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椎间盘假体与腰椎融合术治疗慢性下腰痛患者的成本效果比较:2 年随访的随机对照试验。

Cost effectiveness of disc prosthesis versus lumbar fusion in patients with chronic low back pain: randomized controlled trial with 2-year follow-up.

机构信息

Department of Orthopedic Surgery, Center for Clinical Research, Falun Hospital, Dalarna, Nissers Väg 3, SE-79182 Falun, Sweden.

出版信息

Eur Spine J. 2011 Jul;20(7):1001-11. doi: 10.1007/s00586-010-1607-3. Epub 2010 Nov 5.

Abstract

This randomized controlled health economic study assesses the cost-effectiveness of the concept of total disc replacement (TDR) (Charité/Prodisc/Maverick) when compared with the concept of instrumented lumbar fusion (FUS) [posterior lumbar fusion (PLF) /posterior lumbar interbody fusion (PLIF)]. Social and healthcare perspectives after 2 years are reported. In all, 152 patients were randomized to either TDR (n = 80) or lumbar FUS (n = 72). Cost to society (total mean cost/patient, Swedish kronor = SEK, standard deviation) for TDR was SEK 599,560 (400,272), and for lumbar FUS SEK 685,919 (422,903) (ns). The difference was not significant: SEK 86,359 (-45,605 to 214,332). TDR was significantly less costly from a healthcare perspective, SEK 22,996 (1,202 to 43,055). Number of days on sick leave among those who returned to work was 185 (146) in the TDR group, and 252 (189) in the FUS group (ns). Using EQ-5D, the total gain in quality adjusted life years (QALYs) over 2 years was 0.41 units for TDR and 0.40 units for FUS (ns). Based on EQ-5D, the incremental cost-effectiveness ratio (ICER) of using TDR instead of FUS was difficult to analyze due to the "non-difference" in treatment outcome, which is why cost/QALY was not meaningful to define. Using cost-effectiveness probabilistic analysis, the net benefit (with CI) was found to be SEK 91,359 (-73,643 to 249,114) (ns). We used the currency of 2006 where 1 EURO = 9.26 SEK and 1 USD = 7.38 SEK. It was not possible to state whether TDR or FUS is more cost-effective after 2 years. Since disc replacement and lumbar fusion are based on different conceptual approaches, it is important to follow these results over time.

摘要

这项随机对照卫生经济研究评估了全椎间盘置换术(TDR)(Charité/Prodisc/Maverick)与后路腰椎融合术(FUS)[后路腰椎融合术(PLF)/后路腰椎体间融合术(PLIF)]相比的成本效益。报告了 2 年后的社会和医疗保健观点。共有 152 名患者被随机分配到 TDR 组(n=80)或腰椎 FUS 组(n=72)。TDR 的社会总成本(每位患者的平均总成本,瑞典克朗=SEK,标准差)为 SEK599560(400272),腰椎 FUS 的 SEK685919(422903)(无统计学差异)。差异无统计学意义:SEK86359(-45605 至 214332)。从医疗保健角度来看,TDR 的成本明显更低,SEK22996(1202 至 43055)。返回工作岗位的患者中,TDR 组的病假天数为 185(146),FUS 组为 252(189)(无统计学差异)。使用 EQ-5D,2 年时 TDR 组总质量调整生命年(QALY)的总增益为 0.41 单位,FUS 组为 0.40 单位(无统计学差异)。基于 EQ-5D,由于治疗结果“无差异”,使用 TDR 代替 FUS 的增量成本效益比(ICER)难以分析,因此成本/QALY 无意义。使用成本效益概率分析,发现净收益(置信区间)为 SEK91359(-73643 至 249114)(无统计学差异)。我们使用 2006 年的货币,1 欧元=9.26 瑞典克朗,1 美元=7.38 瑞典克朗。无法确定 2 年后 TDR 或 FUS 更具成本效益。由于椎间盘置换术和腰椎融合术基于不同的概念方法,因此随着时间的推移跟踪这些结果非常重要。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2c7b/3176705/184586e1fc35/586_2010_1607_Fig1_HTML.jpg

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