Xiu-Hui Li1, Shuang-Jie Li2, Yi Xu3, Dan Wei4, Qing-Sheng Shi5, Qing-Xiong Zhu6, Tong Yang7, Jian-Bo Ding1, Yi-Mei Tian1, Ji-Han Huang8, Kun Wang8, Tao Wen9, Xi Zhang10. 1. Department of Integrated Traditional Chinese Medicine and Western Medicine, Beijing Youan Hospital Affiliated to Capital Medical University, Beijing, 100069, China. 2. Department of Communicable Diseases, Children's Hospital of Hunan Province, Changsha, 410007, China. 3. Department of Pediatrics, Guangzhou Medical Center for Women and Children, Guangzhou, 510623, China. 4. Department of Pediatrics, First Hospital Affiliated to Guangxi Medical University, Nanning, 530021, China. 5. Department of Internal Medicine, Handan Maternal and Child Health Hospital, Handan, Hebei Province, 056001, China. 6. Department of Internal Medicine, Children's Hospital of Jiangxi Province, Nanchang, 330006, China. 7. Department of Pediatrics, The People's Hospital of Liuzhou, Liuzhou, Guangxi Province, 545006, China. 8. Center for Drug Clinical Research, Shanghai University of Chinese Medicine, Shanghai, 201203, China. 9. Medical Research Center, Beijing Chaoyang Hospital, Capital Medical University, Beijing, 100020, China. wentao5281@163.com. 10. Department of Pediatrics, Kaifeng Children's Hospital, Kaifeng, Henan Province, 475003, China. springmaze@sina.com.
Abstract
OBJECTIVE: To evaluate the efficacy and safety of Chinese medicine (CM) plus Western medicine (WM) in the treatment of pediatric patients with severe hand, foot and mouth disease (HFMD) by conducting a prospective, controlled, and randomized trial. METHODS: A total of 451 pediatric patients with severe HFMD were randomly assigned to receive WM therapy alone (224 cases, WM therapy group) or CM [Reduning Injection ( ) or Xiyanping Injection ()] plus WM therapy (227 cases, CM plus WM therapy group) for 7-10 days, according to a web-based randomization system. The primary outcome was fever clearance time, which was presented as temperature decreased half-life time. The secondary outcomes included the rate of rash/herpes disappearance within 120 h, as well as the rate for cough, runny nose, lethargy and weakness, agitation or irritability, and vomiting clearance within 120 h. The drug-related adverse events were also recorded. RESULTS: The temperature decreased half-life time was 40.4 h in the WM therapy group, significantly longer than 27.2 h in the CM plus WM therapy group (P<0.01). Moreover, the rate for rash/herpes disappearance within 120 h was 43.6% (99/227) in the CM plus WM therapy group, significantly higher than 29.5% (66/224) in the WM therapy group (P<0.01). In addition, the rate for cough, lethargy and weakness, agitation or irritability disappearance within 120 h was 32.6% (74/227) in the CM plus WM therapy group, significantly higher than 19.2% (43/224) in the WM therapy group (P<0.01). No drug-related adverse events were observed during the course of the study. CONCLUSION: The combined CM and WM therapy achieved a better therapeutic efficacy in treating severe HFMD than the WM therapy alone. Reduning or Xiyanping Injections may become an important complementary therapy to WM for relieving the symptoms of severe HFMD. (Registration No. NCT01145664).
OBJECTIVE: To evaluate the efficacy and safety of Chinese medicine (CM) plus Western medicine (WM) in the treatment of pediatric patients with severe hand, foot and mouth disease (HFMD) by conducting a prospective, controlled, and randomized trial. METHODS: A total of 451 pediatric patients with severe HFMD were randomly assigned to receive WM therapy alone (224 cases, WM therapy group) or CM [Reduning Injection ( ) or Xiyanping Injection ()] plus WM therapy (227 cases, CM plus WM therapy group) for 7-10 days, according to a web-based randomization system. The primary outcome was fever clearance time, which was presented as temperature decreased half-life time. The secondary outcomes included the rate of rash/herpes disappearance within 120 h, as well as the rate for cough, runny nose, lethargy and weakness, agitation or irritability, and vomiting clearance within 120 h. The drug-related adverse events were also recorded. RESULTS: The temperature decreased half-life time was 40.4 h in the WM therapy group, significantly longer than 27.2 h in the CM plus WM therapy group (P<0.01). Moreover, the rate for rash/herpes disappearance within 120 h was 43.6% (99/227) in the CM plus WM therapy group, significantly higher than 29.5% (66/224) in the WM therapy group (P<0.01). In addition, the rate for cough, lethargy and weakness, agitation or irritability disappearance within 120 h was 32.6% (74/227) in the CM plus WM therapy group, significantly higher than 19.2% (43/224) in the WM therapy group (P<0.01). No drug-related adverse events were observed during the course of the study. CONCLUSION: The combined CM and WM therapy achieved a better therapeutic efficacy in treating severe HFMD than the WM therapy alone. Reduning or Xiyanping Injections may become an important complementary therapy to WM for relieving the symptoms of severe HFMD. (Registration No. NCT01145664).
Entities:
Keywords:
Chinese medicine; Reduning Injection; Xiyanping Injection; foot and mouth disease; hand