1.Clinical Characteristics and Use of Traditional Chinese Medicine Therapy in 222 Malignant Tumor Cases with COVID-19: A Retrospective Study
Yingtian WANG ; Hong SUN ; Man LI ; Na SONG ; Jiao GOU ; Wenfang LUO ; Jun LIU ; Rong MA ; Wei WANG ; Zhandong LI ; Bo MENG ; Xiaoyan YAO
Journal of Traditional Chinese Medicine 2024;65(7):716-721
ObjectiveTo analyze the clinical characteristics and the use of traditional Chinese medicine (TCM) therapy in cancer patients with COVID-19, and to provide reference for making TCM prevention and treatment strategies and determining diagnosis and treatment priorities for patients with malignant tumors in the COVID-19 epidemic. MethodsThe medical records of 225 malignant tumor cases with COVID-19 who were admitted to 7 national research centers from January 1st to 20th, 2023 were retrospectively collected, and the main symptoms and duration after infection, nucleic acid negative conversion time, use of TCM therapy, and changes in adverse reactions after resuming anti-tumor treatment were analyzed. ResultsA total of 222 malignant tumor patients with COVID-19 were included in the analysis, involving 205 mild cases and 17 moderate cases. The top four most frequently reported clinical symptoms were fever (165 cases), expectoration or dry cough (99 cases), decreased appetite (95 cases) and fatigue (85 cases), of which 40 expectoration or dry cough cases , 37 fatigue cases and 29 decreased appetite cases lasted for more than 14 days. One hundred and five patients with nucleic acid detection report had a median negative conversion time of 14 days. The nucleic acid negative conversion time was significantly longer in patients with lung cancer compared to those with digestive system malignant tumors, and in those with myelosuppression than those without (P<0.01). During the infection period, 47.30% (105/222) of the patients used Chinese patent medicine, and 21.17% (47/222) were treated with herbal decoctions. The use of TCM in patients during the prevention and rehabilitation period, was 1.80%(4/222) and 7.21%(16/222), respectively. Fifty-five patients resumed anti-tumor treatment after nucleic acid negative conversion, and received TCM simultaneously. Observed adverse reactions, including gastrointestinal reactions, bone marrow suppression, and neurotoxicity, were all grade 1 to 2, and no new adverse events occurred during follow-up. ConclusionCertain malignant tumor patients with COVID-19 had prolonged symptoms and nucleic acid negative conversion time Rational use of TCM can help to promote the rehabilitation of the patients and ensure the smooth process of anti-tumor treatment after infection.
2.Phase 1 trial of the safety, pharmacokinetics, and antiviral activity of EDP-514 in untreated viremic chronic hepatitis B patients
Man-Fung YUEN ; Wan-Long CHUANG ; Cheng-Yuan PENG ; Wen-Juei JENG ; Wei-Wen SU ; Ting-Tsung CHANG ; Chi-Yi CHEN ; Yao-Chun HSU ; Guy DE LA ROSA ; Alaa AHMAD ; Ed LUO ; Annie L. CONERY
Clinical and Molecular Hepatology 2024;30(3):375-387
Background/Aims:
Oral EDP-514 is a potent core protein inhibitor of hepatitis B virus (HBV) replication, which produced a >4-log viral load reduction in HBV-infected chimeric mice with human liver cells. This study evaluated the safety, pharmacokinetics, and antiviral activity of three doses of EDP-514 in treatment-naive viremic patients with HBeAgpositive or -negative chronic HBV infection.
Methods:
Patients with HBsAg detectable at screening and at least 6 months previously were eligible. HBeAg-positive and -negative patients had a serum/plasma HBV DNA level ≥20,000 and ≥2,000 IU/mL, respectively. Twenty-five patients were randomized to EDP-514 200 (n=6), 400 (n=6) or 800 mg (n=7) or placebo (n=6) once daily for 28 days.
Results:
A dose-related increase in EDP-514 exposure (AUClast and Cmax) was observed across doses. At Day 28, mean reductions in HBV DNA were –2.9, –3.3, –3.5 and –0.2 log10 IU/mL with EDP-514 200 mg, 400 mg, 800 mg, and placebo groups, respectively. The corresponding mean change from baseline for HBV RNA levels was –2.9, –2.4, –2.0, and –0.02 log10 U/mL. No virologic failures were observed. No clinically meaningful changes from baseline were observed for HBsAg, HBeAg or HBcrAg. Nine patients reported treatment emergent adverse events of mild or moderate severity with no discontinuations, serious AEs or deaths.
Conclusions
In treatment-naïve viremic patients, oral EDP-514 was generally safe and well-tolerated, displayed PK profile supportive of once-daily dosing, and markedly reduced HBV DNA and HBV RNA.
3.Progress on clinical trials of common gastrointestinal cancer drugs in China from 2012 to 2021.
Hui Yao HUANG ; Da Wei WU ; Qi ZHU ; Yue YU ; Hai Xue WANG ; Jun WANG ; Man GA ; Xin Yu MENG ; Jing Ting DU ; Shuang Man MIAO ; Zhi Xia ZHAO ; Xin WANG ; Pu SHANG ; Min Jiang GUO ; Li Hong LIU ; Yu TANG ; Ning LI ; Cai CAO ; Bing He XU ; Yan SUN ; Jie HE
Chinese Journal of Oncology 2022;44(3):276-281
Objective: Systematically summarize the research progress of clinical trials of gastric cancer oncology drugs and the overview of marketed drugs in China from 2012 to 2021, providing data and decision-making evidence for relevant departments. Methods: Based on the registration database of the drug clinical trial registration and information disclosure platform of Food and Drug Administration of China and the data query system of domestic and imported drugs, the information on gastric cancer drug clinical trials, investigational drugs and marketed drugs from January 1, 2012 to December 31, 2021 was analyzed, and the differences between Chinese and foreign enterprises in terms of trial scope, trial phase, treatment lines and drug type, effect and mechanism studies were compared. Results: A total of 114 drug clinical trials related to gastric tumor were registered in China from 2012 to 2021, accounting for 3.7% (114/3 041) of all anticancer drug clinical trials in the same period, the registration number showed a significant growth rate after 2016 and reached its peak with 32 trials in 2020. Among them, 85 (74.6%, 85/114) trials were initiated by Chinese pharmaceutical enterprise. Compared with foreign pharmaceutical enterprise, Chinese pharmaceutical enterprise had higher rates of phase I trials (35.3% vs 6.9%, P=0.001), but the rate of international multicenter trials (11.9% vs 67.9%, P<0.001) was relatively low. There were 76 different drugs involved in relevant clinical trials, of which 65 (85.5%) were targeted drugs. For targeted drugs, HER2 is the most common one (14 types), followed by PD-1 and multi-target VEGER. In the past ten years, 3 of 4 marketed drugs for gastric cancer treatment were domestic and included in the national medical insurance directory. Conclusions: From 2012 to 2021, China has made some progress in drug research and development for gastric carcinoma. However, compared with the serious disease burden, it is still insufficient. Targeted strengthening of research and development of investment in many aspects of gastric cancer drugs, such as new target discovery, matured target excavating, combination drug development and early line therapy promotion, is the key work in the future, especially for domestic companies.
China
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Gastrointestinal Agents/therapeutic use*
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Gastrointestinal Neoplasms
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Humans
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Pharmaceutical Preparations
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United States
;
United States Food and Drug Administration
4.Inter-hemispheric Functional Connections Are More Vulnerable to Attack Than Structural Connection in Patients With Irritable Bowel Syndrome
Guangyao LIU ; Shan LI ; Nan CHEN ; Ziyang ZHAO ; Man GUO ; Hong LIU ; Jie FENG ; Dekui ZHANG ; Zhijun YAO ; Bin HU
Journal of Neurogastroenterology and Motility 2021;27(3):426-435
Background/Aims:
Irritable bowel syndrome (IBS) is a prevalent functional gastrointestinal disease characterized by recurrent abdominal pain and bowel dysfunction. However, the majority of previous neuroimaging studies focus on brain structure and connections but seldom on the inter-hemispheric connectivity or structural asymmetry. This study uses multi-modal imaging to investigate the abnormal changes across the 2 cerebral hemispheres in patients with IBS.
Methods:
Structural MRI, resting-state functional MRI, and diffusion tensor imaging were acquired from 34 patients with IBS and 33 healthy controls. The voxel-mirrored homotopic connectivity, fractional anisotropy, fiber length, fiber number, and asymmetry index were calculated and assessed for group differences. In addition, we assessed their relevance for the severity of IBS.
Results:
Compared with healthy controls, the inter-hemispheric functional connectivity of patients with IBS showed higher levels in bilateral superior occipital gyrus, middle occipital gyrus, precuneus, posterior cingulate gyrus, and angular gyrus, but lower in supplementary motor area. The statistical results showed no significant difference in inter-hemispheric anatomical connections and structural asymmetry, however negative correlations between inter-hemispheric connectivity and the severity of IBS were found in some regions with significant difference.
Conclusions
The functional connections between cerebral hemispheres were more susceptible to IBS than anatomical connections, and brain structure is relatively stable. Besides, the brain areas affected by IBS were concentrated in default mode network and sensorimotor network.
5.Inter-hemispheric Functional Connections Are More Vulnerable to Attack Than Structural Connection in Patients With Irritable Bowel Syndrome
Guangyao LIU ; Shan LI ; Nan CHEN ; Ziyang ZHAO ; Man GUO ; Hong LIU ; Jie FENG ; Dekui ZHANG ; Zhijun YAO ; Bin HU
Journal of Neurogastroenterology and Motility 2021;27(3):426-435
Background/Aims:
Irritable bowel syndrome (IBS) is a prevalent functional gastrointestinal disease characterized by recurrent abdominal pain and bowel dysfunction. However, the majority of previous neuroimaging studies focus on brain structure and connections but seldom on the inter-hemispheric connectivity or structural asymmetry. This study uses multi-modal imaging to investigate the abnormal changes across the 2 cerebral hemispheres in patients with IBS.
Methods:
Structural MRI, resting-state functional MRI, and diffusion tensor imaging were acquired from 34 patients with IBS and 33 healthy controls. The voxel-mirrored homotopic connectivity, fractional anisotropy, fiber length, fiber number, and asymmetry index were calculated and assessed for group differences. In addition, we assessed their relevance for the severity of IBS.
Results:
Compared with healthy controls, the inter-hemispheric functional connectivity of patients with IBS showed higher levels in bilateral superior occipital gyrus, middle occipital gyrus, precuneus, posterior cingulate gyrus, and angular gyrus, but lower in supplementary motor area. The statistical results showed no significant difference in inter-hemispheric anatomical connections and structural asymmetry, however negative correlations between inter-hemispheric connectivity and the severity of IBS were found in some regions with significant difference.
Conclusions
The functional connections between cerebral hemispheres were more susceptible to IBS than anatomical connections, and brain structure is relatively stable. Besides, the brain areas affected by IBS were concentrated in default mode network and sensorimotor network.
6.Association between Selenium in Soil and Diabetes in Chinese Residents Aged 35-74 Years: Results from the 2010 National Survey of Chronic Diseases and Behavioral Risk Factors Surveillance.
Qi Qi WANG ; Shi Cheng YU ; Cheng Dong XU ; Jian Jun LIU ; Yuan Qiu LI ; Man Hui ZHANG ; Xiao Juan LONG ; Yun Ning LIU ; Yu Fang BI ; Wen Hua ZHAO ; Hong Yan YAO
Biomedical and Environmental Sciences 2020;33(4):260-268
Objective:
To explore the association between soil selenium levels and the risk of diabetes in Chinese adults aged 35-74 years.
Methods:
Data for this study were derived from the China Chronic Diseases and Behavioral Risk Factors Surveillance 2010 survey. Selenium concentrations in soil were obtained from the Atlas of Soil Environmental Background Values in China. A two-level binary logistic regression model was used to determine the association between soil selenium concentrations and the risk of diabetes, with participants nested within districts/counties.
Results:
A total of 69,332 participants aged 35-74 years, from 158 districts/counties were included in the analysis. Concentrations of selenium in soil varied greatly across the 158 districts/counties, with a median concentration of 0.219 mg/kg ( : 0.185-0.248). The results showed that both Quartile 1 (0.119-0.185 mg/kg) and Quartile 4 (0.249-0.344 mg/kg) groups were positively associated with diabetes compared to a soil selenium concentration of 0.186-0.219 mg/kg (Quartile 2), crude odds ratios ( s) (95% ) were 1.227 (1.003-1.502) and 1.280 (1.048-1.563). The values were 0.045 and 0.013, for Quartile 1 and Quartile 4 groups, respectively. After adjusting for all confounding factors of interest, the Quartile 1 group became non-significant, and the Quartile 4 group had an adjusted (95% ) of 1.203 (1.018-1.421) relative to the reference group (Quartile 2), the values was 0.030. No significant results were seen for the Quartile 3 group (0.220-0.248 mg/kg) compared to the reference group.
Conclusion
Excessive selenium concentrations in soil could increase the risk of diabetes among Chinese adults aged 35-74 years.
Adult
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Aged
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China
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epidemiology
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Diabetes Mellitus
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chemically induced
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epidemiology
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Diet
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Female
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Humans
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Logistic Models
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Male
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Middle Aged
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Odds Ratio
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Risk Factors
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Selenium
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deficiency
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metabolism
;
Soil
;
chemistry
7.Liver Stiffness Assessment by Sound Touch Elastography versus Two-dimensional Shear Wave Elastography: a Comparative Study
Jian ZHENG ; Man-li WU ; Qing-juan WANG ; Jin-fen WANG ; Min ZHANG ; Xiang PENG ; Xiao-hong YAO ; Rong-qin ZHENG
Journal of Sun Yat-sen University(Medical Sciences) 2020;41(4):644-648
【Objective】 To compare sound touch elastography(STE), a new technique for the measurement of liver stiffness, and two-dimensional shear wave elastography(2D-SWE), and to provide an evidence base for STE’s clinical practice. 【Methods】 The study included forty-three healthy volunteers and sixty-three patients with liver cirrhosis, in which liver stiffness was measured by means of STE and 2D-SWE. We compared the technical success rate, intra-operator reproducibility and liver stiffness values. 【Results】 The success rates of STE and 2D-SWE were 100%(106/106) and 96.2%(102/106), respectively(χ2=2.320, P=0.128), with four 2D-SWE examination failures in four patients with liver cirrhosis. Compared with those assessed by 2D-SWE, liver stiffness values assessed by STE were higher [5.83(5.30~ 6.37) kPa vs. 5.00(4.80~5.20) kPa, Z=4.419, P<0.001] in the healthy group, but lower [15.82(11.71~25.02) kPa vs. 18.50(11.95~29.93) kPa, Z=-2.981, P=0.003] in the liver cirrhosis group. The Spearman's rank correlation coefficient of STE and 2D-SWE was 0.896(95%CI: 0.849~0.928, P<0.001) . 【Conclusion】 With equally good reproducibility, STE is superior to 2D-SWE due to its higher success rate and better penetration especially in patients with cirrhosis. The liver stiffness values assessed by STE and 2D-SWE are not equivalent, which deserves our special attention in clinical application.
8.Consensus by Chinese Expert Panel on-Resistant and-Persistent Infection.
Man-Li QI ; Yuan-Li GUO ; Qian-Qiu WANG ; Xiang-Sheng CHEN ; Jian-De HAN ; Xiao-Hong SU ; Wen-Hui LUN ; Hao CHENG ; Jin-Hua XU ; Hong-Qing TIAN ; Li CHEN ; Zhi-Yuan YAO ; Wen-Li FENG ; Juan JIANG ; Ping-Yu ZHOU ; Xian-Biao ZOU ; Hong-Hui XU ; Wei-Min SHI ; Jun LIU ; Lin ZHU ; Quan-Zhong LIU
Chinese Medical Journal 2017;130(23):2852-2856
9.Autophagy and its role in the pathogenesis of multiple sclerosis
Xiao-Hong GAO ; Bo-Yao YUAN ; Xin-Yan ZHANG ; Jin ZHAO ; Man-Xia WANG
Medical Journal of Chinese People's Liberation Army 2017;42(9):833-837
Autophagy generally reside in eukaryote and is a highly conserved protein degradation pathway,which take part in the maintenance of cellular homeostasis as well as the growth of cells.The characterization of autophagy being reported over years has revealed that it involved in immune response,such as removal of intracellular bacteria,inflammatory cytokine secretion,antigen presentation,and lymphocyte development,and then involved in the pathogenesis of multiple sclerosis indirectly.So,in this review,we focus on the pathway ofautophagy and the role of which in the multiple sclerosis (MS) in order to further understand the important effect and potential therapeutic value of autophagy in MS.
10.Preparation of polyvinyl alcohol/lota-carrageenan scaffolds and its biocompatibility
Jing CUI ; Yabin ZHANG ; Siqi MA ; Yanjie XIONG ; Man CUI ; Shuofeng LI ; Pengcheng CHE ; Fanglian YAO ; Hong SUN
Chinese Journal of Tissue Engineering Research 2017;21(2):215-220
BACKGROUND:Polyvinyl alcohol (PVA) hydrogel with similar porous structure and mechanical properties to the natural cartilage is very suitable for the repair of articular cartilage. However, the pure PVA hydrogel after lyophilization wil be accompanied by the shrinkage of the polymer network and the col apse of the pores, leading to the inhomogeneous performance of the material even in the state of re-swel ing. Addition of the active polymer wil increase the cel adhesion ability of PVA hydrogel. OBJECTIVE:To construct PVA/lota-carrageenan (l-CA) composite materials with different mass fractions of l-CA and evaluate the biocompatibility with vascular endothelial cel s. METHODS:PVA/l-CA composite films with different contents of l-CA were fabricated and then co-cultured with vascular endothelial cel s. Attachment, proliferation and morphological changes of vascular endothelial cel s on the composite were observed by scanning electron microscope and MTT assay to evaluate its biocompatibility. PVA/l-CA three-dimensional scaffold with different contents of l-CA were constructed, and hemolysis experiment was conducted according to the biological evaluation standards of medical devices, and the porosity and pore size were observed using scanning electron microscope. RESULTS AND CONCLUSION:In vitro experimental results showed that the addition of l-CA could significantly increase the biological activity of PVA hydrogel, and promote the cel attachment and proliferation on the scaffold. The hemolysis rate of each experimental group was less than 5%(the accepted safety standard), suggesting that the composite materials were in accordance with the standard of medical devices for hemolysis experiment. These findings indicate that the composite scaffolds with 20%-30%l-CA possess the pore size suitable for cel growth and proliferation and the porosity beneficial for transportation of nutrients and metabolites, which can serve as an excel ent scaffold for tissue engineering.

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