1.Mechanism of Bushen Gutai Mixture on Improving Uterine Decidual Tissue and Spiral Artery Blood Supply of Abortion Model Rats by Regulating PKA/CREB/AQP5 Pathway
Yujuan GAN ; Yingchun ZHANG ; Min XIAO ; Jiawen LIU ; Hejing LIU ; Qin PAN ; Yaoyao XU
World Science and Technology-Modernization of Traditional Chinese Medicine 2023;25(8):2792-2799
Objective To observe the effect of Bushen Gutai mixture on uterine blood supply of rat model of abortion induced by hydroxyurea tablets combined with mifepristone through PKA-CREB signal pathway and its mechanism of calming fetus.Methods 60 pregnant rats of SPF grade SD rats were prepared by closing cages at 2∶1.According to the order of pregnancy,60 pregnant rats were randomly divided into 6 groups with 10 rats in each group:Bushen Gutai mixture group(low,middle and high dose),normal pregnancy group,model group and Di qu progesterone group.On the 1st to 9th day of pregnancy,except the normal group,the pregnant rats in each group were gavaged with hydroxyurea tablets at 5∶00 pm every day(450 mg·kg-1),and at 10∶00 am on the 10th day of pregnancy.Mifepristone tablets were given by intragastric administration(4.0 mg·kg-1).At 9∶00 am every day from the 1st to 9th day of pregnancy,Bushen Gutai mixture was given to the low,middle and high dose groups(0.5,1.0,2.0 g·kg-1),didrone group(3.02 mg·kg-1),model group and normal pregnancy group with 0.9%normal saline.24 hours after the last administration of pentobarbital sodium(50 mg kg-1),all pregnant rats were killed by intraperitoneal injection of pentobarbital sodium,and the uterine decidual tissue of pregnant rats was bluntly isolated in sterile environment.Hematoxylin-eosin(HE)staining was used to observe the lumen diameter and wall thickness of spiral artery in uterine decidual tissue.Immunohistochemical staining(IHC)was used to detect the expression of vascular endothelial growth factor(VEGF)in decidual tissues.Western blot was used to detect the protein expression of phosphorylated protein kinase A,protein kinase A,phosphorylated cyclic adenosine monophosphate response element binding protein,Cyclic Adenosine monophosphate response element binding protein and aquaporin 5 in the decidua of pregnant rats.The apoptosis of decidual cells was detected by in situ end labeling(TUNEL)of DNA fragmentation.Results Compared with the model group,the wall thickness of spiral artery was higher than that in other groups(P<0.05),the lumen diameter was lower than that in other groups(P<0.05)and the expression of VEGF protein was lower than that of other groups(P<0.01).Compared with the model group,the apoptosis level of decidual cells in uterine decidua of abortive rats in high,middle and low dose groups of Bushen Gutai mixture and diqu progesterone group decreased in varying degrees.Bushen Gutai mixture can up-regulate the levels of p-PKA/PKA and p-CREB/CREB in uterine decidua(P<0.01)and promote the expression of AQP5 protein in uterine decidua of abortion rats(P<0.01).Conclusion Bushen Gutai mixture can improve uterine blood supply of aborted rats by activating PKA and CREB phosphorylation,up-regulating AQP5 expression,promoting physiological recasting of spiral artery and high expression of Vascular endothelial growth factor.
2.Effectiveness of Zhenqi Buxue Oral Liquid Combined with Progesterone for Treatment of Oligomenorrhea and Hypomenorrhea with Qi-Blood and Kidney (Shen) Essence Deficiency: A Randomized Controlled Trial.
Jing-Wen GAN ; De-Xin LV ; Jin FU ; Liang-Yan SHI ; Chun-Yan YUAN ; Xiao-Qin ZENG ; Jun LI ; Ai-Jun SUN
Chinese journal of integrative medicine 2023;29(11):963-970
OBJECTIVE:
To evaluate the effectiveness and safety of Zhenqi Buxue Oral Liquid (ZQ), progesterone capsules, and their combination in treating oligomenorrhea and hypomenorrhea with qi-blood and Kidney (Shen) essence deficiency.
METHODS:
This was a prospective, randomized, multi-center controlled trial between June 2022 to December 2022. Ninety-six oligomenorrhea and hypomenorrhea patients with qi-blood and Shen essence deficiency were randomly assigned to receive ZQ (ZQ group, 29 cases), progesterone capsules (PG group, 32 cases), or the combined Chinese and Western medicine (COM group, 31 cases) at a ratio of 1:1:1. Patients in the ZQ or PG group took daily 10 mL twice a day of ZQ or 200 mg once a day of progesterone capsules for 10 consecutive days on day 15 of the menstrual cycle respectively, and patients in the COM group received the same ZQ combined with progesterone capsules. The treatment course lasted for 3 months and follow-up was performed at 1 and 3 months after the end of treatment. Primary endpoint was the menstrual Traditional Chinese Medicine Syndrome Scale (TCMSS) scores. Secondary endpoints included pictorial blood loss assessment chart (PBAC) scores, clinical efficacy rate, 36-item Short Form Health Survey (SF-36) scores, sex hormones and thickness of endometrium. Adverse events (AEs) were recorded.
RESULTS:
TCMSS scores after 1- and 3-month treatment in all groups were significantly lower than those at baseline (P<0.05). Only TCMSS scores after 3-month treatment in the ZQ and COM groups continuously decreased compared with those after 1-month treatment in the same group (P<0.01). TCMSS scores after 3-month treatment in the ZQ and COM groups were significantly lower than those in the PG group (P<0.05, P<0.01). Compared with baseline, PBAC scores in the ZQ and COM groups after 3 months of treatment were also significantly higher (both P<0.01). The total effective rates of TCM syndrome of 3-month treatment were significantly improved in all groups compared with that after 1 month of treatment (P<0.05). The total effective rate of the COM group was the highest in the 3rd month of treatment and significantly higher than that of PG group alone (P<0.05). Compared with baseline, only the SF-36 scores of COM group were significantly improved after 3 months of treatment (P<0.05). No serious adverse reactions were observed after treatment.
CONCLUSIONS
The combination of ZQ and PG, or ZQ only had better effects on reducing TCMSS scores compared with PG, and COM showed the higher total effective rate compared with monotherapy. Besides, COM could effectively improve menstrual blood loss and quality of life. ZQ combined with PG may be an effective and safe option for oligomenorrhea and hypomenorrhea patients with qi-blood and Shen essence deficiency.
Female
;
Humans
;
Progesterone/therapeutic use*
;
Qi
;
Oligomenorrhea/drug therapy*
;
Quality of Life
;
Prospective Studies
;
Medicine, Chinese Traditional
;
Drugs, Chinese Herbal/adverse effects*
;
Capsules
;
Kidney
3.Research progress on health hazards and occupational protection of prolymethylmethacrylate bone cement in the operating room.
Qiu Ping WU ; Xiao Qin GAN ; Hao Yu PEI
Chinese Journal of Industrial Hygiene and Occupational Diseases 2022;40(5):396-400
There are many occupational risk factors in operating room work. Polymethyl methacrylate (PMMA) , as a kind of common bone filling and repairing material, is widely used in the fixation of artificial joints, oral braces and orthopedic prosthesis. However, PMMA will release methyl methacrylate (MMA) monomer when it is implanted into human tissues and polymerized to harden, which is toxic to the body. This paper analyzes harmful factors in using PMMA bone cement, and then explores corresponding occupational protection knowledge, in order to reduce the occurrence of occupational hazards related to PMMA bone cement and enhance the self-protection ability of the operation room medical staff.
Bone Cements/adverse effects*
;
Humans
;
Operating Rooms
;
Polymethyl Methacrylate/adverse effects*
4.Clinical follow-up analysis of multidisciplinary treatment of children with spinal muscular atrophy.
Yu XIA ; Yi Jie FENG ; Mei YAO ; Jia Ning JIN ; Jia WEI ; Yi Qin CUI ; Ling Shuang WANG ; Ting Ting CHEN ; Xiao Yang CHEN ; Hai Bing LI ; Jing Fang XU ; Qi LONG ; Yuan JIANG ; Jin Ling LIU ; Jin Gan LOU ; Feng GAO ; Shan Shan MAO
Chinese Journal of Pediatrics 2022;60(11):1134-1139
Objective: To analyze the follow-up and clinical effect of multidisciplinary treatment on the children with spinal muscular atrophy (SMA). Methods: The clinical data including nutritional status, respiratory function, bone health and motor function of 45 children with SMA who received multidisciplinary management 1-year follow-up in the Children's Hospital, Zhejiang University School of Medicine from July 2019 to October 2021 were retrospectively collected. Comparisons before and after management were performed using paired-samples t-test or Wilcoxon rank-sum test, etc. Results: The age of 45 patients (25 boys and 20 girls) was 50.4 (33.6, 84.0) months at the enrollment, with 6 cases of type 1, 22 cases of type 2, and 17 cases of type 3 respectively. After the multidisciplinary management, the cases of SMA patients with malnutrition decreased from 22 to 12 (P=0.030), the level of vitamin D were significantly increased ((45±17) vs. (48±14) nmol/L, t=-4.13, P<0.001). There was no significant difference in the forced vital capacity %pred, the forced expiratory volume at 1 second %pred, and the peak expiratory flow %pred ((76±19)% and (76±21)%, (81±18)% and (79±18)%, (81±21)% and (78±17)%; t=-0.24, 1.36, 1.21; all P>0.05). The Cobbs angle of scoliosis also improved significantly (8.0°(0°, 13.0°) vs. 10.0°(0°, 18.5°), Z=-3.01, P=0.003). The Hammersmith functional motor scale expanded scores of children with SMA type 2 and type 3 both showed significant elevation (11.0 (8.0, 18.0) vs. 11.0 (5.0, 18.5) scores, 44.0 (36.5, 53.0) vs. 44.0 (34.0, 51.5) scores, Z=2.44, 3.11, P=0.015, 0.002). Conclusion: Multidisciplinary management is beneficial for delaying the progression of the multi-system impairments of SMA patients, such as malnutrition, restrictive ventilation dysfunction and scoliosis.
Child
;
Male
;
Female
;
Humans
;
Child, Preschool
;
Scoliosis
;
Retrospective Studies
;
Follow-Up Studies
;
Muscular Atrophy, Spinal
;
Malnutrition
5.Long-term outcomes and independent predictors of mortality in patients presenting to emergency departments with acute heart failure in Beijing: a multicenter cohort study with a 5-year follow-up.
Yang LI ; Xiao-Lu SUN ; Hong QIU ; Jian QIN ; Chun-Sheng LI ; Xue-Zhong YU ; Guo-Xing WANG ; Yan FU ; Ya-An ZHENG ; Bin ZHAO ; Dong-Ming YU ; Si-Jia WANG ; Guo-Gan WANG
Chinese Medical Journal 2021;134(15):1803-1811
BACKGROUND:
Acute heart failure (AHF) is the most common disease in emergency departments (EDs). However, clinical data exploring the outcomes of patients presenting AHF in EDs are limited, especially the long-term outcomes. The purposes of this study were to describe the long-term outcomes of patients with AHF in the EDs and further analyze their prognostic factors.
METHODS:
This prospective, multicenter, cohort study consecutively enrolled 3335 patients with AHF who were admitted to EDs of 14 hospitals from Beijing between January 1, 2011 and September 23, 2012. Kaplan-Meier and Cox regression analysis were adopted to evaluate 5-year outcomes and associated predictors.
RESULTS:
The 5-year mortality and cardiovascular death rates were 55.4% and 49.6%, respectively. The median overall survival was 34 months. Independent predictors of 5-year mortality were patient age (hazard ratio [HR]: 1.027, 95 confidence interval [CI]: 1.023-1.030), body mass index (BMI) (HR: 0.971, 95% CI: 0.958-0.983), fatigue (HR: 1.127, 95% CI: 1.009-1.258), ascites (HR: 1.190, 95% CI: 1.057-1.340), hepatic jugular reflux (HR: 1.339, 95% CI: 1.140-1.572), New York Heart Association (NYHA) class III to IV (HR: 1.511, 95% CI: 1.291-1.769), heart rate (HR: 1.003, 95% CI: 1.001-1.005), diastolic blood pressure (DBP) (HR: 0.996, 95% CI: 0.993-0.999), blood urea nitrogen (BUN) (HR: 1.014, 95% CI: 1.008-1.020), B-type natriuretic peptide (BNP)/N-terminal pro-B-type natriuretic peptide (NT-proBNP) level in the third (HR: 1.426, 95% CI: 1.220-1.668) or fourth quartile (HR: 1.437, 95% CI: 1.223-1.690), serum sodium (HR: 0.980, 95% CI: 0.972-0.988), serum albumin (HR: 0.981, 95% CI: 0.971-0.992), ischemic heart diseases (HR: 1.195, 95% CI: 1.073-1.331), primary cardiomyopathy (HR: 1.382, 95% CI: 1.183-1.614), diabetes (HR: 1.118, 95% CI: 1.010-1.237), stroke (HR: 1.252, 95% CI: 1.121-1.397), and the use of diuretics (HR: 0.714, 95% CI: 0.626-0.814), β-blockers (HR: 0.673, 95% CI: 0.588-0.769), angiotensin-converting enzyme inhibitors (ACEIs) (HR: 0.714, 95% CI: 0.604-0.845), angiotensin-II receptor blockers (ARBs) (HR: 0.790, 95% CI: 0.646-0.965), spironolactone (HR: 0.814, 95% CI: 0.663-0.999), calcium antagonists (HR: 0.624, 95% CI: 0.531-0.733), nitrates (HR: 0.715, 95% CI: 0.631-0.811), and digoxin (HR: 0.579, 95% CI: 0.465-0.721).
CONCLUSIONS
The results of our study demonstrate poor 5-year outcomes of patients presenting to EDs with AHF. Age, BMI, fatigue, ascites, hepatic jugular reflux, NYHA class III to IV, heart rate, DBP, BUN, BNP/NT-proBNP level in the third or fourth quartile, serum sodium, serum albumin, ischemic heart diseases, primary cardiomyopathy, diabetes, stroke, and the use of diuretics, β-blockers, ACEIs, ARBs, spironolactone, calcium antagonists, nitrates, and digoxin were independently associated with 5-year all-cause mortality.
Angiotensin Receptor Antagonists
;
Angiotensin-Converting Enzyme Inhibitors
;
Beijing/epidemiology*
;
Biomarkers
;
Cohort Studies
;
Emergency Service, Hospital
;
Follow-Up Studies
;
Heart Failure/mortality*
;
Humans
;
Natriuretic Peptide, Brain
;
Peptide Fragments
;
Prognosis
;
Prospective Studies
6.Effect of pertussis vaccination on clinical manifestations of infants and young children with pertussis.
Qi-Qin TANG ; Chuan GAN ; Xiao-Ying WU ; Hong-Mei XU ; Zhen-Zhen ZHANG
Chinese Journal of Contemporary Pediatrics 2021;23(2):138-142
OBJECTIVE:
To study the effect of pertussis vaccination on the clinical manifestations of infants and young children with pertussis.
METHODS:
A retrospective analysis was performed to investigate the differences in clinical manifestations and peripheral blood cell levels between pertussis children with different pertussis vaccination status.
RESULTS:
A total of 1 083 children with pertussisat at age of < 3 years were enrolled, with 551 children in the unvaccinated group and 532 in the vaccinated group. Of all the children, 392 had an age of onset of < 3 months (372 were unvaccinated and 20 were vaccinated) and 691 children had an age of onset of ≥ 3 months (179 were unvaccinated and 512 were vaccinated). Compared with the vaccinated group, the unvaccinated group had a longer length of hospital stay and a higher incidence rate of respiratory failure (
CONCLUSIONS
Pertussis vaccination can reduce the incidence of severe pneumonia and respiratory failure and alleviate the severity of respiratory complications in infants and young children with pertussis.
Child
;
Child, Preschool
;
Humans
;
Incidence
;
Infant
;
Pneumonia
;
Retrospective Studies
;
Vaccination
;
Whooping Cough/prevention & control*
7.Spectrum and indications of acupuncture and moxibustion therapy based on bibliometric analysis.
Qin-Feng HUANG ; Chen XIE ; Huan-Gan WU ; Guang YANG ; Jie LIU ; Xiao-Cong GUO ; Xiao-Peng MA
Chinese Acupuncture & Moxibustion 2021;41(9):1055-1059
OBJECTIVE:
To analyze the literature of acupuncture and moxibustion for diseases in the recent 5 years, and discuss the spectrum and indications of acupuncture and moxibustion.
METHODS:
The literature on acupuncture and moxibustion for diseases in CNKI, Wanfang and VIP databases from January 1, 2015 to December 31, 2019 was searched, summarized and analyzed, and the disease spectrum was summarized. At the same time, the literature from 2015 to 2019 (group A), 1978 to 2005 (group B), and 1949 to 2005 (group C) was compared, and the indications of acupuncture and moxibustion therapy were summarized.
RESULTS:
There were 32 011 articles on acupuncture and moxibustion for diseases in the recent 5 years, including 377 kinds of indications. These indications can be mostly classified as neurology (9384), orthopedics and traumatology (7765), gastroenterology (3529) and obstetrics and gynecology (2283). The types of diseases were mostly gastroenterology (52 types), neurology (47 types), ophthalmology and otorhinolaryngology (47 types), and obstetrics and gynecology (42 types). The first-class indications of acupuncture and moxibustion therapy in the recent 5 years were hemiplegia, lumbar disc herniation, cervical spondylosis, knee osteoarthritis, insomnia, constipation and cerebrovascular diseases; the second-class were facial neuritis, shoulder pain and headache; the third-class were dysphagia, dysmenorrhea and depression; the forth-class were asthma, urinary retention, cerebral palsy, hypertension, dementia, side effects of radiotherapy and chemotherapy, infertility, allergic rhinitis, vertigo, shoulder-hand syndrome, diabetic neuropathy, herpes zoster, pain, hiccup, diarrhea, lumbar sprain and sciatica.
CONCLUSION
Although the disease spectrum and indications of acupuncture and moxibustion therapy have changed to some extent in the recent 5 years, neurology and orthopedics and traumatology are still predominant, and the observation objects tend to transition from symptoms to diseases.
Acupuncture
;
Acupuncture Therapy
;
Bibliometrics
;
Dysmenorrhea
;
Female
;
Humans
;
Moxibustion
8. 1, 8-CineoIe improves endothelial cell injury induced by high glucose via regulating autophagy
Xiao-Mei SONG ; Hong YANG ; Qiu-Shuang LONG ; Guan-Qin FANG ; Ge GAO ; Shi-Quan GAN ; Yan CHEN ; Xiang-Chun SHEN ; Xiao-Mei SONG ; Qiu-Shuang LONG ; Guan-Qin FANG ; Ge GAO ; Shi-Quan GAN ; Yan CHEN ; Xiang-Chun SHEN ; Hong YANG
Chinese Pharmacological Bulletin 2021;37(4):472-477
Aim To investigate the protective effect of 1, 8-Cineole on the injury of human aortic endothelial cells (HAECs) induced by high glucose (HG) via regulating autophagy. Methods Cells were incubated with different doses of 1, 8-Cineole followed by exposing to HG for 60 h, and MTT assay was used to analyse cell viability, lactate dehydrogenase (LDH) was used to detect cytotoxicity, and Western blot was used to detect Beclin1, LC3-II/I, p62, caspase-3 and caspase-9 expressions. Autophagy inhibitor (chloroquine, CQ) was treated on HAECs, and the expressions of Beclinl, LC3-II/I, p62, caspase-3 and caspase-9 were measured by Western blot. Results 1, 8-Cineole increased cell viability, reduced the content of LDH, activated autophagy and inhibited apoptosis. Compared with control group, the expression of Beclinl, LC3-II/I, p62, caspase-3 and caspase-9 in CQ group increased. Simultaneously, the expression of above-mentioned between CQ + HG group and CQ + HG + CH group. Conclusions 1, 8-Cineole has protective effect on the injury of HAECs induced by high glucose, and its effect is related to improving autophagy flux.
9.Adefovir Dipivoxil plus Chinese Medicine in HBeAg-Positive Chronic Hepatitis B Patients: A Randomized Controlled 48-Week Trial.
Xiao-Ke LI ; Ming-Xiang ZHANG ; Feng-Zhen SHAO ; Da-Qiao ZHOU ; Jing-Dong XUE ; Tie-Jun LIU ; Xiao-Ling CHI ; Bing-Jiu LU ; Xian-Bo WANG ; Qin LI ; Jun LI ; De-Wen MAO ; Hua-Sheng YANG ; Hong-Zhi YANG ; Wen-Xia ZHAO ; Yong LI ; Guo-Liang ZHANG ; Yi-Ming ZHAO ; Jian-Dong ZOU ; Meng-Yang LIU ; Ke-Ke ZHANG ; Xian-Zhao YANG ; Da-Nan GAN ; Ying LI ; Peng ZHANG ; Zhi-Guo LI ; Shuo LI ; Yong-An YE
Chinese journal of integrative medicine 2020;26(5):330-338
OBJECTIVE:
To evaluate the effects of a 48-week course of adefovir dipivoxil (ADV) plus Chinese medicine (CM) therapy, namely Tiaogan Jianpi Hexue () and Tiaogan Jiedu Huashi () fomulae, in hepatitis B e antigen (HBeAg)-positive Chinese patients.
METHODS:
A total of 605 HBeAg-positive Chinese CHB patients were screened and 590 eligible participants were randomly assigned to 2 groups in 1:1 ratio including experimental group (EG, received ADV plus CM) and control group (CG, received ADV plus CM-placebo) for 48 weeks. The major study outcomes were the rates of HBeAg and HBV-DNA loss on week 12, 24, 36, 48, respectively. Secondary endpoints including liver functions (enzymes and bilirubin readings) were evaluated every 4 weeks at the beginning of week 24, 36, and 48. Routine blood, urine, and stool analyses in addition to electrocardiogram and abdominal B scan were monitored as safety evaluations. Adverse events (AEs) were documented.
RESULTS:
The combination therapy demonstrated superior HBeAg loss at 48 weeks, without additional AEs. The full analysis population was 560 and 280 in each group. In the EG, population achieved HBeAg loss on week 12, 24, 36, and 48 were 25 (8.90%), 34 (12.14%), 52 (18.57%), and 83 (29.64%), respectively; the equivalent numbers in the CG were 20 (7.14%), 41 (14.64%), 54 (19.29%), and 50 (17.86%), respectively. There was a statistically significant difference between these group values on week 48 (P<0.01). No additional AEs were found in EG. Subgroup analysis suggested different outcomes among treatment patterns.
CONCLUSION
Combination of CM and ADV therapy demonstrated superior HBeAg clearance compared with ADV monotherapy. The finding indicates that this combination therapy may provide an improved therapeutic effect and safety profile (ChiCTR-TRC-11001263).
Adenine
;
analogs & derivatives
;
therapeutic use
;
Adult
;
Antiviral Agents
;
therapeutic use
;
Double-Blind Method
;
Drug Therapy, Combination
;
Drugs, Chinese Herbal
;
therapeutic use
;
Female
;
Hepatitis B e Antigens
;
immunology
;
Hepatitis B, Chronic
;
drug therapy
;
immunology
;
Humans
;
Male
;
Medicine, Chinese Traditional
;
Organophosphonates
;
therapeutic use
;
Young Adult
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).

Result Analysis
Print
Save
E-mail