基于真实世界研究评价四桑明目方联合西医治疗对晚期湿性老年性黄斑变性患者视力、眼底情况及生活质量的影响

Real-world study of Sisang Mingmu Formula combined with Western medicine on vision,fundus and quality of life in patients with advanced wet age-related macular degeneration

目的基于真实世界研究评价四桑明目方联合西医治疗对晚期湿性老年性黄斑变性(wAMD)患者视力、眼底情况及生活质量的影响。方法将198例(322眼)晚期wAMD患者按照治疗方法不同分为2组。对照组119例(183眼)接受西医治疗,试验组79例(139眼)在对照组基础上加四桑明目方治疗。2组均治疗3个月,随访3个月。记录所有患者基本信息、检查结果。应用倾向性评分匹配法(PSM)匹配2组中基线一致患者,剔除不匹配患者,得到试验组69例(116眼),对照组69例(115眼)。统计基线匹配的2组患者治疗前后最佳矫正视力(BCVA)的总有效率、黄斑中心凹厚度(CMT)、眼底病灶总面积和低视力者生活质量量表(CLVQOL)评分变化、安全指标及随访3个月后BCVA总有效率。结果治疗后试验组BCVA总有效率31.90%(37眼/116眼),对照组为19.13%(22眼/115眼),试验组优于对照组(P<0.05)。随访3个月试验组BCVA总有效率26.72%(31眼/116眼),对照组为13.04%(15眼/115眼),试验组优于对照组(P<0.05)。2组治疗后眼底CMT均较本组治疗前降低(P<0.05),且试验组治疗后低于对照组(P<0.05);2组治疗后眼底视网膜病灶总面积均较本组治疗前增大(P<0.05),而对照组治疗后高于试验组(P<0.05)。2组治疗后远视力、移动、光感和日常生活能力评分均较本组治疗前升高(P<0.05),且试验组治疗后以上评分均高于对照组(P<0.05)。2组治疗前后安全指标正常且无不良反应发生。结论四桑明目方联合西医治疗晚期wAMD能一定程度提高患者视力,改善眼底水肿,延缓病情发展,提高患者生活质量。

Objective To evaluate the effects of Sisang Mingmu Formula combined with Western medicine on vision,fundus and quality of life in patients with advanced wet age-related macular degeneration(wAMD)based on real-world study.Methods Totally 198 patients(322 eyes)with advanced wAMD were assigned to receive either Western medicine(the control group,n=119,183 eyes)or Sisang Mingmu Formula combined with Western medicine(the test group,n=79,139 eyes).The 3-month follow-up were performed following 3-month of treatment.The basic information and examination results were recorded.Propensity score matching(PSM)was used to match baseline consistent in patients of the both groups.After excluding unmatched patients,69 patients(116 eyes)in the test group and 69 patients(115 eyes)in the control group were matched.The total effective rate of best-corrected visual acuity(BCVA),central macular thickness(CMT),the area of fundus lesions,Chinese-version low vision quality of life questionnaire(CLVQOL),safety indicators,the 3-month follow-up BCVA were included as comparators between the two groups.Results The total effective rate of BCVA in the test group was better than that in the control group(After treatment:31.90%[37 eyes/116 eyes]vs 19.13%[22 eyes/115 eyes];3-month follow-up:26.72%[31 eyes/116 eyes]vs 13.04%[15 eyes/115 eyes],both P<0.05).After treatment,CMT was significantly decreased in the both groups,especially in the test group(P<0.05).The area of fundus lesions was significantly enlarged in the both groups,which was significantly higher in the control group than in the test group(P<0.05).The score of distance visual acuity,mobility,light perception and activity of daily living(ADL)in the both groups were significantly increased(P<0.05),which increased notably in the test group compared with the control group(P<0.05).Neither safety indicators and nor adverse reactions occurred in the both groups after treatment.Conclusion For patients with advanced wAMD,Sisang Mingmu Formula combined with Western medicine can improve vision and fundus edema,delay the enlargement of fundus lesions and improve the quality of life to some extent.