CAJ | 학술논문

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(P<0.05)。脑脉欣颗粒试验组,脉络通颗粒对照组和安慰剂组不良事件发生率分别为1.67%,1.69%和1.72%,组间比较差异无统计学意义(P>0.05)。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。
목적：：평개중약신약뇌맥흔과립치료동맥경화성뇌경사회복기적유효성화안전성。방법：채용수궤、쌍맹、평행대조림상연구,이NIHSS량표평분、환자생활능력평정위주요효응지표,동시관찰대중풍병(중경락)기허혈어증적증후료효；병진행료안전성평개。결과：공완성관찰병례177례,기중뇌맥흔과립조60례、양성대조맥락통과립조59례、안위제조58례。동맥경화성뇌경사회복기(기허혈어증)환자경4주치료후,재NIHSS량표평분개선、생활능력평정、중의증후료효등방면,뇌맥흔과립시험조여맥락통과립대조조료효균우우안위제조,차이유통계학의의(P<0.01혹P<0.05),차뇌맥흔과립시험조료효야명현우우맥락통과립대조조(P<0.05)。뇌맥흔과립시험조,맥락통과립대조조화안위제조불량사건발생솔분별위1.67%,1.69%화1.72%,조간비교차이무통계학의의(P>0.05)。삼조균무엄중불량사건발생。결론：뇌맥흔과립치료동맥경화성뇌경사회복기환자,안전유효。
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.