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.A nucleus location method based on distance estimation.
Wenhao SUN ; Fuxiang LU ; Yide MA
Journal of Biomedical Engineering 2018;35(3):435-442
To locate the nuclei in hematoxylin-eosin (HE) stained section images more simply, efficiently and accurately, a new method based on distance estimation is proposed in this paper, which shows a new mind on locating the nuclei from a clump image. Different from the mainstream methods, proposed method avoids the operations of searching the combined singles. It can directly locate the nuclei in a full image. Furthermore, when the distance estimation built on the matrix sequence of distance rough estimating (MSDRE) is combined with the fact that a center of a convex region must have the farthest distance to the boundary, it can fix the positions of nuclei quickly and precisely. In addition, a high accuracy and efficiency are achieved by this method in experiments, with the precision of 95.26% and efficiency of 1.54 second per thousand nuclei, which are better than the mainstream methods in recognizing nucleus clump samples. Proposed method increases the efficiency of nuclear location while maintaining the location's accuracy. This can be helpful for the automatic analysis system of HE images by improving the real-time performance and promoting the application of related researches.
4.Group psychotherapy on anxiety and depression symptoms in patients with alcohol dependence
Jianfen LI ; Wenxing LU ; Banglei LIAO ; Linghong DUAN ; Fuxiang LI ; Qiang LU ; Jianjun BAI ; Haiyan ZHENG ; Xiaohong YANG
Chinese Mental Health Journal 2017;31(2):118-122
Objective:To explore the clinical effect of group psychotherapy on relieving anxiety and depression symptoms in patients with alcohol dependence.Methods:Totally 117 patients with alcohol dependence accompanied with anxiety and depression symptoms were selected from the Second People's Hospital of Puer City from 2014 January 1 to December 31.The anxiety and depression symptoms were assessed with the Self-Rating Anxiety Scale (SAS),Self-Rating Depression Scale (SDS) and Brief Psychiatric Rating Scale (BPRS).They were divided into drug combined group (intervention group,n =89) and single drug treatment group (control group,n =88).The two groups were administrated diazepam replacement therapy,and the intervention group combined group psychotherapy.Eight weeks later,treatment effect of the two groups were evaluated with the Clinical Global Impression Scale (CGI).Results:After intervention,the scores of SAS,SDS,BPRS,and CGI in intervention group decreased [(21.1 ±8.3) vs.(65.3± 10.2),(35.1 ±3.5) vs.(51.7 ±5.6),(4.3 ± 1) vs.(5.4 ±0.6),Ps <0.05].There was no significant difference in above scores between before and after treatment in the control group (Ps > 0.05).Conclusion:The effect of group psychotherapy on the basis of medicine may be better than that of single drug therapy on relieving anxiety and depression in patients with alcohol dependence.
5.Radiosensitization of clioquinol and zinc in human cervical cancer cell lines
Shan LU ; Yuan KE ; You WANG ; Hong ZHAO ; Xiaojia GAO ; Haijun YU ; Fuxiang ZHOU
Chinese Journal of Radiological Medicine and Protection 2016;36(4):241-245
Objective To investigate the radiosensitization effects of the combination treatment of clioquinol (CQ) and zinc on human cervical cell line HeLa in vitro.Methods Cells were divided into the 4 groups:controls,drug,radiation,and combined drug and radiation group.Cytotoxic effect of CQ and zinc on cell viability was determined by CCK-8 assay.Radiosensitization effect of CQ and zinc on HeLa cells was detected by colongenic assay,and the single-hit multi-target model was used to stimulate the doseresponse curve of survival and to calculate radiosensitization parameters.The cell cycle and apoptosis of HeLa cells were analyzed with flow cytometry.Luciferase reporter assay was used to study NF-κB activity of HeLa cells.Results The combination of CQ and zinc inhibited cell growth in a dose-dependent manner (F =188.00,P < 0.01).The mean lethal dose was 3.16 and 2.04 Gy for radiation group and combined drug and radiation group,respectively,and hence the SER was 1.55.Compared with the radiation group,the ratio of G2-phase cells in the combined drug and radiation group decreased(t =10.39,P < 0.05),the apoptosis rate increased at 24 h post-irradiation (t =5.64,P < 0.01),and the NF-κB activity decreased (t =21.42,P < 0.05).Compared to the control group,the NF-κB activity increased in the radiation group(t=6.23,P<0.05),but decreased in the drug group(t =12.48,P<0.05).Conclusions The combination of CQ and zinc could increase the radiosensitivity of HeLa cells by decreasing the ratio of G2-phase cells,increasing apoptosis and the inhibiting of NF-κB activity.

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