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多基质系统美沙拉嗪:用还是不用。

Multi-matrix system mesalamine: to use or not to use.

作者信息

Kale-Pradhan Pramodini B, Pradhan Rohan S, Wilhelm Sheila M

机构信息

Wayne State University, St. John Hospital and Medical Center, Detroit, MI 48236, USA.

出版信息

Ann Pharmacother. 2008 Feb;42(2):265-9. doi: 10.1345/aph.1K469. Epub 2008 Jan 8.

Abstract

OBJECTIVE

To evaluate the role of Multi-Matrix System (MMX) mesalamine in the treatment of ulcerative colitis (UC).

DATA SOURCES

Literature was obtained through searches of MEDLINE (1966-October 2007) and a bibliographic review of published articles. Key terms used in the searches included ulcerative colitis, mesalamine, MMX, SPD476, and Lialda.

STUDY SELECTION AND DATA EXTRACTION

All English-language articles that were identified through the search were evaluated. All primary literature was included in the review.

DATA SYNTHESIS

The standard treatment for the induction and maintenance of remission in patients with mild-to-moderate UC is aminosalicylate products (mesalamine, sulfasalazine, balasalazide, olsalazine). Current mesalamine formulations are not ideal for long-term treatment due to issues with patient adherence secondary to complex dosing regimens and high pill burden. Clinical studies show that MMX mesalamine achieves clinical and endoscopic remission more frequently compared with placebo or mesalamine enema. Patients receiving MMX mesalamine achieved statistically significant clinical and endoscopic remission when compared with those taking placebo (34.1% vs 12.9%; p < 0.001 with 2.4 g/day vs placebo, and 29.2% vs 12.9%; p = 0.009 with 4.8 g/day vs placebo). Similarly, in another study, significantly more patients achieved remission in the MMX mesalamine groups compared with patients in the placebo group (40.5% vs 22.1% with 2.4 g/day vs placebo; p = 0.01, and 41.2% vs 22.1% with 4.8 g/day vs placebo; p = 0.007). MMX mesalamine is well tolerated, with headache, flatulence, and abdominal pain being the most frequently reported adverse events.

CONCLUSIONS

Current evidence supports the use of MMX mesalamine for treatment of mild-to-moderate UC by demonstrating that MMX mesalamine 2.4-4.8 g daily induces remission. It has the advantage of once-daily dosing regimens with lower pill burden than comparable products and, as an oral agent, may have better patient acceptability compared with topical mesalamine formulations. Therefore, MMX mesalamine is an option in patients with UC. The cost of MMX mesalamine is comparable to that of oral and rectal formulations of mesalamine. Further pharmacoeconomic studies are warranted to examine the cost impact of MMX mesalamine.

摘要

目的

评估多矩阵系统(MMX)美沙拉嗪在溃疡性结肠炎(UC)治疗中的作用。

数据来源

通过检索MEDLINE(1966年 - 2007年10月)及对已发表文章进行文献综述获取文献。检索中使用的关键词包括溃疡性结肠炎、美沙拉嗪、MMX、SPD476和Lialda。

研究选择与数据提取

对通过检索识别出的所有英文文章进行评估。所有原始文献均纳入综述。

数据综合

轻至中度UC患者诱导缓解和维持缓解的标准治疗是氨基水杨酸类产品(美沙拉嗪、柳氮磺胺吡啶、巴柳氮、奥沙拉嗪)。由于复杂给药方案和高 pill负担导致患者依从性问题,当前美沙拉嗪制剂并非长期治疗的理想选择。临床研究表明,与安慰剂或美沙拉嗪灌肠剂相比,MMX美沙拉嗪更频繁地实现临床和内镜缓解。与服用安慰剂的患者相比,接受MMX美沙拉嗪的患者在临床和内镜缓解方面具有统计学显著差异(2.4 g/天与安慰剂相比,34.1% 对12.9%;p < 0.001,4.8 g/天与安慰剂相比,29.2%对12.9%;p = 0.009)。同样,在另一项研究中,与安慰剂组患者相比,MMX美沙拉嗪组中实现缓解的患者显著更多(2.4 g/天与安慰剂相比,40.5%对22.1%;p = 0.01,4.8 g/天与安慰剂相比,41.2%对22.1%;p = 0.007)。MMX美沙拉嗪耐受性良好,头痛、肠胃气胀和腹痛是最常报告的不良事件。

结论

当前证据支持使用MMX美沙拉嗪治疗轻至中度UC,表明每日2.4 - 4.8 g的MMX美沙拉嗪可诱导缓解。它具有每日一次给药方案的优势,与同类产品相比 pill负担更低,并且作为口服制剂,与局部美沙拉嗪制剂相比可能具有更好的患者可接受性。因此,MMX美沙拉嗪是UC患者的一种选择。MMX美沙拉嗪的成本与美沙拉嗪口服和直肠制剂相当。有必要进行进一步的药物经济学研究以考察MMX美沙拉嗪的成本影响。

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