Clinical Observation of Naomaixin Granules in the Treatment of Arteriosclerotic Cerebral Infarction in Convalescent / 中国药师

ABSTRACT

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(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.