Nishikawa Alvaro Mitsunori, Paladini Luciano, Delfini Régis, Kotze Paulo Gustavo, Clark Otavio
Pontifícia Universidade Católica do Paraná (PUCPR), PR, Brasil.
Arq Gastroenterol. 2013 Oct-Dec;50(4):297-303. doi: 10.1590/S0004-28032013000400011.
Unspecified Ulcerative Rectocolitis is a chronic disease that affects between 0.5 and 24.5/105 inhabitants in the world. National and international clinical guidelines recommend the use of aminosalicylates (including mesalazine) as first-line therapy for induction of remission of unspecified ulcerative rectocolitis, and recommend the maintenance of these agents after remission is achieved. However, multiple daily doses required for the maintenance of disease remission compromise compliance with treatment, which is very low (between 45% and 65%). Use of mesalazina in granules (2 g sachet) once daily--Pentasa® sachets 2 g--can enhance treatment adherence, reflecting in an improvement in patients' outcomes.
To evaluate the evidence on the use of mesalazine for the maintenance of remission in patients with unspecified ulcerative rectocolitis and its effectiveness when taken once versus more than once a day. From an economic standpoint, to analyze the impact of the adoption of this dosage in Brazil's public health system, considering patients' adherence to treatment.
A decision tree was developed based on the Clinical Protocol and Therapeutic Guidelines for Ulcerative Colitis, published by the Ministry of Health in the lobby SAS/MS n° 861 of November 4 th, 2002 and on the algorithms published by the Associação Brasileira de Colite Ulcerativa e Doença de Crohn, aiming to get the cost-effectiveness of mesalazine once daily in granules compared with mesalazine twice daily in tablets.
The use of mesalazine increases the chances of remission induction and maintenance when compared to placebo, and higher doses are associated with greater chance of success without increasing the risk of adverse events.
The use of a single daily dose in the maintenance of remission is effective and related to higher patient compliance when compared to the multiple daily dose regimens, with lower costs.
未特指的溃疡性直肠结肠炎是一种慢性病,全球每10.5万居民中就有0.5至24.5人受其影响。国家和国际临床指南推荐使用氨基水杨酸类药物(包括美沙拉嗪)作为诱导未特指的溃疡性直肠结肠炎缓解的一线治疗药物,并建议在实现缓解后维持使用这些药物。然而,维持疾病缓解所需的每日多次给药会影响治疗依从性,依从性非常低(45%至65%)。使用美沙拉嗪颗粒剂(2克小包装)每日一次——Pentasa® 2克小包装——可提高治疗依从性,从而改善患者预后。
评估美沙拉嗪用于维持未特指的溃疡性直肠结肠炎患者缓解的证据,以及每日服用一次与多次服用的有效性。从经济角度分析在巴西公共卫生系统中采用这种给药剂量的影响,并考虑患者的治疗依从性。
根据巴西卫生部于2002年11月4日在SAS/MS第861号公告中发布的《溃疡性结肠炎临床方案和治疗指南》以及巴西溃疡性结肠炎和克罗恩病协会发布的算法,绘制决策树,旨在比较美沙拉嗪颗粒剂每日一次与美沙拉嗪片剂每日两次的成本效益。
与安慰剂相比,使用美沙拉嗪可增加诱导和维持缓解的机会,更高剂量与更大的成功机会相关,且不会增加不良事件风险。
与每日多次给药方案相比,每日单次给药维持缓解有效,患者依从性更高,成本更低。