改良真方白丸方联合丁苯酞氯化钠注射液治疗风痰入络型急性缺血性脑卒中的疗效与安全性

The Efficacy and Safety of the Modified Zhenfang Baiwan Formula Combined with Butylphthalide and Sodium Chloride Injection in the Treatment of Acute Ischemic Stroke with Wind-Phlegm Invading Collaterals Type

摘要

目的 评价改良真方白丸方联合丁苯酞氯化钠注射液治疗风痰入络型急性缺血性脑卒中（acute ischemic stroke，AIS）患者的疗效与安全性。方法 前瞻性纳入 2022 年 1 月至 2025 年 4 月期间阜阳市中医医院收治的风痰入络型 AIS 患者 96 例，采用随机数字表法进行分组，分为对照组和观察组，各 48 例。对照组给予丁苯酞氯化钠注射液常规治疗，观察组在对照组治疗基础上加用改良真方白丸方。观察并比较 2 组的临床治疗有效率、治疗前后中医证候积分与神经功能变化，并记录治疗期间的不良反应以评估安全性。结果 观察组的临床治疗总有效率显著高于对照组（P< 0.05）。在中医证候改善方面，治疗后观察组的言语不利、口舌歪斜、半身不遂积分均低于对照组（ P< 0.05）。在神经功能恢复方面，2 组治疗后的美国国立卫生研究院卒中量表（National Institutes of Health Stroke Scale，NIHSS）评分和改良 Rankin 量表（modified Rankin Scale，mRS）评分相较于同组治疗前均显著下降（ P< 0.05），且观察组的神经功能改善程度更为明显，其 ΔNIHSS 评分与 ΔmRS 评分均显著高于对照组（ P< 0.05）。2 组不良反应发生率差异无统计学意义（ P= 0.642）。结论 改良真方白丸方联合丁苯酞氯化钠注射液治疗风痰入络型 AIS 患者的临床效果较好，可改善患者神经功能及中医证候，安全性相对较高。

Abstract

Objective To evaluate the efficacy and safety of modified Zhenfang Baiwan Formula combined with butylphthalide and sodium chloride injection in the treatment of acute ischemic stroke (AIS) with wind-phlegm invading collaterals type. Methods This prospective study enrolled 96 AIS patients characterized by the wind-phlegm invading collaterals syndrome who were admitted to Fuyang Traditional Chinese Medicine Hospital from January 2022 to April 2025. Patients were randomly divided into the control group and the observation group (n= 48 in each group) using a random number table. The control group received conventional treatment with butylphthalide and sodium chloride injection, while the observation group was additionally treated with modified Zhenfang Baiwan Formula on the basis of the control treatment. The clinical effective rates, Traditional Chinese Medicine (TCM) syndrome scores and neurological function were compared before and after treatment between the two groups, and adverse reactions during treatment were recorded to evaluate safety. Results The observation group demonstrated a significantly higher clinical efficacy rate compared to the control group (P< 0.05). Regarding TCM syndromes, the observation group exhibited significantly lower scores for speech impairment, facial deviation, and hemiplegia than the control group after treatment ( P< 0.05). For neurological recovery, both groups showed significant improvements, as indicated by reduced National Institutes of Health Stroke Scale (NIHSS) and modified Rankin Scale (mRS) scores post-treatment compared to baseline ( P< 0.05). The observation group achieved a significantly greater degree of recovery, evidenced by higher ΔNIHSS and ΔmRS scores relative to the control group ( P< 0.05). There was no statistical difference in the incidence of adverse reactions between the observation group and the control group ( P= 0.642). Conclusion The modified Zhenfang Baiwan Formula combined with butylphthalide and sodium chloride injection yields satisfactory clinical efficacy in the treatment of AIS with the syndrome of wind-phlegm invading collaterals. It can ameliorate neurological function and TCM syndromes with favorable safety.

关键词

改良真方白丸方 / 丁苯酞 / 急性缺血性脑卒中 / 风痰入络型 / 神经功能

Key words

modified Zhenfang Baiwan Formula / butylphthalide / acute ischemic stroke / wind-phlegm invading collaterals type / neurological function

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基金资助

2022安徽省红十字会中医药传承创新发展研究项目(2022ZYYD11)