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.Anteromedial cortical support reduction in treatment of trochanteric femur fractures: a ten-year reappraisal.
Sunjun HU ; Shouchao DU ; Shimin CHANG ; Wei MAO ; Zhenhai WANG ; Kewei TIAN ; Tao LIU ; Yunfeng RUI
Chinese Journal of Reparative and Reconstructive Surgery 2025;39(12):1501-1509
OBJECTIVE:
This review summarized the first 10-year progresses and controversies in the concept of anteromedial cortical support reduction, to provide references for further study and clinical applications.
METHODS:
Relevant domestic and foreign literature on cortical support reduction was extensively reviewed to summarize the definition of positive, neutral, and negative support, anteromedial cortices at the inferior corner, intraoperative technical tips for fracture reduction, radiographic assessment at different periods, comparison between positive versus neutral and medial versus anterior support, and the clinical efficacy of Chang reduction quality criteria (CRQC) and postoperative stability score.
RESULTS:
Anteromedial cortical support reduction was only focused on the cortex of anteromedial inferior corner, with no concern the status of lateral wall or lesser trochanter. Anteromedial cortex was seldom involved by fracture comminution, it was thicker, denser, and stronger, and was the key for mechanical buttress of the head-neck fragment to share compression load. Positive, neutral, and negative support were also called "extramedullary, anatomic, and intramedullary reduction", respectively. There was hardly seen parallel cortical apposition, but characterized by some kinds of head-neck rotation, for example 10°-15° flexed rotation for positive cortical contact and support. Due to intraoperative compression and postoperative impaction, the status of cortical support may be changed at different time of radiographic examination. The positive medial cortex support was more reliable with less reduction loss than its neutral counterpart, and the anterior cortex contact was more predictive than the medial cortex for final results. As incorporation the bearing of cortex apposition and using a 4-point score, CRQC demonstrated more efficacy and was gradually accepted and applied in the evaluation of trochanteric fracture reduction quality. Postoperative stability score (8 points) provided a assessment tool for early weight-bearing in safety to prevent mechanical failure.
CONCLUSION
Anteromedial cortical support reduction is a key point for stability reconstruction in the treatment of trochanteric femur fractures. Evidence has definitely shown that non-negative (positive and neutral) is superior to negative (loss of cortical support). There is a tendency that positive cortex support is superior to neutral, but high quality study with large sample size is needed for a clear conclusion.
Humans
;
Femur/diagnostic imaging*
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Fracture Fixation, Internal/methods*
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Hip Fractures/diagnostic imaging*
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Treatment Outcome
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Fracture Fixation, Intramedullary/methods*
3.Predictive value of dose surface histogram for acute radiation proctitis induced by image guided radiotherapy for cervical cancer
Qing-xiao LIU ; Yue-xiang ZHU ; Wei WEI ; Long TIAN ; Song-lin YANG ; Zheng WANG ; Yu-sen ZHAO ; Su-li WANG ; Mao-ye CHANG
Chinese Medical Equipment Journal 2025;46(3):48-53
Objective To explore the predictive value of dose surface histogram(DSH)in image guided radiotherapy(IGRT)for radiotherapy-induced acute radiation proctitis(ARP)in cervical cancer(CCA).Methods Totally 380 patients with CCA IGRT admitted to some hospital from May 2019 to May 2023 were selected prospectively and randomly divided into a control group(n=1 80)and an experimental group(n=200).The patients in the 2 groups were followed up and the incidence rates of ARP were counted,and rectal dose distribution was evaluated using dose volume histogram(DVH)in the control group and DSH in the experimental group.The predictive values of DVH and DSH for ARP were evaluated and compared using ROC curves.Statistical analysis was performed using SPSS 21.0 software.Results The two groups did not have statistically significant difference in the incidence rate of ARP(P>0.05),while there were significant differences in the evaluation indicators of the rectal dose distribution(P<0.05).V40,V50,S40 and S50 proved to have low predictive values for grade Ⅰ-Ⅳ ARP with AUC 0.700(P<0.05);V60 and S60 had moderate predictive values for grade Ⅰ-Ⅳ ARP with AUC greater than 0.700 and less than or equal to 0.900(P<0.05);V70,V78,S70 and S7s showed high predictive values for grade Ⅰ-Ⅳ ARP with AUC higher than 0.900(P<0.05).Delong's test results indicated that DVH and DSH had no significant differences in AUC when used to predict gradeⅠ-Ⅳ ARP(allP>0.05).Conclusion DSH is essentially the same as DVH when used for the prediction of grade Ⅰ-Ⅳ ARP due to CCA IGRT,and thus can be used for the supplementation and optimization of radiotherapy planning systems.[Chinese Medical Equipment Journal,2025,46(3):48-53]
4.Predictive value of dose surface histogram for acute radiation proctitis induced by image guided radiotherapy for cervical cancer
Qing-xiao LIU ; Yue-xiang ZHU ; Wei WEI ; Long TIAN ; Song-lin YANG ; Zheng WANG ; Yu-sen ZHAO ; Su-li WANG ; Mao-ye CHANG
Chinese Medical Equipment Journal 2025;46(3):48-53
Objective To explore the predictive value of dose surface histogram(DSH)in image guided radiotherapy(IGRT)for radiotherapy-induced acute radiation proctitis(ARP)in cervical cancer(CCA).Methods Totally 380 patients with CCA IGRT admitted to some hospital from May 2019 to May 2023 were selected prospectively and randomly divided into a control group(n=1 80)and an experimental group(n=200).The patients in the 2 groups were followed up and the incidence rates of ARP were counted,and rectal dose distribution was evaluated using dose volume histogram(DVH)in the control group and DSH in the experimental group.The predictive values of DVH and DSH for ARP were evaluated and compared using ROC curves.Statistical analysis was performed using SPSS 21.0 software.Results The two groups did not have statistically significant difference in the incidence rate of ARP(P>0.05),while there were significant differences in the evaluation indicators of the rectal dose distribution(P<0.05).V40,V50,S40 and S50 proved to have low predictive values for grade Ⅰ-Ⅳ ARP with AUC 0.700(P<0.05);V60 and S60 had moderate predictive values for grade Ⅰ-Ⅳ ARP with AUC greater than 0.700 and less than or equal to 0.900(P<0.05);V70,V78,S70 and S7s showed high predictive values for grade Ⅰ-Ⅳ ARP with AUC higher than 0.900(P<0.05).Delong's test results indicated that DVH and DSH had no significant differences in AUC when used to predict gradeⅠ-Ⅳ ARP(allP>0.05).Conclusion DSH is essentially the same as DVH when used for the prediction of grade Ⅰ-Ⅳ ARP due to CCA IGRT,and thus can be used for the supplementation and optimization of radiotherapy planning systems.[Chinese Medical Equipment Journal,2025,46(3):48-53]
5.Clinical efficacy and failure analysis of biplane double-supported screw fixation in treatment of femoral neck fracture
Chang-tie LIU ; Yu-lin MAO ; Jun-lin LIU ; Shi-qiang WEI
Journal of Regional Anatomy and Operative Surgery 2025;34(10):876-881
Objective To explore the clinical efficacy of biplane double-supported screw fixation(BDSF)in the treatment of femoral neck fracture(FNF)and the influencing factors of surgical failure.Methods A total of 360 patients with FNF hospitalized in our hospital from November 2022 to May 2024 were selected as the research objects.According to the random number table method,the patients were divided into the observation group[application of BDSF under the multi-disciplinary treatment(MDT)and green channel mode]and the control group[application of cannulated compression screw(CCS)fixation under the MDT and green channel mode],with 180 cases in each group;According to the failure of surgical treatment or fixation in the observation group,the patients were further divided into the surgical failure group(n=50)and effective surgery group(n=130).The risk factors were analyzed by multivariate Logistic regression.The establishment and fitting of the model were analyzed by Logistic regression.The discrimination,prediction accuracy and clinical value of the model were evaluated by receiver operating characteristic(ROC)curve,calibration curve and decision curve analysis(DCA)curve,respectively.Results Compared with the control group,the observation group had shorter operation time and hospitalization time(P<0.05),less intraoperative blood loss and fewer intraoperative fluoroscopy times(P<0.05),lower proportion of patients with avascular necrosis of femoral head and fixation failure(P<0.05),and higher Harris hip score 24 months after operation(P<0.05).Garden classification,fracture line location,reduction quality and preoperative traction were the independent influencing factors of surgical failure(P<0.05).The ROC curve analysis showed that the area under the curve(AUC)of the model to predict the risk of surgical failure was 0.867(95%CI:0.751 to 0.946).The calibration curve analysis results showed that the predicted probability of the model was approximately equal to the actual probability,with a Brier value of 0.095.DCA analysis results showed that the threshold probability of the model was 0.1 to 0.9,indicating a high net profit.Conclusion BDSF has a good effect in FNF surgery,which can shorten the operation time and hospitalization time,reduce the number of intraoperative fluoroscopy and bleeding,which is more conducive to hip joint function recovery.Garden classification,fracture line location,reduction quality,and preoperative traction are all the independent influencing factors for surgical failure.
6.Clinical efficacy and failure analysis of biplane double-supported screw fixation in treatment of femoral neck fracture
Chang-tie LIU ; Yu-lin MAO ; Jun-lin LIU ; Shi-qiang WEI
Journal of Regional Anatomy and Operative Surgery 2025;34(10):876-881
Objective To explore the clinical efficacy of biplane double-supported screw fixation(BDSF)in the treatment of femoral neck fracture(FNF)and the influencing factors of surgical failure.Methods A total of 360 patients with FNF hospitalized in our hospital from November 2022 to May 2024 were selected as the research objects.According to the random number table method,the patients were divided into the observation group[application of BDSF under the multi-disciplinary treatment(MDT)and green channel mode]and the control group[application of cannulated compression screw(CCS)fixation under the MDT and green channel mode],with 180 cases in each group;According to the failure of surgical treatment or fixation in the observation group,the patients were further divided into the surgical failure group(n=50)and effective surgery group(n=130).The risk factors were analyzed by multivariate Logistic regression.The establishment and fitting of the model were analyzed by Logistic regression.The discrimination,prediction accuracy and clinical value of the model were evaluated by receiver operating characteristic(ROC)curve,calibration curve and decision curve analysis(DCA)curve,respectively.Results Compared with the control group,the observation group had shorter operation time and hospitalization time(P<0.05),less intraoperative blood loss and fewer intraoperative fluoroscopy times(P<0.05),lower proportion of patients with avascular necrosis of femoral head and fixation failure(P<0.05),and higher Harris hip score 24 months after operation(P<0.05).Garden classification,fracture line location,reduction quality and preoperative traction were the independent influencing factors of surgical failure(P<0.05).The ROC curve analysis showed that the area under the curve(AUC)of the model to predict the risk of surgical failure was 0.867(95%CI:0.751 to 0.946).The calibration curve analysis results showed that the predicted probability of the model was approximately equal to the actual probability,with a Brier value of 0.095.DCA analysis results showed that the threshold probability of the model was 0.1 to 0.9,indicating a high net profit.Conclusion BDSF has a good effect in FNF surgery,which can shorten the operation time and hospitalization time,reduce the number of intraoperative fluoroscopy and bleeding,which is more conducive to hip joint function recovery.Garden classification,fracture line location,reduction quality,and preoperative traction are all the independent influencing factors for surgical failure.
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.Iodine Nutrition,Thyroid-stimulating Hormone,and Related Factors of Postpartum Women from three Different Areas in China:A Cross-sectional Survey
Yun Xiao SHAN ; Yan ZOU ; Chun Li HUANG ; Shan JIANG ; Wen Wei ZHOU ; Lan Qiu QIN ; Qing Chang LIU ; Yan Xiao LUO ; Xi Jia LU ; Qian De MAO ; Min LI ; Yu Zhen YANG ; Chen Li YANG
Biomedical and Environmental Sciences 2024;37(3):254-265
Objective Studies on the relationship between iodine,vitamin A(VA),and vitamin D(VD)and thyroid function are limited.This study aimed to analyze iodine and thyroid-stimulating hormone(TSH)status and their possible relationships with VA,VD,and other factors in postpartum women. Methods A total of 1,311 mothers(896 lactating and 415 non-lactating)from Hebei,Zhejiang,and Guangxi provinces were included in this study.The urinary iodine concentration(UIC),TSH,VA,and VD were measured. Results The median UIC of total and lactating participants were 142.00 μg/L and 139.95 μg/L,respectively.The median TSH,VA,and VD levels in all the participants were 1.89 mIU/L,0.44 μg/mL,and 24.04 ng/mL,respectively.No differences in the UIC were found between lactating and non-lactating mothers.UIC and TSH levels were significantly different among the three provinces.The rural UIC was higher than the urban UIC.Obese mothers had a higher UIC and a higher prevalence of excessive TSH.Higher UICs and TSHs levels were observed in both the VD deficiency and insufficiency groups than in the VD-sufficient group.After adjustment,no linear correlation was observed between UIC and VA/VD.No interaction was found between vitamins A/D and UIC on TSH levels. Conclusion The mothers in the present study had no iodine deficiency.Region,area type,BMI,and VD may be related to the iodine status or TSH levels.
9.Clinical trial of Morinda officinalis oligosaccharides in the continuation treatment of adults with mild and moderate depression
Shu-Zhe ZHOU ; Zu-Cheng HAN ; Xiu-Zhen WANG ; Yan-Qing CHEN ; Ya-Ling HU ; Xue-Qin YU ; Bin-Hong WANG ; Guo-Zhen FAN ; Hong SANG ; Ying HAI ; Zhi-Jie JIA ; Zhan-Min WANG ; Yan WEI ; Jian-Guo ZHU ; Xue-Qin SONG ; Zhi-Dong LIU ; Li KUANG ; Hong-Ming WANG ; Feng TIAN ; Yu-Xin LI ; Ling ZHANG ; Hai LIN ; Bin WU ; Chao-Ying WANG ; Chang LIU ; Jia-Fan SUN ; Shao-Xiao YAN ; Jun LIU ; Shou-Fu XIE ; Mao-Sheng FANG ; Wei-Feng MI ; Hong-Yan ZHANG
The Chinese Journal of Clinical Pharmacology 2024;40(6):815-819
Objective To observe the efficacy and safety of Morinda officinalis oligosaccharides in the continuation treatment of mild and moderate depression.Methods An open,single-arm,multi-center design was adopted in our study.Adult patients with mild and moderate depression who had received acute treatment of Morinda officinalis oligosaccharides were enrolled and continue to receive Morinda officinalis oligosaccharides capsules for 24 weeks,the dose remained unchanged during continuation treatment.The remission rate,recurrence rate,recurrence time,and the change from baseline to endpoint of Hamilton Depression Scale(HAMD),Hamilton Anxiety Scale(HAMA),Clinical Global Impression-Severity(CGI-S)and Arizona Sexual Experience Scale(ASEX)were evaluated.The incidence of treatment-related adverse events was reported.Results The scores of HAMD-17 at baseline and after treatment were 6.60±1.87 and 5.85±4.18,scores of HAMA were 6.36±3.02 and 4.93±3.09,scores of CGI-S were 1.49±0.56 and 1.29±0.81,scores of ASEX were 15.92±4.72 and 15.57±5.26,with significant difference(P<0.05).After continuation treatment,the remission rate was 54.59%(202 cases/370 cases),and the recurrence rate was 6.49%(24 cases/370 cases),the recurrence time was(64.67±42.47)days.The incidence of treatment-related adverse events was 15.35%(64 cases/417 cases).Conclusion Morinda officinalis oligosaccharides capsules can be effectively used for the continuation treatment of mild and moderate depression,and are well tolerated and safe.
10.Application of remote fundus image reading training in improving the diagnostic ability of ophthalmologists in Xinjiang Uygur Autonomous Region
Xufeng ZHAO ; Xiuyan MA ; Xuejing LI ; Li QIN ; Lina SUO ; Wenping MA ; Shihao LI ; Jiaxing CHEN ; Yaxin YANG ; Xinxia LI ; Tao XIE ; Juan LI ; Yuanshan XIONG ; Zhiyong WU ; Zhihuai CHANG ; Mowen FANG ; Ting WANG ; Hong LIU ; Pengju MA ; Pengpeng LIU ; Jing RAN ; Di YANG ; Changle XUE ; Zhen XIE ; Zhao FAN ; Yang WANG ; Peng LEI ; Qingjiang HUANG ; Bing LI ; Shi FENG ; Zhangwanyu WEI ; Yishuang MAO ; Weihong YU ; Linjun ZHANG
Chinese Journal of Ocular Fundus Diseases 2024;40(12):941-946
Objective:To explore the feasibility and effect of remote medical education model using online film reading training to improve the ability of ophthalmologists in the Xinjiang Uygur Autonomous Region (hereinafter referred to as "Xinjiang Region" ) in diagnosing fundus diseases.Methods:The three-level film reading training system of Xinjiang Production and Construction Corps system division hospital-Corps Hospital-Peking Union Medical College Hospital was established. From June 2022 to January 2023, 4 159 posterior color fundus images were continuously collected from Department of Ophthalmology of Xinjiang Corps Hospital and 4 divisional hospitals in the Corps medical system. Among them, hypertensive retinopathy, diabetic retinopathy, exudative age-related macular degeneration (AMD), atrophic AMD and retinal vein occlusion were 3 073, 651, 43, 186 and 206 cases, respectively. The images were divided into 3 rounds (first, second and last) according to the proportion of diseases. The doctors who participated in the training (hereinafter referred to as the "training") were 15 ophthalmologists from the Corps Hospital of Xinjiang Region and the division hospital of the Corps system. There were 7 male and 8 female. Age was (38.1±4.0) years. The titles of senior, deputy senior, intermediate and junior are 1, 6, 5 and 3 respectively; Bachelor's degree and master's degree are 13 and 2 respectively. The working time of fundus disease specialty was (9.6±3.3) years. The film reading system training was conducted before the first round of labeling, and after each round of film reading, the doctors of Peking Union Medical College Hospital gave feedback and explanation on the film reading results. The diagnostic consistency, sensitivity and specificity were compared by paired sample t test. Spearman or Pearson correlation analysis was conducted between the improvement of diagnostic level and professional title, education, age and working hours of ocular fundus disease. Results:All the participating doctors completed the first, second and last reading. After each round of film reading, the film reading summary was carried out for 2 hours. The average diagnostic agreement rates of participating physicians were 53.0%, 67.0% and 75.0%, respectively. The sensitivity and specificity were 0.38, 0.69, 054 and 0.66, 0.85, 0.96, respectively. There was significant difference between the first and last examination ( P<0.001). The sensitivity of the second reading was significantly higher than that of the first reading, and the sensitivity of the last reading was significantly lower than that of the second reading, with statistical significance ( P<0.05). The specificity of the second reading was significantly higher than that of the first reading, and the last reading was significantly higher than that of the second reading, with statistical significance ( P<0.05). There was no significant correlation ( P>0.05) between the improvement of diagnostic level of participating physicians and educational background ( Rho=0.07), professional title ( Rho=0.13), age ( r=0.20), and working time of ophthalmofundus disease specialty ( r=0.26). Conclusions:Relying on the three-level online telemedicine training, it can improve the ability of ophthalmologists in Xinjiang region to diagnose fundus diseases. The preliminary telemedicine education model has demonstrated potential for feasibility and effectiveness in remote areas with inadequate medical resources.

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