目的 观察和血明目片联合抗血管内皮生长因子(vascular endothelial growth factor, VEGF)药物雷珠单抗治疗湿性年龄相关性黄斑变性(wet age-related macular degeneration, wAMD)的临床效果。方法 选择2016-06至2018-06收治的96例(96只眼)wAMD患者,按照随机数字表法分为治疗组和对照组,每组48例(48只眼)。治疗组给予雷珠单抗球内注射联合和血明目片口服治疗,对照组仅给予雷珠单抗球内注射治疗。两组均连续治疗3个月,治疗结束后随访3个月,观察最佳矫正视力(best corrected visual acuity,BCVA)、黄斑区视网膜中央厚度(central retinal thickness,CRT)、黄斑出血面积、渗出面积及累积损伤面积等情况,随访结束后黄斑水肿复发情况,并进行统计学评价。结果 (1)BCVA:治疗3个月后,两组均比治疗前升高(t=8.320,t=4.689,P＜0.01),且治疗组高于对照组(t=2.509,P＜0.01);随访3个月后,两组均比治疗前高,差异有统计学意义(t=7.909,t=3.808,P＜0.01),且治疗组高于对照组(t=3.164,P＜0.01)。(2)CRT:治疗3个月后,两组均低于治疗前(t=16.864,t=14.175,P＜0.01),但两组间差异无统计学意义(t=1.402);随访3个月后,两组均低于治疗前,差异有统计学意义(t=14.478,P＜0.01),且治疗组低于对照组(t=2.687,P＜0.05)。(3)治疗后3个月,两组眼底出血、渗出及总的累积损伤面积均较治疗前明显缩小(P均＜0.05),且治疗组眼底出血面积(t=2.893,P＜0.05)和累积损伤面积缩小幅度(t=2.164,P＜0.05)较对照组更明显,均有统计学意义。(4)两组复发率比较,差异有统计学意义(χ²=4.937,P＜0.05)。结论 抗VEGF球内注射联合和血明目片治疗wAMD的临床疗效肯定,联合治疗在控制黄斑出血及水肿复发方面有优势。

Objective To observe the clinical efficacy of Hexue Mingmu tablets combined with anti-vascular endothelial growth factor (VEGF) drug (ranibizumab) in the treatment of wet age-related macular degeneration (wAMD).Methods Ninety-six patients (96 eyes) with wAMD were randomly divided into two groups using the random number table method: the treatment group (48 eyes)that was treated with anti- VEGF intravitreal injection combined with Hexue Mingmu tablets and the control group(48 eyes) treated with anti-VEGF intravitreal injection alone. Both groups were treated for three consecutive months. The best corrected visual acuity (BCVA), central retinal thickness in the macular area (CRT), macular hemorrhage area, exudation area and cumulative injury area were observed in both groups for 3 months. The recurrence of macular edema was analyzed and evaluated statistically after the follow-up.Results (1)After 3 months of treatment, BCVA was increased in both groups(t=8.320 vs t=4.689),especially in the treatment group. After 6 months of treatment, BCVA was increased in both groups (t=7.909 vs t=3.808) and the difference between the two groups was statistically significant.(2)After 3 months of treatment, CRT was decreased in both groups(t=16.864 vs t=14.175), but there was no statistically significant difference between the two groups. After 6 months of treatment, CRT was decreased in both groups, especially in the treatment group, but there was statistically significant difference between the two groups.(3) After 3 months of treatment, the areas of macular hemorrhage, exudation and cumulative injury in both groups were significantly smaller, especially in the treatment group (P<0.05). (4) The recurrence rate was significantly different between the two groups (χ²=4.937,P<0.05).Conclusions The clinical efficacy of anti-VEGF intravitreal injection combined with Hexue Mingmu tablets in the treatment of age-related macular degeneration is confirmed, and the combined treatment is superior to the single anti-VEGF intravitreal injection in the control of macular hemorrhage and edema recurrence.