Objective: To assess the effect of Xingnao Kaiqiao (regaining consciousness and opening orifices) acupuncture on the efficacy and safety of intravenous thrombolysis with recombinant tissue plasminogen activator (rt-PA) in patients with cerebral infarction.
Methods: A total number of 142 patients of cerebral infarction undergoing rt-PA intravenous thrombolysis were randomized into an acupuncture-medication group (71 cases) and a western medication group (71 cases, 1 case dropped off). In the western medication group, rt-PA intravenous thrombolysis was given. In the acupuncture-medication group, besides the intervention as the control group, Xingnao Kaiqiao acupuncture was provided at Shuigou (GV 26), Neiguan (PC 6), Sanyinjiao (SP 6), Jiquan (HT 1), etc. once daily. One treatment session contained 6 treatments and 1 session was required. Before and after treatment, the score of the National Institute of Health stroke scale (NIHSS), the levels of the relevant indexes of symptomatic intracerebral hemorrhage (sICH) (platelet [PLT], D-dimer and fibrinogen), the incidences of sICH and adverse effect were compared between groups. The efficacy was assessed in two groups.
Results: After treatment, NIHSS scores and the levels of D-dimer were reduced compared with those before treatment in both groups (P<0.05), and those in the acupuncture-medication group were lower than the western medication group (P<0.05). The level of fibrinogen in the acupuncture-medication group was increased in comparison with that before treatment (P<0.05), and also higher than the western medication group (P<0.05). The incidence of sICH was 0% (0/71) in the acupuncture-medication group, lower than 8.6% (6/70) in the western medication group (P<0.05). The effective rate was 97.2% (69/71) in the acupuncture-medication group, higher than 87.1% (61/70) in the western medication group (P<0.05). The incidence of adverse effect was 2.8% (2/71) in the acupuncture-medication group, lower than 12.9% (9/70) in the western medication group (P<0.05).
Conclusion: Xingnao Kaiqiao acupuncture may improve the efficacy of rt-PA intravenous thrombolysis in the patients with cerebral infraction and decrease the incidences of sICH and adverse effect. The mechanism may be related to the regulation of fibrinogen and D-dimer levels.
目的：观察醒脑开窍针刺法对脑梗死患者重组组织型纤溶酶原激活剂（rt-PA）静脉溶栓疗效及安全性的影响。方法：将142例脑梗死rt-PA静脉溶栓患者随机分为针药组（71例）和西药组（71例，脱落1例）。西药组予rt-PA静脉溶栓治疗，针药组在西药组的基础上予醒脑开窍针刺法治疗，穴取水沟、内关、三阴交、极泉等，每日针刺1次，6 d为一疗程，共治疗1个疗程。比较两组患者治疗前后美国国立卫生研究院卒中量表（NIHSS）评分、症状性颅内出血（sICH）相关指标[血小板计数（PLT）、D-二聚体、纤维蛋白原]水平及sICH发生率、不良反应发生率，评定两组患者临床疗效。结果：治疗后，两组患者NIHSS评分、D-二聚体水平均较治疗前降低 （P<0.05），且针药组低于西药组（P<0.05）；针药组患者纤维蛋白原水平较治疗前升高（P<0.05），且针药组高于西药组（P<0.05）。针药组sICH发生率为0%（0/71），低于西药组的8.6%（6/70，P<0.05）。针药组有效率为97.2%（69/71），高于西药组的87.1%（61/70，P<0.05）。针药组不良反应发生率为2.8%（2/71），低于西药组的12.9%（9/70，P<0.05）。结论：醒脑开窍针刺法可提高脑梗死患者rt-PA静脉溶栓的疗效，降低sICH和不良反应发生率，其机制可能与调节纤维蛋白原和D-二聚体水平有关。.
Keywords: Xingnao Kaiqiao acupuncture; acupuncture; cerebral infarction; intravenous thrombolysis; randomized controlled trial (RCT); symptomatic intracerebral hemorrhage.