药物基因检测干预对重症肌无力患者他克莫司治疗效果及费用的影响  

The effect of drug gene detection on the standard status of tacrolimus effectiveness and cost in patients with myasthenia gravis

作　　者：陈頔[1] 殷剑[2] 田晓鑫[1] 侯世芳[2] 赵明[1] 张华[2] 杨莉萍[1] CHEN Di;YIN Jian;TIAN Xiaoxin;HOU Shifang;ZHAO Ming;ZHANG Hua;YANG Liping(不详;Department of Pharmacy,Beijing Hospital,National Center of Gerontology,Institute of Geriatric Medicine Chinese Academy of Medical Sciences,Beijing Key Laboratory of Assessment of Clinical Drugs Risk and Individual Application(Beijing Hospital),Beijing 100730,China)

机构地区：[1]北京医院药学部国家老年医学中心中国医学科学院老年医学研究院北京市药物临床风险与个体化应用评价重点实验室(北京医院),100730 [2]北京医院神经内科国家老年医学中心中国医学科学院老年医学研究院,100730

出　　处：《中国神经免疫学和神经病学杂志》2022年第4期291-294,299,共5页Chinese Journal of Neuroimmunology and Neurology

基　　金：北京市科学技术委员会首都临床诊疗技术研究及示范应用课题(Z191100006619015);北京医院院级科研课题(bj-2018-014,bj-2019-182)。

摘　　要：目的探讨依据CYP3A5基因型制定给药方案对重症肌无力(MG)患者他克莫司(FK506)治疗的影响。方法采集2013年1月至2019年12月北京医院神经内科使用FK506的住院MG患者的病例资料,根据是否按CYP3A5基因多态性指导个体化治疗分为基因指导治疗组和常规治疗组。基因指导治疗组采用荧光染色原位杂交检测CYP3A5*3基因多态性,并依据基因型制定给药方案。常规治疗组采用FK506的逐渐增量法给药。两组患者均采用化学发光微粒子免疫分析法测定FK506血药浓度。比较两组患者血药浓度达标情况、疗效、住院时间及治疗费用情况。结果共纳入546例MG患者,其中基因指导治疗组363例、常规治疗组183例。基因指导治疗组患者FK506血药浓度达标率高于常规治疗组(38.18%比29.58%,P<0.05);与常规治疗组比较,基因指导治疗组患者平均住院日缩短、药品数减少〔分别为(26.0±19.1)d比(31.7±21.3)d,(15.5±14.0)种比(20.0±18.1)种,均P<0.05〕。两组患者的MG临床相对评分、次均住院费用、日均治疗费用、次均药品费用、日均药品费用、药占比差异无统计学意义(均P>0.05)。结论在CYP3A5基因指导下的个体化给药,有利于提高MG患者FK506血药浓度的达标率、缩短住院时间。Objective To investigate the effect of CYP3A5 genotype based dosage regimen on tacrolimus(FK506)treatment in patients with myasthenia gravis(MG).Methods The data of MG patients using FK506 in the Neurology Department of Beijing Hospital were collected from January 2013 to December 2019.Patients were divided into gene guided treatment group and routine treatment group.CYP3A5*3 gene polymorphism was detected by fluorescence staining in situ hybridizationmethod and the administration regimen was made according to the gene type in the gene guided treatment group.The routine treatment group was given FK506 by gradual increments.The FK506 blood concentration was measured by chemiluminescence micro particle immunoassay in both groups.We compared the differences in blood concentrations,treatment effect,hospitalization time and treatment cost between the two groups.Results A total of 546 MG patients were included 363 patients in the gene guided treatment group and 183 patients in the routine treatment group.The compliance rate of FK506 blood concentration in the gene guided treatment group(38.18%)was higher than that in the routine treatment group(29.58%)(P<0.05).Compared with the routine treatment group,the average days of hospitalization of the gene guided treatment group was shortened〔(26.0±19.1)d vs.(31.7±21.3)d〕,and the number of drugs was reduced(15.5±14.0 vs.20.0±18.1)(P<0.05).There was no significant difference in the MG clinical relative score,the average medical cost perhospitalization,average daily treatment cost,average drug cost perhospitalization,average daily drug cost,and drug proportion between the two groups(P>0.05).Conclusions Individualized administration by the guidance of CYP3A5 gene could improve the rate of reaching standard of blood concentration and shorten the hospitalization time.

关 键 词：他克莫司 重症肌无力 CYP3A5基因 血药浓度 治疗费用 

分 类 号：R746.1[医药卫生—神经病学与精神病学]