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美沙拉嗪颗粒剂型比片剂剂型更能改善克罗恩病的临床数据。

Mesalazine granule formulation improves clinical data in Crohn's disease compared with tablet formulation.

机构信息

First Department of Medicine, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan.

Department of Laboratory Medicine, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan.

出版信息

Sci Rep. 2020 Dec 7;10(1):21353. doi: 10.1038/s41598-020-78603-9.

DOI:10.1038/s41598-020-78603-9
PMID:33288852
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7721736/
Abstract

The efficacy of sustained-release preparations of mesalazine as a remission maintenance treatment for Crohn's disease remains to be established. We aimed to examine the changes in compliance rate and clinical data 2 years after switching from mesalazine tablet to granule formulation at our facility among patients with Crohn's disease in remission. We investigated the rate of continuous treatment of mesalazine granules and examined the changes in Crohn's Disease Activity Index (CDAI) and serum C-reactive protein (CRP), albumin, and hemoglobin (Hb) levels 2 years after the switch. Compliance rate (continuous treatment vs. additional treatment) and continuous treatment rate [good (rate of ≥ 70%) vs. poor (rate < 70%)] were investigated. Of 46 patients, 12 (27.3%) received additional treatment and 32 (72.7%) did not require additional treatment in 2 years. No significant change in CDAI after switching to granule modification was noted in 32 patients in the continuous treatment group. Nevertheless, clinical remission was maintained for 2 years, and serum CRP levels decreased significantly (P = 0.023) and Hb levels increased significantly (P = 0.002). No change in the compliance rate was found. Our results suggest that mesalazine granule formulation may have a remission maintenance effect that is superior to that of mesalazine tablets.

摘要

美沙拉嗪缓释制剂作为克罗恩病缓解期维持治疗的疗效尚待确定。我们旨在研究在本机构中，处于缓解期的克罗恩病患者由美沙拉嗪片转换为颗粒剂后，2 年内顺应性变化和临床数据的变化。我们调查了美沙拉嗪颗粒持续治疗的比率，并检查了切换后 2 年内克罗恩病活动指数（CDAI）以及血清 C 反应蛋白（CRP）、白蛋白和血红蛋白（Hb）水平的变化。我们研究了顺应性（持续治疗与附加治疗）和持续治疗率（好[≥70%]与差（<70%））。46 例患者中，12 例（27.3%）接受了附加治疗，32 例（72.7%）在 2 年内无需附加治疗。在持续治疗组的 32 例患者中，转换为颗粒剂型后 CDAI 无明显变化。尽管如此，临床缓解仍持续 2 年，血清 CRP 水平显著下降（P=0.023），Hb 水平显著升高（P=0.002）。顺应性率没有变化。我们的结果表明，美沙拉嗪颗粒剂可能具有优于美沙拉嗪片剂的缓解维持作用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5016/7721736/cfec3608a8fc/41598_2020_78603_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5016/7721736/a18af68a2d6a/41598_2020_78603_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5016/7721736/d01a646dc1fe/41598_2020_78603_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5016/7721736/27208fce3e65/41598_2020_78603_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5016/7721736/cfec3608a8fc/41598_2020_78603_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5016/7721736/a18af68a2d6a/41598_2020_78603_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5016/7721736/d01a646dc1fe/41598_2020_78603_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5016/7721736/27208fce3e65/41598_2020_78603_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5016/7721736/cfec3608a8fc/41598_2020_78603_Fig4_HTML.jpg

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