Center for Gastrointestinal Disorders, Hollywood, FL 33021, USA.
Dig Dis Sci. 2011 Feb;56(2):513-22. doi: 10.1007/s10620-010-1334-y. Epub 2010 Jul 30.
Ulcerative proctitis (UP) is a prevalent condition associated with increased morbidity and mortality. Topical mesalamine (5-aminosalicylic acid [5-ASA]) inhibits inflammatory processes in UP.
We evaluated effects of mesalamine 1-g suppository administered QHS compared with 500-mg suppository administered BID on UP activity (e.g., disease extension/mucosal appearance), remission, onset of response, safety and compliance in 97 patients with UP. A 6-week, randomized, multicenter, parallel-group, noninferiority study was conducted (and published) with Disease Activity Index (DAI) at week 6 as the primary efficacy variable and individual components of DAI at week 6 (i.e., stool frequency, rectal bleeding, mucosal appearance, global assessment) as secondary variables. Unreported outcomes were remission (DAI < 3 at weeks 3 and 6), disease extension, and complete response to treatment (DAI = 0; post-hoc, exploratory analysis).
DAI values after 6 weeks were significantly reduced (±SD) from 6.6 ± 1.5 to 1.6 ± 2.3 (500-mg BID); and from 6.1 ± 1.5 to 1.3 ± 2.2 (1-g QHS). Mucosal appearance significantly improved from baseline after 3 and 6 weeks of treatment from 1.8 ± 0.5 to 0.8 ± 0.7 and 0.5 ± 0.7 (500-mg BID; P ≤ 0.0062) and from 1.7 ± 0.5 to 0.9 ± 0.5 and 0.4 ± 0.6 (1-g QHS; P ≤ 0.0001), respectively. Remission was comparable (78.3-86.1%); onset of response generally occurred within 3 weeks, and disease extension was reduced (>70%) after 6 weeks in both groups. Mesalamine was well tolerated. Compliance was >96%.
Mesalamine 500-mg BID and 1-g QHS suppositories are safe and effective for patients with UP. Most patients reported significant improvement within 3 weeks and UP remission and reduced disease extension after 6 weeks of treatment. Validity of QHS administration was confirmed.
溃疡性直肠炎（UP）是一种常见的疾病，与发病率和死亡率的增加有关。局部美沙拉嗪（5-氨基水杨酸[5-ASA]）可抑制 UP 的炎症过程。
我们评估了 QHS 给予 1g 栓剂与 BID 给予 500mg 栓剂对 97 例 UP 患者的 UP 活性（例如疾病延伸/黏膜外观）、缓解、应答开始、安全性和依从性的影响。进行了一项为期 6 周、随机、多中心、平行组、非劣效性研究（并已发表），主要疗效变量为第 6 周疾病活动指数（DAI），次要变量为第 6 周 DAI 的各个组成部分（即粪便频率、直肠出血、黏膜外观、总体评估）。未报告的结局包括缓解（第 3 和第 6 周 DAI < 3）、疾病延伸和对治疗的完全应答（DAI = 0；事后，探索性分析）。
6 周后 DAI 值从 6.6 ± 1.5 显著降低至 1.6 ± 2.3（500mg BID）；从 6.1 ± 1.5 降低至 1.3 ± 2.2（1-g QHS）。黏膜外观从基线开始在治疗后第 3 和第 6 周分别从 1.8 ± 0.5 改善至 0.8 ± 0.7 和 0.5 ± 0.7（500mg BID；P ≤ 0.0062）和从 1.7 ± 0.5 改善至 0.9 ± 0.5 和 0.4 ± 0.6（1-g QHS；P ≤ 0.0001）。缓解率相当（78.3-86.1%）；应答开始通常发生在 3 周内，两组患者在第 6 周时疾病延伸均减少（>70%）。美沙拉嗪耐受良好。依从性>96%。
500mg BID 和 1-g QHS 栓剂治疗 UP 患者安全有效。大多数患者在 3 周内报告有显著改善，在治疗 6 周后 UP 缓解和疾病延伸减少。证实了 QHS 给药的有效性。
