Department of Clinical Pharmacy, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt, a joint Supervision Committee for the Ph.D. with the Department of Pharmacy Practice & Science, R. K. Coit College of Pharmacy, University of Arizona, Tucson, AZ, USA.
Eur Rev Med Pharmacol Sci. 2022 Oct;26(20):7506-7513. doi: 10.26355/eurrev_202210_30021.
Painful crises represents a predominant complication of sickle cell disease (SCD). The only approved treatments for painful crises in many countries are hydroxyurea plus potent analgesics. Our earlier clinical trial concluded that omega-3 and vitamin D had a potential therapeutic impact on painful crises. However, there is limited research evaluating their therapeutic applications and cost-effectiveness. This paper aims at comparing the cost-effectiveness of omega-3 and vitamin D supplementation to the standard therapy in treating painful crises among children with SCD.
Cost-effectiveness analyses of daily supplementation of omega-3 and vitamin D were performed. The economic evaluation was based on data derived from a prospective 10-month randomized clinical trial (n = 165 patients; 15 patients dropped). 50 patients were recruited into the omega-3 + standard therapy group (hydroxyurea and folic acid daily with ibuprofen as needed), 50 patients into the vitamin D + standard therapy group, and 50 patients receiving standard therapy alone served as a control group. Outcome measures from the randomized clinical trial were used to determine incremental effectiveness. Cost estimates were calculated from the healthcare payer's perspective. The analysis considered the improvement in various outcome measures and are presented here as percent change from baseline to determine the incremental effectiveness and the incremental cost for the treatment of both interventions.
Adding omega-3 or vitamin D to the standard therapy was more cost-effective than standard treatment alone. Vitamin D was a cheaper but less cost-effective alternative for most outcomes between the two treatments, including LDL-C and HDL-C. It was also more cost-effective but less clinically effective in reducing vaso-occlusive crisis episodes and pain severity. Omega-3 supplementation was significantly more cost-effective than vitamin D supplementation and the standard treatment for those measures.
The present study showed that using vitamin D and omega-3 as add-on treatments for a painful crisis in pediatric sickle cell disease could have overall cost-saving and clinical benefits. However, further studies with a longer treatment duration are needed to establish more significant effects of the interventions for better policy and clinical decision-making.
疼痛危象是镰状细胞病(SCD)的主要并发症之一。在许多国家,治疗疼痛危象的唯一批准方法是使用羟基脲加强效镇痛药。我们之前的临床试验得出结论,ω-3 和维生素 D 对疼痛危象有潜在的治疗作用。然而,评估其治疗应用和成本效益的研究有限。本文旨在比较 ω-3 和维生素 D 补充剂与 SCD 儿童标准治疗疼痛危象的成本效益。
对 ω-3 和维生素 D 的每日补充进行成本效益分析。经济评估基于一项为期 10 个月的前瞻性随机临床试验的数据(n = 165 例患者;15 例患者脱落)。50 例患者被纳入 ω-3 + 标准治疗组(每天服用羟基脲和叶酸,按需服用布洛芬),50 例患者纳入维生素 D + 标准治疗组,50 例接受标准治疗的患者作为对照组。随机临床试验的结果用于确定增量效果。从医疗保健支付者的角度计算成本估计。该分析考虑了各种结果衡量标准的改善,并以百分比变化表示,以确定两种干预措施的增量效果和增量成本。
与单独标准治疗相比,在标准治疗中添加 ω-3 或维生素 D 更具成本效益。对于两种治疗方法之间的大多数结果,包括 LDL-C 和 HDL-C,维生素 D 是一种更便宜但效果较差的替代方法。它还可以降低血管阻塞性危象发作和疼痛严重程度,但成本效益较低。与维生素 D 补充剂和标准治疗相比,ω-3 补充剂的成本效益更高。
本研究表明,在儿科镰状细胞病中,将维生素 D 和 ω-3 作为疼痛危象的附加治疗方法可能具有总体成本节约和临床益处。然而,需要进行更长治疗时间的进一步研究,以确定干预措施的更显著效果,从而为更好的政策和临床决策提供依据。