1.The effects of Dyad Flow in the minimal invasive treatment of deciduous molar caries
Mengchao CHI ; Ti LI ; Jianwen BAI
Journal of Practical Stomatology 2015;(5):713-715
Objective:To observe the effects of Dyad Flow self-adhering flowable composite in the minimal invasive treatment of decid-uous molar caries.Methods:31 7 deciduous molars caries of 206 patients were randomly divided into 3 groups and treated by minimal invasive method,the cavities of the molars were filled with Dyad Flow self-adhering flowable composite(group A,n =1 07),traditional flowable composite and self-etching adhesive(group B,n =1 04)and glass ion(group C,n =1 06)respectively.The children were fol-lowed up for 1 and 2 years after treatment.Results:1 year after treatment the success rate(%)of group A,B and C was 95.3,96.77 and 91 .84(P >0.05);2 years after treatment 89.1 9,90.67 and 79.45(P >0.05),respectively.Conclusion:Dyad Flow self-adhe-ring flowable composite is effective in the treatment of deciduous molar caries.
2.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).
3.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