| Objective To provide scientific basic for generalization and application of Tongning capsule in clinical,this subject contains experimental and clinical two aspects to investigate the neurobiological mechanism of Tongning capsule in the treatment of migraine and observe the clinical efficiency on treating migraine headache with blood stasis symptom.Experimental study Objective To observe the effects of Tongning capsule on the plasma concentration of Nitric oxide(NO),Hydroxytamine (5-HT)and on the Nitric oxide synthesis(NOS),Hydroxytamine and immediate-early gene c-fos expression of hypothalamus and brain stem in the nitroglycerin experimentl migrainous rats. Methods SD rat were randomly assigned to 6 groups:blank control group,model control group,masculine drug control group,study drug groups(including high dose, middle dose and low dose Tongning capsule subgroup). All the groups were reproduced the rat migraine model by subcutaneously administration of nitroglycerin-except blank contol group.After 30 minutes, The intragastric administration dose of Tongning capsule was divided into three groups as follows:high dose, middle dose and low dose in the study drug group. Masculine drug control group was administrated Sumatriptan Succinate physic liquor following the dose of 6mg/kg.Blank control group and model control group were administrated corresponding volume of distilled water. Collected plasma from abdominal aorta after the migraine animol model established 4h,and measured the concentration of NO by means of nitrate reductase method and the concentration of 5-HT was measured by enzyme linked immuno sorbent assay (ELISA).Then got the brain tissue sample and measured the expression of NOS,5-HT and c-fos in hypothalamus and brain stem by means of immunohistochemical method. Result①Masculine drug control group, Tongning capsule high dose group,and middle dose group all reduced the concentration of NO,and increased the concentration of 5-HT,which were all significant compared to model control group(P<0.05或P<0.01)), Compared Tongning capsule high does group with masculine drug control group in the effect on the plasma concentration of NO and 5-HT,there were no significances between them(p>0.05).②The expression of NOS and c-fos in hypothalamus and brain stem of model control group were enhanced, but the expression of 5-HT were decreased,which were both significant compared with blank control group(P<0.05 或P<0.01). Both masculine drug control group and Tongning capsule expecially high does group could significantly suppress the expression of NOS,c-fos and increase 5-HT expression, there were statistical significances compared to model control group (P<0.05或P<0.01). However,compared Tongning capsule expecially high does group with masculine drug control group in the effect on the expression of NOS,c-fos and 5-HT,there were both no significances between them(p>0.05).Clinical study Objective To observe the clinical efficiency on treating migraine. Methods 125 blood stasis type migraineurs were randomly assigned to 3 groups,including 40 subjects in Western medicine control group,40 subjects in Chinese patent medicine control group and 45 subjects in study drug group. Subjects in Western medicine control group were treated with Ibuprofen sustained release capsule (Ibuprofen),subjects in Chinese patent medicine control group were treated with Xuefuzhuyu capsule, and subjects in study drug group were treated with Tongning capsule.Course of treatment in all groups were two weeks and all subjects were followed up one months. It is designed to observe the differences of the three groups on treating blood stasis type migraine in the clinical efficiency and traditional chinese medicine syndrome improvement. Result Integrated efficiency,the total effective rate of study drug group was 82.2%, that of Western medicine control group and Chinese patent medicine control group were 92.5% and 82.5%. Chinese medicine syndrome efficiency, the total effective rate of study drug group was 84.2%, that of Western medicine control group and Chinese patent medicine control group were 92.5% and 85%.The difference test demonstrated that there were no significances in the clinical efficiency and traditional chinese medicine syndrome improvement during three groups.Then we used equivalence test to evaluate them,the results showed that Tongning capsule had the equivalent effect to Xuefuzhuyu capsule on treating blood stasis type migraine,However,both of them did not possess equivalent effect with Ibuprofen.Conclusion①Tongning capsule can reduce migrainous rats the plasma concentration of NO, increase the plasma concentration of 5-HT,and can suppress the expression of NOS in hypothalamus and brain stem, up-regulated the level of 5-HT, This further can regulate the levels of vasoactive substances and neurotransmitters in migraine rats during the migraine attacks;Inadition,it also can reduce the expression of c-fos in hypothalamus and brain stem,the effect can depress neuronal excitability in hypothalamus and brain stem,and inhibit nociceptive pain information transmitting,it, maybe the possible mechanisms in the treatment of migraine using Tongning capsule.②Tongning capsule has equal effect to Xuefuzhuyu capsule on treating migraine headache with blood stasis symptom. It has high value of clinic and is deserved to be generalized and applied more. |
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