| Objective: To observe the clinical effect of Guizhi Fuling Pill on acute ischemic stroke(wind-phlegm-blood stasis syndrome)and evaluate its clinical safety,so as to provide basis for further expanding the application of Guizhi Fuling Pill in cerebrovascular diseases.Methods: In this study,a simple randomized controlled design was used to select60 patients who met the admission criteria from May 2017 to December 2018 in the Department of Encephalopathy,Wuyi Hospital of Traditional Chinese Medicine,Jiangmen City.The patients were divided into treatment group and control group with 30 cases in each group by random number table.Both groups were guided by the Chinese Acute Ischemic Stroke Diagnosis and Treatment Guidelines 2014 formulated by the Chinese Medical Association.According to the clinical pathway of Acute Ischemic Stroke formulated by the Department of Encephalopathy of our hospital,the patients in the treatment group were treated by routine standardized treatment.On this basis,the traditional Chinese medicine decoction "Guizhi Fuling Pill Modified" was added orally or nasal feeding.Two weeks were used as a course of treatment in both groups.The scores of TCM syndromes,NIHSS scale and improved Barthel index were used to evaluate the improvement of TCM syndromes,the degree of neurological impairment and the ability of daily living in the two groups before and on the 14 th day after treatment.The improved Barthel index was used to evaluate the improvement of daily living ability of patients on the 28 th day after treatment.The changes of blood homocysteine were observed before and 14 days after treatment,and the vital signs,liver and kidney function,coagulation function and electrocardiogram were observed before and after admission.Finally,the relevant data were processed by statistical analysis to evaluate the efficacy and safety of Guizhi Fuling Pill in the treatment of acute ischemic stroke.Results:(1)Comparisons of TCM syndrome scores: There was no significant difference between the two groups before treatment(P>0.05);after treatment,TCM syndrome scores of the two groups were significantly lower than those of the same group before treatment(P<0.01),and there was significant difference between the two groups after treatment(P<0.05),suggesting that the treatment group was better thanthe control group in improving TCM syndrome scores.(2)Comparison of the total curative effect of TCM syndromes:The total effective rate of TCM syndromes was 93.34% in the treatment group and 73.33% in the control group.Statistical analysis showed that there was a significant difference in the total effective rate between the two groups(P<0.05),suggesting that the treatment group was significantly better than the control group in the total curative effect of TCM syndromes.(3)NIHSS score comparison:There was no significant difference between the two groups before treatment(P>0.05);after treatment,the NIHSS score of the two groups was significantly lower than that of the same group before treatment(P< 0.01),and there was a significant difference between the two groups after treatment(P< 0.05),suggesting that the treatment group was better than the control group in improving neurological deficits.(4)BI score comparison: There was no significant difference between the two groups before treatment(P>0.05).After treatment,the NIHSS score of the two groups was significantly lower than that of the same group before treatment(P<0.01).The difference between the two groups after treatment was statistically significant(P<0.05),suggesting that the treatment group was superior to the control group in improving patients' life activity ability.(5)Blood homocysteine level: There was no significant difference between the two groups before treatment(P>0.05).After treatment,the blood Hcy level of the two groups decreased significantly compared with that of the same group before treatment(P<0.01);there was no significant difference between the two groups after treatment(P>0.05),suggesting that there was no significant difference between the two groups in reducing blood Hcy level.(6)In the course of treatment,the vital signs,blood routine,defecation and urination routine,liver and kidney function,coagulation function,electrocardiogram and other indicators of the two groups were in the normal range,and no obvious adverse reactions occurred.Conclusion:(1)Modified Guizhi Fuling Pill combined with western medicine in the treatment of acute ischemic stroke is superior to the control group in improving the total curative effect of TCM syndromes and the total score of TCM syndromes.(2)Modified Guizhi Fuling Pill combined with western medicine can effectively improve the clinical symptoms,neurological deficits and disability of patients with acute ischemic stroke,and improve the quality of life of patients,and the effect is better than that of simple western medicine treatment group.(3)In this study,it has not been confirmed that the modified Guizhi Fuling Pill is related to the level of homocysteine in blood.(4)No adverse safety events and side effects occurred in the clinical study of Guizhi Fuling Pill,which has high clinical safety and is worthy of promotion. |
PDF Full Text Request