| Objective:To compare the efficacy and safety of flunarizine and topiramate in preventing migraine,and to explore the difference of efficacy between the two drugs in different doses.Methods:A prospective,randomized,controlled study was conducted to select patients admitted to Panzhihua Central Hospital from January 2022 to December 2022 who were diagnosed with migraine by International Diagnostic Criteria III and eligible for the study after screening by inclusion and exclusion criteria.They were randomly divided into flunarizine group(5mg or 10mg)and topiramate group(25mg or 50mg)according to the order of treatment.Flunarizine 5mg,flunarizine 10 mg,topiramate25mg and topiramate 50 mg groups were recorded as groups A,B,C and D,respectively.Records into groups before treatment of the patient’s general condition,headache frequency(time/month),pain duration(h/h),pain degree,visual analog pain scale,Visual Simulation Scaleof Pain,VAS)and the accompanying symptoms(nausea,vomiting,photophobia,afraid of sound,etc.),Mental health was assessed using the Hamilton Depression Scale(HAMD).Patients in the four treatment groups were followed up 1,2 and 3 months after treatment,and headache data were collected.Primary assessment endpoints: frequency of headache attacks,duration of pain,severity of pain,adverse reactions.After treatment,the efficacy and safety between the two drugs and between different doses of the two drugs were compared,and the correlation between the accompanying symptoms and the effectiveness of preventive treatment was discussed.Results: A total of 183 patients were enrolled according to strict inclusion and exclusion criteria and followed up for 3 months,including 90 patients in flunarizine group and 93 patients in topiramate group(46 patients in group A,44 patients in group B,48 patients in group C and 45 patients in group D,respectively).(1)General situation:There were no significant differences in basic characteristics(gender,age,nationality,education level,course of disease)and initial diagnosis pain outcome indexes(headache there was no significant difference in the total effective rate between flunarizine and topiramate after1 and 2 months of treatment(P>0.05).After 3 months of treatment,the total effective rate of flunarizine(91.1%)was higher than that of topiramate(80.6%),and the difference was statistically significant(P<0.05).After 3 months of treatment,flunarizine improved the frequency of headache attacks significantly compared with topiramate,and the difference was statistically significant(P<0.05).There was no significant difference in the duration of pain between the two drugs(P>0.05).Flunarizine improved the degree of pain significantly compared with topiramate,and the difference was statistically significant(P<0.05).(3)Comparison of different doses of the two drugs:there was no significant difference in the total effective rate of the A-B group and the C-D group after 1,2 and 3 months of treatment(P>0.05).There was no significant difference between group A-B and group C-D on pain frequency.Compared with group C,the pain frequency in group A was significantly relieved after 3 months of treatment(P<0.05).Abstract: Compared with Group D and group IIA,the pain frequency of group A was significantly relieved 1 month after treatment(P<0.05).Compared with group C,the pain frequency in group B was significantly relieved 3 months after treatment(P<0.05).Compared with group D,the pain frequency of group B was significantly relieved 1 month after treatment(P<0.05).(4)Safety: the total adverse reaction rate was15.6% in flunarizine group and 22.6% in topiramate group.The adverse reaction rate was 13.0% in group A,18.2% in group B,18.75% in group C and 26.7% in group D.(5)Correlation analysis: with accompanying symptoms,the effective rate of flunarizine group(90.7%)was higher than that of topiramate group(80.3%),and the difference was not statistically significant(P>0.05).Without accompanying symptoms,the effective rate of flunarizine group(91.7%)was higher than that of topiramate group(81.5%),but the difference was not statistically significant(P>0.05).The effective rate(91.7%)in flunarizine group was higher than that in patients with concomitant symptoms(90.7%),and the effective rate(81.5%)in topiramate group was higher than that in patients with concomitant symptoms(80.3%),the difference was not statistically significant(P>0.05).Conclusions:1.Flunarizine and topiramate showed high overall effective rates in the prevention and treatment of migraine patients.2.Compared with topiramate,flunarizine has a significant effect in the preventive treatment of migraine,mainly in the improvement of headache attack frequency and pain degree.3.There was no significant difference in the total effective rate between different doses of the two drugs,and there was no significant difference in the efficacy of different doses of the same drug on pain frequency.However,different doses of flunarizine improved the pain frequency significantly compared with different doses of topiramate.4.There was no significant difference in adverse reactions between the two drugs and between different doses of the two drugs.5.There was no significant correlation between concomitant symptoms and the effectiveness of migraine prevention treatment.6.The conclusions of this paper need to be verified by larger sample size,longer preventive treatment and follow-up time,and joint multi-center clinical observation,so as to refine migraine classification and further explore the differences in efficacy and safety of the two drugs. |