1.Analysis and evaluation of quality concerns of fluid infusion and blood transfusion warmer
Peng-Tao MOU ; Ke ZHANG ; Hui-Fang NIU ; Li FU ; Jian LU ; Zai-Ai ZHANG ; Jian-Zhong HUANG
Chinese Medical Equipment Journal 2023;44(10):76-80
The main components and working principle of the fluid infusion and blood transfusion warmer were introduced,and the causes for the adverse events of the warmer were summarized based on National Medical Device Adverse Event Monitoring Information System and related literature in the world.The potential risks of the warmer were analyzed during operation,and the quality concerns and corresponding evaluation methods were proposed for the warmer from the aspects of device marking and documentation,structure,and temperature.References were provided for standard preparation,pre-market technical review and system verification of the fluid infusion and blood transfusion warmer.[Chinese Medical Equipment Journal,2023,44(10):76-80]
2.Chemical constituents of Cassia occidentalis.
Zai ZHANG ; Shao-Wei NI ; Xue XU ; Wen-Zhong HUANG ; Shan-Shan WANG ; Hong ZHU ; Xue-Mei GAO
China Journal of Chinese Materia Medica 2021;46(15):3873-3876
Compounds(1-6) were isolated and identified from 90% ethanol extract of the stems and leaves of Cassia occidentalis through column chromatography with silica gel, ODS, and Sephadex LH-20. These compounds were identified as 7-hydroxy-5-(3-hydroxy-2-oxopropyl)-2-methyl-4H-chromen-4-one(1), saccharonol A(2), S-6-hydroxymullein(3), 2-methyl-5-acetonyl-7-hydroxy-chromone(4), 2-(2'-hydroxypropyl)-5-methyl-7-hydroxychromone(5) and 7,4'-dihydroxyflavone(6) based on their physicochemical and spectroscopic data. Among them, compound 1 was a new compound, and all the compounds were isolated from this plant for the first time. DPPH method was employed to determine the antioxidant activities of these compounds in vitro. Six compounds exhibited weak antioxidant activities.
Chromones
;
Plant Leaves
;
Senna Plant
;
Spectrum Analysis
3.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*
;
Antibodies, Monoclonal, Humanized
;
China
;
Double-Blind Method
;
Humans
;
Psoriasis/drug therapy*
;
Severity of Illness Index
;
Treatment Outcome
4. The relationship between PD-L1 statusandradiosensitivity of breast cancer
Zhong⁃song MAN ; Zai⁃xiang TANG ; Jin ZHOU ; Xin ZHAO ; Hai⁃tao ZHANG
Journal of Medical Postgraduates 2019;32(2):171-177
Objective Programmed cell death ligand 1 (PD-L1) plays an important role in the treatment of malignant tumors. Thestudy explores the relationship between PD-L1 status and breast cancer radiotherapy and clinical prognosis. Methods Using the Cancer Genome Atlas (TCGA) database analyze the relationshipof PD-L1 expression, radiotherapy and prognosis in breast cancer. 1007 patients were included in the statistical analysis. Based on the median value of CD274 mRNA expression levels in the database, the total sample was divided into a PD-L1 -high state group (503 cases) and a PD-L1-low state group (504 cases). Survival analysis was carried out for patients in the high and low state group with and without radiotherapyrespectively. Results The univariate analysis showed that the overall survival rate was improved in patients with PD-L1high status compared with patients with PD-L1-low status. The difference was statistically significant(P=0.047). InPD-L1-high status group, univariate analysis and multivariate analysis showed no significant difference in the overall survival rate between patients with radiotherapy and without radiotherapy, and the P values were 0.352 and 0.242 respectively. However, the overall survival rate of radiotherapy patients with PD-L1-low status group was significantly improved (HR0.550, 95%CI:0.335~0.904, P=0.017), and there was still statistical significance after multivariate factors adjustment (HR0.415, 95%CI:0.194~0.872, P=0.025). Chi-square analysis showed that PD-L1 status was associated with ER status (χ2=18.44,P<0.001), HER2 status (χ2=7.943,P=0.047) and molecular typing (χ2=14.52,P=0.006), but not with age, histological type, surgical treatment, postoperative tissue margin status and PR status. Conclusion The PD-L1 status was associated with the radiosensitivity of breast cancer. The overall survival rate of postoperative radiotherapy in patients with PD-L1⁃low expression was significantly improved.It is speculated that PD-L1 may be a radiosensitivity gene for breast cancer.
5.Chemical constituents of Cassia siamea.
Shan-Shan WANG ; Wen-Zhong HUANG ; Guang-Zhi ZENG ; Hong ZHU ; Zai ZHANG ; Gan-Peng LI ; Meng-Yuan JIANG ; Xue-Mei GAO
China Journal of Chinese Materia Medica 2019;44(4):712-716
A total of ten compounds were isolated from the 90% Et OH extract of Cassia siamea by using various chormatographic techniques,and their structures were established as( 2' S)-2-( propan-2'-ol)-5,7-dihydroxy-benzopyran-4-one( 1),chrobisiamone( 2), 2-( 2'-hydroxypropyl)-5-methyl-7-hydroxychromone( 3), 2,5-dimethyl-7-hydroxychromone( 4), 2-methyl-5-acetonyl-7-hydroxychromone( 5),3-O-methylquercetin( 6),3,5,7,3',4'-pentahydroxyflavonone( 7),luteolin-5,3'-dimethylether( 8),4-( trans)-acetul-3,6,8-trihydroxy-3-methyl-dihydronapht halenone( 9) and 6-hydroxymellein( 10) based on the spectroscopic data.Compound 1 was a new compound,and 3,4,6,8 were isolated from this plant for the first time.
Cassia
;
Luteolin
;
Senna Plant
;
Spectrum Analysis
6.Effect of genetic polymorphism of CYP2B6 * 6 on pharmacokinetics and pharmacodynamics of single dose propofol in Chinese healthy subjects
An-Cheng GU ; Wan-Wen CAO ; Jian-Ping ZHANG ; Zai-Sheng QIN ; Bin CHEN ; Peng-Xiang HUANG ; Zhong-Yuan XU
The Chinese Journal of Clinical Pharmacology 2018;34(9):1052-1055
Objective To investigate the effects of CYP2B6 * 6 gene polymorphism on the pharmacokinetics and pharmacodynamics of propofol in Chinese healthy subjects.Methods Twenty male healthy subjects were intravenously injected a single dose of 2.0 mg · kg-1 propofol.The plasma concentration of propofol was examined by HPLC-MS/MS method.The genotype of the subjects was determined by pyrosequencing.The pharmacokinetics and pharmacodynamic parameters of different genotype were compared.Results Among the 20 subjects,there were 14 cases of G516T-GG,6 cases of G516T-GT/TT,10 cases of A785G-AA and 10 cases of A785G-AG/GG.The bispectral index-loss of conscious (BIS-LOC) of G516T-GT/TT group and G516T-GG group were 74.33 ± 7.20 and 60.43 ± 13.64,the t1/2β of A785G-AG/GG group and A785G-AA group were (0.13 ±0.06) and (0.41 ±0.38)h,with significant difference (P < 0.05).Other parameters like Cmax,tmax,AUC0-t,AUC0-∞,t1/2α,MRT0-∞,t-LOC,BIS-LOC,BIS-ROC,t-BISmin,BISmin,d-LOC all had no statistical significance (all P > 0.05).Conclusion The pharmacokine-tics and pharmacodynamics of propofol are correlated with the polymorphism of CYP2B6 * 6,individualized dosing regimens based on genotypes contribute to the rational use of propofol.
7.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
8.Effect of topical propranolol gel on plasma renin, angiotensin II and vascular endothelial growth factor in superficial infantile hemangiomas.
Yu-juan TANG ; Zai-zhong ZHANG ; Shao-quan CHEN ; Shu-ming CHEN ; Cheng-jin LI ; Jian-wei CHEN ; Bo YUAN ; Yin XIA ; Lie WANG
Journal of Huazhong University of Science and Technology (Medical Sciences) 2015;35(5):759-762
The effect of topical propranolol gel on the levels of plasma renin, angiotensin II (ATII) and vascular endothelial growth factor (VEGF) in superficial infantile hemangiomas (IHs) was investigated. Thirty-three consecutive children with superficial IHs were observed pre-treatment, 1 and 3 months after application of topical propranolol gel for the levels of plasma renin, ATII and VEGF in Department of General Surgery of Dongfang Hospital from February 2013 to February 2014. The plasma results of IHs were compared with those of 30 healthy infants of the same age from out-patient department. The clinical efficiency of topical propranolol gel at 1st, and 3rd month after application was 45%, and 82% respectively. The levels of plasma renin, ATII and VEGF in patients pre-treatment were higher than those in healthy infants (565.86 ± 49.66 vs. 18.19 ± 3.56, 3.20 ± 0.39 vs 0.30 ± 0.03, and 362.16 ± 27.29 vs. 85.63 ± 8.14, P < 0.05). The concentrations of VEGF and renin at 1st and 3rd month after treatment were decreased obviously as compared with those pre-treatment (271.51 ± 18.59 vs. 362.16 ± 27.29, and 405.18 ± 42.52 vs. 565.86 ± 49.66 P < 0.05; 240.80 ± 19.89 vs. 362.16 ± 27.29, and 325.90 ± 35.78 vs. 565.86 ± 49.66, P < 0.05, respectively), but the levels of plasma ATII declined slightly (2.96 ± 0.37 vs. 3.20 ± 0.39, and 2.47 ± 0.27 vs. 3.20 ± 0.39, P > 0.05). It was indicated that the increased renin, ATII and VEGF might play a role in the onset or development of IHs. Propranolol gel may suppress the proliferation of IHs by reducing VEGF.
Administration, Cutaneous
;
Adrenergic beta-Antagonists
;
therapeutic use
;
Angiotensin II
;
blood
;
Case-Control Studies
;
Female
;
Gels
;
Hemangioma, Capillary
;
blood
;
blood supply
;
drug therapy
;
pathology
;
Humans
;
Infant
;
Infant, Newborn
;
Male
;
Propranolol
;
therapeutic use
;
Renin
;
blood
;
Skin Neoplasms
;
blood
;
blood supply
;
drug therapy
;
pathology
;
Treatment Outcome
;
Vascular Endothelial Growth Factor A
;
blood
9.Quality evaluation of guizhi fuling capsule using self-control method of reference Chinese medicine preparation.
Ting GENG ; Zai-juan ZHANG ; Yan-jing LI ; Gang DING ; Yu-an BI ; Zhen-zhong WANG ; Wei XIAO
China Journal of Chinese Materia Medica 2014;39(21):4127-4132
Taking guizhi fuling capsule (GZFL) for instance, a new method about reference Chinese medicine preparation which was used as standard substance for the quality evaluation of complex Chinese medicine preparation by the fingerprint of reference preparation instead of standard fingerprint was proposed. It could eliminate the errors from different instruments, chromatographic columns and solve the problem of similarity matching in the absence of standard fingerprint. The qualification of reference GZFL was evaluated according to the quality control method of GZFL from Chinese Pharmacopoeia. Then multiple batches of GZFL were estimated, taking fingerprint of reference preparation and standard fingerprint as references, respectively, at different instruments and chromatographic columns. Finally, the packaging and expiration date for reference GZFL were confirmed according to the results of stability investigation. The results indicated that the fingerprint of reference GZFL could be used to assess the quality of GZFL better than standard fingerprint. The data of accelerated stability and long-term stability test demonstrated that reference GZFL was stable in the conditions of double blister package. Therefore, reference GZFL can be used as standard substance in quality control of GZFL.
Capsules
;
Drug Stability
;
Drugs, Chinese Herbal
;
chemistry
;
standards
;
Reference Standards
10.Roles of N-glycosylation in immunity of prME and NS1 gene of JEV.
Zi-Zhong ZHANG ; Xue WANG ; Jun-Jie ZAI ; Le-Qiang SUN ; Yun-Feng SONG ; Huan-Chun CHEN
Chinese Journal of Virology 2012;28(3):213-218
PrME and NS1 gene were the two main immuneprotect proteins of Japanese encephalitis virus (JEV), and they were also N-linked glycosylation proteins. To clear the effect of N-glycosylation on JEV immunity, the N-glycosylation site of prME and NS1 gene were eliminated by site-directed mutant PCR, subtituting the N to Q. And the the mutant genes were subcloned into eukaryotic expression plasmid. Four-weeks female mice were immuned with the wildtype and mutant gene by twice. The antibodies against prME were detected by ELISA and the neutralization antibodies were tested by viral neutralizing assay. The immunoprotection were determined by attack with JEV virulent strain. Compare with the wild-type gene immuned-groups, one N-glycan eliminated prME gene could induce a little higher ELISA antibody, neutralization antibody and immunoprotection, but the immunity of gene with both N-glycan absence was decreased. The similar status were observed in the wildtype and mutant NS1 groups. Thus these results show that the N-linked glycosylation in the prME and NS1 gene were correlated with the immunity, one glycan absent would enhance the immunity but both two loss would impair it.
Animals
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Antibodies, Viral
;
immunology
;
Encephalitis Virus, Japanese
;
genetics
;
immunology
;
metabolism
;
Encephalitis, Japanese
;
immunology
;
virology
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Female
;
Glycosylation
;
Humans
;
Mice
;
Mice, Inbred BALB C
;
Viral Nonstructural Proteins
;
genetics
;
immunology
;
metabolism

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