目的：探讨康柏西普对糖尿病性黄斑水肿(DME)患者血清lncRNA MALAT1水平、黄斑中央区厚度(CMT)及最佳矫正视力(BCVA)的影响，观察其治疗的有效性与安全性。

方法：纳入DME患者300例300眼，均为单眼病变。按照随机数字表法进行分组：非注射组100例100眼，对照组100例100眼给予雷珠单抗治疗，研究组100例100眼给予康柏西普治疗。

结果：治疗前与治疗后1、2、3mo测定患者BCVA、血清lncRNA MALAT1水平及CMT，同时对比临床疗效，并对患者进行随访，记录不良反应发生情况。非注射组患者的BCVA(LogMAR)、血清lncRNA MALAT1水平与CMT均无明显变化(P>0.05)。对照组、研究组患者治疗后1、2、3mo的BCVA(LogMAR)与治疗前相比明显提高(均P<0.05)，但研究组与对照组相比，差异无统计学意义。对照组患者治疗后1、2、3mo血清lncRNA MALAT1水平降低，研究组患者治疗后1、2、3mo血清lncRNA MALAT1水平降低更明显，研究组治疗后血清lncRNA MALAT1水平明显低于对照组(均P<0.05)。对照组患者治疗后1、2、3mo CMT降低，研究组患者治疗后1、2、3mo CMT降低更明显，研究组治疗后CMT明显低于对照组(均P<0.05)。研究组不良反应发生率(2.0%)明显低于对照组(11.0%)。

结论：康柏西普能够显著降低DME患者血清lncRNA MALAT1水平，降低CMT、减轻黄斑水肿，改善视力，其治疗有效性与安全性明显优于雷珠单抗。

METHODS: A total of 300 patients(300 eyes)with DME were included in this study, all of whom had monocular lesions. They were divided into non-injection group with 100 patients(100 eyes), control group with 100 patients(100 eyes)treated with Ranibizumab injections and study group with 100 patients(100 eyes)treated with Conbercept injections according to a random numbers table.

RESULTS: The BCVA, serum lncRNA MALAT1 level and CMT were measured before and 1, 2 and 3mo after treatment. In addition, the clinical efficacy was assessed and the patients were followed up to record the adverse reactions. There were no significant changes in BCVA(LogMAR), serum lncRNA MALAT1 level and CMT in the non- injection group(P>0.05). The BCVA(LogMAR)in the control group and study group at 1, 2 and 3mo after treatment was significantly higher than that before treatment(all P<0.05). The BCVA(LogMAR)of patients in the study group at 1, 2 and 3mo after treatment was significantly higher than that before treatment(all P<0.05), but there was no significant difference between the study group and control group. The level of serum lncRNA MALAT1 in the control group decreased at 1, 2 and 3mo after treatment, and it decreased more significantly in the study group at 1, 2 and 3mo after treatment. The level of serum lncRNA MALAT1 in the study group was significantly lower than that in the control group(all P<0.05).The CMT of patients in the control group decreased at 1, 2 and 3mo after treatment; however, the CMT of patients in the study group decreased more significantly at 1, 2 and 3mo after treatment. The CMT of the study group was significantly lower than that of the control group(all P<0.05).The incidence of adverse reactions in the study group(2.0%)was significantly lower than that in the control group(11.0%).

CONCLUSION: Conbercept can significantly reduce the level of serum lncRNA MALAT1, CMT and macular edema and improve BCVA in patients with DME. Its therapeutic efficacy and safety are significantly better than Ranibizumab.