Safety and Tolerance of Sodium Mycophenolate in Patients After Renal Transplantation-An Observational Study
Safety and Tolerance of Sodium Mycophenolate in Patients After Renal Transplantation-An Observational Study
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DOI：
10.1016/j.transproceed.2009.07.102
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发表时间：
2009-10-01
影响因子：
0.9
通讯作者：
Durlik, M.
中科院分区：
文献类型：
--
作者：
Gozdowska, J.;Urbanowicz, A.;Durlik, M.
背景麦考酚酸钠肠溶包衣片（EC-MPS）是一种新型的霉酚酸酯（MMF）的替代药物，旨在减少胃肠道并发症。74例患者（平均年龄42.3岁）从MMF转换为MPS，入组研究并随访3个月（访视0、1个月后访视2和3个月后访视3）。从移植到转换的平均时间为3.7年。在访视2和3期间，记录以下内容：治疗变化对GI症状严重程度的影响（4分量表：1-恶化，2-无变化，3-改善，4-消退），EC-MPS耐受性，不良事件（AE），患者依从性和医生对治疗的满意度（4分量表：1-差，2-一般，3-好，4-非常好）。63例患者完成了研究（85.1%）。EC-MPS剂量范围为720 - 1440 mg。GI症状严重程度评分平均为3.41。最常见的促使转换的症状是：腹痛、腹泻、腹绞痛、恶心、厌食和呕吐。在175例投诉中，144例（82%）改善或解决，5例（2.86%）加重，25例（14.86%）持续存在。访视3时，患者依从性和平均医生满意度评分分别为3.70和3.02。报告了9起AE（2起重度）。5例病例怀疑与药物存在因果关系（1例SAE）。最常见的不良事件为：贫血、感染（包括败血症）、胃肠道症状（腹痛、腹泻）。我们的研究得出以下结论：（1）霉酚酸钠耐受性良好;（2）从MMF转换为EC-MPS后，胃肠道症状减轻;（3）EC-MPS是一种安全的药物，不良事件发生率低。
Background. Enteric-coated mycophenolate sodium (EC-MPS) was developed as an alternative agent to mycophenolate mofetil (MMF), aimed at reduction of gastrointestinal (GI) complications.Methods. Seventy-four patients (mean age 42.3 years) switched from MMF to MPS were included in the study and followed-up for 3 months (Visit 0, Visit 2 after 1 month and Visit 3 after 3 months). The mean time from transplantation to switch was 3.7 years. During Visit 2 and 3 the following were recorded: impact of treatment change on the severity of GI symptoms (4 point scale: 1-worsening, 2-no change, 3-improvement, 4-resolution), EC-MPS tolerance, adverse events (AEs), patient compliance and physician satisfaction with treatment (4 point scale: 1-bad, 2-fair, 3-good, 4-very good).Results. Sixty-three patients completed the study (85.1%). EC-MPS dose ranged from 720 to 1440 mg. GI symptom severity score averaged at 3.41. Symptoms most commonly compelling a conversion were: abdominal pain, diarrhea, abdominal colic, nausea, anorexia and vomiting. Out of 175 complaints, 144 (82%) either improved or resolved, 5 (2.86%) aggravated, and 25 (14.86%) persisted. Patient compliance and mean physician satisfaction score averaged at 3.70 and 3.02 at Visit 3, respectively. 9 AEs (2 severe) were reported. Causal relationship with the medication was suspected in 5 cases (1 case of SAE). The most common AEs were: anemia, infection (including sepsis), GI symptoms (abdominal pain, diarrhea).Conclusions. The following was concluded in our study: (1) sodium mycophenolate is well tolerated; (2) after switching from MMF to EC-MPS, gastrointestinal symptoms alleviated; (3) EC-MPS is a safe medication, with a low adverse events rate.