1.Quality of moxa from Artemisia argyi and A. stolonifera in different storage years based on simultaneous thermal analysis.
Bing YI ; Jia-Qi QIAO ; Li-Chun ZHAO ; Xian-Zhang HUANG ; Da-Hui LIU ; Li ZHOU ; Li-Ping KANG ; Yuan ZHANG
China Journal of Chinese Materia Medica 2023;48(14):3693-3700
		                        		
		                        			
		                        			The quality of moxa is an important factor affecting moxibustion therapy, and traditionally, 3-year moxa is considered optimal, although scientific data are lacking. This study focused on 1-year and 3-year moxa from Artemisia stolonifera and A. argyi(leaf-to-moxa ratio of 10∶1) as research objects. Scanning electron microscopy(SEM), Van Soest method, and simultaneous thermal analysis were used to investigate the differences in the combustion heat quality of 1-year and 3-year moxa and their influencing factors. The results showed that the combustion of A. stolonifera moxa exhibited a balanced heat release pattern. The 3-year moxa released a concentrated heat of 9 998.84 mJ·mg~(-1)(accounting for 54% of the total heat release) in the temperature range of 140-302 ℃, with a heat production efficiency of 122 mW·mg~(-1). It further released 7 512.51 mJ·mg~(-1)(accounting for 41% of the total heat release) in the temperature range of 302-519 ℃. The combustion of A. argyi moxa showed a rapid heat release pattern. The 3-year moxa released a heat of 16 695.28 mJ·mg~(-1)(accounting for 70% of the total heat release) in the temperature range of 140-311 ℃, with an instantaneous power output of 218 mW·mg~(-1). It further released 5 996.95 mJ·mg~(-1)(accounting for 25% of the total heat release) in the temperature range of 311-483 ℃. Combustion parameters such as-R_p,-R_v, D_i, C, and D_b indicated that the combustion heat quality of 3-year moxa was superior to that of 1-year moxa. It exhibited greater combustion heat, heat production efficiency, flammability, mild and sustained burning, and higher instantaneous combustion efficiency. This study utilized scientific data to demonstrate that A. stolonifera could be used as excellent moxa, and the quality of 3-year moxa surpassed that of 1-year moxa. The research results provide a scientific basis for the in-depth development of A. stolonifera moxa and the improvement of moxa quality standards.
		                        		
		                        		
		                        		
		                        			Artemisia
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		                        			Hot Temperature
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		                        			Moxibustion
		                        			;
		                        		
		                        			Plant Leaves
		                        			
		                        		
		                        	
2.Key quality attributes of benchmark samples of famous classical formula Kaixin Powder.
Bing-Xian SHANG ; Zhen-Xia ZHAO ; Qi ZENG ; Jian SU ; Bing XU ; Yong-Li LIU ; Hai-Min LEI
China Journal of Chinese Materia Medica 2023;48(2):382-389
		                        		
		                        			
		                        			We prepared 15 batches of Kaixin Powder benchmark samples with the decoction pieces of different batches. Further, we established the specific chromatograms and index component content determination method of Kaixin Powder benchmark samples and analyzed the peaks and similarity of the chromatograms. With sibiricose A5, sibiricose A6, polygalaxanthone Ⅲ, 3,6'-disinapoyl sucrose, ginsenoside Rb_1, β-asarone, α-asarone, and dehydropachymic acid as index components, the index component content determination method was established and 70%-130% of the mean content of each component was set as the range. The chromatograms of 15 batches of Kaixin Powder benchmark samples had a total of 22 characteristic peaks, among which 8 peaks were identified, which represented sibiricose A5, sibiricose A6, polygalaxanthone Ⅲ, 3,6'-disinapoyl sucrose, ginsenoside Rb_1, β-asarone, α-asarone, and dehydropachymic acid, respectively. The chromatograms shared the similarity of 0.992-0.999. The 15 batches of benchmark samples had sibiricose A5 of 0.34-0.55 mg·g~(-1), sibiricose A6 of 0.43-0.57 mg·g~(-1), polygalaxanthone Ⅲ of 0.12-0.19 mg·g~(-1), 3,6'-disinapoyl sucrose of 1.08-1.78 mg·g~(-1), ginsenoside Rb_1 of 0.33-0.62 mg·g~(-1), β-asarone of 2.34-3.72 mg·g~(-1), α-asarone of 0.11-0.22 mg·g~(-1), and dehydropachymic acid of 0.053-0.079 mg·g~(-1). This study established the specific chromatograms and index component content determination method of Kaixin Powder benchmark samples, and the method was simple, feasible, reproducible, and stable. This study provides a scientific basis for further research on the key chemical properties of the benchmark samples and preparations of Kaixin Powder.
		                        		
		                        		
		                        		
		                        			Powders
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		                        			Ginsenosides
		                        			;
		                        		
		                        			Benchmarking
		                        			;
		                        		
		                        			Drugs, Chinese Herbal/chemistry*
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		                        			Sucrose
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		                        			Chromatography, High Pressure Liquid/methods*
		                        			
		                        		
		                        	
3.A Novel Diagnostic and Therapeutic Strategy for Cancer Patients by Integrating Chinese Medicine Syndrome Differentiation and Precision Medicine.
Shu-Xian YU ; Zi-Mao LIANG ; Qi-Biao WU ; Lan SHOU ; Xing-Xing HUANG ; Qian-Ru ZHU ; Han XIE ; Ru-Yi MEI ; Ruo-Nan ZHANG ; Xiang-Yang ZHAI ; Tian XIE ; Xin-Bing SUI
Chinese journal of integrative medicine 2022;28(10):867-871
		                        		
		                        			
		                        			Applying Chinese medicine (CM) is an important strategy for malignant tumor treatment in China. One of the significant characteristics of CM is to treat diseases based on syndrome differentiation. For Western medicine, it is of important clinical significance to formulate guidelines for the diagnosis and treatment of cancer patients based on the characteristics of disease differentiation. In Chinese clinical practice, the combination of disease differentiation and syndrome differentiation is an important feature for cancer treatment in the past. Currently, molecular profiling and genomic analysis-based precision medicine optimizes the anticancer drug design and holds the greatest success in treating cancer patients. Therefore, we want to know which populations of cancer patients can benefit more from CM treatment if the theory of precision medicine is applied to CM clinical practice. So, we developed a novel diagnostic and therapeutic strategy "disease-syndrome differentiation-genomic profiling-prescriptions" for cancer patients by CM syndrome differentiation and precision medicine. As a result, this strategy has greatly enhanced the anti-tumor efficacy of CM and improved clinical outcomes for cancer patients with some gene mutations. Our idea will hopefully establish a novel approach for the inheritance and innovation of CM.
		                        		
		                        		
		                        		
		                        			Antineoplastic Agents
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		                        			Drugs, Chinese Herbal/therapeutic use*
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		                        			Humans
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		                        			Medicine, Chinese Traditional
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		                        			Neoplasms/therapy*
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		                        			Precision Medicine
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		                        			Syndrome
		                        			
		                        		
		                        	
4.Effects of Bupleurum chinense on the diversity of intestinal flora in depressed mice.
Sai-Bo CAI ; Huan-Yu ZHOU ; Xin-Yu JI ; Qi-Lin ZHANG ; Xian-Yu DENG ; Feng WANG ; Yong-Hui LI ; Lian-Bing LIN
China Journal of Chinese Materia Medica 2021;46(16):4222-4229
		                        		
		                        			
		                        			Bupleuri Radix, serving as the sovereign medicinal in many antidepressant compound preparations, has been proved effective in treating depression in mice, but its effect on the intestinal flora remains unclear. The present study aimed to investigate the effects of Bupleurum chinense(one of the original materials of Bupleuri Radix) on the behaviors and the diversity of intestinal flora of depressed mice. A depression mouse model was induced by repeated social defeat stress. Specifically, C57 BL/6 J male mice were exposed to the attack from the CD-1 mice. Then, C57 BL/6 J male mice were divided into a depression group and a B. chinense group, with normal saline and B. chinense administered(ig) respectively. Sucrose preference test and tail suspension test were conducted during and after the experiment respectively, to analyze the effects of B. chinense on the behaviors of the depressed mice. The feces were collected after the experiment. The V3-V4 16 S rDNA regions of intestinal flora of mice in each group were sequenced by Ion S5 TMXL for the analysis of the number of operational taxonomic units(OTUs), richness, alpha and beta diversity indexes, and differential phyla and genera. The results indicated that B. chinense could decrease depressive-like behaviors of mice, increase sucrose preference, and shorten the time of immobility in tail suspension test. After B. chinense intervention, the relative abundance of Firmicutes was significantly decreased, while that of Bacteroidetes was increased at the phylum level. At the genus level, the relative abundance of Lactobacillus and Lachnoclostridium decreased(P<0.05), while that of Bacteroides, Alistopes, etc. was elevated(P<0.05). The findings demonstrate that B. chinense can regulate the intestinal flora and improve the depressive-like behaviors of mice with depression.
		                        		
		                        		
		                        		
		                        			Animals
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		                        			Bupleurum
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		                        			Feces
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		                        			Gastrointestinal Microbiome
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		                        			Lactobacillus
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		                        			Mice
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		                        			Mice, Inbred C57BL
		                        			
		                        		
		                        	
5.A multi-center retrospective study of perioperative chemotherapy for gastric cancer based on real-world data.
Xue Wei DING ; Zhi Chao ZHENG ; Qun ZHAO ; Gang ZHAI ; Han LIANG ; Xin WU ; Zheng Gang ZHU ; Hai Jiang WANG ; Qing Si HE ; Xian Li HE ; Yi An DU ; Lu Chuan CHEN ; Ya Wei HUA ; Chang Ming HUANG ; Ying Wei XUE ; Ye ZHOU ; Yan Bing ZHOU ; Dan WU ; Xue Dong FANG ; You Guo DAI ; Hong Wei ZHANG ; Jia Qing CAO ; Le Ping LI ; Jie CHAI ; Kai Xiong TAO ; Guo Li LI ; Zhi Gang JIE ; Jie GE ; Zhong Fa XU ; Wen Bin ZHANG ; Qi Yun LI ; Ping ZHAO ; Zhi Qiang MA ; Zhi Long YAN ; Guo Liang ZHENG ; Yang YAN ; Xiao Long TANG ; Xiang ZHOU
Chinese Journal of Gastrointestinal Surgery 2021;24(5):403-412
		                        		
		                        			
		                        			Objective: To explore the effect of perioperative chemotherapy on the prognosis of gastric cancer patients under real-world condition. Methods: A retrospective cohort study was carried out. Real world data of gastric cancer patients receiving perioperative chemotherapy and surgery + adjuvant chemotherapy in 33 domestic hospitals from January 1, 2014 to January 31, 2016 were collected. Inclusion criteria: (1) gastric adenocarcinoma was confirmed by histopathology, and clinical stage was cT2-4aN0-3M0 (AJCC 8th edition); (2) D2 radical gastric cancer surgery was performed; (3) at least one cycle of neoadjuvant chemotherapy (NAC) was completed; (4) at least 4 cycles of adjuvant chemotherapy (AC) [SOX (S-1+oxaliplatin) or CapeOX (capecitabine + oxaliplatin)] were completed. Exclusion criteria: (1) complicated with other malignant tumors; (2) radiotherapy received; (3) patients with incomplete data. The enrolled patients who received neoadjuvant chemotherapy and adjuvant chemotherapy were included in the perioperative chemotherapy group, and those who received only postoperative adjuvant chemotherapy were included in the surgery + adjuvant chemotherapy group. Propensity score matching (PSM) method was used to control selection bias. The primary outcome were overall survival (OS) and progression-free survival (PFS) after PSM. OS was defined as the time from the first neoadjuvant chemotherapy (operation + adjuvant chemotherapy group: from the date of operation) to the last effective follow-up or death. PFS was defined as the time from the first neoadjuvant chemotherapy (operation + adjuvant chemotherapy group: from the date of operation) to the first imaging diagnosis of tumor progression or death. The Kaplan-Meier method was used to estimate the survival rate, and the Cox proportional hazards model was used to evaluate the independent effect of perioperative chemo therapy on OS and PFS. Results: 2 045 cases were included, including 1 293 cases in the surgery+adjuvant chemotherapy group and 752 cases in the perioperative chemotherapy group. After PSM, 492 pairs were included in the analysis. There were no statistically significant differences in gender, age, body mass index, tumor stage before treatment, and tumor location between the two groups (all P>0.05). Compared with the surgery + adjuvant chemotherapy group, patients in the perioperative chemotherapy group had higher proportion of total gastrectomy (χ(2)=40.526, P<0.001), smaller maximum tumor diameter (t=3.969, P<0.001), less number of metastatic lymph nodes (t=1.343, P<0.001), lower ratio of vessel invasion (χ(2)=11.897, P=0.001) and nerve invasion (χ(2)=12.338, P<0.001). In the perioperative chemotherapy group and surgery + adjuvant chemotherapy group, 24 cases (4.9%) and 17 cases (3.4%) developed postoperative complications, respectively, and no significant difference was found between two groups (χ(2)=0.815, P=0.367). The median OS of the perioperative chemotherapy group was longer than that of the surgery + adjuvant chemotherapy group (65 months vs. 45 months, HR: 0.74, 95% CI: 0.62-0.89, P=0.001); the median PFS of the perioperative chemotherapy group was also longer than that of the surgery+adjuvant chemotherapy group (56 months vs. 36 months, HR=0.72, 95% CI:0.61-0.85, P<0.001). The forest plot results of subgroup analysis showed that both men and women could benefit from perioperative chemotherapy (all P<0.05); patients over 45 years of age (P<0.05) and with normal body mass (P<0.01) could benefit significantly; patients with cTNM stage II and III presented a trend of benefit or could benefit significantly (P<0.05); patients with signet ring cell carcinoma benefited little (P>0.05); tumors in the gastric body and gastric antrum benefited more significantly (P<0.05). Conclusion: Perioperative chemotherapy can improve the prognosis of gastric cancer patients.
		                        		
		                        		
		                        		
		                        			Chemotherapy, Adjuvant
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		                        			Female
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		                        			Gastrectomy
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		                        			Humans
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		                        			Male
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		                        			Neoadjuvant Therapy
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		                        			Neoplasm Staging
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		                        			Prognosis
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		                        			Retrospective Studies
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		                        			Stomach Neoplasms/surgery*
		                        			
		                        		
		                        	
6.Systematic Implementation of World Health Organization Family International Classifications in Rehabilitation: Protocol and Roadmap
Jing-yuan JIANG ; Zhuo-ying QIU ; Guo-xiang WANG ; Fu-bing QIU ; Jian YANG ; An-qiao LI ; Hong-zhuo MA ; Ting ZHU ; Mei WANG ; Hong-wei SUN ; Di CHEN ; Qiu-chen HUANG ; Jie-jiao ZHENG ; Ming-sheng ZHANG ; Xiu-e SHI ; Tao TANG ; Tao XU ; Ai-min ZHANG ; Xian-guang WU ; Qiao-yun LIU ; Xiao-fei XIAO ; Qi JING
Chinese Journal of Rehabilitation Theory and Practice 2020;26(11):1241-1255
		                        		
		                        			
		                        			Objective:To explore systematic implementation of World Health Organization Family International Classifications (WHO-FICs) in the field of rehabilitation: the theoretical and policy framework at macro level, governance and management mechanism at meso level, and implementation modules at micro levels, respectively. Methods:The policy and theoretical framework of rehabilitation development was discussed based on the international rehabilitation policy documents of WHO, mainly as World Report on Disability, Global Action Plan on Disability and Rehabilitation in Health Service System. Protocol and roadmap of systematic implementation of WHO-FICs, including International Classification of Diseases (ICD-11), International Classification of Functioning, Disability and Health (ICF), and International Classification of Health Intervention (ICHIβ-2) was proposed. Results:With the use of WHO-FICs, the theoretical and policy framework of rehabilitation was constructed, and the contents and principles of modern rehabilitation services were clarified at macro-level. Rehabilitation is an important part of health service, there are six building blocks: i.e. leadership and governance, financing, human resources for health, service providing, medical technology and health information system. It proposed to use knowledge management system of WHO-FICs, including the classification, nomenclature, definitions, descriptions, terminology and coding systems, to standardize rehabilitation evaluation and statistics. The management and governance system of rehabilitation should be implemented using WHO-FICs. Rehabilitation services are based on the bio-psycho-social model and implemented the principles of people-centered and functioning-oriented. The systematic implementation of WHO-FICs in rehabilitation abide by the model of "Evaluation (ICHI)-Evaluation, Description, Classification and Coding of Functioning (ICF)-Disease Classification, Diagnosis and Coding (ICD)-Rehabilitation Intervention (ICHI)", and with the standardized process of "Evaluation (Functioning and unmet needs)-Diagnose (Disease and Functioning)-Planning of Rehabilitation-Intervention-Evaluation of Outcome". The mic-modules of implementation of WHO-FICs in rehabilitation had been constructed. There were 28 categories of diseases, 7 categories of functioning and 6 categories of rehabilitation interventions in rehabilitation proposed by International Society of Physical and Rehabilitation Medicine. According to ICD-11 and ICF, it proposed to use WHO Disability Assessment Schedule 2.0 (WHODAS 2.0), Brief Model Disability Survey (MDS-B) and VB40 Generic Functioning Domains (VB40), and the ICF core-sets in evaluation of functioning and rehabilitation outcome. The implementation of WHO-FICs in management of medical records and reporting realized the standardized management of medical record, encoding of diseases, functioning and intervention, reporting of performance, and provided tools for billing, reimbursement and payment management of rehabilitation. It proposed to develop WHO-FICs based clinical data sets and big data to implement functioning-related Diagnosis Related Groups and case-mix statistics. Conclusion:With the systematic implementation of WHO-FICs in rehabilitation, the policy and theoretical framework at macro level had been developed. The mechanism of management and governance at meso level had been explored. The application modules and approaches at micro level had been established. A scientific and effective overall solution had been proposed to enhance the scientific, standardized, refined and informatization level, strengthen the level and governance capacity, and improve the quality, safety and the coverage of rehabilitation services.
		                        		
		                        		
		                        		
		                        	
7.Rules of acupoint selection and drug use in clinical treatment of hypertension with acupoint application therapy.
Ya-Qi HE ; Bing-Xue LIANG ; Wen-Yue FENG ; Shao-Xiang XIAN
Chinese Acupuncture & Moxibustion 2020;40(5):565-569
		                        		
		                        			OBJECTIVE:
		                        			To explore the rules of acupoint selection and drug use in treatment of hypertension with acupoint application therapy.
		                        		
		                        			METHODS:
		                        			The articles of the clinical research of hypertension treated with acupoint application therapy were retrieved from Chinese journal full-text database (CNKI), VIP database (VIP) and Wanfang databases from the time of establishment to January 20, 2019. The database was set up with Microsoft Excel 2010. Using the cloud platform of the ancient and modern medicine record, the frequency statistical and clustering analyses were conducted.
		                        		
		                        			RESULTS:
		                        			A total of 117 articles were collected, including 191 prescriptions, 60 aucpoints and 236 kinds of herbal drugs. It was found in the frequency statistical analysis that the top 6 acupoints in use frequency were Yongquan (KI 1), Quchi (LI 11), Taichong (LR 3), Shenque (CV 8), Sanyinjiao (SP 6) and Neiguan (PC 6). According to the correlation analysis, corresponding to these top 6 acupoints, the pairs of acupoints were Sanyinjiao (SP 6) and Yongquan (KI 1), Shenque (CV 8) and Yongquan (KI 1), Neiguan (PC 6) and Yongquan (KI 1), Zusanli (ST 36) and Sanyinjiao (SP 6), Sanyinjiao (SP 6) and Neiguan (PC 6) with Yongquan (KI 1), as well as Yongquan (KI 1) and Neiguan (PC 6) with Sanyinjiao (SP 6). The dominant meridians were the kidney meridian, the conception vessel and the bladder meridian. The special acupoints referred to -source point, -connecting point, back- point and front- point. The top 3 herbal drugs in use frequency included , and . The herbs used were mainly warm and slight cold in nature and neutral in property. The frequencies of the drug use were similar in the application for cold and heat purposes. The common flavors of the herbal medicines were pungent, sweat and bitter and the liver, kidney and spleen meridians were generally involved in meridian tropism.
		                        		
		                        			CONCLUSION
		                        			In treatment of hypertension with acupoint application therapy, the commonly used single acupoint is Yongquan (KI 1), which is generally combined with Sanyinjiao (SP 6), Shenque (CV 8), Neiguan (PC 6) and Zusanli (ST 36). The correlation is emphasized on the application of special acupoints, meridian points and organs. The vesicatory herbal drugs are predominant in the drug use. In generally, this therapy embodies the treatment principles as tonifying for the deficiency and reducing for the excess, as well as balancing of cold and heat.
		                        		
		                        		
		                        		
		                        			Acupuncture Points
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		                        			Acupuncture Therapy
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		                        			Humans
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		                        			Hypertension
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		                        			therapy
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		                        			Meridians
		                        			
		                        		
		                        	
8.Quality Control of Dynamic Volatile Components in Lonicerae Japonicae Flos and Lonicerae Flos
Hai-ying LI ; Qi-meng FAN ; Yu-ting HE ; Peng HE ; Min-cun WANG ; Run-nan LIU ; Zhuo ZHOU ; Xue-bing QIAN ; Xian-ping ZENG ; Mei-feng XIAO ; Fu-yuan HE
Chinese Journal of Experimental Traditional Medical Formulae 2020;26(22):148-155
		                        		
		                        			
		                        			Objective:The molecular connectivity index method and total statistical moment method were used to control the quality of traditional Chinese medicine (TCM), and the stability and consistency of volatile components of Lonicerae Japonicae Flos and Lonicerae Flos were clarified. Method:Volatile oils in Lonicerae Japonicae Flos and Lonicerae Flos from different producing areas was extracted for GC-MS determination with electron bombardment ion source, ion source temperature of 230 ℃, and detection range of 
		                        		
		                        	
9.MGST1 overexpression promotes hepatocellular carcinoma development
Pei CAI ; Fu-Qiang HUANG ; Qi ZHAO ; Xian ZHOU ; Hua-Yu YANG ; Yi-Lei MAO ; Hong-Bing ZHANG
Basic & Clinical Medicine 2018;38(7):950-956
		                        		
		                        			
		                        			Objective To investigate the expression of microsomal glutathione S-transferase 1 ( MGST1) in hepa-tocellular carcinoma ( HCC) and its significance in the development of HCC. Methods Western blot was used to measure MGST1 expression in human hepatocellular carcinoma and adjacent tissues and HCC cell lines. Further-more, shRNA targeting MGST1 was constructed and transected into MHCC97H and HCCLM3 cells to deplete MGST1 expression. MGST1 was over-expressed in SK-Hep-1 cells using pCDH lentivirus system. Cell proliferation and migration were analyzed by colony formation and Transwell migration assay, respectively. The subcutaneous xenograft model of MHCC97H cells in nude mice was established to check tumor development and mouse survival.Results MGST1 was higher in 71% (17/24) of HCC tissues compared with their adjacent liver tissues. Cell proliferation and migration were significantly decreased by MGST1 knockdown, while they were increased by MGST1 overexpression. Furthermore, mice implanted with shMGST1 MHCC97H cells exhibited retarded tumor formation and tumor progression compared with control group. Conclusions MGST1 overexpression promotes hepatocellular carcinoma development and this molecule targeted for HCC treatment.
		                        		
		                        		
		                        		
		                        	
10.Chinese Herbal Medicine Combined with Entecavir for HBeAg Positive Chronic Hepatitis B: Study Protocol for a Multi-Center, Double-Blind Randomized-Controlled Trial.
Yong-An YE ; Xiao-Ke LI ; Da-Qiao ZHOU ; Xiao-Ling CHI ; Qin LI ; Li WANG ; Bing-Jiu LU ; De-Wen MAO ; Qi-Kai WU ; Xian-Bo WANG ; Ming-Xiang ZHANG ; Jing-Dong XUE ; Yong LI ; Wei LU ; Jian-Chun GUO ; Feng JIANG ; Xin-Wei ZHANG ; Hong-Bo DU ; Xian-Zhao YANG ; Hui GUO ; Da-Nan GAN ; Zhi-Guo LI
Chinese journal of integrative medicine 2018;24(9):653-660
BACKGROUNDThe domestic prevalence of chronic hepatitis B (CHB) in China is 7.18% in 2006, imposing great societal healthcare burdens. Nucleot(s)ide analogues (NUCs) anti-hepatitis B virus (HBV) therapies are widely applied despite the relatively low rate of seroconversion and high risk of drug-resistant mutation. More effective treatments for CHB deserve further explorations. Combined therapy of NUCs plus Chinese herbal medicine (CHM) is widely accepted in China, which is recognized as a prospective alternative approach. The study was primarily designed to confirm the hypothesis that Tiaogan-Yipi Granule (, TGYP) or Tiaogan-Jianpi-Jiedu Granule (, TGJPJD) plus entecavir tablet (ETV) was superior over ETV monotherapy in enhancing HBeAg loss rate.
METHODSThe study was a nationwide, large-scale, multi-center, double-blind, randomized, placebo-controlled trial with a designed duration of 108 weeks. A total of 16 hospitals and 596 eligible Chinese HBeAg positive CHB patients were enrolled from November 2012 to September 2013 and randomly allocated into 2 groups in 1:1 ratio via central randomization system: experimental group (EG) and control group (CG). Subjects in EG received CM formulae (TGYP or TGJPJD, 50 g per dose, twice daily) plus ETV tablet (or ETV placebo) 0.5 mg per day in the first 24 weeks (stage 1), and CHM granule plus ETV tablet (0.5 mg per day) from week 25 to 108 (stage 2). Subjects in CG received CHM Granule placebo plus ETV tablet (0.5 mg per day) for 108 weeks throughout the trial. The assessments of primary outcomes (HBV serum markers and HBV-DNA) were conducted by a third-party College of American Pathologists (CAP) qualified laboratory. Adverse effects were observed in the hospitals of recruitment.
DISCUSSIONThe study was designed to compare the curative effect of CM plus ETV and ETV monotherapy in respect of HBeAg loss, which is recognized by the European Association for the Study of the Liver as "a valuable endpoint". We believe this trial could provide a reliable status for patients' "journey" towards durable responses after treatment discontinuation. The trial was registered before recruitment on Chinese Clinical trial registry (No. ChiCTR-TRC-12002784, Version 1.0, 2015/12/23).
            
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