Mariani L, Formelli F, De Palo G, Manzari A, Camerini T, Campa T, Di Mauro M G, Crippa A, Delle Grottaglie M, Del Vecchio M, Marubini E, Costa A, Veronesi U
Istituto Nazionale per lo Studio e la Cura dei Tumori, Milan, Italy.
Tumori. 1996 Sep-Oct;82(5):444-9. doi: 10.1177/030089169608200506.
Fenretinide (4-HPR) is a synthetic retinoid being clinically tested in the chemoprevention of different tumors and precancerous lesions. Though safer than many other retinoids in experimental models, in humans 4-HPR may induce adverse effects that mainly affect the eye and visual function. Such effects are thought to be caused by the reduction of plasma retinol levels, which occurs after administration of the retinoid.
A series of 826 women treated with 4-HPR was studied to quantify the incidence and temporal pattern of occurrence of visual (dark adaptation) and ophthalmologic complaints (ocular dryness, lacrimation, conjunctivitis or photophobia) and to investigate the possible association between their occurrence and plasma retinol levels.
The cumulative incidence of visual complaints reached nearly 20% at 5 years. The occurrence of these symptoms was more frequent at the start of treatment. The probability of developing visual complaints was significantly higher in patients with lower plasma retinol concentrations following 4-HPR treatment. The cumulative incidence of ophthalmologic complaints was 8% at 5 years. The occurrence of these complaints was evenly distributed during treatment. Ophthalmologic complaints were not associated with a greater degree of reduction of plasma retinol concentrations, but rather with the patient's age, since symptomatic patients were generally older than asymptomatic patients.
Visual and ophthalmologic complaints are common during 4-HPR treatment; their estimated 5-year cumulative incidence is close to 20% and 8%, respectively. However, the pattern of occurrence over time and the underlying mechanisms of these two types of complaints seem different.
芬维A胺（4-HPR）是一种合成类视黄醇，正在进行预防不同肿瘤及癌前病变的临床试验。尽管在实验模型中比许多其他类视黄醇更安全，但在人类中，4-HPR可能会引发主要影响眼睛和视觉功能的不良反应。此类影响被认为是由服用该类视黄醇后血浆视黄醇水平降低所致。
对一系列826名接受4-HPR治疗的女性进行研究，以量化视觉（暗适应）和眼科不适（眼干、流泪、结膜炎或畏光）的发生率及发生的时间模式，并调查这些症状的发生与血浆视黄醇水平之间的可能关联。
视觉不适的累积发生率在5年时接近20%。这些症状在治疗开始时出现得更为频繁。4-HPR治疗后血浆视黄醇浓度较低的患者出现视觉不适的可能性显著更高。眼科不适的累积发生率在5年时为8%。这些不适在治疗期间分布均匀。眼科不适与血浆视黄醇浓度降低的程度无关，而是与患者年龄有关，因为有症状的患者通常比无症状的患者年龄更大。
在4-HPR治疗期间，视觉和眼科不适很常见；其估计的5年累积发生率分别接近20%和8%。然而，这两种不适随时间的发生模式及潜在机制似乎有所不同。
