OBJECTIVE:To guarantee the quality of the clinical drug trial and to ensure the interests of the subjects.ME- THODS:The basic principles,procedures and methods of ISO9001quality management standards were applied in the whole construction of clinical drug trial institution.RESULTS&CONCLUSION:The construction of clinical drug trial institution based on the ISO9001quality management standards was in conformity with the principle of Good Clinical Practice,which was helpful for the guarantee of the quality of clinical drug trial and the interests the subjects.

Objective To explore the titre of serum anti-phospholipase A2 receptor antibodies (anti-PLA2 R antibodies) detected by the enzyme-linked immunosorbent assay (ELISA) to provide a more specific serological index for clinical diagnosis and disease judgment of membranous nephropathy (MN).Methods Thirty-four cases of MN confirmed by kidney biopsy ,32 inpatients with autoimmune diseases ,nephrotic syndrome and renal insufficiency in the nephrology department of our hospital and 12 persons un-dergoing physical examination were selected.The serum was collected for detecting anti-PLA2 R antibodies level.Then its diagnostic performance for diagnosing MM was analyzed by combining with serum TP ,ALB ,IgG ,IgA ,IgM ,C3 and C4 indicators.Results The medians of anti-PLA2 R antibodies titres in the MN group ,disease control group and healthy control group were 22.1 ,2.0 ,2.0 RU/mL respectively ,which had statistical difference between the MN group and other two groups (P<0.05).Seventeen cases of anti-PLA2R antibodies positive were in the MN group(positive rate50% )and 17 cases were negative,the disease control group and healthy control group all were negative.Its specificity and positive predictive value were 100% ,TP ,ALB and IgG had statistical difference between the MN group with the disease control group and healthy control group (P<0.05);the relative coefficients of anti-PLA2 R antibodies with TP ,ALB and IgG ,IgA ,IgM ,C3 and C4 were in turn -0.382 ,-0.344 ,-0.502 ,-0.295 ,0.062 , 0.005 and 0.241 respectively ,anti-PLA2R antibodies were negatively correlated with TP ,ALB ,IgG and IgA(P<0.01) ,positively correlated with C4(P<0.05) and had no relation with IgM and C3(P>0.05).Conclusion Anti-PLA2 R antibodies have higher specificity for the diagnosis of MN and can serve as the necessary and specific serologic detection indicator in the patients unable to conduct renal biopsy.Quantitative detection helps to condition judgment.

Objective To evaluate clinical effect of Compound Fanshiliu Recipe(CFR) for the treatment of over-weighted type 2 diabetes mellitus(T2DM). Methods One hundred and twenty over-weighted T2DM patients were randomized into treatment group and control group, 60 cases in each group. Both groups were given oral use of Metformin Hydrochloride Enteric-Coated Tablets, and additionally the treatment group was treated with CFR orally. The treatment of both groups lasted for 12 continuous weeks. Before and after treatment, we detected the waist circumference (WC), body mass index (BMI), and the levels of fasting blood glucose(FBG), postprandial 2-hour blood glucose(P2hBG), glycosylated hemoglobin(HbA1c), total cholesterol(TC), triglyceride (TG), and free fatty acid (FFA). The therapeutic effect of the two groups was also evaluated after treatment. Results (1) The total effective rate for traditional Chinese medical symptoms was 95.00% in the treatment group, and was 70.00%in the control group, the difference being significant(P<0.01).(2) After treatment, WC and BMI were decreased in the treatment group(P<0.01 compared with those before treatment), but had no significant decrease in the control group(P>0.05). The decrease of WC and BMI of the treatment group was superior to that of the control group(P<0.05).(3) After treatment, levels of FBG, P2hBG, HbA1c, TC, TG, and FFA of both groups were significantly improved (P<0.05), and the improvement of the treatment group was superior to that of the control group(P<0.05).(4) Three patients of the treatment group suffered from slight gastric discomfort, and the discomfort was relieved without any special treatment. Other patients of the two groups had no adverse reaction. Conclusion Treatment of CFR combined with Metformin has been proved to be an effective and safe approach to decrease blood glucose and blood lipid levels, promote weight loss, and ameliorate traditional Chinese medical symptoms.

Febrile seizures is one of the most common neurological diseases in childhood and the most common reason of convulsions. Although most of the convulsions have a good prognosis, prolonged febrile seizures can lead to hypoxic ischemic brain injury and influence the long-term intellectual development if the convulsions are repeated. It will lead to cognitive abilities, learning and memory decline, and even become the pathophysiological etiology of intractable epilepsy. Therefore,it has been became a great concern due to its serious impact on the quality of the child′s life. How to safely and effectively prevent the onset of febrile seizures has been an important task in pediatric clinical work. At present,there are some variously pre-ventive treatment guidelines or specifications,but it still left a debate about its effect. This article reviewed the progress of the studies on the preventive treatment of febrile seizures,so as to improve the understanding and the level of clinical preventive treatment of febrile seizures of the pediatricians.

BACKGROUND:Previous studies have shown the correlation between lumbosacral sagittal plane parameters and natural absorption of lumbar disc herniation.However,the lumbosacral sagittal plane parameters included lumbar lordosis angle,lumbosacral joint angle,sacral inclination angle and many other parameters.The effects of each parameter on the natural absorption of the herniated disc were different.In addition,there are few studies on the reabsorption of a specific segment of intervertebral disc herniation at present,and most of the measured data are obtained from digital radiography or CT,while the correlation between lumbosacral sagittal plane parameters measured from MRI and reabsorption after L5/S1 intervertebral disc herniation is rarely reported. OBJECTIVE:To study the corresponding changes of lumbar sagittal plane parameters after L5/S1 intervertebral disc herniation reabsorption and to screen out the lumbosacral sagittal plane parameters with the most significant changes during intervertebral disc reabsorption. METHODS:Totally 57 patients with lumbar disc herniation who had complete MRI image data were selected and met the diagnostic criteria for lumbar disc herniation and only received non-surgical treatment for reabsorption of L5/S1 protrusion segments.MRI measured the protrusion area of the maximum protrusion plane in the coronal plane,lumbosacral sagittal plane parameters[lumbar curvature index,lumbar lordosis(α),L5/S1 disc angle(β),intervertebral height measurement,lumbosacral joint angle,sacral platform angle,sacral inclination angle,and lower lumbar lordosis angle].Besides,lumbosacral sagittal plane parameters were ranked in the importance of variables by random forest model in R software,and then significant variables were fitted with multiple linear regression.The changes between parameters before and after treatment were analyzed and compared by paired sample t-test. RESULTS AND CONCLUSION:(1)A total of 57 patients with L5/S1 lumbar disc herniation were included in this study,and the symptoms and imaging features of the patients were significantly relieved to a large extent.(2)Before treatment,there were 4 cases of grade 1,29 cases of grade 2 and 24 cases of grade 3 according to the Classification of Michigan State University.After treatment,there were 48 cases of grade 1 and 9 cases of grade 2.(3)The random forest model suggested that intervertebral height,lumbar curve index,sacral inclination angle,and lower lumbar lordosis angle changed significantly in L5/S1 disc herniation reabsorption,and the order of their change significance was lumbar curve index>intervertebral space height>sacral inclination angle>lower lumbar lordosis angle.(4)Lumbar curve index,lumbar lordosis and sacral platform angle increased,with statistical significance(P<0.05).There were no significant differences in disc angle,intervertebral height,lower lumbar lordosis angle,sacral inclination angle or lumbosacral joint angle(P>0.05).(5)Lumbar curvature index was the most significant parameter of the lumbosacral sagittal plane in herniated disc reabsorption.In addition,lumbar curve index,sacral inclination angle,and lower lumbar lordosis angle are commonly used clinically to describe the change of lumbar curvature,suggesting that L5/S1 disc herniation reabsorption is correlated with the change of lumbar curvature.It is indicated that in the treatment of lumbar disc herniation,a clinical cure can be achieved by improving or restoring the disordered lumbar curvature.

Objective: To investigate the effect of pure titanium surface of large diameter TiO2 nanotubes modified by RGD peptide on the adhesion and proliferation of MG63 osteoblasts. to provide theoretical proof for developing titanium implants. Methods: Commercially pure titanium discs were divided into four groups and treated with SLA to obtain a microrough surface (SLA group). Then, nanotubes were imposed on this microrough surface by anodization (SLA+80 group). The surface was then modified by dopamine (DOPA) (DOPA Group), after which bioactive RGD peptide layers were generated on the TiO2 nanotube surfaces via electrochemical and molecular self-assembly techniques (RGD group). The titanium surface morphology and elemental composition of each group were characterized by field emission scanning electron microscopy (FE-SEM) and X-ray photoelectron spectroscopy (XPS). MG63 cells were cultured in vitro to evaluate biological activities of titanium before and after treatment, including the evaluation of early-stage cell adhesion capacity by fluorescence microscopy, proliferation capacity by MTS assay, and mRNA expression of the cell osteoblast-related genes alkaline phosphatase (ALP) and osteocalcin (OCN) by qRT-PCR. Results: FE-SEM and XPS showed that hierarchical micro/nanosurfaces decorated with TiO2 nanotubes were produced on titanium using sandblasting and large grit etching combined with anodization, dopamine was then self-polymerized to form a polydopamine film on the TiO2 nanotube surfaces, and RGD peptides were then conjugated to the polydopamine film, finally forming RGD peptide-modified bioactive layers. In vitro experiments showed that compared with the other three materials, the RGD-modified material was more conducive to cell adhesion and proliferation (P < 0.05). The expression levels of ALP and OCN mRNA in the RGD group were significantly higher than those in the SLA group and DOPA group (P < 0.05). Conclusion Hierarchical micro/nanosurfaces decorated with TiO2 nanotubes functionally modified with RGD peptides have good biocompatibility and could be used for developing titanium implants and further improving early osseointegration.