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驻景丸加减方治疗肝肾不足型干性AMD的临床疗效观察

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目的 研究驻景丸加减方治疗干性年龄相关性黄斑变性(AMD)临床疗效及其抗氧化作用.方法 纳入2021年3月—2023年3月江苏省溧阳市中医医院就诊的肝肾不足型干性AMD患者48例(74只眼),随机分为治疗组24例(38只眼)和对照组24例(36只眼).治疗组予驻景丸加减方口服,对照组予叶黄素胶囊口服,均连续用药3个月.分别于治疗前及治疗后3个月,检测并记录患者视力、眼底自发荧光强度、血清氧化指标[丙二醛(MDA)、核转录因子(Nrf2)、活性氧(ROS)、谷氨酸半胱氨酸连接酶(GCL)、I型血红素氧化酶(HO-1)、NAD(P)H醌氧化还原酶1(NQO-1)、超氧化物歧化酶(SOD)、谷胱甘肽过氧化物酶(GSH-Px)、过氧化氢酶(CAT)]及中医临床证候评分等情况.结果 (1)视力:治疗组治疗后视力较治疗前提高,差异有统计学意义(t=3.443,P=0.001);对照组治疗后视力与治疗前比较,差异无统计学意义(P>0.05).治疗后2组间比较,差异无统计学意义(P>0.05).(2)眼底自发荧光强度:治疗后2组眼底自发荧光强度与治疗前比较及治疗后2组间比较,差异均无统计学意义(P>0.05).(3)血清氧化指标:2组治疗后ROS、MDA水平均低于治疗前,Nrf2、GSH-Px、SOD2、GCL、CAT、HO-1、NQO-1水平均高于治疗前,差异均有统计学意义(治疗组:tROS=-3.594,P=0.002;tMDA=-3.395,P=0.002;tNrf2=3.146,P=0.005;tGSH-Px=2.081,P=0.049;tSOD2=2.335,P=0.029;tGCL=3.173,P=0.004;tCAT=3.086,P=0.005;tHO-1=3.526,P=0.002;tNQO-1=6.195,P=0.000.对照组:tROS=-2.225,P=0.036;tMDA=-3.037,P=0.006;tNrf2=2.245,P=0.035;tGSH-Px=3.714,P=0.001;tSOD2=2.852,P=0.009;tGCL=2.248,P=0.034;tCAT=2.649,P=0.014;tHO-1=2.121,P=0.045;tNQO-1=2.792,P=0.010).治疗后治疗组HO-1、NQO-1水平均高于对照组、GSH-Px水平低于对照组,差异均有统计学意义(tHO-1=2.242,P=0.030;tNQO-1=3.544,P=0.001;tGSH-Px=-2.127,P=0.039);余指标治疗后2组间比较,差异无统计学意义(P>0.05).(4)中医证候积分:治疗后2组中医证候积分均较治疗前降低,差异均有统计学意义(t治疗组=7.258、t对照组=4.818,均P=0.000).治疗后2组间比较,治疗组低于对照组,差异有统计学意义(t=2.236,P=0.030).(5)临床疗效:2组临床疗效比较,差异无统计学意义(P>0.05).结论 驻景丸加减方治疗干性AMD具有良好疗效,可增强机体抗氧化能力.
Clinical Efficacy of Zhujing Pill with Modifications in the Treatment of Dry Age-related Macular Degeneration and Its Antioxidant Effects
OBJECTIVE To evaluate the clinical efficacy and antioxidant effects of Zhujing Pill with modifications in the treatment of dry age-related macular degeneration(AMD).METHODS A total of 48 patients(74 eyes)with dry AMD and liver-kidney deficiency syndrome,who visited Liyang Hospital of Chinese Medicine between March 2021 and March 2023 were enrolled in the study.The patients were randomly divided into a treatment group(24 cases,38 eyes)and a control group(24 cases,36 eyes).The treatment group received oral Zhujing Pill with modifications,while the control group received oral Lutein.Both groups underwent continuous treatment for three months.Visual acuity,fundus autofluorescence intensity,serum oxidative markers[malondialdehyde(MDA),nuclear factor erythroid 2-related factor 2(Nrf2),reactive oxygen species(ROS),glutamate-cysteine ligase(GCL),heme oxygenase-1(HO-1),NAD(P)H quinone oxidoreductase 1(NQO-1),superoxide dismutase(SOD),glutathione peroxidase(GSH-Px),catalase(CAT)],and Traditional Chinese Medicine(TCM)clinical syndrome scores were measured and recorded before and after the three-month treatment period.RESULTS(1)Visual acuity:The treatment group showed a statistically significant improvement in visual acuity after treatment(t=3.443,P=0.001),while the control group did not show a statistically significant difference(P>0.05).However,there was no significant difference between the two groups after treatment(P>0.05).(2)Fundus autofluorescence intensity:There were no statistically significant differences in fundus autofluorescence intensity within or between the groups before and after treatment(P>0.05).(3)Serum oxidative markers:Post-treatment,the levels of ROS and MDA were significantly lower,while the levels of Nrf2,GSH-Px,SOD2,GCL,CAT,HO-1,and NQO-1 were significantly higher in both groups compared to pre-treatment levels(treatment group:tROS=-3.594,P=0.002;tMDA=-3.395,P=0.002;tNrf2=3.146,P=0.005;tGSH-Px=2.081,P=0.049;tSOD2=2.335,P=0.029;tGCL=3.173,P=0.004;tCAT=3.086,P=0.005;tHO-1=3.526,P=0.002;tNQO-1=6.195,P=0.000.control group:tROS=-2.225,P=0.036;tMDA=-3.037,P=0.006;tNrf2=2.245,P=0.035;tGSH-Px=3.714,P=0.001;tSOD2=2.852,P=0.009;tGCL=2.248,P=0.034;tCAT=2.649,P=0.014;tHO-1=2.121,P=0.045;tNQO-1=2.792,P=0.010).The treatment group showed significantly higher levels of HO-1 and NQO-1 and lower levels of GSH-Px compared to the control group after treatment(tHO-1=2.242,P=0.030;tNQO-1=3.544,P=0.001;tGSH-Px=-2.127,P=0.039),while the other markers showed no significant differences between the two groups(P>0.05).(4)TCM syndrome scores:Both groups showed a significant reduction in TCM syndrome scores after treatment(tTG=7.258,tCG=4.818,both P=0.000),the treatment group was lower than the control group after treatment,with a statistically significant difference(t=2.236,P=0.030).(5)Clinical Efficacy:There were no statistically significant differences in clinical efficacy between two groups(P>0.05).CONCLUSIONS Zhujing Pill with modifications provide effective treatment for dry AMD and can enhance the body's antioxidant capacity.

dry age-related macular degenerationZhujing Pillanti-oxidationNrf2 signal-ing pathway

李敏、陈春明、徐新荣、杨宁、张元钟、邵雁

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溧阳市中医医院,溧阳 213300

南京中医药大学附属医院,南京 210029

干性年龄相关性黄斑变性 驻景丸加减方 抗氧化 Nrf2信号通路

2024

中国中医眼科杂志
中国中医科学院

中国中医眼科杂志

CSTPCD
影响因子:0.476
ISSN:1002-4379
年,卷(期):2024.34(12)