Comparison between mono-tacrolimus and mono-glucocorticoid in the treatment of myasthenia gravis.
Comparison between mono-tacrolimus and mono-glucocorticoid in the treatment of myasthenia gravis.
复制标题
DOI：
10.1002/acn3.51746
复制
发表时间：
2023-04
影响因子：
5.3
通讯作者：
Da, Yuwei
中科院分区：
文献类型：
--
作者：
Fan, Zhirong;Lei, Lin;Su, Shengyao;Zhang, Shu;Xie, Nairong;Li, Ling;Lu, Yan;Di, Li;Wang, Min;Xu, Min;Shen, Xin-Ming;Da, Yuwei
他克莫司在轻中度重症肌无力（MG）中的使用通常仅限于糖皮质激素难治性病例;单他克莫司相对于单糖皮质激素的优势尚不清楚。我们纳入了接受单他克莫司（mono-TAC）或单糖皮质激素（mono-GC）治疗的轻度至中度MG患者。在1：1倾向评分匹配中检查了免疫治疗选择与治疗疗效和副作用之间的相关性。主要结局是至最小临床表现状态或更好（MMS或更好）的时间。次要结局包括复发时间、重症肌无力特异性日常生活活动（MG‐ADL）评分的平均变化和不良事件发生率。基线特征显示匹配组（49对匹配对）之间无差异。单TAC组和单GC组之间至MMS或更佳的中位时间无差异（5.1 vs. 2.8个月：未校正的风险比[HR]，0.73; 95% CI，0.46-1.16; p = 0.180），以及中位复发时间（由于49名受试者中有44名[89.8%]保持MMS或更好，因此单TAC组的数据不可用;单GC组39.7个月：未校正HR，0.67; 95% CI，0.23-1.97; p = 0.464）。两组间MG‐ADL评分的变化相似（平均差异为0.3; 95% CI为-0.4至1.0; p = 0.462）。单TAC组的不良事件发生率低于单GC组（24.5% vs. 55.1%，p = 0.002）。在拒绝使用糖皮质激素或有糖皮质激素禁忌症的轻中度重症肌无力患者中，与单药糖皮质激素相比，单药他克莫司具有上级耐受性和非劣效性。
Use of tacrolimus in mild to moderate myasthenia gravis (MG) is generally limited to glucocorticoid‐refractory cases; the advantage of mono‐tacrolimus over mono‐glucocorticoids is unknown. We included mild to moderate MG patients treated with mono‐tacrolimus (mono‐TAC) or mono‐glucocorticoids (mono‐GC). The correlation between the immunotherapy options and the treatment efficacy and side effects were examined in 1:1 propensity‐score matching. The main outcome was time to minimal manifestations status or better (MMS or better). Secondary outcomes include time to relapse, the mean changes in Myasthenia Gravis‐specific Activities of Daily Living (MG‐ADL) scores and the rate of adverse events. Baseline characteristics showed no difference between matched groups (49 matched pairs). There were no differences in median time to MMS or better between the mono‐TAC group and mono‐GC group (5.1 vs. 2.8 months: unadjusted hazard ratio [HR], 0.73; 95% CI, 0.46–1.16; p = 0.180), as well as in median time to relapse (data unavailable for the mono‐TAC group since 44 of 49 [89.8%] participants remained in MMS or better; 39.7 months in mono‐GC group: unadjusted HR, 0.67; 95% CI, 0.23–1.97; p = 0.464). Changes in MG‐ADL scores between the two groups were similar (mean differences, 0.3; 95% CI, −0.4 to 1.0; p = 0.462). The rate of adverse events was lower in the mono‐TAC group compared to the mono‐GC group (24.5% vs. 55.1%, p = 0.002). Mono‐tacrolimus performs superior tolerability with non‐inferior efficacy compared to mono‐glucocorticoids in mild to moderate myasthenia gravis patients who refuse or have a contraindication to glucocorticoids.
登录
查看更多内容
影响因子：
9.9
作者：
Sanders DB;Wolfe GI;Benatar M;Evoli A;Gilhus NE;Illa I;Kuntz N;Massey JM;Melms A;Murai H;Nicolle M;Palace J;Richman DP;Verschuuren J;Narayanaswami P
通讯作者：
Narayanaswami P
影响因子：
5.8
作者：
Qin, Xiao Ling;Bi, Hui Chang;Huang, Min
通讯作者：
Huang, Min
影响因子：
5.1
作者：
Kanai, T.;Uzawa, A.;Kuwabara, S.
通讯作者：
Kuwabara, S.
影响因子：
19.6
作者：
Praga, M.;Barrio, V.;Luno, J.
通讯作者：
Luno, J.
影响因子：
9.9
作者：
Lee, Ikjae;Kuo, Hui-Chien;Wolfe, Gil I.
通讯作者：
Wolfe, Gil I.