| ObjectiveBy observing the clinical curative effect of the seventy flavor Pearl Pill for the patients in the recovery period of stroke,the purpose of this study was to determine the efficacy and safety of this trug,and to provide a new way for clinical treatment.MethodsAccording to the two sample mean comparison,and taking into the off rate of 20%,the size of the sample in this study was 72 cases,by using PASS software.These data was divided into two groups,the treatment group and the control group,of which 9 date was lost.In the remaining 63 cases,there were 31 cases in treatment group and 32 cases in control group.The control group was treated with basic therapy and modern rehabilitation.The treatment group was treated with seventy Pearl Pill on the basis of basic treatment and modern rehabilitation.Before treatment,treatment for twenty-eighth days,for fifty-sixth days and for eighty-fourth days,efficacy evaluation and safety assessment were separately conducted.Efficacy evaluation included Fugl-Meyer assessent(FMA),National Institute of Health stroke scale(NIHSS),Modified Barthel Index(MBI)and Stroke-Specific Quality of Life Scale(SS-QOL).Safety assessments included general vital signs,liver function,renal function,blood routine,urine routine,blood coagulation function,ECG,etc.Finally all data were analyzed by SPSS18.0 software.Result1.Baseline comparison:There was no difference between the two groups in the scores of FMA,NIHSS,MBI,and SS-QOL before treatment(P>0.05).It is that the difference between the treatment group and the control group,in respiration,blood pressure,heart rate,electrocardiogram,blood routine,urine routine,blood coagulation function and biochemical indexes,had no significant difference(P>0.05).2.Comparison of curative effect:Treatment for twenty-eighth days and fifty-sixth days,the scores of FMA and MBI of treatment group was higher than that of control group,the difference was statistically significant(P<0.05).Treatment for fifty-sixth days,the scores of NIHSS in treatment group,was higher than that in control group,the difference was statistically significant(P<0.05).Treatment for eighty-fourth days,the scores of SS-QOL in treatment group,was higher than that in control group,the difference was statistically significant(P<0.05).Compared with the scores of the two groups in rest of the time period,there were no significant difference(P>0.05).3.Eeffect comparison in classifiation group:There were no statistically significant differences in age and course of disease(P>0.05).In the fator of injury severity of motor function,there was statistical significance in scres of FMA and NIHSS between pre-treatment and pro-treatment(P<0.05).4.Safety evaluation:After treatment,there was no difference between the treatment group and the control group in respiration,blood pressure,heart rate,electrocardiogram,liver function,blood coagulation function,and urine routine.After treatment,creatinine of the treatment group was higher than that of the control group,the difference was statistically significant(P<0.05).After treatment,the platelet count of the treatment group was higher than that of the control group,the difference was statistically significant(P<0.05).Conclusion1.Curative effect:Seventy flavour Pearl Pill helps to improve limb movement function,reduce neurological deficit,improve the ability of daily life and quality of life in patients of stroke at recovery stage.This advantage was most pronounced on the fifty-sixth day of treatment.2.Security aspects:Because the study did not make strict demands on liver and kidney function when enrolled in the study group,and there were many clinical factors,such as age,course of disease,complication of basic diseases and more combined use of drugs,the relationship of which the increase of creatinine,urea,ALT,platelet count and the drugs is clear for the time being.And further clinical studies are needed. |
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