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.Clinical Characteristics of Rare Extrapulmonary Hepatic Tuberculosis
Xingyun HU ; Xiaoyan JIN ; Pan YANG ; Jinglan FU
Journal of Sun Yat-sen University(Medical Sciences) 2025;46(5):872-880
[Objective]Hepatic tuberculosis(HTB),an exceptionally rare and clinically heterogeneous form of extra-pulmonary tuberculosis,is frequently misdiagnosed as hepatocellular carcinoma,lymphoma,or pyogenic liver abscess,this diagnostic challenge contributing to persistently high rates of missed and incorrect diagnoses.This study aims to sys-tematically analyze clinical profiles of HTB patients to provide evidence-based guidance for early identification,accurate diagnosis,and timely intervention.[Methods]We conducted a retrospective analysis of all HTB cases confirmed at Sun Yat-sen Memorial Hospital between January 2012 and December 2023.Comprehensive data were collected and evaluated,including demographic characteristics,clinical presentations,laboratory findings,imaging features,and histopathological results.[Results]Ten patients(9 males,1 female;mean age 44.6±15.5 years)were enrolled totally,with prevalent symp-tom of abdominal pain or distension(8/10).Among the patients tested,purified protein derivative(PPD)was positive in 2 of 6 cases,serum tuberculosis antibody was positive in 1 of 5,and T-cell spot of tuberculosis(T-SPOT)was positive in 3 of 5.Chest imaging(n=9)revealed active miliary tuberculosis in 1 case and inactive post-tuberculous sequelae in 5 cases,while the remainder showed no abnormalities.Contrast-enhanced CT(n=6)demonstrated hypodense patchy or nodular le-sions with absent or mild heterogeneous enhancement.MRI(n=3)showed well-circumscribed oval/round hypointense lesions on T1-weighted imaging(T1WI)and mildly hyperintense ones on T2-weighted imaging(T2WI)and diffusion weighted imaging(DWI).Percutaneous or surgical liver biopsy was performed in 8/10 cases,revealing chronic granuloma-tous inflammation in all subjects and acid-fast bacilli in 2 specimens.[Conclusion]HTB lacks pathognomonic clinical or radiological features,and conventional laboratory tests exhibit low sensitivity.A high index of suspicion is warranted for pa-tients presenting with hepatic nodular lesions accompanied by fever,abdominal pain,or emaciation.Early pathogen detec-tion and histopathological confirmation via liver biopsy are critical to minimize diagnostic delays and ensure prompt initia-tion of anti-tuberculous therapy.
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.Value of transcranial Doppler foaming test combined with transthoracic echocardiography in evaluating cerebral blood flow characteristics in patients with migraine
Weiwei YIN ; Lingjuan YAN ; Jinglan JIN
Journal of Apoplexy and Nervous Diseases 2024;41(10):898-903
Objective To investigate the changes in cerebral hemodynamic parameters in patients with migraine and different grades of patent foramen ovale(PFO)using contrast-enhanced transcranial Doppler(cTCD)foaming test and contrast-enhanced transthoracic echocardiography(cTTE).Methods A total of 85 patients with migraine in our hospital were enrolled,and cTCD and cTTE were used in combination to determine whether a subject had right to left shunt(PFO-RLS)caused by PFO,which was graded according to the grading criteria(grades 0,Ⅰ,Ⅱ,and Ⅲ).Meanwhile,TCD was used to observe the ultrasound parameters of the middle cerebral artery before and after Valsalva maneuver(VM),in-cluding peak systolic blood flow velocity(Vs),mean blood flow velocity(Vm),peak diastolic blood flow velocity(Vd),resistance index,and pulsatility index,and these ultrasound parameters were compared between grade 0 PFO-RLS and grade Ⅰ/Ⅱ/Ⅲ PFO-RLS.Results Among the 85 subjects,13 patients had migraine with grade 0 PFO-RLS,34 patients had migraine with grade I PFO-RLS,17 patients had migraine with grade Ⅱ PFO-RLS,and 21 patients had migraine with grade Ⅲ PFO-RLS.The results before VM showed that compared with the patients with migraine and grade 0 PFO-RLS,the patients with migraine and grade Ⅱ PFO-RLS had significant increases in Vs,Vm,and Vd(P<0.05),and the results after VM showed that compared with the patients with migraine and grade 0 PFO-RLS,the patients with migraine and grade Ⅲ PFO-RLS had significant increases in Vm and Vd(P<0.05).Conclusion There are different changing trends of cerebral blood flow in patients with migraine and different grades of PFO-RLS,and the characteristic changes in cere-bral blood flow can provide a certain clinical theoretical basis for the etiological diagnosis and treatment of patients with mi-graine.
5.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
6.Research status and challenges in the prognosis of primary biliary cholangitis after liver transplantation
Lin CHEN ; Ning LIU ; Jinglan JIN ; Yanjun CAI ; Fang XU ; Junqi NIU ; Wanyu LI
Journal of Clinical Hepatology 2021;37(4):955-958
Primary biliary cholangitis (PBC) is a chronic cholestatic liver disease with unknown etiology, and patients with poor response to ursodeoxycholic acid and obeticholic acid may eventually progress to liver cirrhosis and even liver failure. Liver transplantation is the only effective treatment method for PBC at present. This article elaborates on liver transplantation, survival time after liver transplantation, complications, recurrence of PBC after liver transplantation, and prospects and challenges of liver transplantation in patients with PBC, so as to provide a reference for clinical outcome and treatment after liver transplantation for PBC.
7.Application study of cerebral blood flow circulation time by contrast-enhanced ultrasound in noninvasive intracranial pressure monitoring
Hongyu CHENG ; Jia WANG ; Hongkui GAO ; Lingjuan YAN ; Jinglan JIN ; Xi LIU
Chinese Journal of Ultrasonography 2021;30(1):37-41
Objective:To evaluate the cerebral blood flow circulation time (CCT) by contrast-enhanced ultrasound, and to explore the change rule of CCT in different degree of intracranial pressure, so as to provide a new method for non-invasive monitoring of intracranial pressure.Methods:Ten patients with hemorrhagic stroke or acute craniocerebral trauma with increased intracranial pressure were selected from Tangdu Hospital, the Air Force Military Medical University from January to December 2019. Contrast-enhanced ultrasound was performed when the invasive intracranial pressure (iICP) increased (>20 mmHg, iICP increased group) and decreased to normal (≤20 mmHg, iICP normal group), CCT was measured and analyzed. The differences of CCTs between different iICP groups were compared and the relationship between CCT and iICP was analyzed.Results:①The CCT on the lesion sides of the same patients in the iICP increased group was significantly longer than in the iICP normal group[(9.34±2.58)s vs (6.48±1.91)s, P=0.002]. ②When iICP was increased in patients with hemorrhagic stroke or acute craniocerebral trauma, the CCTs of the diseased side and the non-pathological side were not statistically significant [(9.34±2.58)s vs (9.01±3.22)s, P=0.809]. ③Pearson correlation analysis and Spearman rank correlation analysis showed that there were no correlations between patient′s breathing, heart rate, carbon dioxide partial pressure, body temperature, GCS score and CCT (all P>0.05). Age, mean arterial pressure and CCT were moderately correlated ( r=0.518, 0.463 and P=0.023, 0.046, respectively). ④Logistic regression analysis showed that CCT was an independent risk factor related to intracranial hypertension( OR=0.7, 95% CI=0.47-0.95, P=0.036). The area under ROC curve (AUC) predicted by logistic regression was 0.750(0.588~0.912). Conclusions:Contrast-enhanced ultrasound noninvasive assessment of CCT can reflect the intracranial pressure in patients with hemorrhagic stroke or acute traumatic brain injury, and CCT has a predictive value for intracranial hypertension. When the patient has limited conditions for invasive intracranial pressure monitoring, or when the invasive monitoring probe is pulled out but still needs to evaluate intracranial pressure, the change of CCT can provide an effective reference for clinical diagnosis and treatment.
8.Preparation of Chelerythrine Nanoparticles and Evaluation of Anti-melanoma Activity in vitro
Jin YANG ; Wei HAN ; Yongping ZHANG ; Xiaolan CHEN ; Zhe LI ; Jie LIU ; Jinglan WU
China Pharmacy 2021;32(24):2980-2986
OBJECTIVE:To prepare chelerythrine nanoparticles(CHE-NPs),optimize their formulation ,and evaluate its drug release behavior in vitro and its inhibitory effect on melanoma. METHODS :Using methoxy polyethylene glycol-poly (lactic-co- glycolic acid )(mPEG-PLGA)as carrier ,CHE-NPs were prepared by the nano-precipitation method. HPLC method and dialysis bag method were used to determine entrapment efficiency and drug loading. The formulation of CHE-NPs was optimized by Box-Behnken response surface design using overall desirability (OD)of them as dependent variables ,CHE dosage ,mPEG-PLGA concentration and poloxamer 188(F68)concentration as independent variables. The particle size and Zeta potential of CHE-NPs prepared by the optimal formulation were detected ;the characteristics of drug release in vitro were investigated ;the effects of CHE and CHE-NPs on survival rate of mice B 16 melanoma cells were compared ,and median inhibition concentrations (IC50)of them were calculated. RESULTS :The optimal formulation included CHE of 2 mg,mPEG-PLGA of 13 mg/mL,F68 of 1.8%. Average entrapment efficiency rate of CHE-NPs prepared by the optimal formulation was (80.18±1.11)%,average drug loading was (11.36±0.28)%,average OD value was 0.96±0.04 [the relative deviation from predicted value (0.90)of OD was 6.67%]; particle size was (113.1±1.40)nm,and Zeta potential was (-21.6±0.29)mV;polydispersity index was 0.07±0.01(n=3); accumulative release rates of CHE control and CHE-NPs were 90.87% and 68.68% within 8 h,and drug release behavior in vitro of the latter was in accordance with Weibull kinetic model. Inhibitory effect of CHE-NPs on B 16 melanoma cells was significantly stronger than that of CHE ;the 24 h IC 50 of CHE-NPs and CHEwere 69.35 and 107.36 μg/mL,respectively. CONCLUSIONS :The prepared CHE-NPs show good sustained-effect and high capacity of drug loading ,and strengthen the inhibitory effect of CHE on melanoma.
9.Chinese consensus on surgical treatment of traumatic rib fractures (2021)
Lingwen KONG ; Guangbin HUANG ; Yunfeng YI ; Dingyuan DU ; Baoguo JIANG ; Jinmou GAO ; Lianyang ZHANG ; Jianxin JIANG ; Xiangjun BAI ; Tianbing WANG ; Xingji ZHAO ; Xingbo DANG ; Zhanfei LI ; Feng XU ; Zhongmin LIU ; Ruwen WANG ; Yingbin XIAO ; Qingchen WU ; Chun WU ; Liming CHENG ; Bin YU ; Shusen CUI ; Jinglan WU ; Gongliang DU ; Jin DENG ; Ping HU ; Jun YANG ; Xiaofeng YANG ; Jun ZENG ; Haidong WANG ; Jigang DAI ; Yong FU ; Lijun HOU ; Guiyou LIANG ; Yidan LIN ; Qunyou TAN ; Yan SHEN ; Peiyang HU ; Ning TAO ; Cheng WANG ; Dali WANG ; Xu WU ; Yongfu ZHONG ; Anyong YU ; Dongbo ZHU ; Renju XIAO ; Biao SHAO
Chinese Journal of Trauma 2021;37(10):865-875
Traumatic rib fractures are the most common injury in thoracic trauma. Previously,the patients with traumatic rib fractures were mostly treated non-surgically,of which 50%,especially those combined with flail chest presented chronic pain or chest wall deformities and over 30% had long-term disabilities,being unable to retain a full-time job. In the past two decades,thanks to the development of internal fixation material technology,the surgical treatment of rib fractures has achieved good outcomes. However,there are still some problems in clinical treatment,including inconsistency in surgical treatment and quality control in medical services. The current consensuses on the management of regional traumatic rib fractures published at home and abroad mainly focus on the guidance of the overall treatment decisions and plans,and relevant clinical guidelines abroad lacks progress in surgical treatment of rib fractures in recent years. Therefore,the Chinese Society of Traumatology affiliated to Chinese Medical Association and Chinese College of Trauma Surgeons affiliated to Chinese Medical Doctor Association,in conjunction with national multidisciplinary experts,formulate the Chinese Consensus for Surgical Treatment of Traumatic Rib Fractures(2021)following the principle of evidence-based medicine,scientific nature and practicality. This expert consensus puts forward some clear,applicable,and graded recommendations from aspects of preoperative imaging evaluation,surgical indications,timing of surgery,surgical methods,rib fracture sites for surgical fixation,internal fixation methods and material selections,treatment of combined injuries in rib fractures,in order to provide references for surgical treatment of traumatic rib fractures.
10.Effect of direct-acting antiviral on the recurrence hepatitis C virus-related hepatocellular carcinoma after curative treatment: A Meta-analysis
Yuwei LIU ; Jinglan JIN ; Tianyi REN ; Xiuzhu GAO ; Jie LI ; Qian ZHU ; Junqi NIU
Journal of Clinical Hepatology 2020;36(12):2714-2719
ObjectiveTo investigate the effect of direct-acting antiviral (DAA) on the recurrence of hepatitis C virus (HCV)-related hepatocellular carcinoma (HCC) after curative treatment. MethodsPubMed, Web of Science, Cochrane Library, CNKI, CBM, Wanfang Data, and VIP were searched for the clinical studies of DAA and the recurrence of HCV-related HCC published up to April 2020. Stata 14.0 software was used to perform the meta-analysis. The Cochran Q test was used to evaluate heterogeneity between studies; the fixed effects model was used for non-heterogeneous data, and the random effects model was used for heterogeneous data. The Egger regression method or the Begg rank correlation method was used to evaluate the presence or absence of publication bias. ResultsA total of 10 articles (11 studies) were included in our study, among which 8 articles (9 studies) compared the effect of DAA versus the absence of anti-HCV therapy on the recurrence of HCC after curative treatment. There were 991 patients in DAA group and 808 patients in untreated group. The results of the meta-analysis showed that DAA reduced the recurrence rate of HCC after curative treatment in patients with HCV infection (hazard ratio [HR]=0.42, 95% confidence interval [CI]: 0.28?0.36, P<0.001). Three articles compared the effect of DAA versus interferon for the treatment of hepatitis C on the recurrence of HCC after curative treatment, with 267 patients in DAA group and 212 in interferon group, and the results of the meta-analysis showed that DAA and interferon had a similar effect on the recurrence rate of HCV-related HCC (HR=0.85, 95% CI: 0.64-1.15, P=0.298). ConclusionBoth interferon and DAA can significantly reduce the recurrence risk of HCV-related HCC after curative treatment, with no significant difference between them.

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