1.Sclera Vessel Segmentation Based on Fusion Filtering and Reflection Suppression
Ming-Xuan FAN ; Zong-Qing MA ; Chu-Xiang GAO ; Yi-Xuan SHI ; Zi-Hang ZHANG ; Zhe-Xuan JIA ; Fan FAN ; Guo-Liang HUANG ; Jiang ZHU
Progress in Biochemistry and Biophysics 2026;53(5):1195-1206
ObjectiveIn traditional Chinese medicine (TCM), the foundational doctrine that the eyes reflect the essence of the internal viscera establishes ocular observation as a cornerstone of diagnostic practice. Specifically, the morphological characteristics and coloration variations of the scleral microvasculature serve as critical clinical indicators for assessing the dynamic balance of Qi and Blood, as well as the pathological status of internal organs. Historically, however, TCM eye diagnosis has relied predominantly on the subjective clinical experience and visual acuity of individual practitioners, leading to inherent challenges in standardization and reproducibility. While automated computer-aided diagnostic systems offer a promising solution, existing vessel segmentation algorithms encounter significant domain-specific bottlenecks when applied to scleral imagery. These challenges primarily stem from the highly reflective and moist nature of the ocular surface, which generates severe reflective interference. Furthermore, the inherent low contrast of fine capillary networks against complex background textures, compounded by non-uniform illumination, frequently results in high false-positive rates, misdetections, and severe vessel fragmentation. To address these critical limitations and advance the objective quantification of TCM diagnostics, this paper proposes a novel, highly robust sclera vessel segmentation framework that innovatively integrates Frangi-Sato dual-filter adaptive enhancement with pixel-level reflection detection. MethodsThe proposed methodology systematically addresses the segmentation pipeline through three synergistic stages. First, to overcome the structural limitations of single-filter approaches, a multi-scale weighted fusion strategy is meticulously designed to harness the complementary extraction capabilities of both Frangi and Sato filters. This adaptive enhancement optimally balances the preservation of main vessel trunk continuity with the heightened sensitivity required for delineating delicate, low-contrast peripheral capillaries. Second, to tackle the persistent issue of reflective highlights, a sophisticated multi-feature synergistic reflection detection module is introduced. By jointly analyzing local information entropy, gradient field variations, and intensity statistical distributions, this module achieves precise, pixel-level identification and elimination of reflective artifacts without compromising the underlying vascular structures. Finally, a dual-level adaptive thresholding strategy, featuring an innovative “core protection” mechanism, is implemented. This critical step effectively suppresses complex background noise while rigorously preserving the structural and topological integrity of the intricate vessel network, preventing the structural breaks often seen in conventional binarization methods. ResultsThe efficacy of the proposed framework was rigorously evaluated using both self-constructed clinical datasets specifically acquired for TCM research and standardized public datasets. Extensive experimental results demonstrate that the proposed method consistently outperforms state-of-the-art traditional approaches and contemporary deep learning models. Specifically, the proposed method achieves a Dice similarity coefficient of approximately 0.71 on the private clinical dataset, and secures the best performance across the majority of quantitative metrics on both datasets. Notably, the framework exhibits exceptional robustness and generalization capabilities in highly challenging scenarios characterized by intense reflective interference, low signal-to-noise ratios, and cross-domain image variations. ConclusionThis study successfully realizes the high-integrity, automated segmentation of scleral vessel networks under complex clinical imaging conditions. By overcoming the fundamental algorithmic challenges of reflection interference and micro-vessel loss, the proposed methodology provides potential support for the digitization, objective standardization, and intelligent advancement of modern TCM eye diagnosis systems.
2.Sclera Vessel Segmentation Based on Fusion Filtering and Reflection Suppression
Ming-Xuan FAN ; Zong-Qing MA ; Chu-Xiang GAO ; Yi-Xuan SHI ; Zi-Hang ZHANG ; Zhe-Xuan JIA ; Fan FAN ; Guo-Liang HUANG ; Jiang ZHU
Progress in Biochemistry and Biophysics 2026;53(5):1195-1206
ObjectiveIn traditional Chinese medicine (TCM), the foundational doctrine that the eyes reflect the essence of the internal viscera establishes ocular observation as a cornerstone of diagnostic practice. Specifically, the morphological characteristics and coloration variations of the scleral microvasculature serve as critical clinical indicators for assessing the dynamic balance of Qi and Blood, as well as the pathological status of internal organs. Historically, however, TCM eye diagnosis has relied predominantly on the subjective clinical experience and visual acuity of individual practitioners, leading to inherent challenges in standardization and reproducibility. While automated computer-aided diagnostic systems offer a promising solution, existing vessel segmentation algorithms encounter significant domain-specific bottlenecks when applied to scleral imagery. These challenges primarily stem from the highly reflective and moist nature of the ocular surface, which generates severe reflective interference. Furthermore, the inherent low contrast of fine capillary networks against complex background textures, compounded by non-uniform illumination, frequently results in high false-positive rates, misdetections, and severe vessel fragmentation. To address these critical limitations and advance the objective quantification of TCM diagnostics, this paper proposes a novel, highly robust sclera vessel segmentation framework that innovatively integrates Frangi-Sato dual-filter adaptive enhancement with pixel-level reflection detection. MethodsThe proposed methodology systematically addresses the segmentation pipeline through three synergistic stages. First, to overcome the structural limitations of single-filter approaches, a multi-scale weighted fusion strategy is meticulously designed to harness the complementary extraction capabilities of both Frangi and Sato filters. This adaptive enhancement optimally balances the preservation of main vessel trunk continuity with the heightened sensitivity required for delineating delicate, low-contrast peripheral capillaries. Second, to tackle the persistent issue of reflective highlights, a sophisticated multi-feature synergistic reflection detection module is introduced. By jointly analyzing local information entropy, gradient field variations, and intensity statistical distributions, this module achieves precise, pixel-level identification and elimination of reflective artifacts without compromising the underlying vascular structures. Finally, a dual-level adaptive thresholding strategy, featuring an innovative “core protection” mechanism, is implemented. This critical step effectively suppresses complex background noise while rigorously preserving the structural and topological integrity of the intricate vessel network, preventing the structural breaks often seen in conventional binarization methods. ResultsThe efficacy of the proposed framework was rigorously evaluated using both self-constructed clinical datasets specifically acquired for TCM research and standardized public datasets. Extensive experimental results demonstrate that the proposed method consistently outperforms state-of-the-art traditional approaches and contemporary deep learning models. Specifically, the proposed method achieves a Dice similarity coefficient of approximately 0.71 on the private clinical dataset, and secures the best performance across the majority of quantitative metrics on both datasets. Notably, the framework exhibits exceptional robustness and generalization capabilities in highly challenging scenarios characterized by intense reflective interference, low signal-to-noise ratios, and cross-domain image variations. ConclusionThis study successfully realizes the high-integrity, automated segmentation of scleral vessel networks under complex clinical imaging conditions. By overcoming the fundamental algorithmic challenges of reflection interference and micro-vessel loss, the proposed methodology provides potential support for the digitization, objective standardization, and intelligent advancement of modern TCM eye diagnosis systems.
3.Plasma exchange and intravenous immunoglobulin prolonged the survival of a porcine kidney xenograft in a sensitized, brain-dead human recipient.
Shuaijun MA ; Ruochen QI ; Shichao HAN ; Zhengxuan LI ; Xiaoyan ZHANG ; Guohui WANG ; Kepu LIU ; Tong XU ; Yang ZHANG ; Donghui HAN ; Jingliang ZHANG ; Di WEI ; Xiaozheng FAN ; Dengke PAN ; Yanyan JIA ; Jing LI ; Zhe WANG ; Xuan ZHANG ; Zhaoxu YANG ; Kaishan TAO ; Xiaojian YANG ; Kefeng DOU ; Weijun QIN
Chinese Medical Journal 2025;138(18):2293-2307
BACKGROUND:
The primary limitation to kidney transplantation is organ shortage. Recent progress in gene editing and immunosuppressive regimens has made xenotransplantation with porcine organs a possibility. However, evidence in pig-to-human xenotransplantation remains scarce, and antibody-mediated rejection (AMR) is a major obstacle to clinical applications of xenotransplantation.
METHODS:
We conducted a kidney xenotransplantation in a brain-dead human recipient using a porcine kidney with five gene edits (5GE) on March 25, 2024 at Xijing Hospital, China. Clinical-grade immunosuppressive regimens were employed, and the observation period lasted 22 days. We collected and analyzed the xenograft function, ultrasound findings, sequential protocol biopsies, and immune surveillance of the recipient during the observation.
RESULTS:
The combination of 5GE in the porcine kidney and clinical-grade immunosuppressive regimens prevented hyperacute rejection. The xenograft kidney underwent delayed graft function in the first week, but urine output increased later and the single xenograft kidney maintained electrolyte and pH homeostasis from postoperative day (POD) 12 to 19. We observed AMR at 24 h post-transplantation, due to the presence of pre-existing anti-porcine antibodies and cytotoxicity before transplantation; this AMR persisted throughout the observation period. Plasma exchange and intravenous immunoglobulin treatment mitigated the AMR. We observed activation of latent porcine cytomegalovirus toward the end of the study, which might have contributed to coagulation disorder in the recipient.
CONCLUSIONS
5GE and clinical-grade immunosuppressive regimens were sufficient to prevent hyperacute rejection during pig-to-human kidney xenotransplantation. Pre-existing anti-porcine antibodies predisposed the xenograft to AMR. Plasma exchange and intravenous immunoglobulin were safe and effective in the treatment of AMR after kidney xenotransplantation.
Transplantation, Heterologous/methods*
;
Kidney Transplantation/methods*
;
Heterografts/pathology*
;
Immunoglobulins, Intravenous/administration & dosage*
;
Graft Survival/immunology*
;
Humans
;
Animals
;
Sus scrofa
;
Graft Rejection/prevention & control*
;
Kidney/pathology*
;
Gene Editing
;
Species Specificity
;
Immunosuppression Therapy/methods*
;
Plasma Exchange
;
Brain Death
;
Biopsy
;
Male
;
Aged
4.Therapeutic Effect of Wenweishu Granules on Functional Dyspepsia Rats with Spleen-stomach Deficiency Cold Syndrome Based on Bioinformatics Analysis and Experimental Validation
Xinyu YANG ; Xiaoyi JIA ; Zihua XUAN ; Shuangying GUI ; Yanfang WU ; Yuhan MA ; Qin RUAN ; Jia ZHENG ; Zhiyong JIAO
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(18):30-40
ObjectiveThis study aims to investigate the therapeutic effects of Wenweishu granule (WWSG) on functional dyspepsia (FD) with spleen-stomach deficiency cold syndrome in rats by integrating network pharmacology, molecular docking, and animal experiments. MethodsActive components and corresponding targets of WWSG were collected from the Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform (TCMSP) and the Bioinformatics Analysis Tool for Molecular Mechanism of Traditional Chinese Medicine (BATMAN-TCM). Disease-related targets for FD with spleen-stomach deficiency cold syndrome were screened using GeneCards and the Integrative Pharmacology-based Research Platform of Traditional Chinese Medicine (TCMIP). Core therapeutic targets were identified via Cytoscape and validated by molecular docking. A rat model of FD with spleen-stomach deficiency cold syndrome was established using vinegar gavage combined with tail-clamping. The rats were randomly divided into a model group, low-, medium-, and high-dose WWSG groups (2.0, 4.0, 8.0 g·kg-1), a domperidone group (3.0 mg·kg-1), a Fuzi Lizhong pillwan (0.8 g·kg-1), and a normal control group (n=10 per group). Drugs were administered once daily by gavage for 14 consecutive days. After treatment, body weight, symptom scores, and gastrointestinal motility indices were recorded. Gastric and duodenal pathologies changes were observed via hematoxylin-eosin (HE) staining. Brain-gut peptides were measured in serum and tissue using enzyme-linked immunosorbent assay (ELISA). Immunohistochemistry and Western blot were performed to assess stem cell factor (SCF) and receptor tyrosine kinase (c-Kit) protein expression in gastric tissues. ResultsA total of 305 drug targets, 1 140 disease targets, and 116 overlapping targets were identified. Cytoscape analysis revealed 104 core targets. Enrichment analysis indicated that the SCF/c-Kit signaling pathway was the key mechanism. Molecular docking confirmed a strong binding affinity between active components of WWSG and SCF/c-Kit proteins (binding energy<-5.1 kcal·mol-1). Compared with the normal group, model rats exhibited slower weight gain (P<0.05), reduced gastric emptying and intestinal propulsion (P<0.01), mild gastric mucosal shedding, duodenal inflammatory cell infiltration, decreased levels of gastrin (GAS), 5-hydroxytryptamine (5-HT), and vasoactive intestinal peptide (VIP) (P<0.05, P<0.01), and elevated somatostatin (SS) expression (P<0.05, P<0.01). WWSG treatment ameliorated weight gain, symptom scores, and low-grade inflammation in gastric/duodenal tissues. High-dose WWSG significantly improved gastric emptying and intestinal propulsion, upregulated GAS, 5-HT, and VIP, and downregulated SS expression in serum and tissues (P<0.05, P<0.01). Immunohistochemistry and Western blot demonstrated that SCF and c-Kit protein expression was decreased in the model group (P<0.05, P<0.01), which was reversed by WWSG intervention (P<0.05). ConclusionWWSG exerts therapeutic effects on FD with spleen-stomach deficiency cold syndrome in rats, potentially by regulating the SCF/c-Kit signaling pathway to enhance gastrointestinal motility.
5.Pathogenesis and Syndrome Differentiation Treatment of Heart Failure Based on "Spleen-mitochondria" and Theory of "Dampness, Turbidity, Phlegm, and Fluid-related Diseases"
Rui ZHANG ; Fuyun JIA ; Jingshun YAN ; Xuan LIU ; Yadong WANG ; Yinan MA ; Yan LIU ; Qiang XU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(10):265-274
Guided by Academician Zhang Boli's theory of "dampness, turbidity, phlegm, and fluid-related diseases",this paper elaborated on the pathogenesis and syndrome differentiation treatment of heart failure from the perspective of the "spleen-mitochondria". It analyzed the essential similarities between "spleen-mitochondria" and "dampness, turbidity, phlegm, and fluid-related diseases", as well as their close association with the onset of heart failure. Furthermore,it explored the connection between spleen function and mitochondrial function in traditional Chinese medicine (TCM),positing that the spleen's role in transportation and transformation is analogous to mitochondrial material metabolism and energy conversion,with spleen deficiency closely related to mitochondrial dysfunction. It thus concluded that mitochondrial material metabolism and energy conversion represent the microscopic essence of the spleen's role in transportation and transformation,and mitochondrial dysfunction is a contributing factor to pathological products like dampness and turbid phlegm,which are closely associated with the occurrence of heart failure. The four elements of dampness,turbidity,phlegm,and fluid are a series of related symptoms resulting from abnormal fluid transportation and transformation,serving as both factors in the onset of heart failure and the core pathological basis for its deterioration. Therefore,during the treatment of heart failure,it is essential to regulate mitochondrial function. Early intervention should focus on eliminating dampness and turbidity to improve mitochondrial function and restore normal energy metabolism. In the middle and late stages,emphasis should be placed on resolving phlegm,promoting blood circulation,warming Yang,and reducing water retention to alleviate mitochondrial damage and improve cardiac function. Supporting Qi and strengthening the spleen should be a continuous approach,and treatment should be adjusted to enhance mitochondrial function and stabilize the condition,thereby improving prognosis. This paper discussed the role of the spleen and mitochondria in the pathogenesis of heart failure,examined the evolution of heart failure mechanisms from the perspective of dampness, turbidity, phlegm, and fluid-related diseases,and proposed a phased treatment strategy. It enriched the theory of dampness, turbidity, phlegm, and fluid-related diseases and offered new strategies for heart failure treatment. However,in practical application,TCM strategies for treating heart failure need to be integrated with modern medical approaches to provide a more solid scientific foundation for treatment.
6.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
7.Research on the operational efficiency of traditional Chinese medicine hospitals in China's Yangtze River Economic Belt in the context of high-quality development
Yi-fan MOU ; Jia-ying SUN ; Jin-ping LUO ; Bao-xuan ZHANG ; Ming-hui GENG ; Wen-qiang YIN ; Zhong-ming CHEN ; Dong-ping MA
Chinese Journal of Health Policy 2025;18(1):66-72
Objective:Based on the background of high-quality development,we analyze the operational efficiency of traditional Chinese medicine(TCM)hospitals in China's Yangtze River Economic Belt in 2021 and explore the impact of external environmental factors on operational efficiency,so as to provide a reference for promoting the high-quality development of TCM hospitals in the Yangtze River Economic Belt.Methods:The three-stage DEA model was used to analyze the operational efficiency of TCM hospitals in 11 provinces and cities in the Yangtze River Economic Zone in China in 2021.Results:After three-stage DEA analysis,the values of comprehensive efficiency,pure technical efficiency and scale efficiency of TCM hospitals in China's Yangtze River Economic Belt are 0.976,0.986 and 0.990,respectively.5 provinces and cities,Shanghai,Jiangsu,Hunan,Chongqing and Guizhou,are efficient before and after the adjustment,and the comprehensive efficiency of Zhejiang,Anhui,Hubei,Jiangxi,Sichuan and Yunnan have increased compared with that before the adjustment.Ranking of the average value of the comprehensive efficiency of TCM hospitals operation in the three major city clusters of the Yangtze River Economic Belt after adjustment:Chengdu-Chongqing city cluster(0.998)>city cluster in the Yangtze River Delta(0.964)>city cluster in the middle reaches of the Yangtze River(0.962).Conclusion:The operational efficiency of TCM hospitals in the Yangtze River Economic Zone has been underestimated,and the comprehensive efficiency is mainly affected by scale efficiency;there are differences in the operational efficiency of TCM hospitals in the three major urban agglomerations,and balanced development is needed between regions;the operational efficiency of TCM hospitals is affected by the external environment,and it is necessary to improve the external environment;it is necessary to strengthen the construction of digital and informatization of TCM,and to pay attention to the role of talents in TCM,so as to promote the high-quality development of TCM hospitals.
8.Diagnostic and treatment strategies for testicular torsion
Qing-song MENG ; Wan-ze ZHANG ; Ming ZHANG ; Jiang-hua JIA ; Xin WANG ; Wan-li MA ; Yao-hua WANG ; Ya-xuan WANG ; Jin-chun QI
National Journal of Andrology 2025;31(3):222-225
Objective:To investigate the differences between high-frequency ultrasound-guided manual detorsion combined with surgery(MD+S)and surgery alone in the treatment of testicular torsion,and to provide some new evidence for the timely diagno-sis and treatment of the disease.Methods:We retrospectively analyzed the clinical data on 134 cases of unilateral testicular torsion within 48 hours treated in our hospital by MD+S or by surgery alone from January 2015 to May 2022.We statistically analyzed the age distribution,and duration and degrees of testicular torsion,followed by comparison between the two groups.Results:In the 134 ca-ses,the median age of onset was 15(13-19)years old,the median onset-to-visit time was 15(8-25)hours,and the median de-gree of torsion was 360°(180°-1080°).Of the total number of patients,21 underwent testicular excision and the other 113 were treated with the testis preserved,with no statistically significant difference in age distribution between the two groups(P>0.05),and a higher rate of testis resection in those with longer duration and greater angle of torsion(P<0.05).Totally,33 of the patients were assigned to the MD+S group and 101 to the surgery alone group.According to the actual clinical conditions and excluding those with torsion time longer than 24 hours and torsion angle greater than 720 °,28 of the patients underwent ultrasound-guided MD+S(with 1 case of testis resection,3.6%),and 68 received surgery alone(with 7 cases of testis resection,10.3%).The rate of testis resection was higher in the surgery alone than that in the MD+S group,but with no statistically significant difference between the two groups(P>0.05),which was considered to be related to the small sample size in this study.Conclusion:The popularization of testicular torsion knowledge can shorten the onset-to-visit time,and reasonable manual detorsion before emergency surgery can reduce the rate of testis resection.
9.Research on the operational efficiency of traditional Chinese medicine hospitals in China's Yangtze River Economic Belt in the context of high-quality development
Yi-fan MOU ; Jia-ying SUN ; Jin-ping LUO ; Bao-xuan ZHANG ; Ming-hui GENG ; Wen-qiang YIN ; Zhong-ming CHEN ; Dong-ping MA
Chinese Journal of Health Policy 2025;18(1):66-72
Objective:Based on the background of high-quality development,we analyze the operational efficiency of traditional Chinese medicine(TCM)hospitals in China's Yangtze River Economic Belt in 2021 and explore the impact of external environmental factors on operational efficiency,so as to provide a reference for promoting the high-quality development of TCM hospitals in the Yangtze River Economic Belt.Methods:The three-stage DEA model was used to analyze the operational efficiency of TCM hospitals in 11 provinces and cities in the Yangtze River Economic Zone in China in 2021.Results:After three-stage DEA analysis,the values of comprehensive efficiency,pure technical efficiency and scale efficiency of TCM hospitals in China's Yangtze River Economic Belt are 0.976,0.986 and 0.990,respectively.5 provinces and cities,Shanghai,Jiangsu,Hunan,Chongqing and Guizhou,are efficient before and after the adjustment,and the comprehensive efficiency of Zhejiang,Anhui,Hubei,Jiangxi,Sichuan and Yunnan have increased compared with that before the adjustment.Ranking of the average value of the comprehensive efficiency of TCM hospitals operation in the three major city clusters of the Yangtze River Economic Belt after adjustment:Chengdu-Chongqing city cluster(0.998)>city cluster in the Yangtze River Delta(0.964)>city cluster in the middle reaches of the Yangtze River(0.962).Conclusion:The operational efficiency of TCM hospitals in the Yangtze River Economic Zone has been underestimated,and the comprehensive efficiency is mainly affected by scale efficiency;there are differences in the operational efficiency of TCM hospitals in the three major urban agglomerations,and balanced development is needed between regions;the operational efficiency of TCM hospitals is affected by the external environment,and it is necessary to improve the external environment;it is necessary to strengthen the construction of digital and informatization of TCM,and to pay attention to the role of talents in TCM,so as to promote the high-quality development of TCM hospitals.
10.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

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