathways, and rational clinical application.

Review on platelet-rich plasma preparation and its quality evaluation / 中国输血杂志

Platelet-rich plasma (PRP) currently has been widely used in various medical fields, such as tissue regeneration, wound healing, scar repair, skin and hair regeneration etc..PRP is rich in platelets, growth factors and other blood components, which can effectively promote tissue repair and healing. However, there is no optimal preparation method and unified standard of composition ratio for PRP, so its clinical application value has not been satisfactorily interpreted yet. In this paper, the preparation and quality standard of PRP were reviewed to provide basis for standardization of RPP in clinical application.

Met-Controlled Allosteric Module of Neural Generation as A New Therapeutic Target in Rodent Brain Ischemia / 中国结合医学杂志

OBJECTIVE@#To investigate a Met-controlled allosteric module (AM) of neural generation as a potential therapeutic target for brain ischemia.@*METHODS@#We selected Markov clustering algorithm (MCL) to mine functional modules in the related target networks. According to the topological similarity, one functional module was predicted in the modules of baicalin (BA), jasminoidin (JA), cholic acid (CA), compared with I/R model modules. This functional module included three genes: Inppl1, Met and Dapk3 (IMD). By gene ontology enrichment analysis, biological process related to this functional module was obtained. This functional module participated in generation of neurons. Western blotting was applied to present the compound-dependent regulation of IMD. Co-immunoprecipitation was used to reveal the relationship among the three members. We used IF to determine the number of newborn neurons between compound treatment group and ischemia/reperfusion group. The expressions of vascular endothelial growth factor (VEGF) and matrix metalloproteinase 9 (MMP-9) were supposed to show the changing circumstances for neural generation under cerebral ischemia.@*RESULTS@#Significant reduction in infarction volume and pathological changes were shown in the compound treatment groups compared with the I/R model group (P<0.05). Three nodes in one novel module of IMD were found to exert diverse compound-dependent ischemic-specific excitatory regulatory activities. An anti-ischemic excitatory allosteric module (AM@*CONCLUSIONS@#AM

Standard Operating Procedures for Chinese Medicine Data Monitoring Committees of Clinical Studies / 中国结合医学杂志

Although there is guidance from different regulatory agencies, there are opportunities to bring greater consistency and stronger applicability to address the practical issues of establishing and operating a data monitoring committee (DMC) for clinical studies of Chinese medicine. We names it as a Chinese Medicine Data Monitoring Committee (CMDMC). A panel composed of clinical and statistical experts shared their experience and thoughts on the important aspects of CMDMCs. Subsequently, a community standard on CMDMCs (T/CACM 1323-2019) was issued by the China Association of Chinese Medicine on September 12, 2019. This paper summarizes the key content of this standard to help the sponsors of clinical studies establish and operate CMDMCs, which will further develop the scientific integrity and quality of clinical studies.

Wake-Promoting Effect of Bloodletting Puncture at Hand Twelve Jing-Well Points in Acute Stroke Patients: A Multi-center Randomized Controlled Trial / 中国结合医学杂志

OBJECTIVE@#To assess the effect and safety of bloodletting puncture at hand twelve Jing-Well points (HTWPs) in acute stroke patients with conscious disturbance.@*METHODS@#In this multi-center and randomized controlled trial, 360 patients suffered from ischemic or hemorrhagic stroke with conscious disturbance within 48 h from the onset of symptom were divided into bloodletting (180 cases) and control (180 cases) groups using a block randomization. Patients in both groups received routine Western medicine, and patients in the bloodletting group received additional bloodletting puncture at HTWPs on admission immediately before conventional treatment. The primary outcome measure was Glasgow Coma Scale (GCS) score and the secondary outcomes included blood pressure, respiratory rate and pulse rate. All variables were evaluated at baseline (before bloodletting), 0 (after bloodletting immediately), 15, 30, 50 and 80 min post bloodletting.@*RESULTS@#At 80 min post bloodletting, the proportion of patients with improved consciousness in the bloodletting group was greater than the control group (P0.05).@*CONCLUSION@#The bloodletting puncture at HTWPs was safe and could improve conscious levels of ischemic stroke patients, highlighting a first-aid intervention for acute stroke. (Registration No. ChiCTR-INR-16009530).

The role of microRNA in chronic myeloid leukemia / 医学研究生学报

Chronic myeloid leukemia（CML）is a common hematological malignancy. Although tyrosine kinase inhibitors（TKIs）have greatly improved the prognosis of CML patients，there are still several defects with TKI treatment including TKI resistance, toxic effects causing intolerance, etc. MicroRNA（miRNA） is a class of non-coding, single-stranded and small RNAs which encoded by endogenous genes and are about 19 to 24 nucleotides in length. miRNAs are closely related to the occurrence，development and prognosis of various tumors. In recent years，many studies have focused on the relationship betweenmiRNA and CML. In this paper，we review therelationship between miR-139-5p，miR-320a，miR-362-5p，miR-126， miR-199a/b-5p，miR-451 and CML .

Advances in Research of Cell Pyroptosis, Ulcerative Colitis and Regulation with Traditional Chinese Medicine / 中国实验方剂学杂志

Pyroptosis，which is different from cell necrosis， apoptosis and autophagy，is a new type of programmed cell death. It is characterized by the swelling of cells until the cell membrane rupture， resulting in the release of cell contents and the activation of a strong inflammatory response. Pyroptosis signaling pathway is divided into the classical pathway dependent on Caspase-1 and the non-classical pathway dependent on Caspase-4， 5 and 11. In classical pathway， activation Caspase-1 depends on inflammasome， whereas in non-classical pathway， Caspase-4， 5， and 11 are activated directly. All of these result in the cleavage of gasdermin D（GSDMD） protein， the formation of membrane pores， the maturation and release of interleukin-1β（IL-1β） and IL-18， and the rupture of the cell membrane， and then leads to pyroptosis. Ulcerative colitis （UC） is a common disease of the digestive system. The UC course is long， easy to relapse， and difficult to cure. The pathogenesis of UC is not completely clear. In recent years， it has been found that pyroptosis plays an important role in the development of UC. Traditional Chinese medicine（TCM） has a long history of preventing and treating UC， with significant clinical effects. It is found that the mechanism of TCM in the prevention and treatment of UC is closely correlated with inflammasome， IL-1β and IL-18. The mechanism of TCM in preventing and treating UC is correlated with cell pyroptosis. Therefore， this paper reviews the relationship between cell pyroptosis and UC and the regulatory effect of TCM.

Analysis of classical prescription Jinshui Liujun Jian based on ancient literature / 中国中药杂志

To provide the ancient literary evidence support for the clinical application and development of classical prescription based on systematical collection and analysis of the ancient Chinese medical literature containing Jinshui Liujun Jian, including its origin and development. Bibliometric analysis was used and information of Jinshui Liujun Jian in ancient Chinese medical literature was then collected for statistical analysis of formula compositions, main indications, dosage, preparation methods, etc. A total of 151 valid items of data were obtained from 48 ancient Chinese medicine books. Jinshui Liujun Jian was first recorded in Jingyue Quanshu written by ZHANG Jiebin. This prescription consisted of Rehmanniae Radix Praeparata, Angelicae Sinensis Radix, Pinelliae Rhizome, Citri Reticulatae Pericarpium, Poria and Glycyrrhizae Radix et Rhizome Praeparata cum Melle, and it was mainly used to treat the deficiency of lung and kidney, edema and excess production of phlegm, or Yin deficiency in the old, insufficient blood-qi, wind-cold evil, cough and disgusting, asthma and excessive phlegm. Doctors in later dynasties mostly followed the prescription compositions, dosages and indications in Jingyue Quanshu, and extended the clinical application of this prescription.

Early screening and prevention of cervical cancer under precise medical background / 中国医师杂志

Cervical cancer is the second most common female reproductive system tumor in developing countries and ranks second among female cancer deaths worldwide. In recent years, with the continuous optimization and popularization of cervical cancer screening and preventive measures, the overall incidence rate of cervical cancer has decreased. But the incidence rate of cervical cancer in China is younger and differentiated. It continues to threaten the fertility, reproduction, mental health and life safety of women in China. In view of the current difficulties, precision medicine initiative (PMI) has opened a new chapter in the individualized prevention and treatment of cancer. Chinese medical workers need to learn from the beneficial results of international research organizations on early screening and prevention of cervical cancer, and explore the appropriate early screening and prevention strategies for cervical cancer in China.

Bioinformatics analysis and systematic review of key genes and therapeutic traditional Chinese medicine of ulcerative colitis active stage / 中国中药杂志

Data GSE75214 and GSE48959 that contained ulcerative colitis(UC) in the active stage was download from GEO database. Differential genes of UC in the active phase were obtained by using adjusted P<0.05 and |log_2 FC|≥1.5, which was the screening criteria. PPI analysis was performed in the STRING database, and GO and KEGG pathway analysis was performed in DAVID database. Cytoscape was used to visualize differential genes, and calculate key genes in the active phase. Coremine Medical was used to analyze and systematically evaluate traditional Chinese medicines for treating key genes. Finally, 139 differentially expressed genes in the active phase were screened out, which included the 109 up-regulated genes and 30 down-regulated genes. DAVID analyzed that the biology and pathways of these differential genes were mainly concentrated in inflammatory response, immune response, chemokine activity, TNF pathway, NF-κB pathway, and Toll-like receptor pathway. Cytoscape software calculated that IL-6, CXCL8, IL-1β, MMP9, CXCL1, ICAM1, CXCL10, TIMP1, PTGS2 and CXCL9 were the key genes of UC in the active phase. According to Coremine Medical analysis, traditional Chinese medicines for UC in the active stage included Curcumae Longae Rhizoma, Scutellariae Radix, Curcumae Radix had clearing heat clearing damp, reducing fire and detoxifying effects, which was in line with the pathogenesis of UC active stage, and was often used in clinical treatment of dampness-heat diarrhea. Therefore, Huangqin Decoction, which Scutellariae Radix was the principal drug, was selected for systematic evaluation. The evaluation showed that Scutellariae Radix was superior to Western medicine in terms of improving clinical efficiency, reducing inflammatory factors and immunoglobulin levels, with statistically significant differences and fewer adverse reactions. This study provided a new idea for further research on the pathogenesis of UC in the active phase by analyzing the genes and their mechanism of action, and the systematic evaluation of Chinese medicine for the treatment of UC active stage provided a basis for the clinical prevention and treatment of UC by Chinese medicine.

New Advane of Reaserch on Relationship between Long Noncoding RNA and Acute Myeloid Leukemia--Review / 中国实验血液学杂志

Acute myeloid leukemia（AML）is a myelopoietic stem/progenitor malignant disease. The exact etiology of this leukemia remains unclear, thus it is important to explore the pathogenesis of AML and to discover the new diagnostic markers and therapeutic targets. The long non coding RNA (lnc RNA) is a class of RNA molecules with transcripts over 200 nucleotides in eukaryotic cells which almost don't possess the ability to code proteins, but can regulate the expression of other genes at transcriptional and post-transcriptional levels, thereby participate in occurrence and development of varied tumors. Of late years, along with the deepening of study, the lncRNA roles played in the AML have been reported and confirmed. In this review, the relationships between the IncRNA (UCA1, ANRIL, H19, HOTAIR, CCAT1, ZFAS1, LINC00152, HOXA-A52, NEAT1, TUG1, IRAIN1, PANDAR, LINC00899, SNHG5, and KCNQ1OT1) and AML is summarized briefly, so as to provide the potential basis for the clinical diagnosis and therapy of AML.

Quantitative computed tomography analysis for stratifying the severity of Coronavirus Disease 2019 / 药物分析学报

To examine the feasibility of using a computer tool for stratifying the severity of Coronavirus Disease 2019 (COVID-19) based on computed tomography (CT) images. We retrospectively examined 44 confirmed COVID-19 cases. All cases were evaluated separately by radiologists (visually) and through an in-house computer software. The degree of lesions was visually scored by the radiologist, as follows, for each of the 5 lung lobes:0, no lesion present;1,<1/3 involvement;2,>1/3 and<2/3 involvement;and 3,>2/3 involvement. Lesion density was assessed based on the proportion of ground-glass opacity (GGO), consolidation and fibrosis of the lesions. The parameters obtained using the computer tool included lung volume (mL), lesion volume (mL), lesion percentage (％), and mean lesion density (HU) of the whole lung, right lung, left lung, and each lobe. The scores obtained by the radiologists and quantitative results generated by the computer software were tested for correlation. A Chi-square test was used to test the consistency of radiologist- and computer-derived lesion percentage in the right/left lung, upper/lower lobe, and each of the 5 lobes. The results showed a strong to moderate correlation between lesion percentage scores obtained by radiologists and the computer software (r ranged from 0.7679 to 0.8373, P < 0.05), and a moderate correlation between the proportion of GGO and mean lesion density (r=-0.5894, P<0.05), and proportion of consolidation and mean lesion density (r=0.6282, P<0.05). Computer-aided quantification showed a statistical significant higher lesion percentage for lower lobes than that assessed by the radiologists (x2 = 8.160, P = 0.004). Our experiments demonstrated that the computer tool could reliably and accurately assess the severity and distribution of pneumonia on CT scans.

Recent advances on pancreatic lipase inhibitors from Chinese herbs / 药学学报

Obesity is an important cause of a panel of metabolic diseases, such as hypertension, hyperlipidemia, arteriosclerosis, type 2 diabetes and various cancers. Discovery of anti-obesity agents has always been a hot spot in the field of new drug research and development. Pancreatic lipase (PL, also named triacylglycerol acyl hydrolase), a key enzyme responsible for the hydrolysis of 50%-70% dietary fats in the gastrointestinal system, which has been recognized as a crucial target for the prevention and treatment of obesity. PL inhibitors can reduce the decomposition and absorption of dietary fat in the digestive organs by decreasing the hydrolytic activity of this key enzyme, which can alleviate the symptoms of metabolic diseases such as obesity and hyperlipidemia. Although a potent PL inhibitor (orlistat) has been marketed, it may trigger gastrointestinal side effects after long-term use. Therefore, it is necessary to develop more new PL inhibitors with strong inhibition potency and safety. In recent years, a large number of studies have found that some Chinese herbal extracts and their constituents can regulate lipid metabolism and treat obesity via inhibiting PL. In this paper, the research progress in the field pancreatic lipase inhibitors, as well as the extracts of Chinese herbs and their constituents with pancreatic lipase inhibitory effects were summarized. Meanwhile, the PL inhibition activities and inhibitory mechanisms of herbal constitutes were also summarized systematically. In addition, the authors also highlight the challenges in this field and the future research directions. All information and knowledge presented in this review will be very helpful for the medicinal chemists to find more potent PL inhibitors from herbs or to develop next generation anti-obesity drugs, as well as helpful for the prevention and treatment of obesity and other related metabolic diseases using herba medicines or related products.

A retrospective analysis of 12 cases of primary thyroid lymphoma / 北京大学学报(医学版)

OBJECTIVE@#To discuss the clinical characteristics and diagnostic and therapeutic considerations of primary thyroid lymphoma (PTL) by reviewing PTL cases.@*METHODS@#In the study, 12 cases of PTL diagnosed and treated in Peking University First Hospital between January 1995 and September 2015 were identified. The clinical characteristics, management experiences and prognosis of these cases were reviewed retrospectively.@*RESULTS@#A total of 12 PTL patients (four males and eight females) were collected, with an average age of 63 years (42 to 81 years) at the time of diagnosis. The average time to clarify diagnosis was 5 months (0.5 to 24 months). Eleven patients presented with a rapidly growing neck mass and visited surgical department, except one complained of coughing and suffocated. Seven patients were hypothyroid, and four were euthyroid at the time of diagnosis. In sonography of 11 cases, nine showed bilateral nodules, with an average diameter of 3.87 cm. Pathologic diagnosis of non-Hodgkin's lymphoma was confirmed in all the 12 cases by means of partial thyroidectomy (four) or core needle biopsy (eight). The pathological subtypes were diffuse large B cell lymphoma in nine patients, mucosa-associated lymphoid tissue lymphoma (MALToma) in two, and small B cell lymphoma in the other one patient. Five patients were concomitant with Hashimoto's thyroiditis. Eleven patients received chemotherapy. Only one patient did not have any further treatment after operation due to an inertia type of tumor. The median overall survival time was 24 months (1-117 months), three patients died. Among the patients who survived, seven completed chemotherapy without disease progression, one MALToma case did not receive chemotherapy after thyroidectomy but was still alive with PTL, and one patient just finished his second course of chemotherapy.@*CONCLUSION@#The diagnosis of PTL should be considered when dealing with rapidly growing goiters in elder female Hashimoto's thyroiditis patients whose B ultrasound indicates hypoechogenicity in thyroid nodules or parenchyma, especially with lymphadenopathy and tracheal compressions. Timely use of coreneedle biopsy on suspicious cases can avoid unnecessary surgical trauma, and chemotherapy is the main treatment.

Comparison study between neural network model and multiple linear regression in predicting pulmonary artery obstruction index in pulmonary embolism / 中华放射学杂志

Objective To compare the predictive capability of multiple linear regression (MLR)and neural network model (NNM) for pulmonary artery obstruction index (PAOI) in pulmonary embolism.Methods One hundred and forty-seven APE patients (79 male,68 female) were collected from March 2015 to July 2016 in our hospital and randomly divided into training group and testing group with the ratio of 3 ∶ 1.Four indexes,including total volume (V),total length (L),total degree of embolism (D) and total number of clots (N) were calculated by computer assisted detection.Qanadli index (Q) as CT PAOI was calculated manually.With SPSS 14.2 modeler,the predictive value of Qanadli index ((Q)) was calculated by MLR and NNM respectively,with Qanadli index as dependent variable and V,L,D,N as independent variables.SPSS 22.0 Spearman test was used to analyze the correlation between (Q) and Q.Mean absolute error (MAE),mean relative error (MRE),root mean square error (RMSE) were used to quantify the accuracies of two methods.Results MLR equation was (Q)=10.98+ 1.37×V+0.06×L,model fitting was 0.764.NNM included one hidden layer and two neurons with accuracy of 0.868.In training group,the correlation between (Q) and Q in NNM (r=0.932,P＜0.01) was higher than MLR (r=0.879,P＜0.01);in testing group,the correlation between (Q) and Q in NNM (r=0.875,P＜0.01) was higher than MLR (r=0.868,P＜0.01).In training group,MAE,MRE and RMSE of NNM (5.144,0.274,6.957) were significantly lower (t=3.402,P=0.002) than MLR (6.784,0.282,8.700);in testing group,MAE,MRE and RMSE of NNM (6.643,0.312,9.195) were significantly lower (t=3.383,P=0.002) than MLR (8.505,0.334,10.361).Conclusion NNM is a better model in predicting CT pulmonary artery obstruction index of APE patients.

Establishment of WHO/ISUP grading prediction model for renal clear cell carcinoma based on CT radiomics / 中华泌尿外科杂志

Objective@#A predictive model of WHO/ISUP grading of renal clear cell carcinoma was constructed based on CT radiomics.@*Methods@#The clinical data of 104 patients with ccRCC confirmed by operation or biopsy from March 2014 to December 2018 in the Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine were retrospectively analyzed. There were 70 males and 34 females, and the age was 61.2±11.7 years. The patients were randomly divided into development cohort (73 cases) and validation cohort (31 cases) by stratified sampling according to 7∶3 ratio. According to the WHO/ISUP pathological grading criteria of renal cancer in 2016, Ⅰ and Ⅱ were defined as low-grade group, Ⅲ and Ⅳ were defined as high-grade group. The radiomics features of ccRCC were calculated in cortical phase images of CT enhanced scanning. LASSO regression was used to reduce the radiomics feature dimensionality in the training group, and to establish radiomics risk scores. The binary logistic regression was used to build the prediction model, which was used in the validation group. Bootstrap method was used to validate the model of training and validation group. AUC, sensitivity and specificity were calculated respectively. Hosmer-Lemeshow goodness-of-fit test was used to evaluate model calibration degree.@*Results@#After dimensionality reduction, the radiomics risk score of ccRCC was established. The low and high-level risk scores of the training group were -2.49±1.73 and 1.23±2.17, with significant difference (t=-7.785, P < 0.01). The binary logistic regression multivariate analysis showed that the radiomics risk score was an independent risk factor in identifying low or high-grade ccRCC with odds ratio of (OR=3.576, 95%CI 1.964~6.513). The predictive model was Y=1/[1+ exp(-Z)], Z=1.274×radiomics risk score+ 0.072. The AUC of radiomics risk score in training group was 0.940 (95%CI 0.883-0.998) with 95.5% sensitivity and 88.2% specificity after internal verification by Bootstrap method, and good Hosmer-Lemeshow goodness-of-fit test (χ2=4.463, P>0.05). The low and high-level risk scores of the Validation group were -2.27±2.02 and 0.82±2.08, with significant difference (t=-3.832, P<0.01). The AUC in validation group was 0.859(95%CI 0.723-0.995) with 77.8% sensitivity and 81.8% specificity, and with good Hosmer-Lemeshow goodness-of-fit test (χ2=14.554, P=0.068) as well.@*Conclusions@#The prediction model based on CT radiomics has high accuracy in predicting high or low grade of ccRCC.

Clinical features of 406 cases of dengue fever in Guangzhou from 2015 to 2018 / 中华实验和临床病毒学杂志

Objective@#By analyzing the clinical features of patients with dengue fever in Guangzhou from 2015 to 2018 to furnish the reference evidences for the diagnoses and treatment of dengue fever.@*Methods@#A total of 406 dengue fever patients admitted to Zhujiang hospital during 2015 to 2018 were analyzed for the clinical manifestations and laboratory examination results, retrospectively. ZIKV, CHIKV and the serotypes of DENV were detected in some samples.@*Results@#DENV serotypes were tested in 96 dengue fever patients and 69 cases were positive. Among them, 58 cases (84.1%) were DENV-1, 10 cases (14.5%) were DENV-2, 1 case (1.5%) was DENV-3, DENV-4 was negative and no co-infection with different serotypes of dengue virus was found. Of all the 406 patients, 371 (91.4%) were diagnosed as dengue fever and 35 (8.6%) were severe cases. The most common manifestations included fever, weakness and rash. Significantly higher incidence (P<0.05) of bleeding, coughing, expectoration, vomiting and abdominal pain were found in severe dengue fever. The most common laboratory findings were leucopenia and thrombocytopenia. Significant increase(P<0.05) of total bilirubin, aspartate aminotransferase, serum creatinine, high-sensitivity C-reactive protein and procalcitonin were observed. ZIKV and CHIKV nucleic acids were tested in 380 dengue fever patients and the result were negative for both.@*Conclusions@#The incidence of dengue fever in Guangzhou increased in 2017 and 2018.Most cases of dengue fever were mild and DENV-1 was the dominant serotype.