方法：通过随机数字表的方法将113例162眼糖尿病黄斑水肿患者分为观察组(55例80眼)和对照组(58例82眼)，观察组给予七叶皂苷钠联合激光光凝治疗，对照组单纯应用激光光凝治疗，同时运用光学相干断层扫描检测和荧光素血管造影检查所有患者不同时间的黄斑水肿厚度和眼底情况，同时检测不同治疗时间双眼视力，治疗同时监测患者的不良反应，评价其安全性。

结果：治疗前观察组和对照组眼压、BCVA、CMT、黄斑区发生荧光渗漏的比例两组比较无统计学差异(P>0.05)。两组治疗前后眼压差异均无统计学差异(P>0.05)，组间比较无统计学差异(P>0.05)。观察组治疗后1、2、3、4mo BCVA、CMT、黄斑区发生荧光渗漏的比例均优于治疗前(P<0.05)，观察组术后各时间点间3 项指标两两比较差异均有统计学意义(均为P<0.05)。对照组治疗后1、2、3、4mo，BCVA、CMT、黄斑区发生荧光渗漏的比例均优于治疗前(P<0.05)，但对照组治疗后各个时间点BCVA两两比较差异均无统计学意义(P>0.05)，对照组治疗后各时间点间CMT及黄斑区发生荧光渗漏的比例两两比较差异均有统计学意义(均为P<0.05)。三项治疗除治疗后1mo BVCA观察组与对照组无统计学差异之外(P>0.05)，其他指标均观察组优于同期对照组(均为P<0.05)。观察期间观察组有 8例9眼(14. 5%)患者发生胃部不适、恶心等不良反应，但未有严重的药物不良反应或后遗症，观察组有4例5眼，对照组有5例5眼因为玻璃体积血需行其他治疗而退出治疗，两组比较无统计学意义(P>0.05)。

结论：七叶皂苷钠片联合激光光凝治疗糖尿病黄斑水肿是一种疗效好且安全的方法。

METHODS:One hundred and sixty-two eyes in 113 DME patients were randomly divided into observation group treated with sodium aescinate combined with 532nm laser(55 cases with 80 eyes)and control group treated with single Nd:YAG 532nm laser(58 cases with 82 eyes). Fundus evaluation including the thickness of macular edema and best corrected visual acuity(BCVA)in all patients were measured by optical coherence tomography(OCT)to analyze the differences before and after treatments(1,2,3 and 4mo). All patients also underwent fundus fluorescein angiography(FFA)before and at 4 mo after treatments.

RESULTS:There was no statistical difference on intraocular pressure(IOP),BCVA,CMT and the number of patient with fluorescence leakage before and after treatments between the two groups(P>0.05).IOP before and after treatments had no significant differences between the two groups(P>0.05). The BCVA,CMT and number of patients with fluorescence leakage at 1,2,3 and 4mo after treatments of two groups were better than those before treatments,and the differences were statistical significant(all P<0.05).The BCVA, CMT and the number of patients with fluorescence leakage at 1,2,3 and 4mo after treatments of observation group by multiple comparison were statistical significant(all P<0.05). The BCVA at 1,2,3 and 4mo after treatments of control group were not statistical significant by multiple comparison(all P>0.05),The CMT and the number of patients with fluorescence leakage at 1,2,3 and 4mo after treatments of control group were statistical significant by multiple comparison(all P<0.05). Except for 1mo after treatments,the BCVA were not statistical significant between two groups(P>0.05). The BCVA,CMT and number of patients of fluorescence leakage of observation group at same time after treatments were better than those of control group,and the differences were statistical significant(all P<0.05).Eight patients with 9 eyes(14.5%)of observation group had upset stomach and nausea. Four cases(5 eyes)in observation group and 5 cases(5 eyes)in control group developed vitreous hemorrhage and the difference was no statistically significant(P>0.05).

CONCLUSION:It is an effective and safe therapeutic method for diabetic macular edema by sodium aescinate combined with laser.