PLACEBO-CONTROLLED STUDY OF MYCOPHENOLATE MOFETIL COMBINED WITH CYCLOSPORINE AND CORTICOSTEROIDS FOR PREVENTION OF ACUTE REJECTION-猫眼课题宝

DOI：

发表时间：

1995-05

期刊：

The Lancet

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通讯作者：

中科院分区：

其他

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作者：

J. Grinyo;C. Groth;R. Pichlmayr;S. Sadek;Y. Vanrenterghem;M. Behrend;R. Lück;F. Moreso;J. Peeters;J. Rodicio;J. Morales;D. Albrechtsen;P. Fauchald;S. Sadek;J. Lodge;J. Soulillou;D. Cantarovich;V. Son;A. Tegzess;K. Wagner;J. Erhard;C. Brattström;L. Mjornstedt;M. Wiesel;S. Carl;H. Neumayer;Hauser;P. Lang;B. Bourgeon;G. Tufveson;G. Gannedahl;H. Ekberg;N. Persson;A. Tarantino;M. Campise;G. Thiel;M. Zeiler;R. Hené;G. Ligtenberg;A. Morgan;K. Rigg;L. Hooftman;K. Hutchinson

初步研究表明，霉酚酸酯(MMF)可抑制T、B细胞的增殖，可减少肾移植后急性排斥反应的发生。我们的随机、双盲、多中心、安慰剂对照研究比较了霉酚酸酯和安慰剂预防第一次或第二次身体肾移植后急性排斥反应的有效性和安全性。491名患者入选；166名患者被分配为安慰剂，165名MMF2g，160名MMF3g。患者还接受环孢素和皮质类固醇治疗。在移植后的头6个月内，服用2克或3克霉酚酸酯的患者(P<或等于0.001)发生活检证实的排斥反应或提前退出试验(无论出于何种原因)的人数明显少于服用安慰剂的患者(56.0%)。活检证实的排斥反应的相应百分比分别为17.0%、13.8%和46.4%。28.5%的MMF2g和24.4%的MMF3g患者在前6个月需要全程皮质类固醇或抗淋巴细胞药物来治疗排斥反应，而接受安慰剂的患者中这一比例为51.8%。到6个月时，安慰剂组、MMF2g组和MMF3g组分别有10.2%、6.7%和8.8%的患者死亡或失去移植物。总体而言，所有治疗组的不良事件发生频率相似，尽管胃肠道问题、白细胞减少症和机会性感染在MMF组中更为常见，而且3g组的不良事件有比2g组更多的趋势。MMF显著降低了移植后前6个月经活检证实的排斥反应或其他治疗失败率，且耐受性良好，3g剂量的耐受性较差。

Preliminary studies suggested that mycophenolate mofetil (MMF), which inhibits proliferation of T and B cells, may reduce the frequency of acute rejection after renal transplantation. Our randomised, double-blind, multicentre, placebo-controlled study compared the efficacy and safety of MMF with placebo for prevention of acute rejection episodes after first or second cadaveric renal allograft transplantation. 491 patients were enrolled; 166 were assigned placebo, 165 MMF 2 g, and 160 MMF 3 g. Patients also received cyclosporin and corticosteroids. Significantly fewer (p less than or equal to 0.001) patients had biopsy-proven rejection or withdrew early from the trial (for any reason) during the first 6 months after transplantation with MMF 2 g (30.3%) or 3 g (38.8%) than with placebo (56.0%). The corresponding percentages for biopsy-proven rejection were 17.0%, 13.8%, and 46.4%. 28.5% of MMF 2 g and 24.4% of MMF 3 g patients needed full courses of corticosteroids or antilymphocyte agents for treatment of rejection episodes in the first 6 months, compared with 51.8% of placebo recipients. By 6 months, 10.2%, 6.7%, and 8.8% of the patients in the placebo, MMF 2 g, and MMF 3 g groups, respectively, had died or lost the graft. Overall, the frequency of adverse events was similar in all treatment groups, although gastrointestinal problems, leucopenia, and opportunistic infections were more common in the MMF groups and there was a trend for more events in the 3 g than the 2 g group. MMF significantly reduced the rate of biopsy-proven rejection or other treatment failure during the first 6 months after transplantation and was well tolerated, The 3 g dose was somewhat less well tolerated.

PLACEBO-CONTROLLED STUDY OF MYCOPHENOLATE MOFETIL COMBINED WITH CYCLOSPORINE AND CORTICOSTEROIDS FOR PREVENTION OF ACUTE REJECTION

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