Division of Rheumatology/Clinical Immunology, Department of Medicine, Saitama Medical Center, Saitama Medical University, 1981, Kamoda, Kawagoe, Saitama, 350-8550, Japan.
Rheumatol Int. 2011 Jun;31(6):757-63. doi: 10.1007/s00296-010-1366-9. Epub 2010 Feb 19.
The aim of this study was to prospectively evaluate the efficacy and safety of tacrolimus (TAC) in various manifestations of systemic lupus erythematosus (SLE) patients in daily clinical practice. Each of the 21 TAC-treated patients with SLE in our care over 2 years was enrolled in this open-label trial. Patients were administered TAC at a dosage of 1-6 mg once daily, followed up for 24 weeks. Efficacy and safety were evaluated utilizing clinical and laboratory findings. As treatment targets, TAC was preferentially used with oral corticosteroid administration for mild active manifestations such as arthritis, skin eruptions, or asymptomatic nephritis. In efficacy, the mean value of the SLE disease activity index was significantly reduced to 4.1, 2.7, 1.8, and 1.2 (N=21, 20, 16 and 13) at 0, 4, 12, and 24 weeks, respectively. In eight cases, treatment was discontinued within 24 weeks due to insufficient effects (6 cases) and side effects (2 cases). Non-serious side effects were observed in only five cases (23.8%) over 24 weeks. TAC can be considered both effective and safe for the treatment of various manifestations of SLE.
本研究旨在前瞻性评估他克莫司（TAC）在日常临床实践中对各种表现的系统性红斑狼疮（SLE）患者的疗效和安全性。在过去 2 年中，我们治疗的 21 例接受 TAC 治疗的 SLE 患者均纳入了这项开放标签试验。患者接受 TAC 每日 1 至 6 毫克的剂量治疗，随访 24 周。通过临床和实验室发现评估疗效和安全性。作为治疗靶点，TAC 优先与口服皮质类固醇联合用于治疗轻度活动性表现，如关节炎、皮疹或无症状性肾炎。在疗效方面，SLE 疾病活动指数的平均值在 0、4、12 和 24 周时分别显著降低至 4.1、2.7、1.8 和 1.2（N=21、20、16 和 13）。在 24 周内，有 8 例因疗效不足（6 例）和副作用（2 例）而停止治疗。在 24 周内，仅在 5 例（23.8%）中观察到非严重副作用。TAC 可被认为对治疗各种表现的 SLE 既有效又安全。
