首页|和营利水方治疗视网膜静脉阻塞继发黄斑水肿的疗效观察

和营利水方治疗视网膜静脉阻塞继发黄斑水肿的疗效观察

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目的 观察和营利水方治疗视网膜静脉阻塞继发黄斑水肿(RVO-ME)的临床疗效.方法 纳入2021年1月—2023年6月上海中医药大学附属龙华医院诊治的RVO-ME患者110例(110只眼).随机分为治疗组和对照组,最终纳入治疗组54例(54只眼)、对照组49例(49只眼).对照组予阿柏西普眼内注射液玻璃体腔内注射治疗.治疗组在对照组的基础上联合和营利水方口服.分别于治疗前、治疗后1、3、6、12个月检测2组受试者的最佳矫正视力(BCVA),采用光学相干断层扫描血管成像(OCTA)检测黄斑中心凹厚度(CMT)、视网膜浅层毛细血管丛血流密度(SCP)、视网膜深层毛细血管丛血流密度(DCP)、中心凹无血管区(FAZ)面积、非圆度指数(AI)和FAZ范围300 μm宽度内的血流密度(FD-300),记录数据并做统计分析.结果 (1)BCVA:治疗组治疗后各时间点的BCVA均较治疗前提高,差异均有统计学意义(t1个月=34.093、t3个月=57.481、t6个月=59.741、t12个月=46.442,均P=0.000).对照组治疗后各时间点BCVA均较治疗前提高,差异均有统计学意义(t1个月=29.606、t3个月=49.027、t6个月=48.711、t12个月=30.826,均P=0.000).治疗后2组间比较,治疗组治疗后各时间点的BCVA均优于对照组,差异均有统计学意义(t1个月=3.646、t3个月=5.068、t6个月=6.758、t12个月=11.549,均P=0.000).(2)CMT:治疗组治疗后各时间点的CMT均较治疗前降低,差异均有统计学意义(t1个月=34.702、t3个月=52.204、t6个月=51.470、t12个月=41.842,均P=0.000).对照组治疗后各时间点的CMT均较治疗前降低,差异均有统计学意义(t1个月=34.950、t3个月=42.529、t6个月=46.152、t12个月=43.355,均P=0.000).治疗后2组间比较,治疗组治疗后各时间点的CMT均低于对照组,差异均有统计学意义(t1个月=2.438,P=0.017;t3个月=6.649、t6个月=3.776、t12个月=6.138,均P=0.000).(3)SCP:治疗组治疗后1个月与治疗前比较,差异无统计学意义(P>0.05),治疗后3、6、12个月的SCP均提高,差异均有统计学意义(t3个月=17.613、t6个月=13.095、t12个月=4.640,均P=0.000).对照组治疗后1个月的SCP较治疗前下降,差异有统计学意义(t=12.963,P=0.000),其余各时间点的SCP均无明显变化,差异均无统计学意义(P>0.05).治疗后2组间比较,治疗组治疗后各时间点的SCP均高于对照组,差异均有统计学意义(t1个月=16.639、t3个月=16.125、t6个月=11.443,均P=0.000;t12个月=2.975,P=0.004).(4)DCP:治疗组治疗后1个月与治疗前比较,差异无统计学意义(P>0.05),治疗后3、6、12个月的DCP均升高,差异均有统计学意义(t3个月=9.261、t6个月=6.833、t12个月=4.749,均P=0.000).对照组治疗后1、3、6个月的DCP均较治疗前下降,差异均有统计学意义(t1个月=26.876、t3个月=10.916,均P=0.000;t6个月=3.486,P=0.001),治疗后12个月的DCP无明显变化,差异无统计学意义(P>0.05).治疗后2组间比较,治疗组治疗后各时间点的DCP均高于对照组,差异均有统计学意义(t1个月=23.077、t3个月=17.558、t6个月=10.694、t12个月=7.299,均P=0.000).(5)FAZ面积:治疗组治疗后1个月与治疗前比较,差异无统计学意义(P>0.05),其余各时间点的FAZ均下降,差异均有统 计 学 意 义(t3个月=20.915、t6个月=16.959、t12个月=9.167,均P=0.000).对照组治疗后1个月的FAZ较治疗前升高,差异有统计学意义(t=22.974,P=0.000),其余各时间点的FAZ均无明显变化,差异均无统计学意义(P>0.05).治疗后2组间比较,治疗组治疗后各时间点的FAZ面积均小于对照组,差异均有统计学意义(t1个月=21.963、t3个月=16.895、t6个月=12.043、t12个月=6.758,均P=0.000).(6)AI:治疗组治疗后3、6个月的AI均较治疗前下降,差异均有统计学意义(t3个月=5.654、t6个月=3.934,均P=0.000),其余时间点的AI均无明显变化,差异均无统计学意义(P>0.05).对照组治疗后1个月的AI较治疗前升高,差异有统计学意义(t=7.797,P=0.000),其余时间点的AI均无明显变化,差异均无统计学意义(P>0.05).治疗后2组间比较,治疗组治疗后1、3、12个月的AI均低于对照组,差异均有统计学意义(t1个月=8.029,P=0.000;t3个月=3.379,P=0.001;t12个月=2.305,P=0.023).而2组治疗后6个月的AI比较,差异无统计学意义(P>0.05).(7)FD-300:治疗组治疗后3、6个月的FD-300较治疗前升高,差异有统计学意义(t3个月=6.022、t6个月=5.020,均P=0.000),其余各时间点均无明显变化,差异无统计学意义(P>0.05).对照组治疗后1、3个月的FD-300较治疗前降低,差异有统计学意义(t1个月=12.729、t3个月=4.391,均P=0.000),其余各时间点的FD-300均无明显变化,差异均无统计学意义(P>0.05).治疗后2组间比较,治疗组治疗后1、3、6个月的FD-300均高于对照组,差异均有统计学意义(t1个月=7.324、t3个月=8.912、t6个月=5.158,均P=0.000).而2组治疗后12个月的FD-300比较,差异无统计学意义(P>0.05).(8)注射次数:治疗组平均注射(4.83±0.38)次,低于对照组的(5.17±0.46)次,差异有统计学意义(t=4.104,P=0.000).结论 和营利水方可改善RVO-ME患者视网膜血流,减少注射次数,值得临床推广.
Efficacy Observation of Heying Lishui Decoction in Treating Macular Edema Second-ary to Retinal Vein Occlusion
OBJECTIVE To observe the clinical efficacy of Heying Lishui Formula in treating macular edema secondary to retinal vein occlusion(RVO-ME).METHODS A total of 110 patients(110 eyes)with RVO-ME treated at Longhua Hospital,affiliated to Shanghai University of Traditional Chinese Medicine from January 2021 to June 2023 were included.The patients were randomly divided into a treatment group and a control group,leaving 54 patients(54 eyes)in the treatment group and 49 patients(49 eyes)in the control group for final analysis.The control group received intravitreal injections of Aflibercept,while the treatment group received oral Heying Lishui Formula in addition to the control group's treatment.before treatment and at one,three,six and 12 months post-treatment,best corrected visual acuity(BCVA)was measured.Optical coherence tomography angiography(OCTA)was used to detect macular foveal thickness(CMT),superficial retinal capillary plexus blood flow density(SCP),deep retinal capillary plexus blood flow density(DCP),foveal avascular area(FAZ),non-roundness index(AI),and FAZ range 300 μm Blood flow density(FD-300).RESULTS(1)BCVA:BCVA at all time points after treatment improved compared to before treatment,with statistically significant differences(t1 mon=34.093,t3 mon=57.481,t6 mon=59.741,t12 mon=46.442,all P=0.000).In the control group,BCVA at all time points after treatment also improved compared to before treatment,with statistically significant differences(t1 mon=29.606,t3 mon=49.027,t6 mon=48.711,t12 mon=30.826,all P=0.000).When comparing the two groups after treatment,the treatment group had significantly better BCVA at all time points compared to the control group(t1 mon=3.646,t3 mon=5.068,t6 mon=6.758,t12 mon=11.549,all P=0.000).(2)CMT:In the treatment group,CMT at all time points after treatment decreased compared to before treatment,with statistically significant differences(t1 mon=34.702,t3 mon=52.204,t6 mon=51.470,t12 mon=41.842,all P=0.000).In the control group,CMT at all time points after treatment also decreased compared to before treatment,with statistically significant differences(t1 mon=34.950,t3 mon=42.529,t6 mon=46.152,t12 mon=43.355,all P=0.000).When comparing the two groups after treatment,the treatment group had significantly lower CMT at all time points compared to the control group(t1 mon=2.438,P=0.017;t3 mon=6.649,t6 mon=3.776,t12 mon=6.138,all P=0.000).(3)SCP:In the treatment group,there was no statistically significant difference in SCP at one month after treatment compared to before treatment(P>0.05).SCP increased significantly at three,six,and 12 months after treatment(t3 mon=17.613,t6 mon=13.095,t12 mon=4.640,all P=0.000).In the control group,SCP decreased significantly at one month after treatment compared to before treatment(t=12.963,P=0.000),with no significant changes at other time points(P>0.05).When comparing the two groups after treatment,the treatment group had significantly higher SCP at all time points compared to the control group(t1 mon=16.639,t3 mon=16.125,t6 mon=11.443,all P=0.000;t12 mon=2.975,P=0.004).(4)DCP:In the treatment group,there was no statistically significant difference in DCP at one month after treatment compared to before treatment(P>0.05).DCP increased significantly at three,six,and 12 months after treatment(t3 mon=9.261,t6 mon=6.833,t12 mon=4.749,all P=0.000).In the control group,DCP decreased significantly at one,three,and six months after treatment compared to before treatment(t1 mon=26.876,t3 mon=10.916,all P=0.000;t6 mon=3.486,P=0.001),with no significant changes at 12 months(P>0.05).When comparing the two groups after treatment,the treatment group had significantly higher DCP at all time points compared to the control group(t1 mon=23.077,t3 mon=17.558,t6 mon=10.694,t12 mon=7.299,all P=0.000).(5)FAZ:In the treatment group,there was no statistically significant difference in FAZ at one month after treatment compared to before treatment(P>0.05).FAZ decreased significantly at other time points(t3 mon=20.915,t6 mon=16.959,t12 mon=9.167,all P=0.000).In the control group,FAZ increased significantly at one month after treatment compared to before treatment(t=22.974,P=0.000),with no significant changes at other time points(P>0.05).When comparing the two groups after treatment,the treatment group had significantly lower FAZ at all time points compared to the control group(t1 mon=21.963,t3 mon=16.895,t6 mon=12.043,t12 mon=6.758,all P=0.000).(6)AI:In the treatment group,AI decreased significantly at 3 and 6 months after treatment compared to before treatment(t3 mon=5.654,t6 mon=3.934,both P=0.000),with no significant changes at other time points(P>0.05).In the control group,AI increased significantly at one month after treatment compared to before treatment(t=7.797,P=0.000),with no significant changes at other time points(P>0.05).When comparing the two groups after treatment,the treatment group had significantly lower AI at one,three,and 12 months compared to the control group(t1 mon=8.029,P=0.000;t3 mon=3.379,P=0.001;t12 mon=2.305,P=0.023),with no significant difference at six months(P>0.05).(7)FD-300:In the treatment group,FD-300 increased significantly at three and six months after treatment compared to before treatment(t3 mon=6.022,t6 mon=5.020,both P=0.000),with no significant changes at other time points(P>0.05).In the control group,FD-300 decreased significantly at one and three months after treatment compared to before treatment(t1 mon=12.729,t3 mon=4.391,both P=0.000),with no significant changes at other time points(P>0.05).When comparing the two groups after treatment,the treatment group had significantly higher FD-300 at one,three,and 6 months compared to the control group(t1 mon=7.324,t3 mon=8.912,t6 mon=5.158,all P=0.000),with no significant difference at 12 months(P>0.05).(8)Injection frequency:The average number of injections in the treatment group was(4.83±0.38),lower than that in the control group(5.17±0.46),and the difference was statistically significant(t=4.104,P=0.000).CONCLUSIONS Heying Lishui Formula can improve the retinal capillary plexus blood flow density of RVO-ME patients and requires fewer injections,making it worthy of clinical promotion.

Heying Lishui Formulaafliberceptretinal vein occlusionmacular edema

苏晶、刘新泉、刘梦婷

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上海中医药大学附属龙华医院,上海 200032

和营利水方 阿柏西普 视网膜静脉阻塞 黄斑水肿

国家自然科学基金项目上海市科委医学创新项目

8190425721Y11923100

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(8)
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