Clinical Observation of Naomaixin Granules in the Treatment of Arteriosclerotic Cerebral Infarction in Convalescent
- VernacularTitle:脑脉欣颗粒治疗动脉硬化性脑梗死恢复期的临床试验
- Author:
Yan CUI
;
Juntian LIU
;
Hui ZHANG
;
Yongqiang SUN
;
Xia GAO
;
Feng WANG
- Publication Type:Journal Article
- Keywords:
Arteriosclerotic cerebral infarction;
Stroke;
Traditional Chinese;
Medicine therapy;
Clinical study;
Naomaixin gran-ules
- From:
China Pharmacist
2015;(8):1333-1335
- CountryChina
- Language:Chinese
-
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(P<0. 01 or P <0. 05). Furthermore, compared with Mailuotong granules group, the curative effect of Maomaixin granules group was much better (P<0. 05). The incidence of adverse events of the test group, positive drug group and placebo group respec-tively was 1. 67%,1. 69% and 1. 72% without statistical significance (P>0. 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.
