摘要
目的 观察阿柏西普联合止血祛瘀明目片治疗增殖性糖尿病视网膜病变(PDR)的临床疗效。方法 收集2020年1月—2021年1月于山东省眼科医院确诊的PDR阴虚肝旺证患者50例(100只眼),随机分为对照组和治疗组,对照组脱落12只眼,治疗组脱落5只眼,最终纳入对照组20例(38只眼),治疗组23例(45只眼)。对照组予阿柏西普玻璃体腔内注射治疗,治疗组予在对照组治疗基础上口服止血祛瘀明目片治疗。分别于治疗前和治疗后第1、3、6个月测量患者最佳矫正视力(BCVA),光学相干断层扫描血管成像(OCTA)检测参数:黄斑中心凹视网膜厚度(CMT)、黄斑旁中心凹视网膜厚度(CPFT)、黄斑中心无血管区(FAZ)的面积、周长(perim)及类圆指数(AI)并记录中医证候积分。结果 2组治疗前BCVA、CMT、CPFT及黄斑区毛细血管参数、中医症候积分比较,差异均无统计学意义(P>0.05)。(1)BCVA:治疗后第3个月对照组BCVA和治疗组治疗后第3个月、第6个月BCVA均较治疗前改善(对照组:t=2.197,P=0.031。治疗组:t_(3个月)=2.148,P=0.034;t_(6个月)=4.045,P=0.000)。2组间比较,治疗后第6个月治疗组BCVA改善优于对照组,差异有统计学意义(t=-2.239,P=0.027)。其余各治疗时间点较治疗前,及2组间比较差异均无统计学意义(P>0.05)。(2)OCTA检测参数:(1)CMT。治疗后对照组1、3个月和治疗组1、3、6个月CMT较治疗前变薄,差异均有统计学意义(对照组:t_(1个月)=2.330,P=0.023;t_(3个月)=5.940,P=0.000。治疗组:t_(1个月)=2.955,P=0.004;t_(3个月)=7.279,P=0.000;t_(6个月)=4.952,P=0.000),其余治疗后2组各时间点CMT较治疗前,及2组间治疗后各时间点比较,差异均无统计学意义(P>0.05)。(2)CPFT。对照组治疗后3个月和治疗组治疗后3、6个月CPFT较治疗前变薄,差异均有统计学意义(对照组:t_(3个月)=3.117,P=0.003。治疗组:t_(3个月)=3.354,P=0.001;t_(6个月)=2.343,P=0.022)。余2组各时间点CPFT较治疗前,及2组组间比较差异无统计学意义(P>0.05)。(3)深层毛细血管丛中央凹血流密度。2组间比较,治疗后6个月治疗组DCP中央凹VD改善优于对照组,差异有统计学意义(t=-2.028,P=0.045),余2组间比较及治疗后2组各时间点较治疗前,差异均无统计学意义(P>0.05)。(4)其他指标。治疗后2组各时间点FAZ的面积、perim、AI,余血流密度均值较治疗前及2组间治疗后比较,差异均无统计学意义(P>0.05)。(3)中医证候积分:治疗后6个月,治疗组中医证候积分较治疗前降低,差异有统计学意义(t=4.828,P=0.000)。2组间比较,治疗组中医证候积分较对照组低,差异有统计学意义(t=-6.273,P=0.000),其余对照组治疗后各时间点与治疗前相比及2组间比较,差异无统计学意义(P>0.05)。结论 止血祛瘀明目片未引起明显缺血及不良反应,其化瘀止血作用可促进玻璃体出血的吸收,阿柏西普联合止血祛瘀明目片能明显提高PDR阴虚肝旺证患者的视力,对血流无明显影响,能够一定程度上改善视功能和微血管循环,为中西医结合治疗该病提供了一定依据。
OBJECTIVE To observe the clinical efficacy of combined use of aflibercept and Zhixue Quyu Mingmu Tablets in the treatment of proliferative diabetic retinopathy (PDR) through a controlled observation.METHODS Fifty patients (100 eyes) diagnosed with PDR of Yin deficiency and Liver hyperactivity at Shandong province eye hospital from January 2020 to January 2021 were collected and randomly divided into a control group (25 cases,50 eyes) and a treatment group (25 cases,50 eyes),12 eyes dropped out from the control group and five eyes dropped out from the treatment group.Finally,20 cases (38 eyes) in the control group and 23 cases(45 eyes) in the treatment group were included.The control group received intravitreal injection of aflibercept,while the treatment group received Zhixue Quyu Mingmu Tablets on the basis of the control group's treatment.Best corrected visual acuity (BCVA),OCTA parameters,including central macular thickness (CMT) central,parafoveal macular thickness (CPFT),area,perimeter,and circularity index (AI) of foveal avascular zone (FAZ),and Traditional Chinese Medicine(TCM)syndrome scores were measured before treatment and at one,three,and six months after treatment.RESULTS There were no statistically significant differences in BCVA,CMT,CPFT,parameters of macular capillaries and TCM syndrome scores in the two groups before treatment (P>0.05).(1) BCVA:The BCVA in the control group after three months treatment and in the treatment group after three,six months treatment improved compared to before treatment with statistically significance (control group:t=2.197,P=0.031.treatment group:t_(3 mon)=2.148,P=0.034;t_(6 mon)=4.045,P=0.000).Comparing the two groups,BCVA improvement in the treatment group was superior to that in the control group at the sixth month after treatment,with statistical significance (t=-2.239,P=0.027).There were no statistically significant differences at other time points or between the two groups (P>0.05).(2) OCTA parameters:CMT in the control group after one,three months treatment,and in the treatment group after one,three,six months treatment decreased significantly compared to before treatment with statistically significance (control group:t_(1 mon)=2.330,P=0.023;t_(3 mon)=5.940,P=0.000.treatment group:t_(1 mon)=2.955,P=0.004;t_(3 mon)=7.279,P=0.000;t_(6 mon)=4.952,P=0.000).There were no statistically significant differences at other time points or between the two groups (P>0.05).CPFT in control group after three months treatment and the treatment group after three,six months treatment decreased significantly compared to before treatment with statistically significance (control group:t_(3 mon)=3.117,P=0.003.treatment group:t_(3 mon)=3.354,P=0.001;t_(6 mon)=2.343,P=0.022).There were no statistically significant differences at other time points or between the two groups (P>0.05).At six months after treatment,the improvement of DCP central foveal vessel density in the treatment group was superior to that in the control group,with statistical significance (t=-2.028,P=0.045).There were no statistically significant differences at other time points or between the two groups (P>0.05).There were also no statistically significant differences in FAZ area,perimeter,AI,or mean blood flow density at other time points after treatment or between the two groups (P>0.05).(3) TCM syndrome scores:At six months after treatment,the TCM syndrome scores in the treatment group decreased significantly compared to before treatment (t=4.828,P=0.000).Comparing the two groups,the TCM syndrome scores in the treatment group were lower than those in the control group,with statistical significance (t=-6.273,P=0.000).There were no statistically significant differences in other time points or between the two groups (P>0.05).CONCLUSIONS Zhixue Quyu Mingmu Tablets did not cause obvious ischemia or adverse reactions.Its composition of promoting blood circulation and stopping bleeding can promote absorption of vitreous hemorrhage.Combined use of aflibercept and Zhixue Quyu Mingmu Tablets can significantly improve the vision of patients with PDR of Yin deficiency and Liver hyperactivity,have no significant effect on blood flow,and can improve visual function and microcirculation to a certain extent,providing a certain basis for the integrated treatment of this disease with TCM and Western Medicine.
作者
王文琪
谢肖
张稚平
袁晓萌
石艳梅
刘婷婷
WANG Wenqi;XIE Xiao;ZHANG Zhiping;YUAN Xiaomeng;SHI Yanmei;LIU Tingting(Shandong University of Traditional Chinese Medicine,Jinan 250014,China)
出处
《中国中医眼科杂志》
2024年第4期334-341,共8页
China Journal of Chinese Ophthalmology
基金
山东中医药大学青年科学基金项目(202201-118)
白求恩·朗沐中青年眼科科研基金(BJ-LM2021007J)。
