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Objective: the evaluation Rotundine particle therapy migraine the validity of the model in rats, and to explore the possible mechanism of the drug to treat the disease. The observed cranial pain particles combined with acupuncture to treat migraine headache the rheumatoid clinical efficacy folder stasis optimize clinical treatment programs. Methods: Experimental use of glyceryl trinitrate (GTN) subcutaneous injection established migraine rat model, 120 healthy adult SD rats were randomly divided into blank group, model group, Rotundine the particles high dose group ( high dose group), the particles Rotundine dose group (middle dose group), Rotundine particles low-dose group (low dose group), flunarizine capsule group, n = 20. Modeling drug, the rats were observed behavioral indicators, plasma calcitonin gene-related peptide (CGRP) in brain tissue serotonin (5-HT) content the trigeminal nucleus tail (TNC), c-fos and c-jun gene expressed. 2 Clinical observation of randomized, controlled, single-blind trial. Select cases 90 cases met the inclusion criteria, were randomly divided into experimental group and control group A and control group B, n = 30. The test group are: Rotundine particles the acupuncture placebo (capsule) treatment; control group A are: the cranial pain particles placebo (capsule) treatment; control group B are: flunarizine capsule placebo (granules) treatment. Observed one week before and after the treatment of headache intensity, duration of episodes, number of episodes of grade points and headache index; observe the clinical efficacy of TCM syndromes, treatment before and after TCM clinical symptom score and drug safety monitoring. Results: 1 animal experiments (1) experiments confirmed nitroglycerin migraine rat model easily replicated high success rate. Compared with the model group, the observation group and flunarizine capsule group rat ear red duration was significantly shortened, scratching their heads and the number of climbing cage were significantly reduced, the difference was statistically significance (P lt; 0.01, P lt; 0.05) ; Rotundine particles high, middle dose group and flunarizine capsules group group comparison, the difference was not statistically significance (P gt; 0.05). (2) rat plasma CGRP content. Model group, the observation group flunarizine capsule rats plasma CGRP content was significantly higher than the control group, the difference was statistically significant (P lt; 0.01); compared with the model group, particles high Rotundine, middle dose flunarizine capsule group to group and rat plasma CGRP levels are significantly lower, the difference was statistically significant (P lt; 0.01); particles high Rotundine, middle dose group, flunarizine capsules versus low-dose group, Plasma CGRP levels were significantly reduced, and the difference was statistically significant (P lt; 0.01). (3) 5-HT content in the brain tissue of rats. Model group, the observation group and flunarizine capsule rat brain 5-HT content was significantly lower than the control group, the difference was statistically significant (P lt; 0.01); compared with the model group, high Rotundine particles 5-HT content in the middle dose group and flunarizine capsule group rat brain tissue was significantly higher difference was statistically significant (P lt; 0.01); particles high Rotundine, middle dose group, flunarizine capsule group with the low-dose group ,5-HT content increased, the difference was statistically significant (P lt; 0.05). (4) rat trigeminal nucleus tail of c-jun gene expression. The trigeminal nerve nuclei tail c-jun-positive cell number and area of ??model group, the observation group and flunarizine capsule rats were significantly more than the control group, the difference was statistically significant (P lt; 0.01); compared with the model group , cranial pain particles, were significantly reduced in dose group and flunarizine capsule group, the difference was statistically significant (P lt; 0.05); particles high Rotundine, middle dose group, flunarizine capsules versus low-dose group comparison, the number of positive cells and area were significantly reduced, and the difference was statistically significant (P lt; 0.01). The 2 clinical observation (1) total clinical efficacy rate was 90.0%, control group A and 80.0%, control group B total efficiency of 76.7%, the test group with the control group A, control group B comparison test group, the difference was statistically significance (P lt; 0.01). Test group TCM syndromes total 93.3% of the control group A and 90.0%, control group B the total effective rate was 70.0%; compared to the experimental group and control group A, the difference was not statistically significance (P gt; 0.05) ; experimental group and control group A, respectively, compared with the control group B, the difference was statistically significant (P lt; 0.01). (2) each group after treatment headache intensity, seizure duration and number of episodes of grading integral and headache index were significantly improved, the test group than in the control group A, the control group B improved more significantly, the difference was statistically significance (P lt; 0.05); controlled group A compared with the control group B treatment, the difference was not statistically significance (P gt; 0.05). (3) The test group, the control group A after treatment headache, dizziness, head, such as wrap, vomiting phlegm, pale mouth, eat less, Tongue showed significant improvement, the difference was statistically significant (P lt; 0.01); controls B group only headache, dizziness two improved (P lt; 0.01), and the test group, the control group A TCM clinical improvement compared with the control group B is more significant. (4) no adverse effects were found in the entire course of treatment. Conclusion: 1 Rotundine particles can significantly improve migraine rat behavioral indicators, its mechanism may be associated with reduced serum of CGRP increased 5-HT content in brain tissue, inhibit trigeminal nucleus tail of c-fos and c-jun gene expression. 2 Rotundine particles Joint acupuncture treatment of migraine clinical efficacy in patients are more satisfied, can significantly with improvement in migraine patients with headache intensity, shorter duration of attack, reducing the number of attacks and reduce the headache index and to improve the TCM symptoms; than the separate use Rotundine particles treatment of clinical efficacy more significant.
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