Guoliang Zhang1, Yong Hou1, Yan Li1, Liyun He2, Liuping Tang3, Tong Yang4, Xinying Zou5, Qingxiong Zhu6, Shiyan Yan7, Baoju Huang8, Jindong Zhao9, Jihan Huang10. 1. Department of Infectious Disease, First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei 230031, China. 2. Clinical Evaluation Center, China Academy of Chinese Medical Sciences, Beijing 100700, China. 3. Department of Pediatrics, Liuzhou Worker's Hospital, Liuzhou 545000, China. 4. Department of Pediatrics, Liuzhou People's Hospital, Liuzhou 545000, China. 5. Department of Emergency, Shenzhen Maternal and Child Hospital, Shenzhen 518000, China. 6. Department of Pediatrics, Jiangxi Provincial Children's Hospital, Nanchang 330000, China. 7. Department of Pediatrics, Second Affiliated Hospital of Zhejiang University of Chinese Medicine, Hangzhou 230031, China. 8. Department of Respiration, Second Affiliated Chinese Medicine Hospital of Jiangsu Province, Nanjing 210017, China. 9. Department of Endocrine Disease, the First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei 230031, China. 10. Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China.
Abstract
OBJECTIVE: To evaluate the clinical effects of Xiyanping injection intervention in pediatric patients with mild hand foot and mouth disease (HFMD). METHODS: A total of 329 patients were stratified and block-randomized for symptomatic treatment of HFMD and assigned to one of the following groups: Western Medicine (group A, n = 103), Xiyanping injection (group B, n = 109), or Xiyanping injection and symptomatic treatment using Western Medicine (group C, n = 117). During the trial, fever, rash, ulcers of the mouth were observed among participants in each group before and after treatment, and conversion rates from mild to severe HFMD were measured. RESULTS: After 3-7 days' treatment, no significant differences in the conversion rates from mild to severe HFMD were observed among the three groups (P > 0.05). There was a significantly low number of patients with the onset time of antifebrile effect, vanished time of hand and foot rashes and cumulative time for the ulcers in the mouth vanished, among the three groups (P < 0.05, P < 0.01). The onset time of antifebrile effect of patients in groups B and C were markedly shorter compared with those in group A (P < 0.05, P < 0.01); there was no statically significant difference observed between groups B and C (P > 0.05). No significant differences were observed in the time for body temperature recovery among the three groups (P > 0.05). There were no significant differences in adverse effects among the three groups (P > 0.05). CONCLUSION: Xiyanping injection together with use of Western Medicine is most effective for symptomatic treatment of mild HFMD. No severe adverse reactions were observed.
RCT Entities:
OBJECTIVE: To evaluate the clinical effects of Xiyanping injection intervention in pediatric patients with mild hand foot and mouth disease (HFMD). METHODS: A total of 329 patients were stratified and block-randomized for symptomatic treatment of HFMD and assigned to one of the following groups: Western Medicine (group A, n = 103), Xiyanping injection (group B, n = 109), or Xiyanping injection and symptomatic treatment using Western Medicine (group C, n = 117). During the trial, fever, rash, ulcers of the mouth were observed among participants in each group before and after treatment, and conversion rates from mild to severe HFMD were measured. RESULTS: After 3-7 days' treatment, no significant differences in the conversion rates from mild to severe HFMD were observed among the three groups (P > 0.05). There was a significantly low number of patients with the onset time of antifebrile effect, vanished time of hand and foot rashes and cumulative time for the ulcers in the mouth vanished, among the three groups (P < 0.05, P < 0.01). The onset time of antifebrile effect of patients in groups B and C were markedly shorter compared with those in group A (P < 0.05, P < 0.01); there was no statically significant difference observed between groups B and C (P > 0.05). No significant differences were observed in the time for body temperature recovery among the three groups (P > 0.05). There were no significant differences in adverse effects among the three groups (P > 0.05). CONCLUSION:Xiyanping injection together with use of Western Medicine is most effective for symptomatic treatment of mild HFMD. No severe adverse reactions were observed.
Entities:
Keywords:
Antipyretic; Body temperature regulation; Hand foot and mouth disease; Randomized controlled trial; Xiyanping injection
Authors: Jie Kai Tan; Ran Chen; Regina Ching Hua Lee; Feng Li; Kun Dai; Guo-Chun Zhou; Justin Jang Hann Chu Journal: Pharmaceuticals (Basel) Date: 2022-01-18