中国中医眼科杂志2025，Vol.35Issue(4)：306-313,329,9.DOI:10.13444/j.cnki.zgzyykzz.2025.04.002
滋肾活血颗粒治疗原发性开角型青光眼阴虚血涩证的多中心随机对照研究
A Multicenter Randomized Controlled Study on the Treatment of Primary Open-angle Glaucoma with Yin Deficiency and Blood Stasis Syndrome Using Zishen Huoxue Granules
摘要
Abstract
OBJECTIVE To evaluate the clinical efficacy of Zishen Huoxue Granules in treating primary open-angle glaucoma(POAG)with Yin deficiency and blood stasis syndrome.METHODS A multicenter randomized controlled study was conducted,enrolling 100 patients(200 eyes)diagnosed with POAG with Yin deficiency and blood stasis syndrome from five hospitals,including Eye Hospital,China Academy of Chinese Medical Sciences.Patients were randomly assigned to either the treatment group(50 patients,100 eyes)or the control group(50 patients,100 eyes).The control group received conventional intraocular pressure-lowering eye drops,while the treatment group received Zishen Huoxue Granules in addition to the standard therapy.Both groups were treated for three months.Visual field,Traditional Chinese Medicine(TCM)syndrome efficacy,best-corrected visual acuity(BCVA),average retinal nerve fiber layer(RNFL)thickness,and intraocular pressure(IOP)were assessed before and after treatment.Psychological status,degree of visual impairment,and quality of life were evaluated using the type a behavior scale,visual function questionnaire,and vision-related quality of life scale.RESULTS(1)Visual field defect:The treatment group showed greater improvement in visual field defects than the control group,with a statistically significant difference(χ2=3.979,P=0.046).(2)TCM syndrome scale scores:After treatment,the total scores of the TCM syndrome scale in the treatment group were significantly lower than those in the control group(Z=-5.210,P=0.001).(3)TCM syndrome efficacy:The improvement in TCM syndrome efficacy in the treatment group was significantly better than that in the control group(χ2=8.392,P=0.004).(4)Ophthalmic examination:After treatment,the pattern standard deviation(PSD)in the treatment group was lower than that in the control group,while RNFL thickness and BCVA were higher,with statistically significant differences(tPSD=-2.550,P=0.012;tRNFL=2.433,P=0.016;tBCVA=2.007,P=0.046).There was no statistically significant difference between the two groups in mean deviation(MD)of the visual field and IOP(P>0.05).(5)Scale scores:The Type A Behavior Scale scores in the treatment group were significantly lower than those in the control group(t=-3.720,P=0.000).The total scores of the Visual Function Questionnaire were also significantly lower in the treatment group(t=-5.123,P=0.000).The overall scores and self-rated quality of life scores on the Vision-Related Quality of Life Scale in the treatment group were significantly higher than those in the control group(toverall score=2.015,P=0.047;tquality of life=4.997,P=0.000).(6)Adverse reactions:No adverse reactions were observed in either group.CONCLUSIONS Zishen Huoxue Granules can effectively improve RNFL thickness,slow the progression of visual field defects,enhance visual acuity,and alleviate TCM clinical symptoms while improving the quality of life in POAG patients with Yin deficiency and blood stasis syndrome.The treatment has definite efficacy and is worthy of clinical promotion.关键词
原发性开角型青光眼/阴虚血涩证/滋肾活血颗粒/青风内障/多中心随机对照研究/临床试验Key words
primary open-angle glaucoma/Yin deficiency and blood stasis syndrome/Zishen Huoxue Granules/Qingfeng Neizhang/multicenter randomized controlled study/clini-cal trial分类
医药卫生引用本文复制引用
倘孟莹,魏宇娇,张丽霞,谢律,邱礼新,杨迎新,周剑,褚利群,杨玥,孙志超..滋肾活血颗粒治疗原发性开角型青光眼阴虚血涩证的多中心随机对照研究[J].中国中医眼科杂志,2025,35(4):306-313,329,9.基金项目
1国家自然科学基金面上项目(82074500)2首都卫生发展科研专项重点攻关项目(2018-1-4181)3中国中医科学院科技创新工程重大攻关项目(CI2021A02605) （82074500）
