目的：系统评价杞菊地黄丸治疗干眼的有效性和安全性。

方法：计算机检索PubMed，EMBASE，Web of Science，The Cochrane Library，CBM，CNKI，VIP和万方等数据库，搜集关于杞菊地黄丸治疗干眼的研究，检索时限均为建库至2019-06。由2名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后，采用RevMan5.3及Stata12.0软件进行Meta分析。

结果：共纳入17篇临床随机对照试验(RCT)共1 662例受试者，其中干预组834例，对照组828例。Meta分析结果显示，与对照组相比，杞菊地黄丸组在泪膜破裂时间[MD=4.32，95%CI(3.15，5.49)，P<0.00001]、泪液分泌量[SMD=1.07，95%CI(0.71，1.42)，P<0.00001]、角膜荧光素钠染色[MD=-1.01，95%CI(-1.61，-0.40)，P=0.001]、总有效率[OR=7.22，95%CI(4.36，11.93)，P<0.00001]等方面更优。两组均无严重的不良反应。GRADE结果表示，与对照组相比，杞菊地黄丸治疗干眼症BUT、S I t、有效率的证据等级为“低”； FL的证据等级为“极低”。

结论：与常规治疗相比，杞菊地黄丸治疗干眼疗效更佳，且未有研究报道出现严重的不良反应。

METHODS: PubMed, EMbase, Web of Science. The Cochrane Library, CBM, CNKI, VIP and WanFang Data databases were electronically searched to identify randomized controlled trials(RCTs)of Qiju Dihuang Pill on xerophthalmia from the inception of the databases to June 2019. Two reviewers independently screened literatures, extracted data and assessed risk of bias of the included trials. The Meta-analysis was conducted with RevMan 5.3 and Stata 12.0 software.

RESULTS: Totally 17 RCTs with 1 662 patients were included. The results of the Meta-analysis showed that, compared with the control group, the Qiju Dihuang Pill group had statistical difference in BUT(MD=4.32, 95% CI 3.15 to 5.49, P<0.00001), SⅠt(SMD =1.07, 95% CI 0.71 to 1.42, P<0.00001), FL(MD= -1.01, 95% CI -1.61 to -0.40, P=0.001), efficiency(OR=7.22, 95% CI 4.36 to 11.93, P<0.00001). There were no serious adverse reactions in either group. The results of GRADE showed that the level of evidence of BUT, SⅠt, efficiency was low, and the level of evidence of FL was very low.

CONCLUSION: The current evidence indicated that Qiju Dihuang Pill had a better therapeutic effect on xerophthalmia than conventional treatment, and no serious adverse reactions were reported in the study. Considering the limitations of the quality and quantity of the included studies,more well-designed randomized controlled trials are required to verify the above conclusions.