Randomized double-blind parallel controlled multicenter trial of Reyanning Mixture in treatment of acute tonsillitis.
10.19540/j.cnki.cjcmm.20200420.501
- Author:
Jian LYU
1
;
Cui YANG
2
;
Lian-Xin WANG
1
;
Yan-Ming XIE
1
;
Xue-Qing YU
3
;
Li GU
4
;
Feng GAO
5
;
Jing-Xiao ZHANG
6
;
Xiao-Kang YU
6
Author Information
1. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China.
2. Beijing First Integrated Traditional Chinese and Western Medicine Hospital Beijing 100021, China.
3. the First Affiliated Hospital of Henan University of Chinese Medicine Zhengzhou 450004, China.
4. Beijing Chaoyang Hospital, Capital Medical University Beijing 100043, China.
5. Wangjing Hospital, China Academy of Chinese Medical Sciences Beijing 100102, China.
6. School of Statistics, Renmin University of China Beijing 100872, China.
- Publication Type:Journal Article
- Keywords:
DDD value;
Reyanning Mixture;
acute tonsillitis;
high quality evidence;
randomized controlled trial;
reduction of antibiotics
- MeSH:
Anti-Bacterial Agents;
therapeutic use;
Double-Blind Method;
Drugs, Chinese Herbal;
Fever;
drug therapy;
Humans;
Tonsillitis;
drug therapy
- From:
China Journal of Chinese Materia Medica
2020;45(14):3282-3291
- CountryChina
- Language:Chinese
-
Abstract:
This study is a randomized controlled trial of Reyanning Mixture in the treatment of acute tonsillitis. According to the ratio of 1∶1∶1, a total of 144 patients were randomly divided into Reyanning Mixture group(RYN), Reyanning Mixture+Amoxicillin Capsules group(RYN+Amoxil) and Amoxicillin Capsules group(Amoxil), with 48 cases in each group, in order to evaluate the efficacy and safety of RYN alone or combined with Amoxil in the treatment of acute tonsillitis, and provided high-quality evidences for treatment of infectious diseases with traditional Chinese medicine and reduced use of antibiotics. The dosage of RYN was 20 mL, 3 times a day, 100 mL/bottle, oral for 7 days, and Amoxil dosage was 0.5 g, 3 times a day, 0.5 g×12 tablets/plate, oral for 7 days. A total of 144 cases were included, 3 cases were excluded(1 case was mistakenly included, 2 cases did not take drugs after inclu-ded), and a total of 141 cases were included in the full analysis set(FAS). The results showed statistical differences in the recovery time of the disease, the disappearance rate of fever on the 3 rd day and the disappearance rate of tonsillar redness and swelling between RYN and Amoxil. There were statistical differences in the cure rate of disease, recovery time of disease, body temperature recovery time, fever disappearance rate on the 3 rd day, pharynx swelling and pain disappearance rate and tonsil swelling disappearance rate between the RYN+Amoxil and Amoxil, but with no significant difference in the above aspects compared with RYN. The DDD of antibiotic use in RYN+Amoxil was significantly lower than that in Amoxil(P<0.01). According to the findings, when RYN was used alone in the treatment of acute tonsillitis, it was superior to Amoxil in time of recovery, short-term improvement of fever and redness and swelling of tonsil. Compared with RYN+Amoxil, there was no difference in cure rate of disease, recovery time of disease, body temperature recovery time, short-term improvement of fever, swelling of pharynx and swelling of tonsil, with a better efficacy than Amoxil. The clinical effect of RYN was similar to that of combined Amoxil in the treatment of acute tonsillitis, and RYN was superior to Amoxil in the time of recovery, short-term improvement of fever and redness and swelling of tonsil, with no adverse event or adverse reaction. RYN+Amoxil can significantly reduce the DDD value of antibiotics in the treatment of acute tonsillitis, with significant clinical advantages over Amoxil.
