阿米三嗪-萝巴新对缺血性卒中恢复期患者的疗效

Effects of almitrine and raubasine on rehabilitation of ischemic stroke patient

目的 评估阿米三嗪 萝巴新对缺血性卒中后功能恢复的疗效。方法 采用多中心、随机、双盲、安慰剂对照研究。缺血性卒中后 1个月患者 ,随机服用阿米三嗪 萝巴新或安慰剂每日 2片 ,共服 3个月。每个月随诊 1次 ,以巴氏指数 (BI) ,神经功能缺损量表 (NFDS)和长谷川痴呆量表(HDS)作为疗效评估指标。结果 74例最终完成了 3个月随访 ,其中药物组 38例 ,安慰剂组 36例。巴氏指数在治疗后 1、2、3个月药物组均优于安慰剂组 (P <0 0 5 ) ;神经功能缺损量表分在治疗第 1个月药物组 (6 7± 4 7)优于安慰剂组 (9 6± 6 8,P =0 0 34<0 0 5 ) ,第 2、3个月两组无显著性差异 ;长谷川痴呆量表分在治疗 1、2、3个月均无显著性差异。阿米三嗪 萝巴新的不良反应发生率为 7 9% ,安慰剂组为 2 7% ,主要表现为头晕、失眠 ,并不影响患者继续治疗。结论 阿米三嗪 萝巴新在一定程度上加快缺血性卒中后患者神经功能恢复 。

Objective To assess the efficacy of almitrine and raubasine (Duxil) on post stroke rehabilitation Methods A clinical trial was done with a randomized, double blind, placebo controlled method Patients with ischemic stroke were included as having 1 month after the acute onset and receiving randomized treatment of either Duxil or placebo 2 tablets daily for 3 months The patients were assessed by using Barthel Index (BI), neurological functional deficit scores (NFDS), and Hasagawa dementia scales (HDS) each month after giving treatment Results In this study, only 74 cases were observed Of them, 38 patients received Duxil and 36 patients received placebo The baseline characteristics were compared between both groups Duxil was significantly shown more effective than placebo by increasing BI at 1, 2 or 3 months and by reducing NFDS at 1 month after treatment, more Duxil treated patients' NFDS had improved as compared with placebo treated patients In comparing with the pre treatment condition, there appeared a strong tendency of improvement in HDS with Duxil, although this significance was not confirmed by the difference of scores between two groups More Duxil treated patients than placebo controlled patients were reported having adverse events, but the difference was not significant at the 5% level All these events were mild, of short duration and resolved without treatment Conclusion Duxil can accelerate the recovery of nervous function to some degrees after stroke