Lamet Mark, Ptak Theodore, Dallaire Chrystian, Shah Umed, Grace Michael, Spenard Jean, de Montigny Danielle
Center for Gastrointestinal Disorders, Hollywood, Florida 33021, USA.
Inflamm Bowel Dis. 2005 Jul;11(7):625-30. doi: 10.1097/01.mib.0000171277.70404.40.
Ulcerative proctitis (UP) usually presents as fresh rectal bleeding. Successful treatment using topical mesalamine 5-aminosalicyclic acid (5-ASA) 500 mg BID suppository led to developing a once-a-day formulation that could contribute to better acceptability and ease of use by patients. The objective of this randomized trial, conducted in 18 centers, was to compare efficacy of 2 modes of treatment with 5-ASA suppositories.
Ninety-nine patients with mild or moderate UP limited to 15 cm of the anal margin, evidenced by a disease activity index (DAI) between 4 and 11, were randomized to 5-ASA 500 mg suppository (Canasa; Axcan Pharma) BID or 1 g at bedtime (HS) for 6 weeks. The study used a noninferiority hypothesis based on the mean difference in DAI values after 6 weeks of treatment on an intent-to-treat basis using analysis of covariance. DAI was derived from a composite of the measures of stool frequency, rectal bleeding, mucosal visualization at endoscopy, and general well being.
There was no difference between groups at baseline for demographic and clinical parameters. Mean DAIs fell from 6.6 +/- 1.5 (SD) to 1.6 +/- 2.3 in the 500 mg BID group (n = 48) and from 6.1 +/- 1.5 to 1.3 +/- 2.2 in the 1 g HS group (n = 39). There was no significant difference (P = 0.74) in mean DAI at week 6 between the 2 groups. Both groups showed a significant reduction (P < 0.0001) in DAI over the course of the 6 weeks. Both formulations showed effectiveness in reducing each individual component of the DAI. There was no significant difference between treatments in adverse events, and both groups had an overall drug compliance of greater than 95%.
This study showed that 1 g HS and 500 mg BID mesalamine suppository treatments of UP patients were equivalent in all facets of efficacy, safety, and compliance in a 6-week trial.
溃疡性直肠炎（UP）通常表现为直肠新鲜出血。使用局部用美沙拉嗪5-氨基水杨酸（5-ASA）500毫克每日两次栓剂进行的成功治疗促使研发出一种每日一次的制剂，该制剂可能有助于提高患者的接受度和使用便利性。这项在18个中心开展的随机试验的目的是比较5-ASA栓剂两种治疗方式的疗效。
99例轻度或中度UP患者，病变局限于距肛缘15厘米以内，疾病活动指数（DAI）在4至11之间，被随机分为5-ASA 500毫克栓剂（Canasa；Axcan制药公司）每日两次组或每晚1克组，治疗6周。该研究基于意向性分析，采用协方差分析，以治疗6周后DAI值的平均差异为基础，采用非劣效性假设。DAI由大便频率、直肠出血、内镜下黏膜观察及总体健康状况等指标综合得出。
两组在基线时的人口统计学和临床参数无差异。500毫克每日两次组（n = 48）的平均DAI从6.6±1.5（标准差）降至1.6±2.3，1克每晚组（n = 39）的平均DAI从6.1±1.5降至1.3±2.2。两组在第6周时的平均DAI无显著差异（P = 0.74）。两组在6周疗程中DAI均显著降低（P < 0.0001）。两种制剂在降低DAI的各个单项指标方面均显示出有效性。治疗组间不良事件无显著差异，两组总体药物依从性均大于95%。
本研究表明，在一项为期6周的试验中，1克每晚和500毫克每日两次美沙拉嗪栓剂治疗UP患者在疗效、安全性和依从性的所有方面均相当。
