| Objective:To explore the influencing factors of LEV plasma concentration,evaluate the safty,and establish the reference interval of LEV plasma concentration,so as to provide reference for safe and reasonable use of LEV in clinic.Method:The basic information,test results,and adverse reactions of patients with LEV plasma concentration monitored in our hospital were collected from Mar 2013-Dec 2020.The correlation between age,gender,nationality,dose and combination of drugs and LEV plasma concentration was statistically analyzed,and the reference interval of LEV plasma concentration was established.Results:1 In the first part,2852 monitoring results of patients were included,including 1783 children(62.52%)and 1069 non children(37.48%);1373 male(48.14%),1479 female(51.86%);2171 Han(76.12%)and 681 minority(23.88%);1357(47.58%)patients treated with single drug and 1495(52.42%)patients treated with multi drug:(1)There was a linear correlation between LEV daily dose,body weight daily dose and plasma concentration in the range of 66-3000mg·d-1 and 4.76-113.32mg·kg-1·d-1(all P<0.001).(2)There were differences in dose corrected concentration(CDR)of LEV in different age groups,which showed that the elderly(over 65 years old)(0.79±0.30kg·L-1)>young and middle-aged people(14-65 years old)(0.53±0.22kg·L-1)>children(≤14 years old)(0.28±0.16kg·L-1)(all P<0.001).(3)The CDR value of LEV in female patients was(0.39±0.24kg.L-1)was higher than male patients(0.36±0.25kg·L-1)(P=0.001);(4)In non-children patients,the CDR value of LEV in OXC group was lower than that in monotherapy group(P<0.05).(5)The creatinine clearance rate(Cre)was negatively correlated with the CDR of LEV at the rang from 9.24 to 545.24 mL·min-1 of 241 inpatients.(6)The incidence of adverse reactions in the combination group was 14.52%,which higher than 13.63%in the monotherapy group,but there was no significant difference between the two groups(P=0.518);The incidence of poor appetite,nausea,vomiting,diarrhea and abdominal pain in the combination group was higher than that in the monotherapy group,while the incidence of fatigue in the monotherapy group was higher than that in the combination group(all P<0.05).(7)Among children under 4 years old,the incidence of adverse reactions in the monotherapy group(7.50%)was lower than that in the combination group(12.70%),but the difference was not statistically significant(P=0.051);Compared with patients aged 4 years and above,the incidence of adverse reactions in children under 4 years old(7.53%)was lower than that in patients aged 4 years and above(15.20%)(P=0.001),while there was no significant difference in the incidence of adverse reactions between the two groups in combination.2 In the second part,a total of 2852 monitoring results of patients were included:the percentile method was used to establish the reference interval of LEV plasma concentration:2～20μg·mL-1 for children(<14 years old),2-22μg·mL-1 for young and middle-aged patients(14-65 years old),2-48μg·mL-1 in elderly(over 65 years old).Conclusion:1 There was a positive linear correlation between plasma LEV concentration and dose;2 Age,gender and combined with OXC are influencing factors of LEV CDR,but gender and combined with OXC may not have significant clinical significance;3 The CDR of LEV was negatively correlated with Ccr.4 The incidence of adverse reactions in monotherapy group was lower than that in combination therapy group,but the difference was not statistically significant,the use of LEV in children under 4 years old was also well tolerated;5 The reference interval for our hospital was established,which can be further verified in clinical application. |
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