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目的比较他克莫司(FK506)和环孢素A(CsA)防治造血干细胞移植后急性移植物抗宿主病(aGVHD)的效果。方法根据所用免疫抑制方案的不同,将118例异基因造血干细胞移植患者分为两组,一组移植后采用以FK506为主的方案预防GVHD(FK506组,n=36例),另一组采用以CsA为主的方案预防GVHD(CsA组,n=82例)。观察两组患者aGVHD的发生情况及治疗效果、造血重建情况、存活率、原发病的复发率以及免疫抑制剂的不良反应。结果FK506组和CsA组aGVHD累积发生率分别为(50.0±8.8)%和(50.7±5.6)%(P>0.05),Ⅱ～Ⅳ度aGVHD累积发生率分别为(13.0±6.1)%和(31.0±5.2)%(P<0.05),Ⅲ～Ⅳ度aGVHD累积发生率分别为(2.8±2.7)%和(12.3±3.7)%(P>0.05)。采用FK506及甲泼尼龙(MP)治疗Ⅰ～Ⅱ度aGVHD的效果优于CsA与MP组合,但差异无统计学意义(P>0.05),而治疗Ⅲ～Ⅳ度aGVHD,FK506与MP组合明显优于CsA与MP组合(P<0.05)。两组在造血重建时间、患者存活率、无原发病的存活率以及原发病复发率等方面的差异均无统计学意义。FK506组16.7%患者血糖升高,而CsA组血糖升高者仅占1.2%。结论FK506可有效预防和治疗异基因造血干细胞移植后的aGVHD,其总体效果优于CsA。
Objective To compare the efficacy of tacrolimus (FK506) and cyclosporin A (CsA) in the prevention and treatment of acute graft-versus-host disease (aGVHD) after hematopoietic stem cell transplantation. Methods According to the different immunosuppressive regimens used, 118 patients with allogeneic hematopoietic stem cell transplantation were divided into two groups. One group received FK506-based regimen to prevent GVHD (FK506 group, n = 36), and the other group CsA-based regimen for the prevention of GVHD (CsA group, n = 82). The incidence of aGVHD, the therapeutic effect, the condition of hematopoietic reconstitution, the survival rate, the relapse rate of primary disease and the adverse reaction of immunosuppressive agents were observed. Results The cumulative incidence of aGVHD in FK506 group and CsA group was (50.0 ± 8.8)% and (50.7 ± 5.6)%, respectively. The cumulative incidence of aGVHD in group Ⅱ ~ Ⅳ was (13.0 ± 6.1)% and ± 5.2%, respectively (P <0.05). The accumulative rates of Ⅲ ~ Ⅳ aGVHD were (2.8 ± 2.7)% and (12.3 ± 3.7)%, respectively. The effect of FK506 and methylprednisolone (MP) in treating grade Ⅰ ~ Ⅱ aGVHD was better than that of CsA and MP, but the difference was not statistically significant (P> 0.05), while the combination of aGVHD and FK506 with MP in treatment Ⅲ ~ Ⅳ was superior CsA combined with MP (P <0.05). There was no significant difference between the two groups in the time of hematopoietic reconstruction, the survival rate of patients, the survival rate of non-primary disease and the recurrence rate of primary disease. Blood glucose was increased in 16.7% of patients in the FK506 group, while only 1.2% of those in the CsA group had hyperglycemia. Conclusion FK506 can effectively prevent and treat aGVHD after allogeneic hematopoietic stem cell transplantation, and its overall effect is better than that of CsA.