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.Primary splenic lymphoma misdiagnosed as Sjögren’s syndrome with liver cirrhosis: A case report
Chengcheng LI ; Yuhong LIU ; Lu WANG ; Hong PENG ; Xinhua LUO ; Hong LI
Journal of Clinical Hepatology 2025;41(9):1883-1887
Primary splenic lymphoma is a rare malignant neoplasm, with similar clinical manifestations to Sjogren’s syndrome and liver cirrhosis, which often leads to misdiagnosis. This article reports a case of primary splenic lymphoma misdiagnosed as Sjogren’s syndrome with liver cirrhosis, in order to improve the understanding of primary splenic lymphoma, Sjogren’s syndrome, and liver cirrhosis and avoid misdiagnosis and treatment delay.
3.Analysis of the safety and associated risk factors of rush immunotherapy in 316 patients with allergic rhinitis
Mengyi WEI ; Xinhua ZHU ; Yating XIAO ; Weiming LUO
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2025;60(8):954-960
Objective:To assess the safety and to identify risk factors associated with systemic adverse effects (SAEs) during the dose-escalation phase of rush immunotherapy (RIT) in patients with allergic rhinitis (AR).Methods:A retrospective analysis was conducted in 316 house dust mite-allergic patients diagnosed with AR who underwent RIT at the Second Affiliated Hospital of Nanchang University between February 2012 and August 2024, including 206 males and 110 females aging from 5 to 58 years old. The number of patients experiencing SAEs, the frequency of SAE incidents, and the severity grades of SAEs during the dose-escalation phase were analyzed. Associations between SAE occurrence and 19 potential factors, including demographic characteristics, serological parameters, and pulmonary function parameters, were investigated. Data were analyzed using IBM SPSS Statistics version 26.0.Results:Among the 316 patients, 4 358 RIT injections were administered during the dose-escalation phase. SAEs occurred in 45 patients (14.24%, 45/316), accounting for 57 distinct SAE incidents. The SAE incidence rate per injection was 1.31%. Of the 57 SAEs, 34 (59.65%) were Grade Ⅰ, 5 (8.77%) were Grade Ⅱ, and 18 (31.58%) were Grade Ⅲ. No Grade Ⅳ or Ⅴ SAEs were observed. SAE occurrence demonstrated significant associations with: age ( Z=-2.73, P=0.006), body mass index (BMI; t=4.08, P<0.001), skin prick test reaction intensity ( χ2=10.34, P=0.006), eosinophil count ( Z=-2.19, P=0.028), eosinophil percentage ( Z=-2.59, P=0.010), forced expiratory volume in one second (FEV?; Z=-2.04, P=0.042), peak expiratory flow (PEF; Z=-2.44, P=0.015). Multivariate logistic regression analysis identified BMI as an independent risk factor for SAEs ( OR=0.86; 95% CI: 0.75-0.99; P=0.034). Conclusions:During the RIT dose-escalation phase for house dust mite-allergic AR patients, the incidence of SAEs was approximately 1.31% per injection. SAEs were predominantly mild (Grade Ⅰ), consistent with a favorable overall safety profile. BMI was identified as a statistically significant risk factor for SAE occurrence.
4.Hesperetin alleviates doxorubicin-induced cardiotoxicity by regulating the AMPK/NLRP3 pathway.
Aili YAN ; Mengyao LUO ; Jinrui CHANG ; Xinhua LI ; Juanxia ZHU
Journal of Southern Medical University 2025;45(9):1850-1858
OBJECTIVES:
To verify whether hesperetin (Hes) alleviates doxorubicin (DOX)-induced cardiotoxicity by reducing inflammation via regulating the AMPK/NLRP3 pathway.
METHODS:
C57/bl6 mice and H9c2 cells treated with DOX to mimic cardiotoxicity were randomly divided into Sham (or control) group, DOX group, DOX+Hes group, DOX+Hes+compound C (CC, an AMPK inhibitor) group. Cardiac function and myocardial pathologies of the mice were evaluated, and the changes in H9c2 cell morphology and viability were assessed. Lactate dehydrogenase (LDH) activity in mouse myocardial tissues and H9c2 cells was measured using ELISA, and H9c2 cell apoptosis was detected with TUNEL staining. In both H9c2 cells and the myocardial tissues of the mice, cellular expression levels of TNF-α, IL-6 and IL-1β mRNAs and cleaved caspase-3, Bcl2, Bax, IL-1β, IL-18, p-AMPK, AMPK, p-mTOR, mTOR, NLRP3, ASC and caspase-1 proteins were detected using RT-PCR and Western blotting.
RESULTS:
DOX treatment caused cell swelling, decreased cell viability and increased LDH activity in H9c2 cells, resulting also in significantly increased cell apoptosis and cleaved caspase-3 expression and decreased Bcl2/Bax ratio. The DOX-treated mice showed obvious myocardial fiber swelling and inflammatory infiltration, decreased cardiac function and significantly increased myocardial LDH activity. In H9c2 cells, DOX treatment significantly increased the mRNA expressions of TNF-α, IL-6 and IL-1β and protein expressions of IL-1β and IL-18, lowered the expressions of p-AMPK and p-mTOR, and increased the expressions of NLRP3, ASC and caspase-1. Hes treatment obviously reduced these toxic effects of DOX in H9c2 cells, but its protective effects were blocked by application of compound C.
CONCLUSIONS
Hes reduces DOX-induced cardiotoxicity by inhibiting inflammation via regulating the AMPK/NLRP3 pathway.
Animals
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Doxorubicin/toxicity*
;
NLR Family, Pyrin Domain-Containing 3 Protein/metabolism*
;
Mice, Inbred C57BL
;
Mice
;
Signal Transduction/drug effects*
;
Cardiotoxicity
;
AMP-Activated Protein Kinases/metabolism*
;
Apoptosis/drug effects*
;
Cell Line
;
Myocytes, Cardiac/drug effects*
;
Rats
5.Expert consensus on the prevention and treatment of radiochemotherapy-induced oral mucositis.
Juan XIA ; Xiaoan TAO ; Qinchao HU ; Wei LUO ; Xiuzhen TONG ; Gang ZHOU ; Hongmei ZHOU ; Hong HUA ; Guoyao TANG ; Tong WU ; Qianming CHEN ; Yuan FAN ; Xiaobing GUAN ; Hongwei LIU ; Chaosu HU ; Yongmei ZHOU ; Xuemin SHEN ; Lan WU ; Xin ZENG ; Qing LIU ; Renchuan TAO ; Yuan HE ; Yang CAI ; Wenmei WANG ; Ying ZHANG ; Yingfang WU ; Minhai NIE ; Xin JIN ; Xiufeng WEI ; Yongzhan NIE ; Changqing YUAN ; Bin CHENG
International Journal of Oral Science 2025;17(1):54-54
Radiochemotherapy-induced oral mucositis (OM) is a common oral complication in patients with tumors following head and neck radiotherapy or chemotherapy. Erosion and ulcers are the main features of OM that seriously affect the quality of life of patients and even the progress of tumor treatment. To date, differences in clinical prevention and treatment plans for OM have been noted among doctors of various specialties, which has increased the uncertainty of treatment effects. On the basis of current research evidence, this expert consensus outlines risk factors, clinical manifestations, clinical grading, ancillary examinations, diagnostic basis, prevention and treatment strategies and efficacy indicators for OM. In addition to strategies such as basic oral care, anti-inflammatory and analgesic agents, anti-infective agents, pro-healing agents, and photobiotherapy recommended in previous guidelines, we also emphasize the role of traditional Chinese medicine in OM prevention and treatment. This expert consensus aims to provide references and guidance for dental physicians and oncologists in formulating strategies for OM prevention, diagnosis, and treatment, standardizing clinical practice, reducing OM occurrence, promoting healing, and improving the quality of life of patients.
Humans
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Chemoradiotherapy/adverse effects*
;
Consensus
;
Risk Factors
;
Stomatitis/etiology*
6.Gallstones, cholecystectomy, and cancer risk: an observational and Mendelian randomization study.
Yuanyue ZHU ; Linhui SHEN ; Yanan HUO ; Qin WAN ; Yingfen QIN ; Ruying HU ; Lixin SHI ; Qing SU ; Xuefeng YU ; Li YAN ; Guijun QIN ; Xulei TANG ; Gang CHEN ; Yu XU ; Tiange WANG ; Zhiyun ZHAO ; Zhengnan GAO ; Guixia WANG ; Feixia SHEN ; Xuejiang GU ; Zuojie LUO ; Li CHEN ; Qiang LI ; Zhen YE ; Yinfei ZHANG ; Chao LIU ; Youmin WANG ; Shengli WU ; Tao YANG ; Huacong DENG ; Lulu CHEN ; Tianshu ZENG ; Jiajun ZHAO ; Yiming MU ; Weiqing WANG ; Guang NING ; Jieli LU ; Min XU ; Yufang BI ; Weiguo HU
Frontiers of Medicine 2025;19(1):79-89
This study aimed to comprehensively examine the association of gallstones, cholecystectomy, and cancer risk. Multivariable logistic regressions were performed to estimate the observational associations of gallstones and cholecystectomy with cancer risk, using data from a nationwide cohort involving 239 799 participants. General and gender-specific two-sample Mendelian randomization (MR) analysis was further conducted to assess the causalities of the observed associations. Observationally, a history of gallstones without cholecystectomy was associated with a high risk of stomach cancer (adjusted odds ratio (aOR)=2.54, 95% confidence interval (CI) 1.50-4.28), liver and bile duct cancer (aOR=2.46, 95% CI 1.17-5.16), kidney cancer (aOR=2.04, 95% CI 1.05-3.94), and bladder cancer (aOR=2.23, 95% CI 1.01-5.13) in the general population, as well as cervical cancer (aOR=1.69, 95% CI 1.12-2.56) in women. Moreover, cholecystectomy was associated with high odds of stomach cancer (aOR=2.41, 95% CI 1.29-4.49), colorectal cancer (aOR=1.83, 95% CI 1.18-2.85), and cancer of liver and bile duct (aOR=2.58, 95% CI 1.11-6.02). MR analysis only supported the causal effect of gallstones on stomach, liver and bile duct, kidney, and bladder cancer. This study added evidence to the causal effect of gallstones on stomach, liver and bile duct, kidney, and bladder cancer, highlighting the importance of cancer screening in individuals with gallstones.
Humans
;
Mendelian Randomization Analysis
;
Gallstones/complications*
;
Female
;
Male
;
Cholecystectomy/statistics & numerical data*
;
Middle Aged
;
Risk Factors
;
Aged
;
Adult
;
Neoplasms/etiology*
;
Stomach Neoplasms/epidemiology*
7.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
8.Analysis of the safety and associated risk factors of rush immunotherapy in 316 patients with allergic rhinitis
Mengyi WEI ; Xinhua ZHU ; Yating XIAO ; Weiming LUO
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2025;60(8):954-960
Objective:To assess the safety and to identify risk factors associated with systemic adverse effects (SAEs) during the dose-escalation phase of rush immunotherapy (RIT) in patients with allergic rhinitis (AR).Methods:A retrospective analysis was conducted in 316 house dust mite-allergic patients diagnosed with AR who underwent RIT at the Second Affiliated Hospital of Nanchang University between February 2012 and August 2024, including 206 males and 110 females aging from 5 to 58 years old. The number of patients experiencing SAEs, the frequency of SAE incidents, and the severity grades of SAEs during the dose-escalation phase were analyzed. Associations between SAE occurrence and 19 potential factors, including demographic characteristics, serological parameters, and pulmonary function parameters, were investigated. Data were analyzed using IBM SPSS Statistics version 26.0.Results:Among the 316 patients, 4 358 RIT injections were administered during the dose-escalation phase. SAEs occurred in 45 patients (14.24%, 45/316), accounting for 57 distinct SAE incidents. The SAE incidence rate per injection was 1.31%. Of the 57 SAEs, 34 (59.65%) were Grade Ⅰ, 5 (8.77%) were Grade Ⅱ, and 18 (31.58%) were Grade Ⅲ. No Grade Ⅳ or Ⅴ SAEs were observed. SAE occurrence demonstrated significant associations with: age ( Z=-2.73, P=0.006), body mass index (BMI; t=4.08, P<0.001), skin prick test reaction intensity ( χ2=10.34, P=0.006), eosinophil count ( Z=-2.19, P=0.028), eosinophil percentage ( Z=-2.59, P=0.010), forced expiratory volume in one second (FEV?; Z=-2.04, P=0.042), peak expiratory flow (PEF; Z=-2.44, P=0.015). Multivariate logistic regression analysis identified BMI as an independent risk factor for SAEs ( OR=0.86; 95% CI: 0.75-0.99; P=0.034). Conclusions:During the RIT dose-escalation phase for house dust mite-allergic AR patients, the incidence of SAEs was approximately 1.31% per injection. SAEs were predominantly mild (Grade Ⅰ), consistent with a favorable overall safety profile. BMI was identified as a statistically significant risk factor for SAE occurrence.
9.Clinical Observation of Supplemented Wendan Decoction Combined with Western Medicine in Treatment of Insomnia Accompanied by Anxiety and Depression in Phlegm-heat Internal Disturbance Syndrome
Jinzhen JIANG ; Guohua CHEN ; Xinhua SONG ; Yihan ZHANG ; Zhiyu LUO ; Guang WANG ; Junhua MEI
Herald of Medicine 2024;43(2):221-227
Objective To explore the clinical effect of clinical observation of supplemented wendan decoction combined with Western medicine in treating insomnia accompanied by anxiety and depression in phlegm-heat internal disturbance syndrome.Methods A total of 120 cases of insomnia with anxiety and depression comorbiditis with phlegm heat disturbance syndrome were randomly divided into control group and treatment group,60 cases in each group.The control group was given escitalopram oxalate tablet combined with dexzopiclonone tablet,and the observation group was given added Wendan decoction on the basis of the control group.Both groups were treated continuously for 6 weeks.Polysomnography monitoring parameters and heart rate variability were compared between the two groups during baseline period and visit 2(baseline period+3 months).Scale scores of the two groups were compared during baseline period,visit 1(baseline period+6 weeks)and visit 2.The content of heart rate variability includes:time domain analysis(standard deviation of normal interval(SDNN),square root of the square sum of the mean of the difference between adjacent normal interval(RMSSD)and frequency domain analysis(LF,HF,LF/HF).The scale scores included the Pittsburgh Sleep Quality Index(PSQI)and Insomnia Severity Index(ISI)to assess sleep status,and the Hamilton Depression Scale(HAMD),Hamilton Anxiety Scale(HAMA),Self-assessment Scale for Depression(PHQ-9)and Generalized Anxiety Disorder Scale(GAD-7)to assess anxiety and depression status.Results(1)Polysomnography monitoring:the wake time of observation group was significantly shorter than that of control group,the number of awakenings was significantly less than that of control group,and the percentage of N3 and REM was significantly higher than these of control group(P<0.05).(2)Heart rate variability:RMSSD and HF values in the observation group were significantly higher than those in the control group,and LF/HF values were significantly lower than those in the control group(P<0.05).(3)In terms of sleep:during the interview,PSQI total score,sleep quality,hypnotic drugs and daytime dysfunction in the observation group were significantly lower than those in the control group(P<0.05);At the 3 months,the sleep quality,hypnotic drugs and daytime dysfunction in the observation group were significantly lower than those in the control group(P<0.05).In terms of emotion:HAMA,HAMD and GAD-7 scores were significantly lower than those of control group at 6 weeks(P<0.05);At the 3 months,HAMA and GAD-7 scores were significantly lower than those of control group(P<0.05).Conclusion Supplemented Wendan decoction combined with western medicine can obviously optimize the sleep structure of insomnia patients with anxiety and depressionof phlegm-heat disturbance syndrome,improve sleep continuity and deepen sleep depth,and improve parasympathetic functional activities,contribute to sympathetic parasympathetic balance,can improve insomniaand depression symptoms recently,and significantly improve anxiety symptoms in the short term,with good safety.
10.Research advances in combined artificial liver
Yue HUANG ; Hong PENG ; Xinhua LUO
Journal of Clinical Hepatology 2024;40(2):233-238
At present, in vitro artificial liver support system has achieved a good therapeutic effect in the diseases such as liver failure due to various causes, non-function state before and after liver transplantation, and severe cholestasis. Non-bioartificial liver (NBAL) is widely used in clinical practice through various combinations of modes, mainly the plasma exchange mode for improving coagulation factors and albumin combined with other modes for enhancing the elimination of toxic substances in the body. Bioartificial liver (BAL), based on the design concept of the synthesis and transformation of hepatocytes, has achieved rapid development in recent years. Patients with liver failure can almost obtain the normal physiological function of human liver after NBAL detoxification and BAL synthesis and transformation of active substances in the body. NBAL mode combined with BAL with a stable therapeutic effect according to the conditions of the patient is the direction of in vitro support treatment for patients with severe liver disease in the future.

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