CAJ | 학술논문

目的：评价脑心通胶囊治疗中风（脑梗死恢复期）气虚血瘀证的疗效和安全性。方法采用随机、阳性药平行对照、多中心临床试验的方法，按国家药品临床研究相关要求，参考新药Ⅲ期临床试验，采用区组随机化按试验组与对照组3∶1的原则，考虑小于10％的退出率，共确定264例患者（试验组198例，对照组66例），分别给予脑心通胶囊和通心络胶囊治疗，连续用药一疗程（28 d），观察结果。评价指标有中风病疗效、中医证候疗效、中国脑卒中量表（CSS）积分、中医证候积分、中风病积分、日常生活活动（DAL）量表积分变化等。结果中风病疗效的总有效率在试验组和对照组分别为87．9％和97．7％；中医症候疗效的总有效率在试验组和对照组分别为81．8％和75．3％，各项疗效指标的组间差异无统计学意义（ P ＞0．05），且两组未发现明显不良反应。结论脑心通胶囊对中风（脑梗死恢复期）气虚血瘀证安全有效。
목적：평개뇌심통효낭치료중풍（뇌경사회복기）기허혈어증적료효화안전성。방법채용수궤、양성약평행대조、다중심림상시험적방법，안국가약품림상연구상관요구，삼고신약Ⅲ기림상시험，채용구조수궤화안시험조여대조조3∶1적원칙，고필소우10％적퇴출솔，공학정264례환자（시험조198례，대조조66례），분별급여뇌심통효낭화통심락효낭치료，련속용약일료정（28 d），관찰결과。평개지표유중풍병료효、중의증후료효、중국뇌졸중량표（CSS）적분、중의증후적분、중풍병적분、일상생활활동（DAL）량표적분변화등。결과중풍병료효적총유효솔재시험조화대조조분별위87．9％화97．7％；중의증후료효적총유효솔재시험조화대조조분별위81．8％화75．3％，각항료효지표적조간차이무통계학의의（ P ＞0．05），차량조미발현명현불량반응。결론뇌심통효낭대중풍（뇌경사회복기）기허혈어증안전유효。
O bjectives To access the clinica l efficacy and safe ty o f N aoxintong capsule(XNT) fo r trea tm ent o f stroke recovery pa tients w ith qi deficiency and blood stasis syndrom e. M e thods A random ized,positive drug paralel controled,double blind,multi center clinica l tria lw as conducted.Tw o hundreds and sixty four e lig ible pa tients w ere a loca ted into trea tm ent g roup( n = 198) and contro l g roup ( n= 66) by block random iza tion technique w ith a fixed ra tio o f trea tm ents ( 3∶ 1) and 10% o f dropout acco rding to the re la ted requirem ents on phase Ⅲ clinica l tria l o f new drugs from S ta te Food and D rug Adm inistra tion. Pa tients w ere g iven XNT in trea tm ent g roup and Tongxinluo capsule in contro lg roup fo r 28 days. The therapeutic effectiveness o f stroke and traditiona lChinese m edicine (TCM) sym ptom s ,im provem ent o f sco res o f C hinese stroke sca le (CSS) ,sco res o f TCM sym ptom s ,sco res o f stroke and sco res o f activities o f da ily living (DAL) sca le w ere eva lua ted.Results The effective ra te o f stroke w as 55.1% in trea tm ent g roup and 87.9% in contro lg roup.The effective ra te o fTCM sym ptom s w as 77.4% in trea tm ent g roup and 69.2% in contro lg roup.There w ere no sta tistica l significance in therapeutic effectiveness and im provem ent o f sco res be tw een the g roups( P > 0.05). N e ither o f the tw o g roups had been found significant adverse reactions. Conclusion XNT is effective and safe fo r trea tm ent o f stroke recovery pa-tients w ith qi deficiency and blood stasis syndrom e.