1.Prevalence of chronic kidney disease and its association with lifestyle factors in adults from 10 regions of China.
Xue WANG ; Ke Xiang SHI ; Can Qing YU ; Jun LYU ; Yu GUO ; Pei PEI ; Qing Mei XIA ; Huai Dong DU ; Jun Shi CHEN ; Zheng Ming CHEN ; Li Ming LI
Chinese Journal of Epidemiology 2023;44(3):386-392
Objective: To investigate the distribution of chronic kidney disease (CKD) in participants from the China Kadoorie Biobank (CKB) study and evaluate the association between lifestyle risk factors and CKD. Methods: Based on the baseline survey data and follow-up data (as of December 31, 2018) of the CKB study, the differences in CKD cases' area and population distributions were described. Cox proportional hazards regression model was used to estimate the association between lifestyle risk factors and the risk of CKD. Results: A total of 505 147 participants, 4 920 cases of CKD were recorded in 11.26 year follow up with a incidence rate of 83.43/100 000 person-years. Glomerulonephropathy was the most common type. The incidence of CKD was higher in the urban area, men, and the elderly aged 60 years and above (87.83/100 000 person-years, 86.37/100 000 person-years, and 132.06/100 000 person-years). Current male smokers had an increased risk for CKD compared with non-smokers or occasional smokers (HR=1.18, 95%CI: 1.05-1.31). The non-obese population was used as a control group, both general obesity determined by BMI (HR=1.19, 95%CI: 1.10-1.29) and central obesity determined by waist circumference (HR=1.27, 95%CI: 1.19-1.35) were associated with higher risk for CKD. Conclusion: The risks for CKD varied with area and population in the CKB cohort study, and the risk was influenced by multiple lifestyle factors.
Aged
;
Adult
;
Humans
;
Male
;
Cohort Studies
;
Prevalence
;
Prospective Studies
;
Risk Factors
;
Obesity/epidemiology*
;
Renal Insufficiency, Chronic/epidemiology*
;
China/epidemiology*
;
Life Style
;
Body Mass Index
2.Chinese expert consensus on emergency surgery for severe trauma and infection prevention during corona virus disease 2019 epidemic (version 2023)
Yang LI ; Yuchang WANG ; Haiwen PENG ; Xijie DONG ; Guodong LIU ; Wei WANG ; Hong YAN ; Fan YANG ; Ding LIU ; Huidan JING ; Yu XIE ; Manli TANG ; Xian CHEN ; Wei GAO ; Qingshan GUO ; Zhaohui TANG ; Hao TANG ; Bingling HE ; Qingxiang MAO ; Zhen WANG ; Xiangjun BAI ; Daqing CHEN ; Haiming CHEN ; Min DAO ; Dingyuan DU ; Haoyu FENG ; Ke FENG ; Xiang GAO ; Wubing HE ; Peiyang HU ; Xi HU ; Gang HUANG ; Guangbin HUANG ; Wei JIANG ; Hongxu JIN ; Laifa KONG ; He LI ; Lianxin LI ; Xiangmin LI ; Xinzhi LI ; Yifei LI ; Zilong LI ; Huimin LIU ; Changjian LIU ; Xiaogang MA ; Chunqiu PAN ; Xiaohua PAN ; Lei PENG ; Jifu QU ; Qiangui REN ; Xiguang SANG ; Biao SHAO ; Yin SHEN ; Mingwei SUN ; Fang WANG ; Juan WANG ; Jun WANG ; Wenlou WANG ; Zhihua WANG ; Xu WU ; Renju XIAO ; Yang XIE ; Feng XU ; Xinwen YANG ; Yuetao YANG ; Yongkun YAO ; Changlin YIN ; Yigang YU ; Ke ZHANG ; Xingwen ZHANG ; Guixi ZHANG ; Gang ZHAO ; Xiaogang ZHAO ; Xiaosong ZHU ; Yan′an ZHU ; Changju ZHU ; Zhanfei LI ; Lianyang ZHANG
Chinese Journal of Trauma 2023;39(2):97-106
During coronavirus disease 2019 epidemic, the treatment of severe trauma has been impacted. The Consensus on emergency surgery and infection prevention and control for severe trauma patients with 2019 novel corona virus pneumonia was published online on February 12, 2020, providing a strong guidance for the emergency treatment of severe trauma and the self-protection of medical staffs in the early stage of the epidemic. With the Joint Prevention and Control Mechanism of the State Council renaming "novel coronavirus pneumonia" to "novel coronavirus infection" and the infection being managed with measures against class B infectious diseases since January 8, 2023, the consensus published in 2020 is no longer applicable to the emergency treatment of severe trauma in the new stage of epidemic prevention and control. In this context, led by the Chinese Traumatology Association, Chinese Trauma Surgeon Association, Trauma Medicine Branch of Chinese International Exchange and Promotive Association for Medical and Health Care, and Editorial Board of Chinese Journal of Traumatology, the Chinese expert consensus on emergency surgery for severe trauma and infection prevention during coronavirus disease 2019 epidemic ( version 2023) is formulated to ensure the effectiveness and safety in the treatment of severe trauma in the new stage. Based on the policy of the Joint Prevention and Control Mechanism of the State Council and by using evidence-based medical evidence as well as Delphi expert consultation and voting, 16 recommendations are put forward from the four aspects of the related definitions, infection prevention, preoperative assessment and preparation, emergency operation and postoperative management, hoping to provide a reference for severe trauma care in the new stage of the epidemic prevention and control.
3.Effects of Cytokines on Early Death in Patients with Newly Diagnosed Acute Promyelocytic Leukemia.
Shi-Xiang ZHAO ; Yuan-Yuan GE ; Zeng-Zheng LI ; Hai-Ping HE ; Cheng-Min SHEN ; Ke-Qian SHI ; Tong-Hua YANG ; Yun-Yun DU
Journal of Experimental Hematology 2023;31(5):1315-1321
OBJECTIVE:
To explore the effect of cytokine levels on early death and coagulation function of patients with newly diagnosed acute promyelocytic leukemia (APL).
METHODS:
Routine examination was performed on 69 newly diagnosed APL patients at admission. Meanwhile, 4 ml fasting venous blood was extracted from the patients. And then the supernatant was taken after centrifugation. The concentrations of cytokines, lactate dehydrogenase (LDH) and ferritin were detected by using the corresponding kits.
RESULTS:
It was confirmed that cerebral hemorrhage was a major cause of early death in APL patients. Elevated LDH, decreased platelets (PLT) count and prolonged prothrombin time (PT) were high risk factors for early death (P <0.05). The increases of IL-5, IL-6, IL-10, IL-12p70 and IL-17A were closely related to the early death of newly diagnosed APL patients, and the increases of IL-5 and IL-17A also induced coagulation disorder in APL patients by prolonging PT (P <0.05). In newly diagnosed APL patients, ferritin and LDH showed a positive effect on the expression of IL-5, IL-10 and IL-17A, especially ferritin had a highly positive correlation with IL-5 (r =0.867) and IL-17A (r =0.841). Moreover, there was a certain correlation between these five high-risk cytokines, among which IL-5 and IL-17A (r =0.827), IL-6 and IL-10 (r =0.823) were highly positively correlated.
CONCLUSION
Elevated cytokine levels in newly diagnosed APL patients increase the risk of early bleeding and death. In addition to the interaction between cytokines themselves, ferritin and LDH positively affect the expression of cytokines, thus affecting the prognosis of APL patients.
Humans
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Leukemia, Promyelocytic, Acute/diagnosis*
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Cytokines/metabolism*
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Interleukin-10
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Interleukin-17/metabolism*
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Interleukin-6/metabolism*
;
Interleukin-5/metabolism*
;
Blood Coagulation Disorders
;
Ferritins
;
Tretinoin
4.Correlation between children and adolescents behavioral habits and the occurrence of myopia in Qamdo
Chinese Journal of School Health 2022;43(3):328-332
Objective:
To investigate the current status of myopia in children and adolescents in Qamdo, Tibet, and analyze related influencing factors, so as to provide a basis for the prevention and control of adolescents in plateau areas.
Methods:
A cross sectional study was conducted among 959 children and adolescents randomly selected from one district and two counties in Qamdo (from the fourth grade of elementary school to the second grade of high school) for visual acuity and refraction tests and filled out a vision related behavior questionnaire to analyze the incidence of myopia among adolescents in the region and its associated factors.
Results:
The myopia rate of adolescents in grades 4-11 was 54.43%, the rate of undercorrection of refractive errors was 85.25%, and the percentage of students wearing eyeglasses was 34.67%,fully vision correction rate was 42.54%. The myopia rate of students in grades 4-6 was 35.14%, 64.71% in grades 7-9, and 73.48% in grades 10-11. The myopia rate increased with grades( χ 2= 101.18 , P <0.01). The myopia rate (70.40%) of urban students (grades 4-9) was higher than that of county level(41.45%), and the myopia rate of students with myopia from either parent (68.24%) was higher than that of students without myopia (51.91%) , the myopia rate of girls (59.96%) was higher than that of boys (48.36%)( χ 2=53.19,13.46,12.98, P <0.01). Use electronic products for more than 2.5 hours per day, electronic devices usage after bedtime, the light low indoor brightness when studying on a sunny day, and only use one of the table lamps or roof lights when studying at night, preference for fried food, poor sleep quality, in the morning the students who still feel tired are at higher risk of myopia( χ 2=10.35, 10.91, 6.87, 4.25, 4.97, 5.71, 12.11, P < 0.05). Multivariate regression analysis showed that the occurrence of myopia was related to region, grade, gender, parental myopia, time spent on electronic products every day in the past 5 months, and sleep quality( P <0.05).
Conclusion
The high rate of myopia in children and adolescents in Qamdo may be related to the quality of sleep, the length of time electronic products are used, the eye environment, and the frequency of eating fried foods. Outdoor activities do not show significant differences.
5. Exercise Enhances SIRT1 Expression and Improves Alzheimer’s Disease
Ke CHEN ; Xiang-Liang ZHANG ; Li-Tao DU
Chinese Journal of Biochemistry and Molecular Biology 2022;38(5):563-569
Alzheimer’s disease (AD) is a neurodegenerative disease, β-amyloid (Aβ) deposition and Tau protein hyperphosphorylation are the main pathological features. Silent mating-type information regulation 2 homolog 1 (SIRT1) can deacetylate various types of histones and non-histones, and play an important role in the pathogenesis of AD. Recent studies found that exercise can activate SIRT1 to delay the progression of AD. The mechanisms may be as follows: inhibit the activity of β-secretase and increase the activity of α-secretase to reduce the production of Aβ; reduce the accumulation of hyperphosphorylated Tau protein; interact with PGC-1α to promote mitochondrial biogenesis; up-regulate PINK1/ Parkin signaling pathway to improve mitochondrial autophagy; and deacetylate NF-κB to inhibit neuroinflammation. In addition, the protein levels of brain-derived neurotrophic factor (BDNF) and glial cell line-derived neurotrophic factor (GDNF) in hippocampus are increased, and ApoE4 gene is inhibited to enhance synaptic plasticity. This article summarizes the role and mechanisms of exercise in improving AD by regulating SIRT1, and provides new ideas for the prevention and treatment of AD.
6.Bendamustine treatment of Chinese patients with relapsed indolent non-Hodgkin lymphoma: a multicenter, open-label, single-arm, phase 3 study.
Yuan-Kai SHI ; Xiao-Nan HONG ; Jian-Liang YANG ; Wei XU ; Hui-Qiang HUANG ; Xiu-Bin XIAO ; Jun ZHU ; Dao-Bin ZHOU ; Xiao-Hong HAN ; Jian-Qiu WU ; Ming-Zhi ZHANG ; Jie JIN ; Xiao-Yan KE ; Wei LI ; De-Pei WU ; Shen-Miao YANG ; Xin DU ; Yong-Qian JIA ; Ai-Chun LIU ; Dai-Hong LIU ; Zhi-Xiang SHEN ; Lian-Sheng ZHANG ; Leonard JAMES ; Edward HELLRIEGEL
Chinese Medical Journal 2021;134(11):1299-1309
BACKGROUND:
Bendamustine was approved in China on May 26th, 2019 by the National Medical Product Administration for the treatment of indolent B-cell non-Hodgkin lymphoma (NHL). The current study was the registration trial and the first reported evaluation of the efficacy, safety, and pharmacokinetics of bendamustine in Chinese adult patients with indolent B-cell NHL following relapse after chemotherapy and rituximab treatment.
METHODS:
This was a prospective, multicenter, open-label, single-arm, phase 3 study (NCT01596621; C18083/3076) with a 2-year follow-up period. Eligible patients received bendamustine hydrochloride 120 mg/m2 infused intravenously on days 1 and 2 of each 21-day treatment cycle for at least six planned cycles (and up to eight cycles). The primary endpoint was the overall response rate (ORR); and secondary endpoints were duration of response (DoR), progression-free survival (PFS), safety, and pharmacokinetics. Patients were classified according to their best overall response after initiation of therapy. Proportions of patients in each response category (complete response [CR], partial response [PR], stable disease, or progressive disease) were summarized along with a two-sided binomial exact 95% confidence intervals (CIs) for the ORR.
RESULTS:
A total of 102 patients were enrolled from 20 centers between August 6th, 2012, and June 18th, 2015. At the time of the primary analysis, the ORR was 73% (95% CI: 63%-81%) per Independent Review Committee (IRC) including 19% CR and 54% PR. With the follow-up period, the median DoR was 16.2 months by IRC and 13.4 months by investigator assessment; the median PFS was 18.6 months and 15.3 months, respectively. The most common non-hematologic adverse events (AEs) were gastrointestinal toxicity, pyrexia, and rash. Grade 3/4 neutropenia was reported in 76% of patients. Serious AEs were reported in 29 patients and five patients died during the study. Pharmacokinetic analysis indicated that the characteristics of bendamustine and its metabolites M3 and M4 were generally consistent with those reported for other ethnicities.
CONCLUSION:
Bendamustine is an active and effective therapy in Chinese patients with relapsed, indolent B-cell NHL, with a comparable risk/benefit relationship to that reported in North American patients.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, No. NCT01596621; https://clinicaltrials.gov/ct2/show/NCT01596621.
Adult
;
Antineoplastic Combined Chemotherapy Protocols
;
Bendamustine Hydrochloride/therapeutic use*
;
China
;
Humans
;
Lymphoma, Non-Hodgkin/drug therapy*
;
Neoplasm Recurrence, Local/drug therapy*
;
Prospective Studies
;
Rituximab/therapeutic use*
7.Establishment of fingerprint of Astragali Radix polysaccharides based on endo-1,4-β-mannanase hydrolysis and identification of Astragali Radix of different germplasm resources.
Di WANG ; Ke LI ; Gui-Zhen WANG ; Zhen-Yu LI ; Xue-Mei QIN ; Guan-Hua DU ; Xiang ZHANG
China Journal of Chinese Materia Medica 2018;43(14):2964-2972
The polysaccharides of different germplasm resources of Astragalus membranaceus var. mongholicus〓(cultured Astragalus Radix (RA) and natural RA) and A. membranaceus (MJ) (cultured RA and natural RA) were studied by using the optimal enzymatic conditions of endo-1,4-β-mannanase. Saccharide fingerprints were obtained for the identification and evaluation of the germplasm resources of RA by Fluorophore-assisted Carbohydrate Electrophoresis (FACE). The data were analyzed by principal component analysis to obtain the difference between RA of different germplasm resources. The results showed that trisaccharide, tetrasaccharide and pentasaccharide of endo-1,4-β-mannanase hydrolyzate could be used as the differential fragments to distinguish MG (cultured RA and natural RA); the pentasaccharide and hexasaccharide can be used as differentially expressed carbohydrate fragments that distinguish MJ (cultured RA and natural RA); the trisaccharide and tetrasaccharide can be used as the differential fragments to distinguish the cultured MG and cultured MJ. Studies have shown that polysaccharide products degraded by endo-1,4-β-mannanase can well distinguish RA species (MG and MJ), growth mode (cultured RA and natural RA). This study laid the foundation for the quality evaluation of Astragalus medicinal herbs and screening of active oligosaccharides.
8.New situation and new strategies——research and development and internationalization of new drugs and health products of traditional Chinese medicine
Ning JIANG ; Chun-Hui QI ; Liang CAO ; Lan-Ying CHEN ; Jin-Hui GU ; Yong KANG ; Inkyeom KIM ; Xiao-Yuan LIAN ; Yin LU ; Gui-Yuan LYU ; Ke NIE ; Yun QI ; SCHINI-KERTH VALÉRIE ; SPEDDING MICHAEL ; WAINWRIGHT CHERRY ; Yue-Hua WANG ; Wei XIAO ; Yong YANG ; Lin-Zhong YU ; Dan-Shen ZHANG ; Yong-He ZHANG ; Wen-Xia ZHOU ; Guan-Hua DU ; Yong-Xiang ZHANG
Chinese Journal of Pharmacology and Toxicology 2018;32(1):1-50
The 2017 China (Lianyungang) International Medical Technology Conference was held in Lianyungang,Jiangsu Province during November 15-17,2017.During this conference,the Division for Traditional Chinese Medicine and Natural Products Pharmacology of Chinese Pharmacological Society (CNPHARS) and Jiangsu Kanion Pharmaceutical Co. Ltd.jointly held the Forum on R&D and Interna-tionalization of New Drugs and Health Products of Traditional Chinese Medicine.The forum was co-chaired by Professor ZHANG Yong-xiang, President of CNPHARS, Chair of Division for Traditional Chinese Medicine and Natural Products Pharmacology of CNPHARS,and Chair of the Natural Product Section of Inter-national Union of Basic&Clinical Pharmacology(IUPHAR), Professor DU Guan-hua,former President of CNPHARS and Vice-Chair of Division for Traditional Chinese Medicine and Natural Products Pharmacology of CNPHARS,and Dr.XIAO Wei,Chairman of the Board of Jiangsu Kanion Pharmaceutical Co. Ltd. And Vice-Chair of Division for Traditional Chinese Medicine and Natural Products Pharmacology of CNPHARS. More than 70 scholars attended the forum, including four foreign experts [Michael SPEDDING, Secretary-General of IUPHAR; Professor Valérie B. SCHINI-KERTH, Vice-Chair of the Natural Product Section of IUPHAR; Professor Cherry WAINWRGHT, Director of Centre for Natural Product Drugs of Robert Gordon University; Professor InKyeom KIM, Director of the Korean Society of Pharmacology], members of the Division for Traditional Chinese Medicine and Natural Products Pharmacology of CNPHARS and leading researchers at Jiangsu Kanion Pharmaceutical Co.,Ltd.GU Jin-hui,Director of the Division of National Science and Technology Major Project for Drug Innovation,Department of Health Science,Technology and Education,National Health and Family Planning Commission of the People's Republic of China was also invited to attend the forum. Representatives discussed the R&D and internationalization of new drugs and health products of traditional Chinese medicine.The summary of views and advice of some experts was published here for the purpose of promoting domestic and overseas academic exchange, and playing an active role in improving the level of R&D and internationalization of new drugs and health products of traditional Chinese medicine in China.
9.Feasibility and preliminary technical experience of single incision plus one port laparoscopic total gastrectomy combined with π-shaped esophagojejunal anastomosis in surgical treatment of gastric cancer.
Guangsheng DU ; Enlai JIANG ; Yuan QIU ; Wensheng WANG ; Shuai WANG ; Yunbo LI ; Ke PENG ; Xiang LI ; Hua YANG ; Weidong XIAO
Chinese Journal of Gastrointestinal Surgery 2018;21(5):556-563
OBJECTIVETo explore the feasibility, safety, and preliminary technical experience of single incision plus one port laparoscopic total gastrectomy combined with π-shaped esophagojejunal anastomosis (SILT-π) in the surgical treatment of gastric cancer.
METHODSClinical data of 5 gastric cancer patients undergoing SILT-π operation at the Department of General Surgery, The Second Affiliated Hospital of the Army Medical University from August to October 2017 were retrospectively analyzed. A 2.5-3.0 cm incision around the umbilicus was made for placing the gloveport as the passage for the lens, and the instruments of the surgeon and the assistant. Another operative port was placed in the left upper quadrant with a 12-mm Trocar for the passage of the energy device, the endoscopic cutting closure, as well as the postoperative drainage tube. A D2 lymph node (LNs) dissection was regularly conducted. After the abdominal esophagus was routinely mobilized, a side-to-side esophagus-jejunum anastomosis was made through a gastric pre-pulling esophagojejunal π-shaped anastomosis. The transection was then performed with a ligation on the cardia (or esophagus above the upper margin of the tumor) using a sterilized hemp rope in order to better expose the abdominal esophagus. Throughout the course of reconstruction, the ligature rope was held by the assistant to hold down the esophagus to allow easier esophagojejunal anastomosis. A hole was then made on the posterior wall of the esophagus, between 2 cm and 3 cm above the ligature rope, and another hole was made at the anti-mesenteric border of the jejunum 40 cm distal to the Treitz ligament. A side-to-side esophagojejunal π-shaped anastomosis was performed through two holes. An entry hole was formed after the anastomosis. After checking the anastomosis, this entry hole was closed through an intestinal mesenteric hole pre-made on its opposite side. The resected esophagus and stomach, together with the afferent loop jejunum, were simultaneously transected above the level of the entry hole by a stapler from the Trocar of the left upper abdominal quadrant. After the gloveport was closed, a side-to-side jejunojejunostomy anastomosis applied with another two staples was performed between the afferent loop stump and the roux limb 30 cm below the esophagojejunal anastomosis.
RESULTSThese five patients were all male, and aged (56.8±8.2) years with preoperative clinical stage cT2-4N0-2M0. All the 5 patients underwent SILT-π operation successfully. The average length of surgical incision was (2.9±0.2) cm. The average operation time was (396.0±36.1) minutes. The intraoperative blood loss was (140.0±66.7) ml. Postoperative pathology showed proximal and distal margins were (2.6±1.1) cm and (8.7±2.5) cm apart respectively, and the average number of retrieved lymph node was 25.8±7.2. Perioperative management was based on enhanced recovery following surgical (ERAS) principles. The average time to the first flatus was (2.6±0.5) days, and the average time to defecation was (3.6±0.5) days. The pain score on postoperative day 1 was 1-2, and the average postoperative hospital stay was (7.0±0.7) days. No perioperative complications occurred.
CONCLUSIONSSILT-π procedure is safe and feasible for patients with gastric cancer, and has positive short-term outcomes, satisfactory cosmetic abdominal incision, light postoperative abdominal pain and rapid postoperative recovery. Preliminary observations show that SILT-π procedure has good potential for clinical application in future.
Aged ; Anastomosis, Surgical ; Esophagus ; surgery ; Gastrectomy ; methods ; Humans ; Jejunum ; surgery ; Laparoscopy ; Male ; Middle Aged ; Retrospective Studies ; Stomach Neoplasms ; surgery
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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