The Correlation Study Between The Dose, Plasma Concentration Of Duloxetine And The Treatment Effect, Adverse Reaction In Depression

ObjectiveIn clinical drug treatment,therapeutic drug monitoring (TDM) refers to test the concentration of specific drugs in the patients blood in specified time interval,in order to make the blood of patients to maintain a constant plasma concentration. TDM is conducive to realize dosage regimen individualization, improve drug efficacy, avoid or reduce the toxicity.TDM has been already widely applied in clinic.In recent years,there is more studies on antidepressant therapeutic drug monitoring. While duloxetine belongs to SNRI drugs, there is less TDM study on this drug currently. This paper studies the correlation between plasma concentration of different doses of duloxetine in the treatment of depression and clinical curative effect and adverse reaction.MethodsThis paper selected 34 patients who had been diagnosized depression in our hospital from July 2014 to March 2015. These patients took a fixed dose of duloxetine hydrochloride enteric capsules treatment for 56 days and they were randomly divided into 60mg and 120mg group.We assessed the HAMD, HAMA, MADRS,VAS,SF-36 and TESS scale to evaluate effecacy and side effect at baseline,7th day,14th day,28th day and 56th day, respectively. Then we used Ultra High-Performance Liquid Chromatograph,(UHPLC) to detect the blood concentration of duloxetine after treatment 7th day,14th day,28th day and 56th day,respectively.We used full analysis set (FAS)and per-protocal population(PP) to analyze the clinical curative effect.We used per-protocal population to analyze the relationship between plasma concentrations of duloxetine and the clinical efficacy.T test and correlation analysis were used to statistical analysis.Results1. Compared with the baseline, HAMD, HAMA, MADRS, SF-36 and VAS scale scores have very significant statistical significance (P< 0.001)after treatment 7th day,14th day,28th day and 56th day;Comparing 60mg group with 120mg group,there was no statistically significant (P> 0.05) in the proportion of patients with effective treatment.Comparing 60mg group with 120mg group,there was also no statistically significant (P> 0.05) in the proportion of patients with clinical cure.2.After treatment the plasma concentration range of duloxetine was (1.67-334.60) ng/ml;Compared with 60mg group,the concentration of duloxetine in 120mg group was hihger after treatment 7th day,14th day, 28day and 56th day,and the differences had statistically significant(P<0.05). In the two groups, there was no correlation between the plasma concontration of duloxetine and HAMD scores(P>0.05) after treatment 7th day,14th day,28th day and 56th day. The treatment of effective plasma concentration was higher than ineffective treatment,but there was no correlation betweenthe plasma concontration of duloxetine and the reduction rate of HAMD (P>0.05) after treatment. There was no statistical significance(P>0.05) between plasma concentration of clinical cure treatment and treatment no cure 56th day.Conclusions1. Different doses group of duloxetine can mitigate the symptoms of depression and improve patient’s quality of life. The common adverse reactions of duloxetine are dry mouth, constipation, nausea,vomiting, lethargy, sweating, anorexia, anorexia etc.2.Plasma concentration of duloxetine is related with dose. There is no correlation between the plasma concentration of duloxetine and HAMD scores.There is no correlation between the plasma concentration of duloxetine and the reduction rate of HAMD.There is no correlation between the plasma concentration of duloxetine and adverse reactions.Plasma concentration of duloxetine may correlate with increasing in heart rate.