Green C, Colquitt J L, Kirby J, Davidson P, Payne E
Southampton Health Technology Assessments Centre, Southampton, UK.
Health Technol Assess. 2004 Nov;8(47):iii,iv, 1-120. doi: 10.3310/hta8470.
To assess the clinical and cost-effectiveness of once-daily use of topical corticosteroids versus more frequent use of same-potency topical corticosteroids in the treatment of people with atopic eczema.
Electronic databases. Bibliographies of included studies and related papers. Experts in the field. Manufacturer submissions to the National Institute for Clinical Excellence.
Studies were assessed for inclusion according to predefined criteria by two reviewers. Data extraction and quality assessment were undertaken by one reviewer and checked by a second reviewer. Clinical effectiveness data were synthesised through a narrative review with full tabulation of results.
One RCT comparing moderately potent corticosteroids, eight RCTs comparing potent corticosteroids and one RCT comparing very potent corticosteroids were included. No RCTs or CCTs of mild corticosteroids were eligible. Most RCTs were of poor methodological quality, although two were judged to be of good quality. The only study that compared moderately potent corticosteroids found no significant difference between once- and twice-daily application. For potent corticosteroids, some statistically significant differences in numbers of patients responding to treatment were identified favouring twice-daily treatment, but these were inconsistent between physician and patient assessment and outcomes selected for analysis. Two studies found a significant improvement in some symptoms with once-daily mometasone furoate compared with twice-daily application of a different active compound, while a third study found no significant differences. One good-quality study favoured twice-daily application of fluticasone propionate ointment, while other studies found no significant difference or an improvement in one symptom but not others. The only study comparing very potent corticosteroids found a statistically significant difference in comparative clinical response in favour of three-times daily treatment, but no difference in number of patients with at least a good response. There appears to be little difference in the frequency or severity of short-term events, however data are limited. No published economic evaluations were identified. Given findings on clinical effectiveness, where outcomes from the comparators are similar, the relative cost-effectiveness of once-daily versus more frequent application of topical corticosteroids becomes a case of cost-minimisation, where the least-cost alternative should be favoured, all else being equal. Topical corticosteroid products included in this review have a wide variation in price; the cost per 30 g/30 ml varies between GBP0.60 and GBP4.88. Specific decisions on the least-cost alternative, between once-daily and more frequent application of products, will be determined by the relative price of the products being compared. Where patients can be appropriately prescribed once-daily treatment of a similarly priced product, a reduction in the quantity of topical corticosteroid used will be expected. However, issues related to pack size for prescribed products and subsequent waste (unused product) could easily erode any potential saving. The potential cost-savings on prescribed products are very small at a patient level; although given the large numbers of patients with atopic eczema, cost savings in theory could be substantial. The presence of specifically marketed 'once-daily' topical corticosteroids, which are relatively expensive (per unit price), may result in additional costs should there be a general recommendation in favour of once-daily use of topical corticosteroids, compared to more frequent use.
The literature is very limited; that available indicates the clinical effectiveness of once-daily and more frequent application of potent topical corticosteroids is very similar, but it does not offer a basis for favouring either option. The cost-effectiveness of once-daily versus more frequent use will depend on the generalisability of the findings to the specific treatment decision and the relative product prices. The trials included in this review generally refer to moderate to severe atopic eczema, whereas most patients have mild disease, and furthermore most of the included trials report on potent topical corticosteroids (eight of 10 RCTs); therefore the generalisability of the findings is limited. Further research is required on the clinical and cost-effectiveness of once-daily versus more frequent use of same potency corticosteroids, specifically on mild potency products for mild to moderate atopic eczema. Outcomes should include quality of life and compliance.
评估每日一次使用外用皮质类固醇与更频繁使用同等效力外用皮质类固醇治疗特应性皮炎患者的临床效果和成本效益。
电子数据库。纳入研究的参考文献及相关论文。该领域专家。制造商提交给国家临床优化研究所的资料。
由两名评审员根据预定义标准评估研究是否纳入。数据提取和质量评估由一名评审员进行,另一名评审员进行核对。临床有效性数据通过叙述性综述进行综合,并完整列出结果。
纳入了一项比较中效皮质类固醇的随机对照试验(RCT)、八项比较强效皮质类固醇的RCT和一项比较超强效皮质类固醇的RCT。没有轻度皮质类固醇的RCT或非随机对照试验(CCT)符合条件。大多数RCT的方法学质量较差,不过有两项被判定质量良好。唯一一项比较中效皮质类固醇的研究发现,每日一次和每日两次应用之间没有显著差异。对于强效皮质类固醇,在治疗反应患者数量上发现了一些统计学上的显著差异,支持每日两次治疗,但在医生和患者评估以及选择进行分析的结果之间并不一致。两项研究发现,与每日两次应用不同活性化合物相比,每日一次应用糠酸莫米松在某些症状上有显著改善,而第三项研究未发现显著差异。一项质量良好的研究支持每日两次应用丙酸氟替卡松软膏,而其他研究未发现显著差异或在一种症状上有改善但其他症状没有。唯一一项比较超强效皮质类固醇的研究发现,在比较临床反应上有统计学上的显著差异,支持每日三次治疗,但在至少有良好反应的患者数量上没有差异。短期事件的频率或严重程度似乎没有太大差异,不过数据有限。未找到已发表的经济评估。鉴于临床有效性的研究结果,在比较组的结果相似的情况下,每日一次与更频繁应用外用皮质类固醇的相对成本效益就变成了成本最小化的问题,即在其他条件相同的情况下应选择成本最低的方案。本综述中纳入的外用皮质类固醇产品价格差异很大;每30克/30毫升的成本在0.60英镑至4.88英镑之间。关于产品每日一次和更频繁应用之间成本最低方案的具体决策,将取决于所比较产品的相对价格。如果能为患者适当开每日一次治疗的价格相似的产品,预计外用皮质类固醇的使用量会减少。然而,与处方产品包装规格及后续浪费(未使用产品)相关的问题可能很容易抵消任何潜在的节省。在患者层面,处方产品潜在的成本节省非常小;不过考虑到特应性皮炎患者数量众多,理论上成本节省可能相当可观。与更频繁使用相比,如果普遍推荐每日一次使用外用皮质类固醇,存在专门销售的相对昂贵(单价)的“每日一次”外用皮质类固醇,可能会导致额外成本。
相关文献非常有限;现有文献表明,每日一次和更频繁应用强效外用皮质类固醇的临床效果非常相似,但没有依据支持任何一种选择。每日一次与更频繁使用的成本效益将取决于研究结果对具体治疗决策的可推广性以及产品的相对价格。本综述纳入的试验一般针对中度至重度特应性皮炎,而大多数患者为轻度疾病,此外纳入试验大多报告的是强效外用皮质类固醇(10项RCT中有8项);因此研究结果的可推广性有限。需要进一步研究每日一次与更频繁使用同等效力皮质类固醇的临床效果和成本效益,特别是针对轻度至中度特应性皮炎的弱效产品。结果应包括生活质量和依从性。