1.Shufeng Jiedu Granule against mild COVID-19: Protocol of the randomized, double-blind, placebo-controlled, multi-center heal-COVID phase III study.
Li YANG ; Thomas FRIEDEMANN ; Jun PAN ; Xiangyu LI ; Fuxiang WANG ; Yuanlong LIN ; Qiang ZHU ; Sven SCHRÖDER ; Qingsong LIU ; Hongzhou LU
Chinese Herbal Medicines 2025;17(3):601-608
OBJECTIVE:
Since Omicron will likely persist, this trial evaluates the safety and efficacy of Shufeng Jiedu Granule (SFJDG) for mild Omicron infection, aims at finding new therapies especially for home-treated patients.
METHODS:
This randomized, double-blind, placebo-controlled, multi-center phase III trial involves 844 patients, divided into a treatment group (422) and control group (422). Participants will receive SFJDG or placebo for 7 d (1.2 g/bag, 2 bags, 3 times/d). Hospital evaluations will be done on days 1 and 8, with telephone assessments on days 3 and 5. Follow-up continues on days 10 and 14. Diary cards will track symptom scores and safety data. The primary outcome is the time to sustained clinical recovery from corona virus disease 2019 (COVID-19) symptoms. An interim analysis will occur after 70 % of patients complete follow-up, with Type I error correction (α1 = 0.015) at interim analysis based on O'Brien-Fleming-type cumulative error spending function.
RESULTS:
This phase III trial evaluates the efficacy and safety of SFJDG for mild COVID-19, focusing on real-world applicability for home-managed patients. The study's randomized, double-blind, placebo-controlled design ensures methodological rigor, while its comprehensive outcome measures address both symptom recovery and treatment safety. By emphasizing symptom resolution and recovery time, the trial aligns with the clinical priorities for managing mild cases of COVID-19. The findings could offer valuable insights into SFJDG's role in improving patient outcomes and addressing gaps left by existing antiviral therapies, particularly in symptom management.
CONCLUSION
The global risk assessment remains high due to the ongoing virulence of SARS-CoV-2 Omicron sub-lineages. This Phase III study adopts a robust methodology to investigate SFJDG as a treatment for mild COVID-19 as well as it's effectiveness and safety. Furthermore, this study aim to provide sufficient scientific evidence for the market registration of SFJDG especially for home-treated patients. If successful, SFJDG could be a meaningful addition to therapeutic options for mild infections, supporting public health strategies in managing the ongoing impact of SARS-CoV-2.
2.Systemic and dynamic immune landscape of Omicron-infected subjects treated with Lianhua Qingwen capsules.
Shijun CHEN ; Fuxiang WANG ; Yuanlong LIN ; Yinyin XIE ; Ruihong ZHANG ; Juan CHEN ; Niu QIAO ; Tong YIN ; Yun TAN ; Hai FANG ; Hongzhou LU ; Zhu CHEN ; Shanhe YU ; Jiang ZHU ; Zhenhua JIA ; Saijuan CHEN
Acta Pharmaceutica Sinica B 2024;14(11):5074-5078
3.Clinical significance of transrectal ultrasound measurement of prostate volume in predicting prostate cancer by free prostate specific antigen density
Wanchao LUO ; Hong WEN ; Huanjia LUO ; Zhanping XU ; Fuxiang LIN ; Bingzi ZOU
Journal of Modern Urology 2023;28(7):623-626
【Objective】 To explore the application value of free prostate specific antigen density(fPSAD) based on rectal ultrasound in the prediction of prostate biopsy results. 【Methods】 Data of 578 patients undergoing transrectal ultrasound guided prostate biopsy during Jan.2014 and Jul.2021 were retrospectively analyzed, including prostate specific antigen(PSA) level, free prostate specific antigen(fPSA) level, fPSA/total prostate specific antigen(tPSA), prostate specific antigen density(PSAD), combined prostate specific antigen density(cPSAD), fPSAD, prostate volume and other clinical parameters. 【Results】 There were 253 cases of prostate cancer and 325 cases of prostatic hyperplasia. The positive puncture rate was 43.8%. The critical value of fPSAD was 0.05, the corresponding area under receiver operating characteristic (ROC) curve was 0.830, and the Yoeden index was 0.539. The sensitivity, specificity, diagnosis accordance rate and Kappa value of fPSAD to predict prostate cancer were 0.76, 0.77, 76.7% and 0.529, respectively. Compared with PSA, fPSA/tPSA and PSAD, PSA had the highest sensitivity (92.5%), fPSAD had the highest specificity (77.2%), and fPSAD had the highest diagnostic accordance rate (76.7%). 【Conclusion】 When transrectal prostate volume measurement is used to predict prostate cancer, fPSAD has relatively high specificity and diagnosis accordance rate, which is obviously better than using PSA, fPSA/tPSA ratio and PSAD alone in the differential diagnosis and prediction of prostate cancer and prostatic hyperplasia.
4.Comparison of 3D-arterial spin labeling and digital subtraction angiography in the diagnosis of occlusion and collateral circulation in patients with acute ischemic stroke
Fuxiang SUN ; Zhe ZHANG ; Lin ZHANG
Journal of Chinese Physician 2023;25(1):81-85,91
Objective:To explore the diagnostic value of 3D-arterial spin labeling (ASL) and digital subtraction angiography (DSA) in the occlusion and collateral circulation (CC) of patients with acute ischemic stroke (AIS).Methods:From January 2019 to June 2020, 53 cases of AIS patients with middle cerebral artery (MCA) occlusion in Langfang Hospital of Traditional Chinese Medicine were selected as the research objects. All patients underwent DSA and 3D ASL examination. According to the gold standard of DSA, the diagnostic value of proximal intra-arterial signal (IAS) in 3D-ASL was observed, and the clinical value of distal IAS in the diagnosis of lateral CC was observed. Univariate and multivariate logistic regression were used to identify risk factors for poor outcome in AIS patients.Results:There were 31 cases with good collateral circulation judged by DSA. Taking DSA as the gold standard, the sensitivity, specificity, positive predictive value, negative predictive value and accuracy of digital IAS in diagnosing CC status were 93.55%, 81.82%, 87.88%, 90.00% and 88.68%, respectively. The National Institutes of Health Stroke Scale (NIHSS) score of patients with good CC assessed by 3D-ASL was lower than that of patients with poor CC at admission, and the good prognosis rate at discharge was higher than that of patients with poor CC, with statistically significant difference (all P<0.05). There was no significant difference in clinical data between patients with good CC and those with poor CC, such as gender, age, history of atrial fibrillation, hypertension, diabetes, smoking, drinking, onset to treatment time, treatment methods, etc (all P>0.05). Univariate and multivariate analysis showed that poor CC assessed by ASL was a risk factor for poor prognosis in AIS patients ( OR=5.897, P<0.05). Conclusions:The proximal and distal IAS of 3D-ASL can provide important diagnostic clues for detecting arterial occlusion and collateral perfusion in patients with AIS, and the detection of CC by ASL is of great value for prognosis.
5.Expressions of Wnt3a and Wnt5a in papillary thyroid carcinoma and their clinical significances
Zhongguo LI ; Daxin CHEN ; Fuxiang YU ; Guangrong LIN
Cancer Research and Clinic 2019;31(5):331-335
Objective To investigate the expressions of Wnt3a and Wnt5a in papillary thyroid carcinoma (PTC) and their clinical significances. Methods Immunohistochemical SABC method was used to detect the expressions of Wnt3a and Wnt5a proteins in PTC tissues and their paracancerous tissues collected from 79 patients in Dandong First Hospital from January 2014 to June 2018, and the relationships between the expressions of Wnt3a and Wnt5a proteins and clinicopathological features of PTC patients were analyzed. The expressions of Wnt3a and Wnt5a proteins in 10 pairs of fresh PTC tissues and paracancerous tissues were detected by Western blot. Results The results of immunohistochemistry showed that the positive expression rates of Wnt3a and Wnt5a proteins in PTC tissues were significantly higher than those in paracancerous tissues [69.6% (55/79) vs. 25.3% (20/79), 60.8% (48/79) vs. 20.2% (16/79)], and the differences were statistically significant (χ 2 values were 31.092 and 26.894, both P < 0.01). The results of Western blot showed that the expressions of Wnt3a and Wnt5a proteins in 10 pairs of fresh PTC tissues was significantly higher than those in paracancerous tissues(1.61±0.40 vs. 0.43±0.14, 1.38±0.291 vs. 0.36±0.13), and the differences were statistically significant (t values were 16.234 and 13.493, both P < 0.01). The expressions of Wnt3a and Wnt5a in PTC tissues were correlated with TNM stage, differentiation, extramembranous invasion and lymph node metastasis (Wnt3a: χ2 values were 6.645, 15.945, 8.783 and 11.220; Wnt5a: χ2 values were 21.525, 7.611, 17.880 and 12.581, all P < 0.05), but not with patients'age, sex and tumor diameter (all P > 0.05). There was a positive correlation between Wnt3a and Wnt5a proteins expressions in PTC (r = 0.597, P < 0.01).Conclusion The abnormal expressions of Wnt3a and Wnt5a proteins in PTC may be related to the development of PTC.
6.Receptor interacting protein kinase 1 and receptor interacting protein kinases 3 mediate glutamate induced cell death in HT-22 hippocampal neuronal cells
Xingfen SU ; Handong WANG ; Dezhi KANG ; Yuanxiang LIN ; Fuxiang CHEN
Chinese Journal of Neuromedicine 2018;17(9):905-912
Objective To explore whether receptor interacting protein (RIP)1/RIP3 pathways participate in glutamate induced cell death in HT-22 neuronal cells and investigate the potential neuroprotection ofnecrostatin-1 in glutamate induced cell death in HT-22.Methods (1) In vitro cultured mouse hippocampal neuronal HT-22 cells were divided into control group,zVAD group,necrostatin-1 (Nec-1) group,glutamate group,glutamate+zVAD group,glutamate+zVAD+Nec-1 group and glutamate+Nec-1 group;they were treated with zVAD,Nec-1 and glutamate at the final concentrations of 20 μmol/L,30 μmol/L and 3 mmol/L for 24 h.Cell viability was detected using a luminescence-based commercial kit Cell Titer-Glo (CTG).Necrotic cell death was measured by propidium iodide (PI) and HE stainings.(2) HT-22 cells were divided into control group Ⅰ,glutamate group Ⅰ and glutamate+Nec-1 group Ⅰ;MitoSox Red was used to detect mitochondrial reactive oxygen species (ROS) level.(3) HT-22 cells were divided into control group Ⅱ,glutamate group Ⅱ and glutamate+tertiary butyl-hydroxyanisole (BHA) group;the final concentration of BHA was 100 μmol/L;necrotic cell death was measured by PI and HE stainings after 24 h of treatment.(4) HT-22 cells were divided into RIP3 siRNA and control group Ⅲ,and then,they were transfected with RIP3 siRNA or negative siRNA,respectively;the RIP3 protein expression was determined by Westem blotting after 72 h of treatment.(5) HT-22 cells were divided into negative siRNA+Control,RIP3 siRNA,negative siRNA+glutamate and RIP3 siRNA+glutamate groups;the cells were transfected with RIP3 siRNA or Negative siNRA,respectively;48 h later,the glutamate groups were treated with 3 mmol/L glutamate;PI positive cells and cell viability were measured by PI and HE stainings and CTG at 24 h after glutamate treatment.Results (1) As compared with control group,percentage of PI positive cells was greatly increased and cell viability was decreased in glutamate group and glutamate+zVAD group,with statistically significant differences (P<0.05);as compared with those in the glutamate group,percentage of percentage of PI positive cells was was significantly decreased and cell viability was statistically increased in glutamate+Nec-1 group (P<0.05).(2) ROS level in HT-22 cells of the glutamate group was significantly increased than that in the control group Ⅰ (P<0.05);however,ROS level in HT-22 cells of glutamate+Nec-1 group Ⅰ was significantly decreased than that in glutamate group Ⅰ (P<0.05).(3)Percentage of PI positive cells in the glutamate group Ⅱ was significantly higher than that in the control group Ⅱ (P<0.05),and that in the glutamate+BHA group was statistically lower than that in the glutamate group Ⅱ (P<0.05).(4) The RIP3 protein expression in the RIP3 siRNA group was obviously down-regulated as compared with that in the control group Ⅲ.(5) As compared with those in the negative siRNA group,percentage of PI positive cells was statistically increased and cell viabilities were statistically decreased in glutamate group (P<0.05);however,percentage of PI positive cells was significantly decreased and cell viability was significantly increased in RIP3 siNRA+glutamate group as compared with those in the glutamate group (P<0.05).Conclusion RIP1/RIP3 pathway and ROS might mediate glutamate induced cell death in HT-22 cells.
7.Relationship between mitochondrial DNA alteration and gastric cancer
Journal of International Oncology 2016;43(8):628-630
Mitochondrial DNA (mtDNA) is more susceptible to oxidative damage and has a higher mutation rate compared with nuclear DNA due to the absence of protective histone proteins and imperfect repair system.Somatic alterations in mtDNA have been proposed to contribute to initiation and progression of human cancer in previous researches.However,the role of these mtDNA alterations in gastric cancer progression remains unclear.Point mutations and mtDNA content alterations are the two most common mtDNA alterations that result in mitochondrial dysfunction in gastric cancers.Identifing somatic mtDNA alterations in gastric cancers as well as their association with the clinicopathological parameters of gastric cancer,and exploring the causative factors of the somatic mtDNA alterations in cancer progression have been a new direction of gastric cancer research in recent years.
8.Ubiquitin and its role in the tumor
Xiaojia GAO ; Hui YANG ; Lin WU ; Fuxiang ZHOU ; Yunfeng ZHOU
Journal of International Oncology 2015;(3):188-191
Ubiquitin-proteasome pathway is one of the primary pathway in intracellular protein degrada-tion,therefore the ubiquitin conjugating enzyme D3(UbE2D3)which involved in the ubiquitin mineralization process can affect the biological effects accordingly to affect some protein and nucleic acid content and activity. The function that participate in modification and degradation of some cancer factors is vital in tumor cells,and followed by tumor biological behavior changing. Researches show that UbE2D3 correlates with human telomer-ase reverse transcriptase( hTERT),radiation sensitivity,aggressive,etc in breast cancer.
9.Stereotactic body radiotherapy for early stage non-small cell lung cancer
Journal of International Oncology 2015;(10):773-775
As one of the treatment options for early stage NSCLC,stereotactic body radiation therapy (SBRT)is mainly applied to the inoperable patients.Compared with small doses of traditional fractionated radi-ation treatment,SBRT are taken a single high dose of radiation.A large body of experience has been accumula-ted over the years and the mathematical model to describe survival in high dose range typically used in SBRT and the best dose of segmentation model were focused on,but there has not yet reached a consensus.Studies show that SBRT has certain advantages in local control ratio and adverse reaction compared with traditional radiotherapy,which can be used in operable patients in the future.
10.The reference values and Z scores regression equations of normal newborns undergoing echocardiography
Zhou, LIN ; Bei, XIA ; Na, XU ; Shuna, LI ; Xuezhi, HE ; Juan, WANG ; Lei, LIU ; Fuxiang, OU ; Weiling, CHEN ; Yanhua, XIE
Chinese Journal of Medical Ultrasound (Electronic Edition) 2014;(2):142-154
Objective To investigate the reference values and Z scores regression equations of newborn undergoing echocardiography. Methods Two hundred and eighty-eight newborns (aged 0-28 days) of Shenzhen Children′s Hospital underwent echocardiography examination, including M-mode, two-dimensional (2D) and real-time three-dimensional (3D) echocardiography, color Doppler lfow imaging (CDFI) and tissue Doppler imaging. The correlation between echocardiography results and weight were analyzed and Z scores were calculated. Results The normal values of right ventricular diameter (RV) and left ventricular end-diastolic diameter (LVEDD) measured by M-mode, the mitral annulus diameter in four chamber view (MV-D1), mitral annulus diameter in two chamber view (MV-D2), mitral annulus diameter in longitudinal view (MV-D3), aortic ring diameter (ARD), aortic sinus diameter (ASD), ascending aorta diameter (AAO), transverse aorta diameter (TA), aortic isthmus diameter (AI), aorta diaphragm diameter (AO-Dia), tricuspid annulus diameter in four chamber view (TV-D1), tricuspid annulus diameter in right ventricular inlfow tract view (TV-D2), right ventricular outlfow tract diameter (RVOT), pulmonary valve diameter (PVD) and main pulmonary artery diameter (PA) measured by 2D echocardiography and the normal values of mitral valve inflow Doppler component during early diastole (MV-E), mitral valve inlfow Doppler component during atrial contraction (MV-A), tricuspid valve inlfow Doppler component during early diastole (TV-E), tricuspid valve inflow Doppler component during atrial contraction (TV-A), aortic valve peak velocity (AV-max), aortic valve velocity-time integral (AV-VTI), pulmonary valve peak velocity (PV-max), pulmonary valve velocity-time integral (PV-VTI) measured by pulse Doppler, the mitral annular tissue Doppler component during systole (MV-s′), mitral annular tissue Doppler component during early diastole (MV-e′), mitral annular tissue Doppler component during atrial contraction (MV-a′), tricuspid annular tissue Doppler component during systole (TV-s′), tricuspid annular tissue Doppler component during early diastole (TV-e′), tricuspid annular tissue Doppler component during atrial contraction (TV-a′), interventricular septum annular tissue Doppler component during systole (IVS-s′), interventricular septum annular tissue Doppler component during early diastole (IVS-e′), interventricular septum annular tissue Doppler component during atrial contraction (IVS-a′) measured by tissue Doppler, the normal values of left atrial volume (LAV), left ventricular end-systolic volume (LVEDV), stroke volume (SV) and cardiac output (CO) measured by bi-plane method and the normal values of LVEDV, SV and CO measured by real-time tri-plane method, together with the normal values of left ventricular (LV) mass, left ventricular mass index [LV mass/BSA, LV mass/H2.7, body surface area (BSA) and height (H)], all showed nonlinear positive correlations with body weight (all P<0.01). The values of MV-E/A, PV-E/A, MV-e′/a′, TV-e′/a′, IVS-e′/a′, MV-E/IVS-e′, LV mass/LVEDV and left ventricular ejection fraction (LVEF) showed no correlations with body weight (all P>0.05). Except for RV, MV-D1, MV-D2, MV-D3, TV-D1, TV-E, MV-s′, IVS-a′, TV-s′and TV-e′, all R2 obtained by nonlinear regression method (lnY=a+bX+cX2+dX3) were larger than those obtained by linear regression method (Y=a+bX). The Z score showed a normal distribution and no correlation with body weight. Conclusions The normal reference values of newborn undergoing echocardiography reflect the variation in weight. The Z scores can be obtained by the predicted nonlinear regression equations and show standard normal distribution. The echocardiography normal reference values have important significance for the diagnosis and treatment of neonatal heart disease.

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