小儿豉翘清热颗粒联合常规西药治疗儿童手足口病疗效及安全性的Meta分析

Meta-analysis of the efficacy and safety of Xiaoer Chiqiao Qingre granules combined with conventional western medicine in the treatment of pediatric hand-foot-mouth disease

目的通过系统评价小儿豉翘清热颗粒联合常规西药治疗儿童手足口病的有效性及安全性。方法计算机检索中国知网、中国生物医学文献数据库、万方数据知识服务平台、维普网及PubMed、the Cochrane Library、Embase数据库中公开发表的关于小儿豉翘清热颗粒治疗儿童手足口病的随机对照试验,检索时限为2010年1月1日—2022年6月1日。对照组患儿予以常规西药治疗,试验组患儿在对照组基础上口服小儿豉翘清热颗粒治疗。由2位研究者严重按照纳入与排除标准独立筛选文献,并交叉核对,并采用5.1.0 Cochrane风险评估工具对纳入文献进行方法学质量评价。采用RevMan 5.3软件进行数据处理。结果最终纳入17篇随机对照试验,共包含2231例患者。Meta分析结果显示,试验组治疗有效率高于对照组[相对危险度(RR)=1.17,95%可信区间(CI)(1.09,1.26)],退热时间[均数差(MD)=-1.64,95%CI(-1.99,-1.30)]、疱疹消退时间[MD=-2.21,95%CI(-2.73,-1.69)]短于对照组(P<0.001);对照组与试验组不良反应发生率比较,差异无统计学意义[RR=0.34,95%CI(0.11,1.09),P=0.07]。采用逐一剔除法进行敏感性分析,结果显示,报告治疗有效率、退热时间、疱疹消退时间的结果稳定性均较好。绘制报道治疗有效率发表偏倚的漏斗图,结果显示各研究分布基本对称,但仍有研究在漏斗图外,提示有可能存在发表偏倚。结论根据当前证据表明,采用小儿豉翘清热颗粒联合常规西药治疗儿童手足口病具有较高的有效性及安全性,可有效缩短患儿退热时间及疱疹消退时间,促进疾病快速恢复。

Objective To systematically evaluate the efficacy and safety of Xiaoer Chiqiao Qingre granules combined with conventional western medicine in the treatment of pediatric hand-foot-mouth disease.Methods RCTs of Xiaoer Chiqiao Qingre granules in the treatment of pediatric hand-foot-mouth disease published on CNKI,CBM,Wanfang Data,VIP and PubMed,the Cochrane Library,Embase databases was conducted by computer,the retrieval time was from 2010-01-01 to 2022-06-01.The control group was treated with conventional western medicine,and the experimental group was treated with Xiaoer Chiqiao Qingre granules on the basis of the control group.Literatures were independently screened and cross-checked by two investigators in serious accordance with the inclusion and exclusion criteria,and the methodological quality of the included literatures were evaluated using the 5.1.0 Cochrane Risk Assessment Tool.RevMan 5.3 software was used for data processing.Results Finally,17 RCTs containing a total of 2231 patients.Meta-analysis results showed that,clinical efficiency of the experimental group was higher than that of the control group[RR=1.17,95%CI(1.09,1.26)],and fever relieving time[MD=-1.64,95%CI(-1.99,-1.30)],herpes remission time[MD=-2.21,95%CI(-2.73,-1.69)]were shorter than those in the control group(P<0.001);There was no statistically significant difference of the incidence of adverse reactions between the control group and the experimental group[RR=0.34,95%CI(0.11,1.09),P=0.07].Sensitivity analyse using the one-by-one exclusion method showed that,the stability of the results for reporting clinical efficacy,fever relieving time and herpes remission time were better.Plotting the funnel plot of publication bias on reporting clinical efficacy showed that the distribution of studies were generally symmetrical,but there were still studies outside the funnel plot,suggested the possibility of publication bias.Conclusion According to the current evidence,Xiaoer Chiqiao Qingre granules combined with conventional western medicine is highly effective and safe in the treatment of pediatric hand-foot-mouth disease,which can shorten the fever relieving time and herpes remission time,and promote the disease recovery rapidly.