Department of Dental Medicine, Karolinska Institutet, Huddinge, Sweden.
Department of Clinical Sciences, Intervention and Technology, Translational cell therapy research group, Karolinska Institutet, Stockholm, Sweden.
Oral Dis. 2021 Jul;27(5):1217-1225. doi: 10.1111/odi.13663. Epub 2020 Oct 27.
To determine whether treatment with tacrolimus plus sirolimus (Tac/Sir) as a prophylaxis for graft-versus-host disease worsens severe oral mucositis and delays healing compared to cyclosporine plus methotrexate (CsA/Mtx) following haematopoietic stem cell transplantation.
The study comprised 141 patients: 73 randomized to receive Tac/Sir and 68 to receive CsA/Mtx. The oral mucositis assessment scale and toxicity grading according to WHO were used to assess the severity, peak and duration of oral mucositis from the day -3 to day 24 post-transplant.
Eighty-seven patients developed oral mucositis in the first 24 days post-transplant. No significant difference in oral mucositis severity between the Tac/Sir and CsA/Mtx groups was observed. The peak oral mucositis score occurred on day 10 in both groups. Although oral mucositis scores had returned to baseline in the CsA/Mtx group on day 24 post-transplant, no significant difference compared with the Tac/Sir group was found.
The introduction of tacrolimus/sirolimus as a graft-versus-host disease prophylaxis in haematopoietic stem cell transplantation increased neither the incidence nor severity of oral mucositis compared with cyclosporine/methotrexate. Furthermore, oral mucositis healing was not prolonged and followed the same time pattern as cyclosporine/methotrexate.
比较他克莫司联合西罗莫司（Tac/Sir）与环孢素联合甲氨蝶呤（CsA/Mtx）作为造血干细胞移植后移植物抗宿主病预防方案时，在口腔黏膜炎的严重程度、愈合时间及愈合速度方面的差异。
共纳入 141 例患者，73 例接受 Tac/Sir 治疗，68 例接受 CsA/Mtx 治疗。采用 WHO 口腔黏膜炎评价标准和毒性分级标准，对移植后第-3 天至第 24 天口腔黏膜炎的严重程度、峰值和持续时间进行评估。
共有 87 例患者在移植后 24 天内发生口腔黏膜炎。两组患者口腔黏膜炎严重程度差异无统计学意义。两组患者的口腔黏膜炎峰值均出现在第 10 天，虽然第 24 天 CsA/Mtx 组患者口腔黏膜炎评分恢复至基线水平，但与 Tac/Sir 组相比，差异无统计学意义。
与环孢素/甲氨蝶呤相比，在造血干细胞移植中应用他克莫司/西罗莫司预防移植物抗宿主病不会增加口腔黏膜炎的发生率和严重程度，也不会延长口腔黏膜炎的愈合时间，其愈合时间与环孢素/甲氨蝶呤相同。
