Wilcox C S, Heiser J F, Crowder A M, Wassom N J, Katz B B, Dale J L
Pharmacology Research Institute, Irvine, California, USA.
Br J Ophthalmol. 1995 Jun;79(6):544-8. doi: 10.1136/bjo.79.6.544.
Patients who have their pupils dilated for an eye examination traditionally have to wait several hours before their pupils return to normal size and their blurred vision (caused by paralysis of accommodation) resolves. Earlier studies with dapiprazole have demonstrated an accelerated reversal of dilatation.
Three regimens of dapiprazole were studied to determine the effects on pupil diameter and accommodation after mydriasis produced by 2.5% phenylephrine and 0.5% tropicamide. Test regimens included one drop and 1 + 1 drop regimens, compared with a 2 + 2 drop reference regimen. Dapiprazole was administered in one eye and placebo in the other. Mean change from baseline was analysed for pupil diameter and accommodation at various time points after drug administration. Also, for the same variables, 90% confidence intervals for the areas under the curve (AUC) were computed.
Both test regimens were equivalent to the reference regimen on the basis of mean change from baseline for pupil diameter and accommodation at individual time points, and for the mean AUC. Most signs and symptoms (injection, stinging, burning, lid oedema, and ptosis) were less frequent in the test regimen treated eyes. There was no significant interaction between regimen and eye colour.
This study indicates that a lower dosage (for example, one drop) is also efficacious and has the added benefit of fewer side effects.
传统上,接受散瞳眼部检查的患者需等待数小时,瞳孔才能恢复正常大小,由调节麻痹引起的视力模糊才能消除。早期使用达哌唑的研究已证明其能加速散瞳的恢复。
研究了三种达哌唑给药方案,以确定其对由2.5%去氧肾上腺素和0.5%托吡卡胺引起的散瞳后瞳孔直径和调节功能的影响。测试方案包括一滴和1+1滴方案,并与2+2滴参考方案进行比较。一只眼睛滴入达哌唑,另一只眼睛滴入安慰剂。分析给药后不同时间点瞳孔直径和调节功能相对于基线的平均变化。此外,针对相同变量,计算曲线下面积(AUC)的90%置信区间。
基于各个时间点瞳孔直径和调节功能相对于基线的平均变化以及平均AUC,两种测试方案均与参考方案等效。测试方案治疗的眼睛中,大多数体征和症状(充血、刺痛、烧灼感、眼睑水肿和上睑下垂)出现的频率较低。给药方案与眼睛颜色之间无显著交互作用。
本研究表明,较低剂量(例如一滴)同样有效,且副作用更少。