1.A phase Ⅲ clinical study to evaluate the efficacy and safety profile of antaitasvir phosphate combined with yiqibuvir in the treatment of adults with chronic hepatitis C
Lai WEI ; Jia SHANG ; Xuan AN ; Guoqiang ZHANG ; Yujuan GUAN ; Hongxin PIAO ; Jinglan JIN ; Lang BAI ; Xingxiang YANG ; Daokun YANG ; Xinhua LUO ; Shufang YUAN ; Yingren ZHAO ; Yingjie MA ; Guangming LI ; Feng LIN ; Xiaoping WU ; Jiawei GENG ; Guizhou ZOU ; Jiabao CHANG ; Zuojiong GONG ; Xiaorong MAO ; Jing ZHU ; Wentao GUO ; Qingwei HE ; Lin LUO ; Yulei ZHUANG ; Hongming XIE ; Yingjun ZHANG
Chinese Journal of Hepatology 2025;33(6):560-569
Objective:To assess the efficacy and safety profile of antaitasvir phosphate combined with yiqibuvir in the treatment of chronic hepatitis C (CHC) of various genotypes, without cirrhosis or with compensated cirrhosis.Methods:394 cases with CHC from 22 centers were collected from October 2021 to April 2023. They were randomly assigned to receive either the experimental drugs (antaitasvir phosphate 100 mg+yiqibuvir 600 mg) or placebo treatment in a 3∶1 ratio. The patients were administered drugs once a day for 12 consecutive weeks, and then followed up for 24 weeks after treatment cessation. All subjects were unblinded at the four-week follow-up following drug discontinuation, with the experimental drug group continuing to complete subsequent post-discontinuation follow-up. The placebo group was switched to receive the experimental drugs for a repeated 12-week treatment period and followed up for another 24 weeks after discontinuation of the drug (placebo delayed treatment phase).The sustained virologic response rate (SVR12) was observed for subjects in the double-blind phase and the placebo delayed-treatment phase at 12 weeks after treatment cessation.Virological resistance analysis was performed on subjects who failed treatment. The primary efficacy endpoint was SVR12. The number and percentage of subjects who achieved "HCV RNA
2.A phase Ⅲ clinical study to evaluate the efficacy and safety profile of antaitasvir phosphate combined with yiqibuvir in the treatment of adults with chronic hepatitis C
Lai WEI ; Jia SHANG ; Xuan AN ; Guoqiang ZHANG ; Yujuan GUAN ; Hongxin PIAO ; Jinglan JIN ; Lang BAI ; Xingxiang YANG ; Daokun YANG ; Xinhua LUO ; Shufang YUAN ; Yingren ZHAO ; Yingjie MA ; Guangming LI ; Feng LIN ; Xiaoping WU ; Jiawei GENG ; Guizhou ZOU ; Jiabao CHANG ; Zuojiong GONG ; Xiaorong MAO ; Jing ZHU ; Wentao GUO ; Qingwei HE ; Lin LUO ; Yulei ZHUANG ; Hongming XIE ; Yingjun ZHANG
Chinese Journal of Hepatology 2025;33(6):560-569
Objective:To assess the efficacy and safety profile of antaitasvir phosphate combined with yiqibuvir in the treatment of chronic hepatitis C (CHC) of various genotypes, without cirrhosis or with compensated cirrhosis.Methods:394 cases with CHC from 22 centers were collected from October 2021 to April 2023. They were randomly assigned to receive either the experimental drugs (antaitasvir phosphate 100 mg+yiqibuvir 600 mg) or placebo treatment in a 3∶1 ratio. The patients were administered drugs once a day for 12 consecutive weeks, and then followed up for 24 weeks after treatment cessation. All subjects were unblinded at the four-week follow-up following drug discontinuation, with the experimental drug group continuing to complete subsequent post-discontinuation follow-up. The placebo group was switched to receive the experimental drugs for a repeated 12-week treatment period and followed up for another 24 weeks after discontinuation of the drug (placebo delayed treatment phase).The sustained virologic response rate (SVR12) was observed for subjects in the double-blind phase and the placebo delayed-treatment phase at 12 weeks after treatment cessation.Virological resistance analysis was performed on subjects who failed treatment. The primary efficacy endpoint was SVR12. The number and percentage of subjects who achieved "HCV RNA
3.A phase Ⅱ clinical study of the efficacy and safety of antaitasvir phosphate combined with yiqibuvir for the treatment of chronic hepatitis C in adults
Lai WEI ; Hongxin PIAO ; Jinglan JIN ; Shufen YUAN ; Xuan AN ; Jia SHANG ; Wenhua ZHANG ; Jiabao CHANG ; Tong SUN ; Yujuan GUAN ; Bo NING ; Jing ZHU ; Wentao GUO ; Qingwei HE ; Lin LUO ; Yulei ZHUANG ; Hongming XIE ; Yingjun ZHANG
Chinese Journal of Hepatology 2024;32(7):637-642
Objective:To evaluate the efficacy and safety of antaitasvir phosphate 100 mg or 200 mg combined with yiqibuvir for 12 weeks in patients with various genotypes of chronic hepatitis C, without cirrhosis or compensated stage cirrhosis.Methods:Patients with chronic hepatitis C (without cirrhosis or compensated stage cirrhosis) were randomly assigned to the antaitasvir phosphate 100 mg+yiqibuvir 600 mg group (100 mg group) or the antaitasvir phosphate 200 mg+yiqibuvir 600 mg group (200 mg group) in a 1∶1 ratio. The drugs were continuously administered once a day for 12 weeks and observed for 24 weeks after drug withdrawal. The drug safety profile was assessed concurrently with the observation of the sustained virological response (SVR12) in the two patient groups 12 weeks following the drug cessation. The intention-to-treat concept was used to define as closely as possible a full analysis set, including all randomized cases who received the experimental drug at least once. The safety set was collected from all subjects who received the experimental drug at least once (regardless of whether they participated in the randomization group) in this study. All efficacy endpoints and safety profile data were summarized using descriptive statistics. The primary efficacy endpoint was SVR12. The primary analysis was performed on a full analysis set. The frequency and proportion of cases were calculated in the experimental drug group (antaitasvir phosphate capsules combined with yiqibuvir tablets) that achieved "HCV RNA
4.The Effects of Mild Hypothermia on MODS Caused by Cerebral Hemorrhage
Liang WEI ; Qi WANG ; Cheng YANG ; Yanfei ZHANG ; Hongxin GUAN ; Zhiyang SUN
Journal of Kunming Medical University 2016;37(12):57-61
Objective To disscuss and analyze the clinical effects of whole body mild hypothermia on MODS caused by cerebral hemorrhage.Methods One hundred and eighty patients with MODS caused by cerebral hemorrhage during the period of hospitalized from January 2013 to December 2015 in ICU of our hospital were divided into two groups (observation group and control group) randomly,90 cases patients in each group.Patients in control group were treated with conventional treatment intervention,patients in control group were treated with whole body mild hypothermia on the base of conventional treatment intervention,the score of MODS,the ratio of,VO2 and DO2,the time during the period of hospitalized in ICU,the time of mechanical ventilation,epilepsy incidence and mortality,NIHSS score and PADL score of the patients in these two group after treatment were compared.Results After the comparion,the score of MODS and the state of oxygen consumption and oxygen supply of the patients in observation group were better than the patients in control group,there was significant differences,and had statistical significance (P<0.05);the time during the period of hospitalized in ICU and the time of mechanical ventilation of the patients in observation group were shorter than the patients in control group,there was significant difference,and had statistical significance (P<0.05);the mortality were reduce significantly of the patients in observation group than the patients in control group,there was significant difference,and had statistical significance (P<0.05);the epilepsy incidence of the patients in observation group and control has no significant difference,has no statistical significance (P>0.05);the NIHSS score and PADL score of the patients in observation group were higher than the patients in control group,there was significant difference,and has statistical significance (P<0.05).Conclusion The clinical effects of whole body mild hypothermia on MODS caused by cerebral hemorrhage have important significance,can effectively improve the balance of multiple organ dysfunction syndrome patients,can delay the progression of multiple organ dysfunction syndrome patients,improve the prognosis,it is worthy of clinical application and promotion.
5.Mild hypothermia can decrease incidence of multiple organ dysfunction syndrome after intracerebral hemorrhage by up-regulating interleukin-10
Liang WEI ; Qi WANG ; Cheng YANG ; Yanfei ZHANG ; Hongxin GUAN ; Zhiyang SUN
Chinese Journal of Neuromedicine 2016;15(5):494-496
Objective To examine whether mild hypothermia can decrease the incidence of multiple organ dysfunction syndrome (MODS) in patients after intracerebral hemorrhage.Methods Forty-eight patients with intracerebral hemorrhage,admitted to our hospital from March 2014 to December 2015,were divided into two groups:one was treated with mild hypothermia,and another was treated with normal methods after the surgery;the incidence of MODS was calculated between the two groups.Serum interleukin-10 (IL-10) levels were measured with enzyme-linked immunosorbent assay and E4 promoter-binding protein 4 (E4BP4) levels were measured with Simple Western in peripheral blood lymphocytes one,two,5,7,14 and 21 d after surgery.Results The incidence of MODS in patients with mild hypothermia treatment was 11.11% and that in patients with normal treatment was 28.57%,with significant difference (P<0.05).The IL-10 and E4BP4 levels in patients with mild hypothermia treatment were significantly higher than those in patients with normal treatment (P<0.05).Conclusion Mild hypothermia can decrease the incidence of MODS in patients after intracerebral hemorrhage,IL-10 has some role,and E4BP4 is associated with release of interleukin-10.
6.Expression of CD200 in peripheral lymphocytes and hair follicles from patients with alopecia areata and its significance
Haihong GUAN ; Hui LI ; Hongxin LI ; Lin LIN ; Hongsheng WANG ; Wuqing ZHOU
Chinese Journal of Dermatology 2013;(1):9-12
Objective To investigate the expression of CD200 in peripheral lymphocytes and hair follicles from patients with alopecia areata (AA).Methods Flow cytometry was used to detect the expression of CD200 in peripheral lymphocytes from 43 patients with AA and 43 healthy controls.Immunohistochemistry was carried out to quantify the expression of CD200 and cytokeratin 15(CK15,a marker for basal cells of the outer root sheath) in resected scalp specimens from 8 patients with AA and 8 healthy controls.Differences in the expression of CD200 and CK15 between the patients and controls were assessed by independent-samples t test and rank sum test.Data were processed by the software SPSS17.0.Results The percentage of CD200-expressing cells in peripheral blood lymphocytes and T lymphocytes was significantly lower in the patients with AA than in the healthy controls (5.73% ± 3.46% vs.12.01% ± 4.90%,8.85% ± 4.80% vs.12.31% ± 3.12%,t =6.865,3.964,respectively,both P < 0.05).However,no significant difference was observed in the percentage of CD200-expressing cells in peripheral blood B lymphocytes between the patients and controls (74.68% ± 8.12% vs.75.75% ± 9.45%,t =0.570,P > 0.05).Further more,the patients showed a lower expression of CD200 (P < 0.05),but a similar expression of CK15 (P > 0.05) in hair follicles compared with the controls.Conclusion The decrease in CD200 expression in peripheral lymphocytes and hair follicles may be involved in the pathogenesis of AA.
7.Expression of adenosine triphosphate-binding cassette transporter 2 in the tissue and side population of a cell line (A431) of human cutaneous squamous cell carcinoma and its significance
Hongxin LI ; Yong ZHAO ; Haihong GUAN ; Lin LIN
Chinese Journal of Dermatology 2012;45(6):392-395
ObjectiveTo investigate the expression of stem cell marker adenosine triphosphate (ATP)-binding cassette transporter 2 (ABCG2) in the tissue and side population (SP) of a cell line A431 of human cutaneous squamous cell carcinoma(SCC).MethodsSP cells were separated by flow cytometry from cultured A431 cells.Methyl thiazolyl tetrazolium(MTT) assay was used to evaluate the proliferative ability of,reverse transcription-PCR to determine the expression of ABCG2 in,SP and non-SP cells.Immunohistochemistry (MaxVision method) was carried out to detect the expression of ABCG2 protein in tissue specimens from 10 patients with SCC.ResultsSP cells existed in cultured A431 cells,and accounted for about 1.1% of A431 cells.The SP cells had a stronger growth and colony-forming ability than non-SP cells did.The number of cell clones formed by SP cells and non-SP cells was 114.8 ± 4.95 and 44.5 ± 3.67,respectively,per well in a 24-well plate( t =27.92,P < 0.01 ).The expression level of ABCG2 mRNA was significantly higher in SP cells than in non-SP cells(t =5.22,P< 0.01).There existed a small number of ABCG2 positive cells in SCC tissue,and ABCG2 was mainly expressed in the cytoplasm and membrane of tumor cells.ConclusionsSP cells exist in A431 cells,which have characteristics of stem cells and highly express ABCG2.ABCG2 may be a potential stem cell surface marker of SCC.
8.Application of spinal cord stimulation in the treatment of cerebral ischemia
Xiaosheng YANG ; Yi XUAN ; Jin ZHU ; Hongxin GUAN ; Jun ZHONG
International Journal of Cerebrovascular Diseases 2010;18(4):286-290
Since Hosobuchi first found that spinal cord stimulation had the effect of significantly increasing cerebral blood flow (CBF) more than two decades ago, spinal cord stimulation had attracted wide attention in the field of treating cerebral ischemia. A large number of animal and clinical studies have been performed in this field, which make it another research focus following thrombolysis and interventional therapy. This article reviews the research history, mechanisms, and current status of clinical applications of spinal cord stimulation in cerebral ischemia protection.
9.Research on cortical stimulation for treatment of stroke
Hongxin GUAN ; Yunshi XIAO ; Jun ZHONG
Journal of Shanghai Jiaotong University(medical Science) 2010;30(1):108-111
Stroke is characterized by a group of acute cerebral vascular diseases which attack acutely with focal neurological deficits. Residual motor deficits often sojourn after stroke. Cortical stimulation, which is a technique developed many decades ago, has recently re-emerged as a promising method for researchers in their quest to causally probe cortical representations of sensorimotor and cognitive functions and to facilitate the treatment of various neuropsychiatric disorders. The article summarizes the research progress of cortical stimulation in the promotion of motor function recovery after stroke, the method of operation, the possible mechanisms and the prospect.
10.Research on spinal cord stimulation for treatment of cerebral ischemia
Journal of Shanghai Jiaotong University(Medical Science) 2009;29(10):1259-1262
Cerebral ischemia is one of the diseases of the central nervous system, which is harmful to the morphology and function of brain cells due to reduced cerebral blood flow. Increasingly more reports have demonstrated that spinal cord stimulation could augment the cerebral blood flow, which is expected to be a potential method for the treatment of cerebral ischemia. In this article, the research progress and related problems of spinal cord stimulation for the treatment of cerebral ischemia are reviewed.

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