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家用紫外线 B 光疗治疗银屑病的成本效益:一项随机对照试验(PLUTO 研究)的经济评估。

Cost effectiveness of home ultraviolet B phototherapy for psoriasis: economic evaluation of a randomised controlled trial (PLUTO study).

机构信息

Department of Dermatology/Allergology (G02.124), University Medical Center Utrecht, Heidelberglaan 100, 3584 CX Utrecht, Netherlands.

出版信息

BMJ. 2010 Apr 20;340:c1490. doi: 10.1136/bmj.c1490.

Abstract

OBJECTIVE

To assess the costs and cost effectiveness of phototherapy with ultraviolet B light provided at home compared with outpatient ultraviolet B phototherapy for psoriasis.

DESIGN

Cost utility, cost effectiveness, and cost minimisation analyses performed alongside a pragmatic randomised clinical trial (the PLUTO study) at the end of phototherapy (mean 17.6 weeks) and at one year after the end of phototherapy (mean 68.4 weeks).

SETTING

Secondary care, provided by a dermatologist in the Netherlands.

PARTICIPANTS

196 adults with psoriasis who were clinically eligible for narrowband (TL-01) ultraviolet B phototherapy were recruited from the dermatology departments of 14 hospitals and were followed until the end of phototherapy. From the end of phototherapy onwards, follow-up was continued for an unselected, consecutive group of 105 patients for one year after end of phototherapy.

INTERVENTIONS

Ultraviolet B phototherapy provided at home (intervention) and conventional outpatient ultraviolet B phototherapy (control) in a setting reflecting routine practice in the Netherlands. Both treatments used narrowband ultraviolet B lamps (TL-01).

MAIN OUTCOME MEASURES

Total costs to society, quality adjusted life years (QALYs) as calculated using utilities measured by the EQ-5D questionnaire, and the number of days with a relevant treatment effect (>/=50% improvement of the baseline self administered psoriasis area and severity index (SAPASI)).

RESULTS

Home phototherapy is at least as effective and safe as outpatient phototherapy, therefore allowing cost minimisation analyses (simply comparing costs). The average total costs by the end of phototherapy were euro800 for home treatment and euro752 for outpatient treatment, showing an incremental cost per patient of euro48 (95% CI euro-77 to euro174). The average total costs by one year after the end of phototherapy were euro1272 and euro1148 respectively (difference euro124, 95% CI euro-155 to euro403). Cost utility analyses revealed that patients experienced equal health benefits-that is, a gain of 0.296 versus 0.291 QALY (home v outpatient) by the end of phototherapy (difference 0.0052, -0.0244 to 0.0348) and 1.153 versus 1.126 QALY by one year after the end of phototherapy (difference 0.0267, -0.024 to 0.078). Incremental costs per QALY gained were euro9276 and euro4646 respectively, both amounts well below the normally accepted standard of euro20 000 per QALY. Cost effectiveness analyses indicated that the mean number of days with a relevant treatment effect was 42.4 versus 55.3 by the end of phototherapy (difference -12.9, -23.4 to -2.4). By one year after the end of phototherapy the number of days with a relevant treatment effect were 216.5 and 210.4 respectively (6.1, -41.1 to 53.2), yielding an incremental cost of euro20 per additional day with a relevant treatment effect.

CONCLUSIONS

Home ultraviolet B phototherapy for psoriasis is not more expensive than phototherapy in an outpatient setting and proved to be cost effective. As both treatments are at least equally effective and patients express a preference for home treatment, the authors conclude that home phototherapy should be the primary treatment option for patients who are eligible for phototherapy with ultraviolet B light.

TRIAL REGISTRATION

Current Controlled Trials ISRCTN83025173 and Clinicaltrials.gov NCT00150930.

摘要

目的

评估家庭光疗与门诊窄谱中波紫外线(NB-UVB)光疗治疗银屑病的成本和成本效益。

设计

在光疗结束时(平均 17.6 周)和光疗结束一年后(平均 68.4 周)进行成本效用、成本效益和成本最小化分析,这是一项与实用随机临床试验(PLUTO 研究)同时进行的分析。

地点

荷兰二级保健机构,由皮肤科医生提供服务。

参与者

196 名符合窄谱(TL-01)NB-UVB 光疗条件的成年银屑病患者从 14 家医院的皮肤科招募而来,随访至光疗结束。从光疗结束开始,对 105 名未经选择的连续患者进行了为期一年的随访,时间为光疗结束后一年。

干预措施

家庭光疗(干预)和常规门诊 NB-UVB 光疗(对照)在反映荷兰常规实践的环境中进行。两种治疗均使用窄谱 UVB 灯(TL-01)。

主要观察指标

社会总成本、使用 EQ-5D 问卷测量的效用计算的质量调整生命年(QALY),以及具有相关治疗效果的天数(>/=50%改善基线自我评估银屑病面积和严重程度指数(SAPASI))。

结果

家庭光疗至少与门诊光疗一样有效和安全,因此可以进行成本最小化分析(只需比较成本)。光疗结束时的平均总成本分别为家庭治疗 800 欧元和门诊治疗 752 欧元,显示每位患者的增量成本为 48 欧元(95%CI-77 欧元至 174 欧元)。光疗结束一年后的平均总成本分别为 1272 欧元和 1148 欧元(差异 124 欧元,95%CI-155 欧元至 403 欧元)。成本效用分析显示,患者获得的健康效益相等,即光疗结束时家庭组获得 0.296 个 QALY,门诊组获得 0.291 个 QALY(差异 0.0052,-0.0244 至 0.0348),光疗结束一年后家庭组获得 1.153 个 QALY,门诊组获得 1.126 个 QALY(差异 0.0267,-0.024 至 0.078)。增量成本每获得一个 QALY 分别为 9276 欧元和 4646 欧元,均远低于通常接受的每 QALY 20000 欧元的标准。成本效益分析表明,光疗结束时家庭组有相关治疗效果的天数为 42.4 天,门诊组为 55.3 天(差异-12.9,-23.4 至-2.4)。光疗结束一年后,家庭组和门诊组分别有 216.5 天和 210.4 天有相关治疗效果(差异 6.1,-41.1 至 53.2),增量成本为每增加一天相关治疗效果 20 欧元。

结论

家庭 NB-UVB 光疗治疗银屑病并不比门诊环境中的光疗更昂贵,并且具有成本效益。由于两种治疗方法至少同样有效,并且患者对家庭治疗表示偏好,作者得出结论,家庭光疗应该是符合 NB-UVB 光疗条件的患者的主要治疗选择。

试验注册

当前对照试验 ISRCTN83025173 和 Clinicaltrials.gov NCT00150930。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/afae/4787881/0aa3c7c8e943/koem676924.f1_default.jpg

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