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.Relationship and predictive value of serum ANXA1, MIP-1α, sTREM-1 with pulmonary infection in elderly patients with coronary heart disease combined with heart failure
Zheng REN ; Hongxin ZHU ; Qiying JIN ; Wenjing SU ; Ying JIANG
Journal of Chinese Physician 2025;27(1):91-95
Objective:To investigate the relationship between serum annexin A1 (ANXA1), macrophage inflammatory protein 1-α (MIP-1α), soluble triggering receptor expressed on myeloid cells-1 (sTREM-1) and pulmonary infection in elderly patients with coronary heart disease complicated with heart failure and their predictive value.Methods:A total of 197 elderly patients with coronary heart disease combined with heart failure admitted to the Second Hospital of Qinhuangdao from January 2021 to January 2023 were retrospectively selected, and divided into pulmonary infection group (36 cases) and non pulmonary infection group (161 cases) according to whether the patients had pulmonary infection during hospitalization. Serum ANXA1, MIP-1α and sTREM-1 levels were detected in two groups. Multivariate logistic regression model was used to analyze the influencing factors of lung infection in elderly patients with coronary heart disease combined with heart failure. The predictive value of serum ANXA1, MIP-1α and sTREM-1 levels on lung infection in elderly patients with coronary heart disease combined with heart failure was analyzed by receiver operating characteristic (ROC) curve.Results:The incidence of pulmonary infection in 197 elderly patients with coronary heart disease combined with heart failure was 18.27%(36/197). Compared with the non pulmonary infection group, the pulmonary infection group had higher levels of serum ANXA1, MIP-1 α, sTREM-1, C-reactive protein, procalcitonin, and higher proportion of New York Heart Association (NYHA) heart function grade Ⅳ and diabetes, and lower left ventricular ejection fraction (all P<0.05). Multivariate logistic regression analysis showed that NYHA cardiac function grade Ⅳ, diabetes mellitus and elevated levels of procalcitonin, ANXA1, MIP-1α and sTREM-1 were independent risk factors for pulmonary infection in elderly patients with coronary heart disease combined with heart failure (all P<0.05). ROC curve analysis showed that the area under the curve predicted by serum ANXA1, MIP-1α and sTREM-1 combined was 0.909, which was larger than that predicted by serum ANXA1, MIP-1α and sTREM-1 alone. Conclusions:Elevated levels of serum ANXA1, MIP-1α and sTREM-1 are independent risk factors for pulmonary infection in elderly patients with coronary heart disease combined with heart failure, and can be used as auxiliary predictors of pulmonary infection in elderly patients with coronary heart disease combined with heart failure.
3.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
4.Relationship and predictive value of serum ANXA1, MIP-1α, sTREM-1 with pulmonary infection in elderly patients with coronary heart disease combined with heart failure
Zheng REN ; Hongxin ZHU ; Qiying JIN ; Wenjing SU ; Ying JIANG
Journal of Chinese Physician 2025;27(1):91-95
Objective:To investigate the relationship between serum annexin A1 (ANXA1), macrophage inflammatory protein 1-α (MIP-1α), soluble triggering receptor expressed on myeloid cells-1 (sTREM-1) and pulmonary infection in elderly patients with coronary heart disease complicated with heart failure and their predictive value.Methods:A total of 197 elderly patients with coronary heart disease combined with heart failure admitted to the Second Hospital of Qinhuangdao from January 2021 to January 2023 were retrospectively selected, and divided into pulmonary infection group (36 cases) and non pulmonary infection group (161 cases) according to whether the patients had pulmonary infection during hospitalization. Serum ANXA1, MIP-1α and sTREM-1 levels were detected in two groups. Multivariate logistic regression model was used to analyze the influencing factors of lung infection in elderly patients with coronary heart disease combined with heart failure. The predictive value of serum ANXA1, MIP-1α and sTREM-1 levels on lung infection in elderly patients with coronary heart disease combined with heart failure was analyzed by receiver operating characteristic (ROC) curve.Results:The incidence of pulmonary infection in 197 elderly patients with coronary heart disease combined with heart failure was 18.27%(36/197). Compared with the non pulmonary infection group, the pulmonary infection group had higher levels of serum ANXA1, MIP-1 α, sTREM-1, C-reactive protein, procalcitonin, and higher proportion of New York Heart Association (NYHA) heart function grade Ⅳ and diabetes, and lower left ventricular ejection fraction (all P<0.05). Multivariate logistic regression analysis showed that NYHA cardiac function grade Ⅳ, diabetes mellitus and elevated levels of procalcitonin, ANXA1, MIP-1α and sTREM-1 were independent risk factors for pulmonary infection in elderly patients with coronary heart disease combined with heart failure (all P<0.05). ROC curve analysis showed that the area under the curve predicted by serum ANXA1, MIP-1α and sTREM-1 combined was 0.909, which was larger than that predicted by serum ANXA1, MIP-1α and sTREM-1 alone. Conclusions:Elevated levels of serum ANXA1, MIP-1α and sTREM-1 are independent risk factors for pulmonary infection in elderly patients with coronary heart disease combined with heart failure, and can be used as auxiliary predictors of pulmonary infection in elderly patients with coronary heart disease combined with heart failure.
5.Study on the Mechanism of Hepatotoxicity Induced by Rhubarb Based on Network Pharmacology and Experimental Verification
Hongxin WANG ; Shiyu ZHANG ; Yang JIN ; Taotao CAO ; Qin QIN ; Wen LIU
World Science and Technology-Modernization of Traditional Chinese Medicine 2024;26(1):167-178
Objective The potential mechanism of hepatotoxicity induced by rhubarb was preliminarily explored by network pharmacology and verified by cell experiments.Methods Based on network pharmacology,component collection and target prediction are carried out through multiple databases.PPI network construction,GO enrichment analysis and KEGG pathway analysis were combined with software to systematically predict the mechanism of hepatotoxicity induced by rhubarb.The pathway information predicted by network pharmacology was verified by primary hepatocyte experiments and Western blot experiments.Results The results of network pharmacology showed that RH was the main component of hepatotoxicity induced by rhubarb.Seventeen core targets of hepatotoxicity induced by rhubarb were obtained.KEGG results suggested that DNA damage and apoptosis were one of the key mechanisms of hepatotoxicity induced by rhubarb.The results of primary hepatocytes and Western blot showed that RH could inhibit the viability of primary hepatocytes in a time-dose dependent manner.ABT and SFP can significantly reduce the toxicity of RH on primary liver cells in mice,and RFP can increase the toxicity of RH to mouse primary liver cells.Upregulation of γ-H2AX and PARP-1 protein in primary liver cells of mice after treatment with different concentrations of RH.Conclusion RH in rhubarb can significantly inhibit the viability of mouse primary hepatocytes,and its toxicity to mouse primary hepatocytes is mainly caused by the metabolic activation of RH by CYP 2C9.RH can activate PARP-1 protein,phosphorylate H2AX,induce DNA damage and apoptosis in mouse primary hepatocytes.
6.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
7.Expert consensus on the clinical application of long-acting cabotegravir and rilpivirine
Lijun SUN ; Hongxia WEI ; Haibo DING ; Ping MA ; Hui WANG ; Lijing WANG ; Chunmei WANG ; Min WANG ; Qian WANG ; Hai LONG ; Jinchuan SHI ; Wei LYU ; Biao ZHU ; Jun LIU ; An LIU ; Lianguo RUAN ; Zaicun LI ; Linghua LI ; Huiqin LI ; Shenghua HE ; Meiyin ZOU ; Yuxia SONG ; Renfang ZHANG ; Jian ZHANG ; Xinping YANG ; Yahong CHEN ; Yaokai CHEN ; Hongxin ZHAO ; Qingxia ZHAO ; Zhongsi HONG ; Feng QIAN ; Guangyong XU ; Huihuang HUANG ; Wei CAO ; Jianhua YU ; Juan JIN ; Lin CAI ; Fujie ZHANG
Chinese Journal of Clinical Infectious Diseases 2024;17(6):431-439
The long-acting cabotegravir and rilpivirine injection regimen(CAB+RPV regimen)is the first approved long-acting antiretroviral therapy(ART)for HIV in China,administered once every two months. This regimen provides an innovative alternative to daily oral ART,benefiting virologically suppressed patients. Several large clinical-studies have shown that the CAB+RPV regimen achieves comparable virologic suppression and safety to daily oral regimens,while significantly enhancing patient satisfaction. Based on international and domestic HIV/AIDs guidelines and clinical evidence,this consensus offers expert recommendations on patient selection,clinical management,and key communication strategies for healthcare providers to support the effective use of this regimen,aiming to improve quality of life for people living with HIV and accumulate domestic clinical experience with this advanced treatment approach.
8.Expert consensus on the clinical application of long-acting cabotegravir and rilpivirine
Lijun SUN ; Hongxia WEI ; Haibo DING ; Ping MA ; Hui WANG ; Lijing WANG ; Chunmei WANG ; Min WANG ; Qian WANG ; Hai LONG ; Jinchuan SHI ; Wei LYU ; Biao ZHU ; Jun LIU ; An LIU ; Lianguo RUAN ; Zaicun LI ; Linghua LI ; Huiqin LI ; Shenghua HE ; Meiyin ZOU ; Yuxia SONG ; Renfang ZHANG ; Jian ZHANG ; Xinping YANG ; Yahong CHEN ; Yaokai CHEN ; Hongxin ZHAO ; Qingxia ZHAO ; Zhongsi HONG ; Feng QIAN ; Guangyong XU ; Huihuang HUANG ; Wei CAO ; Jianhua YU ; Juan JIN ; Lin CAI ; Fujie ZHANG
Chinese Journal of Clinical Infectious Diseases 2024;17(6):431-439
The long-acting cabotegravir and rilpivirine injection regimen(CAB+RPV regimen)is the first approved long-acting antiretroviral therapy(ART)for HIV in China,administered once every two months. This regimen provides an innovative alternative to daily oral ART,benefiting virologically suppressed patients. Several large clinical-studies have shown that the CAB+RPV regimen achieves comparable virologic suppression and safety to daily oral regimens,while significantly enhancing patient satisfaction. Based on international and domestic HIV/AIDs guidelines and clinical evidence,this consensus offers expert recommendations on patient selection,clinical management,and key communication strategies for healthcare providers to support the effective use of this regimen,aiming to improve quality of life for people living with HIV and accumulate domestic clinical experience with this advanced treatment approach.
9.Study on clearance of chlorfenapyr via blood purification (a case analysis)
Na MENG ; Yu GONG ; Yingli JIN ; Yiqing SUN ; Hongxin ZHANG ; Yingping TIAN
Chinese Journal of Industrial Hygiene and Occupational Diseases 2023;41(11):840-843
This paper analyzed the clinical data of a patient with acute oral emamectin·chlorfenapyr poisoning, and discussed the effect of blood purification therapy on chlorfenapyr poisoning. Chlorfenapyr was detected in the blood, urine, ultrafiltrate and plasma exchange fluid of the patient, and the concentrations of chlorfenapyr poison gradually decreased with time. Blood purification has a certain effect on chlorfenapyr, and early blood purification may be an effective measure to treat chlorfenapyr poisoning.
10.Study on clearance of chlorfenapyr via blood purification (a case analysis)
Na MENG ; Yu GONG ; Yingli JIN ; Yiqing SUN ; Hongxin ZHANG ; Yingping TIAN
Chinese Journal of Industrial Hygiene and Occupational Diseases 2023;41(11):840-843
This paper analyzed the clinical data of a patient with acute oral emamectin·chlorfenapyr poisoning, and discussed the effect of blood purification therapy on chlorfenapyr poisoning. Chlorfenapyr was detected in the blood, urine, ultrafiltrate and plasma exchange fluid of the patient, and the concentrations of chlorfenapyr poison gradually decreased with time. Blood purification has a certain effect on chlorfenapyr, and early blood purification may be an effective measure to treat chlorfenapyr poisoning.

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