1.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
2.Hepatocellular carcinoma prediction model performance decreases with long-term antiviral therapy in chronic hepatitis B patients
Xiaoning WU ; Xiaoqian XU ; Jialing ZHOU ; YaMeng SUN ; Huiguo DING ; Wen XIE ; Guofeng CHEN ; Anlin MA ; HongXin PIAO ; Bingqiong WANG ; Shuyan CHEN ; Tongtong MENG ; Xiaojuan OU ; Hwai-I YANG ; Jidong JIA ; Yuanyuan KONG ; Hong YOU
Clinical and Molecular Hepatology 2023;29(3):747-762
Background/Aims:
Existing hepatocellular carcinoma (HCC) prediction models are derived mainly from pretreatment or early on-treatment parameters. We reassessed the dynamic changes in the performance of 17 HCC models in patients with chronic hepatitis B (CHB) during long-term antiviral therapy (AVT).
Methods:
Among 987 CHB patients administered long-term entecavir therapy, 660 patients had 8 years of follow-up data. Model scores were calculated using on-treatment values at 2.5, 3, 3.5, 4, 4.5, and 5 years of AVT to predict threeyear HCC occurrence. Model performance was assessed with the area under the receiver operating curve (AUROC). The original model cutoffs to distinguish different levels of HCC risk were evaluated by the log-rank test.
Results:
The AUROCs of the 17 HCC models varied from 0.51 to 0.78 when using on-treatment scores from years 2.5 to 5. Models with a cirrhosis variable showed numerically higher AUROCs (pooled at 0.65–0.73 for treated, untreated, or mixed treatment models) than models without (treated or mixed models: 0.61–0.68; untreated models: 0.51–0.59). Stratification into low, intermediate, and high-risk levels using the original cutoff values could no longer reflect the true HCC incidence using scores after 3.5 years of AVT for models without cirrhosis and after 4 years of AVT for models with cirrhosis.
Conclusions
The performance of existing HCC prediction models, especially models without the cirrhosis variable, decreased in CHB patients on long-term AVT. The optimization of existing models or the development of novel models for better HCC prediction during long-term AVT is warranted.
3.Cyclic arginine-glycine-aspartic acid-modified red blood cells for drug delivery:Synthesis and in vitro evaluation
Chen WANG ; Min WANG ; Yan ZHANG ; Hongxin JIA ; Binbin CHEN
Journal of Pharmaceutical Analysis 2022;12(2):324-331
Red blood cells(RBCs)are an excellent choice for cell preparation research because of their biocom-patibility,high drug loading,and long half-life.In this study,doxorubicin(DOX)was encapsulated with RBCs as the carrier.The biotin-avidin system binding principle was used to modify biotinylated cyclic arginine-glycine-aspartic acid(cRGD)onto RBC surfaces for accurate targeting,high drug loading,and sustained drug release.The RBC drug delivery system(DDS)was characterized,and the concentration of surface sulfur in the energy spectrum was 6.330%.The physical and chemical properties of RBC DDS were as follows:drug content,0.857 mg/mL;particle size,3339 nm;potential value,-12.5 mV;and cumu-lative release rate,81.35%.There was no significant change in RBC morphology for up to seven days.The results of the targeting and cytotoxicity studies of RBC DDS showed that many RBCs covered the surfaces of U251 cells,and the fluorescence intensity was higher than that of MCF-7 cells.The IC50 value of un-modified drug-loaded RBCs was 2.5 times higher than that of targeted modified drug-loaded RBCs,indicating that the targeting of cancer cells produced satisfactory inhibition.This study confirms that the RBC DDS has the characteristics of accurate targeting,high drug loading,and slow drug release,which increases its likelihood of becoming a clinical cancer treatment in the future.
4.Development of Traditional Chinese Medicine in Mongolia
Lanye HE ; Xiaoqiang JIA ; Jiajun LI ; Khurelbaatar KHONGORZUL ; Jargalsaikhan GOMBODORJ ; Jingjing WEI ; Jing ZHAO ; Kakit HUI ; Hongxin CAO
International Journal of Traditional Chinese Medicine 2021;43(1):17-21
Mongolia is a parliamentary republic country in the north of our country. Healthcare system is mainly composed of three parts: state-owned medical institutions, private clinics and mixed-ownership medical institutions, characteris by the wide coverage but uneven resources. Due to the folk customs and climate, diseases of the digestive system are more common, and the main diseases that cause deaths of Mongolian residents are ischemic heart disease, stroke, and liver cancer. Mongolia is located by and culturally related to China, so the development and dissemination of Traditional Chinese Medicine (TCM) is likely acceptable to the public. Mongolia’s traditional medicine and TCM have long-term exchanges and influences, promoting each other’s development, which also are protected by Mongolian laws. The concerns such as the inheritance, study and protection of Mongolian traditional medicine, the promotion of non-medicinal therapies restrict the development Mongolian and Chinese traditional medicine. It is recommended that Mongolian and TCM jointly promote the development and dissemination of traditional medicine in the world by cultivating high-level medical talents, increasing research and protection of herbal medicines, and expanding the application of non-drug therapies.
5.Summary of research in economic burden of hand, foot, and mouth disease in China
Xiaoli WANG ; Hongxin WEI ; Lei JIA ; Da HUO ; Huaqing WANG ; Quanyi WANG
Chinese Journal of Epidemiology 2020;41(2):273-279
Since 2010,the incidence of hand,foot,and mouth disease (HFMD) has ranked top in notifiable infectious disease in China,causing economic losses to many families and the society of China.This paper summarizes the related methods,results and problems systematically in the research of economic burden of HFMD in China to provide reference for the better estimation of the economic burden caused by HFMD.Many studies showed that HFMD,especially severe and fatal cases,had posed heavy economic burden on the society.To mitigate the burden caused by HFMD,it is necessary to decrease the risk of severe and fatal cases,as well as to reduce the incidence of mild cases.
6. Qualitative pathological assessment of liver fibrosis regression after antiviral therapy in patients with chronic hepatitis B
Yameng SUN ; Jialing ZHOU ; Lin WANG ; Xiaoning WU ; Yongpeng CHEN ; Hongxin PIAO ; Lungen LU ; Wei JIANG ; Youqing XU ; Bo FENG ; Yuemin NAN ; Wen XIE ; Guofeng CHEN ; Huanwei ZHENG ; Hai LI ; Huiguo DING ; Hui LIU ; Fudong LYU ; Chen SHAO ; Tailing WANG ; Xiaojuan OU ; Binqiong WANG ; Shuyan CHEN ; Hong YOU ; Jidong JIA
Chinese Journal of Hepatology 2017;25(11):819-826
Objective:
To investigate the methods for qualitative pathological assessment of dynamic changes in liver fibrosis/cirrhosis after antiviral therapy in patients with chronic hepatitis B (CHB), since antiviral therapy can partially reverse liver fibrosis and cirrhosis caused by hepatitis B and semi-quantitative, rather than qualitative, pathological assessment is often used for the research on liver fibrosis regression.
Methods:
Previously untreated CHB patients with liver fibrosis and cirrhosis were enrolled, and liver biopsy was performed before treatment and at 78 weeks after the antiviral therapy based on entecavir. The follow-up assessment was performed once every half a year. Based on the proportion of different types of fibrous septum, we put forward the new qualitative criteria called P-I-R classification (predominantly progressive, predominantly regressive, and indeterminate) for evaluating dynamic changes in liver fibrosis. This classification or Ishak fibrosis stage was used to evaluate the change in liver fibrosis after treatment and Ishak liver inflammation score was used to evaluate the change in liver inflammation after treatment.
Results:
A total of 112 CHB patients who underwent liver biopsy before and after treatment were enrolled, and among these patients, 71 with an Ishak stage of ≥3 and qualified results of live biopsy were included in the final analysis. Based on the P-I-R classification, 58% (41/71) were classified as predominantly progressive, 29% (21/71) were classified as indeterminate, and 13% (9/71) were classified as predominantly regressive; there were no significant differences between the three groups in alanine aminotransferase, aspartate aminotransferase, albumin, HBeAg positive rate, HBV DNA, and liver stiffness (
7.Formula Optimization of Ibuprofen Sustained-release Dropping Pills by Box-Behnken Response-surface Method
Yanli SHEN ; Hao CHEN ; Hongxin SONG ; Weixia DU ; Yongyan JIA
China Pharmacist 2017;20(6):1012-1016
Objective: To prepare ibuprofen sustained-release dropping pills, to evaluate the accumulative release percentage in vitro and to study the drug state in the base.Methods: With the drug content, mass ratio of water-soluble base to insoluble base and mass ratio of stearic acid to glyceryl monostearate as the investigation factors, and the comprehensive score of 2-hour and 10-hour cumulative dissolution rate as the evaluation index, a Box-Behnken response-surface method was used to screen the optimal formula of ibuprofen sustained-release dropping pills.The drug state in the matrix was examined by differential scanning calorimetry (DSC).Results: The optimal formula of ibuprofen sustained-release dropping pills was as follows: the drug content of 10%, water-soluble and insoluble matrix ratio of 4∶1, and stearic acid and glyceryl monostearate ratio of 3∶1.The maximum cumulative dissolution rate of ibuprofen sustained-release dropping pills was 78.85%.The DSC analysis showed that the drug crystallization peak disappeared in the sustained-release dropping pills, and formed a solid dispersion.Conclusion: The preparation has good sustained-release effect, and the preparation process is simple.
8.Radiation injury of interstitial implantation 125I seeds on normal trachea tissue of rabbits.
Haiyan WANG ; Hongxin CHEN ; Haiying JIA ; Dongxiu RONG ; Xiuxian LIN ; Tao ZHANG
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2015;29(13):1213-1216
OBJECTIVE:
To study the radition injury of tracheal mucous membrane tissue after interstitial implanted radioactive 125I in normal rabbit,improve the safety of clinical application.
METHOD:
Sixty New Zealand rabbits, weighing 2.15-2.30 kg, were randomly divided into 1 w, 1 m, 2 m, 4 m and the control group, the control group was further divided into four subgroups. The 0.8mCi 125I seeds were implanted into the tissue by the first tracheal ring in the treatment groups and nonradioactive seeds were implanted in the control group. Taking the tracheal mucous membrane tissue for pathological examination by HE staining to observe the mucosal injury and VEGF, Pan-Cadherin immunohistochemical staining to observe the expression in differernt time.
RESULT:
Immunohistochemical staining: VEGF and Pan-Cadherin have statistically significant differences in the expression on different time, the expression is dynamic.
CONCLUSION
The expression of VEGF and Pan-Cadherin reflect the radioactive 125I seed has little influence on normal trachea tissue and the damage can be repaired by the regeneration of the basal cell.
Animals
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Brachytherapy
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adverse effects
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Iodine Radioisotopes
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adverse effects
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Rabbits
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Radiation Injuries
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pathology
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Trachea
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pathology
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radiation effects

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