A Randomized Controlled Study Of Pregabalin Combined With Duloxetine And High Dose Pregabalin In The Treatment Of Herpes Zoster Neuralgiaia

Objective: The purpose of this study was to observe the efficacy and major adverse reactions of Pregabalin combined with Duloxetine and high dose Pregabalin alone in the treatment of herpes zoster neuralgia by a randomized controlled trial.Methods: This study collected herpes zoster patients from September 2017 to April2018 in the Pain Department of the First Affiliated Hospital of China Medical University.The patients were selected according to inclusion/exclusion criteria.Patients who entered the study were first screened for a 3-day unified drug treatment.The drug treatment regimen of all patients was adjusted as follows: 75 mg of Pregabalin was taken every 12 hours,and 2.5 mg of Tallerenin was taken every 8 hours.The VAS score and the number of outbreaks of pain were evaluated on the third day.For patients with VAS(≥ 4)and outbreaks of pain(≥3 times per day),they entered the formal research stage.Patients with VAS(< 4)and outbreaks of pain(< 3 times per day)were not included in the study,and the current clinical treatment program was maintained.Age,sex,weight,course of disease(days)and the highest VAS score were recorded,and the scores of HAMD-17 and PSQI scales were measured.98 patients were randomly divided into experimental group and control group,49 cases in each group.The experimental group was given Pregabalin 75 mg every 12 hours,combined with Duloxetine 60 mg daily,oral at breakfast.Duloxetine was given orally 30 mg on the first day and the second day,and 60 mg on the third day.The control group was given Pregabalin 150 mg once every 12 hours.Pregabalin was also given in a gradual incremental way.Pregabalin was given 75 mg early and 150 mg late on the first and second days.Pregabalin was given 150 mg every 12 hours on the third day.The highest VAS score,the number of outbreaks of pain and the occurrence of major adverse reactions were recorded at 1,2,3 and 4 weeks after formal treatment.The scores of HAMD-17 and PSQI scales were recorded after 4 weeks.Results:1.There was no statistical difference in baseline data between the two groups(P>0.05).2.The main treatment index VAS was significantly decreased at all time points after treatment compared with before treatment(P<0.05).The VAS score of the control group was lower than that of the experimental group in the first week after treatment(P<0.05).There was no statistical difference in VAS score between the twogroups in the second week after treatment(P>0.05),VAS score in the experimental group was lower than that in the control group at the 3rd and 4th week after treatment(P<0.05).The VAS score of the experimental group was lower than that of the control group at the fourth week(P<0.05).3.the scores of HAMD-17 and PSQI scale were significantly improved before and after treatment(P<0.05),and there was no significant difference between the two groups at the fourth week after treatment(P>0.05).4.Incidence of adverse reactions.This study mainly observed dizziness/lethargy,nausea/vomiting,edema,dry mouth and other adverse reactions.The incidence of dizziness/sleepiness reaction in the control group was higher than that in the experimental group at all time points(P<0.05).Nausea/vomiting reaction in the experimental group was significantly higher than that in the control group at the first week after treatment(P<0.05).There was no significant difference between the two groups at the 2nd,3rd and 4th week.There was no significant difference in edema reaction between the two groups at the 1st,2nd and 3rd week after treatment.At the 4th week,the control group was higher than the experimental group,and the difference was statistically significant(P<0.05).The incidence of xerostomia was lower in both groups,and there was no significant difference between the two groups at different time points after treatment(P>0.05).Conclusion: For patients with herpes zoster neuralgia with poor therapeutic effect of low-dose Pregabalin,compared with high-dose Pregabalin alone,the high-dose Pregabalin group has a faster effect,and the incidence of dizziness/lethargy,edema and other adverse reactions is higher than that of the combination group;the VAS improvement of the combination group is more significant at the end of the 4th observation period.The incidence of adverse reactions was low.The main adverse reactions of nausea/vomiting occurred in the first week and then decreased.