阿柏西普联合口服止血祛瘀明目片治疗PDR的临床观察.pdf
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1、中国中医眼科杂志2024 年 4 月第 34 卷第 4 期 临床经验 阿柏西普联合口服止血祛瘀明目片治疗PDR的临床观察王文琪1,2,谢肖2,张稚平1,2,袁晓萌2,石艳梅1,2,刘婷婷1,2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
2、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(P0.05)。(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:t3 个月=2.148,P=0.034;t6个月=4.045,P=
3、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(P0.05)。(2)OCTA 检测参数: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:t1个月=2.330,P=0.023;t3 个月=5.940,P=0.000。治疗组:t1 个月=2.955,P=0.004;t3 个月=7.279,P=0.000;t6 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,
4、差异均无统计学意义(P0.05)。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:t3个月=3.117,P=0.003。治疗组:t3个月=3.354,P=0.001;t6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(P0.05)。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(P0.05)。其他指标。治疗后2组各时间点FAZ的面积
5、、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(P0.05)。(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(P0.05)。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
6、中西医结合治疗该病提供了一定依据。关键词 糖尿病视网膜病变;止血祛瘀明目片;阿柏西普中图分类号:R276.7 文献标识码:B 文章编号:1002-4379(2024)04-0334-08Clinical Observation on the Treatment of PDR by Aflibercept Combined with Zhixue Quyu Mingmu Tablets WANG Wenqi,XIE Xiao,ZHANG Zhiping,YUAN Xiaomeng,SHI DOI:10.13444/ki.zgzyykzz.2024.04.007基金项目:1 山东中医药大学青年科学
7、基金项目(202201-118)2 白求恩朗沐中青年眼科科研基金(BJ-LM2021007J)作者单位:1 山东中医药大学,济南 2500142 山东省眼科医院,济南 250002通讯作者:刘婷婷,E-mail:334中国中医眼科杂志2024 年 4 月第 34 卷第 4 期Yanmei,LIU Tingting.Shandong University of Traditional Chinese Medicine,Jinan 250014,ChinaAbstract OBJECTIVE To observe the clinical efficacy of combined use of a
8、flibercept 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
9、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 in
10、cluded.The control group received intravitreal injection of aflibercept,while the treatment group received Zhixue Quyu Mingmu Tablets on the basis of the control groups treatment.Best corrected visual acuity(BCVA),OCTA parameters,including central macular thickness(CMT)central,parafoveal macular thi
11、ckness(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,paramete
12、rs 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 gr
13、oup:t=2.197,P=0.031.treatment group:t3 mon=2.148,P=0.034;t6 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 sig
14、nificant differences at other time points or between the two groups(P0.05).(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
15、(control group:t1 mon=2.330,P=0.023;t3 mon=5.940,P=0.000.treatment group:t1 mon=2.955,P=0.004;t3 mon=7.279,P=0.000;t6 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 t
16、he treatment group after three,six months treatment decreased significantly compared to before treatment with statistically significance(control group:t3 mon=3.117,P=0.003.treatment group:t3 mon=3.354,P=0.001;t6 mon=2.343,P=0.022).There were no statistically significant differences at other time poi
17、nts 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
18、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
19、 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 differ
20、ences 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.335中国中医眼科杂志2024 年 4 月第 34 卷第 4 期C
21、ombined 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 fo
22、r the integrated treatment of this disease with TCM and Western Medicine.Keywords diabetic retinopathy;Zhixue Quyu Mingmu Tablets;aflibercept目前,我国是全球糖尿病患病人数最多的国家,患病人数可达1.4亿1,增殖性糖尿病视网膜病变(proliferative diabetic retinopathy,PDR)是糖尿病视网膜病变(diabetic retinopathy,DR)发展进程中较晚期的阶段,常出现新生血管、玻璃体积血和牵拉性视网膜脱离等表现2,且预
23、后较差。既往研究4-5表明,抗血管内皮生长因子(vascular endothelial growth factor,VEGF)药物对PDR患者新生血管的消退有积极作用,能够减轻血管渗漏3,且至少1年内可以提高患者的视力,可见抗VEGF治疗对DR患者至关重要。近代的中医学者6-7将糖尿病眼部并发症统称为“消渴目病”,其属于中医的“视瞻昏渺”“云雾移睛”“血灌瞳神”等范畴,为消渴病日久的变证。止血祛瘀明目片是一种能化瘀止血、滋阴清肝,治疗DR阴虚肝旺、热伤血络而至眼底出血的中药制剂。光学相干断层扫描血管成像(optical coherence tomography angiography,OCT
24、A)不仅实现了对血管形态的精密观察,而且可以定量分析DR的微血管病变。其可实现无创、快速地生成立体视网膜血管的高分辨率图像8-9,可以观察PDR患者黄斑区视网膜的形态学改变10-11。邓宇等10的研究表明浅层血流密度、深层血流密度等OCTA指标可以辅助评估DR的疾病进展。本研究通过观察PDR阴虚肝旺证患者口服止血祛瘀明目片联合玻璃体腔注射阿柏西普注射液治疗前后视力、OCTA及眼底变化,探讨该治疗方法对视网膜微循环和视力的影响。1对象与方法1.1研究对象纳入2020年1月2021年1月于山东省眼科医院诊治的阴虚肝旺证PDR患者50例(100只眼),随机分为其中对照组 25 例(50 只眼)和治疗
25、组 25 例(50 只眼)。对照组脱落 12只眼,治疗组脱落 5只眼,最终共纳入43例(86只眼),对照组20例(38只眼),治疗组 23 例(45 只眼)。其中,对照组男性10 例(19 只眼),女性 10 例(19 只眼),平均年龄(59.159.65)岁,糖尿病病程(14.006.22)年,平均糖化血红蛋白(hemoglobin A1C,HbA1c)为(7.051.01)%,DR分级为20只眼IV期,18只眼V期;治疗组男性12例(23只眼),女性11例(22只眼),平均年龄为(58.098.70)岁,平均糖尿病病程为(13.175.95)年,平均 HbA1c 为(6.940.74)%,
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