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.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
3.Correlation analysis between macular thickness and visual field mean defect in pseudoexfoliation glaucoma
Fan LI ; Guangxian TANG ; Lihua MA ; Yulei GENG ; Hengli ZHANG ; Xiaowei YAN ; Qing ZHANG
Chinese Journal of Experimental Ophthalmology 2019;37(6):447-452
Objective To compare and analyze differences in macular thickness and to discuss the correlation between macular thickness and visual field mean defect (MD) in early and moderate,late pseudoexfoliation glaucoma (PXG) patients and normal control subjects.Methods A series of cases-observation study was adopted.Thirty-three early and moderate PXG patients (33 eyes) and 24 late PXG patients (24 eyes) were collected in the First Hospital of Shijiazhuang from May 2013 to May 2018.Meanwhile,34 age,gender and diopermatched healthy subjects (34 eyes) were included as normal control group.Spectral domain optical coherence tomography (SD-OCT) was used to measure macular thickness and volume in every quadrant.The correlation between the macular thickness and visual field MD were analyzed.This study followed the Helsinki declaration and was approved by the ethics committee of the First Hospital of Shijiazhuang.Written informed consent was obtained from each subject prior to any medical examination.Results The average macular thickness in normal control group,early and moderate PXG group and late PXG group were (305 ± 15),(297 ± 15) and (287 ± 17) μm,respectively;the average macular volume were (0.94 ± 0.05),(0.91 ± 0.05) and (0.89 ± 0.05) μm3,respectively.The macular thickness and volume differences between the 3 groups were statistically significant in nasal inner macula,superior inner macula,temporal inner macula,inferior inner macula,superior outer macula,temporal outer macula,inferior outer macula quadrants (Fthickness =4.226,9.335,12.133,10.115,11.298,8.243,12.142;all at P<0.05.Fvolume =3.812,9.152,12.774,8.889,11.284,7.937,11.652;all at P<0.05).The macular thickness of early and moderate PXG group in superior inner macula,temporal inner macula,inferior inner macula,superior outer macula and temporal outer macula quadrants were statistically thinner than those in the normal control group (all at P<0.05);the macular thickness of late PXG group in inferior inner macula,temporal inner macula,superior outer macula and inferior outer macula quadrants were statistically thinner than those in the early and moderate PXG group (all at P<0.05);the macular thickness of late PXG group in inner and outer rings were statistically thinner than those in the normal control group (all at P<0.05).The macular thickness was not correlated with visual field MD in normal control group and the early and moderate PXG group in every quadrants (all at P>0.05),but it was positively correlated with visual field MD in the late PXG group in nasal inner macula,superior outer macula and temporal inner macula quadrants (r =0.527,0.544,0.417;all at P<0.05).Conclusions SD-0CT can quantify the macular thickness,and can be used an important reference index for the staging and follow-up of PXG combined with perimetry.
4.Determination of 4,5-Dicaffeoyquinic Acid in Elehantopus Scaber Linn by HPLC
China Pharmacist 2014;(2):312-314
Objective:To establish an HPLC method for the determination of 4,5-dicaffeoyquinic acid in Elehantopus scaber Linn. Methods:The separation was carried out on an Agilent SB C18 column(250 mm × 4. 6 mm, 5 μm). The mobile phase was acetoni-trile-0. 1% phosphoric acid (17∶83) and the flow rate was 1. 0 ml·min-1 . The detection wavelength was set at 327nm, the column temperature was 30℃ and the injection volume was 10 μl. Results: The calibration curve showed a good linearity over the range of 0. 023 5-2. 352 0 μg(r=0. 999 9). The average recovery was 98. 75% with RSD of 1. 24%(n=6). Conclusion: The method is simple, rapid and accurate, and can be used as a quantitative analysis method for Elehantopus scaber Linn.

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