关于国产吗替麦考酚酯分散片与进口胶囊预防肾移植术后急性排斥反应的比较

Comparison between domestic mycophenolate mofetil dispersible tablet and imported capsule for preventing acute rejection following renal transplantation

目的比较国产吗替麦考酚酯(MMF)分散片与进口胶囊预防肾移植术后急性排斥反应的疗效与安全性。方法针对一项随机、开放、平行对照、为期3个月的多中心临床研究,根据其126例受试患者的统计学结果 ,对国产吗替麦考酚酯分散片与进口胶囊预防肾移植术后急性排斥反应的疗效与安全性进行比较。结果术后3个月,分散片组意向治疗(ITT)人群和符合方案(PP)人群的急性排斥反应发生率分别为7.1%和6.7%,胶囊组ITT人群和PP人群的急性排斥反应发生率分别为4.9%和5.9%,无论是ITT人群还是PP人群两组间的急性排斥反应发生率差异均无统计学意义。两组的移植物存活和患者生存良好,组间比较差异也无统计学意义。分散片组和胶囊组全部不良反应的发生率分别为18.8%和19.5%(P>0.05),主要表现为消化系统异常和血液系统异常。试验期间,两组感染的发生率分别为22.4%和24.4%(P>0.05)。结论国产吗替麦考酚酯分散片与进口胶囊在预防肾移植术后3个月内急性排斥反应的有效性和安全性上具有可比性。

Objective To compare the efficacy and safety of domestic mycophenolate mofetil（MMF） dispersible tablet and imported capsule for preventing acute rejection following renal transplantation.Methods In view of the statistical results of 126 patients who had attended a 3-month randomized,open-label,parallel controlled,multicentre clinical study,to compare the efficacy and safety of domestic mycophenolate mofetil（MMF） dispersible tablet and imported capsule for preventing acute rejection following renal transplantation.Results At 3 months＇ post-transplant,the incidence of acute rejection of intention-to-treated（ITT） crowd and per-protocol（PP） crowd：the dispersible tablet group was 7.1% and 6.7% separately;the capsule group was 4.9% and 5.9% separately.The acute rejection rate of two groups had no significant difference between ITT crowd and PP crowd.The survival of allografts and patients in both groups were favorable,and there was no significant difference between two groups,either.The incidence of adverse effects was 18.8% in the dispersible tablet group and 19.5% in the capsule group（P〉0.05）.MMF-related adverse events were mainly abnormities of digestive system and hematological system.The infection rate was 22.4% in the dispersible tablet group and 24.4% in the capsule group（P〉0.05）.Conclusion These results suggest the comparable efficacy and safety of domestic MMF dispersible tablet with imported capsule for preventing acute rejection within 3 months＇ post-transplant.