Higgins P D R, Rubin D T, Kaulback K, Schoenfield P S, Kane S V
Division of Gastroenterology, Department of Internal Medicine, University of Michigan, Ann Arbor, MI 48109, USA.
Aliment Pharmacol Ther. 2009 Feb 1;29(3):247-57. doi: 10.1111/j.1365-2036.2008.03865.x. Epub 2008 Oct 7.
Ulcerative colitis (UC) can be maintained in remission with 5-aminosalicylic acid (5-ASA) medications, but frequent non-adherence by patients who are feeling well has been associated with more frequent flares of colitis.
To perform a systematic review of the published literature and unpublished randomized clinical trials (RCTs) regarding the impact of non-adherence with 5-ASA medications on the incidence of UC flares and costs of care.
A search of MEDLINE, EMBASE and the Cochrane databases was performed. Prospective studies of UC maintenance with 5-ASAs in adults were selected if they included data on adherence and disease flares. Studies using insurance claims data to estimate the impact of non-adherence on cost of care were included. Data from unpublished RCTs were obtained from the FDA with a request under the Freedom of Information Act.
The relative risk for flare in non-adherent vs. adherent patients ranged from 3.65 to infinity. Data were obtained from six unpublished 5-ASA RCTs, but none measured the impact of adherence on disease activity. The comorbidity-adjusted annual costs of care in adherent patients were 12.5% less than in non-adherent patients, despite increased medication expenditures.
A substantial proportion of UC flares and medical costs of UC are attributable to 5-ASA non-adherence. As non-adherence to 5-ASA medications is common, cost-effective strategies to improve adherence are needed. The impact of adherence on disease activity should be measured in RCTs of all inflammatory bowel disease treatments.
溃疡性结肠炎（UC）可通过5-氨基水杨酸（5-ASA）药物维持缓解，但病情好转的患者频繁不遵医嘱与结肠炎更频繁发作有关。
对已发表的文献和未发表的随机临床试验（RCT）进行系统评价，以探讨不遵医嘱使用5-ASA药物对UC发作发生率和护理费用的影响。
检索了MEDLINE、EMBASE和Cochrane数据库。如果前瞻性研究包含了关于依从性和疾病发作的数据，则选择其中关于成人使用5-ASA维持UC的研究。纳入使用保险理赔数据来估计不依从对护理费用影响的研究。根据《信息自由法》的要求，从未发表的RCT中获取的数据来自美国食品药品监督管理局（FDA）。
不依从患者与依从患者发作的相对风险范围为3.65至无穷大。从六项未发表的5-ASA RCT中获得了数据，但没有一项研究测量了依从性对疾病活动的影响。尽管药物支出增加，但依从患者经合并症调整后的年度护理费用比不依从患者低12.5%。
UC发作和UC医疗费用的很大一部分归因于不遵医嘱使用5-ASA。由于不遵医嘱使用5-ASA药物的情况很常见，因此需要具有成本效益的策略来提高依从性。在所有炎症性肠病治疗的RCT中，都应测量依从性对疾病活动的影响。
