Internal Medicine Department, Toulouse University Hospital, Toulouse, France; University of Toulouse, Toulouse, France; Inserm, UMR1027, Toulouse, France.
Am J Hematol. 2014 Jan;89(1):41-6. doi: 10.1002/ajh.23580. Epub 2013 Sep 30.
Splenectomy and rituximab are both recommended as second-line treatment in immune thrombocytopenia (ITP), but they have never been directly compared. We compared their efficacy and serious adverse outcomes in a retrospective cohort of 105 adult primary ITP patients exposed to one or other of these treatments. Primary outcome was composite: death from hemorrhage or from infection and hospitalization for bleeding or for infection. Secondary outcomes were overall mortality, hospitalization for bleeding, hospitalization for infection, as well as response and complete response (international definitions). Analyses were adjusted on a propensity score. Patients treated with rituximab (n = 43) were older and had more comorbidities than the splenectomized patients (n = 62). Mean follow-up was, respectively, 3 and 8.4 years. After adjustment on the propensity score, there was no difference between the two groups regarding the primary and other clinical outcomes. In the multivariate analysis, only a history of mucosal bleeding (HR 3.2 95% CI [1.2-8.5]) and a Charlson score ≥1 (HR 4.2 95% CI [1.8-9.6]) were associated with the primary outcome. These two factors were also associated with hospitalization for bleeding. As expected, response, complete response and maintenance rates were higher in the splenectomy group. Splenectomy compared with rituximab was independently associated with a response at 12 months (OR 4.4, 95% CI [1.7-11.8]). Then, adjusted analyses in this real-life cohort confirmed the better results of splenectomy compared with rituximab.
脾切除术和利妥昔单抗均被推荐作为成人原发免疫性血小板减少症(ITP)的二线治疗,但两者从未被直接比较过。我们比较了 105 例接受其中一种治疗的成人原发 ITP 患者的疗效和严重不良结局。主要结局为复合结局:出血或感染导致的死亡以及因出血或感染导致的住院。次要结局为全因死亡率、因出血导致的住院、因感染导致的住院、以及反应和完全反应(国际标准定义)。分析基于倾向评分进行调整。接受利妥昔单抗治疗的患者(n=43)比接受脾切除术的患者(n=62)年龄更大,合并症更多。平均随访时间分别为 3 年和 8.4 年。在倾向评分调整后,两组在主要结局和其他临床结局方面无差异。在多变量分析中,仅黏膜出血史(HR 3.2,95%CI [1.2-8.5])和 Charlson 评分≥1(HR 4.2,95%CI [1.8-9.6])与主要结局相关。这两个因素也与出血住院相关。正如预期的那样,脾切除术组的反应、完全反应和维持率更高。与利妥昔单抗相比,脾切除术在 12 个月时独立与反应相关(OR 4.4,95%CI [1.7-11.8])。然后,在这个真实世界队列的调整分析中,确认了脾切除术优于利妥昔单抗的结果。