AIM:To explore the clinical efficacy and safety of self Yiqi Yangyin Sanyu Fang in treatment of dry eyes syndrome. METHODS: Totally 78 patients ( 96 eyes ) were randomly divided into two groups from January 2009 to December 2012 in Ophthalmology Department of our hospital, control group was given local artificial tears, the observation group was given artificial tears and Chinese medicine Yiqi Yangyin Sanyu Fang, SchirmerⅠtest ( SⅠ t ) , tear break -up time ( BUT ) , corneal fluorescein staining ( FL) and clinical efficacy of the two groups were compared. RESULTS: After treatment, SⅠt, BUT of two groups were higher than that of before treatment, FL was lower than that of before treatment, the difference was statistically significant (P<0.05), after treatment SⅠt, BUT of observed group were higher than that of the control group, FL was lower than the control group, the difference was statistically significant ( P<0.05 ); the efficiency rate of observation group was 83%, control group 71%, there were statistically significant differences in the two groups ( Ridit z =24.382, P =0.000 ), the observation group effect was better than that of control group. CONCLUSION: Chinese medicine Yiqi Yangyin Sanyu Fang have no obvious side effect, it can improve the clinical symptoms of dry eye syndrome and is worthy clinical application.%目的：探讨自拟益气养阴散瘀方对干眼症的临床疗效和安全性。 方法：将2009-01/2012-12我院眼科收治78例96眼干眼患者随机分为两组，对照组给予局部人工泪液，观察组增加中药益气养阴散瘀方治疗，比较两组泪液分泌量（Schirmer Ⅰtest，SⅠt）、泪膜破裂时间（BUT）、角膜荧光素染色（ FL）及临床疗效。 结果：治疗后，两组SⅠt，BUT均高于治疗前，FL低于治疗前，差异有统计学意义（P＜0．05），观察组SⅠt，BUT高于对照组， FL 低于对照组，差异有统计学意义（ P＜0.05）；经治疗后观察组有效率为83％，对照组为71％，两组患者疗效差异有统计学意义（ Ridit z＝24．382，P＝0.000），观察组疗效优于对照组。 结论：中药益气养阴散瘀方无明显毒副作用，能够改善干眼症临床症状，值得临床推广应用。
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