中药联合微脉冲治疗糖尿病黄斑水肿的临床观察

Observation on therapeutic effect of subthreshold micropulse diode laser combined with Traditional Chinese Medicine on diabetic macular edema

目的观察微脉冲激光与中药联合治疗糖尿病黄斑水肿的疗效,探讨糖尿病黄斑水肿的优化治疗方案。方法将符合纳入标准的46例(74只眼)糖尿病视网膜病变非增生期或增生Ⅳ期合并糖尿病黄斑水肿的患者随机分2组:治疗组23例(36只眼)和对照组23例(38只眼)。所有患者行黄斑区微脉冲光凝,并根据病情配合传统光凝方式。治疗组于首次激光光凝后开始服用中药益气通络利水方,对照组仅行光凝治疗。观察2组治疗前、光凝后1个月、3个月的最佳矫正视力(BCVA)、视网膜中央厚度(CRT)、眼底体征积分、Amsler表疗效评价等指标。结果 (1)临床疗效:治疗组有效率为80.56%,对照组为68.42%,差异有统计学意义(χ^2=5.958,P=0.043)。(2)最佳矫正视力(BCVA):治疗组和对照组光凝3个月后与同组治疗前相比有显著提高(t治疗组=6.196,t对照组=4.831,均P=0.000)。2组间比较,治疗前、治疗后1、3个月均无统计学意义(P>0.05)。(3)视网膜中央厚度(CRT):治疗1、3个月后,治疗组与治疗前比较均有明显降低(t1个月=3.329,P1个月=0.002;t3个月=7.822,P3个月=0.000),有统计学意义。对照组与治疗前比较也有明显降低(t1个月=3.529, P1个月=0.001;t3个月=7.309,P3个月=0.000)。2组比较,治疗3个月后治疗组CRT低于对照组(t=2.693,P=0.009)。(4)眼底体征积分:治疗组,治疗1、3个月后与治疗前比较均有明显降低(t1个月=5.000,t3个月=13.094,均P=0.000),有统计学意义。对照组,与治疗前比较也有明显降低(t1个月=2.737,P1个月=0.009;t3个月=7.977,P3个月=0.000)。2组比较,治疗3个月后治疗组眼底体征积分低于对照组(t=2.873,P=0.005)。(5)Amsler方格表疗效评价:2组有效率比较,在2个时间点均无统计学意义(P>0.05)。结论微脉冲与传统激光联合中药益气通络利水方能有效减轻糖尿病黄斑水肿,减少眼底微血管瘤、出血和渗出,可达到优势互补,减毒增效和标本兼治的目的。

OBJECTIVE To observe and compare the therapeutic effects of Traditional Chinese Medicine combined with subthreshold micropulse diode laser plus conventional photocoagulation and laser alone on diabetic macular edema, in order to explore a better treatment method. METHODS Seventy-four eyes of 46 patients were randomly divided into two groups, which were conf irmed as non-proliferative diabetic retinopathy or proliferative diabetic retinopathy Ⅳphase with macular edema. The treatment group had 23 patients(36 eyes) and the control group had 23 patients(38 eyes). All cases in two groups underwent micropulse laser in macular areas, then all patients underwent conventional photocoagulation according to their situations. The cases in treatment group were given Chinese medicine Yiqi Tongluo Lishui formula after the first laser treatment, while the control group only received laser treatment. The best corrected visual acuity(BCVA), central retinal thickness(CRT),fundus symptoms and signs scores, Amsler grid scores of all cases were recorded before laser treatment, 1 month and 3 months after laser treatment. The data were analyzed by SPSS software. RESULTS(1) Therapeutic effective rate of treatment group was 80.56%. Correspondingly, control group was 68. 42 %. The differences between them were statistically significant(χ^2= 5. 958, P =0. 043).(2) BCVA of treatment group had significant improvement on 3 months after intervention(t=6.196, P=0.000), and control group also had significant increase(t=4.831, P=0.000). There was no significant difference between two groups before intervention, 1 month and 3 months after treatment(P>0.05).(3) After treatment, CRT of treatment group decreased significantly on the 1 st, 3 rd month(t1 mon=3.329, P1 mon=0.002;t3 mon=7.822, P3 mon=0.000). CRT of control group also had significant decrease on 1 month, 3 months after treatment(t1 mon=3.529, P1 mon=0.001;t3 mon=7.309, P3 mon=0.000).Comparison of result between two groups on the 3 rd month showed significant difference(t=2.693,P=0.009).(4) Fundus scores of symptoms and signs in treatment group varied significantly on the 1 st month and 3 rd month after treatment(t1 mon=5.000, P1 mon=0.000;t3 mon=13.094, P3 mon=0.000).Scores of control group also had significant decrease on the 1 st month, 3 rd month after treatment(t1 mon=2.737, P1 mon=0.009;t3 mon=7.977, P3 mon=0.000). There was significant reduction in scores after 3 month of treatment(t=2.873, P=0.005).(5) According to the Amsler grid effective standard,no statistic differences were observed(P>0.05) at two time points between two groups. CONCLUSIONS Subthreshold micropulse diode laser plus conventional laser and Traditional Chinese Medicine Yiqi Tongluo Lishui formula significantly decreased diabetic macular edema, decreased microhemangioma, hemorrhage and exudation, which complemented each other’s advantages, reduced the toxic effect sides, enhanced the efficacy and treated both manifestation and root cause of disease. However, there was still deficiency in the aspect of improving subjective symptoms such as visual acuity and Amsler assessment.