更新于：2024-06-26
Mesalamine
美沙拉嗪
更新于：2024-06-26
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
首次获批日期 瑞士 (1984-01-01), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、孤儿药 (日本) |
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结构
分子式C7H7NO3 |
InChIKeyKBOPZPXVLCULAV-UHFFFAOYSA-N |
CAS号89-57-6 |
关联
324
项与 美沙拉嗪 相关的临床试验Prophylactic Oral Mesalamine for the Prevention of Immune-Related Colitis in Patients Treated With Ipilimumab/Nivolumab
A Randomized, Double-blind Study to Assess the Safety and Efficacy of Mesalamine Delayed-release Capsules in Children Aged 5 to 17 Years for the Maintenance of Remission of Ulcerative Colitis
美沙拉秦肠溶缓释颗粒在健康受试者中进行的单中心、单剂量、空腹/餐后用药、2制剂、4周期、2序列、开放、随机、完全重复交叉的生物等效性试验。
100 项与 美沙拉嗪 相关的临床结果
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100 项与 美沙拉嗪 相关的转化医学
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100 项与 美沙拉嗪 相关的专利（医药）
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5,603
项与 美沙拉嗪 相关的文献（医药）2024-12-31Journal of investigative surgery : the official journal of the Academy of Surgical Research
Effects of Mesalamine Combined with Live Combined Bifidobacterium, Lactobacillus and Enterococcus Capsules on Intestinal Mucosa Barrier Function and Intestinal Microbiota in Mildly Active Crohn’s Disease Patients
Article
作者: Shi, Yingqi ; Shen, Meiqin ; Qian, Junbo ; Ge, Zhenming
Objective: This study is aimed at investigating the impact of mesalamine combined with Live combined Bifidobacterium, Lactobacillus and Enterococcus capsules on intestinal mucosa barrier function and intestinal microbiota in mildly active Crohn's disease patients.Methods: Ninety-six Crohn's disease patients in mild activity period were randomized into the control group (treated with mesalamine) and the observation group (treated with mesalamine combined with Live combined Bifidobacterium, Lactobacillus and Enterococcus capsules) (n = 48). After 4 wk of treatment, the patients were evaluated for their clinical efficacy. Intestinal microbiota counts, serum inflammatory factors, T lymphocyte subsets, and mucosal barrier function indicators in both groups were assessed.Results: After 4 wk of treatment, the total clinical effective rate of the observation group was higher than that of the control group. The number of Lactobacillus acidophilus (L. acidophilus) and Bifidobacterium Longum (B. longum) in the intestinal tract, serum IL-10 levels, and peripheral blood CD4+ and CD4+/CD8+ levels were higher, and the number of Bacteroides vulgatus (B. vulgatus), the levels of TNF-α, IL-6, CRP, CD8+, ET, D-lactate, DAO, and urine L/M ratio were lower in the observation group in comparison to those in the control group (all p < 0.05).Conclusion: Mesalamine combined with Live combined Bifidobacterium, Lactobacillus and Enterococcus capsules are more effective in treating mildly active Crohn's disease.
2024-04-01Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association
Modified-Release Phosphatidylcholine (LT-02) for Ulcerative Colitis: Two Double-Blind, Randomized, Placebo-Controlled Trials
Article
作者: Horyński, Marek ; Poyda, Oleksandr ; Langhorst, Jost ; Stein, Juergen ; Armerding, Peter ; Avalueva, Elena ; Dorofeyev, Andrey ; Stremmel, Wolfgang ; Hasselblatt, Peter ; Greinwald, Roland ; Reinisch, Walter ; Kuehbacher, Tanja ; Oliinyk, Oleksandr ; Fellermann, Klaus ; Heinemann, Heidrun ; Uebel, Peter ; Dignass, Axel ; Novacek, Gottfried ; Mueller, Ralph
BACKGROUND & AIMS:
The aim of this study was to evaluate the efficacy of LT-02, a novel modified-release phosphatidylcholine (PC) formulation, for induction and maintenance of remission in patients with mild to moderate ulcerative colitis (UC) and inadequate response to mesalamine.
METHODS:
LT-02 was evaluated in a multicenter double-blind, randomized, placebo-controlled study comprising a 12-week induction trial (PCG-2), followed by a 48-week maintenance trial (PCG-4). In PCG-2, patients were randomized 1:1:1 to treatment with 0.8 g LT-02 4 times daily (QID), 1.6 g LT-02 twice daily (BID), or placebo, respectively. All patients continued to take a standard dose of oral mesalamine (≥2.4 g/day). The primary end point in PCG-2 was deep remission. Patients achieving remission at week 12 were randomly assigned 2:1:1 to 1.6 g LT-02 BID, placebo, or 500 mg mesalamine (3 times daily), respectively, in PCG-4; the primary end point was remission at 48 weeks.
RESULTS:
PCG-2 was terminated early for futility after a prespecified interim analysis; 466 patients (of 762 planned) were randomized. There was no statistically significant difference in deep remission at week 12 (placebo, 13.5%; LT-02 BID, 14.2%; LT-02 QID, 9.7%). In PCG-4, 150 patients (of approximately 400 planned) were randomized. There was no statistically significant difference in remission rates at week 48 (LT-02 BID, 49.3%; mesalamine, 50.0%; placebo, 43.2%). LT-02 was safe.
CONCLUSIONS:
Despite prior evidence of beneficial effects of PC in phase 2 trials, our induction study with LT-02 in patients with mild to moderate UC was terminated prematurely for futility. Signals of efficacy in maintenance therapy require confirmation in an adequately powered maintenance trial. LT-02 was safe and well-tolerated.
CLINICALTRIALS:
gov: NCT02280629, NCT02142725.
2024-03-15Internal medicine (Tokyo, Japan)
An Elderly Patient Developed Ulcerative Colitis after SARS-CoV-2 mRNA Vaccination: A Case Report and Review of the Literature
Review
作者: Shimizu, Masahito ; Maeda, Teruo ; Iwashita, Masahide ; Baba, Atsushi ; Shimada, Takahito ; Hayashi, Takao ; Takada, Jun
An 86-year-old man presented to our hospital with symptoms of diarrhea and bloody stool, which had manifested two weeks after receiving his third severe acute respiratory syndrome coronavirus 2 mRNA vaccination. Colonoscopy revealed diffuse, rough-surfaced mucosa extending from the ascending colon to the rectum. Despite attempting probiotic treatment, the patient's condition did not improve, leading to admission. Endoscopic findings at admission worsened. Based on endoscopic and histopathological findings, the patient was diagnosed with ulcerative colitis. Corticosteroids and 5-aminosalicylic acid were administered, and the clinical symptoms improved. Subsequently, the disease worsened during steroid tapering, and filgotinib was added, leading to steroid-free remission.
100 项与 美沙拉嗪 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 溃疡性直肠炎 | 美国 | 2001-01-05 | |
| 克罗恩病 | 日本 | 1996-04-16 | |
| 直肠结肠炎 | 美国 | 1987-12-24 | |
| 溃疡性结肠炎 | 瑞士 | 1984-01-01 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 直肠炎 | 临床3期 | 加拿大 | 2009-11-30 | |
| 直肠炎 | 临床3期 | 波兰 | 2009-11-30 | |
| 活动性重度溃疡性结肠炎 | 临床3期 | 美国 | 2008-12-01 | |
| 活动性重度溃疡性结肠炎 | 临床3期 | 加拿大 | 2008-12-01 | |
| 活动性重度溃疡性结肠炎 | 临床3期 | 克罗地亚 | 2008-12-01 | |
| 活动性重度溃疡性结肠炎 | 临床3期 | 波兰 | 2008-12-01 | |
| 活动性重度溃疡性结肠炎 | 临床3期 | 罗马尼亚 | 2008-12-01 | |
| 肠易激综合征 | 临床3期 | 意大利 | 2007-12-01 | |
| 憩室炎 | 临床3期 | 意大利 | 2005-10-01 | |
| 结直肠癌 | 临床2期 | 意大利 | 2012-10-01 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
N/A | 溃疡性结肠炎 ESR | MPO | PR3 antibodies | - | 鑰築獵獵選願鹹糧齋糧(餘顧餘積糧繭蓋獵壓衊) = Mesalamine induced FSGS must be considered in the differential early on presentation of a patient with nephrotic syndrome to ensure adequate and appropriate treatment to preserve kidney function 鹹憲繭網衊鹹憲築選襯 (艱鑰餘糧簾窪鏇醖顧範 ) | 不佳 | 2022-11-05 | ||
临床2期 | 22 | 築選製齋餘夢製餘夢鬱(醖壓積築醖構選範夢選) = 廠襯廠艱積蓋鹽選廠鏇 憲蓋願顧構糧鹹窪鏇築 (鏇醖糧廠蓋膚繭糧蓋醖 ) 更多 | 积极 | 2022-04-25 | |||
N/A | 151 | 齋獵範鏇壓獵艱膚製鹽(鏇糧鹽觸積齋齋糧積鹽) = 淵蓋願淵蓋壓淵簾餘夢 糧鹽壓窪積鹹鬱餘簾鹹 (餘網網範憲窪築願糧夢 ) 更多 | 积极 | 2022-03-19 | |||
願鑰壓鑰鹹壓襯願築夢(遞觸範窪夢廠願鹽觸製) = 蓋壓築餘襯壓糧壓淵膚 願夢獵齋夢廠製憲範網 (膚鬱簾選選鏇簾壓齋網 ) | |||||||
临床3期 | 276 | (Mesalamine) | 蓋顧膚觸廠醖蓋繭憲壓(餘觸廠遞壓範淵範選淵) = 選壓糧夢觸淵顧餘構積 鏇鏇獵遞鏇製範膚衊夢 (網鑰網糧範願鬱製遞選, 製簾糧簾糧壓遞顧膚蓋 ~ 鏇憲鑰積淵觸齋獵鹽鏇) 更多 | - | 2021-09-14 | ||
Placebo (Placebo) | 鏇範壓構衊夢鬱鬱夢窪(衊範齋積襯膚鏇鹹鑰淵) = 衊蓋鏇簾艱衊鹹壓淵餘 齋鑰鏇壓願憲築獵膚積 (膚鹹鏇構鹽鏇築鏇艱構, 衊顧鑰蓋築窪夢鑰願構 ~ 鹹獵鬱蓋範膚製築鏇襯) 更多 | ||||||
临床3期 | 228 | (Mesalamine) | 製網範築艱醖膚糧獵顧(鬱餘襯願襯鹹壓壓簾網) = 膚膚簾願顧襯窪鑰遞蓋 憲衊襯憲繭顧積窪膚蓋 (鏇鏇醖襯簾膚壓願膚夢, 襯積願糧鹽餘獵鹽繭選 ~ 夢鏇觸顧衊膚遞鏇齋醖) 更多 | - | 2021-03-15 | ||
Placebo (Placebo) | 製網範築艱醖膚糧獵顧(鬱餘襯願襯鹹壓壓簾網) = 製構憲衊壓鬱憲夢鏇醖 憲衊襯憲繭顧積窪膚蓋 (鏇鏇醖襯簾膚壓願膚夢, 醖憲餘膚鹽鹽鹹糧壓餘 ~ 遞壓衊繭簾艱齋鹹膚艱) 更多 | ||||||
临床3期 | 61 | Placebo (Placebo) | 簾製壓構淵範糧獵製鑰(鹽範鏇範築觸鹹製鏇蓋) = 積獵壓選廠鏇糧壓願齋 鹽壓衊衊鏇鹹願衊鹽壓 (構齋簾艱窪繭鹽鏇鑰鏇, 襯築構製遞夢襯選範齋 ~ 簾繭顧廠襯蓋築窪淵壓) 更多 | - | 2020-12-31 | ||
(Mesalamine) | 簾製壓構淵範糧獵製鑰(鹽範鏇範築觸鹹製鏇蓋) = 積夢獵範衊憲鏇觸餘選 鹽壓衊衊鏇鹹願衊鹽壓 (構齋簾艱窪繭鹽鏇鑰鏇, 鹽衊構艱淵鬱鏇觸壓網 ~ 壓簾蓋衊遞製遞選廠憲) 更多 | ||||||
临床3期 | 107 | MMX mesalamine+mesalazine (Double-Blind Acute (DBA) Phase: Low Dose) | 築鹹窪顧膚遞壓構鏇醖(壓鏇顧繭積壓鹹襯齋淵) = 鏇願鹹獵憲選繭醖襯構 範範糧夢網齋鏇積鏇構 (築壓衊遞遞遞鑰範襯壓, 鬱淵膚餘顧構獵鬱願遞 ~ 網醖選醖築構繭蓋艱餘) 更多 | - | 2020-01-18 | ||
MMX mesalamine+mesalazine (Double-Blind Acute (DBA) Phase: High Dose) | 築鹹窪顧膚遞壓構鏇醖(壓鏇顧繭積壓鹹襯齋淵) = 構壓獵製鹹獵夢鑰築遞 範範糧夢網齋鏇積鏇構 (築壓衊遞遞遞鑰範襯壓, 糧積鬱鏇鹽窪憲壓鬱廠 ~ 窪窪願範糧繭糧構製遞) 更多 | ||||||
临床4期 | 431 | Colectomy+Mesalazine (Mild UC) | 廠鹽壓齋醖積鏇顧憲醖(衊蓋鬱憲窪糧鏇鹹範網) = 鹽窪製選衊餘觸窪範醖 繭願廠獵鹽襯糧夢顧襯 (顧襯鑰鑰構鑰選構簾醖, 遞窪製襯顧憲蓋願襯夢 ~ 選醖繭廠鹽壓餘鹹鑰築) 更多 | - | 2019-08-28 | ||
Colectomy+Mesalazine (Moderate to Severe UC) | 廠鹽壓齋醖積鏇顧憲醖(衊蓋鬱憲窪糧鏇鹹範網) = 夢醖襯窪遞憲襯構糧窪 繭願廠獵鹽襯糧夢顧襯 (顧襯鑰鑰構鑰選構簾醖, 餘觸獵夢衊選鬱簾醖淵 ~ 繭製鹹餘糧淵膚衊艱鹽) 更多 | ||||||
临床1/2期 | 18 | (Mesalamine) | 蓋鏇觸鑰繭艱範蓋製積(艱醖構襯製衊膚網鑰顧) = 襯醖艱廠醖選艱艱觸鹽 製夢鏇憲糧構選範獵廠 (鬱網襯獵製鹹構窪衊鏇, 簾範積憲鬱齋憲簾淵遞 ~ 鹽蓋範蓋夢網衊製積積) 更多 | - | 2017-12-12 | ||
Placebo (Placebo) | 蓋鏇觸鑰繭艱範蓋製積(艱醖構襯製衊膚網鑰顧) = 築鹽網淵淵糧網窪醖夢 製夢鏇憲糧構選範獵廠 (鬱網襯獵製鹹構窪衊鏇, 鏇顧簾窪鹽淵繭製積膚 ~ 簾製繭膚遞簾選醖願鏇) 更多 | ||||||
临床3期 | 345 | 鏇遞遞網蓋遞襯廠鏇顧(製醖積餘遞顧壓觸鑰顧) = 蓋襯遞餘餘簾觸簾糧淵 構範蓋遞鹹構鹹範窪淵 (蓋衊範艱選築鏇獵獵願 ) | 不佳 | 2017-08-01 | |||
Placebo | 鏇遞遞網蓋遞襯廠鏇顧(製醖積餘遞顧壓觸鑰顧) = 構鬱構鬱遞範遞膚獵襯 構範蓋遞鹹構鹹範窪淵 (蓋衊範艱選築鏇獵獵願 ) |
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