2.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
3.Investigation on ergonomic load of ceramic and porcelain manufacturing workers.
Si-hao LIN ; Pei-yuan ZHOU ; Wen-juan TANG
Chinese Journal of Industrial Hygiene and Occupational Diseases 2010;28(3):following 240-following 240
Ceramics
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Ergonomics
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Female
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Humans
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Male
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Occupational Exposure
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Workload
4.Sequence analysis for full length genomes of human enterovirus 71 strains isolated in Linyi, Shandong Province
Hongling WEN ; Shubin HAO ; Feng GAO ; Li ZHAO ; Luying SI ; Xiaojing YUAN ; Dongxu WANG ; Zhiyu WANG
Chinese Journal of Microbiology and Immunology 2011;31(7):603-608
Objective To isolate enterovirus 71 from a death children,and analyze whether the neurovirulence was related to the variation of nucleotide and amino acid. Methods Enterovirus 71 was isolated from throat swabs which were colleted from Shandong Linyi People's Hospital. The full length genome was sequenced by amplification with RT-PCR and sequencing of 9 overlapped gene fragments covering full length of the genomes. The nucleotide and amino acid sequenced was aligned by BLAST, Bioedit and MEGA 4. Results A strain of enterovirus 71 was isolated and named as SDLY107. The full length was 7405 bp. The results of homology analysis of overall nucleotide sequence showed that strain Fuyang. Anhui. P. R. C/17.08/2 had highest homology (98.6%)with strain SDLY107, and the homology was 80.0% between strain SDLY107 with prototype strain BrCr/70,and 86. 5% between strain SDLY107 with nerve strain MS/87. Phylogenetic analysis showed that the phylogeny was close between SDLY107 with some isolated strains from Chinese Mainland, such as Beijing, Henan, Guangxi, Sbenzhen, Lanzhou, Fuyang, Chongqing and Zhejiang strains, which was clustered for C4 subtype. The results of amino acid sequence analysis showed that there were 2 mutations, E947D and K1873R, for strain SDLY107. Conclusion SDLY107 belonged to C4 subtype, amino acid mutations E947D and K1873R of which may be relevant to the pathogenicity of EV71.
5.Clinical significance of different antiphospholipid antibody isotypes in systemic lupus erythematosus
Shulan ZHANG ; Ziyan WU ; Si CHEN ; Yuan LI ; Wen ZHANG ; Yongzhe LI
Chinese Journal of Laboratory Medicine 2014;37(8):597-602
Objective To investigate the prevalence and clinical significance of different subtypes (IgG,IgM and IgA) of anticardiolipin antibodies (aCL) and anti-β2-glycoprotein Ⅰ antibodies (aβ 2GP1),as well as lupus anticoagulant (LA) in systemic lupus erythematosus (SLE).Methods IgG/IgM/IgA,IgG,IgM,IgA aCL and anti-β2GP1 were tested by enzyme-linked immunosorbent assay (ELISA) in 100 patients with SLE (42 patients were diagnosed as secondary antiphospholipid syndrome),44 healthy controls and 32 patients with other connective tissue diseases excluding SLE and antiphospholipid syndrome (APS).Meanwhile,LA was tested by modified Dilute Russell's viper venom time (dRVVT).The correlation between antiphospholipid antibodies and clinical manifestation was analyzed by Spearman correlation analysis.The postiverate of antiphospholipid antibodies in SLE patients,health controls and patients with other connective tissue diseases were compared by chi square test.The concentrations of antiphospholipid antibodies in different groups were compared using independent sample Kruskal Wallis test.The diagnostic efficacy of antiphospholipid antibodies in SLE patients was analyzed by crosstable using clinical diagnosis of APS as gold standard.P < 0.05 was considered statistically significant.Results The prevalence of IgG aCL (x2 =15.031,P < 0.001),IgA/G/M (x2 =11.678,P =0.003) and IgA (x2 =6.17,P =0.036) antiβ2GP1 were significantly higher in patients with SLE than in the other two groups.IgA/G/M (r =0.207,P=0.039),IgG (r=0.230,P=0.021) and IgA (r=0.217,P=0.030) aCL,IgA/G/M (r=0.218,P=0.029) and IgA (r =0.255,P =0.01) anti-β2GP1,as well as LA (r =0.233,P =0.02) were associated with thrombotic events.IgA/G/M anti-β2GP1 (r =0.22,P =0.029) and LA (r =0.254,P =0.011) were associated with pathological pregnancy.23.1% (6/26) aCL positive SLE patients were IgM and/or IgA aCL positive.53.6% (15/28) anti-β2GP1 positive SLE patients were IgM and/or IgA antiβ2GP1 positive.In SLE patients,the specificity and sensitivity of IgA/G/M aCL for APS were 98.3% and 26.2%,respectively.The specificity and sensitivity of IgA/G/M anti-β2GP1 were 84.5% and 40.5%,respectively.The specificity of at least two isotypes positive for APS (both aCL and anti-β2GP1 were 98.3%),was higher than IgG aCL (94.8%) or anti-β2GP1 (93.1%).The sensitivity of at least one isotype of aCL (47.6%) or anti-β2GP1 (42.9%) positive for APS were higher than IgG aCL (40.5%)and anti-β2GP1 (21.4%).Conclusions IgG and IgM aCL together would be better than IgA/G/M aCL for APS screening.IgA/G/M anti-β2GP1 would be better for APS screen due to higher sensitivity and strong association with thromboembolic events and pathologic pregnance.IgA aCL or anti-β2GP1 was associated with thromboembolic events.IgA aCL or anti-β2GP1 would be useful for APS diagnosis in IgG and IgM aCL or anti-β2GPl negative patients.
6.Investigation on anti-hepatitis B virus active components and mechanism of Salvia miltiorrhiza based on network pharmacology
Hai-mei WEN ; Si-yuan WANG ; Ya-ru WANG ; Feng-li XING ; Yong CHEN ; Wen-tao CAI
Acta Pharmaceutica Sinica 2022;57(5):1375-1386
We predicted the anti-hepatitis B virus (HBV) active components and mechanism of
7.Regularity of drugs compatibility of anti-hepatoma traditional Chinese medicine ancient prescriptions and risk evaluation of anti-hepatoma new drug research and development.
Jing ZHANG ; Hong-Fa LI ; Wei FAN ; Zhen LIU ; Shu-Li MAN ; Shu-Yong SI ; Wen-Yuan GAO
China Journal of Chinese Materia Medica 2014;39(19):3870-3875
Traditional Chinese ancient prescriptions have been used for treatment of liver cancer for a long history and the scientific and rational compatibility is a great wealth for modern research and development (R&D) of new drugs. The research and development of new drugs are often accompanied with a large investment, a long cycle and a high risk, especially for the anti-tumor drugs R&D which are facing more risks and lower successful rate. In this research, the regularity of compatibility of drugs was analyzed from 124 anti-hepatoma ancient prescriptions by computer program. The results can offer help to the R&D of anti-hepatoma new drugs and reduce the risk of drug screening. In addition, we surveyed 22 companies in this field from six provinces such as Beijing, Shanghai, Tianjin and so on and obtained 240 risk assessment questionaires. Then we used qualitative analysis method to interpret the greatest impacts for the risks in the process of R&D, production and sales of anti-hepatoma new drugs. The study provides a basis for anti-liver cancer drugs R&D researchers, who can take effective measures to reduce the R&D risks and improve successful rate.
Carcinoma, Hepatocellular
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drug therapy
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history
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China
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Drug Discovery
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history
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Drug Incompatibility
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Drug Prescriptions
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history
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Drugs, Chinese Herbal
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history
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therapeutic use
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History, Ancient
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Humans
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Liver Neoplasms
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drug therapy
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history
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Research
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history
8.Diagnostic value of renal phospholipase A2 receptor and serum anti-phospholipase A2 receptor antibody in membranous nephropathy
Xiaoxiang WU ; Si WEN ; Xuejing ZHU ; Shuguang YUAN ; Xiangqing XU ; Danyi YANG ; Lin SUN ; Hong LIU ; Fuyou LIU
Journal of Central South University(Medical Sciences) 2017;42(4):395-399
Objective:To examine the expression ofphospholipase A2 receptor (PLA2R) in renal tissues and the level of anti-PLA2R antibody in serum in patients with idiopathic membranous nephropathy (IMN) and secondary membranous nephropathy (SMN),and to evaluate their diagnostic value in IMN.Methods:A total of 73 patients,who were diagnosed between May,2014 and February,2015 in the Department of Nephrology of the Second Xiangya Hospital,Central South University,were divided into three groups:an IMN group (n=48),an SMN group (n=17) and a minimal change disease group (n=8) according to the renal biopsy.PLA2R expression in renal tissues and the level of antiPLA2R antibody in serum were detected by indirect immunofluorescence technique.Results:The positive rate and fluorescence intensity for PLA2R in the renal tissues in the IMN group were higher than those in the SMN group (91.7% in the IMN group vs 29.4% in the SMN group,P<0.05),while the positive rate and serum level for anti-PLA2R antibody in the IMN group were higher than those in the SMN group (85.4% in the IMN group vs 29.4% in the SMN group,P<0.05);the expression of PLA2R in renal tissues and the serum level for anti-PLA2R antibody were not detected in the minimal change disease group,The serum level of anti-PLA2R antibody was positively correlated with 24 h urine protein (r=0.432,P<0.01) and negatively correlated with serum albumin (r=-0.307,P<0.05).Conclusion:The expression of PLA2R in renal tissues and the serum level of anti-PLA2R antibody might be potential markers for diagnosis oflMN.
9.Preliminary study on treatment of partial androgen deficiency in aging males with Jingui Shenqi Pill.
Wen-jun CHE ; Xiao-zhou HE ; Jian-pin JIANG ; Wen-yuan CAI ; Si-jie XIE
Chinese journal of integrative medicine 2005;11(4):300-302
OBJECTIVETo observe the efficacy and safety of Jingui Shengqi Pill in treating partial androgen deficiency in aging males (PADAM), and to explore the new approach in improving the quality of life in PADAM patients.
METHODSForty patients with PADAM were treated with JSP, the efficacy was evaluated with international index of erectile function (IIEF) scoring, PADAM questionnaire scoring, hormone, prostatic specific antigen (PSA), etc., and the data before treatment were compared with those after treatment in the same group.
RESULTSAfter 3 months of treatment, PADAM scoring and IIEF scoring were all significantly improved. Symptoms regarding physical ability, vasomotion, and psychical and mental condition all got improved more markedly than symptoms regarding sexual hypofunction. The serum level of testosterone was 3.85 +/- 0.36 before treatment and 5.02 +/- 0.83 after treatment (P < 0.05); luteinizing hormone of 7.33 +/- 2.14 and 4.84 +/- 1.43 (P < 0.01), follicle-stimulating hormone of 10.22 +/- 4.48 and 6.47 +/- 3.28 (P < 0.01), respectively. The level of PSA failed to change significantly (1.94 +/- 0.55 and 2.06 +/- 0.47, P > 0.05).
CONCLUSIONJSP is effective and safe in treating PADAM, the mechanism of it is different from supplementing extrinsic androgen. It may have produced the effect by means of favorably regulating the condition of sex hormone to improve the balance of pituitary-sex gland axis, so it has more extensive clinical application.
Aged ; Androgens ; deficiency ; Drugs, Chinese Herbal ; adverse effects ; therapeutic use ; Erectile Dysfunction ; drug therapy ; Follicle Stimulating Hormone ; blood ; Humans ; Luteinizing Hormone ; blood ; Male ; Middle Aged ; Prostate-Specific Antigen ; blood ; Testosterone ; blood
10.The assessment of vulnerability to floods in Guangdong province at district level.
Qi ZHU ; Tao LIU ; Yong-hui ZHANG ; Yuan LUO ; Yao WEI ; Jian-peng XIAO ; Si-qing ZENG ; Wen-jun MA
Chinese Journal of Preventive Medicine 2012;46(11):1020-1024
OBJECTIVETo evaluate the vulnerability to floods in Guangdong province at district level.
METHODSData were collected from the sixth census, the 2010 Statistical Yearbook of Guangdong, the 2010 Health Statistics Yearbook of Guangdong and China Disease Prevention and Control information systems, etc. The weight of each indicator was determined based on subjective method and objective method respectively; and finally the results of the two methods were compared.
RESULTS13 indicators were selected for the assessment of vulnerability to floods, including 6 sensitivity indicators, 5 adaptability indicators and 2 exposure indicators. Indicators with large weight (subjective weight/objective weight) were the proportion of population older than 65 years old (0.31/0.30), the proportion of population older than 65 years old (0.16/0.23), infant mortality rate (0.18/0.20), the total Gross Domestic Product (GDP) per capita (0.33/0.21), the proportion of illiterate in the population older than 15 years old (0.19/0.28), history frequency of floods (0.75/0.75). The mean vulnerability index (VI) calculated by subjective method was 0.35 with the standard deviation of 0.10; the mean vulnerability index calculated by objective method was 0.31 with the standard deviation of 0.08. The two weighting methods showed consistent results of vulnerability index (ICC = 0.975, P < 0.01). VI of most districts dropped in the interval of 0.30 - 0.39. Districts with subjective VI > 0.50 or objective VI > 0.40 should pay more attention to floods, including parts of the coastal areas, Beijiang River Basin, the eastern tributary area of Dongjiang River and the northern part of Pearl River Delta. Dapu district of Meizhou (0.55/0.45), Dianbai district and Maogang district of Maoming (0.54/0.48) were most vulnerable. Districts of Heyuan, Dongguan, Zhaoqing and Huizhou were less vulnerable, Yuancheng district of Heyuan showed least vulnerable to floods (0.15/0.12) followed by Dongguan (0.18/0.16), Duanzhou district (0.18/0.16) and Guangning (0.17/0.15) district of Zhaoqing. The score of indicators differed among different level of vulnerability (P < 0.05).
CONCLUSIONDifferent regions of Guangdong province showed different vulnerability to floods, vulnerable areas should be priority in the prevention and control of floods.
China ; Climate ; Demography ; Disasters ; Floods ; Humans ; Risk Assessment ; Rivers