Zhongguo quanke yixue (Aug 2023)
Retrospective Analysis of 2 992 Times of Therapeutic Drug Monitoring of Valproic Acid from 2019 to 2021
Abstract
Background Valproic acid, as a mood stabilizer, has been extensively used for the treatment of bipolar disorder and other psychiatric conditions. Although therapeutic drug monitoring (TDM) of valproic acid has been carried out at home and abroad for many years, controversies persist regarding the influence of age, sex and other factors on its plasma concentration. Objective To analyze the TDM results of valproic acid, providing a reference for rationalized individualized treatment of bipolar disorders or other psychiatric conditions. Methods Through the laboratory information system of Ruimei Medical Laboratory, information on TDM of valproic acid in outpatients and inpatients (including the patient's age, sex, TDM raw data, monitoring samples, and monitoring frequency) was obtained from Xi'an Mental Health Center from 2019 to 2021. The plasma concentration of valproic acid was classified into three categories (<50 mg/L, 50-100 mg/L and >100 mg/L) according to the therapeutic window range recommended in the Consensus Guidelines for Therapeutic Drug Monitoring in Neuropsychopharmacology (hereinafter referred to as AGNP Consensus) , and the percent of each category was calculated. And subsequent data analysis was performed using MedCalc 5.2. Results A total of 2 431 patients were monitored 2 992 times for understanding valproic acid treatment status, of which 1 637 were for men, and 1 355 for women. The frequencies of TDM of valproic acid increased by 54.93% in 2020 and 44.00% in 2021 compared to those reported in 2019. The proportion of patients who received only once was about 74.41%. Compared with inpatients, outpatients had higher prevalence of receiving one TDM of valproic acid (χ2=95.15, P<0.001) , and lower prevalence of receiving two, or at least three TDM of valproic acid (χ2=49.41, 34.24, P<0.001) . The plasma valproic acid concentration in inpatients was higher than that in outpatients (Z=-11.60, P<0.001) . Meanwhile, higher plasma valproic acid concentration was observed in female patients than in male patients (Z=-4.39, P<0.001) . However, there was no significant difference between the age groups (Z=0.75, P>0.05) . For each study year 2019-2021, the proportion of plasma concentration of valproic acid within the therapeutic window was 57.72%, which was significantly higher than that of the proportion of below and above the therapeutic window (χ2=155.38, 1 216.68, P<0.001) . The proportion of the plasma valproic acid concentration (<50 mg/L, 50-100 mg/L, or >100 mg/L) had statistically significant differences between different age and gender groups, and over the years (P<0.05) . The plasma valproic acid concentration ranged between 40-80 mg/L for males, females, or total participants, which was slightly lower than the therapeutic range (50-100 mg/L) recommended by the AGNP Consensus. Conclusion The individual treatment program in patients should be determined clinically according to age and sex to increase the proportion of plasma valproic acid concentration in the therapeutic window. Additionally, TDM of valproic acid should be emphasized in inpatients and outpatients to ensure safe and effective medication administration in clinical practice.
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