1.Secukinumab demonstrates high efficacy and a favorable safety profile over 52 weeks in Chinese patients with moderate to severe plaque psoriasis.
Lin CAI ; Jian-Zhong ZHANG ; Xu YAO ; Jun GU ; Quan-Zhong LIU ; Min ZHENG ; Shi-Fa ZHANG ; Jin-Hua XU ; Cheng-Xin LI ; Hao CHENG ; Qing GUO ; Wei-Li PAN ; Shen-Qiu LI ; Ruo-Yu LI ; Zai-Pei GUO ; Zhi-Qi SONG ; Shan-Shan LI ; Xiu-Qin DONG ; Linda WANG ; Rong FU ; Pascaline REGNAULT ; Pascal CHAREF ; Rafal MAZUR ; Manmath PATEKAR
Chinese Medical Journal 2020;133(22):2665-2673
BACKGROUND:
Psoriasis is a chronic inflammatory skin disease, affecting about 0.6% of the Chinese population. Many patients are not well controlled by conventional treatments, thus there is need for new treatment regimens. In this study, we assessed the efficacy and safety of secukinumab in Chinese patients with moderate to severe plaque psoriasis.
METHODS:
This study was a 52-week, multicentre, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 trial. A sub-population of study participants (≥18 years) of Chinese ethnicity were randomized to receive subcutaneous injections of 300 or 150 mg secukinumab, or placebo. The co-primary endpoints were psoriasis area severity index (PASI) 75 and Investigator's Global Assessment (IGA) 0/1 at Week 12.
RESULTS:
A total of 441 Chinese patients were enrolled in this study. Co-primary outcomes were achieved; 300 and 150 mg secukinumab were superior to placebo as shown in the proportion of patients that achieved PASI 75 (97.7% and 87.2% vs. 3.7%, respectively; P < 0.001), and IGA 0/1 (82.3% and 69.7% vs. 2.7%; P < 0.001) at Week 12. Treatment efficacy was maintained until Week 52. There was no increase in overall adverse events with secukinumab relative to placebo throughout the 52-week period.
CONCLUSION:
Secukinumab is highly effective and well tolerated in Chinese patients with moderate to severe plaque psoriasis.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT03066609; https://clinicaltrials.gov/ct2/show/record/NCT03066609.
Antibodies, Monoclonal/therapeutic use*
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Antibodies, Monoclonal, Humanized
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China
;
Double-Blind Method
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Humans
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Psoriasis/drug therapy*
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Severity of Illness Index
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Treatment Outcome
2.Application of apparent diffusion coefficient in children aged 2-12 years with intellectual disability/global developmental delay who have normal conventional brain MRI findings.
Lin LI ; Jian-She ZHAO ; Zai-Fen GAO ; Chang-You MA ; Chun-Hua DONG ; Hong-Wei ZHANG
Chinese Journal of Contemporary Pediatrics 2019;21(6):541-546
OBJECTIVE:
To study the value of fast spin-echo diffusion weighted imaging (TSE-DWI) apparent diffusion coefficient (ADC) in children aged 2-12 years with intellectual disability (ID)/global developmental delay (GDD) who have normal conventional brain MRI findings.
METHODS:
A total of 578 children with normal conventional brain MRI findings who met the diagnostic criteria for ID/GDD and 375 normal children were enrolled. Their imaging and clinical data were collected. All children underwent scanning with brain TSE-DWI sequence and routine sequence. ADC values of each brain region were compared between normal children with different ages, as well as between children with different degrees of ID/GDD in each age group. The influence of Adaptive Behavior Assessment System-II (ABAS-II) score on ADC values of each brain region was analyzed.
RESULTS:
For the normal children, the ADC values of the frontal and temporal white matter, the corpus callosum, the inner capsule, the centrum semiovale, the cerebellar dentate nucleus, the optic radiation, the thalamus, the lenticular nucleus, and the caudate nucleus gradually decreased with age (P<0.05). ADC values of the deep white matter, the shallow white matter, the deep gray matter nuclei, and the shallow gray matter increased with the increase in the degree of ID/GDD in the ID/GDD children aged 4-6 years (P<0.05). In the children with ID/GDD, the ADC values of the deep white matter, the shallow white matter, and the deep gray matter nuclei decreased with age (P<0.05). The ADC values of the children with ID/GDD decreased with the increase in ABAS-II score (P<0.05).
CONCLUSIONS
ADC can reflect the subtle structural changes of brain regions in children with ID/GDD who have normal conventional brain MRI findings. It may be associated with social adaptation. It can provide an objective basis for the quantitative diagnosis of ID/GDD in children.
Brain
;
Child
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Child, Preschool
;
Diffusion Magnetic Resonance Imaging
;
Humans
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Intellectual Disability
;
diagnostic imaging
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Magnetic Resonance Imaging
;
White Matter
3.Efficacy and Safety of the WATCHMAN Left Atrial Appendage System for Stroke Prevention in Chinese Patients with Nonvalvular Atrial Fibrillation: A Single-center, Prospective, Observational Study.
Wei-Ping HUANG ; Yong-Hua ZHANG ; Lei HE ; Xi SU ; Xin-Wei YANG ; Zai-Xiong GUO
Chinese Medical Journal 2017;130(4):434-438
BACKGROUNDIn patients with nonvalvular atrial fibrillation (NVAF), embolic stroke is thought to be associated with left atrial appendage (LAA) thrombi. The WATCHMAN LAA Occlusion Device has been shown to be noninferior to conventional oral anticoagulation with warfarin for stroke prevention in patients with NVAF. This study aimed to evaluate the procedural feasibility, safety and 12-month outcomes of the WATCHMAN LAA Occlusion Device in NVAF patients with high risk for stroke in China.
METHODSThe clinical data of 106 NVAF patients, who were consecutively underwent LAA closure with the WATCHMAN Device between April 2014 and May 2015, were collected. Patients were followed up at 1, 3, 6, and 12 months after discharge. A transesophageal echocardiograph was performed at 45 days after implantation and repeated in case of an unexpected event during the follow-up period.
RESULTSThis study included 106 NVAF patients with a mean age of 64.2 ± 8.6 years (ranging from 50 to 88 years), and the mean CHA2DS2-VASc score of all patients was 3.6 ± 1.6 (ranging from 2 to 9). Among those 106 NVAF patients, 100 (94.3%) patients were implanted with the device successfully. The procedural success rate was 94.3% (100/106), and the occlusion rate was 100.0% (100/100). There were one tamponade, one ischemic stroke, and eight minor pericardial effusions during hospitalization. During 12-month follow-up period, two patients developed a thrombus layer on the device that resolved with additional anticoagulation: one with visible device-thrombus experienced transient ischemic stroke, and one had a hemorrhagic stroke. There were no deaths in this study. The overall survival rate was 100.0%, and nonmajor adverse event rate was 95.0% (95/100). In this study, the expected annual rate of ischemic stroke risk in these patients according to the CHA2DS2-VASc score was 4.0%, while the observed ischemic stroke rate was 2.0% per year.
CONCLUSIONSLAA closure with the WATCHMAN Device was feasible, efficient, and safe for NVAF to prevent the accidence of stroke in Chinese patients. During the 12-month follow-up period, the observed ischemic stroke rate (2.0% per year) in our study was lower than the predicted annual stroke risk (4.0%) using the CHA2DS2-VASc score.
Aged ; Aged, 80 and over ; Atrial Appendage ; surgery ; Atrial Fibrillation ; complications ; Cardiac Surgical Procedures ; methods ; China ; Female ; Humans ; Male ; Middle Aged ; Prospective Studies ; Prosthesis Implantation ; adverse effects ; methods ; Stroke ; prevention & control
4.Discussion of development of Chinese Practice Guideline for Individualized Medication of Voriconazole
Ken CHEN ; Shu-Yao LIANG ; Zai-Wei SONG ; Xiang-Lin ZHANG ; Guan-Hua DU ; Xiao-Yan KE ; Ke-Hu YANG ; Suo-Di ZHAI
The Chinese Journal of Clinical Pharmacology 2017;33(3):265-266,270
Collection and rating of evidence,survey of patients' preference and value and economic evaluation of the Practice Guideline for Therapeutic Drug Monitoring of Voriconazole have been finished.The Guideline Consensus Panel reached consensus of the recommendations by 3 rounds Delphi and Grading of Recommendations Assessment,Development and Evaluation grid method.Consensus of 38 recommendations was reached,with a consensus percentage of 50.7%.Twenty seven recommendations were finalized and approved by the Guideline Steering Committee.Draft recommendations were generated.
5.Clinical Features of Adult/Adolescent Atopic Dermatitis and Chinese Criteria for Atopic Dermatitis.
Ping LIU ; Yan ZHAO ; Zhang-Lei MU ; Qian-Jin LU ; Li ZHANG ; Xu YAO ; Min ZHENG ; Yi-Wen TANG ; Xin-Xiang LU ; Xiu-Juan XIA ; You-Kun LIN ; Yu-Zhen LI ; Cai-Xia TU ; Zhi-Rong YAO ; Jin-Hua XU ; Wei LI ; Wei LAI ; Hui-Min YANG ; Hong-Fu XIE ; Xiu-Ping HAN ; Zhi-Qiang XIE ; Xiang NONG ; Zai-Pei GUO ; Dan-Qi DENG ; Tong-Xin SHI ; Jian-Zhong ZHANG
Chinese Medical Journal 2016;129(7):757-762
BACKGROUNDAtopic dermatitis (AD) is an inflammatory skin disease characterized by chronic recurrent dermatitis with profound itching. Most patients have personal and/or family history of atopic diseases. Several criteria have been proposed for the diagnosis of AD. Although the clinical features of childhood AD have been widely studied, there has been less large-scale study on adult/adolescent AD. The aim of this study was to investigate the clinical features of adult/adolescent patients with chronic symmetrical eczema/AD and to propose Chinese diagnostic criteria for adult/adolescent AD.
METHODSA hospital-based study was performed. Forty-two dermatological centers participated in this study. Adult and adolescent patients (12 years and over) with chronic symmetrical eczema or AD were included in this study. Questionnaires were completed by both patients and investigators. The valid questionnaires were analyzed using EpiData 3.1 and SPSS 17.0 software.
RESULTSA total of 2662 valid questionnaires were collected (1369 male and 1293 female). Of all 2662 patients, 2062 (77.5%) patients had the disease after 12 years old, while only 600 (22.5%) patients had the disease before 12 years old, suggesting late-onset eczema/AD is common. Two thousand one hundred and thirty-nine (80.4%) patients had the disease for more than 6 months. One thousand one hundred and forty-four (43.0%) patients had a personal and/or family history of atopic diseases. One thousand five hundred and forty-eight (58.2%) patients had an elevated total serum IgE and/or eosinophilia and/or positive allergen-specific IgE. Based on these clinical and laboratory features, we proposed Chinese criteria for adult/adolescent AD. Of all 2662 patients, 60.3% were satisfied with our criteria, while only 48.2% satisfied with Hanifin Rajka criteria and 32.7% satisfied with Williams criteria, suggesting a good sensitivity of our criteria in adult/adolescent AD patients.
CONCLUSIONLate-onset of eczema or AD is common. The clinical manifestations of AD are heterogeneous. We have proposed Chinese diagnostic criteria for adolescent and adult AD, which are simple and sensitive for diagnosis of adult/adolescent AD.
Adolescent ; Adult ; Dermatitis, Atopic ; diagnosis ; immunology ; Eczema ; diagnosis ; Female ; Humans ; Immunoglobulin E ; blood ; Male ; Middle Aged ; Retrospective Studies ; Surveys and Questionnaires
6.Cassane diterpenes from the seeds of Caesalpinia decapetala
Hua WEI ; Jie ZHENG ; Yi-han LIU ; Zai ZHANG ; Qian PU ; Jun-shan YANG ; Guo-xu MA
Acta Pharmaceutica Sinica 2016;51(9):1441-1444
Four casssane diterpenes were isolated from the ethanol extract of the seeds of Caesalpinia decapetala (Fabaceae), with a combination of various chromatographic approaches, including silica gel, Sephadex LH-20, reverse phase C18 and so on. On the basis of spectroscopic data analysis, they were identified as caesalpinin MQ (1), neocaesalpin N (2), caesalmin F (3) and α-caesalpin (4). Among them, compound 1 is a new diterpene, compounds 2-4 were isolated for the first time from the plant of C. decapetala.
7.Studies on flavonoids from Derris eriocarpa.
Lun-xing WANG ; Hong-guo WU ; Hua ZHANG ; Hua-yong LOU ; Guang-yi LIANG ; Wen-wen JIANG ; Zai-chang YANG ; Wei-dong PAN
China Journal of Chinese Materia Medica 2015;40(15):3009-3012
Derris eriocarpa, a traditional Chinese medicine belonging to the family of Leguminosae, is widely distributed mainly over Yunnan, Guangxi and Guizhou of China. Modern pharmacological researches on this herb showed that it had extensive bioactivities, such as promoting urination, removing dampness and cough and reducing inspissated mucus and other biological activities. The extensive studies on the chemical constituents of this plant have resulted in the isolation of triterpenoids, steroids, fatty acid and others, but the flavone compounds haven't reported before. In our further research on the ethyl acetate of this plant, nine flavone compounds were obtained by column chromatography on silica gel, Sephadex LH-20, semi-prep HPLC, polyamide column chromatography and recrystallization for separation and purification. The structures were determined on the basis of extensive spectroscopic analysis, including MS, NMR experiments and comparison with spectroscopic data in the literature, respectively, as diosmetin (1), 3, 3'-di-O-methylquercetin (2), afromosin (3), 6, 3'-dihydroxy-7, 4'-dimethoxyisoflavone (4), odoratin (5), 7, 3'-dihydroxy-8, 4'-dimethoxyisoflavone (6), 6, 4'-dihydroxy-7, 3'-dimethoxyisoflavone (7), 5, 7, 4'-trihydroxy-3, 3', 5'-trimethoxyflavone (8), and alpinumisoflavone (9). All these compounds were isolated from Derris eriocarpa How for the first time. And the in vitro assays showed that compound 2 possessed moderate inhibitory activity against human cancer cells K562 and HEL.
Derris
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chemistry
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Flavonoids
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chemistry
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isolation & purification
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pharmacology
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Humans
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K562 Cells
8.One craniotomy at the highest altitude in the world and follow-up study.
Hai-Ning ZHEN ; Wei ZHAO ; Jin-Yin ZHU ; Li WANG ; Zai-Hua GAN ; Wei-Xing DENG ; Peng-Qi LI ; Chang-Bai DENG ; Hai WANG ; Jiang WANG ; Zhou FEI
Chinese Medical Journal 2015;128(7):993-994
Adult
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Altitude
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Craniotomy
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methods
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Follow-Up Studies
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Humans
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Male
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Young Adult
9.Distribution laws of Chinese medical syndrome types and analyses of risk factors in senile hypertension patients: a clinical study.
Pi-Hua HOU ; Gai-Ling CHEN ; Wan-Li GU ; Da-Wei WANG ; Xiao-Feng WANG ; Xiao-Hua ZHAO ; Tao XU ; Zai-xiang SHI
Chinese Journal of Integrated Traditional and Western Medicine 2014;34(5):536-540
OBJECTIVETo explore the distribution laws of TCM syndrome types and to analyze the distribution of dynamic blood pressure curve, atherosclerosis, and age in senile hypertension patients.
METHODSTotally 1 131 senile hypertension patients were recruited from 7 provinces and municipal cities. Features of TCM syndromes, classification and distribution curves, and syndrome distribution laws were observed. The distribution curves of dynamic blood pressure, carotid atherosclerosis, and age were compared in each TCM syndrome types.
RESULTSThere were four main syndrome types in 736 cases (56.15%), i.e., excessive accumulation of phlegm-dampness syndrome (210 cases, 16.02%), yin deficiency and hyperactivity of yang syndrome (177 cases, 13.50%), Gan-Shen yin deficiency syndrome (79 cases, 6.03%), and deficiency of qi and yin syndrome (252 cases, 19.22%). Besides, there were two more sub-types, i.e., collateral obstruction by blood stasis syndrome and collateral obstruction by phlegm and stasis. Circadian blood pressure monitor was completed in 211 cases. Of them, abnormal circadian blood pressure occurred in 152 cases (accounting for 72. 38%); yin deficiency and hyperactivity of yang syndrome, excessive accumulation of phlegm-dampness syndrome, deficiency of qi and yin syndrome plus collateral obstruction by blood stasis syndrome were most often seen. Color ultrasound of carotid artery was performed in 660 patients of main syndromes. The incidence was quite higher in those of excessive accumulation of phlegm-dampness syndrome (182 cases, 27. 58%), deficiency of qi and yin syndrome plus collateral obstruction by blood stasis syndrome or collateral obstruction by phlegm and stasis (322 cases, 48.79%). Yin deficiency and hyperactivity of yang syndrome was dominant in patients 60 -79 years old, while deficiency of qi and yin syndrome and Gan-Shen yin deficiency syndrome were dominant in patients older than 80 years.
CONCLUSIONSExcessive accumulation of phlegm-dampness syndrome, yin deficiency and hyperactivity of yang syndrome, Gan-Shen yin deficiency syndrome, and deficiency of qi and yin syndrome were main syndrome types in senile hypertension patients. There was statistical difference in the distribution curves of blood pressure, atherosclerosis, and age of various TCM syndrome types.
Aged ; Asian Continental Ancestry Group ; Atherosclerosis ; epidemiology ; Biomedical Research ; Blood Pressure ; Humans ; Hypertension ; epidemiology ; Medicine, Chinese Traditional ; Qi ; Research Design ; Risk Factors ; Yin Deficiency ; epidemiology
10.Decomposition of life expectancy among permanent residents of Beijing, 2000-2010
Jian-Ting SU ; Yan-Lin GAO ; Zai-Hua WEI ; Jing WANG
Chinese Journal of Epidemiology 2013;34(3):250-253
Objective To analyze the change of life expectancy and the impact of mortality by age and causes of death on this issue among permanent residents of Beijing.Methods Abridged Life Table and Arriaga method were used to calculate and to decompose the changes on life expectancy by age and causes of death in 2000-2010.Results From 2000-2010,life expectancy under this studied population had an increase of 3.35 years.Most part of the increases (44.27%,1.48 years) within the last 10 years could be explained by the decrease of mortality in the population at age ≥ 80.Both cerebrovascular and heart diseases were contributing the most to the increment of life expectancy while mortality of malignant tumors appeared a negative contributor to this increment.Conclusion From 2000 to 2010,increment in life expectancy contributed to the decrease of mortality in the elderly and the decrease of mortalities on both cardio-and cerebro-vascular diseases.The decrease of life expectancy was mainly due to the increase of mortality related to malignant tumors.

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