Kane Sunanda, Holderman William, Jacques Peter, Miodek Todd
Mayo Clinic College of Medicine, Rochester, MN, USA;
Patient Prefer Adherence. 2008 Feb 2;2:253-8. doi: 10.2147/ppa.s3698.
Multiple studies have demonstrated the efficacy of aminosalicylates in maintaining remission in ulcerative colitis (UC). A newer formulation of mesalamine can be administered once daily. We aimed to examine the efficacy and tolerability of pH-dependent mesalamine for long-term maintenance, and compare the rates of medication consumption between groups over a prolonged period.
Subjects whose UC had been quiescent for at least 4 months, and who had been receiving mesalamine for maintenance only, were randomized to once daily or conventional dosing for 12 months. Disease activity and medication consumption was assessed every 3 months. The primary endpoint was the percentage of those with quiescent disease at 12 months.
We enrolled 20 patients, 12 to once daily and 8 to conventional dosing. Six of the 12 patients (50%) in the once daily group compared with 5 of the 8 patients (62.5%) in the conventional group experienced a flare (p = 0.31). Only 5 of the 12 (42%) patients in the once daily group were adherent compared with 3 of 8 patients (37.5%) in the conventional dosing group (p = NS). Median amount consumed in the once daily group was 63% (range 0%-100%) and in the conventional group 55% (range 0%-100%), (p > 0.5). None of the adherent subjects in the once daily group experienced a flare, while 6 out of 7 (86%) who were non-adherent experienced a flare (p < 0.01). In the conventional dosing group, 1 in 3 adherent patients (33%) experienced a flare compared with 4 out of 5 (80%) in the non-adherent group (p < 0.01).
Adherence, rather than medication regimen, appeared to be important in disease outcome at 12 months.
多项研究已证实氨基水杨酸盐在维持溃疡性结肠炎（UC）缓解方面的疗效。一种新型美沙拉嗪制剂可每日给药一次。我们旨在研究pH依赖型美沙拉嗪长期维持治疗的疗效和耐受性，并比较两组在较长时期内的药物服用率。
UC病情已静止至少4个月且仅接受美沙拉嗪维持治疗的受试者被随机分为每日一次给药组或传统给药组，为期12个月。每3个月评估疾病活动度和药物服用情况。主要终点是12个月时病情静止患者的百分比。
我们纳入了20例患者，12例为每日一次给药组，8例为传统给药组。每日一次给药组的12例患者中有6例（50%）病情复发，而传统给药组的8例患者中有5例（62.5%）病情复发（p = 0.31）。每日一次给药组的12例患者中只有5例（42%）坚持服药，传统给药组的8例患者中有3例（37.5%）坚持服药（p = 无显著性差异）。每日一次给药组的药物服用中位数为63%（范围0%-100%），传统给药组为55%（范围0%-100%），（p > 0.5）。每日一次给药组中坚持服药的受试者均未病情复发，而7例未坚持服药的受试者中有6例（86%）病情复发（p < 0.01）。在传统给药组中，3例坚持服药的患者中有1例（33%）病情复发，而5例未坚持服药的患者中有4例（80%）病情复发（p < 0.01）。
在12个月时，对疾病结局而言，坚持服药似乎比用药方案更重要。
