1.Quality Analysis of Schefflera kwangsiensis Merr.Based on HPLC Fingerprinting Combined with Chemometrics
Xin YANG ; Nianzhi XU ; Wenfeng FU ; Wentao ZHANG ; Hanzhi YIN ; Bing LI
Herald of Medicine 2024;43(2):267-273
Objective Based on HPLC fingerprinting and chemometrics,to evaluate the quality of Schefflera kwangsiensis Merr.from Guangxi.Methods HPLC was used to establish fingerprints of Schefflera kwangsiensis Merr.from ten different origins,and gradient elution was carried out with methanol-0.1%phosphoric acid aqueous solution as mobile phase.Cluster analysis(CA),principal component analysis(PCA)and orthogonal partial least squares-discriminant analysis(OPLS-DA)were applied to evaluate quality.Results The fingerprints of Schefflera kwangsiensis Merr.from ten different origins were established by HPLC,a total of 22 common peaks were calibrated,with a similarity range of 0.922-0.999.Four chromatographic peaks were identified as rhodopsin,4,5-bis-O-caffeoylquinic acid,caffeic acid,and naringin.The samples were classified into four types according to the CA and OPLS-DA.PCA identified four principal components with a cumulative contribution rare of 95.39%.Conclusion The quality of Schefflera kwangsiensis Merr.can be comprehensively evaluated by fingerprinting combined with CA,PCA and OPLS-DA analysis.The Study can provide a reference for improving the quality control and assessment of Schefflera kwangsiensis Merr.
2.Efficacy and safety of LY01005 versus goserelin implant in Chinese patients with prostate cancer: A multicenter, randomized, open-label, phase III, non-inferiority trial.
Chengyuan GU ; Zengjun WANG ; Tianxin LIN ; Zhiyu LIU ; Weiqing HAN ; Xuhui ZHANG ; Chao LIANG ; Hao LIU ; Yang YU ; Zhenzhou XU ; Shuang LIU ; Jingen WANG ; Linghua JIA ; Xin YAO ; Wenfeng LIAO ; Cheng FU ; Zhaohui TAN ; Guohua HE ; Guoxi ZHU ; Rui FAN ; Wenzeng YANG ; Xin CHEN ; Zhizhong LIU ; Liqiang ZHONG ; Benkang SHI ; Degang DING ; Shubo CHEN ; Junli WEI ; Xudong YAO ; Ming CHEN ; Zhanpeng LU ; Qun XIE ; Zhiquan HU ; Yinhuai WANG ; Hongqian GUO ; Tiwu FAN ; Zhaozhao LIANG ; Peng CHEN ; Wei WANG ; Tao XU ; Chunsheng LI ; Jinchun XING ; Hong LIAO ; Dalin HE ; Zhibin WU ; Jiandi YU ; Zhongwen FENG ; Mengxiang YANG ; Qifeng DOU ; Quan ZENG ; Yuanwei LI ; Xin GOU ; Guangchen ZHOU ; Xiaofeng WANG ; Rujian ZHU ; Zhonghua ZHANG ; Bo ZHANG ; Wanlong TAN ; Xueling QU ; Hongliang SUN ; Tianyi GAN ; Dingwei YE
Chinese Medical Journal 2023;136(10):1207-1215
BACKGROUND:
LY01005 (Goserelin acetate sustained-release microsphere injection) is a modified gonadotropin-releasing hormone (GnRH) agonist injected monthly. This phase III trial study aimed to evaluated the efficacy and safety of LY01005 in Chinese patients with prostate cancer.
METHODS:
We conducted a randomized controlled, open-label, non-inferiority trial across 49 sites in China. This study included 290 patients with prostate cancer who received either LY01005 or goserelin implants every 28 days for three injections. The primary efficacy endpoints were the percentage of patients with testosterone suppression ≤50 ng/dL at day 29 and the cumulative probability of testosterone ≤50 ng/dL from day 29 to 85. Non-inferiority was prespecified at a margin of -10%. Secondary endpoints included significant castration (≤20 ng/dL), testosterone surge within 72 h following repeated dosing, and changes in luteinizing hormone, follicle-stimulating hormone, and prostate specific antigen levels.
RESULTS:
On day 29, in the LY01005 and goserelin implant groups, testosterone concentrations fell below medical-castration levels in 99.3% (142/143) and 100% (140/140) of patients, respectively, with a difference of -0.7% (95% confidence interval [CI], -3.9% to 2.0%) between the two groups. The cumulative probabilities of maintaining castration from days 29 to 85 were 99.3% and 97.8%, respectively, with a between-group difference of 1.5% (95% CI, -1.3% to 4.4%). Both results met the criterion for non-inferiority. Secondary endpoints were similar between groups. Both treatments were well-tolerated. LY01005 was associated with fewer injection-site reactions than the goserelin implant (0% vs . 1.4% [2/145]).
CONCLUSION:
LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT04563936.
Humans
;
Male
;
Antineoplastic Agents, Hormonal/therapeutic use*
;
East Asian People
;
Gonadotropin-Releasing Hormone/agonists*
;
Goserelin/therapeutic use*
;
Prostate-Specific Antigen
;
Prostatic Neoplasms/drug therapy*
;
Testosterone
3.Clinical characteristics of infection-induced central nervous system complications in renal transplant recipients
Yuchen WANG ; Ziyan YAN ; Mingli HUANG ; Wenfeng DENG ; Renfei XIA ; Wenli ZENG ; Susha YAN ; Shaojie FU ; Jian XU ; Yun MIAO
Chinese Journal of Organ Transplantation 2021;42(4):219-223
Objective:To summarize the clinical characteristics of central nerve system (CNS) infection and grasp the necessity and possibility of early diagnosis and precise intervention of CNS infection after renal transplantation.Methods:This retrospective study enrolled consecutive recipients of renal transplantation with CNS infection after transplant between January 2000 and December 2020. Correlative factors for CNS infection after renal transplant were determined by comparing the clinical data between recipients with and without CNS infection. After screening 3, 199 consecutive renal transplant recipients, 12 patients with CNS infection post-transplant were identified and recruited. The median age-of-onset was 48.5 (23-65) years. And the median time to disease onset after transplant was 50.5(1-204) months. The most common symptoms of CNS infection after renal transplant included fever (75.00%), consciousness disorder (58.33%), headache (58.33%) and neck rigidity (41.67%).Results:Hepatitis B virus carrier and pulmonary infection were correlated with CNS infection after transplantation ( P<0.05). Nine patients failed to identify the pathogen and only received empirical anti-infective regimen. The outcomes were curing ( n=3) and death ( n=6). Metagenomic sequencing was performed for identifying the pathogen in three recipients and actively adjusting the anti-infective regimen. As a result, 2 were cured and 1 died. The overall mortality was 58.33%. The median time to death or curing from disease onset were 20(2-19) and 25(16-35) days respectively in surviving and non-surviving recipients. Conclusions:The progress of CNS infection after transplantation is rapid with a high mortality. HBV carrier and pulmonary infection are possible risk factors of CNS infection after renal transplantation. Early pathogenic identification and precise etiological intervention are vital for better clinical outcomes.
4.De novo malignant tumor after renal transplantation: single-center trial
Daming SU ; Wenfeng DENG ; Rumin LIU ; Jiangtao LI ; Fangxiang FU ; Haiqiang NI ; Yangcheng HU ; Lixin YU ; Jian XU ; Yun MIAO
Organ Transplantation 2020;11(4):449-
Objective To analyze the incidence and risk factors of
5.Effect of miR-5581-5p/TRIM22 on acute promyelocytic leukemia cell differentiation
Wangnan SUN ; Pengchao DU ; Fu QI ; Wenfeng WANG ; Guosheng JIANG
Journal of International Oncology 2020;47(3):129-134
Objective:To investigate the function of miR-5581-5p and its interaction with tripartite motif 22 (TRIM22) during the terminal differentiation of human acute promyelocytic leukemia (APL) cells into granulocytes.Methods:APL cells (NB4) were differentiated into granulocytes by all-trans retinoic acid (ATRA), using dimethylsulfoxide (DMSO) as the control. The expression of TRIM22 was detected by real-time fluorescent quantitative PCR (qRT-PCR) and Western blotting, and the expression of miR-5581-5p was detected by qRT-PCR during cell differentiation. miRNA expression was regulated by cell transfection with miR-5581-5p mimic and inhibitor, and negative control was set, and qRT-PCR was used to verify the regulatory effect. Luciferase binding assay was performed to detect the presence of targeted binding. Western blotting was used to detect the expression of TRIM22 after miRNA differential expression. Flow cytometry was used to detect the effects of the regulation of miR-5581-5p on the differentiation of NB4 cells induced by ATRA.Results:After ATRA induced NB4 cells to differentiate into granulocytes, the gene expression level of TRIM22 was significantly higher than that of the control group (24.56±2.80 vs. 1.02±0.13; t=8.392, P=0.001). The level of protein expression was also significantly higher than that of the control group (0.80±0.01 vs. 0.17±0.01; t=44.900, P<0.001). The expression level of miR-5581-5p in NB4 cells differentiation group was significantly lower than that in the control group (0.14±0.02 vs. 1.01±0.08; t=10.840, P<0.001). The results of the dual luciferase reporter gene showed that the luciferase activity of the co-transfected miR-5581-5p mimic and TRIM22 WT group was significantly lower than that of the co-transfected miR-5581-5p mimic and TRIM22 MUT group (0.73±0.02 vs. 0.98±0.03; t=7.534, P=0.002). Western blotting showed that after transfection with miR-5581-5p inhibitor, the expression of TRIM22 was significantly higher than that of the negative control (0.44±0.01 vs. 0.21±0.01; t=18.290, P<0.001). While after transfection with miR-5581-5p mimic, the expression of TRIM22 decreased significantly compared with the negative control (0.62±0.01 vs. 0.80±0.02; t=6.402, P=0.003). CD11b expression of miR-5581-5p mimic group after ATRA treatment was significantly lower than that of the control group (45.80±1.80 vs. 56.61±1.88; t=4.159, P=0.014). The expression of CD11b in miR-5581-5p inhibitor group was significantly higher than that in the control group (66.48±2.54 vs. 52.60±1.70; t=4.539, P=0.011). Conclusion:miRNA-5581-5p can bind to TRIM22 3′UTR and negatively regulate TRIM22 expression. The decrease of miR-5581-5p can increase the expression of TRIM22, then promote the differentiation of ATRA-induced NB4 cells into granulocytes.
6.A double-blind, randomized, placebo- and positive-controlled phase III trial of 1% benvitimod cream in mild-to-moderate plaque psoriasis.
Lin CAI ; Gen-Hui CHEN ; Qian-Jin LU ; Min ZHENG ; Yu-Zhen LI ; Jin CHEN ; Jie ZHENG ; Fu-Ren ZHANG ; Jian-Bin YU ; Sen YANG ; Fu-Qiu LI ; Sheng-Xiang XIAO ; Qiu-Ning SUN ; Jin-Hua XU ; Xing-Hua GAO ; Hong FANG ; Tian-Wen GAO ; Fei HAO ; Quan-Zhong LIU ; Ya-Ting TU ; Ruo-Yu LI ; Bao-Xi WANG ; Dan-Qi DENG ; Qing-Shan ZHENG ; Hong-Xia LIU ; Jian-Zhong ZHANG
Chinese Medical Journal 2020;133(24):2905-2909
BACKGROUND:
Benvitimod cream, a novel synthetic small molecule, was effective in treating mild-to-moderate plaque psoriasis. We conducted a phase III clinical trial to assess the efficacy and safety of benvitimod cream in patients with mild-to-moderate plaque psoriasis.
METHODS:
We randomly assigned 686 patients (2:1:1) to receive 1% benvitimod cream, 0.005% calcipotriol ointment or placebo twice a day for 12 weeks. The primary efficacy end points were the percentage of patients with a 75% or greater reduction from baseline in the psoriasis area and severity index (PASI 75) score and with a score of 0 or 1 in static physician's global assessment (sPGA) at week 12.
RESULTS:
The results showed that 50.4% of patients in the benvitimod group achieved PASI 75, which was significantly higher than that in the calcipotriol (38.5%, P < 0.05) and placebo (13.9%, P < 0.05) groups. The proportion of patients achieving an sPGA score 0 or 1 was 66.3% in the benvitimod group and 63.9% in the calcipotriol group, which were both significantly higher than that in the placebo group (34%, P < 0.05). In the long-term follow-up study, 50.8% of patients experienced recurrence. After retreatment with 1% benvitimod, 73.3% of patients achieved an sPGA score of 0 or 1 again at week 52. Adverse events included application site irritation, follicular papules, and contact dermatitis. No systemic adverse reactions were reported.
CONCLUSION:
During this 12-week study, benvitimod cream was demonstrated with high effectiveness and safety in patients with mild-to-moderate plaque psoriasis.
TRIAL REGISTRATION
Chinese Clinical Trial Registry (ChiCTR), ChiCTR-TRC-13003259; http://www.chictr.org.cn/showprojen.aspx?proj=6300.
Double-Blind Method
;
Follow-Up Studies
;
Humans
;
Ointments
;
Psoriasis/drug therapy*
;
Resorcinols
;
Severity of Illness Index
;
Stilbenes
;
Treatment Outcome
7.Characteristics of BK polymavirus infection in kidney transplant recipients.
Yi ZHOU ; Leiyu YAO ; Zhe YU ; Naiqian CUI ; Fangxiang FU ; Yuedian YE ; Wenfeng DENG ; Jian XU ; Shaojie FU ; Ruming LIU ; Lixin YU ; Yun MIAO
Journal of Southern Medical University 2019;39(1):120-124
OBJECTIVE:
To analyze the characteristics of BK polymavirus (BKV) infection and the optimal time window for intervention in kidney transplant recipients (KTRs).
METHODS:
We retrospectively analyzed the clinical data and treatment regimens in 226 KTRs in our center between January, 2013 and January, 2018. Among the recipients, 157 had a urine BKV load ≥1.0×10 copy/mL after transplantation, and 69 had a urine BKV load below 1.0×10 copy/mL (control group).
RESULTS:
Among the 157 KTRs, 60 (38.2%) recipients were positive for urine BKV, 66 (42.0%) had BKV viruria, and 31(19.7%) had BKV viremia. The incidence of positive urine occult blood was significantly higher in BKV-positive recipients than in the control group ( < 0.05). The change of urine BKV load was linearly related to that of Tacrolimus trough blood level (=0.351, < 0.05). In urine BKV positive group, the average estimated glomerular filtration rate (eGFR) was below the baseline level (60 mL·min·1.73 m) upon diagnosis of BKV infection reactivation, and recovered the normal level after intervention. In patients with BKV viruria and viremia, the average eGFR failed to return to the baseline level in spite of improvement of the renal function after intervention.
CONCLUSIONS
Positive urine occult blood after transplantation may be associated with BKV infection reactivation in some of the KTRs. BKV infection is sensitive to changes of plasma concentration of immunosuppressive agents. Early intervention of BKV replication in KTRs with appropriate dose reduction for immunosuppression can help to control virus replication and stabilize the allograft function.
BK Virus
;
physiology
;
Humans
;
Kidney Transplantation
;
Polyomavirus Infections
;
virology
;
Retrospective Studies
;
Transplant Recipients
;
Tumor Virus Infections
;
virology
;
Viral Load
;
Virus Replication
8.Epidemiological characteristics of product-related injuries among children in Changshan County
Ming ZHAO ; Jieming ZHONG ; Jiafu DUAN ; Zhengfu WU ; Lihua GUO ; Hongxia ZENG ; Meihua FU ; Wenfeng LIU ; Sheng LIU ; Min YU
Journal of Preventive Medicine 2019;31(8):765-770
Objective:
To understand the epidemiological characteristics of product-related injuries among children in Changshan County from 2011 to 2017 and to provide evidence for targeted intervention.
Methods:
The surveillance data of product-related injuries among children aged below 18 years from 2011 to 2017 was collected from three sentinel hospitals in Changshan County. The characteristics of product-related injuries among children were analyzed,especially those injuries caused by furniture,stationery and sporting goods,commodities and toys.
Results:
A total of 5 111 product-related injury cases among children were reported,accounting for 13.49% of product-related injury cases of all age. There were 3 138 boys and 1 973 girls,accounting for 61.40% and 38.60%. There were 2 973 cases less than 10 years old,accounting for 58.17%. The main causes of product-related injuries were road traffic injury(49.46%),blunt(16.02%),stab/cut(12.39%)and fall(10.37%). The main categories of products included transportation equipments(not including motor vehicles,36.83%),motor vehicles(17.82%),furniture(12.23%),stationery and sporting goods(8.45%),commodities(4.89%)and toys(3.25%). Stab/cut(53.01%)was the main cause of commodities related injuries;blunt was the main cause of furniture,stationery and sporting goods and toys. The stationery and sporting goods related injuries occurred mainly in schools/public places(64.57%)and sports venues(18.48%)when engaging in sports(54.13%);furniture,commodities and toys related injuries injured cases occurred at home when engaging in leisure activities. Commodities mainly resulted in sharp/bite/open wound(51.50%);furniture,stationery and sporting goods and toys mainly resulted in bruises. Most cases were injured in head,slight and allowed home after treated.
Conclusion
The product-related injuries among children in Changshan County are more boys. The products mainly involve transportation equipments(not including motor vehicles),motor vehicles,furniture,stationery and sporting goods,commodities and toys,with emphasis on the latter four categories in the prevention of product-related child injury.
9.Alterations of Whole Brain Networks Degree Centrality in Patients with Primary Insomnia after Acupuncture Therapy:A Voxel-based Resting-state fMRI Research
Xiaoyue XU ; Shui WANG ; Ru LU ; Xiaofen MA ; Guihua JIANG ; Shishun FU ; Wenfeng ZHAN ; Jin FANG
Journal of Sun Yat-sen University(Medical Sciences) 2017;38(2):296-300
[Objective]To investigate the value of degree centrality(DC),a novel resting-state fMRI parameter,in voxel-wise whole-brain functional networks analysis in primary insomnia(PI)after acupuncture therapy.[Methods]The resting state fMRI were performed in 29 PI patients and 22 age,education,and sex-matched normal healthy subjects. Analysis of DC map changes between the two patient groups and the control group were performed by two sample t test.(threshold at P<0.05).[Results]Compared with the control group,patients with PI showed significantly reduced DC value in middle temporal gyrus(MTG. R);hippocampus(HIP. B);parahippocampal gyrus(PHG. R);putamen(PUT. R);cuneus(CUN. L).[Conclusions]Changes of DC value occurred in some region of brain in the PI patient groups when compared with the control group. It was indicated that DC ,as a novel resting-state fMRI parameter in the voxel-wise whole-brain functional networks ,might be an appealing alternative approach for further study on pathologic and neuropsychological states of PI.
10.Change of fractional amplitude of low frequency fluctuation in untreated primary insomnia patients: a resting state functional magnetic resonance imaging
Xiaofen MA ; Yunfang WU ; Shaoqing ZENG ; Jin FANG ; Shishun FU ; Kelei HUA ; Yi YIN ; Wenfeng ZHAN ; Guihua JIANG
Chinese Journal of Neuromedicine 2017;16(7):701-705
Objective The aim of this study is to understand the impairment and compensation mechanism of brain function in untreated primary insomnia (PI) patients.The approach of fractional amplitude of low frequency fluctuation (fALFF) is used to analyze raw data between the PI patients and the normal control group in resting state using functional magnetic resonance imaging (fMRI).Methods Fifty-nine PI patients,admitted to our hospital from November 2015 to November 2016,and 47 age-,education-,and gender-matched normal healthy subjects were chosen in our study.Pittsburg sleep quality index (PSQI),insomnia severity index (ISI) were employed to evaluate the sleep quality.Self-rating anxiety scale (SAS) and self-rating depression scale (SDS) were employed to evaluate the emotion.Resting state fMRI and fALFF analyses were used to compare the functional regional activities.The correlations of fALFF data with PSQI,SAS and SDS scores were analyzed.Results In PI patients,2 had mild to moderate insomnia,41 had moderate insomnia,and 16 had serious insomnia.ISI scores in the normal healthy subjects were less than 7.The PSQI,SAS,SDS and ISI scores in the PI patients were significantly higher than those in the normal healthy subjects (P<0.05).As compared with the control group,the PI group had significantly increased fALFF value in the right hippocampus (HIP),right parahippocampa gyms,right amygdala,and bilateral thalamus.The fALFF value was positively correlated PSQI,SASandSDSscores (r=0.582,P=0.000;r=0.617,P=0.000;r=0.653,P=0.000).Conclusion Some brain regions in the PI patients are abnormal in the resting state,which can reflex functional regional activities of PI patients.


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