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准分子原位角膜磨镶术(LASIK)治疗中度近视的临床疗效、并发症类型及成本效益:临床结局和术后并发症概况的独立荟萃分析结果

Clinical benefit, complication patterns and cost effectiveness of laser in situ keratomileusis (LASIK) in moderate myopia: results of independent meta analyses on clinical outcome and postoperative complication profiles.

作者信息

Lamparter J, Dick H B, Krummenauer Frank

机构信息

Clinical Epidemiology and Health Economy Unit, Dresden University of Technology, Medical Faculty, Fetscherstr. 74, Haus 29, D-01307 Dresden, Germany.

出版信息

Eur J Med Res. 2005 Sep 12;10(9):402-9.

PMID:16183554
Abstract

PURPOSE

Laser in situ keratomileusis (LASIK) means a patient investment of 2426 Euro per eye, which usually cannot be funded by European health care insurers. In the context of recent resource allocation discussions, however, the cost effectiveness of LASIK could become an important indication of allocation decisions. Therefore an evidence based estimation of its incremental cost effectiveness was intended.

METHODS

Three independent meta analyses were implemented to estimate the refractive gain (dpt) due to conventional LASIK procedures as well as the predictability of the latter (%) (fraction of eyes achieving a postoperative refraction with maximum deviation of +/- 0.5 dpt from the target refraction). Study reports of 1995 - 2004 (English or German language) were screened for appropriate key words. Meta effects in refractive gain and predictability were estimated by means and standard deviations of reported effect measures. Cost data were estimated by German DRG rates and individual clinical pathway calculations; cost effectiveness was then computed in terms of the incremental cost effectiveness ratio (ICER) for both clinical benefit endpoints. A sensitivity analysis comprised cost variations of +/- 10 % and utility variations alongside the meta effects' 95% confidence intervals.

RESULTS

Total direct costs from the patients' perspective were estimated at 2426 Euro per eye, associated with a refractive meta benefit of 5.93 dpt (95% meta confidence interval 5.32 - 6.54 dpt) and a meta predictability of 67% (43% - 91%). In terms of incremental costs, the unilateral LASIK implied a patient investion of 409 Euro (sensitivity range 351 - 473 Euro) per gained refractive unit or 36 Euro (27 - 56 Euro) per gained percentage point in predictability. When LASIK associated complication patterns were considered, the total direct costs amounted up to 3075 Euro, resulting in incremental costs of 519 Euro / dpt (sensitivity range 445 - 600 Euro / dpt) or 46 Euro / % (34 - 72 Euro / %). Most frequently reported LASIK complications were "central islands / over- / undercorrection / regression" (meta incidence estimate 24%) and "haze" (15%), which were identified by means of an independent meta analysis.

CONCLUSION

Bearing incremental costs of 519 Euro per gained refractive unit in mind, the conventional LASIK procedures showed an encouraging cost effectiveness range; the latter estimate may serve as a rationale for future allocation discussions in ophthalmology.

摘要

目的

准分子原位角膜磨镶术(LASIK)意味着患者每只眼睛需花费2426欧元,而这笔费用通常无法由欧洲医疗保险机构承担。然而,在近期的资源分配讨论中,LASIK的成本效益可能成为分配决策的重要依据。因此,旨在对其增量成本效益进行基于证据的评估。

方法

进行了三项独立的荟萃分析,以评估传统LASIK手术带来的屈光增益(屈光度)以及该手术的可预测性(%)(术后屈光度与目标屈光度最大偏差在±0.5屈光度范围内的眼睛比例)。筛选了1995 - 2004年(英文或德文)的研究报告以查找合适的关键词。通过报告效应量的均值和标准差来估计屈光增益和可预测性方面的荟萃效应。成本数据通过德国疾病诊断相关分组费率和个体临床路径计算进行估计;然后根据两个临床获益终点的增量成本效益比(ICER)计算成本效益。敏感性分析包括成本±10%的变化以及与荟萃效应95%置信区间相关的效用变化。

结果

从患者角度估计,每只眼睛的总直接成本为2426欧元,屈光方面的荟萃效益为5.93屈光度(95%荟萃置信区间5.32 - 6.54屈光度),荟萃可预测性为67%(43% - 91%)。就增量成本而言,单侧LASIK每获得一个屈光单位意味着患者投资409欧元(敏感性范围351 - 473欧元),或每提高一个百分点的可预测性投资36欧元(27 - 56欧元)。当考虑LASIK相关的并发症模式时,总直接成本高达3075欧元,导致增量成本为519欧元/屈光度(敏感性范围445 - 600欧元/屈光度)或46欧元/%(34 - 72欧元/%)。最常报告的LASIK并发症是“中央岛/矫正过度/不足/回退”(荟萃发生率估计为24%)和“角膜雾状混浊”(15%),这是通过一项独立的荟萃分析确定的。

结论

考虑到每获得一个屈光单位需承担519欧元的增量成本,传统LASIK手术显示出令人鼓舞的成本效益范围;后一估计可为未来眼科领域的分配讨论提供依据。

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