摘要
目的探讨五酯胶囊对重症肌无力(MG)患者他克莫司(FK506)血药浓度及临床疗效的影响,并进行用药成本及安全性评估。方法采用双向队列研究方法,纳入2018年2月至2020年5月于北京医院神经内科应用他克莫司治疗的MG住院患者共85例,患者均为CYP3A5基因表达型(AA、AG型)。根据是否联用五酯胶囊将患者分为联合组(FK506+五酯胶囊,n=41例)和单药组(单用FK506,n=44例),对患者进行随访至少2年。比较两组患者FK506临床起效时间、FK506年均血药浓度、日均使用剂量、日均费用及临床疗效的差异,并评估相关副作用。结果联合组临床起效时间明显短于单药组〔(13.14±3.30)d比(20.45±3.92)d;P<0.01〕;1年内FK506年均血药浓度〔(10.03±1.36)ng/mL比(4.78±1.71)ng/mL〕、许氏评分改善率〔M d(Q):92.0%(51.00%)比45.5%(28.75%)〕明显高于单药组(均P<0.01),日均FK506使用剂量〔(2.10±0.703)mg比(3.83±0.976)mg〕、日均费用〔(34.71±11.27)元比(61.27±15.62)元〕、许氏临床绝对评分〔M d(Q):1.00(3.50)分比5.00(9.75)分〕明显低于单药组(均P<0.01);用药2年后两组患者血糖、血脂、肌酐、尿酸异常率无显著统计学差异(均P>0.05),联合组临床痊愈比例(92.7%比72.7%)、停用溴吡斯的明比例(73.2%比11.4%)、FK506减药者比例(17.1%比2.3%)明显高于单药组(P<0.05或P<0.01)。结论五酯胶囊可缩短CYP3A5基因表达型MG患者FK506临床起效时间,提高FK506血药浓度,降低FK506日均使用剂量,明显降低治疗成本,并显著提高临床治疗效果,且未增加FK506的副作用。五酯胶囊为临床应用FK506治疗MG的有效增效剂及费用节省剂。
Objective To study the effects of Wuzhi Capsule on the blood concentration of tacrolimus and clinical efficacy of myasthenia gravis(MG)patients after treatment with tacrolimus,and to evaluate the medication cost and safety.Methods This is an ambispective cohort study.We selected a total of 85 MG patients with CYP3A5 genotypes expression(AA,AG types)from February 2018 to May 2020 in the Neurology Department of Beijing Hospital treated with tacrolimus.All patients were assigned to two groups according to whether combined with Wuzhi Capsules:the combined therapy group(treated with both Wuzhi Capsule and tacrolimus,n=41)and the monotherapy group(treated with tacrolimus only,n=44),and were followed up for two years.The clinical onset time,the blood concentration of tacrolimus,the average daily dose of tacrolimus,the average daily cost,the clinical efficacy,and side effects were compared between the two groups.Results Compared with the monotherapy group,the combined therapy group had a shorter clinical onset time[(13.14±3.30)days vs.(20.45±3.92)days;P<0.01],a higher blood concentration of tacrolimus[(10.03±1.36)ng/mL vs.(4.78±1.71)ng/mL],a higher improvement rates of Xu's score[M d(Q):92.0%(51.00%)vs.45.5%(28.25%)](all P<0.01),and a lower daily dosage of tacrolimus[(2.10±0.703)mg vs.(3.83±0.976)mg],a lower average daily cost[(34.71±11.27)Yuan vs.(61.27±15.62)Yuan],and a lower Xu's absolute score[M d(Q):1.0(3.50)score vs.5.00(9.75)score]in one year later(all P<0.01).There were no significant differences in the incidences of adverse effects(including abnormal rates of the blood sugar level,the blood lipid level,the blood creatinine level,and the blood uric acid level)between the two groups in two years later(all P>0.05).Compared with the monotherapy group,the combined therapy group had a higher remission rate(92.7%vs.72.7%),a higher withdrawal rate of pyridostigmine bromide(73.2%vs.11.4%),and a higher reduction rate of tacrolimus(17.1%vs.2.3%)(P<0.05 or P<0.01)in two years later.Conclusions The application of tac
作者
侯世芳
张磊
殷剑
陈頔
王红
张华
HOU Shifang;ZHANG Lei;YIN Jian;CHEN Di;WANG Hong;ZHANG Hua(不详;Department of Neurology,Beijing Hospital,National Center of Gerontology,Institute of Geriatric Medicine,Chinese Academy of Medical Sciences,Beijing 100730,China)
出处
《中国神经免疫学和神经病学杂志》
CAS
北大核心
2023年第5期316-320,共5页
Chinese Journal of Neuroimmunology and Neurology
