他克莫司治疗重症肌无力疗效及安全性评价

The clinical efficacy and safety of tacrofimus in patients with myasthenia gravis

目的评价他克莫司治疗全身型重症肌无力（MG）的疗效及不良反应。方法回顾性分析69例全身型MG患者接受他克莫司（2-6mg／d）治疗前及治疗后1、3、6及12个月时MG严重程度评分及不良反应，并监测服药1个月后他克莫司血药浓度（FK506），分析其与临床疗效的相关性。结果他克莫司治疗1、3、6及12个月的总有效率分别为81．2％、87．6％、92．2％及93．8％。治疗1个月后，临床显效及好转组FK506[（7．1±3．9）ug／L，（6．3±3．8）u∥L]明显高于无效组[（3．4±1．3）ug／L]（P〈0．01，P〈0．05）。主要的不良反应：血糖升高5例，出现白细胞减少及头晕、耳鸣各3例。结论他克莫司治疗MG，起效快，临床疗效确切。在治疗剂量范围内其副作用小，主兽为1111糖手卜高殛骨髂柳制。

Objective To evaluate the efficacy and safety of tacrolimus in patients with generalized myasthenia gravis （MG）. Methods A total of 69 cases admitted to our hospital were given 2-6 mg/day tacrolimus （FKS06） for 12 months. The MG absolute and relative clinical scores were used to monitor the efficacy of tacrolimus. Clinical evaluation was conducted at month 1, 3, 6, and 12, while the serum concentration of FKS06 was measured at one month after administration of tacromus for one month. Results The therapeutic response presenting as improved muscular strength showed within one month after administration of tacrolimus. The overall response rates （ MG relative clinical score≥25% ） at month 1, 3, 6 were 81.2%, 87. 6%, 92. 2% respectively. It reached 93.8% by the final visit at month 12. MG score to evaluate disease severity decreased significantly as the subjects continued to take tacrolimus. Statistic analysis suggested that the serum concentration of FKS06 was correlated with its therapeutic effect. Serum trough levels in remission and response groups [（7. 1 ± 3.9） Ixg/L and （6. 3 ± 3.8） ug/L, respectively] were significantly higher than that of no response group [ （3.4 ± 1.3 ） ug/L ]. The most common adverse effects included hyperglycemia （5 cases）, myelosuppression （3 cases）, and dizziness tinnitus （3 cases）, majority of which were temporary and manageable. Conclusions Our study has shown that tacrolimus significantly improved muscular strength of generalized MG patients. The treatment is well tolerated. The therapeutic effect of tacrolimus is observed within 1 month after initial use. Adverse events were manageable and not common.