摘要
背景:目前在健康志愿者和肾移植患者中进行的药代动力学试验表明,吗替麦考酚酯肠溶衣片、分散片、胶囊三者间有生物等效性。但3种剂型的临床效果是否等效有待进一步研究。目的:观察活体亲属肾移植后早期应用吗替麦考酚酯分散片、环孢素及泼尼松行三联免疫抑制治疗的有效性和安全性,与吗替麦考酚酯胶囊对比。方法:纳入活体亲属肾移植受者90例,按随机数字表法分为2组,每组45例。吗替麦考酚酯分散片组移植后采用吗替麦考酚酯分散片+环孢素+泼尼松治疗;吗替麦考酚酯胶囊组移植后采用吗替麦考酚酯胶囊+环孢素+泼尼松治疗。两组环孢素、泼尼松用法和血药浓度控制相同;吗替麦考酚酯分散片、吗替麦考酚酯胶囊用量为0.5g(体质量大于70kg者给予0.75g),2次/d口服。密切观察和详细记录两组肾移植后的不良事件和各项实验室化验指标,并进行对比分析。结果与结论:病例全部如期完成观察,两组患者的6个月人肾存活率为100%,吗替麦考酚酯分散片组、吗替麦考酚酯胶囊组分别发生急性排斥反应各1例,经激素冲击治疗后逆转。两组不良事件发生率、血三酰甘油、总胆固醇及肌酐浓度差异无显著性意义(P>0.05)。提示吗替麦考酚酯分散片用于活体亲属肾移植后早期的免疫抑制治疗,与吗替麦考酚酯胶囊一样是安全、有效的。而且应用吗替麦考酚酯分散片可以减少患者的医药费用,值得推广应用,
BACKGROUND： Pharmacokinetics of healthy volunteers and patients undergoing renal transplantation shows that Mycophenolate Mofetil enteric coating tablets, dispersible tablets, and capsule display identical biological effects. However, the clinical effects remain unclear. OBJECTIVE： To observe the effects and safety of cycopin （Mycophenolate Mofetil Dispersible Tablets） in combination with Cyclosporine A （CsA） and prednisone （Pred） as triple regimen for immunosuppressive therapy after living related renal transplantation. METHODS： A total of 90 recipients of living related renal transplantation were randomized into two groups. In the study group, 45 patients were treated with cycopin, CsA and Pred. In the control group, 45 patients were treated with Cellcept （Mycophenolate mofetil capsule）, CsA and Pred. The same concentration ranges of CsA were controlled in two groups. The use of prednisone was the same in two groups. Cycopin and Cellcept （body mass ≤ 70 kg, 0.5 g; body mass 70 kg, 0.75 g） was taken two times a day. Any adverse event and the laboratory results were recorded and analyzed. RESULTS AND CONCLUSION： All patients finished this study. The 6-month patient and graft survival rates in two groups were 100%. Only one case suffered from acute rejection respectively in each group. But the rejections were reversed by methylprednisolone. The difference of adverse event, the blood concentrations of triglyceride, total cholesterol and the level of serum creatinine in two groups were not significant. Cycopin is an effective and safe immunosuppressive drug for in vivo kidney transplantation and allows reducing the cost of drug.
出处
《中国组织工程研究与临床康复》
CAS
CSCD
北大核心
2010年第31期5709-5712,共4页
Journal of Clinical Rehabilitative Tissue Engineering Research
