文摘
The National Asthma Education and Prevention Program (NAEPP) recommends inhaled corticosteroids (ICS) for treatment of mild to severe asthma. Even though the efficacy of ICS is well established,the products have not been compared head-to-head in long-term pragmatic trials. We compared triamcinolone acetonide (TAA) and fluticasone propionate (FP) in the treatment of asthma in a 'real world' setting over one year. We conducted a randomized,open-label,pragmatic trial in ten asthma clinics across the United States from March 1998 through October 1999. Three hundred four adult (age >17 yrs) patients with asthma previously untreated with ICS participated. Patients were randomized to treatment with triamcinolone (n = 153) or fluticasone (n = 151). Physicians determined initial medication regimens and modified them as necessary during follow-up. Effectiveness was compared using the number of symptom-free days (SFD) over one year. Fluticasone-treated patients had more SFD than triamcinolone-treated patients (FP = 164 SFD vs TAA = 143 SFD; Difference in SFD = 21 days; 90% confidence interval [CI],-1.4 to 43.6). However,there were differences in relative dosages between treatments. More triamcinolone-treated patients were given doses below NAEPP recommendations (TAA = 49% vs FP = 5%),and more fluticasone patients were given higher than recommended doses (FP = 48% vs TAA = 3%). In a sub-group analysis of patients given appropriate doses,the difference in SFD was 0.7 days (FP SFD = 140.2 vs TAA SFD = 139.5; 90% CI,-34.5 to 35.9). The annual per-person asthma-related costs were higher in fluticasone-treated patients (FP = $1,141 vs TAA = $1,080; Difference in costs = $61; 95% CI,[-$87.75 to $211.23]). In the sub-group given appropriate doses the difference in total costs was $14.00 (95% CI [-$205.22 to $222.07]). The incremental cost-effectiveness ratio (ICER) was $2.35 per SFD gained (95% CI [-$4.03 to -$27.99]) when comparing fluticasone to trimacinolone. In the appropriately treated subgroup,the ICER was $20.00 per SM gained. Results were sensitive to changes in costs of triamcinolone. Our primary results indicate treatment with fluticasone results in more SFD and is cost-effective,but the results are confounded by physicians' differential dosing of the products. Fluticasone and triamcinolone appear similar when comparing results from sub-group analyses of patients given recommended doses.