和血明目片治疗湿性年龄相关性黄斑变性的临床观察

Clinical observation on Hexue Mingmu tablets in treatment of wet age-related macular degeneration

目的观察和血明目片治疗湿性年龄相关性黄斑变性(AMD)的临床疗效。方法收集符合纳入标准的湿性AMD患者99例(99只眼),随机分为治疗组50例(50只眼)和对照组49例(49只眼)。治疗组予和血明目片口服联合雷珠单抗球内注射治疗,和血明目片口服3个月;对照组予单纯雷珠单抗球内注射治疗。2组均球内注射3次,每个月1次。分别于治疗前、治疗后3个月对患者行最佳矫正视力(BCVA)、荧光素眼底血管造影(FFA)、光学相干断层扫描(OCT)和眼底照相检查,比较2组患者BCVA,黄斑区视网膜中央厚度(CRT),眼底视网膜渗漏面积、视网膜出血面积变化情况。结果 (1)BCVA:治疗3个月后,2组比较,差异有统计学意义(t=-2.423,P=0.017)。治疗前后比较,t治疗组=18.610,t对照组=12.718,均P=0.000,差异有统计学意义。(2)CRT:治疗3个月后,2组比较差异有统计学意义(t=-2.415,P=0.018)。治疗前后比较,t治疗组=154.517,t对照组=107.747,均P=0.000,差异有统计学意义。(3)视网膜渗漏面积:治疗3个月后,2组比较,差异无统计学意义(t=-0.394,P=0.694)。治疗前后比较,t治疗组=9.590,t对照组=10.127,均P=0.000,差异有统计学意义。(4)视网膜出血面积:治疗3个月后,2组比较,差异有统计学意义(t=-3.459,P=0.001)。治疗前后比较,t治疗组=5.629,P治疗组=0.000,t对照组=2.835,P对照组=0.006,差异有统计学意义。结论和血明目片联合雷珠单抗治疗湿性AMD,能更好的改善患者眼部指标,优于单独使用雷珠单抗球内注射治疗。

OBJECTIVE To observe the clinical efficacy of Hexue Mingmu tablets in the treatment of wet age-related macular degeneration(AMD). METHODS A total of 99 patients(99 eyes) with wet AMD who met the inclusion criteria were randomly divided into the treatment group(50 cases, 50 eyes) and the control group(49 cases, 49 eyes). The treatment group was treated with Hexue Mingmu tablets orally and Lucentis intravitreal injection, and Hexue Mingmu tablets was taken for 3 months;the control group was treated with Lucentis intravitreal injection alone. Both groups were injected 3 times, once a month. Before the treatment and 3 months after the treatment,the patients underwent examinations as the best corrected visual acuity(BCVA), fluorescein fundus angiography(FFA), optical coherence tomography(OCT), and fundus photography. The LogMAR BCVA, macular changes in central retinal thickness(CRT), fundus retinal leakage area, and retinal hemorrhage area of two groups were compared. RESULTS(1) BCVA: Three months after treatment, the difference between the two groups was statistically significant(t =-2.423, P =0.007).Comparison within groups showed that, the treatment group(t=18.610, P=0.000) and the control group(t=12.718, P=0.000) both experienced statistically significant variation.(2) CRT: Three months after treatment, the difference between the two groups was statistically significant(t=-2.415,P=0.018). Comparison within groups showed that, the treatment group(t=154.517, P=0.000) and the control group(t= 107.747, P=0.000) both experienced statistically significant variation.(3) Fundus retinal leakage area: Three months after treatment, the difference between the two groups was not statistically significant(t=-0.394,P=0.694). Comparison within groups showed that, the treatment group(t =9.590, P=0.000) and the control group(t= 10.127, P=0.000) both experienced statistically significant variation.(4) Fundus retinal hemorrhage area: Three months after treatment, the difference between the two groups was not statistically significant(t=-3.459,P=0.001). Comparison within groups showed that, the treatment group(t = 5.629, P= 0.000) and the control group(t= 2.835, P=0.006) both experienced statistically significant variation. CONCLUSIONS In the treatment of wet AMD, Hexue Mingmu tablets combined with Lucentis better improved the ocular index of patients, which was better than treatment with Lucentis intravitreal injection alone.