行气活血健脾利水方治疗糖尿病性黄斑水肿的临床研究

Clinical research of Xingqi Huoxue Jianpi Lishui method for diabetic macular edema

目的观察行气活血健脾利水方治疗糖尿病性黄斑水肿(DME)的临床疗效。方法将65例糖尿病性黄斑水肿患者随机分为治疗组(33例)和对照组(32例)。治疗组予活血健脾利水方免煎颗粒剂联合激光治疗,对照组予中药安慰剂联合激光治疗。两组疗程均为2个月,观察视力、视网膜黄斑部厚度和眼部血流动力学变化情况。结果所有患眼经FFA和OCT检查确诊为DME。FFA显示治疗4周后黄斑部高荧光渗漏均有所好转,治疗8周后黄斑部渗漏明显好转。视网膜黄斑厚度OCT显示治疗组和对照组在治疗4周、治疗8周组内比较差异有统计学意义(P<0.05),表明激光联合口服中药的治疗对两组患者的黄斑厚度均有减轻;组间同期比较,在治疗4周、治疗8周后黄斑厚度差异也有统计学意义(P<0.05),其中治疗组黄斑厚度减轻更明显。治疗组视力总有效率为66.7%,其视力疗效优于对照组(P<0.05)。治疗组口服中药后与本组治疗前比较,治疗4周、治疗8周后眼动脉、视网膜中央动脉、睫状后动脉在收缩期峰值流速、舒张末期流速和搏动指数上差异均有统计学意义(P<0.05),表明治疗组口服中药后眼部血流增快,阻力降低;对照组差异无统计学意义。而2组间同期比较,在治疗4周、治疗8周后各指标差异均有统计学意义(P<0.05),说明两组患者中,仅治疗组患者眼部血流有所改变,即血流增快,阻力降低。结论行气活血健脾利水方联合激光治疗糖尿病性黄斑水肿,可提高患者的视力、减轻视网膜黄斑水肿、增加眼部血流。

OBJECTIVE To observe the clinical efficacy of Xingqi Huoxue and Jianpi Lishui method for diabetic macular edema. METHODS Sixty-five diabetic macular edema patients were randomly divided into control group using the envelope method（traditional Chinese medicine decoction and comfort granule preparation combined with laser therapy）and treatment group（traditional Chinese medicine granules preparation combined with laser therapy）. After 2 months of treatment,visual acuity,retinal macular thickness and ocular hemodynamic situation of the two groups were observed. RESULTS All eyes of DME were confirmed by OCT and FFA examination. FFA revealed that the leakage of macular after treatment of 4 weeks high fluorescence were improved, macular exudate improved obviously after treatment of 8 weeks indicating traditional Chinese medicine granules preparation combined with laser therapy could reduce macular thickness of both groups. Total effective rate of visual acuity in treatment group was 66.7%,which was superior to the control group（P〈0.05）; The comparison of macular thickness between the 2groups was statistically significant within 4 and 8 weeks treatment（P〈0.05）, and the treatment group was more obvious than that of control group; And contemporary comparison between groups, 4 weeks, 8 weeks after treatment macular thickness difference showed statistical significance（P〈0.05）. Compared with groups before treatment, patients in oral Chinese medicine treatment group, 4weeks, 8 weeks after treatment of OA and CRA and PCA on the PSV, EDV and RI difference had statisticalsignificance（P〈0.05） indicating that oral Chinese medicine could speed up the blood flow of ocular area to reduce the resistance; There was no statistical significant difference in the control group. And contemporary comparison between the 2 groups＇ 4 weeks and 8 weeks after treatment, the differences were statistically significant indicating that the blood flow increase was changed only in the treatment group. CONCLUSIONS Invigorating the circulation of qi and blood of Jianpi Lishui decoction combined with laser could be effective for the treatment of diabetic macular edema, improve the patient＇s visual acuity, macular edema, and increase blood flow to the eye.