| Objective To observe the Clinical effect and explore safety and therapeutic effect of Dianxianning pian for patients with epilepsy.Method Multi-center, randomize,double-blind,to choose generalized tonic-clonic seizures or partial seizure with secondarily generalized seizure 42 cases,in the control group of conventional Western medicine to give a kind of anti-epileptic,study group were given a Western medicine treatment of epilepsy add on the Dianxianning pian with epilepsy plus films,four tablets each time,three times a day and over three-month period.Observed improvement of clinical symptoms before and after the test,EEG,ECG,blood concentration of western medicine, blood,urine routine,blood biochemical changes and so on.Data analysis with SPSS13.0 statistic software.Result 1 Analysis of clinical efficacy,The number of total number of valid test group of 13,the total effective rate 53%;the number of total number of valid control group 6,the total effective rate 29%;experimental group and control group differences in the distribution of effects were statistically significant differences(p=0.01);the total efficiency of the two groups the differences were intended to(P＜0.05),test group was significantly better than the control group,2 experimental and control groups before taking medication, one month after treatment,two months after treatmengt,the first-three months of total clinical points of comparison,before given drug,after one month,months of follow-up time of different points between the two groups was no significant difference(p＞0.05).symptom score of three months after treatment were difference between the two groups was statistically significant,(p＜0.05) between the two groups from the end of the previous medication, symptom score showed a clear downward trend.3 The test group was significantly better than the control group,when three month after treatment,attack in nearly a month,the experimental group in attack recent a month,no seizures in 13 cases(61.9%),three cases of the control group(14.3%);the experimental group attack 8(38.10%),the control group 13 (14.3%),(P＞0.05),the difference was statistically significant.Two months after the medication, the number of attacks of the third month in recent months,the test group was significantly better than the control group,the difference between the two groups was statistically significant(P＜0.05),prompted by the treatment of epilepsy-Dianxianning pian in third month after nearly a month whether or not the number of seizures and seizure attack or not were significantly improved,and episodes from the beginning of second month after treatment than the control group decreased significantly.4 three months after treatment effects of seizure frequency between the two groups was no significant difference(p＞0.05).5 Pre-treatment and post-treatment tests in third month and EEG changes in the control and study group was no significant difference.6 The severity of seizures total score test group and control group in pre-medication,after one month,after two months,after three months compared to test group,before the medication,after one month,after two months there was no significant difference(P＞0.05).In the experimental group,after three months taking the severity of seizures mean total score difference was statistically significant(P＜0.05).Test group and control group in the total score after treatment was a clear downward trend is more obvious and the experimental group;the experimental group in the medication before and after treatment the severity of seizures after three months total score differences were significant (P＜0.05),the control group in the medication before and after treatment th severity of epilepsy after three months,the total points of comparison,the difference was not statistically significant(P＞0.05).The experimental group was significantly difference to reduce the severity after treatment.7 Test group and treated group before and after the treatment of blood, hepatic and renal function,plasma concentration of western medicine and body temperature, pulse,blod pressure indicators were within the normal range,the two groups before and aider treatment(p＞0.05),no significant difference.The comparison between two groups,the experimental group and control group after treatment and the laboratory data the third month compared to the two groups before and after treatment through T test(p＞0.05),no significant difference.Inter-group comparison,the experimental group and control group after treatment and the laboratory data in third month compared to the experimental group before the serum creatinine in the treatment of liver to 63.35±24.43,Control group was 73.65±29.62;The third month after test group after treatment for75.06±30.64,the control group was 52.96±25.94(P＜0.05),Difference between the two groups was statistically significant,the experimental group than the control group increased serum creatinin values,but in the normal range.Indicator of the rest of the group difference was not statistically significant.Conclusion 1 Before treatment epilepsy should accurately determine the type or syndrome of epilepsy,individual treatment.Add-on Dianxianning pian epilepsy of generalized tonic-clonic seizures or partial seizure with secondarily generalized seizure can raise curative effect in patients,prevention and mitigation of adverse reactions of Western medicine,raising patients life quality.2 This study confirmed that Dianxianning pian treatment of epileptic seizures is safe and well tolerated. |
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