中国全科医学 ›› 2026, Vol. 29 ›› Issue (29): 4241-4247.DOI: 10.12114/j.issn.1007-9572.2025.0556

• 论著 • 上一篇    下一篇

针刺联合替罗非班治疗对溶栓后缺血性脑卒中患者早期神经功能恶化的影响:一项随机对照试验

占道伟1, 魏绪旺2, 胡旻雷3, 徐颖梅1, 杨喜兵4, 罗开涛4,*()   

  1. 1.314001 浙江省嘉兴市,浙江中医药大学附属嘉兴市中医医院康复科
    2.314001 浙江省嘉兴市,浙江中医药大学附属嘉兴市中医医院神经外科
    3.314001 浙江省嘉兴市,浙江中医药大学附属嘉兴市中医医院脑病科
    4.314001 浙江省嘉兴市,浙江中医药大学附属嘉兴市中医医院针灸科
  • 收稿日期:2026-04-02 修回日期:2026-06-20 出版日期:2026-10-15 发布日期:2026-09-02
  • 通讯作者: 罗开涛

  • 作者贡献:

    占道伟提出主要研究目的,负责研究的构思与设计,研究的实施,论文撰写;魏绪旺进行数据的收集与整理,统计学处理,图、表的绘制与展示;胡旻雷进行论文的修订;徐颖梅、杨喜兵负责研究的实施与可行性分析;罗开涛负责文章的质量控制与审查,监督管理及论文修订工作,对整体文章负责。

  • 基金资助:
    浙江省康复医学会项目(ZKKY2023007); 浙江省中医药科技计划项目(2026ZL0871); 嘉兴市公益性研究计划项目(2020AD30026,2024AD10009); 嘉兴市脑血管病中西医结合康复研究重点实验室项目(嘉科高〔2022〕38号); 第二批嘉兴市中医药重点学科支撑类-中医养生康复学(嘉卫[2023]65号-7)

Effect of Acupuncture Combined with Tirofiban on Early Neurological Deterioration in Patients with Ischemic Stroke after Thrombolysis: a Randomized Controlled Trial

ZHAN Daowei1, WEI Xuwang2, HU Minlei3, XU Yingmei1, YANG Xibing4, LUO Kaitao4,*()   

  1. 1. Department of Rehabilitation, Jiaxing Hospital of Traditional Chinese Medicine Affiliated to Zhejiang University of Traditional Chinese Medicine, Jiaxing 314001, China
    2. Department of Neurosurgery, Jiaxing Hospital of Traditional Chinese Medicine Affiliated to Zhejiang University of Traditional Chinese Medicine, Jiaxing 314001, China
    3. Department of Neurology, Jiaxing Hospital of Traditional Chinese Medicine Affiliated to Zhejiang University of Traditional Chinese Medicine, Jiaxing 314001, China
    4. Department of Acupuncture, Jiaxing Hospital of Traditional Chinese Medicine Affiliated to Zhejiang University of Traditional Chinese Medicine, Jiaxing 314001, China
  • Received:2026-04-02 Revised:2026-06-20 Published:2026-10-15 Online:2026-09-02
  • Contact: LUO Kaitao

摘要: 背景 急性缺血性脑卒中(AIS)患病率仍居高不下,溶栓治疗后可发生临床症状加重或恶化现象(END),目前仍缺乏有效的临床防治措施。因此,研究针刺联合替罗非班治疗AIS溶栓后出现END的疗效、安全性以及作用机制,具有重要的临床意义。 目的 观察针刺联合替罗非班治疗对AIS溶栓后出现END的疗效与安全性。 方法 选取2021年12月—2024年6月于浙江中医药大学附属嘉兴市中医医院脑病科住院治疗的AIS静脉溶栓后出现END的76例患者为研究对象,采用随机数字表法随机分为联合组与对照组,各38例。对照组使用替罗非班注射液微泵滴注72 h,并行序贯药物及康复等综合治疗,联合组在对照组基础上配合针刺治疗,选取头皮针与体针治疗,两组均治疗2周。比较两组患者治疗前和治疗后3 d、14 d超敏C反应蛋白(hs-CRP)水平变化情况。采用美国国立卫生研究院卒中量表(NIHSS)、改良Rankin量表(mRS)、改良Barthel指数(MBI)和中医症状积分量表评价两组患者治疗前和治疗后14 d、90 d随访时神经功能缺损状况、日常生活能力、独立预后以及中医症状变化情况。同时记录两组患者治疗期间的不良反应。 结果 研究期间联合组脱落2例,完成36例;对照组脱落1例,完成37例。组别与时间对NIHSS、mRS、MBI、中医症状积分量表评分存在交互作用(P交互<0.05),时间对NIHSS、mRS、MBI、中医症状积分量表评分主效应均显著(P时间<0.01)。治疗后14 d两组NIHSS、mRS、中医症状积分量表评分均较治疗前降低(P<0.05),且联合组NIHSS、中医症状积分量表评分低于对照组(P<0.05)。治疗后90 d两组NIHSS、mRS、中医症状积分量表评分均较治疗前降低(P<0.05),且联合组NIHSS、mRS、中医症状积分量表评分均低于对照组(P<0.05)。治疗后14、90 d两组MBI评分均较治疗前升高(P<0.05);联合组治疗后90 d MBI评分高于对照组(P<0.05)。组别与时间对hs-CRP水平存在交互作用(P交互<0.01),时间对hs-CRP水平主效应显著(P时间<0.01)。治疗后3、14 d,两组患者血清hs-CRP水平与治疗前比较均有下降,且联合组低于对照组(P<0.05)。两组共有5例患者出现不良反应,其中联合组2例,对照组3例。 结论 针刺联合替罗非班治疗可有效改善AIS患者溶栓后END症状,保护神经功能,提升患者生活独立能力。其机制可能与减轻炎性反应有关,从而有利于患者整体康复。

关键词: 急性缺血性脑卒中, 针刺, 替罗非班, 早期神经功能恶化, 溶栓, 随机对照试验

Abstract:

Background

The prevalence of acute ischemic stroke (AIS) remains high, and early neurological deterioration (END) can occur following thrombolytic therapy; however, effective clinical prevention and treatment strategies are currently lacking. Therefore, to explore the efficacy, safety, and potential mechanisms of acupuncture combined with tirofiban in the treatment of END after thrombolysis for AIS holds significant clinical importance.

Objective

To evaluate the efficacy and safety of acupuncture combined with tirofiban in the treatment of END following thrombolysis for AIS.

Methods

Seventy-six subjects were patients with END who received intravenous thrombolysis for AIS and were hospitalized in the Neurology Department, Jiaxing Hospital of Traditional Chinese Medicine Affiliated to Zhejiang University of Traditional Chinese Medicine from December 2021 to June 2024. They were randomized into a combined group and a control group via the random number table method, with 38 cases in each group. The control group received micro-pump infusion of tirofiban for 72 hours, sequential medication and rehabilitation therapy. The combined group received acupuncture treatment in addition to the control group, using both scalp acupuncture and body acupuncture. Both groups underwent treatment for 2 weeks. Compare the changes in high-sensitivity C-reactive protein (hs-CRP) levels between the two groups before treatment and at 3 and 14 days after treatment. The National Institutes of Health Stroke Scale (NIHSS), Modified Rankin Scale (mRS), Modified Barthel Index (MBI), and Traditional Chinese Medicine (TCM) Symptom Scale were used to assess neurological deficits, activities of daily living, long-term functional independence prognosis, and changes in TCM symptoms in both groups of patients before treatment, 14 days after treatment, and at the 90-day follow-up. At the same time, adverse reactions of two group patients were recorded during the treatment period.

Results

During the study period, 2 cases dropped out in the combined group, and 36 cases were completed; 1 case dropped out in the control group, and 37 cases were completed. There was an interaction between group and time for NIHSS, mRS, and TCM Symptom Scale scores (Pinteraction<0.05), and time had a significant main effect on NIHSS, mRS, and TCM Symptom Scale scores (Ptime<0.01). After 14 days post-treatment, the NIHSS, mRS, and TCM Symptom Scale scores were all lower in both groups compared to baseline (P<0.05). After 14 days post-treatment, the NIHSS and TCM Symptom Scale scores were lower in the combined group than in the control group (P<0.05). At the 90 days post-treatment, the NIHSS, mRS, and TCM Symptom Scale scores in both groups were lower than those before treatment (P<0.05); at the 90 days post-treatment, the NIHSS, mRS, and TCM Symptom Scale scores in the combined group were lower than those in the control group (P<0.05). At 14 days and 90 days post-treatment, the MBI scores in both groups were higher than before treatment (P<0.05); at the 90 days post-treatment, the MBI score in the combined group was higher than that in the control group (P<0.05). At 3 days and 14 days post-treatment, the serum hs-CRP levels of both groups decreased compared with those before treatment. There was an interaction between group and time on hs-CRP levels (Pinteraction<0.01), and the main effect of time on hs-CRP levels was significant (Ptime<0.01). The levels in the combined group were lower than those in the control group (P<0.05). A total of 5 cases of adverse reactions occurred in the two groups of patients, with 2 cases in the combined group and 3 cases in the control group.

Conclusion

The acupuncture combined with tirofiban treatment can effectively improve END symptoms after thrombolysis in AIS, protect neurological function, and enhance patients' ability to live independently. This may be related to the reduction of inflammatory responses, thereby promoting overall patient recovery.

Key words: Acute ischemic stroke, Acupuncture, Tirofiban, Early neurological deterioration, Thrombolysis, Randomized controlled trial