环孢素A治疗全身型重症肌无力疗效及安全性观察

Clinical efficacy and safety of cyclosporine A in patients with generalized myasthenia gravis

目的评价免疫抑制剂环孢素A(Cyclosporine A,Cs A)治疗全身型重症肌无力(myasthenia gravis,MG)的疗效及其不良反应。方法回顾性分析51例全身型MG患者接受Cs A治疗前及治疗后1、3、6、12个月时MG严重程度评分及不良反应,并通过监测患者服药1个月后血Cs A浓度,分析Cs A血药浓度与临床疗效的相关性。结果接受Cs A治疗1、3、6、12个月时的总有效率(临床相对评分≥25%)分别为78.4%、80.4%、84.3%、90.2%,且随服用Cs A时间的延长,MG临床绝对评分进一步下降(P<0.05)。临床显效及好转组患者血Cs A浓度[(97.3±25.4)ng/ml,(85.3±32.4)ng/ml]与无效组[(86.3±27.9)ng/ml]比较差异无统计学意义(P>0.05)。Cs A主要不良反应为肾功能损伤6例(11.8%),肝功能损伤3例(5.9%),胃肠道反应8例(15.7%)。结论 Cs A治疗全身型MG,起效快,临床疗效确切。

Objective To evaluate the efficacy and safety of cyclosporine A （CsA） in generalized myasthenia gravis （MG） patients. Methods A total of 51 cases admitted to our department were given CsA for 12 months. The MG absolute and relative clinical scores were used to monitor the effect of CsA. Clinical evaluations were conducted at months 1, 3, 6 and 12 while the serum concentration of CsA was measured after received CsA for one month. Results The therapeutic effect of CsA could be observed within 1 month after the initiation of treatment. The muscular strength improved obviously （MG relative clinical score≥25%） by 78.4%, 80.4%, 84.3%, 90.2% at 1, 3, 6, 12 month after initiating CsA therapy. MG score for disease severity decreased significantly as the subjects continued to take CsA. There were no significant difference in serum concentration of CsA between remission groups [（97.3±25.4）ng/ml, （85.3±32.4）ng/ml] and ineffective group [（86.3±27.9） ng/ml, P 〉0.05]. The adverse events were also observed during the study and the most frequent events inculded renal dysfunction （6 cases, 11.8%）, liver dysfunction （3 cases, 5.9%） and gastrointestinal reaction （8 cases, 15.7%）. Most of the side effects were experienced temporarily with or without management. Conclusion The results of this study have shown that CsA improves the clinical conditions of generlized MG patients and is well tolerated.