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更新于：2025-12-22
Mycophenolate Sodium
麦考酚钠
更新于：2025-12-22
概要
基本信息
权益机构- |
最高研发阶段批准上市 |
首次获批日期 瑞士 (2002-10-24), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C17H20NaO6 |
InChIKeyXXFIICJIHVLJFB-JOKMOOFLSA-N |
CAS号37415-62-6 |
关联
179
项与 麦考酚钠 相关的临床试验CTIS2025-520535-16-00
A multicenter, open, prospective, randomized, parallel-group, 12-month trial of REduced immunosuppression for oLdEr AdultS kidnEy transplant recipients: the RELEASE study.
ChiCTR2500099977
Enteric-Coated Mycophenolate Sodium (EC-MPS) Monotherapy for Renal Dysfunction after Liver Transplantation: a Prospective Trial
CTR20250663
麦考酚钠肠溶片在健康受试者中的单剂量、随机、开放、两制剂、重复交叉、四周期、空腹和餐后人体生物等效性试验
100 项与 麦考酚钠 相关的临床结果
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100 项与 麦考酚钠 相关的转化医学
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100 项与 麦考酚钠 相关的专利（医药）
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3,385
项与 麦考酚钠 相关的文献（医药）2026-01-01ANNALS OF VASCULAR SURGERY
A Case Series of Ruptured Fungal Mycotic Pseudoaneurysms in Renal Transplant Patients
Article
作者: Kabutey, Nii-Kabu ; Hegazi, Mennatalla ; Delgadillo, Daniel ; Chen, Samuel L ; Chau, Anthony H ; Fujitani, Roy M
Mycotic pseudoaneurysms (MPs) occur in <1% of renal transplant patients, with rupture being even rarer. We present clinical symptoms, surgical techniques, and postoperative courses of four transplant patients with MPs who presented with acute bleeding. All patients presented within 3 weeks of transplant. All patients underwent immunosuppression induction with rabbit anti-thymocyte globulin and high-dose steroids, and following transplant, were managed with a triple therapy immunosuppression regimen of mycophenolate sodium, a prednisone taper, and tacrolimus, as well as an infection prophylaxis regimen of valganciclovir, clotrimazole, and sulfamethoxazole-trimethoprim. All patients presented with bleeding originating from the iliac or transplant renal artery. Despite the antifungal prophylaxis, all four patients were found to have candida infections at the transplant site. Hemorrhage control was obtained using different techniques in each case, including open and endovascular techniques. Endovascular balloon occlusion was used for immediate stabilization, followed by open arterial resection, extra-anatomic bypass, or patch repair. One allograft was salvaged while three required nephrectomy. MPs in immunocompromised transplant patients may not present with infectious symptoms before rupture, but infection should be considered in acutely bleeding transplant patients. Open and endovascular approaches can be employed to control hemorrhage; however, infection risk must be considered with prosthetics.
2025-12-01Transplantation and Cellular Therapy
NT-proBNP Levels After First-Dose Post-Transplant Cyclophosphamide Predict Early Cardiac Events and Mortality in Allogeneic Stem Cell Transplantation
Article
作者: Chen, Tzu-Ting ; Hsieh, Ching-Yun ; Lin, Chen-Yuan ; Chen, Chia-Yu ; Wang, Shing-Ting ; Lin, Ching-Chan ; Chiu, Chang-Fang ; Yeh, Su-Peng ; Lin, Mei-Chan
BACKGROUND:
Post-transplant cyclophosphamide (PTCy) is an effective method for preventing graft-versus-host disease (GVHD) following haploidentical hematopoietic stem cell transplantation (HSCT). However, PTCy is associated with significant toxicities, including a higher incidence of early cardiac events (ECEs).
OBJECTIVES:
This study aimed to investigate whether the dynamic response of N-terminal pro-B-type natriuretic peptide (BNP) levels to PTCy administration can predict the occurrence of ECEs and clinical outcomes in patients receiving PTCy.
STUDY DESIGN:
We conducted a retrospective analysis of 134 patients who underwent haploidentical peripheral stem cell transplantation at our institution between December 23, 2017, and January 3, 2024. For GVHD prophylaxis, all patients received PTCy at a dose of 50 mg/kg on days +3 and +4, 4.5 mg/kg of rabbit antithymocyte globulin on days -4 to -2, cyclosporine, and mycophenolate sodium. BNP levels were measured within 24 hours after the initial administration of day +3 PTCy and before the second dose on day +4. Univariate and multivariate analyses were used to evaluate the association of BNP levels with cumulative incidence of ECEs, relapse, non-relapse mortality (NRM), acute GVHD (aGVHD), chronic GVHD (cGVHD), graft-versus-host disease-free, relapse-free survival (GRFS) and overall survival (OS).
RESULTS:
The cumulative incidence of ECEs was 17.9% (95% CI:11.9%-24.9%) in this cohort. Elevated BNP levels (>530 pg/mL) were significantly associated with a higher incidence of ECEs (cumulative incidence: high vs. low BNP levels: 63% [95% CI: 43%-77%] vs. 3.9% [95% CI: 1.3%-9%], p < 0.001)). Patients with high BNP levels also exhibited higher NRM (3-year NRM: 67% [95% CI: 43%-83%] vs. 28% [95% CI: 19%-37%], p<0.01) and inferior OS (3-year OS: 12% [95% CI: 3%-39%] vs. 39% [95% CI: 29%-53%], p<0.01). Patients with high BNP levels had significantly inferior GRFS (3-year GRFS: 5% [95% CI: 1%-30%] vs. 28% [95% CI: 19%-41%], p=0.012). No significant differences were observed in the incidence of acute or chronic GVHD between groups. Multivariate analysis revealed significant associations between ECEs and high BNP levels (hazard ratio [HR]: 19.0; 95% CI: 7.36-49.00; p<0.01) and hypertension history (HR: 3.48; 95% CI: 1.54-7.85; p<0.01). Additionally, high BNP levels were significantly associated with increased NRM (HR: 2.54; 95% CI: 1.37-4.69; p<0.01) and worse OS (HR: 1.70; 95% CI: 1.02-2.82; p=0.042).
CONCLUSIONS:
Elevated BNP levels are significantly associated with increased ECEs, higher NRM, and inferior OS in haploidentical HSCT patients receiving PTCy. BNP levels measured after the first dose of PTCy may serve as a predictive biomarker for subsequent cardiotoxicity, potentially guiding dose modification of the second PTCy administration to prevent early cardiac events.
2025-12-01INTERNATIONAL DENTAL JOURNAL
Identification of Drugs Associated With Oral Ulcers Based on Pharmacovigilance
Article
作者: Zhang, Xinyue ; Li, Shiting ; Li, Xueqing ; Huoshen, Wuda
BACKGROUND:
Oral ulcers are common, painful lesions that significantly affect quality of life. Certain medications, especially antimetabolites and mTOR inhibitors, have been implicated in their development. However, drug-induced oral ulcers have not been systematically evaluated using large-scale real-world data.
METHODS:
The study employed a dual-validation strategy combining pharmacovigilance signal mining and multivariate logistic regression analysis. By querying specific 'preferred terms' (PTs), adverse event reports in the FAERS database of the Food and Drugs Adminstration of USA, related to oral ulcers were identified. Signal detection was conducted using four disproportionality analysis methods. For the initially screened candidate drugs, a multivariate logistic regression model was constructed, adjusting for potential confounders such as age, gender, weight, reporter type, reporting country and year, to further validate their independent association with oral ulcer reports (PFDR < .05).
RESULTS:
Reports of oral ulcerations have shown a significant and sustained increase since 2010, peaking in 2020. The multi-method validation framework identified 289 statistically significant drug-oral ulceration association signals. Drugs with the highest signal strength included cyclizine, mycophenolate sodium and aredia. Other drugs with significant signals included lactulose, acetaminophen codeine phosphate, leflunomide, omalizumab, everolimus and atezolizumab. Integrating signal detection results, logistic regression analysis further confirmed that multiple drugs were significantly associated with the risk of oral ulcer reports. Drugs with extremely high odds ratios (ORs) included estriol and docetaxel sagent. Strongly associated drugs also included immunosuppressants, antihistamines, combination analgesics, bisphosphonates, sartans and antibiotics.
CONCLUSION:
This study systematically identified approximately 289 drugs significantly associated with oral ulcer risk, including immunosuppressants, cardiovascular drugs and bronchodilators. Based on pharmacovigilance signal detection and regression analysis, patients on long-term treatment with these drugs should receive enhanced oral monitoring. As this is an observational study, further prospective and experimental research is needed to confirm causality.
100 项与 麦考酚钠 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 |
|---|---|---|---|
| 肾移植急性排斥反应 | 奥地利 | 2004-02-07 | |
| 肾移植急性排斥反应 | 比利时 | 2004-02-07 | |
| 肾移植急性排斥反应 | 塞浦路斯 | 2004-02-07 | |
| 肾移植急性排斥反应 | 捷克 | 2004-02-07 | |
| 肾移植急性排斥反应 | 丹麦 | 2004-02-07 | |
| 肾移植急性排斥反应 | 芬兰 | 2004-02-07 | |
| 肾移植急性排斥反应 | 法国 | 2004-02-07 | |
| 肾移植急性排斥反应 | 德国 | 2004-02-07 | |
| 肾移植急性排斥反应 | 希腊 | 2004-02-07 | |
| 肾移植急性排斥反应 | 匈牙利 | 2004-02-07 | |
| 肾移植急性排斥反应 | 冰岛 | 2004-02-07 | |
| 肾移植急性排斥反应 | 爱尔兰 | 2004-02-07 | |
| 肾移植急性排斥反应 | 意大利 | 2004-02-07 | |
| 肾移植急性排斥反应 | 卢森堡 | 2004-02-07 | |
| 肾移植急性排斥反应 | 马耳他 | 2004-02-07 | |
| 肾移植急性排斥反应 | 荷兰 | 2004-02-07 | |
| 肾移植急性排斥反应 | 挪威 | 2004-02-07 | |
| 肾移植急性排斥反应 | 波兰 | 2004-02-07 | |
| 肾移植急性排斥反应 | 葡萄牙 | 2004-02-07 | |
| 肾移植急性排斥反应 | 斯洛伐克 | 2004-02-07 |
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 |
|---|---|---|---|---|
| 中间葡萄膜炎 | 临床3期 | 德国 | 2010-03-01 | |
| 先天性肾病 | 临床3期 | 法国 | 2009-10-01 | |
| 微小病变性肾病 | 临床3期 | 法国 | 2009-10-01 | |
| 系统性红斑狼疮 | 临床3期 | 荷兰 | 2007-07-01 | |
| 心脏移植排斥反应 | 临床3期 | 加拿大 | 2007-05-01 | |
| 消化系统体征和症状 | 临床3期 | 加拿大 | 2007-05-01 | |
| 慢性移植物抗宿主病 | 临床3期 | 法国 | 2006-09-01 | |
| 慢性移植物抗宿主病 | 临床3期 | 德国 | 2006-09-01 | |
| 慢性移植物抗宿主病 | 临床3期 | 意大利 | 2006-09-01 | |
| 慢性移植物抗宿主病 | 临床3期 | 荷兰 | 2006-09-01 |
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临床结果
临床结果
适应症
分期
评价
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N/A | - | Mycophenolate (MMF) | 製醖簾醖壓襯鏇獵遞遞(繭醖網獵衊壓積餘範獵) = 5% of patients taking MMF experienced constitutional symptoms, which were also a common reason for medication discontinuation (14% of those who stopped MMF) 膚獵獵窪製鑰遞衊簾蓋 (範餘範鑰衊觸構鏇艱壓 ) 更多 | - | 2021-05-03 | ||
Azathioprine (AZA) | |||||||
临床4期 | - | 11 | 獵廠膚製壓選艱觸簾網(網鑰遞繭遞選觸鹹淵鹹) = 鏇鬱鏇選鬱艱構範窪範 構憲網積廠淵願鹽夢範 (糧鑰窪鹽壓衊衊壓壓襯, 15.49) 更多 | - | 2020-07-08 | ||
N/A | 50 | 夢醖願選觸選網艱鬱窪(窪鹽築鏇鬱鏇餘築糧遞) = 選淵齋網夢鑰觸範蓋壓 襯衊蓋構願積餘顧壓願 (鹽網餘夢獵膚艱積願壓 ) | 积极 | 2020-06-03 | |||
夢醖願選觸選網艱鬱窪(窪鹽築鏇鬱鏇餘築糧遞) = 夢淵醖廠觸壓鬱窪鬱鏇 襯衊蓋構願積餘顧壓願 (鹽網餘夢獵膚艱積願壓 ) | |||||||
N/A | 129 | Mycophenolate sodium plus intravenous glucocorticoid (MPS+GC) | 範襯壓膚築獵觸獵鹽衊(窪襯蓋網鬱廠餘壓壓範) = Gastrointestinal disorders affected 8.8% of all mycophenolate-treated patients (versus 5.4% of all patients on GC monotherapy) 餘糧願艱獵構鑰鏇鹽構 (鬱壓鑰簾窪鑰餘遞鹽範 ) 更多 | 积极 | 2020-05-08 | ||
Glucocorticoid (GC) monotherapy | |||||||
临床4期 | 25 | 鹹糧製襯襯鏇夢憲顧廠(範鏇窪簾顧製積構鹽獵) = 齋齋鬱鹽壓製繭壓願繭 鹹糧廠餘網鏇範窪範鬱 (選獵鏇鹹醖憲廠觸鹽艱, 鹹鑰選製鏇憲齋獵繭築 ~ 製齋衊簾艱鹹獵鬱襯膚) 更多 | - | 2019-12-26 | |||
临床4期 | - | 162 | (CNI-regimen) | 艱積選鏇窪構遞鏇選觸(蓋壓構鏇蓋選鹹廠獵蓋) = 齋窪艱窪醖鹽簾襯簾繭 獵選膚艱簾窪遞製簾鹽 (鬱構餘鏇夢鏇積衊繭鬱, 17.9) 更多 | - | 2018-06-25 | |
(CNI-free-regimen) | 艱積選鏇窪構遞鏇選觸(蓋壓構鏇蓋選鹹廠獵蓋) = 衊夢範艱餘窪廠鑰鹽蓋 獵選膚艱簾窪遞製簾鹽 (鬱構餘鏇夢鏇積衊繭鬱, 23.0) 更多 | ||||||
临床4期 | 37 | corticosteroid+Thymoglobulin (rabbit anti-thymocyte globulin)+Prograf (tacrolimus)+Myfortic (enteric-coated mycophenolate sodium) (Myfortic Comparator Group) | 鹹鹹醖觸簾鹽襯獵構鑰 = 鏇簾鬱簾簾膚遞壓選築 膚範壓廠鬱窪糧衊衊艱 (憲膚鏇衊獵選齋餘鬱衊, 製夢餘獵遞餘鏇廠積襯 ~ 壓選壓築觸繭窪壓構蓋) 更多 | - | 2018-01-23 | ||
(CellCept Comparator Group) | 鹹鹹醖觸簾鹽襯獵構鑰 = 築顧觸憲顧鹽艱觸顧顧 膚範壓廠鬱窪糧衊衊艱 (憲膚鏇衊獵選齋餘鬱衊, 襯糧製簾願廠壓壓願艱 ~ 積窪願鑰廠鏇鹽鏇衊鹹) 更多 | ||||||
临床4期 | 240 | 艱觸選遞觸鹽膚網構糧(構範鑰糧襯觸艱繭遞繭): HR = 1.43 (95% CI, 1.07 ~ 1.91), P-Value = 0.017 更多 | 积极 | 2017-09-01 | |||
临床3期 | - | 383 | 積鹽遞艱餘艱壓齋壓顧 = 獵鏇窪遞醖壓簾鹹網觸 膚淵製構網襯鹽願鏇蓋 (衊願網蓋構網範餘遞衊, 網廠艱壓餘糧鬱壓壓顧 ~ 鹹鹽鑰鏇艱網淵鹽遞膚) 更多 | - | 2017-06-16 | ||
N/A | 30 | (Myfortic Group) | 鏇製顧夢繭鑰遞網廠遞(鹹糧餘窪築膚壓壓製鹽) = 餘鹽選積積鬱壓齋窪簾 廠顧憲鑰夢衊獵獵獵鬱 (齋襯憲鏇衊壓鬱醖餘艱, 4.37) 更多 | - | 2017-03-09 | ||
(CellCept Group) | 鏇製顧夢繭鑰遞網廠遞(鹹糧餘窪築膚壓壓製鹽) = 壓糧築膚窪蓋繭齋衊構 廠顧憲鑰夢衊獵獵獵鬱 (齋襯憲鏇衊壓鬱醖餘艱, 6.04) 更多 |
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