This trial compared antithymocyte globulin (ATG) + cyclosporine A (CsA) + avatrombopag (AVA) and CsA + AVA in older adults with severe aplastic anemia (SAA). The patients were randomized to receive either ATG + CsA + AVA or CsA + AVA. Of 84 included patients, 42 were treated with ATG + CsA + AVA and 42 with CsA + AVA. With a median follow-up of 13 (0.3–17) months, the objective response rates (ORRs) at 3, 6, and 12 months and the end of follow-up were 53.7%, 65.9%, 80.6%, and 71.4% in the ATG + CsA + AVA group and 61.9%, 73.2%, 77.4%, and 64.3% in the CsA + AVA group, respectively (P > 0.05 at any time point). Three-month ORR was an independent predictor of 6-month complete response rates (P = 0.019). Patients in the ATG + CsA + AVA group showed a higher incidence of adverse events than those in the CsA + AVA group (64.3% vs. 35.7%, P = 0.009). The rates of relapse (P = 0.667), mortality (P = 1.000) and clonal evolution (P = 1.000) were comparable between the groups. The combination of CsA + AVA achieved comparable efficacy with superior safety compared to the combination of ATG + CsA + AVA in older adults newly diagnosed with SAA.
本研究比较了抗胸腺细胞球蛋白（ATG）+环孢素A（CsA）+阿伐曲泊帕（AVA）方案与CsA+AVA方案在老年重症再生障碍性贫血（SAA）患者中的疗效。患者被随机分配接受ATG+CsA+AVA或CsA+AVA治疗。在纳入的84例患者中，42例接受ATG+CsA+AVA治疗，42例接受CsA+AVA治疗。中位随访时间为13（0.3–17）个月，ATG+CsA+AVA组在3、6、12个月及随访结束时的客观缓解率（ORR）分别为53.7%、65.9%、80.6%和71.4%，而CsA+AVA组分别为61.9%、73.2%、77.4%和64.3%（各时间点P均>0.05）。3个月ORR是6个月完全缓解率的独立预测因子（P=0.019）。ATG+CsA+AVA组患者的不良事件发生率高于CsA+AVA组（64.3% vs. 35.7%，P=0.009）。两组在复发率（P=0.667）、死亡率（P=1.000）和克隆演变率（P=1.000）方面无显著差异。对于新诊断的老年SAA患者，CsA+AVA联合方案在疗效相当的情况下，安全性优于ATG+CsA+AVA联合方案。
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