Abstract: Objective　To investigate the impacts of vaccination with inactivated SARS-COV-2 vaccine on the clinical manifestations and serological responses of COVID-19 patients infected by Delta and Alpha variants. Methods　Clinical and experimental data of 341 confirmed SARS-COV-2 patients were collected from The Eighth Affiliated Hospital of Guangzhou Medical University May 1- September 30, 2021. The subjects were divided into Delta and Alpha variant group according to virus variants, and were divided into vaccinated group and unvaccinated group according to whether they had received inactivated COVID-19 vaccine or not. The clinical manifestations and serological responses of patients with Delta and Alpha variant, and vaccinated and unvaccinated patients with Delta and Alpha variants were compared. Results　Totally 253 patients were infected with Delta variant (103 vaccinated and 150 unvaccinated patients), and 88 patients were infected with Alpha variant (21 vaccinated and 67 unvaccinated patients). The proportion of asymptomatic infection in Delta variants group was significantly lower than that in Alpha variants group (P<0.01). Delta variant group of vaccination rates and vaccine breakthrough infection rate was 40.7% (103/253) and 22.9% (58/253), were higher than Alpha variant group was 23.9% (21/88) and 8.0% (7/88), difference was statistically significant (χ2= 8.009, 9.484, P<0.01). The proportion of cough and fever in Delta variant group was higher than that in Alpha variant group (both P<0.01), the peak viral load was higher than that of Alpha variant group (P<0.01), the virus duration was longer than that of Alpha variant group (P<0.01), the levels of SAA, CRP and IFN were higher than those of Alpha variant group (all P<0.05), CD4+T cell count was lower than that of Alpha variant group (P<0.05), IgG and IgM levels were lower than those of Alpha variant group (both P<0.01). The proportion of moderate COVID-19 in the vaccinated group was lower than that in the unvaccinated group (P<0.01). In these two variants, the peak viral load of vaccinated group was lower than that of the unvaccinated group (both P<0.01), the duration of virus was shorter than that of unvaccinated group (both P<0.01). The levels of SAA, CRP and IL-6 in the vaccinated group were lower than those in the unvaccinated group (all P<0.05), CD4+T cell level was higher than that of unvaccinated group (both P<0.05), IgG and IgM level were higher than those in unvaccinated group (both P<0.05). Conclusions　Delta variant can lead to higher viral load and more severe disease course, which is associated with vaccine breakthrough infection. Inactivated vaccines for COVID-19 can reduce severe illness and death by reducing viral load, disease duration and inflammatory response through humoral and cellular immune mechanisms.

BACKGROUND: Recent studies have reported that more and more methods were used to prevent and cure tendon adhesion following tendon rupture by repairing tendinous sheath. Especially, amnion membrane is commonly used to effective prevent and cure adhesion and promote healing of biomembrane; however, the effect on tendon adhesion needs to be further studied. OBJECTIVE: To verify the efficacy of amnion membrane preserved in Honghua injection on preventing and curing tendon adhesion following transplanting into foot flexor tendon. METHODS: Bilateral foot flexor tendons of 32 healthy mature chickens were cut off. By anastomosis, amnion membrane preserved in Honghua injection was transplanted into left foot flexor tendon, considering as experimental group. Right foot flexor tendons were randomly divided into two groups: blank control group, anastomosis was performed alone; positive control group, amnion membrane not preserved in any injections was transplanted. At 4 weeks after fixation by plaster cast, sliding function of tendon was detected using biomechanics, and local samples were obtained for histopathological observation. RESULTS AND CONCLUSION: In the experimental group, broken end of left tendon was well healed; fiber tissues were formed surrounding tendon; tissue adhesion was not observed surrounding tendon. Proliferative quantity and adhesion of fiber tissues, as well as content of hydroxyproline in the experimental group were significantly less than in the blank control and positive control groups (P < 0.05, P < 0.01); total inflexion angle of articulationes digitorum pedis and slipping distance of flexor digitorum profundus tendon in the experimental group were significantly greater than in the blank control and positive control groups (P < 0.05, P < 0.01). The results indicated that amnion membrane preserved in Honghua injection might prevent tendon adhesion and effectively promote tendon healing.

OBJECTIVETo observe the effect of total flavones of Epimedium leptorrhizum (YYH-C) on osteoporosis in ovariectomized rats.

METHODOvariectomized female rats were randomly divided into the model group, YYH-C lower, middle and high dose (0.7, 1.4, 2.8 g x kg(-1)) groups, the positive drug Bujiale (0.15 mg x kg(-1)) group, and the sham group. The rats were orally ad-ministrated with drugs for three months. Parathyroid hormone (PTH), procollagen I N-terminal peptide (PINP), alkaline phosphatase (ALP), calcium (Ca) and phosphrous (P) in serum were detected. Femur bones and vertebrae bones of left side were collected to determined bone metrological indexes, including bone mineral density (BMD), bone Ca, and bone ash weight/dry weight percentage. Femur bones of right side were collected to for a morphological observation of bone.

RESULTCompared with the sham group, the model group showed significantly higher PTH and ALP content but obviously lower PINP and Ca content. The three YYH-C 3 groups could resist the decrease of PINP. Specifically, low and middle dose groups could remarkably inhibit the increase of PTH, and the high dose group could increase the Ca content in serum, but without significant effect on the rise in ALP. There was no significant difference in P content in serum in each group. BMD, ash weight/dry weight percentage, Ca and P content of the model group were significantly lower than those in the sham group. The high dose YYH-C group could significantly increase BMD. All of the three YYH-C groups could notably increase ash weight/dry weight percentage and Ca, P content in femur bones and vertebrae bones. YYH-C could significantly increase average thickness, area, area percentage of bony trabeculae, cortical bone area percentage of femoral shaft and the number of osteoblasts on the surface of bony trabeculae, and decrease the number of osteoclasts.

CONCLUSIONYYH-C can effectively control the bone mass loss of rats with ovariectomy-induced osteoporosis, prevent the changes in bone microstructure, and inhibit bone absorption, so as to resist high turn-over osteoporosis after ovariectomy. [Key words] total flavones of Epimedium leptorrhizum; ovariectomized rat; osteoporosis

Alkaline Phosphatase ; metabolism ; Animals ; Bone Density ; drug effects ; Calcium ; metabolism ; Drugs, Chinese Herbal ; administration & dosage ; Epimedium ; chemistry ; Female ; Flavones ; administration & dosage ; Humans ; Osteoporosis, Postmenopausal ; drug therapy ; metabolism ; physiopathology ; Ovariectomy ; Parathyroid Hormone ; metabolism ; Rats ; Rats, Sprague-Dawley

Data is the basis and soul of clinical trials. To obtain accurate data, strict and standard data management is essential, which can be effectively supported by quality control in statistical analysis. In this paper, we briefly introduce the concept of the quality control in clinical trials, and describe its contents and methods. We hope that this work will be helpful to the application of statistical quality control in data management of clinical trials.
Clinical Trials as Topic ; standards ; Data Collection ; standards ; Quality Control ; Statistics as Topic

Objective To investigate the biological markers and their clinical significance in diagnosis and differential diagnosis of inlfammatory bowel disease (IBD) in children.Methods The study had 22 cases of IBD including 6 cases of ulcerative colitis (UC) and 16 cases of Crohn’s Disease (CD). Twenty-four children without IBD were selected as controls. The serum perinuclear anti-neutrophil cytoplasmic antibody (pNACA) was measured by indirect immune lfuorescence method. The serum anti-saccharomyces cerevisiae antibody (ASCA) IgG and IgA, anti-B mannose glycoside antibody (AMCA) IgG, anti-B glycoside sugar shell antibody (ACCA) IgA, Anti-bacterial lfagellin antibody (Anti-cBir1) IgG, and the fecal calprotectin (FC) were determined by Enzyme linked immunosorbent assay (ELISA). Results The positive rate of serum pANCA was 100% in 6 cases of UC while it was negative in CD cases and control, and there was significant difference among three groups (P

Objective:To evaluate the clinical efficacy between preparation porcelain veneer(PPV)and no-preparation porcelain veneer(NPPV).Methods:44 patients with 97 PPVs and 23 patients with 57 NPPVs were followed up for 3 years.Mental tension, postoperative dentin sensitivity and satisfaction of the patients,survival rate of the veneers,sulcus bleeding index(SBI)of preopera-tive and postoperative 3 years were evaluated.A comparative analysis was taken to examine the clinical indicators of 2 groups accord-ing to the modified CDA /Ryge criteria.Results:Survival rates of PPVs and NPPVs were 96.91 % and 96.49%(P >0.05),satisfac-tion rates of the 2 group patients were 95.45% and 95.65%(P >0.05),respectively.Mental tension and the postoperative dentin sensitivity of patients in PPV group was higher than those in NPPV group.Preoperative and postoperative SBI were not statistically dif-ferent between the 2 groups(P >0.05).Marginal adaptation in PPV group was better than that in NPPV group.Color matching, Porcelain surface and Marginal stain were not statistically different between 2 groups.Conclusion:Preparation porcelain veneers and no-preparation porcelain veneers both are effective in clinical application.

Objective:To study the distribution pattern of CIK cells re-infused by different manner.Methods:Isotope 32P-? dATP and fluorescence dye CM-DiI were used individually to label CIK cells. CIK cells labeled by the two methods in vitro were inoculated to nude mice by intraperitoneal injection or tail vein injection. Radioactivity quantitative measurement and fluorescence microscopy were used to analysis dynamic distribution of CIK cells among organs of mice.Results:The CIK cells were quickly distributed to organs such as liver, spleen, kidney, lung, stomach and intestine after inoculation into nude mice. Among those organs, the liver, spleen and kidney showed highest distribution concentration of CIK cells. Early stage after infusion, concentration of CIK cells in lung above all reached peak via tail vein, and by means of intraperitoneal injection, distribution of CIK cells in intraperitoneal organs firstly got to max. CIK cells remained alive in liver and spleen for more than 2 weeks.Conclusion:The extensive distribution pattern of CIK cells among organs shows that CIK cells can be used as drugs against various malignant tumors in organism. Infusion of CIK cells via blood vessel maybe suit for tumor of organs with rich blood supply, and application by means of body-cavity way should suit for malignant effusions and limited lesion in it.

BACKGROUND:Previous studies have indicated that ulinastatin can inhibit RANKL-induced osteoclastogenesis on RAW264.7 cells and also lower matrix metal oproteinase-9 expression and activity. However, it remains be unclear whether ulinastatin has the intervention effect on polymethyl methacrylate (PMMA)-induced MC3T3-E1 mouse preosteoblast apoptosis or not. ＜br> OBJECTIVE:To explore the intervention role of ulinastatin on the PMMA-induced MC3T3-E1 mouse preosteoblast apoptosis and its effects on type I col agen, osteocalcin, matrix metal oproteinase-2 mRNA expression. ＜br> METHODS:MC3T3-E1 mouse preosteoblasts at passages 6 and 7 were divided into four groups:blank group (only cultured MC3T3-E1 mouse preosteoblast), PMMA-induced group (MC3T3-E1 mouse preosteoblast+1 g/L PMMA bone cement suspension), low dose ulinastatin group (MC3T3-E1 mouse preosteoblast+1 g/L PMMA bone cement suspension+500 U/mL ulinastatin) and high dose ulinastatin group (MC3T3-E1 mouse preosteoblast+1 g/L PMMA bone cement suspension+5 000 U/mL ulinastatin). MTT method was adopted to detect the proliferation activity of proliferative activity of MC3T3-E1 mouse preosteoblast;alizarin red staining method was used to observe mineralization nodules of MC3T3-E1 mouse preosteoblast among different groups;the change of apoptosis rate for MC3T3-E1 cells was detected by flow cytometry analysis;semi-quantitative RT-PCR was taken to analyze type I col agen, osteocalcin, matrix metal oproteinase-2 mRNA expression level in MC3T3-E1 mouse preosteoblasts among different groups. ＜br> RESULTS AND CONCLUSION:Compared with the blank group, PMMA significantly inhibited the proliferation activity of MC3T3-E1 mouse preosteoblast (P＜0.05), and however significantly promoted cells apoptosis (P＜0.05). After addition of different concentrations of ulinastatin (500, 5 000 U/mL), the proliferation activity of MC3T3-E1 mouse preosteoblasts significantly raised (P＜0.05), and cells apoptosis rate significantly decreased (P＜0.05), showing the dose and time-dependent relation. Type I col agen and osteocalcin mRNA expression levels both significantly decreased after co-culture in PMMA group compared with the blank group (P＜0.05), matrix metal oproteinase-2 mRNA expression level, however, significantly increased (P＜0.05). After intervention with 5000 U/mL ulinastatin, type I col agen and osteocalcin mRNA expression levels both significantly increased, while matrix metal oproteinase-2 mRNA expression level significantly decreased (P＜0.05). PMMA group showed no obvious mineralization nodules. Yet, mineralization nodules were formed in the blank group, high and low dose ulinastatin groups. These results indicate that ulinastatin could have the inhibitory effect on the PMMA-induced MC3T3-E1 mouse preosteoblast apoptosis, and it could promote type I col agen and osteocalcin mRNA expression and yet suppress matrix metal oproteinase-2 mRNA expression.

Objective To compare the advantages and values of several special staining methods of chondrocytes . Methods Twelve 7-day old healthy C57BL/6J mice were killed to obtain the cartilage tissue of the knee joint in order to isolate the chondrycytes .Type II collagen was used to assess the chondrocytes .Then the chondrocyte climbing slices were prepared.The materials were fixed, and HE staining, Safranin O-fast green staining, SA-β-gal staining and immunohistochemical staining of Type II collagen were performed and compared .Results HE staining showed clear morphology of the chondrocytes .The cell nuclei were stained blue and the cytoplasm was pink .Safranin O-fast green staining showed that the nuclei were pink and the cytoplasm green .SA-β-gal staining showed that the aging cells were green while the young cells were colorless .Immunohistochemical staining of type II collagen showed the distribution of type II collagen and they were stained brown while the cell nuclei were blue .Conclusions HE staining and safranin O-fast green staining can provide more information than the other staining techniques .SA-β-gal staining is useful in the analysis of aging chondrocytes .Immunohistochemical of type II collagen can be used to study type II collagen .

Objective To assess the safety and efficacy of an olive oil-based lipid emulsion for parenteral nutrition in patients after esophagectomy.Methods In the randomized controlled trial,60 patients undergoing esophagectomy were divided into study group(n=30,received olive oil-based lipid emulsion)and control group [n=30,received medium-chain triglyceride/long-chain triglyceride(MCT/LCT)emulsion].The parenteral nutrition Was provided for 7-10 postoperative days.The nutritional formulas were equivalent in nitrogen,calorie,osmotic pressure,and fluid volume.Peripheral venous blood tests were performed before operation and on the first and eighth postoperative days.All the patients were evaluated by nutritional status(weight,body mass index,nutritional risk screening,etc.),safety profiles[full blood test,electrolytes,aspartate aminotransferase(AST),alanine amiotransferase(ALT),total bilirubin and direct bilirubin,blood urea nitrogen(BUN),creatinine,blood glucose,etc.],and efficacy indicators(hemoglobin,albumin,total protein,etc.).Results The albumin and total protein levels returned to the normal ranges in beth groups 8 days after operation,although both levels were significantly higher in study group(P=0.000).Also,the difference of total protein levels between the eighth and first postoperative days Was significantly higher in the study group(P=0.002).In addition,the AST and BUN readings returned to normal ranges 8 days after operation in the study group, which were significantly lower than those in control group (P = 0.025, P = 0.013).No serious adverse events were reported in both groups.Other nutritional parameters, renal and hepatic safety profiels, vital signs, and hematology showed no significant difference between two groups.Conclusions Olive oil-based lipid emulsion is a safe and efficient lipid emulsion for parenteral nutrition in patients undergoing esophagectomy.Compared with MCT/LCT, it has less effect on AST and BUN.