聂文祎,吕健,谢雁鸣,孙梦华
NIE Wen-yi,LYU Jian,XIE Yan-ming,SUN Meng-hua

• 1:中国中医科学院中医临床基础医学研究所
• 2:中国中医科学院中医基础理论研究所

摘要(Abstract)：

该文系统评价了小儿柴桂退热颗粒治疗手足口病的有效性和安全性。使用计算机检索CNKI、CBM、万方、VIP中文数据库和PubMed,Cochrane Library,EMbase,Web of Science英文数据库。以中文"小儿柴桂退热颗粒""手足口病"和英文"Xiao′er Chaigui Tuire Granules""hand,foot and mouth disease"为主题词和关键词,检索小儿柴桂退热颗粒单用及联合西药治疗手足口病的随机对照临床试验(RCT),检索时间从建库至2020年1月20日。筛选所有符合要求并纳入质量评价标准的文献,提取相关基线数据信息并进行最终的相关文献质量评估,质量评价采用RevMan 5.3软件,对结果相关数据的可靠性进行统计学分析。共纳入RCT 7篇,样本量619例,试验组321例,对照组298例。Meta分析结果显示,小儿柴桂退热颗粒能提高临床总有效率(RR_(单用)=1.28,95%CI[1.11,1.46],P=0.000 4;RR_(联合常规治疗)=1.62,95%CI[1.06,2.48],P=0.02);小儿柴桂退热颗粒联合西药可明显缩短手足口病患儿口腔溃疡愈合时间(MD_(联合常规治疗)=-1.11,95%CI[-1.44,-0.78],P<0.000 01;MD_(单用)=-2.13,95%CI[-2.37,-1.89],P<0.000 01;MD_(联合常规治疗+利巴韦林颗粒)=-1.10,95%CI[-1.38,-0.82],P<0.000 01)及缩短退热时间(MD_(联合常规治疗)=-1.21,95%CI[-2.15,-0.27],P=0.01;MD_(单用)=-1.93,95%CI[-2.35,-1.51],P<0.000 01;MD_(联合常规治疗+利巴韦林颗粒)=-2.00,95%CI[-2.60,-1.40],P<0.000 01),同时也无严重的不良反应。结果表明,针对手足口病,与单纯西医常规治疗相比,联合使用小儿柴桂退热颗粒在有效缩短口腔溃疡愈合时间和退热时间方面更具明显优势,而且对于手足口病的早期患者临床治疗,在症状和病理上具有更好的改善和控制作用,有效率明显提高,无严重不良反应的发生,可考虑与辨证治疗联合使用。但由于目前纳入临床研究的数量较少,且质量不高等诸多制约因素,以致目前该研究纳入结果的质量偏低,其结论的科学可靠性和质量受到较大的影响,因此还需要进一步临床结果加以证实。
The 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.

关键词(KeyWords)： 小儿柴桂退热颗粒;手足口病;系统评价;Meta分析
Xiao′er Chaigui Tuire Granules;hand,foot and mouth disease;systematic review;Meta-analysis

Abstract:

Keywords:

基金项目(Foundation): 国家重点研发计划项目(2018YFC1707400)

作者(Author): 聂文祎,吕健,谢雁鸣,孙梦华
NIE Wen-yi,LYU Jian,XIE Yan-ming,SUN Meng-hua

DOI: 10.19540/j.cnki.cjcmm.20200507.501

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