Rheumatology Unit, Department of Clinical Medicine and Immunological Sciences, University of Siena, Italy.
Clin Exp Rheumatol. 2013 Nov-Dec;31(6):877-82. Epub 2013 Aug 2.
This work aims to prospectively assess the long-term effects of intravenous immunoglobulin (IVIG Flebogamma®) in a small cohort of patients affected by primary or secondary antiphospholipid syndrome (APS), in addition to conventional therapy.
Three primary and four secondary APS patients (6 women and 1 man), aged between 40 and 62 years, were treated with IVIG in addition to conventional therapy with anticoagulants or antiplatelets, while six primary and one secondary APS patients (6 women and 1 man), aged between 31 and 61 years, continued their regular conventional therapy. One infusion of IVIG was administered at a dose of 0.4 g/kg/day every month to the first group of patients for two years. Patients were assessed at baseline, after 1 year and 2 years from the beginning of the study and were evaluated for the occurrence of any thromboembolic events and by laboratory measurement of antiphospholipides antibodies (aPL).
No venous or arterial thromboses occurred in patients treated with IVIG, whereas in the control group two patients presented cerebral ischaemic attacks and one patient reported a deep vein thrombosis during the follow-up. At the end of the study, in the group treated with IVIG, we observed a statistically significant decrease of anticardiolipin antibodies (IgG and IgM) and of IgM anti-β2-glycoprotein I antibodies.
Our results show the efficacy of IVIG in addition to conventional therapy, in primary and secondary APS patients, preventing the occurrence of thromboembolic events. However, further clinical studies on a larger group of patients are necessary to fully understand the mechanisms of action and the optimal doses of IVIG in APS.
本研究旨在前瞻性评估静脉注射免疫球蛋白(IVIG Flebogamma®)在除常规抗凝或抗血小板治疗外,对原发性或继发性抗磷脂综合征(APS)患者的长期疗效。
纳入 3 名原发性和 4 名继发性 APS 患者(6 名女性和 1 名男性),年龄 40-62 岁,在接受常规抗凝或抗血小板治疗的基础上加用 IVIG,剂量为 0.4 g/kg/d,每月 1 次,连用 2 年。另一组纳入 6 名原发性和 1 名继发性 APS 患者(6 名女性和 1 名男性),年龄 31-61 岁,继续接受常规治疗。两组患者在基线、治疗 1 年和 2 年后进行评估,观察血栓栓塞事件的发生情况,同时检测抗磷脂抗体(aPL)。
IVIG 治疗组患者均未发生静脉或动脉血栓形成,而对照组有 2 例发生脑缺血发作,1 例发生下肢深静脉血栓形成。研究结束时,IVIG 治疗组患者的抗心磷脂抗体(IgG 和 IgM)和 IgM 抗-β2-糖蛋白 I 抗体水平显著下降。
我们的研究结果表明,IVIG 联合常规治疗可预防原发性和继发性 APS 患者血栓栓塞事件的发生。然而,还需要进一步开展更大规模患者的临床研究,以充分了解 IVIG 在 APS 中的作用机制和最佳剂量。