Vondeling H, Rosendal H, Banta D
Department of Epidemiology and Biostatistics, Free University Amsterdam, The Netherlands.
Health Policy. 1995 Oct;34(1):21-33. doi: 10.1016/0168-8510(95)00718-8.
Excimer laser photorefractive keratectomy (PRK) is an experimental treatment to correct myopia (short-sightedness) that is diffusing into use without convincing evidence of safety and efficacy. It has been claimed that PRK may render conventional methods of correcting myopia, such as wearing glasses or contact lenses, obsolete. Since about 25% of the world's population is myopic, the consequences of this technology in terms of benefits, risks, and costs could be truly enormous. The fee for the procedure in various countries such as the United States, the Netherlands, and Australia varies from about US $1500 to US $2250 per eye. In the United States, the Food and Drug Administration, acting as authorized in the Medical Devices Act of 1976, has limited the use of PRK to patients participating in clinical trials. In the Netherlands, in contrast, where medical equipment is not regulated, the method has diffused without controls, although it is not reimbursed by health insurance agencies. The procedure has become controversial in the Netherlands because it is provided privately and has been aggressively and inappropriately promoted. The case illustrates the limitations of health policy concerning technologies provided privately and raises a number of social and political questions.
准分子激光屈光性角膜切削术（PRK）是一种用于矫正近视（近视眼）的实验性治疗方法，目前正在推广使用，但却没有令人信服的安全性和有效性证据。有人声称，PRK可能会使传统的矫正近视方法，如戴眼镜或隐形眼镜，过时。由于世界上约25%的人口患有近视，这项技术在益处、风险和成本方面的影响可能非常巨大。在美国、荷兰和澳大利亚等国，每只眼睛的手术费用从约1500美元到2250美元不等。在美国，食品药品监督管理局根据1976年《医疗器械法》的授权，将PRK的使用限制在参与临床试验的患者身上。相比之下，在荷兰，医疗设备不受监管，这种方法在没有控制的情况下得到了推广，尽管医疗保险机构不予报销。该手术在荷兰引起了争议，因为它是由私人提供的，并且被过度且不恰当地推广。这个案例说明了关于私人提供的技术的卫生政策的局限性，并引发了一些社会和政治问题。
