Randomized， Open， Parallel Controlled， Multi-center Study for Efficacy and Safety of Lianhua Qingke Tablets in Treatment of Acute Bronchitis in Children with Syndrome of Phlegm-heat Obstructing Lung
10.13422/j.cnki.syfjx.20232124
- VernacularTitle:连花清咳片治疗小儿急性支气管炎痰热壅肺证有效性和安全性的随机、开放、平行对照、多中心临床观察
- Author:
Nan LI
1
;
Shaoyi GENG
2
;
Xiaofang WANG
1
;
Xiaowei ZHANG
3
;
Lixia JIA
4
;
Rongzhen KANG
5
;
Xiangjun DU
6
;
Lichun WU
7
;
Linlin ZHANG
3
Author Information
1. Shijiazhuang Maternal and Child Health Care Hospital, Shijiazhuang 050000, China
2. Hebei Province Hospital of Traditional Chinese Medicine(TCM), Shijiazhuang 050000, China
3. Shijiazhuang Hospital of TCM, Shijiazhuang 050000, China
4. The Third Hospital of Shijiazhuang, Shijiazhuang 050011, China
5. Jinzhou People's Hospital, Shijiazhuang 052200, China
6. The Hospital of Zanhuang County, Shijiazhuang 051230, China
7. The Hospital of Yuanshi County, Shijiazhuang 051130, China
- Publication Type:Journal Article
- Keywords:
acute bronchitis;
Lianhua Qingke tablets;
clinical efficacy;
safety
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2024;30(10):90-94
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo evaluate the efficacy and safety of Lianhua Qingke tablets in the treatment of acute bronchitis in children with the syndrome of phlegm-heat obstructing lung. MethodA randomized， open， parallel controlled， and multi-center clinical study was conduted. Children with acute bronchitis （syndrome of phlegm-heat obstructing lung） were randomly assigned to an observation group and a control group. The control group received routine basic treatment， and the observation group was treated with Lianhua Qingke Tablets on the basis of routine basic treatment. After 7 days of treatment， the clinical efficacy， TCM efficacy， time to symptom disappearance， time to cough disappearance， and clinical safety were compared between the two groups. ResultA total of 248 children were included （124 in the observation group and 124 in the control group）. After 7 days of treatment， the total response rate in terms of clinical efficacy in the observation group was 96.8% （120/124）， which was higher than that （90.3%， 112/124） in the control group （Z=-5.034， P<0.01）. The total response rate in terms of TCM syndrome in the observation group was 97.6% （121/124）， which was higher than that （93.5%， 116/124） in the control group （χ2=-5.326， P<0.01）. The scores of physical signs and TCM symptoms in the observation group were lower than those in the control group at the time of taking medicine for 3 days and 7 days （P<0.01）. The time to symptom disappearance and the time to cough disappearance in the observation group were shorter than those in the control group （P<0.01）. Drug-related adverse reactions occurred in neither group. ConclusionLianhua Qingke tablets demonstrate a definite effect on acute bronchitis in children with the syndrome of phlegm-heat blocking lung. The tablets can significantly shorten the course of disease and relieve cough and TCM symptoms， with high safety， which is worthy of clinical application and promotion.
