Safety assessment in clinical trials is dependent on an in-depth analysis of the adverse events to a great extent. However, there are difficulties in summary classification, data management and statistical analysis of the adverse events because of the different expressions on the same adverse events caused by regional, linguistic, ethnic, cultural and other differences. In order to ensure the normative expressions, it's necessary to standardize the terms in recording the adverse events. MedDRA (medical dictionary for regulatory activities) has been widely recommended and applied in the world as a powerful support for the adverse events reporting in clinical trials. In this paper, the development history, applicable scope, hierarchy structure, encoding term selection and standardized query strategies of the MedDRA is introduced. Furthermore, the practical process of adverse events encoding with MedDRA is proposed. Finally, the framework of statistical analysis about adverse events is discussed.
Adverse Drug Reaction Reporting Systems ; standards ; statistics & numerical data ; Databases, Pharmaceutical ; standards ; Humans

Objective] To summarize the clinical key points of acupoint sticking therapy in the application of treating disease before its onset. [Method] From the treatment timing, treatment principle, acupoint selection to expound the academic perspective and clinical experience of our department in the application of acupoint sticking therapy by consulting the ancient literature and summarizing clinical practice. [Result] Through the correct selection of treatment timing for acupoint sticking therapy, which is mainly used in summer, secondly used in winter, and focusing on tonifying Yang-qi, and point selection by pattern identification, paying attention to the accumulation of curative effect, this therapy has good curative effect in the treating disease before its onset.[Conclusion] Nowadays, there are more and more sub-health people. Since acupoint sticking therapy has advantages of“easy, convenient, cheap, uesful”and safe, it is a good therapy to apply for treating disease before its onset.

Objective To analyse effects of the serum levels of thyroid peroxidase antibodies (TPOAb) on antithyroid drugs (ATD) treatment in patients with incipient Graves disease (GD). Methods A total of 121 patients with incipient GD, who were used anti thyroid drugs for 12 months, were included in this study. Patients were dvided into two groups:TPOAb negative group (TPOAb≤35 IU/mL, n=49) and TPOAb positive group (TPOAb>35 IU/mL, n=72). According to the degree of TPOAb drops the TPOAb positive group was sub-divided into low level positive group (35 IU/mL1 000 IU/mL, n=20). The ATD total dosage for 12 months and thyroid-stimulating hormone (TSH), which returned to normal rate after treatment of 3, 6 and 12 months, were compared between groups. Results ATD total dose was lower in TPOAb positive group (1 743.82±265.38) mg than that of negative group (1 889.18 ±125.51) mg. The ATD total dosages were (1 759.71±230.29) mg, (1 793.75±299.02) mg, (1 731.54± 236.44) mg and (1 710.00 ± 290.73) mg for low level TPOAb positive group, medium level TPOAb positive group, high level TPOAb positive group, and very high level TPOAb positive group respectively. The recovering ratio of TSH was significantly higher in TPOAb positive group than that of TPOAb negative group after 3-month treatment (P<0.05). Conclusion TPOAb positive serum can lead to shorten the course of ATD treatment and reduce the total amount of ATD treatment in GD patients.

Animals ; Antibodies, Monoclonal ; pharmacokinetics ; Iodine Radioisotopes ; pharmacokinetics ; Leukocyte Common Antigens ; immunology ; Male ; Mice ; Radiation Monitoring ; methods ; Rats ; Tissue Distribution

Objective:To study the effect of mindfulness-based training intervention on clinical efficacy in patients with nitrous oxide(laughing gas) addiction.Methods:From June 2019 to June 2020, sixty-six patients with nitrous oxide addiction in Beijing Gaoxin Hospital were selected and randomly divided into experimental group( n=33) and control group( n=33). The control group received Taijiquan training and physical training, while the experimental group added mindfulness-based training intervention on the basis of Taijiquan training and physical training.Symptom checklist 90 (SCL-90) scores and visual analog scales (VAS) craving scores were compared between the two groups at admission and 8 weeks after treatment.SPSS 22.0 software was used for statistical analysis.Independent sample t test and paired sample t test were used to compare the differences between groups and within groups. Results:(1)Before treatment, there were no significant differences in subscale scores of SCL-90 between the two groups except for depression factor((2.45±0.86), (2.03±0.46), t=2.474, P<0.05). After treatment, the subscale scores of somatization((1.38±0.35), (1.68±0.34), t=-3.656, P<0.05), phobic anxiety((1.49±0.37), (1.81±0.30), t=-3.993, P<0.05), paranoid ideation((1.50±0.47), (1.88±0.31), t=-3.898, P<0.05) and psychotism((1.34±0.54), (1.55±0.27), t=-3.094, P<0.05) of SCL-90 in the experimental group were significantly lower than those in the control group.(2)Before treatment, there was no significant difference in VAS craving score between the two groups( t=0.857, P=0.395). After treatment, the score of VAS in the experimental group was significantly lower than that in the control group( t=27.427, P<0.05). Conclusion:Mindfulness training intervention can effectively improve the clinical symptoms of patients with nitrous oxide addiction, which is worthy of clinical application.

Objective To establish a TaqMan real-time fluorescent quantitative PCR to detect Vibrio vulnificus based on hemolysin gene(vvhA)that coding cytolysin.Method By using software Primer Express, the PCR primers and TaqMan probe,which located in the conserved region of vvhA gene sequence,were designed for establishment of a TaqMan real-time fluorescent quantitative PCR to detect 100 bp amplicon from V.vulnificus DNA.A recombinant plasmid pMD19-vvhA100 as a positive control during detection was constructed using gene cloning technique.Minimal amplification cycles(Ct value)and fluorescence intensity enhancement (△Rn value)were used as observing index to optimize the reaction conditions of the TaqMan real-time fluorescent quantitative PCR.The DNAs with different concentrations from V.vulnificus and other eight bacteria and pMD19- vvhA100 were applied as templates to determine the specificity,sensitivity and reappearance of the TaqMan real- time fluorescent quantitative PCR.ICR mice were intraperitoneally,subcutaneously and orally infected with V. vulnificus,respectively.The detection effect of the TaqMan real-time fluorescent quantitative PCR was measured using the specimens of peripheral blood,subcutaneous tissue and intestinal content collected from the infected mice.Results The established TaqMan real-time fluorescent quantitative PCR showed positive results only for V. vulnificus DNA and pMD19-vvhA100.The detection effectiveness of the TaqMan real-time fluorescent quantitative PCR was as high as 0.01 ng of V.vulnificus DNA or 103 copies of pMD19-vvhA100.The SD values of the detection results repeated for three times using pMD19-vvhA100 with different concentrations were lease than 0.79. The detection results of TaqMan real-time fluorescent quantitative PCR were positive for all the specimens of peripheral blood and subcutaneous tissue.Conclusions The TaqMan real-time fluorescent quantitative PCR established in this study for V.vulnificus vvhA gene detection has advantages such as quickness,stability, sensitivity and specificity,indicating this method can be used for clinical laboratory diagnosis of septicemia and wound infection caused by V.vulnificus.

Objective:To investigate the relationship between serum lipocalin-2 level and the risk of cardiovascular disease(CVD) in patients with type 2 diabetes.Methods:A total of 279 type 2 diabetic patients were enrolled in this study. Basic information and clinical data were collected. These patients were divided into CVD group and non-CVD group according to their cardiovascular disease status. Serum lipocalin-2 level was assessed by enzyme linked immunosorbent assay.Results:Compared to non-CVD group, serum lipocalin-2 level was significantly higher in CVD group( P<0.01). The Spearman correlation analysis showed that serum lipocalin-2 level was positively correlated with waist circumstance, diastolic blood pressure, uric acid, triglyceride, and HbA 1C( P<0.05), while negatively correlated with high density lipoprotein-cholesterol level( P<0.01). In addition, the univariate and multivariate logistic regression analysis revealed that serum lipocalin-2 was an independent risk factor for CVD( P<0.01)after adjustment for potential confounders. Moreover, receiver operating characteristic curve analysis demonstrated that the area under curve value of lipocalin-2 was 0.74, with the optimal cutoff value of lipocalin-2 66.84 ng/mL. Conclusion:Serum lipocalin-2 is closely associated with CVD in patients with type 2 diabetes, which might be considered as one of the predictors for CVD in type 2 diabetes mellitus.

To identify whether a highly repeated GT sequence from DCA1 promoter from Dunaliella salina,which have been proved to be a salt-inducible promoter in our previous study,would be a salt-inducible regulation element,different primers were designed to amplify 6 different-length fragments of DCA1 promoter from D.salina by PCR.After these fragments were respectively inserted into the HindⅢ-BamH I sites of the vector pU?GUS,serial expression vectors containing the gus gene were generated.D.salina cells transformed with these recombinant plasmids by electroporation were grown in liquid media containing different concentrations of sodium chloride respectively.GUS enzyme activity was measured histochemically and fluorometrically.The results revealed that 3 fragments containing GT repeated sequence drove the external gus gene expression and the expression pattern of the gus gene was regulated by the concentrations of sodium chloride.Additionally,the 2 fragments without tandem GT sequence drove the gus gene expression,but the expression pattern of the gus gene wasn't regulated by the concentration of sodium chloride;Also,the upstream fragment of the tandem GT sequence wasn't able to drive the gus gene expression.In conclusion,the highly repeated GT sequence from the DCA1 promoter plays an important role in the salt-inducible regulation of DCA1 promoter from D.salina and might be a novel salt-inducible element.

OBJECTIVETo investigate the clinical effects of close reduction and minimally invasive percutaneous plate osteosynthesis in treating proximal humerus fractures in the aged.

METHODSFrom February 2012 to December 2013,39 patients with proximal humerus fractures were treated with minimally invasive percutaneous plate osteosynthesis (MIPPO group, 21 cases) and open reduction internal fixation (ORIF group, 18 cases). Including 17 males and 22 females in the study, and aged from 67 to 88 years old with an average of (71.8 ± 5.2) years old. In MIPPO group, there were 11 males and 10 females with an average age of (70.0 ± 5.3) years old;and in ORIF group, there were 10 males and 8 females with an average age of (72.0 ± 4.2) years old. Operation time, blood loss during operation, fracture healing time and postoperative complications were recorded. The functions of the shoulder joints were assessed according to Constant-Murley score at final follow-up.

RESULTSAll the patients were followed up from 11 to 27 months with an average of 18.1 months. The mean blood loss of the MIPPO group was (176.0 ± 57.4) ml,while the ORIF group was (356.0 ± 66.9) ml (t = 7.22,P = 0.01). The operation time of the MIPPO group was (47.4 ± 14.9) min, while the ORIF group was (92.7 ± 15.8) min (t = 0.79, P = 0.03). Fracture healing time in the MIPPO group and ORIF group was (17.6 ± 5.8), ( 21.7 ± 4.9) weeks, respectively (P < 0.05). The mean Constant-Murley score at final follow-up was 89.7 ± 14.5 in MIPPO group, and 81.8 ± 13.2 in ORIF group (P < 0.05).

CONCLUSIONMIPPO has advantages of little trauma, less blood loss, rapid recovery, less vascular damage and so on and can effectively treat the proximal humerus fracture in the aged.

Aged ; Aged, 80 and over ; Bone Plates ; Case-Control Studies ; Female ; Fracture Fixation, Internal ; methods ; Humans ; Male ; Minimally Invasive Surgical Procedures ; Shoulder Fractures ; surgery

Objective To prepare a novel radiolabeled FR?positive tumor targeting agent 99 Tcm?( HYNIC?NHHN?FA) ( EDDA) and evaluate its biological properties. Methods FA derivative FA?NHHN?HYNIC was synthesized and radiolabeled with 99 Tcm using EDDA as a coligand. The radiochemical purity, octanal/water partition coefficient and in vitro stabilities of the complex were studied after purified by HPLC. In vitro cellular uptakes were performed on FR?positive KB cells ( human oral epidermoid carcinoma cells) . Biodistribution and microSPECT/CT imaging were investigated on normal Kunming mice and nude mice bearing KB tumors, respectively. Results The radiochemical purity of the complex was over 95% after pu?rified by HPLC. It displayed high stability both in saline and in serum. It also exhibited high specific FR binding in FR?positive KB cells in vitro. The binding ratio was (6.76±0.60)%1 h after incubation, and de?creased to (0.24±0.02)% after adding excessive FA. The results of biodistribution showed high kidney up?take in normal mice, and the uptake reached (21.79±9.79) %ID/g 0.5 h after injection. Flank KB tumors were clearly visualized with 99 Tcm?( HYNIC?NHHN?FA ) ( EDDA ) by microSPECT/CT imaging at 2 h postinjection, and the uptake could be inhibited by excessive FA. Conclusions 99 Tcm?( HYNIC?NHHN?FA) ( EDDA) exhibits good pharmacokinetic properties, suggesting its potential as a promising FA targeting agent for tumor imaging.