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.Research progress of fatigue in patients with cirrhosis
Yujuan LIU ; Xiaodan ZHANG ; Ying YI ; Xueyao MA ; Juan MAO ; Yangyang DING ; Lingling DUAN
Chinese Journal of Practical Nursing 2024;40(24):1917-1921
Fatigue is one of the common symptoms in patients with liver cirrhosis, which has a serious impact on the quality of life of patients. This article reviews the influencing factors and intervention strategies of fatigue in patients with cirrhosis, aiming to provide reference for early recognition and intervention of fatigue in patients with cirrhosis.
4.Impact of residual cholesterol on the progression of arteriosclerosis in individuals receiving physical examination
Zhaoqin DONG ; Fuliang YI ; Yujuan YING ; Weijian MAO ; Yuanfang ZHU ; Yang GAO ; You YOU
Chinese Journal of Health Management 2024;18(9):686-692
Objective:To investigate the impact of residual cholesterol (RC) on the progression of arteriosclerosis in individuals receiving physical examination.Methods:A cross-sectional study. Participants aged 18 years and above who underwent arteriosclerosis testing at the Health Management Center of Zigong Fourth People′s Hospital from January to December 2023 were selected as the subjects of the study. A total of 9 016 subjects were included in this study, of whom 6 213 were considered to have arteriosclerosis. The physical examination conclusions, basic information (age, gender, body mass index, waist circumference, blood pressure, history of hypertension, history of smoking and drinking), and biochemical indicators (lipids, fasting blood glucose, liver and kidney function) were extracted in those individuals. Based on the examination results, the subjects were categorized into arteriosclerosis and normal groups. The RC levels of the participants were calculated using a formula and then the subjects were categorized into binary and quartile RC groups. Additionally, four regression models were used to analyze the impact of RC levels on the progression of arteriosclerosis while adjusting for various confounding factors.Results:The RC level was (0.63±0.44) mmol/L in the normal group and (0.76±0.61) mmol/L in the arteriosclerosis group. Based on level of RC, the normal group was divided into two subgroups: 652 individuals with elevated RC level and 2 241 with normal RC level. In the arteriosclerosis group, there were 2 069 individuals with elevated RC level and 4 144 with normal RC level. Grouped according to quartiles of RC level, the number of individuals with RC in the Q1-Q4 interval in the normal group was 838 (28.97%), 752 (25.99%), 760 (26.27%), and 543 (18.77%), respectively, showing a gradual decreasing trend. The number of individuals with RC in the Q1-Q4 interval in the arteriosclerosis group was 1 414 (22.76%), 1 438 (23.15%), 1 589 (25.58%), and 1 771 (28.51%), respectively, showing a gradual increasing trend. The difference between the groups was statistically significant ( P<0.05). After adjusting for various factors by four regression models, it was found that elevated RC levels increased the risk of arteriosclerosis progression, with a odds ratio ( OR) of 1.381, 1.242, 1.233, and 1.214, respectively. Additionally, individuals in the Q4 RC level quartile had 1.502, 1.318, 1.311, and 1.284-times higher risk of arteriosclerosis progression when compared to those in the Q1 quartile. Conclusion:The impact of RC on the progression of arteriosclerosis tend to stabilize and remain consistent, indicating that elevated RC is an independent risk factor for the progression of arteriosclerosis.
5.Risk factors of senile degenerative valvular heart disease
Wenhua YU ; Yujuan LIU ; Yao YU ; Jia LIU ; Shan WANG ; Song HU ; Yongjun MAO
Chinese Journal of Geriatrics 2022;41(12):1468-1472
Objective:To explore the clinical characteristics and related risk factors of senile degenerative valvular heart disease(SDHVD), and to provide clinical basis for early prevention intervention of SDHVD.Methods:Clinical data of 1568 elderly patients ≥60 years old hospitalized in our hospital from January 2022 to June 2022 were collected to compare the clinical characteristics and analyze the risk factors of patients in the degenerative heart valve disease group and the non-degenerative heart valve disease group.Results:Age(per 10-year increase)( OR=2.107, 95% CI=1.518-2.924), blood calcium( OR=8.934, 95% CI=2.023-39.447), total cholesterol( OR=1.167, 95% CI=1.044-1.304), female( OR=2.098, 95% CI=1.305-3.374), and reduced mean platelet volume(MPV)( OR=0.818, 95% CI=0.682-0.981)were independent risk factors for the development of SDHVD( P<0.05).Post hoc two-by-two comparisons showed that different degrees of calcification were associated with age( P<0.05); apoA, UA, P, and FT3 were statistically significant in the no-calcification group compared with the control group( P<0.05); E/e′, PASP, and NT-ProBNP were statistically significant in the moderate calcification group compared with the control group( P<0.05); TC was statistically significant in the no-calcification and mild calcification groups compared with the control group There was statistical significance( P<0.05)compared with the control group. Conclusions:Age, blood calcium, total cholesterol, female, and reduced MPV are independent risk factors for SDHVD.
7. Effect of different proportions of piper chinaroot and rhubarb on the dissolution rate of five effective components in rhubarb
Hong CHEN ; Yi HAN ; Mengxi QIAN ; Xiaohui SHI ; Yujuan MAO
International Journal of Traditional Chinese Medicine 2019;41(11):1231-1235
Objective:
To study the effect of different proportions of piper chinaroot and rheum palmatum on the dissolution rate of five effective components (aloe emodin, emodin acid, emodin, emodin, emodin methyl ether).
Methods:
The high performance liquid chromatography (HPLC) method was used to analyz the contents of five effective components of rheum palmatum in the extracts of different combination of piper chinaroot and rheum palmatum. The tests were carried out by Thermo C18 (250 mm×4.6 mm, 5 μm) by gradient elution with methanol and 0.1% phosphoric acid water solution as mobile phase at a flow rate of 1ml/min, the column temperature was 30 ℃ and the detection wavelength was 254 nm.
Results:
The linear ranges of aloe emodin, emodin acid, emodin, emodin, emodin methyl ether were 0.018 5-0.741 8, 0.017 9-0.717 8, 0.015 9-0.635 5, 0.054 2-2.167 2, 0.016 2-0.646 4 μg, respectively. The average recoveries of aloe emodin, emodin acid, emodin, emodin, emodin methyl ether were 94.35%, 95.50%, 100.61%, 96.27%, 97.39%, and the
8. A phase II, single-arm, open-label, multicenter clinical study to evaluate the efficacy and safety of sofosbuvir combined with ribavirin in patients with genotype 2 chronic hepatitis C virus infection
Yinghui GAO ; Guangming LI ; Qinglong JIN ; Yingren ZHAO ; Zhansheng JIA ; Xiaorong MAO ; Yongfeng YANG ; Jia SHANG ; Gongchen WANG ; Wen XIE ; Shanming WU ; Mingxiang ZHANG ; Jinlin HOU ; Dongliang LI ; Yuemin NAN ; Yujuan GUAN ; Chunxia ZHU ; Yangzhou YUAN ; Lai WEI
Chinese Journal of Hepatology 2019;27(5):352-357
Objective:
To evaluate the efficacy and safety of sofosbuvir (Nanjing Zhengda Tianqing Pharmaceutical Co., Ltd.) combined with ribavirin in patients with genotype 2 chronic hepatitis C virus infection.
Methods:
Treatment-naïve or treatment experienced genotype 2 chronic hepatitis C patients from sixteen research centers of China were screened. All subjects received once-daily dose of sofosbuvir (400 mg) combined with ribavirin (body weight < 75 kg, 1 000 mg/day, 400 mg in the morning and 600 mg in the evening; body weight > 75 kg, 1 200 mg/d, 600 mg in the morning and 600 mg in the evening) for 12 weeks. Patients were followed-up for a period of 12 weeks after discontinuation of treatment. Continuous variables were expressed as mean ± standard deviation. The proportion of subjects with virologic response at different follow-up time points and 95% confidence intervals were estimated by maximum likelihood ratio and Clopper-Pearson interval.
Results:
132 cases with genotype 2 chronic hepatitis C virus infection from sixteen research centers of China were included, 12 cases of whom were associated with cirrhosis, and the remaining 120 cases were not associated with cirrhosis. One hundred and thirty-one cases completed the study, and one patient lost to follow-up at week 4 after the end of treatment. The sustained virological response rate was 96.2% (95% confidence interval: 92.37% - 99.16%) after 12 weeks of drug withdrawal. Virological relapse occurred in four cases. Of the 132 subjects enrolled in the study, 119 (90.2%) reported 617 adverse events during treatment, of which 359 (76.5%) were TEAE related to sofosbuvir and/or ribavirin. There were nine TEAEs of grade 3 and above, and six cases (4.5%) of them had six severe adverse events. Only one serious adverse event was associated with sofosbuvir and ribavirin (unstable angina pectoris). There were no adverse events leading to drug discontinuation or death.
Conclusion
Sofosbuvir combined with ribavirin has a high SVR rate in the treatment of genotype 2 chronic hepatitis C virus infection, and most of the adverse events occurred were mild with acceptable safety profile.
9.Risk factors for ovarian metastasis in endometrial carcinoma:a Meta analysis
Luwen ZHAO ; Aijun YU ; Yujuan ZHANG ; Xiaoli SONG ; Shufang MAO
Chongqing Medicine 2018;47(4):497-501,507
Objective To systematically evaluate the risk factors for ovarian metastasis of endometrial carcinoma(EC) to provide an evidence-based medicine basis for formulating the EC surgical mode and ovarian metastatic risk.Methods Studies about the risk factors for EC ovarian metastasis were retrieved by computer from the Pubmed,Embase,Cochrane Library,WanFang database,CNKI,China Biology Medicine(CBM) from Jan.1,1990 to Sep.1,2016.The quality evaluation of included literature was performed by using the Newcastle-Ottawa Scale(NOS).Results A total of 13 studies were included,involving 6 140 EC patients,of whom 344 cases(5.60%) had ovarian metastasis.The Meta analysis results showed that a total of 9 factors had statistical significance,which were deep myometrial infiltration(OR =0.28,95 % CI:0.21-0.39),cervical involvement (OR =0.27,95 % CI:0.16-0.45),lymph node involvement (OR =0.21,95 % CI:0.15-0.27),fallopian tube involvement (OR =0.05,95 % CI:0.02-0.10),non-endometrioid adenocarcinoma(OR=0.32,95%CI:0.24-0.43),low differentiation(OR=0.39,95%CI:0.31-0.50),positive ascites cytologic detection(OR=0.14,95%CI:0.09-0.20),high serum CA125 level(OR=0.12,95%CI:0.08-0.19) and lymphovascular cancer embolus(OR =0.34,95 % CI:0.23-0.50),the differences were statistically significant(P<0.05).But the age,lesion location,lesion diameter and estrogenic receptor level had no statistical difference(P>0.05).Conclusion Deep myometrial infiltration,cervical involvement,lymph node involvement,fallopian tube involvement,non-endometrioid adenocarcinoma,low differentiation and positive ascites cytologic detection,high CA125 level and lymphovascular cancer embolus are the risk factors for EC ovarian metastasis.
10.Comparison of laparoscopic versus laparotomic operation for cervical carcinoma in elderly Chinese women: a meta-analysis
Luwen ZHAO ; Aijun YU ; Yujuan ZHANG ; Xiaoli SONG ; Shufang MAO
China Journal of Endoscopy 2017;23(4):18-25
Objective To compare the curative effect of laparoscopic and laparotomic operation for elderly Chinese women with cervical cancer. Methods The randomized controlled trials (RCT) and case controlled trials (CCT) were collected by searches of WanFang database, CNKI, VIP, China Biology Medicine (CBM) , PubMed. Data were extracted from these trials and data analysis was performed by RevMan 5.2.9. Results There were no RCTs, however, a total of 10 CCTs met the inclusion criteria and had data extracted for this review. The baseline characteristics of the laparoscopic group were similar to those of the laparotomic group. Comparing to laparotomic group, the laparoscopic group have longer operation time (MD =32.60, 95%CI: 5.65~59.55, P = 0.020), less amount of bleeding (MD = -94.01, 95%CI: -130.65 ~ -57.37, P = 0.000), smaller number of lymph node dissection(MD = 1.69, 95%CI: 0.67 ~ 2.72, P = 0.001), earlier anus exhaustion (MD=-17.09, 95%CI: -21.19 ~ -12.98, P = 0.000) and shorter hospital stays (MD = -4.30, 95%CI: -5.57 ~ -3.02, P = 0.000). There was significant difference between the two groups. But there was no statistical significance in postoperative indwelling catheter time (MD = -0.67, 95%CI: -1.92 ~ 0.58, P = 0.290) and surgical complications incidence (OR=0.62, 95%CI: 0.27 ~ 1.42, P = 0.260) between the two groups. Conclusion Laparoscopic management has the advantages of less traumatic and recovered quickly, and did not increase the incidence of complications. Laparoscopic operation is an ideal procedure for elderly Chinese women with cervical carcinoma.

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