| Objective:By observing the effect of Huoxue Huatan Xifeng Decoction for patients with acute cerebral infarction in the syndrome of wind-phlegm stasis in neural function scale,daily life ability scale,Chinese medicine syndrome rating scale,and the influence of inflammatory factor levels,to evaluate the clinical efficacy of Huoxue Huatan Xifeng Decoction in the treatment of ACI,explore its possible mechanism of action from the perspective of inflammation,and conduct the pharmacoeconomic evaluation.Method:The study selected 174 patients with ACI with the syndrome of wind-phlegm stasis in the Department of Neurology of Hubei Hospital of Integrated Traditional Chinese and Western Medicine from June2019 to November 2020.Using a computer-generated random number table,according to the order of visits,174 ACI patients with the syndrome of wind-phlegm stasis that meet the criteria were randomly divided into observation group and control group.On this basis,the observation group was treated with Huoxue Huatan Xifeng Decoction,200 m L each time,2 times a day.Take 14 days as a course of treatment.Observe NIHSS(National Institutes of Health Stroke Scale),m RS(Modified Rankin Scale),BI(Barthel Index),TCM Clinical Syndrome Scale,and inflammatory factors IL-1 β(Interleukin-1β),IL before and after treatment-6(interleukin-6)and TNF-α(tumor necrosis factor-α)serum levels.The patient’s length of stay in hospital and expenses at discharge were recorded,and the cost-effectiveness ratio(CER)and incremental cost-effectiveness ratio(ICER)were calculated and analyzed after the trial.Result:The trial plan included 174 ACI patients who met the criteria for inclusion and exclusion,and a total of 13 cases were eliminated and dropped.In the observation group,4 cases were eliminated and1 case was dropped;in the control group,5 cases were eliminated and 3 cases were dropped.Finally,161 cases were included,82 cases were in the observation group,and 79 cases were in the control group.1.Analysis of curative effect:(1)Comparison of efficiency: According to the changes of the NIHSS score before and after treatment,the total efficacy rate was82.9% in the observation group,and 68.4% in the control group.There was statistical significance between the two groups after treatment(P<0.05).The treatment group was superior to the control group in clinical efficacy.(2)The comparison of neurological deficits: After 14 days of treatment,the observation group was 4(2,7)points,and the control group was 6(3,9)points.The difference of the neurological deficit score before and after treatment in the two groups was statistically significant(P<0.01);By comparison,the difference was found to be statistically significant(P<0.05),and the improvement of the observation group was better than that of the control group.(3)The comparison of m RS score: 14 days after the patient’s medication,the difference in m RS scores measured before and after treatment in the two groups was statistically significant(P<0.01);the comparison between the two groups after treatment showed that the difference was statistically significant(P<0.05).And the improvement degree of the observation group was better than that of the control group.(4)The comparison of BI score: 14 days after the patient took the medicine,the BI score of the observation group was 71.16±23.48 points,and that of the control group was 60.38±26.16 points.There was a statistically significant difference in the index scores between the two groups before and after treatment(P<0.01);the two groups were grouped after treatment Comparison between the two groups showed that the difference was statistically significant(P<0.01),and the improvement degree of the observation group was better than that of the control group.(5)The comparison of TCM symptoms: After 14 days of treatment,the score of the TCM Syndrome Scale in the observation group was6.71±3.03 points,and the control group was 9.18±4.06 points.The scores of the TCM Syndrome Scale in the two groups were compared before and after treatment,and the difference between the two was statistically significant(P<0.01);the two groups were compared between the groups after treatment,and the difference was found to be statistically significant(P<0.01),and the improvement of the observation group was better than that of the control group.3.Levers of inflammatory factors: After 14 days of medication,there was a statistically distinct difference between the two group in reducing inflammatory cytokine(IL-1β、IL-6、TNF-α)before and after treatment(P<0.01).After treatment,the comparison between the two groups showed that the difference between the two groups after treatment was statistically significant(P<0.01),and the observation group was able to reduce inflammatory factors(IL-1β,IL-6 and TNF-α),and the effect is better than the control group.4.Pharmacoeconomic evaluation: There was no significant difference between the two groups of patients in hospitalization days and hospitalization expenses.The CER of the observation group was 2738.46 yuan/min,the CER of the control group was 4064,04yuan/min,and the ICER between the two groups was 383.88 yuan/min.That is,for every 1 point decrease in the NIHSS score of the control group compared with the observation group,it will cost 383.88 yuan more.5.Safety indicators: During the treatment period,2 patients in the observation group had stomach discomfort and 1 cases had mild diarrhea;in the control group,1 case had stomach discomfort.The relevant safety indicators of the two groups of patients were within the normal range,such as blood routine,liver and kidney function,blood sugar,coagulation function,stool routine,electrocardiogram,and other indicators.There were no serious adverse reactions in both groups.The results showed that Huoxue Huatan Xifeng Decoction combined with Western medicine routine treatment of acute ACI of wind phlegm and blood stasis syndrome is safe.Conclusion:(1)Huoxue Huatan Xifeng Decoction combined with conventional Western medicine treatment can improve the neurological dysfunction of ACI patients with the syndrome of wind-phlegm stasis,reduce the degree of disability of the patients,improve the patients’ activities of daily living,and reduce the total points of the ACI TCM Syndrome Scale;(2)Huoxue Huatan Xifeng Decoction combined with conventional Western medicine treatment alleviate the inflammatory response of ACI with the syndrome of wind-phlegm stasis better than conventional Western medicine treatment(3)The combined traditional Chinese and Western medicine treatment plan of Huoxue Huatan Xifeng Decoction combined with conventional Western medicine has certain pharmacoeconomic advantages for patients with ACI with the syndrome of wind-phlegm stasis;(4)There were no serious adverse reactions in the two groups of patients,indicating that the Huoxue Huatan Xifeng Decoction is safe,and it is recommended to be promoted and applied in the clinic. |
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