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.Survey on the awareness and clinical application of guidelines for the prevention and treatment of chronic hepatitis B (2022 edition) among clinicians
Yuanyuan KONG ; Yujie GUO ; Yujuan GUAN ; Xuan LIANG ; Zhongjie HU ; Xiaobo LU ; Mingqin LU ; Yongfeng YANG ; Meifang HAN ; Hong YOU ; Zhiyun YANG ; Jidong JIA
Journal of Clinical Hepatology 2025;41(6):1068-1074
ObjectiveTo investigate the awareness and clinical practice of guidelines for the prevention and treatment of chronic hepatitis B (2022 edition) among clinicians. MethodsFrom July 19 to December 31, 2024, a self-designed electronic questionnaire was distributed via the WeChat mini program to collect related data from 1 588 clinicians nationwide, including their awareness and practice based on 18 questions regarding testing and referral, diagnosis and treatment, and follow-up. ResultsAmong all respondents, only 350 clinicians correctly understood all the updated key points of antiviral indications and treatment for special populations in the 2022 edition of guidelines for the prevention and treatment of chronic hepatitis B, with an overall awareness rate of 22.0%. Only 20% — 40% of the patients with positive HBV DNA and an age of >30 years receive antiviral therapy, while 80% — 100% of the patients with positive HBV DNA and a family history of hepatitis B cirrhosis or hepatocellular carcinoma receive antiviral therapy. The median follow-up rates at 1 year, 3 years, and 5 years were 67.5% 57.5% and 47.5%,respectively, showing a trend of gradual reduction, which might be associated with the influencing factors such as insufficient time for follow-up management by clinicians, insufficient awareness of the disease among patients, and poor adherence to follow-up. ConclusionThere is a gap between the awareness and practice of guidelines for the prevention and treatment of chronic hepatitis B (2022 edition) among clinicians. It is recommended to further strengthen training and focus on the whole process of “detection, diagnosis, treatment, and management” for patients with chronic hepatitis B in healthcare institutions, in order to promote the implementation of the guidelines.
3.The Mechanism of Xiaoding Ointment Regulating the NLRP3/NF-κB/Caspase-1 Pathway in Treatment of Acute Closed Soft Tissue Injury
Yujuan WANG ; Yonglong JIA ; Jing LIU
Acta Medicinae Universitatis Scientiae et Technologiae Huazhong 2025;54(3):328-334
Objective To investigate the molecular mechanism of Xiaoding Ointment in inhibiting pyroptosis through nucle-otide binding oligomerization of domain like receptor protein 3(NLRP3)/nuclear factor kappa B(NF-κB)/caspase-1 pathway,and to analyze its therapeutic effect on acute closed soft tissue injury.Methods Sixty SPF SD rats were selected and randomly divided into four groups:blank group,model group,positive control group(Qizheng Xiaotong plaster),and Xiaoding Ointment group(topical application).The blank group did not receive any treatment,while the other groups received corresponding inter-vention treatment after preparing the acute closed soft tissue injury model,with a treatment period of seven days.The conditions such as swelling,pain and limited movement were evaluated through the injury symptom score.Hematoxylin-eosin(HE)staining was used to observe the histopathological changes of rat leg muscle tissue.ELISA was used to detect the levels of serum inflam-matory factors IL-1β and TNF-α.TUNEL staining was used to observe the pyroptosis of cells.The expression levels of NLRP3,NF-κB,p65 and Caspase-1 proteins were analyzed by Western blotting and immunohistochemistry to evaluate the therapeutic effect and mechanism of action of Xiaoding Ointment.Results Compared with the model group,the swelling degree,appearance changes,activity and pain behavior of rats in the Xiaoding Ointment group were significantly improved(all P<0.05).Histopa-thology showed a decrease in inflammatory cell infiltration and a normalization of muscle fiber arrangement.The levels of serum inflammatory factors IL-1β and TNF-α were significantly reduced(both P<0.05);The number of pyroptosis positive cells and pyroptosis positive rate significantly decreased(both P<0.05);The protein expressions of NLRP3,NF-κB,p65,and Caspase-1 was significantly reduced(all P<0.05).Conclusion Xiaoding Ointment inhibits NLRP3 inflammasome activation and NF-κB signaling pathway through targeted inhibition,blocks Caspase-1-dependent apoptosis process,and reduces the release of inflam-matory factors such as IL-1β and TNF-α,thereby alleviating the inflammatory response after acute soft tissue injury and promo-ting tissue repair.
4.The Mechanism of Xiaoding Ointment Regulating the NLRP3/NF-κB/Caspase-1 Pathway in Treatment of Acute Closed Soft Tissue Injury
Yujuan WANG ; Yonglong JIA ; Jing LIU
Acta Medicinae Universitatis Scientiae et Technologiae Huazhong 2025;54(3):328-334
Objective To investigate the molecular mechanism of Xiaoding Ointment in inhibiting pyroptosis through nucle-otide binding oligomerization of domain like receptor protein 3(NLRP3)/nuclear factor kappa B(NF-κB)/caspase-1 pathway,and to analyze its therapeutic effect on acute closed soft tissue injury.Methods Sixty SPF SD rats were selected and randomly divided into four groups:blank group,model group,positive control group(Qizheng Xiaotong plaster),and Xiaoding Ointment group(topical application).The blank group did not receive any treatment,while the other groups received corresponding inter-vention treatment after preparing the acute closed soft tissue injury model,with a treatment period of seven days.The conditions such as swelling,pain and limited movement were evaluated through the injury symptom score.Hematoxylin-eosin(HE)staining was used to observe the histopathological changes of rat leg muscle tissue.ELISA was used to detect the levels of serum inflam-matory factors IL-1β and TNF-α.TUNEL staining was used to observe the pyroptosis of cells.The expression levels of NLRP3,NF-κB,p65 and Caspase-1 proteins were analyzed by Western blotting and immunohistochemistry to evaluate the therapeutic effect and mechanism of action of Xiaoding Ointment.Results Compared with the model group,the swelling degree,appearance changes,activity and pain behavior of rats in the Xiaoding Ointment group were significantly improved(all P<0.05).Histopa-thology showed a decrease in inflammatory cell infiltration and a normalization of muscle fiber arrangement.The levels of serum inflammatory factors IL-1β and TNF-α were significantly reduced(both P<0.05);The number of pyroptosis positive cells and pyroptosis positive rate significantly decreased(both P<0.05);The protein expressions of NLRP3,NF-κB,p65,and Caspase-1 was significantly reduced(all P<0.05).Conclusion Xiaoding Ointment inhibits NLRP3 inflammasome activation and NF-κB signaling pathway through targeted inhibition,blocks Caspase-1-dependent apoptosis process,and reduces the release of inflam-matory factors such as IL-1β and TNF-α,thereby alleviating the inflammatory response after acute soft tissue injury and promo-ting tissue repair.
5.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
6.Influencing factors for medication compliance in patients with comorbidities of chronic diseases: a meta-analysis
LIU Yudan ; ZHANG Caiyun ; GUO Mingmei ; ZHENG Yujuan ; JIA Ming ; YANG Jiale ; HOU Jianing ; ZHAO Hua
Journal of Preventive Medicine 2024;36(9):790-795,800
Objective:
To systematically evaluate the influencing factors for medication compliance in patients with comorbidities of chronic diseases, so as to provide the evidence for improving medication compliance.
Methods:
Literature on influencing factors for medication compliance in patients with comorbidities of chronic diseases were retrived from CNKI, Wanfang Data, VIP, SinoMed, PubMed, Web of Science, Cochrane Library and Embase from inception to January 20, 2024. After independent literature screening, data extraction, and quality assessment by two researchers, a meta-analysis was performed using RevMan 5.4 and Stata 16.0 softwares. Literature were excluded one by one for sensitivity analysis. Publication bias was assessed using Egger's test.
Results:
Initially, 7 365 relevant articles were retrieved, and 35 of them were finally included, with a total sample size of about 150 000 individuals. There were 30 cross-sectional studies and 5 cohort studies; and 11 high-quality studies and 24 medium-quality studies. The meta-analysis showed that the demographic factors of lower level of education (OR=2.148, 95%CI: 1.711-2.696), lower economic income (OR=1.897, 95%CI: 1.589-2.264), male (OR=0.877, 95%CI: 0.782-0.985), living alone (OR=2.833, 95%CI: 1.756-4.569) and unmarried (OR=2.784, 95%CI: 1.251-6.196); the medication treatment factors of polypharmacy (OR=1.794, 95%CI: 1.190-2.706), potentially inappropriate medication (OR=2.988, 95%CI: 1.527-5.847), low frequency of daily medication (OR=0.533, 95%CI: 0.376-0.754) and adverse drug reactions (OR=3.319, 95%CI: 1.967-5.602); the disease factors of long course of disease (OR=2.118, 95%CI: 1.643-2.730), more comorbidities (OR=1.667, 95%CI: 1.143-2.431) and cognitive impairment (OR=2.007, 95%CI: 1.401-2.874); and the psychosocial factors of poor belief in taking medication (OR=1.251, 95%CI: 1.011-1.547), poor self-rated health (OR=1.990, 95%CI: 1.571-2.522) and being guided by healthcare professionals (OR=0.151, 95%CI: 0.062-0.368) were the influencing factors for medication compliance in patients with chronic comorbidities.
Conclusion
The medication compliance in patients with comorbidities of chronic diseases is associated with demographic factors, pharmacological factors, disease factors and psychosocial factors, mainly including living alone, adverse drug reactions, course of disease, number of comorbidities and medication beliefs.
7.Application of the excellent doctor-oriented teaching evaluation method in the clinical teaching of dermatology and venereology
Ting LIU ; Ruimin JIANG ; Yujuan WANG ; Xi DUAN ; Jia HE ; Jie CHEN ; Liang LIU
Chinese Journal of Medical Education Research 2024;23(3):391-396
Objective:To investigate the application value of the teaching evaluation method guided by cultivating "excellent doctors" in the clinical teaching of dermatology and venereology.Methods:A non-simultaneous control study was conducted, and the medical students who received theoretical learning and clinical internship in Department of Dermatology and Venereology, Affiliated Hospital of North Sichuan Medical College, from March 2020 to February 2022, were enrolled as subjects. According to the order of enrollment, 32 students who were enrolled from March 2020 to February 2021 were set up as control group, and 31 students who were enrolled from March 2021 to February 2022 were set up as experimental group. The students in the control group received lecture-based learning, and those in the experimental group received clinical teaching using a teaching and evaluation method guided by cultivating "excellent doctors". After the course ended, the two groups were compared in terms of the scores of theoretical knowledge and operation skills, clinical thinking ability [Self-Assessment of Clinical Reasoning and Reflection (SACRR)], core competence [Mini-Clinical Evaluation Exercise (Mini CEX)], and degree of satisfaction with teaching. SPSS 25.0 software was used to perform the independent samples t-test, the Mann-Whitney U test, the chi-square test, and the rank sum test. Results:One student in the control group voluntarily withdrew from the study, and one student in the experimental group did not complete the contents of internship. Finally, 31 students in the control group and 30 in the experimental group were included in the study. After 4 weeks of internship, compared with the control group, the experimental group had significantly higher scores of theoretical knowledge (88.00±4.30 vs. 85.71±4.12, t=2.12, P=0.040) and operation skills (91.87±3.99 vs. 88.23±3.84, t=3.63, P<0.05). After 4 weeks of internship, compared with the control group, the experimental group had significantly higher information systematization score (47.23±3.11 vs. 45.16±3.00), analysis problem score (34.87±2.30 vs. 31.29±2.30), truth finding score (16.30±1.49 vs. 14.45±1.52), reflective ability score [3.50 (3.00, 4.00) vs. 3.00 (3.00, 3.00)], and total score of SACRR (101.87±4.47 vs. 93.90±4.47), with significant differences between the two groups ( t/ Z=2.65, 6.17, 4.79, 3.15, and 6.96, all P<0.05). After 4 weeks of internship, the experimental group had a significantly better core competence than the control group ( Z=2.12, P=0.030); compared with the control group, the experimental group had significantly higher classroom teaching score (20.17±1.98 vs. 18.45±2.23, t=3.17, P<0.05), clinical practice score (19.83±2.10 vs. 17.65±2.17, t=4.00, P<0.05), learning plan score (18.63±2.24 vs. 17.03±2.15, t=2.85, P<0.05), teaching resource score (20.07±1.82 vs. 18.58±2.00, t=3.04, P<0.05) and total score (78.70±3.67 vs. 71.71±4.13, t=6.98, P<0.05). Conclusions:The application of the teaching and evaluation method guided by cultivating "excellent doctors" in the clinical teaching of dermatology and venereology can improve clinical theoretical knowledge, practical operation skills, clinical thinking ability, and core ability among interns and thus help to improve teaching quality. Therefore, it holds promise for clinical application.
8.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
9.Summary of best evidence on medication adherence interventions for patients with multiple chronic conditions
Yudan LIU ; Caiyun ZHANG ; Mingmei GUO ; Yujuan ZHENG ; Ming JIA ; Jiale YANG ; Jianing HOU ; Hua ZHAO
Chinese Journal of Modern Nursing 2024;30(30):4156-4162
Objective:To summarize the best evidence of medication adherence interventions for patients with multiple chronic conditions.Methods:According to the "6S" evidence model, literature on medication adherence in patients with multiple chronic conditions was retrieved from BMJ Best Clinical Practice, UpToDate, Medlive, National Institute for Health and Clinical Excellence, Cochrane Library, Embase, PubMed, Web of Science, China Biology Medicine disc, China National Knowledge Infrastructure, WanFang data and so on. The search period was from establishing the database to August 30, 2023.Results:A total of 16 articles were included, including three guidelines, four expert consensus, seven systematic reviews, and two meta-analyses. Twenty-seven pieces of evidence were summarized from six aspects of compliance assessment, educational intervention, behavioral intervention, optimized treatment program, technical reminder intervention, and social-psychological-emotional intervention.Conclusions:The best evidence of medication adherence interventions for patients with multiple chronic conditions summarized provides a reference for medical and nursing staff to develop medication adherence interventions.
10.Effects of Acupuncture on Functional Connectivity Changes of What Visual Pathway in the Brain in Children with Monocular Refractive Amblyopia
Yujuan YE ; Jing JIA ; Yan SUN ; Yuting WEI ; Cui MA ; Xingke YAN
Journal of Traditional Chinese Medicine 2023;64(20):2101-2108
ObjectiveTo explore the efficacy of acupuncture intervention for children with monocular refractive-parallax amblyopia and the possible mechanisms of brain function based on resting-state functional magnetic resonance (rs-fMRI). MethodsSeventy-six children with anisometropic amblyopia were randomly divided into routine treatment group (38 cases) and acupuncture treatment group (38 cases). In the conventional group, the children were given three regular treatments of red flash, grating and visual stimulation for 5 mins each time; in the acupuncture group, on the basis of the conventional treatment, the children were given acupuncture for 20 mins each time on bilateral Jingming (BL 1), Cuanzhu (BL 2), Guangming (GB 37) and Fengchi (GB 20); the children in both groups were treated once every other day and three times a week for 4 weeks. The corrected visual acuity was compared between groups before and after treatment. Fifteen children with left-sided refractive amblyopia were randomly selected from each of the above two groups and underwent brain rs-fMRI scans before and after treatment, and 10 healthy children with normal visual acuity of the matched gender and age were included in the normal group and underwent brain rs-fMRI scans. Based on the activation likelihood estimation (ALE) method, we constructed the what visual pathway network, and compared and analyzed the spherical regions of interest (ROIs) of the children with normal children, and both groups of children with differences in functional connectivity (FC values) within the what pathway in the brain before and after treatment. ResultsTwo cases dropout in the acupuncture group, and finally 36 cases in the acupuncture group and 38 cases in the conventional group were included in the analysis. Compared with before treatment, the best corrected visual acuity of amblyopia in both groups was significantly improved after treatment (P<0.05), and the improvement of vision in the acupuncture group was significantly better than that in the conventional group (P<0.05). The results of rs-fMRI showed that the FC values of the primary optic cortex and the right fusiform gyrus, the left lingual gyrus and the right fusiform gyrus, and the right infraoccipital gyrus and the right middle temporal gyrus were significantly elevated in the brain of the refractive amblyopia children with the whitepathic amblyopia, compared with that of the normal children (P<0.05). The FC values of the left lingual gyrus, the right suboccipital gyrus with the right fusiform gyrus, the left lingual gyrus with the right middle temporal gyrus, the right and left lateral middle occipital gyrus, and the right and left lateral middle occipital gyrus with the right suboccipital gyrus were significantly (P<0.05) lower in the conventional group compared with those in the conventional group before treatment. Compared with that before acupuncture treatment, the FC values of the right lingual gyrus and the right fusiform gyrus, the primary visual cortex and the right middle temporal gyrus increased significantly after acupuncture treatment (P<0.05), and the FC values of the left inferior occipital gyrus and the right middle temporal gyrus, the FC values of the left lingual gyrus and the right middle occipital gyrus decreased significantly (P<0.05). Compared between groups after treatment, the FC between the left suboccipital gyrus and the right fusiform gyrus in the acupuncture group was significantly higher than that in the conventional group (P<0.05), and the FC between the left middle occipital gyrus and the right and left suboccipital gyrus was significantly lower than that in the conventional group (P<0.05). ConclusionAcupuncture can significantly improve the corrected vision of anisometropic amblyopic children, and its effect mechanism may focus on regulating the occipito-temporal interlobular functional connectivity within the what pathway, thus improving the children's visual function of shape and color vision and visual learning and memory ability.


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