温经通络汤联合丁苯酞治疗气虚血瘀型急性脑梗死的疗效及安全性分析

Analysis of the Efficacy and Safety of Wenjing Tongluo Decoction Combined with Butylphthalide in Treating Acute Cerebral Infarction with Qi Deficiency and Blood Stasis Type

摘要

目的 探讨温经通络汤联合丁苯酞治疗气虚血瘀型急性脑梗死的疗效及安全性。方法 本研究选取2022年2月—2025年1月期间，在安徽省广德市中医院就诊的152例符合气虚血瘀型急性脑梗死诊断标准的患者作为研究对象。按照随机数字表法将研究对象分为对照组（n=76，接受丁苯酞治疗）和观察组（n=76，接受温经通络汤联合丁苯酞治疗）。比较2组患者神经功能、自理能力、中医证候积分、血清指标及不良反应发生率的差异。结果 治疗2周及4周后，与治疗前相比，2组口舌歪斜、偏身麻木、舌强语謇、四肢乏力、气短懒言、面色㿠白、自汗、肢体肿胀的积分均显著降低（P<0.05）；且观察组治疗2周及4周后上述积分均低于对照组（P<0.05）。治疗2、4周后，观察组美国国立卫生研究院卒中量表（National Institutes of Health Stroke Scale，NIHSS）评分较对照组显著降低，日常生活活动能力量表（Activities of Daily Living，ADL）评分明显高于对照组（P<0.05）。与对照组相比，观察组治疗2、4周后血清D-二聚体（D-dimer，D-D）、同型半胱氨酸（homocysteine，Hcy）、C反应蛋白（C-reactive protein，CRP）水平下降更为显著（P<0.05）。2组不良反应发生率比较，差异无统计学意义（P>0.05）。结论 在气虚血瘀型急性脑梗死患者中予以温经通络汤联合丁苯酞治疗，可促进神经功能恢复，降低血清Hcy、D-D、CRP水平，改善患者临床症状，且安全性较高。

Abstract

Objective This study aimed to investigate the clinical efficacy and safety of the combined therapy of Wenjing Tongluo Decoction and butylphthalide in patients with acute cerebral infarction of Qi deficiency and blood stasis type. Methods A total of 152 patients diagnosed with acute cerebral infarction of Qi deficiency and blood stasis type, admitted to Guangde Traditional Chinese Medicine Hospital in Anhui Province between February 2022 and January 2025, were selected as study subjects. According to the random number table method, the patients were divided into a control group (n=76, treated with butylphthalide alone) and an observation group (n=76, treated with Wenjing Tongluo Decoction combined with butylphthalide). Neurological function, self-care ability, Traditional Chinese Medicine syndrome scores, serum indicators, and the incidence of adverse reactions were compared between the two groups. Results After 2 and 4 weeks of treatment, the scores for symptoms such as deviation of the mouth and tongue, numbness on one side of the body, stiff tongue with slurred speech, limb weakness, shortness of breath and lack of desire to speak, pale complexion, spontaneous sweating, and limb swelling all decreased significantly compared with those before treatment in both groups (P<0.05). Moreover, the above-mentioned symptom scores in the observation group were lower than those in the control group at both 2 and 4 weeks of treatment (P<0.05). After 2 and 4 weeks of treatment, the National Institutes of Health Stroke Scale (NIHSS) scores of the observation group were lower than those of the control group, while the Activities of Daily Living (ADL) scores were higher (P<0.05). Compared with the control group, the observation group showed more significant reductions in serum D-dimer (D-D), homocysteine (Hcy), and C-reactive protein (CRP) levels after 2 and 4 weeks of treatment (P<0.05). There was no significant difference in the incidence of adverse reactions between the two groups (P>0.05).Conclusion In patients with acute cerebral infarction of Qi deficiency and blood stasis type, the combination therapy of Wenjing Tongluo Decoction and butylphthalide can promote neurological recovery, reduce serum levels of Hcy, D-D, and CRP, alleviate clinical symptoms, and demonstrate a favorable safety profile.

关键词

温经通络汤 / 丁苯酞 / 急性脑梗死 / 气虚血瘀型 / 中医证候积分

Key words

Wenjing Tongluo Decoction / butylphthalide / acute cerebral infarction / Qi deficiency and blood stasis type / Traditional Chinese Medicine syndrome score

参考文献

[1] 徐榛敏, 梁晓, 代玲玲, 等. 近五年中医药治疗急性脑梗死临床RCT研究证据图[J].中国中药杂志, 2021, 46(12):2942-2948.

[2] Wang A, Jia B, Zhang X,et al. Efficacy and safety of butylphthalide in patients with acute ischemic stroke: a randomized clinical trial[J].JAMA Neurol, 2023, 80(8):851-859.

[3] 贾佳奇, 张春鹏, 王慎安, 等. 天丹通络片联合丁苯酞治疗急性脑梗死的临床研究[J].现代药物与临床, 2023, 38(10):2469-2474.

[4] 中华医学会神经病学分会, 中华医学会神经病学分会脑血管病学组. 中国急性缺血性脑卒中诊治指南2018[J].中华神经科杂志, 2018, 51(9):666-682.

[5] 国家中医药管理局. ZY/T001.1—94 中医病证诊断疗效标准[S].北京: 中国中医药出版社, 1994.

[6] 陈振中, 陈晨, 朱化珍, 等. 复元通络汤结合针刺治疗气虚血瘀型脑梗死恢复期的疗效研究[J].中国医药导刊, 2023, 25(10):1002-1007.

[7] Chen C L H, Pokharkar Y, Venketasubramanian N,et al. Association between baseline NIHSS limb motor score and functional recovery after stroke: analysis based on a multicountry dataset[J].Cerebrovasc Dis, 2023, 52(2):160-165.

[8] Liu Y Q, Wang C Y, Han Y P . Management of acute cerebral infarction by intravenous thrombolysis with recombinant T cell receptor and plasminogen activator and association of emergency nursing route in the prognosis[J]. Cell Mol Biol (Noisy—le—grand) , 2023, 69(8):18-24.

[9] Li H, Feng X, Wang J,et al. Research progress in acute anticoagulation therapy for cerebral infarction[J].Minerva Pediatr, 2023, 75(6):939-942.

[10] 陈运红, 王志. 虚拟现实生物反馈训练联合重复经颅磁刺激在急性脑梗死后吞咽困难患者康复治疗中的应用[J].中国医学物理学杂志, 2023, 40(7):904-908.

[11] 张萍, 李洁, 易兴阳, 等. 丁苯酞预防脑梗死后早期神经功能恶化的真实世界研究[J].华西医学, 2023, 38(5):680-687.

[12] 王华强, 李迪, 凌军, 等. 醒脑通络开窍汤联合丁苯酞注射液对急性脑梗死神经恢复以及炎症介质的影响[J].中华中医药学刊, 2020, 38(10):226-229.

[13] 时兴华, 曲立新, 周君, 等. 首发急性缺血性脑卒中患者神经功能损伤程度及其危险因素分析[J].实用预防医学, 2022, 29(7):861-863.

[14] 臧艳静, 郑宏伟, 崔泽岩. 基于血清学指标的脑梗死患者预后列线图预测模型的建立与评估[J].中华老年心脑血管病杂志, 2022, 24(3):277-280.

[15] 白雪峰, 任凤霞. 自拟益气活血通络方联合丁苯酞注射液治疗对急性脑梗死患者Hcy、hs—CRP及D—Dimer水平的影响[J].贵州医药, 2022, 46(6):945-946.

[16] 肖海燕, 杨淑贤, 韩雯, 等. 丁苯酞及其衍生物药理学研究进展[J].中国中药杂志, 2022, 47(13):3425-3431.

[17] 王珊玉, 冯毅, 胡丽莉. 中医化痰通络法对急性脑梗死缺血再灌注损伤患者神经、运动功能及高敏C反应蛋白、同型半胱氨酸的影响[J].现代中西医结合杂志, 2020, 29(26):2945-2948.