From the Hematology Research Center and Bone Marrow Transplantation Center, Shiraz University of Medical Sciences, Shiraz, Iran.
Exp Clin Transplant. 2021 Dec;19(12):1328-1333. doi: 10.6002/ect.2020.0004. Epub 2020 Aug 7.
With the standard regimen for graft-versushost disease prophylaxis in allogeneic stem cell transplant with human leukocyte antigen-matched donor, grade II-IV acute graft-versus-host disease occurs in 30% to 50% of sibling and up to 80% of unrelated recipients. Studies with limited patient numbers have shown efficacy and safety of mycophenolate mofetil for graft-versus-host disease prophylaxis. We investigated the effect of low-dose mycophenolate mofetil added to a standardized prophylaxis regimen for graft-versus-host disease in related human leukocyte antigen-matched allogeneic stem cell transplant.
In this prospective randomized clinical trial, we compared cyclosporine and methotrexate versus the combination of cyclosporine, methotrexate, and mycophenolate mofetil in all patients who underwent human leukocyte antigencompatible related donor allogeneic stem cell transplant for acute leukemia during 3 years at the Bone Marrow Transplant Unit at Namazi Hospital, Shiraz University of Medical Sciences (Shiraz, Iran).
All 134 patients in both groups underwent successful engraftment. Recovery times for neutrophils and platelets were not significantly different between groups (P < .05). Incidence of acute graft-versus-host disease in the cyclosporine, methotrexate, and mycophenolate mofetil group was less than in the cyclosporine and methotrexate group (21.6% vs 40.9%; P = .041). Incidence of grade II-IV acute graftversus-host disease in the mycophenolate mofetil group was 15.2% versus the control group at 33% (P = .045).
Our single-center study suggests the combination of mycophenolate mofetil, cyclosporine, and methotrexate is superior to the standard regimen of cyclosporine and methotrexate for graft-versushost disease prophylaxis after human leukocyte antigen-matched related donor allogeneic stem cell transplant.
在接受人白细胞抗原匹配供体的同种异体干细胞移植中,采用标准的移植物抗宿主病预防方案,30%至 50%的同胞和高达 80%的无关受者会发生 2 级至 4 级急性移植物抗宿主病。一些研究显示,霉酚酸酯在移植物抗宿主病预防方面具有疗效和安全性,但这些研究的纳入患者数量有限。我们研究了在人白细胞抗原匹配的相关供体同种异体干细胞移植中,添加小剂量霉酚酸酯到标准移植物抗宿主病预防方案中对移植物抗宿主病的影响。
在这项前瞻性随机临床试验中,我们比较了环孢素和甲氨蝶呤与环孢素、甲氨蝶呤和霉酚酸酯联合用于在纳马齐医院骨髓移植科接受人白细胞抗原相容相关供体同种异体干细胞移植的急性白血病患者(伊朗设拉子)。在 3 年期间。
两组所有 134 例患者均成功植入。两组中性粒细胞和血小板的恢复时间无显著差异(P <.05)。环孢素、甲氨蝶呤和霉酚酸酯组的急性移植物抗宿主病发生率低于环孢素和甲氨蝶呤组(21.6%对 40.9%;P =.041)。霉酚酸酯组的 2 级至 4 级急性移植物抗宿主病发生率为 15.2%,而对照组为 33%(P =.045)。
我们的单中心研究表明,霉酚酸酯、环孢素和甲氨蝶呤联合应用优于标准的环孢素和甲氨蝶呤方案,可用于人白细胞抗原匹配相关供体同种异体干细胞移植后的移植物抗宿主病预防。