Comparative Study on Risk Assessment Tools for Clinical Trials in England, Germany and France / 中国医学伦理学

Risk assessment of clinical trials is of great significance to improve the quality of clinical trials. Through systematic comparative analysis of risk assessment tools for clinical trials in Britain, Germany and France, this paper found that the three countries’ risk assessment tools were consistent in terms of legal system guarantee and assessment process, but there were obvious differences in the basic risk classification and risk grading standards of clinical trials. Based on the experience of Britain, France and Germany, this paper proposed to improve the relevant regulations and documents of clinical trial risk management in China from the perspective of Chinese national conditions, further explore the factors affecting clinical trial risk, and develop and design clinical trial risk assessment tools with different discipline characteristics according to the specialties of the discipline to improve the quality and level of clinical trials.

Efficacy of Chinese Medicine Acupoint Application Combined with Montelukast on Children with Perennial Allergic Rhinitis: A Randomized Controlled Trial / 中国结合医学杂志

OBJECTIVE@#To evaluate the efficacy of Chinese medicine acupoint application (CMAA) combined with Western medicine for perennial allergic rhinitis (PAR) in children.@*METHODS@#In this prospective, parallel, randomized, placebo-controlled and single-blind trial from August to September, 2017, 180 children with PAR were randomly assigned to an integrative group (CMAA and Montelukast), CMAA group (CMAA and placebo tablet), or Montelukast group (placebo CMAA and Montelukast). Participants were applied with CMAA for 6 sessions over 2 weeks, and/or Montelukast Chewable Tablet orally once daily for 12 weeks. The changes in severity of symptoms were measured by Visual Analog Scale (VAS) and rhinitis control assessment test (RCAT) at 0, 2, 4 and 12 weeks of treatment. Blood samples were collected for serum interleukin-4, interferon gamma γ and T helper type 1 (Th1)/Th2 flow cytometric analysis at the time points of 0, 4 and 12 weeks.@*RESULTS@#Eight cases dropped out from the trial, 3 in the integrative group, 2 in the CMAA group and 3 in the Montelukast group. The VAS scores decreased significantly while the RCAT scores increased significantly in all three groups at 4 and 12 weeks compared with baseline (P<0.01 or P<0.05). The VAS scores were significantly lower while the RCAT scores were significantly higher in the integrative and CMAA groups than the Montelukast group at 2 and 4 weeks (P<0.01 or P<0.05). At 2, 4 and 12 weeks, the scores of nasal congestion, sneezing, sleep problem, and rhinitis symptom control in the integrative and CMAA groups increased significantly compared with baseline (P<0.01 or P<0.05). The least percentages of Th2 and the most alleviated Th2 shift (highest Th1/Th2) were observed in the integrative group at 12 weeks compared with the other two groups (P<0.05).@*CONCLUSION@#The combination of CMAA with Montelukast might be more effective and appropriate than either option alone for children with PAR. (Registered at Chinese Clinical Trial Register, registration No. ChiCTR-IOR-17012434).

Changes in serum YKL-40 level and humoral immune function and their significance in children with recurrent pneumonia / 中国当代儿科杂志

<p><b>OBJECTIVE</b>To investigate the changes in serum YKL-40 level and humoral immune function and their significance in children with recurrent pneumonia.</p><p><b>METHODS</b>Blood samples were collected from 30 children with recurrent pneumonia (recurrent pneumonia group), 30 children with acute pneumonia (acute pneumonia group), and 30 healthy children (control group). Serum YKL-40 levels were measured by enzyme-linked immunosorbent assay. The correlation between serum YKL-40 level and laboratory indices related to humoral immune function was analyzed. The receiver operating characteristic (ROC) curve was used to analyze the diagnostic value of serum YKL-40 level for recurrent pneumonia.</p><p><b>RESULTS</b>The recurrent pneumonia group had a significantly higher serum YKL-40 level than the acute pneumonia and control groups (P<0.05). The acute pneumonia group had a significantly higher serum YKL-40 level than the control group (P<0.05). Serum levels of IgG and complement 4 in the recurrent pneumonia group were significantly lower than in the acute pneumonia group (P<0.05). Serum YKL-40 level was negatively correlated with serum IgG level (r=-0.309, P=0.047) and serum complement 4 level (r=-0.324, P=0.039). The area under the ROC curve of serum YKL-40 level for diagnosing recurrent pneumonia was 0.958 (95%CI: 0.921-0.994).</p><p><b>CONCLUSIONS</b>Humoral immune function is low in children with recurrent pneumonia. Serum YKL-40 may be involved in the occurrence of recurrent pneumonia and can be used as a reference index for diagnosing recurrent pneumonia.</p>

A pilot study of the ERCC1 and XPF genes in forensic age estimation / 中国法医学杂志

Objective The aim of this study is to detect the mRNA and protein expression levels of ERCC1 and XPF genes among different age groups of healthy Chinese Han individuals,and to analyze the correlation between the mRNA and protein expression levels andthe age of individuals in order to find new molecular markers for forensic age estimation.Methods Peripheral blood samples were obtained from 150 unrelated healthy Chinese Han individuals.The plasma was centrifuged from the whole blood by gradient centrifugation,and the totalRNA was extractedwithTrizol fromperipheral blood mononuclear cells(PBMCs).Real-time quantitative reverse transcription polymerase chain reaction (RT-qPCR) was used to quantitatively analyze the mRNA relative expression levels of ERCC1and XPF in PBMCs.Enzyme linked immunosorbent assay (ELISA) was used to quantitatively analyze the protein expression levels of ERCC1and XPF in plasma.Results There were no significant differences in the mRNA relative expression levels of ERCC1 and XPF in PBMCs between males and females(P＞0.05).Significant differences were found in the mRNA relative expression levels of ERCC1 and XPF between different age groups (P＜0.05).Regression analysis showed thatthe mRNA relative expression levels of ERCC1 and XPF were both negatively correlated with age.The correlation coefficients(r) were-0.578 and-0.844,respectively.When the age was used as independent variable(x) and the mRNA expression relative level as dependent variable (y),the fitting curveswere Y=3.3E-5X2-0.0261X+1.9175 (R2=0.3244,P＜0.01),Y=0.0003X2-0.0459X+2.0439 R2=0.729,P＜0.01),respectively.There were no significant differences inthe protein expression levels of ERCC1 and XPF in plasma between different age groups or genders (P＞0.05).Conclusion The mRNA relative expression levels of ERCC1 and XPF in PBMCsdeclined with the increase of age,however,the protein expression levels in plasma were unrelated to age.ERCC 1 and XPF genes can be used asnew molecular markers for forensic age estimation,so as to providetheoretical basis for establishing the mathematical model of ERCC1/XPF genesin concern ofindividual ages.

Effect of mitochondrial DNA 5178 C/A polymorphism on risks for type 2 diabetes mellitus and its complications / 中华医学遗传学杂志

<p><b>OBJECTIVE</b>To explore the role of mitochondrial DNA 5178 C/A (Mt5178) polymorphism of NADH-dehydrogenase subunit 2 (ND2) gene in type-2 diabetes mellitus (T2DM) among ethnic Han Chinese through a case-control study.</p><p><b>METHODS</b>The Mt5178C/A polymorphism was determined by sequencing 1103 T2DM patients and 791 healthy controls. Logistic regression analysis was conducted to estimate odds ratios (OR) and 95% confidence intervals (CI). To confirm the results, a meta-analysis was conducted based on published literature on the association of Mt5178 variant with T2DM.</p><p><b>RESULTS</b>No significant association was found between the Mt5178C/A variant and T2DM either by our study or the meta-analysis which included eight published studies. Nevertheless, it was found that the T2DM patients with 5178C genotype were at a higher risk for nephropathy complication (OR=1.49, 95%CI: 1.005-2.197, P<0.05) and at significantly lower risk for hypertension complication (OR=0.744, 95%CI: 0.556-0.996, P<0.05) compared with those carrying a 5178A genotype.</p><p><b>CONCLUSION</b>No association was found between the Mt5178C/A polymorphism of mitochondrial ND2 gene with the increased risk of T2DM. However, the polymorphism may affect the development of nephropathy and hypertension complications among T2DM patients.</p>

Surgery for T4 hypopharyngeal cancer and reconstruction after hypopharyngo-oesphagectomy / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To explore the surgical treatment of hypopharyngeal and cervical esophageal cancers and the ways of reconstruction after hypopharyngo-oesphagectomy, and to evaluate their efficacy.</p><p><b>METHODS</b>Twenty five patients with cancer of the laryngopharynx and cervical esophagus treated in our department between 1995 and 2007 were included in this study. Their clinical data were restrspectively analyzed. Among them, 17 cases had the tumor originated from the pyriform sinus, 3 of the posterior pharyngeal wall and 5 of the postcricoid region. Acording to the 2002 UICC criteria, all the tumors were stage T4, including 9 patients with cN0, 11 with cN1, and 5 with cN2 disease. The pharyngoesophageal defect reconstruction methods were as following: pharyngogastric anastomosis in 7 patients, free jejunal transplantion in 4, laryngotracheal flap in 8, and pectoralis major musculocutaneous flap in 6 patients. All patients were treated with modified and/or selective neck dissection. Among them, 8 cases received pre-operation radiotherapy, 17 received post-operative auxiliary radiotherapy.</p><p><b>RESULTS</b>There was no operation death case in this group. All patients were followed up for 3 to 5 years. Three patients died in the first year. According to Kaplan-Meier analysis, the 1-year survival rate was 88.0%, 3-year survival rate was 48.0%, and 5-year survival rate was 28.0%.</p><p><b>CONCLUSIONS</b>The use of primary repair of the defects of laryngopharynx and cervical esophagus expands the operative indication for cancers of the laryngopharynx and cervical esophagus, improves the survival rate and life quality of the patients. Regarding the repair method of choice, site of the tumor and size of the defect are the most important factors regarding choice of reconstruction method, while the patients' age and general condiction should also be considered to minimize the complications as more as possible.</p>

Development of a novel stretch strain cell loading unit / 医用生物力学

Objective To develop a set of stretch strain cell loading unit with proprietary intellectual property rights so as to provide a necessary tool for the research of cellular mechanics. Methods Based on the deformation theory of round substrates, the stretch strain cell loading unit could apply the stretch strain to cultured cells in vitro by utilizing digital measuring controlling system and computer software. MTT colorimetric test was adopted to evaluate the ability of human periodontal ligament cells (HPDLCs) to attach and grow on the silastic membrane. The cultured HPDLCs were loaded with 1%, 10% and 20% stretch strain for 0.5, 1 and 24 h, respectively, by the loading unit, and an inverted phase contrast microscope was used to observe the morphology and realignment of HDPLCS. Results The stretch strain cell loading unit could apply the stretch strain of different magnitude, frequency and duration to cultured cells in vitro, with the advantage of a large range strain output, high precision, convenient operation and clear visual monitoring. When cells were seeded for 1, 2, 4, 7, 8 d, respectively, there was no statistical difference between the MTT absorbance value of silastic membrane group and that of control group (P>0.05), showing the good ability of cultured cells to attach and grow on the silastic membrane. After HPDLCs were loaded with 10% and 20% strain for 24 h, the morphology and realignment of HPDLCs changed, and cells became spindle shaped, being parallel to each other with long axis perpendicular to the stretch vector. Conclusions The stretch strain cell loading unit is capable of loading the stretch strain to cultured cells effectively and provides a necessary method for cytomechanical research.

Immunological killing effect of recombicant adenovirus vector rAD-mTERT-m4-1BBL on mouse hepatoma cell line Hepa1-6 cells co-cultured with T lymphocytes / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To study the immunological suppressing effect of recombinant adenovirus vector rAD-mTERT promotor-m4-1BBL (rAD-mTERT) on mouse hepatoma cell line Hepa1-6 cells in co-culture with T lymphocytes.</p><p><b>METHODS</b>Adding recombinant adenovirus rAD, rAD-CMV-m4-1BBL (rAD-CMV) and rAD-mTERT to Hepa1-6 and L929 cells, respectively, to observe the effect of these adenoviruses on growth and apoptosis of these cells in co-culture with T lymphocytes.</p><p><b>RESULTS</b>Adding adenovirus significantly suppressed the growth and slightly increased apoptosis of the two types of cells (P < 0.05). rAD-mTERT promotor-m4-1BBL showed only pro-apoptotic effect on Hepa1-6 cells. When co-cultured with T lymphocytes, rAD-CMV-m4-1BBL showed promoting effect on apoptosis of the cells. Compared with that of T cells pre-co-culture, CD4(+) and CD8(+) T cells were proliferated, and the ratio of CD4/CD8 was significantly reduced (from 1.27 to 1.08).</p><p><b>CONCLUSION</b>Adding the recombinant adenoviruses only suppresses the cell growth, but not promotes their apoptosis. In co-culture with T lymphocytes, recombinant adenovirus vector rAD-mTERT promotor-m4-1BBL can targetingly suppress the growth and induce apoptosis of Hepa1-6 cells. The apoptosis is induced through the immunological killing effect of T lymphocytes.</p>

Operation Mode for the Management of Donated Medicines / 中国药房

OBJECTIVE: To discuss the optimal operation mode for the management of donated drugs.METHODS: The possible problems existed in the management of donated medicines were found out through summarizing our practical experience in the inventory,storage and use etc of the donated drugs.RESULTS & CONCLUSIONS: In the management of donated medicines,emphasis should be attached to the inventory,storage and use of the donated medicines,meanwhile,a sound supervising system for the donation affairs should be set up to standardize the donation behavior,strengthen expiration date management and gradually establish the practical and effective work mode.

Expressions of MMP-2, MMP-7 and TIMP-2 in lung carcinoma and their significance / 第三军医大学学报

Objective To investigate the expressions of matrix metalloproteinase 2 (MMP 2), matrix metalloproteinase 7 (MMP 7), and tissue inhibitor of matalloproteinase 2 (TIMP 2) in lung carcinoma tissue and their significance Methods The expressions of MMP 2, MMP 7, and TIMP 2 in 74 cases of lung carcinoma tissues and 20 cases of peri cancerous normal lung tissues were detected by immunohistochemical method, and the correlation between the expressions of these proteins and the clinicopathological parameters and the prognosis was analyzed Results MMP 2 and MMP 7 expressions in lung carcinoma tissues were significantly higher than those in peri cancerous normal lung tissues ( P 0 05), and the expression of TIMP 2 was significantly lower in lung carcinomas with lymph node metastasis than that in lung carcinomas without lymph node metastasis ( P

Effect of berberine on visfatin expression in 3T3-L1 adipocytes / 中华内分泌代谢杂志

Objective To observe the effect of berberine on visfatin expression in 3T3-L1 adipocytes,and to explore the mechanism underlying berberine improving insulin resistance.Methods Visfatin mRNA and protein expressions were assayed by RT-PCR and Western blot after incubation of berberine at different concentrations and durations with 3T3-L1 adipocytes.Results In 3T3-L1 adipocytes,visfatin mRNA expression was increased at 0- 10?mol/L berberine with the maximum effect at 10?mol/L,being 4.96 folds of control group.While as the berberine concentrations were further increased above 10?mol/L,the visfatin mRNA level decreased.After incubation with berberine for 3 h,the visfatin mRNA level began to increase,and reached the peak when incubation for 12 h(4.57 fold of basal group).Then the mRNA level decreased,though it was still higher than that in control group after 48h intervention.5,10, 20?moL/L berberine could increase visfatin protein expression by 1.13,2.46,2.34 folds respectively as compared with control group(P