Abstract:

Objective　To evaluate the efficacy, quality of survival, and safety of tacrolimus in the treatment of myasthenia gravis by meta-analysis. Methods　We searched CNKI, Wanfang Database, Vip Database, Web of Science, OVID, and Cochrane Library Database, and extracted the control studies of tacrolimus in the treatment of myasthenia gravis from the establishment of databases to May 2023. According to the inclusion and exclusion criteria, two researchers independently screened the literatures, extracted the data, and evaluated the quality of included literatures by using the risk bias evaluation tool of Cochrane Collaboration Network. The data were analyzed by using RevMan 5.3 software. Results　A total of 1 007 patients were included in 14 studies, including 521 patients in the experimental group and 486 patients in the control group. The results of meta-analysis showed that the effective rate of the experimental group was higher than that of the control group [OR=5.68, 95%CI (3.33, 9.67), P<0.000 01]; the score of activities of daily living (ADL) in the experimental group was higher than that in the control group [SMD=1.37, 95%CI (1.10, 1.64), P<0.000 01]; the Quantitative MG Scoring System (QMG) score of the experimental group was lower than that of the control group [SMD=-0.47, 95%CI (-0.86, -0.09), P=0.02]; the 6 indexes of Busch score (role function, physical function, cognitive function, 6 vital forces, social function, and emotional function) in the experimental group were lower than those in the control group [SMD=-1.17, 95%CI (-1.50, -0.85), P<0.000 01; SMD=-1.72, 95%CI (-2.07, -1.37), P<0.000 01; SMD=-0.69, 95%CI (-1.00, -0.39), P<0.000 01; SMD=-1.15, 95%CI (-1.47, -0.83), P<0.000 01; SMD=-1.98, 95%CI (-2.67, -1.29), P<0.000 01; SMD=-0.69, 95%CI (-1.00, -0.39), P<0.000 01; SMD=-1.14, 95%CI (-1.78, -0.49), P=0.000 5]; the Manual Muscle Test (MMT) score of the experimental group was lower than that of the control group [SMD=-2.09, 95%CI (-2.80, -1.39), P<0.000 01]; there was no statistically significant difference in the Xu's absolute score between the experimental group and the control group [SMD=-0.34, 95%CI (-0.87, 0.19), P=0.21]; there was no statistically significant difference in the incidence of adverse reactions between the experimental group and the control group [OR=0.93, 95%CI (0.48, -1.80), P=0.83]. Conclusion　Tacrolimus can better improve the severity of myasthenia gravis patients and improve the patients' quality of life, with reliable safety. However, due to the quality limitation of the included studies, large-sample, multi-center, and high-quality randomized controlled trials are still needed to confirm its clinical efficacy and safety.

Key words:

Tacrolimus, Myasthenia gravis, Curative effect, Quality of survival, Safety, Meta-analysis

摘要：

目的　通过meta分析方法系统评价他克莫司治疗重症肌无力患者的疗效、生存质量及安全性。方法　检索中国知网、万方数据库、维普数据库、PubMed、Web of Science、OVID及Cochrane Library，提取从建库至2023年5月关于他克莫司治疗重症肌无力的对照研究。由2名研究者根据纳入与排除标准独立筛选文献、提取数据并采用Cochrane协作网风险偏倚评价工具对纳入研究质量进行评价，运用RevMan 5.3软件进行数据分析。结果　纳入14项研究，共1 007例患者，其中试验组521例、对照组486例。meta分析结果显示：试验组有效率高于对照组［OR=5.68，95%置信区间（CI）（3.33～9.67），P<0.000 01］；试验组日常生活活动能力（ADL）评分高于对照组［SMD=1.37，95%CI（1.10～1.64），P<0.000 01］；试验组重症肌无力定量评分表（QMG）评分低于对照组［SMD=-0.47，95%CI（-0.86～-0.09），P=0.02］；试验组Busch评分的6个指标（角色功能、体力功能、认知功能、6个生命力、社会功能、情感功能）均低于对照组［SMD=-1.17，95%CI（-1.50～-0.85），P<0.000 01；SMD=-1.72，95%CI（-2.07～-1.37），P<0.000 01；SMD=-0.69，95%CI（-1.00～-0.39），P<0.000 01；SMD=-1.15，95%CI（-1.47～-0.83），P<0.000 01；SMD=-1.98，95%CI（-2.67～-1.29），P<0.000 01；SMD=-1.14，95%CI（-1.78～-0.49），P=0.000 5］；试验组徒手肌力检查（MMT）评分低于对照组［SMD=-2.09，95%CI（-2.80～-1.39），P<0.000 01］；试验组的许氏绝对评分与对照组比较差异无统计学意义［SMD=-0.34，95%CI（-0.87～0.19），P=0.21］；试验组的不良反应发生率与对照组比较差异无统计学意义［OR=0.93，95%CI（0.48～1.80），P=0.83］。结论　他克莫司能更好地改善重症肌无力患者的严重程度，并提高患者生存质量，安全可靠。但受纳入研究文献质量限制，仍需要大样本、多中心、高质量的随机对照试验以证实临床疗效及安全性。

关键词:

他克莫司, 重症肌无力, 疗效, 生存质量, 安全性, meta分析