1.Key Points for Design and Evaluation of Clinical Studies in Treating Children's Attention Deficit Hyperactivity Disorder by Chinese Medical New Drugs.
Wen SHEN ; Rong MA ; Si-yuan HU
Chinese Journal of Integrated Traditional and Western Medicine 2015;35(5):627-630
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
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drug therapy
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Biomedical Research
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Child
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Clinical Studies as Topic
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Data Collection
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Drugs, Chinese Herbal
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therapeutic use
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Humans
2.A retrospective analysis of severe multiple trauma with secondary thrombocytosis
Li LU ; Ping HU ; Yuming WEN ; Yu MA
Chinese Journal of Emergency Medicine 2015;24(5):493-497
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.
3.Analysis of medical scientific theses of Union Hospital of Tongji Medical College in last 5 years
Wen DUAN ; Yu HU ; Jiahong XIA ; Ming MA
Chinese Journal of Medical Science Research Management 2009;22(2):116-117,封3129
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.
4.Analysis of Interleukin-1 Recepetor Antagonist Gene Polymorphisms of Children with Febrile Seizwres
shu-hua, LI ; chao-feng, HU ; wen-cheng, MA
Journal of Applied Clinical Pediatrics 2004;0(07):-
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
5.The effect of exposure to 50 Hz magnetic fields on the proliferation of different cell densities of human MG-63 osteosarcoma cell line in vitro
Wen-Chun ZHAO ; Hua WU ; Wei-Ming MA ; Hai-Hu HAO ; Hai-Jun ZHANG ; An HU ;
Chinese Journal of Physical Medicine and Rehabilitation 2003;0(05):-
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,
6.Study of local immunity of lower genital tract infections
Dai ZHANG ; Zhaohui LIU ; Qinping LIAO ; Jingmei MA ; Yufeng SUN ; Shangrong FAN ; Lina HU ; Haijun JIA ; Wen DI ; Wen WANG
Chinese Journal of Obstetrics and Gynecology 2009;44(1):13-15
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.
7.Comparison of frame and fixed protraction appliances in the treatment of skeletal Ⅲ malocclusion in mixed dentition
Chunyan LIU ; Haiyan LU ; Wen WANG ; Wensheng MA ; Xiaoying HU ; Wenjing CHEN
Journal of Practical Stomatology 2014;(2):227-231
Objective:To compare the efficacy of casting frame and traditional fixed maxillary protraction appliances in the correc-tion of skeletal Ⅲ malocclusion in mixed dentition.Methods:30 cases with Class Ⅲ malocclusion in mixed dentition were random-ly divided into 2 groups.Casting frame maxillary protraction appliance was applied in group 1 (1 5 cases)and traditional fixed maxil-lary protraction appliance in group 2(15 cases).X-ray cephalometric examination results before and after treatment,treatment time, and the number of visit in 2 groups were analyzed with SPSS 1 3.0.Results:The treatment time in group 1 and 2 was (7.03 ±1 .32) and (9.07 ±1 .31 )months(P <0.05),the number of visiting was (8.00 ±1 .46)and (10.47 ±1 .85)(P <0.05),the cephalomet-ric measurement change of △U1 -SN was (3.85 ±0.95)°and (5.25 ±0.95)°(P <0.05),respectively.Conclusion:Casting frame protraction appliance is an efficient and practical intraoral device,which can prevent anterior upper teeth inclined to labial.
8.Gabapentin reduces mechanical allodynia in a rat model of tibial bone cancer pain
Liping CHEN ; Wen SHEN ; Dongmei YUE ; Xueming HU ; Jiao LIU ; Yan YUAN ; Zhengliang MA
Chinese Journal of Behavioral Medicine and Brain Science 2012;21(8):693-695
ObjectiveTo explore the effects of gabapentin on mechanical allodynia in rats with tibial bone cancer pain (BCP).MethodsForty-two female SD rats were randomized into 7 groups ( n=6):naive group (group N ),sham operation + NS control group (group SN),sham operation + GBP200mg/( kg · d) group (group SG200),BCP + NS control group (group BN),BCP + GBP50mg/( kg · d) group ( group BGS0),BCP +GBP100mg/(kg · d) group (group BG100),and BCP + GBP200mg/(kg · d) group (group BG200).The rats in group N,SN and BN received 5 ml normal saline and the rats in group SG200,BG50,BG100 and BG200 received 200,50,100 and 200 mg/( kg · d) dose of GBP via feeding from day 7 to 13 after operation,respectively.Mechanical withdrawal threshold(MWT) of the right paw and behavioral assays for ambulatory pain were measured just before operation and on days 1,3,5,7,8,10,12 and 14 after operation.ResultsMWT( (3.78 ± 0.38)g) in rats with BCP decreased and behavioral assays for ambulatory pain (0.76 ± 0.44) increased on day 7 after operation,as compared with those in group N ( ( 14.50 ± 1.38 ) g,(0.00 ± 0.00 ) ) and group sham ( ( 10.21 ± 0.88 ) g,( 0.00 ±0.00) ) (P < 0.05 ).There was no apparent praxiological difference between group SN and group SG200 in a week of continuous application of gabapentin(P> 0.05 ).Compared with those in group BN,there was no change on MWT in group BG50 (P > 0.05 ),and however,behavioral assays for ambulatory pain decreased (P < 0.05 ).MWT in group BG100( (5.35 ±0.85)g) and BG200( (5.71 ±0.72) g) increased in day 10 after operation,as compared with those in group BN ( ( 2.61 ± 0.40) g) and group BG50 ( ( 3.28 ± 1.15 ) g) (P < 0.05 ),and the difference was still statistically significant until day 14 (P < 0.05 ).Behavioral assays for ambulatory pain in group BG100 and BG200 decreased from day 8 after operation,as compared with those in group BN and group BG50 (P < 0.05 ).ConclusionGabapentin,in medium to large dosage,can inhibit pain reaction of rats with bone cancer pain.Nevertheless,with the development of cancer,the effect of gabapentin decreases.
9.A study on short-term outcome of ultrasound-guided percutaneous microwave ablation therapy of uterine fibroids by magnetic resonance imaging
Bo, WEN ; Jing, ZHANG ; Lei, FENG ; Dongmei, HU ; Xia, MA ; Fang, WANG ; Yuhong, ZHOU
Chinese Journal of Medical Ultrasound (Electronic Edition) 2015;(7):574-578
Objective To study the short-term outcome of the uterine fibroids treated with ultrasound-guided percutaneous microwave ablation therapy (PMAT) by magnetic resonance imaging (MRI). Methods PMAT was performed in 46 symptomatic patients with a total of 49 uterine fibroids. Pre-and post-contrast MRI was scanned at 3 days before treatment and 3 days after treatment to assess image changes of both fibroids and surrounding tissues. The fibroids were divided into group A (low signal), B (iso-signal), C (high signal) by the signal intensity on T2WI. According to the volume changes of fibroids and uterine, ablation rate and the reduction rate of the fibroids after treatment were calculated. Results There were 28, 17 and 4 fibroids in the group A, B and C respectively. Before the treatment the volume of the fibroids showed no statistical difference between the group A, B and C (P>0.05). Fibroids and uterine showed shrinkage after the treatment in the group A and B (t=5.644, 5.998, 6.725 and 4.678, all P<0.001). The fibroids ablation rate showed no statistical difference between the groups (F=0.852, P>0.05). Fibroids and uterine showed shrinkage after the treatment in the group C, but there was no obvious statistical difference. Conclusion The outcome of PAMT is good for the fibroids with different signal intensity on T2WI. But the fibroids with high signal intensity are not as sensitive as those with low or iso intensity to achieve the same ablation level.
10.Exploration of risk factors on the occurrence of osteoporotic vertebral fracture in patients with rheumatoid arthritis
Wen LIU ; Shengqian XU ; Xixi MA ; Linwei HU ; Liping PENG ; Jianhua XU
Chinese Journal of Internal Medicine 2014;53(11):852-857
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.