十一味化痰通络汤辨治风痰瘀阻证缺血性脑卒中的临床疗效与安全性研究

Clinical Efficacy and Safety Evaluation of Shiyiwei Huatan Tongluo Decoction(十一味化痰通络汤)in Syndrome Differentiation and Treatment of Ischemic Stroke of Wind-Phlegm Stagnation Syndrome

目的 探讨十一味化痰通络汤辨治风痰瘀阻证缺血性脑卒中的临床疗效与安全性。方法 选取2022年7月—2023年5月开封市中医院脑病科收治住院的60例缺血性脑卒中病人为研究对象,用随机数字表法,将患者分成西医干预组和中医干预组,每组30例。西医干预组采用指南规范化治疗,中医干预组采用指南规范化治疗+十一味化痰通络汤治疗,观察两组患者治疗前后NIHSS评分、MRS评分、ADL量表(BI)评分、中医证候评分以及中医证候疗效。结果 治疗后7 d、14 d两组患者NIHSS评分、MRS评分、中医证候评分均明显降低,且中医干预组评分较西医干预组显著下降,差异有统计学意义(P<0.05);治疗后7 d、14 d两组患者Barthel评分均明显升高,且中医干预组评分较西医干预组显著升高,差异有统计学意义(P<0.05);中医干预组治疗效果86.67%高于西医干预组60.00%,差异具有统计学意义(P<0.05)。结论 十一味化痰通络汤治疗缺血性脑卒中的疗效确切且能较好地改善神经功能缺损等。

Objective To evaluate the clinical efficacy and safety of Shiyiwei Huatan Tongluo Decoction(十一味化痰通络汤)in the syndrome differentiation and treatment of ischemic stroke of wind-phlegm stagnation syndrome.Methods Eighty ischemic stroke patients in the Encephalopathy Department of Kaifeng Hospital of Traditional Chinese Medicine from July 2022 to May 2023 were selected,and the patients were assigned into western medicine(WM)group and traditional Chinese medicine(TCM)group using random number table method,each with 30 cases.WM group was given standardized western medicine treatment,while TCM group received standardized western medicine treatment plus Shiyiwei Huatan Tongluo Decoction.Then the National Institutes of Health Stroke Scale(NIHSS),modified Rankin scale(mRS),Barthel Index(BI),TCM syndrome scores and clinical efficacy rate were compared between two groups.Results At 7 d and 14 d of interventions,a decrease in NIHSS,mRS and TCM syndrome scores,along with an increase in BI were observed in both groups(all P<0.05).TCM group scored lower on NIHSS,mRS and TCM syndrome,whereas higher on BI than those of WM group at 7 d and 14 d of interventions,with statistical difference(all P<0.05).The clinical efficacy rate was 86.67%in TCM group,which was higher than 60.00%in WM group(P<0.05).Conclusion Application of Shiyiwei Huatan Tongluo Decoction in the syndrome differentiation and treatment of ischemic stroke can effectively improve the clinical symptoms and neurological deficits in patients,and obtain good short-term efficacy.