Efficiency And Safety Of Lomerizine Hydrochloride In Preventive Treatment Of Migraine

Migraine is a common, chronic, multi-functional factors of neurovascular disorders disease, and has become the most serious dysfunction of chronic dis -eases with paralysis of limbs, mental disorders and dementia. Migraine is one of the chronic diseases having serious impact on the lives of patients. The inci -dence rate of migraine from epidemiological investigations is 12.9% -17.6% for women and 3.4-6.1% for men. The prevalence rate of migraine in China is 985.2/10 million, and the annual incidence rate is 4.2% -14.6% changing with age, the distribution of the age is 25-55. The male to female ratio of migraine which has a high positive family history was 1:4.The treatment of migraine consists of acute treatment and preventive tre -atment.With the growth of the patient's age and increasing level of migraine, patients gradually became aware of the importance of preventive treatment. Pr -eventive medications includeβ-blockers, calcium antagonists, 5 - HT receptor antagonist, antiepileptic drugs, and antidepressants and traditional Chinese me -dicine. It is now generally considered that migraine may be an ion channel dis -orders'disease, and the calcium channel blocker on the preventive treatment of migraine become an important strategy.Currently the representation drug in the calcium channel blocker is flunar -izine hydrochloride, which is non-competitive two-piperazine calcium chann -el blocker. The nerves and blood vessels play a role in the main mechanism of flunarizine, which impacts neurotransmitter receptors in the treatment of preve -nting migraine. Flunarizine hydrochloride in clinical is good at migraine, dizz -iness, and cerebrovascular ischemic diseases and epilepsy. There exist a varie -ty of adverse reactions involving multiple systems in the application of flun -arizine. There are the central nervous system effects, such as drowsiness, fati -gue, depression, extrapyramidal reactions, delirium, headaches, et al.Lomerizine hydrochloride called Migsis and Terranas is a new anti-migr -aine drug developed by Kanebo and Pharmacia & Upjohn Company in Japan in 1999. Lomerizine hydrochloride as calcium, sodium dual channel blocker plays roles in the following areas: (1) block Ca2 + influx in the brain cells, inh -ibit vascular smooth muscle contraction, selectively expand the brain blood v -essels and increase cerebral blood flow. In addition, it inhibits non-competiti -vely the brain and peripheral arterial vasoconstriction induced by K +, PGF2αand 5-HT; (2) inhibit the cortical spreading depression, (3) inhibit nerve inflam -mation caused by trigeminal nerve stimulation, such as plasma protein leakag -e; (4) protect the neurons after ischemia-reperfusion injury or hypoxia ; (5) re -duce cerebral infarction area caused by carotid artery occlusion. The clinical tests in the foreign showed that it is a relatively safe and effective drug in the preventive treatment for migraine. However, it is less in the current domestic clinical research.To explore the efficiency and safety of lomerizine hydrochloride, this study deployed a randomized, double-blind, controlled trial method. We selected 92 patients with migraine as a research objects in neurology clinic in China-Japan Hospital in Jilin University, which lomerizine hydrochloride and the placebo g -roup 46 cases, lomerizine hydrochloric and flunarizine hydrochloric group 46 cases. All the patients were in accordance with the 1988 International Headac -he Society classification of the head and face pain of migraine with aura and migraine without aura diagnostic criteria, and interruption and exclusion crite -ria/standards of withdrawing from the experiment. In selected patients there was no significant difference between general information and the past history.The course of study were 8 weeks in lomerizine and placebo group, and 12 weeks in lomerizine and flunarizine group. We compared the frequency , duration, severity and associated symptoms of migraine attacks, and record adverse events from the clinical perspective.In lomerizine and placebo group, the clinical study results confirmed that: lomerizine reduces the frequency, average duration, and the severity of the hea -dache after 4 weeks, 8 weeks statistically significant. We can see that the clini -cal efficacy in lomerizine group is more than that in placebo group in the freq -uency and the severity of the headache after 8 weeks. There was no significan -t difference in improving nausea, vomiting, photophobia, phonophobia in two groups. It appeared one case of nausea, two cases of sleep thinking in lomerizi -ne group, and sleep thinking one case , increased menstrual flow one case in placebo group, but the symptoms were lighter, and did not affect the continued medication. The adverse events appeared in lomerizine group were one case more than that in placebo group, but there had no significant difference in the two groups. In placebo group there was a patient with increased menstrual flo -w, which was not considered with medication. This study confirmed that lom -erizine hydrochloride is safe and effective in preventive treatment of migraine. In lomerizine and flunarizine group, the clinical study results confirmed:there were notable differences after 4,8 and 12 weeks treatment in the average frequency , duration and severity of the headache attacks compared with the tr -eatment when the study began. Compared lomerizine with flunarizine, there were no significant differences in the average frequency, duration and severity of headache after 4, 8 and 12 weeks. we can see that the efficacy is same betw -een lomerizine and flunarizine. There was no significant difference in impro -ving nausea, vomiting, photophobia, phonophobia in two groups. It appeared one case of abdominal pain, one case of drowsiness in lomerizine group and t -wo cases of dizziness, one case of edema, insomnia and three case of drowsi -ngess in flunarizine group. The drowsiness did not rule out the possibility of drug, and disappeared without deal, but the patient of abdominal pain was stop -ped temporarily in observation. Through the two drugs, we confirmed that lo -merizine and flunarizine for the treatment of migraine are effective, the result -s are similar and those of similar security.There are nausea, drowsiness, abdominal pain in the process of lomerizi -ne treatment appeared as major adverse events, which are similar to the drug reports in abroad. The overwhelming majority of patients can tolerate these ad -verse events without special treatment. There were no statistical significance in the adverse events in lomerizine and placebo, flunarizine group. we can see that it is the security.Compared after-test and before-test, there were no apparent changes in the general state of patients and blood, urine, blood biochemistry, ECG bet -ween both groups. Hydrochloride lomerizine had no adverse effects for pat -ients in general signs and other important organs.In sum, hydrochloride lomerizine as calcium, sodium dual channel blo -cker, can directly expand of blood vessels ,inhibit vasoconstriction, and sign -ificantly increase cerebral blood flow with highly cerebrovascular selective; inhibit cortical spreading depression; inhibit nerve inflammation; protect neu -rons. In the preventive treatment of migraine, it can reduce monthly frequen -cy, duration and severity of headache attacks. It is similar to flunarizine in the clinical efficacy. The lomerizine dose not sound markedly improved accompa -nied by symptoms of migraine in nausea, vomiting, photophobia, phonophob -ia and dose not cause serious adverse reactions. Take into account a smaller n -umber of samples in the present study, we observe adverse drug reactions lim -itly, and still need a large sample clinical study to confirming. In addition, the lomerizine has nerve protective effects after ischemia-reperfusion and hypoxic brain dysfunction, and can reduce cerebral infarction area caused by carotid art -ery occlusion, which can be used for the prevention and treatment of certain cerebral circulation abnormal diseases, such as glaucoma, stroke and vertigo. Lomerizine which is wide range of pharmacological effects, has vast potential clinical application.