0.05).The prevalence rates of ID in first trimester group and second trimester group were 14.29% and 33.81%,respectively,showing significantly higher rate in the latter group(?2=6.33,P

Objective:To better understand the karyotype distribution ofthe patients with Down's syndrome(DS)who have been finally diagnosed in our hospital.To compare the strengths of G-banding karyotype analysis and FISH(Fluorescence In Situ Hybridization, FISH)in diagnosing the DS patients with the Chromosome mosaicism and Calculating the percentage of abnormal karyotypes.Methods:Blood of the patients who were likely to suffer from DS was selected for G-banding karyotype analysis to describe the karyotype distribution.5 of the finally diagnosed patients with the chromosome mosaicism were randomly selected for FISH to compare the percentage of abnormal karyotypes of the two methods.Results:287 DS patients were diagnosed,91.29%of whom had the simple karyotype.Among the patients with the translocation karyotype, 11 D/G translocation karyotype were detected,accounting for 73.33%,while 4 G/G translocation karyotype were diagnosed, constituting 26.67%.One patient with both of the translocation karyotype and the mosaicism karyotype was detected in our research,which was uncommon in recent report.The results of FISH and G-banding karyotype analysis were consistent.There was no significant difference of the abnormal karyotype rates for DS patients with the chromosome mosaicism by G-banding karyotype analysis and FISH.Conclusion:The simple karyotype is the main karyotype of the DS patients in our research.Among the translocation karyotype,the D/G kind is common.DS patients can be diagnosed efficiently by G-banding karyotype analysis,but we still suggest to use FISH to get the proportion of the abnormal cell for the patients who have less triploid cell and slighter clinical manifestation.

With the development of antibody manufacturing technology and improvement of new drug research in domestic industry, more innovative monoclonal antibody products submitted investigational new drug (IND) application. At the same time, monoclonal antibody products from abroad which have been approved marketing authorization and/or conducted clinical trials submitted IND applications in China. The National Medical Products Administration (NMPA) issued the "Guideline of Investigational New Drug Application" (No. 16, 2018) which emphasized the chemical, manufacturing, and control (CMC) regulatory, and dossier requirements in IND application, greatly promoted the application quality of innovative biological products. However, compared to the Food and Drug Administration (FDA) and European Medicines Agency (EMA), our particular guidelines are insufficient, such as guideline on virus safety evaluation of biotechnological investigational medicinal products. This review investigated the questions raised by sponsors from 2018 to 2020, including the end of production cell (EOPC) and/or unprocessed bulk (UPB) testing and virus removal or inactivation validation. Meanwhile, sponsors submitted different dossiers due to differences in understanding of stage requirements of guidelines from domestic and abroad. Based on the guidelines of virus safety from NMPA, FDA, and EMA, and the technical considerations, this review puts forward personal suggestions on the adventitious agents testing and virus removal or inactivation validation in manufacturing process, aim to ensure virus safety of innovative monoclonal antibody products in clinical trials.

Objective To investigate the effect of target diameter and target-to-background ratio (TBR) on the measurement of SUVmax [| (true SUV-SUVmax)/true SUV | × 100％,△SUVmax) in PET.Methods Six cylinders with various diameters from 5 to 29 mm were inserted in National Electrical Manufacturers Association (NEMA) NU 2-1994 phantom.The six cylinders and background of phantom were filled with18F-FDG solution.Six different TBRs (1.79,3.70,6.25,10.59,14.87 and 17.88) were obtained by changing the 18F-FDG concentration in the six cylinders.The PET data were acquired in the 2D mode,and the target's inner diameter and SUVmax were measured.The logarithmic fitting curves of △SUVmax with diameter in different TBRs using equations (y=aln(x)+b) were acquired by Microsoft excel,| a| as the influence power of diameter on △SUVmax.Statistical analysis was performed with Pearson correlation test and curve estimation utilizing SPSS 17.0.Results The Pearson correlation coefficient between △SUVmax and diameter was-0.806 (P＜0.01).△SUVmax was inversely correlated with the diameter.When the diameter (the inner diameter measured on PET images) was 4.0 mm,△SUVmax could be as high as 79.73％ with different TBRs.The Pearson correlation coefficient between the influence power of diameter on △SUVmax (| a |) and TBRs was 0.848 (P＜0.05).When TBR was 6.25,10.59 and 14.87,the corresponding |a| was similar:38.019,39.998 and 39.362,respectively.When TBR was 17.88,| a| was the highest as 43.234.When TBR was 1.79 and 3.70,|a| was much smaller:14.141 and 23.411 respectively.Conclusions The lesion diameter is inversely correlated with △SUVmax.The influence power of diameter on △SUVmax is strongly correlated with TBR.Therefore,the effect of target diameter and TBR on the measurement of SUVmax should be taken into consideration for follow-up studies.

Objective To investigate the serum level of vascular endothelial growth factor (VEGF) in patients with coronary artery disease (CAD) and its clinical significance. Methods The study included 36 patients with CAD and 10 non-coronary heart disease patients as the control. The concentrations of serum VEGF in the coronary veins and the aorta were measured by an enzyme-linked immunsorbent assay (ELISA). Total mononuclear cells were isolated from peripheral blood by Ficoll density gradient centrifugation, and were cultured in M199 medium supplemented with 20% fetal bovine serum. After 7 days culture, attached cells were collected. The effect of VEGF on the migration of endothelial progenitor cells (EPCs) were assayed with modified Boyden chamber assay. Results The serum VEGF levels of stable angina pectoris (SAP) patients (208.46?44.74 ?g/L) and acute coronary syndrome (ACS) patients (267.29?93.99 ?g/L) were much higher than that of the controls group (120.77?26.25 ?g/L,P

Hepatocellular carcinoma(HCC) is one of the most common malignant tumors with the highest cause of death and increasing incidence worldwide, and the annual incidence rate is rising. The early diagnosis of HCC is very essential to its prognosis. At present, AFP has been widely used in the survey of HCC diagnosis, therapeutic effect and predict recurrence. However, the sensitivity and specificity of AFP is not satisfactory. In recent years a variety of new serum tumor markers have emerged one after another. A new serum marker-Golgi glycoprotein-73(GP-73) in early diagnosis of HCC is expected to become the new target maker,its sensitivity and specificity are better than AFP.

Objecfive To study T cell subsets distribution in peripheral blood from patients with ankylosing spondylitis(AS)and the role of cell immunity in AS.Methods 30 patients with untreated active phase AS and 30 healthy volunteers were enrolled.The expression of CD4+ and CD8+ T cell subsets were evaluated by flow eytome try.The correlation among T cell subsets and Bath AS function index(BASFI).Bath AS measurement index(BASMI),course of disease,age,ESR,hyper-sensitive C-reactive protein (hs-CRP) were analyzed.Results The level of CD4+ T cell and CD4/CD8+ratio were significantly lower than that of healthy volunteers[(29.24±9.22)% vs.(40.09±6.86) %,(0.96±0.49 ) vs.(1.70±0.67 ),P ＜ 0.01 ],and CD8+ T cell were significantly higher than that of healthy volunteers [(32.91±6.86) % vs.(25.60± 5.97 ) %,P ＜ 0.01 ].The level of CD4+ T cell subsets in peripheral blood of AS patients was negatively correlated with BASMI (r =-0.479,P ＜ 0.01 ),and CD8+ T cell subsets were positively correlated with ESR,hs-CRP,BASFI and BASMI ( r = 0.373,0.430,0.462,0.530,P ＜0.05 ).The ratio of CD4+/CD8+ was negatively correlated with hs-CRP,BASFI and BASMI (r = -0.465,- 0.473,- 0.426,P ＜ 0.05 ).CD4+,CD8+,ratio of CD4/CD8 were not significantly correlated with age and course of disease in patients with AS.Conclusion T cell subsets are significantly abnormal in peripheral blood of patients with AS,and the imbalance degree of T cell is correlated with severity and activity of AS,suggesting that T cell subsets imbalance plays an important role in the pathologensis of AS.

Objective To study the protective effect and mechanism of Lycopus lucidus Turcz ethanol extract on STZ induced diabetic mice kidney.Methods The diabetic mice model were induced by single intraperitoneal injection of 0.12 mg/g STZ.After 60h, the mice successful modeling were divided into model control group,Lycopus lucidus Turcz ethanol extract high-dose group [5.0g/(kg? d)]and low-dose group [1.25/(kg? d)], 10 mice in each group.Another 10 normal mice were used as normal control group.The high-and low-dose group were intragastric administrated corresponding dose Lycopus lucidus Turcz ethanol extract, normal control group and model control group were given the same volume of sterile distilled water.After 5 weeks, the mice kidney structure was observed by periodic acid-Schiff ( PAS ) , advanced glycosylation end products ( AGEs ) and transforming growth factorβ1 (TGF-β1) in kidney tissue were detected by ELISA.The monocyte chemotactic protein-1 (MCP-1) mRNA expression were detected by RT-PCR and MCP-1 protein expression by Western blot in mice kidney.Results PAS staining results showed, compared with model control group,renal structural changes in high-dose group was significantly increased.ELISA results showed AGEs and TGF-β1 content in kidney tissue of model control group were higher than normal control group (P<0.01), the above indexes of high-dose group were lower than model control group (P<0.05) .RT-PCR results showed MCP-1 mRNA expression of model control group was higher than normal control group (P<0.01), MCP-1 mRNA expression of low-and high-dose group model group were lower than model control group (P<0.01), and MCP-1 mRNA expression of high-dose group was lower than low-dose group (P<0.05).Western blot results showed MCP-1 protein expression of model group was higher than normal control group (P<0.01), but there were no significant differences of MCP-1 protein expression between low-or high-dose group model group and model control group. Conclusion Lycopus lucidus Turcz ethanol extract can protect the STZ-induced diabetic mice kidney, and it might be the reason of inhibiting the expression of AGEs-MCP-1-TGF-β1.

OBJECTIVE: To explore the circadian distribution of premature ventricular contractions (PVCs) in patients with viral myocarditis (VM) according to the theory of chronomedicine in traditional Chinese medicine (TCM) in order to find out the scientific evidence for a reasonable administration time. METHODS: Two hundred and forty patients with VM were enrolled and electrocardiograms were examined for all by Holter monitor. The circadian distribution of PVCs was evaluated according to the theory of chronomedicine of TCM about time periods corresponding to five zang viscera. RESULTS: PVCs mostly happened in periods of 3:00-5:00, 5:00-7:00, 7:00-9:00 and 9:00-11:00, in which 5:00-7:00 was the most serious time. Less PVCs happened in periods of 17:00-19:00, 19:00-21:00 and 21:00-23:00. The frequency of PVCs in midnight also increased with aging. The time periods of the frequency peak of PVCs in patients with different syndromes were also different. In patients with syndrome of pathogenic heat invading heart (PHIH), the PVCs mostly appeared in midday. In patients with syndrome of flaring of fire due to yin-deficiency (FFYD), the PVCs were most serious in daytime and aggravated at noon. And in patients with syndrome of insufficiency of heart-qi and yang (IHQY), the PVCs mostly happened in early morning or midnight. CONCLUSION: There was a manifest regulation of the pathological circadian rhythm of PVCs in patients with VM. The circadian distributions of PVCs were variable in patients with different syndromes. Therefore the theory of chronomedicine of TCM may be used to guide the treatment based on syndrome differentiation.

Cystatin Cystatin(CST)is a class of proteins that inhibit cysteine proteases and are widely distributed in human body fluid and secretion.The present study shows that the CST superfamily is closely related to the tumor,in which the cysteine protease inhibitor SN is the product expressed by the CST1 gene and is abnormal expression in various tumors.However,its occurrence and development of tumor as well as effects of invasion and metastasis on the specific mechanism is not yet clear.In this paper,we retrospectively analyze the related studies in recent years and review the progress of CST1 gene in tumor.