The effect of the aldose reductase inhibitor, ponalrestat, on the progression of diabetic retinopathy
The effect of the aldose reductase inhibitor, ponalrestat, on the progression of diabetic retinopathy
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DOI：
10.1016/1056-8727(92)90024-f
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发表时间：
1992-01-01
影响因子：
3
通讯作者：
Raskin, Philip
中科院分区：
文献类型：
--
作者：
Arauz-Pacheco, Carlos;Ramirez, Luis C.;Raskin, Philip
本研究的目的是评价ponalrestat（一种醛糖还原酶抑制剂）对糖尿病视网膜病变进展的影响。在这项研究中，62例糖尿病患者接受了一项双盲安慰剂对照临床试验，比较ponalrestat 600 mg/天与安慰剂对糖尿病视网膜病变进展的影响。两组在年龄、性别分布、糖尿病病程、代谢控制以及糖尿病视网膜病变的存在和严重程度方面具有可比性。在0个月（基线）、12个月和18个月时进行了七视野立体眼底照片; 49例患者完成了研究（ponalrestat组26例，安慰剂组23例）。在两个治疗组中，观察到糖尿病视网膜病变的显著进展，如早期治疗糖尿病视网膜病变研究分类所评价的（Wilcoxon秩和检验，p lt 0.05）。两个治疗组之间的视网膜病变进展无差异（p = 0.96）。两个研究组的微动脉瘤数量增加（安慰剂组从5.6 ± 1.2增加至10.5 ± 1.3，ponalrestat组从10.3 ± 1.4增加至12.7 ± 1.4）;然而，仅安慰剂组的增加具有统计学显著性（p lt 0.05）。当通过微动脉瘤计数类别的变化评价微动脉瘤数量的增加时，未观察到显著差异。我们得出结论，ponalrestat在600 mg/天的剂量对糖尿病视网膜病变的进展没有临床意义的影响。
The objective of this study was to evaluate the effects of ponalrestat, an aldose reductase inhibitor, on the progression of diabetic retinopathy. In this study, 62 patients with diabetes mellitus underwent a double-masked placebo-controlled clinical trial comparing the effect of ponalrestat 600 mg per day with a placebo on the progression of diabetic retinopathy. Both groups were comparable in terms of age, gender distribution, diabetes duration, metabolic control, and presence and severity of diabetic retinopathy. Seven-field stereo fundus photographs were performed at 0 (baseline), 12, and 18 months; 49 patients completed the study (26 in the ponalrestat group and 23 in the placebo group). In both treatment groups, a significant progression of diabetic retinopathy as evaluated by the Early Treatment Diabetic Retinopathy Study classification was observed (Wilcoxon Rank-Sum Test, p lt 0.05). No difference was observed in the progression of retinopathy between the two treatment groups (p = 0.96). The number of microaneurysms increased in the two study groups (from 5.6 +- 1.2 to 10.5 +- 1.3 in the placebo group and from 10.3 +- 1.4 to 12.7 +- 1.4 in the ponalrestat group); however, the increase was statistically significantly only in the placebo group (p lt 0.05). When the increase in the number of microaneurysms was evaluated by change of category of microaneurysm count, no significant difference was observed. We conclude that ponalrestat at a dose of 600 mg per day has no clinically significant effect on the progression of diabetic retinopathy.