一项关于巴柳氮（6.75克）、巴柳氮（2.25克）和美沙拉嗪（2.4克）治疗轻至中度活动性溃疡性结肠炎的随机、双盲、剂量反应比较研究。
A randomized, double blind, dose-response comparison of balsalazide (6.75 g), balsalazide (2.25 g), and mesalamine (2.4 g) in the treatment of active, mild-to-moderate ulcerative colitis.
作者信息
Levine Douglas S, Riff Dennis S, Pruitt Ronald, Wruble Lawrence, Koval George, Sales David, Bell John K, Johnson Lorin K
机构信息
Division of Gastroenterology, University of Washington School of Medicine, Seattle, USA.
出版信息
Am J Gastroenterol. 2002 Jun;97(6):1398-407. doi: 10.1111/j.1572-0241.2002.05781.x.
OBJECTIVE
Balsalazide is a new innovative, mesalamine-containing prodrug that is activated by bacteria in the colon. Balsalazide has been shown previously to be well tolerated and effective in the treatment of acute ulcerative colitis. The aim of this study was to determine the dose-response of balsalazide for efficacy and safety in active, mild-to-moderate ulcerative colitis and to compare this profile with that of mesalamine, pH-dependent, delayed-release tablets.
METHODS
A multicenter, randomized, active control, double-blind, double-dummy, dose-response, parallel-group study was performed comparing balsalazide (6.75 g daily), balsalazide (2.25 g daily), and mesalamine (2.4 g daily), administered for 8 wk to 154 patients with active, mild-to-moderate ulcerative colitis as verified by sigmoidoscopy.
RESULTS
Eight weeks of treatment with 6.75 g of balsalazide daily provided significantly greater improvement than did balsalazide (2.25 g daily) in rectal bleeding (64.7% [6.75-g balsalazide] vs 32.4% [2.25-g balsalazide], p < 0.006), stool frequency (58.8% vs 29.4%, p < 0.006), sigmoidoscopic score (78.9% vs 52.5%, p < 0.015), and Physician's Global Assessment (73.7% vs 51.3%, p < 0.03). The efficacy of balsalazide showed a significantly more rapid onset of action than that of mesalamine (2.4 g daily) (2-wk sigmoidocopic score improvement, 54.7% [6.75-g balsalazide] vs 29.4% [2.4-g mesalamine], p = 0.006) with numerically greater improvement at 8 wk in five of seven measured signs and symptoms. Balsalazide (6.75 g daily) was well tolerated, and the safety profile did not differ significantly from that of balsalazide (2.25 g daily) or mesalamine.
CONCLUSIONS
Eight weeks of treatment with balsalazide (6.75 g daily) is significantly more effective than balsalazide (2.25 g daily) and more rapid in onset than mesalamine (2.4 g daily) in improving signs and symptoms of acute ulcerative colitis. Balsalazide (6.75 g daily) is well tolerated, and the safety profile does not differ from that of balsalazide (2.25 g daily) and mesalamine (2.4 g daily).
目的
巴柳氮是一种新型的含美沙拉嗪的前体药物，在结肠中被细菌激活。此前已证明巴柳氮耐受性良好，对治疗急性溃疡性结肠炎有效。本研究的目的是确定巴柳氮在活动性轻至中度溃疡性结肠炎中的疗效和安全性的剂量反应，并将此情况与pH依赖性缓释美沙拉嗪片进行比较。
方法
进行了一项多中心、随机、活性对照、双盲、双模拟、剂量反应、平行组研究，比较巴柳氮（每日6.75 g）、巴柳氮（每日2.25 g）和美沙拉嗪（每日2.4 g），对154例经乙状结肠镜检查证实为活动性轻至中度溃疡性结肠炎的患者给药8周。
结果
每日服用6.75 g巴柳氮治疗8周，在直肠出血方面（64.7%[6.75 g巴柳氮组]对32.4%[2.25 g巴柳氮组]，p<0.006）、排便频率（58.8%对29.4%，p<0.006）、乙状结肠镜评分（78.9%对52.5%，p<0.015）和医生整体评估（73.7%对51.3%，p<0.03）方面，比每日服用2.25 g巴柳氮有显著更大的改善。巴柳氮的疗效显示起效比美沙拉嗪（每日2.4 g）明显更快（2周时乙状结肠镜评分改善，54.7%[6.75 g巴柳氮组]对29.4%[2.4 g美沙拉嗪组]，p = 0.006），在7项测量的体征和症状中的5项上，8周时数值上有更大改善。每日服用6.75 g巴柳氮耐受性良好，安全性情况与每日服用2.25 g巴柳氮或美沙拉嗪无显著差异。
结论
在改善急性溃疡性结肠炎的体征和症状方面，每日服用6.75 g巴柳氮治疗8周比每日服用2.25 g巴柳氮显著更有效，且起效比每日服用2.4 g美沙拉嗪更快。每日服用6.75 g巴柳氮耐受性良好，安全性情况与每日服用2.25 g巴柳氮和美沙拉嗪（每日2.4 g）无差异。
Zotero 插件