The Prospective Study Of Efficacy And Safety Of Topiramate In Children With Migraine

ObjectiveMigraine (MG) is a clinically common disease of the nervous system, which has seriously affected the quality of life in children. Topiramate (TPM) in foreign countries has been used for the treatment of migraine in children, since the Chinese people are smaller and lighter than the Westerners, the doses should be also relatively smaller. Due to the paucity of literature in China, we conducted the prospective study to evaluate the efficacy, safety and the optimal dose of topiramate for the treatment of migraine in children.Methods1. The study was comprised of201children, who were diagnosed as migraine in Children’s Hospital of Chongqing Medical University in September2009to April2011. The children were8to12years old with at least3months history of migraine, and118children were male and the other83children were female, and their weight were25to39kg. According to random number tables, they were divided into four groups: TPMa group (25mg/d), TPMb group (50mg/d), TPMc group (75mg/d) and the control group (Ginkgo Biloba Leaves Extract, GBE80mg/d).2. When children took the drug regularly, we made unified follow-up lists to record all the disease characteristics and the quality of life during the entire study, including the frequency, duration, severity, Pediatric Quality of Life Inventory Measurement Models4.0(PedsQLTM4.0), effective rate, adverse effects, drug retention rate (DRR), withdrawal situations, Transcranial Doppler Sonography(TCD), liver and kidney function and so on.Results1. The attack frequency:After receiving the treatment, the attack frequency decreased during the different period and the differences were statistically significant (P<0.05). After one month treatment, the differences among the groups were not statistically significant (P>0.05). After four and seven months treatment, the differences between TPM groups and Con group were statistically significant (P<0.05); Among the TPM groups, TPMb group decreased most obviously and the differences were statistically significant (P<0.05).2. The duration of attack:After receiving the treatment, the duration of attack shortened at different time and the differences were statistically significant (P<0.05). After one month treatment, the differences among the groups were not statistically significant (P>0.05). After four and seven months treatment, the differences between TPM groups and Con group were statistically significant (P<0.05); Among the TPM groups, TPMb group shortened most obviously and the differences were statistically significant (P<0.05).3. The attack severity:After receiving the treatment, the attacks in any time points were less severer and the difference were statistically significant (P<0.05), but the differences among the groups were not statistically significant (P>0.05).4. The abnormal rate of TCD:After receiving the treatment, the abnormal rate of TCD decreased at different time and the differences were statistically significant (P<0.05). After one month treatment, the differences among the groups were not statistically significant(P>0.05). After four and seven months treatment, the differences between TPM groups and Con group were statistically significant(P<0.05); Among the TPM groups, TPMb group decreased most obviously and the differences were statistically significant (P<0.05).5. The effective rate:After one month treatment, the differences among the groups were not statistically significant (P>0.05). After four and seven months treatment, the differences between TPM groups and Con group were statistically significant (P<0.05); Among the TPM groups, the effective rate of TPMb group was highest and the differences were statistically significant (P<0.05). 6. PedsQLTM4.0:After seven months treatment, the PedsQLTM4.0marks rised and the differences were statistically significant (P<0.05). After seven months treatment, the differences between TPM groups and Con group were statistically significant (P<0.05); Among the TPM groups, TPMb group rised most obviously and the differences were statistically significant(P<0.05).7. The incidence of adverse effects:The highest incidence of adverse effects belonged to the Con group, the differences between TPM groups and Con group were statistically significant (P<0.05); When TPMb group compared with TPMc, the difference was statistically significant (P<0.05). Although the lowest incidence of adverse effects belonged to the TPMa group, the difference between TPMb and TPMa groups was statistically significant (P<0.05).8. The withdrawal rate:After one month treatment, the differences among the groups were not statistically significant (P>0.05). After four and seven months treatment, the differences between TPM groups and Con group were statistically significant (P<0.05); Among the TPM groups, the lowest rate of withdrawal belonged to TPMb group and the differences were statistically significant (P<0.05).9. The retention rate:After one month treatment, the differences among the groups were not statistically significant (P>0.05). After four and seven months treatment, the differences between TPM groups and Con group were statistically significant (P<0.05); Among the TPM groups, the highest rate of retention belonged to TPMb group and the differences were statistically significant (P<0.05).Conclusions1. The clinical efficacy of topiramate is better than GBE in the treatment of migraine in children and therefore leads to a better improvement of their life.2. TPM50mg/d is more clinically efficacious than any other TPM doses.3. TPM50mg/d has a low incidence of adverse effects and an excellent tolerance for children.4. The low withdrawal rate and high retention rate of TPM50mg/d embodies its great efficacy and safety.