Offner Gisela, Toenshoff Burkhard, Höcker Britta, Krauss Manuela, Bulla Monika, Cochat Pierre, Fehrenbach Henry, Fischer Wolfgang, Foulard Michel, Hoppe Bernd, Hoyer Peter F, Jungraithmayr Therese C, Klaus Günter, Latta Kay, Leichter Heinz, Mihatsch Michael J, Misselwitz Joachim, Montoya Carmen, Müller-Wiefel Dirk E, Neuhaus Thomas J, Pape Lars, Querfeld Uwe, Plank Christian, Schwarke Dieter, Wygoda Simone, Zimmerhackl Lothar B
Kinderklinik der Medizinischen Hochschule, Carl-Neuberg-Str 1, Hannover, Germany.
Transplantation. 2008 Nov 15;86(9):1241-8. doi: 10.1097/TP.0b013e318188af15.
Basiliximab, a monoclonal CD25 antibody has proofed effective in reducing acute rejection episodes in adults in various immunosuppressive regimens. The effect of basiliximab in the pediatric population is controversial.
In a 12-month, double-blind, placebo-controlled trial, renal transplant patients aged 1 to 18 years were randomized to basiliximab or placebo with cyclosporine microemulsion, mycophenolate mofetil, and corticosteroids. The intent-to-treat population comprised 192 patients (100 basiliximab and 92 placebo).
The primary efficacy endpoint, time to first biopsy-proven acute rejection episode, or treatment failure by month 6, occurred in 16.7% of basiliximab-treated patients and 21.7% of placebo-treated patients (Kaplan-Meier estimates; hazard ratio 0.72, two-sided 90% confidence interval 0.416-1.26, n.s.). The rate and severity of subclinical rejections in protocol biopsies performed at 6 months posttransplant was higher in the basiliximab group (25.0%) than in the placebo group (11.7%). Patient and death-censored graft survival at 12 months was 97% and 99%, respectively, in the basiliximab cohort, and 100% and 99% among placebo-treated patients (n.s.). Renal function was similar in both treatment groups, and there were no significant between-treatment differences in the incidence of adverse events or infections.
Addition of basiliximab induction to a regimen of cyclosporine microemulsion, mycophenolate mofetil, and steroids resulted in a numerically lower but not significant incidence of biopsy-proven acute rejection versus placebo and excellent graft and patient survival at 1 year in pediatric renal transplant recipients. Whether this numerical difference is a true therapeutic benefit in view of the higher rate and severity of subclinical rejections in the basiliximab group in the protocol biopsy will be investigated in a long-term follow-up study.
巴利昔单抗，一种单克隆CD25抗体，已被证明在各种免疫抑制方案中可有效减少成人急性排斥反应的发作。巴利昔单抗在儿科人群中的效果存在争议。
在一项为期12个月的双盲、安慰剂对照试验中，将1至18岁的肾移植患者随机分为接受巴利昔单抗或安慰剂治疗，并联合环孢素微乳剂、霉酚酸酯和皮质类固醇。意向性治疗人群包括192例患者（100例接受巴利昔单抗治疗，92例接受安慰剂治疗）。
主要疗效终点为首次经活检证实的急性排斥反应发作时间或至第6个月时的治疗失败时间，接受巴利昔单抗治疗的患者中该终点事件发生率为16.7%，接受安慰剂治疗的患者中为21.7%（Kaplan-Meier估计值；风险比0.72，双侧90%置信区间0.416 - 1.26，无统计学意义）。移植后6个月进行的方案活检中亚临床排斥反应的发生率和严重程度，巴利昔单抗组（25.0%）高于安慰剂组（11.7%）。在巴利昔单抗队列中，12个月时患者和死亡截尾的移植物存活率分别为97%和99%，在接受安慰剂治疗的患者中分别为100%和99%（无统计学意义）。两个治疗组的肾功能相似，不良事件或感染的发生率在治疗组之间无显著差异。
在环孢素微乳剂、霉酚酸酯和类固醇治疗方案中添加巴利昔单抗诱导治疗，与安慰剂相比，经活检证实的急性排斥反应发生率在数值上较低但无显著差异，且在儿科肾移植受者中1年时移植物和患者存活率良好。鉴于在方案活检中巴利昔单抗组亚临床排斥反应的发生率和严重程度较高，这种数值差异是否为真正的治疗益处将在长期随访研究中进行调查。
Zotero 插件