| Objective:To evaluate the validity of Lu Tong Granule on treatment of migraine model rats, and investigate the probable mechanism of Lu Tong Granule on treatment of migraine. It also observe the clinical therapeutic effect of Lu Tong Granule combined with acupuncture therapy on migraine patients with syndrome of wind-dampness mixed with stasis blood, which can optimize the clinical treatment plan. Methods:1 Experimental Part:Established the migraine rat model by using glyceryltrinitrate hypodermic injected method.120 adult healthy rats were randomly divided into six groups, each group contained 20 rats, those groups were normal contrast group, model group, high dose Lu Tong Granule group, moderate dose Lu Tong Granule group, low dose Lu Tong Granule group and Flunarizine capsule group. After the drug intervention in each model group, we can observe the behavior index of rats, the CGRP in blood plasma,5-HT in rat brain tissue and the expression of c-jun,c-fos gene in trigeminal nucleus caudalis.2 Clinical Observation:It was a randomized, controlled, single blind trial.90 cases consistent with the case selection criteria are randomly divided into test group,comparison A group and comparison B group, while each group contained 30 cases. The treatment of test group was Lu Tong Granule combined with acupuncture and dummy capsule, the treatment of comparison A group was Lu Tong Granule and dummy capsule, the treatment of comparison B group was Flunarizine capsule and dummy Granule. After the treatment, we can observe the integrates of the intension,persistence time,the frequency of headache and headache index before and after one week. It also observed the clinical therapeutic effect.the TCM clinical syndrome effect and the security. Results:1 The experiment results:(1) The experiment proved that the glyceryltrinitrate migraine model rat were easily made. Compared with the model group, the high,moderate,low dose Lu Tong Granule group and Flunarizine capsule group can obviously shorten the time of rat ear becoming red and decreased the frequency of touch head and climb cage, it had significantly difference((P<0.01, P<0.05). The high,moderate dose Lu Tong Granule group and Flunarizine capsule group, compared with each other, it didn't have significantly difference (P>0.05). (2) CGRP of rat blood plasma. The CGRP content in rat blood plasma of model group,high,moderate,low dose Lu Tong Granule group and Flunarizine capsule group were higher than that of normal group, it had significantly difference(P<0.01); Compared with the model group, the CGRP content in rat blood plasma of high,moderate dose Lu Tong Granule group and Flunarizine capsule group were significant lower than those of model group, it had significantly difference (P<0.01). The high,moderate dose Lu Tong Granule group and Flunarizine capsule group, compared with low dose group, it has significantly difference (P<0.01). (3) 5-HT in rat brain tissue. The 5-HT content in rat brain tissue of model group,high,moderate,low dose Lu Tong Granule group were significant lower than those of normal group, the differences has statistical significance (P<0.01). Compared with the model group, the 5-HT content in rat brain tissue of high,moderate dose Lu Tong Granule group and Flunarizine capsule group were significant higher than that of model group, the differences has statistical significance (P<0.01). The high,moderate dose Lu Tong Granule group and Flunarizine capsule group, compared with low dose group, it has significantly difference (P<0.05). (4) The expression of c-jun,c-fos gene in trigeminal nucleus caudalis of rat. The expression content of c-jun,c-fos gene in trigeminal nucleus caudalis of model group% high,moderate,low dose Lu Tong Granule group are much higher than that of normal group. Compared with the model group, the expression content of c-jun,c-fos gene in trigeminal nucleus caudalis in high,moderate dose Lu Tong Granule group and Flunarizine capsule group were lower than that of model group, the differences had statistical significance (P<0.05). The high,moderate dose Lu Tong Granule group and Flunarizine capsule group, compared with low dose group, the differences have statistical significance(P<0.01).2 The Clinical results:(1) The total effective rate of clinical therapeutic effect of test group was 90.0%, which was 80.0% of comparison A group, and which is 76.7% of comparison B group. Compared with the comparison A or B group, the differences had statistical significance (P<0.01). The total effective rate of TCM syndrome therapeutic effect of test group was 93.3%, which was 70.0% of comparison A group, and which was 90.0% of comparison B group. Test group compared with the comparison A, the differences did not have statistical significance (P>0.05), test group and comparison A group compared with comparison B group, the difference had statistical significance(P<0.01).(2) It was significantly improved of integrates of the intension,persistence time,the frequency of headache and the headache index after the treatment in three groups. Compared with comparison A and B group, the test group significantly improved, the differences had statistical significance(P<0.01).Compared between comparison A and B group, the changes were fairly, the differences did not have statistical significance(P>0.05).(3) The test group and the comparison A group were significantly improved the syndrome of headache, dizzy, head as wrapped, spew saliva, tasteless, eat few, tongue demonstration, the differences had statistical significance(P<0.01).but only headache and dizzy of comparison B group was improved(P<0.01).The improving of other TCM clinical syndrome of test group and comparison A group surpass that of comparison B group.(4) During the entire treatment, there were no adverse effect. Conclusion:1 Lu Tong Granule can obviously improve the behavior index of migraine rat. The mechanism may be associated with decreasing the CGRP content in rat blood plasma and raising 5-HT content in rat brain tissue, inhibiting the expression of c-jun and c-fos gene within trigeminal nucleus caudalis.2 It was satisfied of the clinical therapeutic effect of Lu Tong Granule combined with acupuncture therapy on patients of migraine. It can also effectively improve the intension, shorten the persistence time, decrease the frequency of headache, improved the headache index and the TCM clinical syndrome.
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