| Object iveThough clinical trials, we observed the therapeutic effect of BaiJinDingXian Pills combined with routine antiepileptic drugs in treating epilepsy patients with shi symptom as well as the effect on cognitive function, and through experiments, we explored the antiepileptic and neuroprotective mechanism.MethodClinical experiment:We collected 65 clinical cases meeting certain criteria from inpatient and outpatient departments of Neurology from Dongguan Traditional Chinese Medicine Hospital affiliated to Guangzhou University of Chinese Medicine, and According to random number table divided them into control and experimental groups. The control group (32 cases) was given the regular western medicine while the experimental group (33 cases) was treated with regular western medicine combined with BaiJinDingXian Pills orally for 4 capsules each time, three times a day after meals(4 pills/qid). The therapeutic course was 1 month and we continued watching for the following 3 months, then we recorded and compared the epilepsy attack frequency, symptom scores, EEG changes, TCM syndrome scores and intelligent cognitive status between the two groups before and after treatment.Animal experiment:The animal experiment used 47 SD male mice at SPF level which were randomly allocated into blank group(n=10), model group(n=14), Sodium Valproate Tablets positive group(n=11,180 mg/Kg) and BaiJinDingXian Pills group(n=12,5.664 g/Kg). The former two groups were given equal amount of normal saline intragastrically and the later two groups were given different drug solution intragastrically with the amount of 10ml/Kg once a day for three continuous days. On the third day, mice in every group except blank control group were injected 1% corazol intraperitoneally one hour after intragastrical injection to set up epilepsy model. Then, we observed the conditions of epilepsy attack, the duration, the cessation time and NSE level changes in hippocampus.ResultPart I:Clinical Research(1)Clinical efficacy evaluation:there are 6 cases in control group that were basically recovered,5 cases were markedly effective,12 cases were effective,4 cases were not that effective and 3 cases were ineffective, in which the total effective rate was 76.6%; in experimental group,9 cases were basically recovered,12 cases were markedly effective,6 cases were effective, 2 cases were not that effective and 1 case was ineffective, in which the total effective rate was 90%. The comparison between control group and experimental group was significantly important (P<0.05).(2)Epilepsy attack evaluation:epilepsy attacks in control and experimental groups before and after treatment were compared respectively, results suggested that there were significant importance in both groups(P <0.05); the attack times after treatment between the control group and the experimental group were also statistically significant (P<0.05).(3)Rating of the epilepsy symptoms:epilepsy symptoms scores in control and experimental groups before and after treatment were compared respectively, results suggested that there were significant importance in both groups(P <0.05); the symptom scores after treatment between the control group and the experimental group were also statistically significant (P<0.05).(4)MMSE score:compared the control group with the experimental group in MMSE scores before and after treatment, results showed that there were no statistically importance in both groups before and after treatment(P> 0.05).(5)TCM symptom scores:TCM symptoms in control and experimental groups before and after treatment were compared respectively, results suggested that there was no significant importance in control group(P>0.05) while there was significant significance in experimental group(P<0.05); the TCM symptom scores after treatment between the control group and the experimental group were also statistically significant (P<0.05).(6)Safety index:in control group,1 patient had significant hair loss after taking Sodium Valproate Tablets, so Sodium Valproate Tablets were gradually reduced. There were no advese events in experimental group during taking BaiJinDingXian Pills orally. There was no statistically significant in both groups.Part Ⅱ:Animal Experimental(1)Behavior observation:compared with model group, the attack episodes(from the beginning of symptoms to completely recovery) in the blank group and the experimental group were shortened, and there was statistically significant (P<0.05); moreover, the rates of severe attacks and mortality rates were also declined, but there were no statistically significant difference between them (P> 0.05).(2)Changes in content of NSE:compared model group and control group, NSE level of the experimental group was significantly decreased, the difference was statistically significant (P<0.05).ConclusionThe experimental results showed that the efficacy in treating epilepsy patients with shi symptom using BaiJinDingXian Pills combined with routine antiepileptic drugs was obvious, with the improvement of TCM symptoms, reduction of the attack times, releasing epilepsy symptoms as well as antiepileptic and neuroprotective effect, which can be clinically useful in the treatment of epilepsy. |
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