Stürzlinger Heidi, Genser Dieter, Fröschl Barbara
Gesundheit Österreich GmbH, Geschäftsbereich ÖBIG, Wien, Österreich.
GMS Health Technol Assess. 2007 Feb 20;3:Doc02.
In industrialised nations age-related macular degeneration (AMD) is the most common cause of blindness and severe visual impairment. AMD is a disease of the retina characterized by the accumulation of metabolic products in the macula. In early stages drusen and pigment disorders occur, in late stages a dry form is distinguished from the exsudative form with choroidal neovascularisation. AMD causes vision disorders such as blurred vision of the central part of the visual field, leading finally to a dark spot. Several therapies are available for the exsudative form, however an exact diagnosis is partially essential. The gold standard for the diagnosis of AMD is fluorescein angiography (FA), an invasive investigation with intravenous application of a dye. Optical coherence tomography (OCT) is a more recent non-invasive procedure.
The aim of this HTA report is to investigate the efficacy and efficiency of OCT compared to FA. Ethical, societal and legal aspects are also considered.
A systematic literature search was performed in 34 international databases which yielded 2324 articles. Eight publications were included for assessment, according to predefined selection criteria.
The number of studies investigating OCT compared to FA in patients with AMD is presently very limited and the quality of the studies is generally low. The number of investigated patients is below 35 in four publications and in only one publication it is above 100. Moreover in most of the articles very selected patient groups are studied. Economic studies concerning the efficiency of OCT compared to FA cannot be identified.
Even though the patient groups investigated and the objectives of the studies are very heterogenous, all publications uniformly show that OCT cannot replace FA. However, OCT yields additional diagnostic findings and may verify unclear findings of FA. Therefore the application of OCT in addition to FA is useful in many cases. With regard to costs German patients on average currently have to pay more for performing OCT than for performing FA.
Future studies have to show whether OCT may give diagnostic information essential for therapeutic decisions in addition to FA and whether it can replace FA in selected cases. The number of patients included in these studies should be high enough to answer relevant questions with sufficient statistical power. An economic model calculation can be built upon the resulting findings.
在工业化国家，年龄相关性黄斑变性（AMD）是导致失明和严重视力损害的最常见原因。AMD是一种视网膜疾病，其特征是黄斑区代谢产物的积累。早期会出现玻璃膜疣和色素紊乱，晚期干性AMD与伴有脉络膜新生血管的渗出性AMD有所不同。AMD会导致视力障碍，如视野中心部分视力模糊，最终导致出现暗点。针对渗出性AMD有多种治疗方法，但准确诊断在一定程度上至关重要。AMD诊断的金标准是荧光素血管造影（FA），这是一种通过静脉注射染料的侵入性检查。光学相干断层扫描（OCT）是一种更新的非侵入性检查方法。
本卫生技术评估报告的目的是研究与FA相比，OCT的有效性和效率。同时也考虑了伦理、社会和法律方面的问题。
在34个国际数据库中进行了系统的文献检索，共检索到2324篇文章。根据预先设定的选择标准，纳入8篇出版物进行评估。
目前，在AMD患者中比较OCT与FA的研究数量非常有限，且研究质量普遍较低。在4篇出版物中，研究患者数量低于35例，只有1篇出版物的患者数量超过100例。此外，大多数文章研究的是非常特定的患者群体。无法找到关于OCT与FA效率的经济学研究。
尽管所研究的患者群体和研究目的非常不同，但所有出版物一致表明OCT不能取代FA。然而，OCT能提供额外的诊断结果，并可能验证FA中不明确的结果。因此，在许多情况下，除FA外应用OCT是有用的。在成本方面，目前德国患者进行OCT平均比进行FA支付更多费用。
未来的研究必须表明，OCT除FA外是否能提供治疗决策所需的诊断信息，以及在某些情况下它是否能取代FA。这些研究纳入的患者数量应足够多，以便有足够的统计能力回答相关问题。可以根据研究结果建立经济学模型计算。
