目的 系統(tǒng)評價益生菌制劑治療兒童手足口病的臨床療效和安全性。方法 計算機檢索PubMed、Cochrane Library、中國學術期刊全文數(shù)據(jù)庫（CNKI）、中國生物醫(yī)學文獻數(shù)據(jù)庫（CBM）和維普中文期刊全文數(shù)據(jù)庫（VIP）和萬方數(shù)據(jù)庫，搜集益生菌制劑治療兒童手足口病的隨機對照試驗（RCTs），檢索時限均為建庫至2019年12月，采用RevMan 5.3軟件進行Meta-分析。結果 共納入16個RCTs，共1 605例患兒。Meta-分析結果顯示，與常規(guī)治療相比，聯(lián)用益生菌制劑能顯著提高臨床有效率[RR=1.26，95% CI=（1.20，1.32）]；縮短退熱時間[MD=-0.76，95% CI=（-0.84，-0.36）]、皰疹結痂時間[MD=-1.23，95% CI=（-1.33，-1.13）]、口腔潰瘍愈合時間[MD=-1.06，95% CI=（-1.36，-0.72）]；減小二胺氧化酶水平[MD=-0.81，95% CI=（-0.96，-0.65）]、D-乳酸水平[MD=-2.40，95% CI=（-2.76，-2.03）]和內(nèi)毒素水平[MD=-0.14，95% CI=（-0.15，-0.12）]；降低TNF-α水平[MD=-0.87，95% CI=（-1.46，-0.28）]、CRP水平[MD=-0.35，95% CI=（-0.47，-0.24）]和IL-6水平[MD=-4.69，95% CI=（-7.09，-2.29）]，組間比較差異均有統(tǒng)計學意義（P<0.01）。在不良反應發(fā)生率，兩組的差異無統(tǒng)計學意義。結論 益生菌制劑能縮短兒童手足口病患者的臨床體征改善時間、改善腸黏膜屏障功能、提高免疫功能和降低炎性因子水平，且安全性較好，值得臨床推廣。

Objective To systematically evaluate the clinical efficacy and the safety of probiotics in the treatment of hand, foot and mouth disease (HFMD) in children. Methods Pubmed, Cochrane Library, CNKI, CBM, VIP and WanFang Data were electronically searched to collect randomized controlled trials (RCTs) of probiotics in the treatment of children with HFMD from inception to December 2019, Meta-analysis was performed by RevMan 5.3 software. Results A total of 16 RCTs involving 1 605 children were included. Meta-analysis results showed that compared with conventional treatment, combined probiotic preparations can significantly:improve total effective rate[RR=1.26, 95% CI=(1.20, 1.32)]; shorten fever time[MD=-0.76, 95% CI=(-0.84, -0.36)], herpes crusting time[MD=-1.23, 95% CI=(-1.33,-1.13)], oral ulcer healing time[MD=-1.06, 95% CI=(-1.36,-0.72)]; reduced DAO levels[MD=-0.81, 95% CI=(-0.96, -0.65)], D-LA levels[MD=-2.40, 95% CI=(-2.76, -2.03)] and ET levels[MD=-0.14, 95% CI=(-0.15, -0.12)]; reduce TNF-α levels[MD=-0.87, 95% CI=(-1.46, -0.28)], CRP levels[MD=-0.35, 95% CI=(-0.47,-0.24)] and IL-6 levels[MD=-4.69, 95% CI=(-7.09,-2.29)], the differences between two group were statistically significant (P<0.01). There were no significant differences in rate of ADR. Conclusion For the children with HFMD, probiotic can short the time for improvement, improve intestinal mucosal barrier function, improve immune function and reduce inflammatory factor levels, and have better safety, worth of clinical promotion.

R978.7;R985