四桑明目方联合抗新生血管药物治疗湿性年龄相关性黄斑变性的临床疗效及经济学价值

Clinical efficacy and economic value of Sisang Mingmu decoction combined with anti-angiogenicdrugs in the treatment of wet age-related macular degeneration

目的观察四桑明目方联合抗新生血管药物治疗痰瘀互结兼肝肾阴虚型湿性年龄相关性黄斑变性(wAMD)患者的临床疗效及经济学价值。方法收集2021年12月—2022年12月在北京中医药大学东方医院眼科和中国中医科学院眼科医院眼底病科治疗的痰瘀互结兼肝肾阴虚型wAMD患者86例,采用随机对照方法将患者分为对照组和治疗组,每组43例。2组均给予抗新生血管药物(雷珠单抗或康柏西普,一种药物无效可更换另一种药物)治疗,在此基础上对照组给予中药安慰剂颗粒口服,治疗组给予四桑明目方颗粒口服,2组疗程均为3个月,随访3个月。观察2组治疗前后最佳矫正视力(BCVA)、黄斑中央厚度(CMT)、眼底脉络膜新生血管(CNV)面积、眼底出血面积、视物变形面积,统计2组治疗3个月后和随访3个月疗效及药物成本-效果(C/E),记录治疗期间不良事件发生情况。结果治疗3个月后,2组BCVA(LogMAR)、CMT、眼底CNV面积、眼底出血面积、视物变形面积均明显低于治疗前(P均<0.05),且治疗组BCVA(LogMAR)、CMT、眼底CNV面积均明显低于对照组(P均<0.05)。治疗3个月后,治疗组总有效率为93.22%(40/43),高于对照组的69.77%(30/43),差异有统计学意义(P<0.05);随访3个月,治疗组总有效率为79.07%(27/34),高于对照组的56.25%(18/32),差异有统计学意义(P<0.05)。治疗3个月后,治疗组药物C/E并不优于对照组(P>0.05),而随访3个月后治疗组药物C/E优于对照组(P<0.05)。治疗期间2组均未发生明显不良事件。结论四桑明目方联合抗新生血管药物治疗痰瘀互结兼肝肾阴虚型wAMD对视力、黄斑水肿、眼底新生血管的影响更明显,对眼底出血、视物变形的影响较单纯西药治疗未显示出明显优势;从长期治疗看,四桑明目方联合抗新生血管药物治疗比单独抗新生血管药物治疗花费低。

Objective It is to observe the clinical efficacy and economic value of Sisang Mingmu decoction combined with anti-angiogenic drugs in the treatment of patients with wet age-related macular degeneration(wAMD)of syndrome of phlegm and blood stasis binding with liver and kidney Yin deficiency.Methods Eighty-six patients with wAMD of syndrome of phlegm and blood stasis binding with liver and kidney Yin deficiency treated at the Department of Ophthalmology of Dongfang Hospital of Beijing University of Chinese Medicine,and the Department of Fundus Disease of Eye Hospital of China Academy of Chinese Medicine Science from December 2021 to May 2023 were collected,and they were divided into the control group and treatment group by a randomized controlled method,with 43 patients in each group.Both groups were treated with antineovascular drugs(either Ranibizumab or Both groups were treated with anti-angiogenic drugs(Ranibizumab or Conbercept,the drug could be replaced if bad effect),additionally,the control group was given herbal placebo granules orally,and the treatment group was given Sisang Mingmu decoction granules orally.Both groups were treated for 3 months,and followed-up for 3 months.The best corrected visual acuity(BCVA),central macular thickness(CMT),area of choroidal neovascularization(CNV),area of fundus hemorrhage,and area of visual distortion were observed before and after treatment in the two groups.The efficacy of the treatment and the drug cost-effectiveness(C/E)were assessed in the 2 groups after 3 months of treatment and 3 months of follow-up,and the occurrence of adverse events during the treatment period was recorded.Results After 3 months of treatment,the BCVA(logMAR),CMT,fundus CNV area,fundus hemorrhage area,and visual distortion area of the two groups were significantly lower than those before treatment(all P<0.05),and the BCVA(logMAR),CMT,and fundus CNV area of the treatment group were significantly lower than those of the control group(all P<0.05).After 3 months of treatment,the total effective rate of the treatment group was 93.22%(40/43),which was higher than that 69.77%(30/43)of the control group,and the difference was statistically significant(P<0.05).After 3 months of follow-up,the total effective rate of the treatment group was 79.07%(27/34),which was higher than that 56.25%(18/32)of the control group,and the difference was statistically significant(P<0.05).After 3 months of treatment,the drug C/E of the treatment group was not superior to that of the control group(P>0.05),while the drug C/E of the treatment group was superior to that of the control group after 3 months of follow-up(P<0.05).No significant adverse events occurred in the 2 groups during the treatment period.Conclusion Sisang Mingmei decoction combined with anti-angiogenic drugs is effective in the treatment of wAMD of syndrome of phlegm and blood stasis binding with liver and kidney Yin deficiency,especially in improving visual acuity,macular edema,and fundus neovascularization,but not significantly better in improving fundus hemorrhage and visual distortion compared with western medicine alone;from the perspective of long-term treatment,the combination of Sisang Mingmei decoction with anti-angiogenic drugs was less costly than that of the anti-angiogenic drugs alone.