• Wen-Yi Nie, Jian Lyu, Yan-Ming Xie, and Meng-Hua Sun.
• Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China Institute of Basic Theory of Traditional Chinese Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China.
• Zhongguo Zhong Yao Za Zhi. 2020 Aug 1; 45 (15): 3539-3546.

AbstractThe efficacy and safety of Xiao'er Chaigui Tuire Granules for the treatment of hand, foot and mouth disease were syste-matically evaluated. Four Chinese databases of CNKI, CBM, WanFang, VIP and four English databases of PubMed, Cochrane Library, EMbase, Web of Science were retrieved by computers. With Chinese and English words "Xiao'er Chaigui Tuire Granules" "hand, foot and mouth disease" as the subject and keywords, randomized controlled trials(RCT) for the effect of Xiao'er Chaigui Tui-re Granules alone and combined with Western medicine in the treatment of hand, foot and mouth disease were retrieved, and the retrieval time was generally from the establishment of the database to January 20, 2020. Then all the relevant documents that meet the requirements and be included in the quality evaluation standard were screened out, relevant baseline data information was extracted, and a final evaluation was conducted for the quality of relevant literatures. The quality evaluation was conducted by the latest RevMan 5.3 software version-based tools. The reliability of the data relating to the results of the literatures was analyzed by statistical data. A total of 7 RCTs were included. The total sample size was 619, including 321 in the experimental group and 298 in the control group. Meta-analysis results show that: Xiao'er Chaigui Tuire Granules could improve the total clinical effectiveness(RR=1.28, 95%CI[1.11, 1.46], P=0.000 4; RR=1.62, 95%CI[1.06, 2.48], P=0.02); Xiao'er Chaigui Tuire Granules combined with Western medicine could significantly shorten the healing time of oral ulcers in children with hand, foot and mouth disease(MD=-1.11, 95%CI[-1.44,-0.78], P<0.000 01; MD=-2.13, 95%CI[-2.37,-1.89], P<0.000 01; MD=-1.10, 95%CI[-1.38,-0.82], P<0.000 01); on the basis of conventional treatment, Xiao'er Chaigui Tuire Granules combined with Western medicine could reduce the fever time(MD=-1.21, 95%CI[-2.15,-0.27], P=0.01; MD=-1.93, 95%CI[-2.35,-1.51], P<0.000 01; MD=-2.00, 95%CI[-2.60,-1.40], P<0.000 01), with no serious adverse reaction. The results showed that, in the treatment of hand, foot and mouth disease, compared with the conventional treatment method of Western medicine alone, the combined use of Xiao'er Chaigui Tuire Granules had more obvious advantage in effectively shortening the healing time of oral ulcers in children and effectively reducing the antipyretic time. Moreover, it had a better clinical efficacy in treating the patients with hand, foot and mouth disease in the early stage in terms of the improvement and control of symptoms and pathology, with a significantly increased effectiveness and no serious adverse reaction. It could be considered to be combined with therapies based on syndrome differentiation. However, due to the small sample size of clinical studies currently included, and the low quality of clinical studies further included, the quality of the studies included was low, which affected the scientific reliability and quality of the conclusions of the study. Therefore, further clinical results are still required for further confirmation.

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