非诺贝特治疗非增生期糖尿病视网膜病变研究

Clinical research of fenofibrate in the treatment of Non-proliferation diabetic retinopathy

目的观察非诺贝特治疗非增生期糖尿病视网膜病变的临床疗效。方法前瞻性随机对照研究。对2010年7月至2011年12月在江西省中医院眼科就诊的40例（80只眼）2型糖尿病并发非增生期糖尿病性视网膜病变患者，按就诊顺序的随机数字分为A、B两组，在严格控制血糖及血压基础上A组（20例，40只眼）口服非诺贝特胶囊0．2g，37次/d；B组（20例，40只眼）口服安慰剂VitC片0．1g，3尉d，饭前0．5h口服；两组均常规口服复方血栓通胶囊0．5g，3次，d，连续用28天。比较观察患者治疗前后视力、眼底镜检查、眼底荧光血管造影及眼底照相的变化。结果两组患者一般情况比较差异均无统计学意义（χ^2性别=0．464，P〉0．05；t年龄0．437，tDM病程=0．484，tDR病程=0．962，t血糖=0．886，t血肌酐=0．768，tBMI=0．812，tTG=0．924，tLDL=0．834，tSBp=0．956，tDBp=0．647，tGh=0．726，t视力=0．864，P均〉0．05）。治疗21d后，视力提高56只眼，其中A组32只眼（占57．1％），B组24只眼（占42．9％），两组视力较治疗前比较差异有统计学意义（，=5．605，P〈0．05）；其中38只眼治疗后矫正视力〉0．05，其中A组26只眼（68．4％），B组12只眼（31．6％），两组比较差异有统计学意义（r=9．264，P〈0．05）。治疗28d后，A组眼底病变治疗有效率为30．0％（12／40），总有效率85．0％（34／40），B组显效率15．0％（6／40），总有效率55．0％（22／40），结果显示A组疗效优于B组，两组有效率比较差异有统计学意义（r=8．571，P〈0．05）。单因素及多因素分析提示NPDR临床疗效与年龄、病程、严重程度呈负相关。结论非诺贝特可提高非增生期DR患者视力，有效改善非增生期DR症状，治疗的临床疗效与年龄、病程、严重程度存在一定关系。

Objective To observe the effect of Fenofibrate treating Non-proliferation diabetic reti- nopathy （NPDR）. Methods A prospective random controlled study. Totally forty patients （80 eyes） with NPDR were randomized into two groups： Fenofibrate （group A, 15g, qd）, placebo Vitamin C （group B, 0.1g, tid）, and all groups were added with Xueshuangtong capsule. They were taken half an hour before meals. The change of ocular fundus, vision, ftmduscopy, FFA and fundus photogra- phy were observed after 28 days. Results There were no significant difference for the items of pa- tients between two groups pre-therapy （χ^2sex=0.464, P 〉0.05; tage=0.437, tDM condition=0.549, tDR history=0.962, tDM history=0.484, tFbg=0.886, tSc=0.768, tBMI=0.812, tTG=0.924, tLDL=0.834, tSBp=0.956, tDBp=0.647, tGh=0.726, tvi-sion=0.864, P 〉0.05）; the visual acuity of total 52 eyes was increased, including 32 eyes （57.1%） of group A, 24 eyes （42.9%） of group B. There were statistically significance for visual acuity at thepost-therapy day 21 in both groups compared with pre-therapy （χ^2=5.605, P 〈0.05 ）, and the number of eyes （BCVA〉0.05） was in 38 eyes, including 26 eyes （68.4%） of group A, 12 eyes （31.6%） of group B, There were statistically significance between group A and group B （χ^2=9.264, P 〈0.05）. Af- ter treaWnent, the effective rate of fundus lesions of group A was 30.0%, total effective rate 85.0%, while the effective rate of group B was 15.0%, total effective rate was 55.0%; and the results showed that the curative effect of group A was better than that of group B. There were significant difference for the effective rate between groups （~=8.571, P 〈0.05）. Logistic analysis results showed NPDR clinical therapeutic effect and traditional Chinese medicine symptom were negative correlated with age, history and severity （P 〈0.05）. Conclusions Fenofibrate can improve the vision of pa- tients with NPDR, the fundus lesions and the traditional Chinese medicine symptoms. The clinical therapeutic effect of NPDR is possibly correlated to age, history and severity.