Evangelisches Krankenhaus Kalk, Cologne, Germany.
Aliment Pharmacol Ther. 2011 Nov;34(9):1115-22. doi: 10.1111/j.1365-2036.2011.04840.x. Epub 2011 Sep 19.
Different oral formulations of 'mesalazine (mesalamine)' may have different efficacy in distal ulcerative colitis.
To evaluate the efficacy of mesalazine granules (Salofalk granules) vs. mesalazine tablets (Salofalk tablets) as induction therapy in patients with distinct extensions of ulcerative colitis.
A pooled analysis of 705 patients from four prospective, randomised, double-blind phase III trials was performed. The efficacy of 8 weeks' induction with 3 g/day mesalazine granules [3 g once daily (o.d.) or 1 g three times daily (t.d.s)] vs. 3 g/day mesalazine tablets (1 g t.d.s.) was compared in terms of clinical remission (CR: CAI ≤ 4) and endoscopic remission (ER: EI ≤ 3) (both according to Rachmilewitz) in subgroups with pancolitis, left-sided colitis, or proctosigmoiditis.
Mesalazine granules were equipotent to mesalazine tablets in pancolitis regarding CR (72% vs. 71%, P = 0.909) and ER (58% vs. 49%, P = 0.338). In left-sided colitis, both mesalazine formulations were equipotent regarding CR (66% vs. 67%; P = 0.843) but mesalazine granules were superior regarding ER (56% vs. 37%; P = 0.025). In proctosigmoiditis, mesalazine granules were significantly more effective than mesalazine tablets regarding CR (78% vs. 55% P < 0.001) and ER (67% vs. 43% P < 0.001). Furthermore, o.d. application of mesalazine granules was more effective than t.d.s. dosing in left-sided colitis (CR 73% vs. 62%, P = 0.181; ER 71% vs. 48% P = 0.005) and proctosigmoiditis (CR 86% vs. 73%, P = 0.020; ER 75% vs. 61%, P = 0.021), but not in pancolitis.
This pooled analysis supports the hypothesis that mesalazine granules are superior to mesalazine tablets in induction of remission in distal colitis and should be taken once daily.
不同的美沙拉嗪（柳氮磺胺吡啶）口服制剂在治疗远端溃疡性结肠炎时可能具有不同的疗效。
评估美沙拉嗪颗粒（颇得斯安颗粒）与美沙拉嗪片剂（颇得斯安片剂）作为诱导治疗药物，在不同延伸范围的溃疡性结肠炎患者中的疗效。
对来自四项前瞻性、随机、双盲 III 期试验的 705 例患者进行汇总分析。比较每日 3 克美沙拉嗪颗粒（每日 1 次，1 克；或每日 3 次，1 克）与每日 3 克美沙拉嗪片剂（每日 3 次，1 克）8 周诱导治疗的疗效，疗效评估指标为临床缓解（CAI≤4）和内镜缓解（EI≤3）（均根据 Rachmilewitz 标准）。在全结肠炎、左半结肠炎或直肠乙状结肠炎亚组中比较疗效。
在全结肠炎患者中，美沙拉嗪颗粒与美沙拉嗪片剂在临床缓解（72%比 71%，P=0.909）和内镜缓解（58%比 49%，P=0.338）方面疗效相当。在左半结肠炎患者中，两种美沙拉嗪制剂在临床缓解（66%比 67%；P=0.843）和内镜缓解（56%比 37%；P=0.025）方面均具有等效性。在直肠乙状结肠炎患者中，美沙拉嗪颗粒明显优于美沙拉嗪片剂，在临床缓解（78%比 55%，P<0.001）和内镜缓解（67%比 43%，P<0.001）方面均具有显著优势。此外，在左半结肠炎和直肠乙状结肠炎中，美沙拉嗪颗粒每日 1 次给药比每日 3 次给药更有效（左半结肠炎：临床缓解 73%比 62%，P=0.181；内镜缓解 71%比 48%，P=0.005；直肠乙状结肠炎：临床缓解 86%比 73%，P=0.020；内镜缓解 75%比 61%，P=0.021）。
这项汇总分析支持美沙拉嗪颗粒在诱导远端结肠炎缓解方面优于美沙拉嗪片剂的假设，且美沙拉嗪颗粒应为每日 1 次给药。
