Based on collecting data at home and abroad, we combined clinical practice of scientific researches. We also summarized key points for design and evaluation of clinical studies in treating children's attention deficit hyperactivity disorder by Chinese medical new drugs from objective and design, selection of diagnostic criteria, recruitment and dropping-out of subjects, effectiveness evaluation, safety evaluation, drug combination, and quality control, and so on. We hope to provide reference for design and evaluation of clinical studies by Chinese medical new drugs.
Attention Deficit Disorder with Hyperactivity ; drug therapy ; Biomedical Research ; Child ; Clinical Studies as Topic ; Data Collection ; Drugs, Chinese Herbal ; therapeutic use ; Humans

Objective To evaluate the relationship between children interleukin-1 receptor antagonist gene(IL-1RN) polymorphisms and susceptibility to febrile seizures(FS).Methods Matching case-control study was carried out,blood samples from 52 patients with FS and 53 healthy children were collected.Genomic DNA was extracted and examined by polymerase chain reaction(PCR) amplification for judging IL-1RN genetype.Results Only Ⅰ/Ⅰ,Ⅰ/Ⅱ,Ⅱ/Ⅳ genetypes of IL-1RN were found in the surveyed Chinese population of Han nationality in Guangdong Province.No significant differences of these genotypes were observed in patients and controls.But the allele frequencise of Ⅰ,Ⅱand Ⅳ in patients were 95.2%,3.8% and 1.0%,respectively,while these frequencise in controls were 84.9%,10.4% and 4.7%,respectively.The allele frequency of IL-1RNⅠin patients was obviously higher than that in controls(P

Objective To estimate the clinic features of severe multiple trauma with secondary thrombocytosis as a factor influencing the prognosis.Methods A retrospective single-center study was carried out in 680 patients with severe multiple trauma survived longer than 72 hours in Chongqing Emergency Medical Center from March 2010 through March 2013.The variables including age,gender,ISS (injury severity score),APACHE Ⅱ score,splenectomy and the usages of vasopressors,blood products transfusion,hematopoietic medicines and anticoagulant were analyzed.The prognosis indices including total in-hospital mortality after 72 hours,length of hospital stay and morbidity of thrombo-embolism were explored.The clinic characteristics and prognosis of severe multiple trauma with secondary thrombocytosis (platelet count more than 450 × 109 L-1) were evaluated.T test or rank sum test was used for comparison between measurement data and Chi-square test or Fisher' s exact test was used for comparison between enumeration data.Results Thrombocytosis was identified in 99 (14.56％) patients and it occurred one week after injury with median time of 27 days (ranged from 8 days to 304 days),and maintained for (18.62±4.38) d.The median of platelet count was 584 × 109 L-1 (lowest 478 × 109 L-1,highest 1 072 × 109 L-1) in severe multiple trauma patients with thrombocytosis.The proportions of splenectomy,prolonged use of vasopressors and employment of hematopoietic medicines or anticoagulant were significantly higher in patients with thrombocytosis than those in patients without thrombocytosis (14.14％ vs.7.06％,P=0.03;62.63％ vs.39.07％,P＜0.01; 28.28％ vs.6.71％,P＜0.01; 90.91％ vs.19.45％,P＜ 0.01).The highest D-Dimer level presenting in patients with thrombocytosis during the time of platelet increasing was significantly more common than that in patients of non-thrombocytosis group 7 days after trauma [(11.68 ± 11.90) vs.(5.05 ± 5.11),P =0.004].However,the mortality,length of hospital stay and morbidity of thrombo-embolism were not significantly increased in patients with thrombocytosis compared with patients without thrombocytosis [8.08％ vs.8.78％,P=0.82; 34 d (28.5,54.5) d vs.45 d (23,67) d,P =0.41; 10.10％ vs.10.50％,P =0.91].Conclusion There was a higher rate of secondary thrombocytosis in severe multiple trauma patients.The factors such as splenectomy,vasopressors,hematopoietic medicines and so on might induce the reactive thrombocytosis in trauma patients.Thrombocytosis might increase the incidence of thromboembolism in severe multiple trauma patients without appropriate prophylactic anticoagulation.For the sake of prophylaxis,employment of anti-platelet agent might be the appropriately therapeutic strategy for patients suffering from severe multiple trauma with secondary thrombocytosis accompanying risk factors of arterial thrombo-embolism.

The publication of the scientific theses and their management are significant for the development of technology and science in the hospital.Therefore.they play an important role iU the hospital management.The retrospective analysis on the theses that published in the last 5 years and embodied by SCI was conducted using the statistics method and analyzed the first 10 departments in the published theses in this paper.The specialty of our hospital and the shortcoming in the scientific research was concluded from the analysis result.The amount of the theses increased steadily,and the research capability of the key subjects and key departments were promoted.The amount and the quality of the theses reflected an important indicator of the development strategy that means to develop the hospital through science.technology and education.Therefore,these conclusions could offer some valuable information to the manage department of t}le hospital.

Objective To study the effects of 50 Hz magnetic fields on the in vitro proliferation of human osteosareoma cell line MG-63 with different cell densities.Methods Four different magnetic intensities(1 mT, 2 mT,3 roT,4 mT)were used to stimulate the cells,and the experiment was repeated with different cell densities. The method of MTT was employed to evaluate the level of proliferation.Results Fifty Hz magnetic fields signifi- cantly affected the level of proliferation of human osteosareoma cell line MG-63,and the 2 mT intensity exerted the greatest influence on it.The effects of the magnetic field differed with different cell densities.Conclusion The effect of 50 Hz magnetic fields on the in vitro proliferation of human osteosarcoma cell line MG-63 was not only relat- ed to the magnetic intensity,but also the cell density,

Objective To investigate the profile of local immunity of vagina and the immune defense mechanisms against lower genital tract infections. Methods Vaginal lavage was collected from healthy women and patients of vulvovaginal candidiasis, bacterial vaginosis, Trichomonol vaginitis, human papilloma virus infection(VVC), and chlamydia trachomatis infection. Each group included 60 cases. The level of interleukin (IL) 2,4,5, 13,8 and human defensin 5 (HD5) were detected by enzyme linked immunosorbent assay(ELISA). Results (1) Cytokine of helper T cell 1(Th1): the level of IL-2 between healthy women and VVC/ bacterial vaginosis (BV)/ trichomonol vaginitis (TV)/ chlamydia trachomatis (CT) patients had no significant difference. The IL-2 level(96±33 )×10-3 pg/L of human papilloma virus (HPV) infection patients was significantly higher than that of healthy women( P<0.05). (2)Cytokine of helper T cell 2 (Th2) : the level of IL-4 between healthy women and VVC/CT patients had no significant difference. The level of IL-5 between healthy women and BV patients had no significant difference. The IL-13 level(42±15)×10-3 pg/L of TV patients was significantly higher than that of healthy women (30±29)×10-3 pg/L (P<0.05). The IL-4 level (103±28)×10-3 pg/L of HPV infection patients was significantly higher than that of healthy women (36±22)×10-3 pg/L (P<0. 05 ). (3) IL-8 : the IL-8 level (5.8± 2.7) pg/L of TV infection patients was significantly higher than that of healthy women (2. 6±2.4) pg/L (P<0.05). The level of IL-8 between healthy women and BV patients had no significant difference. (4)HD5:the HD5 level of TV , BV, VVC, HPV and CT infection patients were significantly higher than that of healthy women (P<0.05). Conclusions (1) HD5 plays an important role in the defence of vaginal epithelial cell. (2) Th2 may be more important than Thl in lower genital tract infections.(3) IL-8 plays an important role in extrinsic source infections.

Objective To explore the prevalence of osteoporosis (OP) and vertebral osteoporotic fracture (OPF) and related risk factors in patients with rheumatoid arthritis (RA).Method A total of 644 patients with RA from Jan.2010 to Oct.2013 were recruited,anteroposterior and lateral X-rays examination of vertebral column (T5-L5) were conducted,and semi-quantity method were used as the standard for judging vertebral OPF.Meanwhile,patients' clinical and laboratory data including daily dosage of glucocorticoid,duration of glucocorticoid usage,cumulative amount dosage of glucocorticoid were recorded in details.158 normal subjects were selected as control group.Results (1)The prevalence of vertebral OPF in patients with RA was 16.6％.Bone mineral density (BMD) of all measured lumbar vertebra in RA group were markedly decreased[(0.97 ±0.22) g/cm2].The total prevalence of OP at lumbar vertebra in RA was 17.9％ (81/452),which was significantly higher than that of control group (4.4％,7/158) (P ＜ 0.001).(2) The percentage of OP in RA patients with vertebral OPF was significantly higher than that in patientswithout OPF [40.6％ (41/101) vs 11.4％ (40/351) ;P ＜ O.001].Patients with OPF were of older age,longer use of glucocorticoid,more cumulative amount dosage of glucocorticoid,longer disease duration,higher scores of health assessment questionnaires (HAQ) and increased ESR (P ＜ 0.05).(3) Logistic regression analysis revealed that age (OR =1.094,95％ CI 1.065-1.125,P ＜0.001) and gender(1 =male,2 =female) (OR=5.600,95％ CI 2.097-15.087,P =0.001) were the risk factors for the development of OP in RA,while body mass index (BMI) was the protective factor (OR =0.770,95％ CI 0.696-0.853,P ＜ 0.001).Age (OR =1.031,95％ CI 1.009-1.053,P =0.005) and occurrence of OP at lumbar vertebra (OR =3.765,95％ CI 2.092-6.776,P ＜ 0.001) were risk factors of the development of OPF in RA patients.Logistic regression analysis also showed that RA was the risk factor of OPF (OR =4.716,95％ CI 1.987-11.192,P ＜ 0.001),even after the adjustment of age,gender and BMI.(4) Receiver operator characteristic(ROC) curve in RA patients with OPF has found that age-OPF and daily dosage of glucocorticoid-OPF AUCRoC were 0.689 and 0.636 respectively.The cut-off value in ROC curve of age and daily dose or treatment course of glucocorticoid-OPF were 54.5 years and 6.25 mg(P ＜0.001),while duration of glucocorticoid usage-OPF AUCROC was 0.685,with cut-off value in ROC of age-OPF 135 days(P ＜ 0.001).Conclusion Prevalence of OPF in patients with RA increases remarkably.Old age and OP at spine are risk factors related to the development of OPF in patients with RA.

Objective To investigate the value of serum receptor activator of nuclear factor kappa B ligand (RANKL)/osteoprotegrin (OPG) ratio in osteoporotic fracture (OPF) of patients with rheumatoid arthritis (RA).Methods Three hundred and eighty four RA patients with mean age of (49 ± 14) y (16-82) admitted in the First Affiliated Hospital of Anhui Medical University from 2010 to 2013 and 158 sex-and age-matched healthy subjects were enrolled in the study.OPF was diagnosed by X-ray examination and BMDs of femur and lumbar spine 2-4 (L2-4) were measured by dual energy X-ray absorptiometry.Levels of RANKL and OPG in the peripheral blood of 220 RA patients and 100 normal subjects were detected by ELISA method.Results Eighty-two cases of OPF was diagnosed in 384 RA patients (21.35％),the rate was higher than that in controls (3.80％,6/158,x2 =25.371,P ＜0.01).The peripheral blood levels of RANKL (0.150 ± 0.143 vs.0.101 ± 0.066,t =4.178,P ＜ 0.01),OPG (0.457 ± 0.293 vs.0.359 ±0.216,t=3.347,P=0.001) and ratio of RANKL/OPG (0.41 ±0.35 vs.0.34±0.20,t =2.111,P=0.036) in RA patients were significantly higher than those in control group.In comparison with normal controls,BMDs of all detected regions in RA were decreased significantly (P ＜0.01).The incidence of osteoporosis in RA (121/327,37％) was higher than that in normal controls (22/158,13.92％) (x2 =27.291,P ＜ 0.01).RA patients with OPF had higher age (t =4.377,P ＜ 0.01),longer duration of disease (t =2.612,P =0.009),higher RANKL level (t =3.554,P =0.001),higher RANKL/OPG ratio (t =2.651,P =0.010),higher health assessment questionnaires (HAQ) score (t =2.418,P =0.016),lower serum calcium level (t =2.183,P =0.030),lower hemoglobin level (t =2.125,P =0.036),higher Sharp score in hands X-ray examination (t =2.747,P =0.007),worse X-ray stage (x2 =7.856,P =0.049),higher glucocorticoid utilization rate (x2 =9.066,P =0.003) and higher incidence of osteoporosis (x2 =38.186,P ＜ 0.01),compared with patients without OPF.RA patients taking corticosteroids had higher incidence of osteoporosis (x2 =7.489,P =0.006) and higher incidence of OPF (x2 =9.066,P =0.003).Logistic regression analysis showed that age (OR =1.029,P =0.039,95％ CI:1.001-1.057)and the occurrence of osteoporosis (OR =3.159,P =0.001,95％ CI:1.562-6.385),RANKL/OPG ratio (OR =3.516,P =0.013,95 ％ CI:1.305-9.647) were risk factors for RA patients with OPF.Conclusion A higher incidence of OPF is prevalent in RA patients,and age,osteoporosis,taking glucocorticoids and RANKL/OPG ratio are risk factors for OPF in RA patients.

Objective:To compare the smile characteristics of the subjects with different types of malocclusion.Methods:1 80 sub-jects with classⅠ(n =60),classⅡ(n =60)and class Ⅲ(n =60)malocclusion at the age of 1 8 to 25 years were included.The smile vidioes and posed smile images of the subjects were acquired.Smile quantitative evaluation indexes were measured and analysed.Re-sults:There were statistical differences in smile indexes and the amount of the gingival exposure in classⅡ subjects between the male and female(P <0.05).There were statistical differences in the quantitative evaluation indexes except the smile symmetry rate among the three groups(P <0.05).The buccal corridor and the gingival exposure ordered from larger to smaller:class Ⅱ >classⅠ >classⅢ,smile index of class Ⅲ was greater than that of class Ⅰ and class Ⅱ,the teeth exposure of class Ⅱ was less than that of class Ⅰand class Ⅲ.Conclusion:Malocclusion types may affect smile characteristics.

Objective:To establish the quality standard for Shule capsules. Methods: The microscopic characteristic identifica-tion of Figwort and Radix bupleuri was performed under a microscope. The qualitative identification of fritillary, andrographispaniculata and polygonumbistorta was studied by TLC. The content of salvianolic acid B in Salvia miltiorrhiza was determined by HPLC. The chro-matographic separation was carried out by using a phenomenex synergi 4 hydro-RP 80A (250 mm × 4. 6 mm) column. The mobile phase consisted of acetonitrile-methanol-formic acid-water(10 :30 :59 :1)with gradient elution at a flow rate of 1. 0 ml·min-1, and the injection volume was 10 μl . The detection wavelength and the column temperature was 286 nm and 20 ℃, respectively. Results:The microscopic characteristics were obvious. The spots in TLC were clear without any interference. The linear range was 10. 001-100. 007 μg·ml-1(r=1. 0000). The average recovery was 99. 3% with RSD of 1. 8% (n=6). Conclusion:The method is simple with high specificity and good repeatability, which can be used as the quality control method for Shule capsules.