Randomized， Double-blind， Single-simulation， Placebo-controlled， Multicenter Clinical Trial of An'erning Granules in Reducing Use of Antibiotics for Children's Community-acquired Pneumonia
10.13422/j.cnki.syfjx.20221994
- VernacularTitle:基于儿童社区获得性肺炎评价安儿宁颗粒减少抗生素应用的随机、双盲单模拟、安慰剂平行对照、多中心临床试验
- Author:
Ruili WEI
1
;
Jian LYU
1
;
Xinmin LI
2
;
Farong YUAN
3
;
Lianxin WANG
1
;
Liqun WU
4
;
Ying DING
5
;
Mengqing WANG
6
;
Baoqing ZHANG
7
;
Zheng XUE
8
;
Yongsheng XU
9
;
Jingxiao ZHANG
10
;
Yanming XIE
1
Author Information
1. Institute of Basic Research in Clinical Medicine，China Academy of Chinese Medical Sciences，Beijing 100700，China
2. First Teaching Hospital of Tianjin University of Traditional Chinese Medicine，Tianjin 300073，China
3. Jinhe Tibetan Medicine Company Limited，Xining 810003，China
4. Dongfang Hospital， Beijing University of Chinese Medicine，Beijing 100078，China
5. The First Affiliated Hospital of Henan University of Chinese Medicine，Zhengzhou 450000，China
6. The First Hospital of Hunan University of Chinese Medicine，Changsha 410007，China
7. The Affiliated Hospital of Shandong University of Traditional Chinese Medicine （TCM），Jinan 250011，China
8. Shanghai Municipal Hospital of TCM，Shanghai 200071，China
9. Tianjin Children's Hospital，Tianjin 300074，China
10. School of Statistics，Renmin University of China，Beijing 100872，China
- Publication Type:Journal Article
- Keywords:
An'erning granules;
community-acquired pneumonia in children;
randomized controlled trial;
antibiotic
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2022;28(19):105-114
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo evaluate the efficacy and safety of An'erning granules in the treatment of community-acquired pneumonia in children. MethodA randomized， double-blind， single-simulation， placebo-controlled trial was designed in this study. The children were randomly assigned into an observation group （An'erning granules combined with ceftriaxone sodium） and a control group （An'erning granules placebo combined with ceftriaxone sodium） according to the ratio of 2∶1. The disease cure rate was taken as the main indicator of efficacy， and the safety of An'erning granules was observed. ResultA total of 206 children （137 in the observation group and 69 in the control group） were included in this study. Before treatment， the age， sex， body height， body weight， diagnosis time of pneumonia， and symptom and sign scores had no significant differences between the two groups. After 8 days of continuous medication， the observation group［70.80%（97/137）］ had higher cure rate than the control group［56.52%（39/69）］（χ2=4.17，P<0.05） and total effective rate of chest X-ray ［97.98%（97/99）］ than the control group［86.27%（44/51）］ （χ2=12.98，P<0.01）. The observation group was superior to the control group in the alleviation of TCM syndrome under the condition of 0-3 g dose stratification on day 3 of medication （P<0.01）. The recovery time， time to complete fever abatement， time to fever abatement and expectoration alleviation， rate of conversion to severe case， and reduction in the frequency of antibiotic use showed no significant differences between the two groups. In terms of safety， 13 and 7 adverse events occurred in the observation group and control group， respectively， which were relieved or disappeared after drug withdrawal or symptomatic treatment and showed no significant difference between the two groups. ConclusionIntravenous drip of ceftriaxone sodium combined with An'erning granules is effective in the treatment of community-acquired pneumonia in children. It can accelerate the absorption of pulmonary inflammation， alleviate the clinical symptoms in a short time for young children or the children with mild symptoms， and is safe in clinical application.
