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目的：：评价中药新药脑脉欣颗粒治疗动脉硬化性脑梗死恢复期的有效性和安全性。方法：采用随机、双盲、平行对照临床研究,以NIHSS量表评分、患者生活能力评定为主要效应指标,同时观察对中风病(中经络)气虚血瘀证的证候疗效；并进行了安全性评价。结果：共完成观察病例177例,其中脑脉欣颗粒组60例、阳性对照脉络通颗粒组59例、安慰剂组58例。动脉硬化性脑梗死恢复期(气虚血瘀证)患者经4周治疗后,在NIHSS量表评分改善、生活能力评定、中医证候疗效等方面,脑脉欣颗粒试验组与脉络通颗粒对照组疗效均优于安慰剂组,差异有统计学意义(P<0.01或P<0.05),且脑脉欣颗粒试验组疗效也明显优于脉络通颗粒对照组(P0.05)。三组均无严重不良事件发生。结论：脑脉欣颗粒治疗动脉硬化性脑梗死恢复期患者,安全有效。“,”To assess the efficacy and safety of a new traditional Chinese medicine called Naomaixin granules in the treatment of arterial cerebral infarction in convalescent. Methods: A randomized, double-blind and parallel controlled clinical study was carried out, and three sets of parallel controlled clinical design with the test group, positive drug group and placebo group were per-formed. The clinical efficacy of Naomaixin granules on arterial cerebral infarction in convalescent was confirmed based on the main ef-fective indicators including NIHSS scale score and the life state assessment for the patients. Meanwhile, the curative effect of Naomaixin granules on stroke disease with Qi deficiency and blood stasis ( QDBS) was observed. The safety of Naomaixin granules was evaluated as well. Results:The clinical design enrolled a total of 177 cases of patients, including 60 ones in Naomaixin granules group, 59 ones in Mailuotong granules group and 58 ones in the placebo group. After the 4-week treatment,NIHSS scale score, life skills, TCM syn-dromes efficacy and the curative effect of Naomaixin granules group and Mailuotong granules group were better than those of the placebo group(P<0. 01 or P <0. 05). Furthermore, compared with Mailuotong granules group, the curative effect of Maomaixin granules group was much better (P0. 05). No serious adverse events appeared during the ob-servation. Conclusion:Naomaixin granules are safe and effective in the treatment of atherosclerotic cerebral infarction in convalescen.