脑心通胶囊治疗脑梗死合并心肌缺血的多中心非随机临床对照试验

目的：观察脑心通胶囊（步长制药）治疗脑梗死合并心肌缺血患者的临床疗效。方法选取2013年10月至2014年12月北京21所医院神经内科收治的符合入组条件的急性脑梗死伴心肌缺血患者，非随机分为脑心通组（基础治疗基础上加用步长脑心通胶囊）和对照组（仅基础治疗）。对比分析第4周、8周、12周时2组心电图变化以及使用NIHSS和改良mRankin评估第12周时神经功能变化。结果入组544例，剔除16例（不良事件2例、自动放弃1例、违背规则1例、失访6例、其他6例），实际完成试验528例（包含测量资料缺失病例），其中脑心通组291例，对照组237例。心肌缺血改善的有效率脑心通组和对照组第4周差异无统计学意义（18．1％、14．9％， P ＝0．704）；但第8周（27．7％、14．3％， P ＝0．001）和第12周（31．3％、16．9％，P ＜0．01）差异有统计学意义（ P ＜0．05）。第12周时NIHSS减少≥2分脑心通组（77．7％）明显高于对照组（68．4％）（ P ＜0．05），mRankin 减少≥1分脑心通组（67．7％）显著高于对照组（56．1％）（ P ＜0．05）。多因素分析心电图改善的独立影响因素是脑心通（ P ＝0．005）和第12周时AST的降低（ P ＝00．47）；神经功能改善的影响因素包括脑心通治疗、基线收缩压和肌酐水平、既往心脏病或高脂血症病史。结论脑心通胶囊联合基础治疗对脑梗死合并心肌缺血临床疗效确切。

Therapeutic effects of Naoxintong capsule on cerebral infraciton complicated by myocardial ischemia-Multicenter nonrando mized controlled clinical trial

Objective To observe the therapeutic effect of Naoxintong capsule on cerebral infarction complicated by myocardial ischemia . Methods The patients with acute cerebral infarction complicated by myocardial ischemia who were admitted and treated in Department of Neurology of 21 hospitals in Beijing from October 2013 to December 2014 were nonrandomly divided into Naoxintong group ( conventional therapy +Buchang Naoxintong capsules ) and control group ( conventional therapy only ) .The changes of electrocardiogram ECG were observed and compared between two groups , moreover, the changes of neurological function on the 4th week, the 8th week,the 12th week were analyzed by using NIHSS and modified mRankin . Results A total of 544 patients were enrolled in the study ,in whom 16 patients were excluded for some reasons,including 2 cases of adverse events , 1 case of automatic give up ,1 case of violation of rules ,6 cases of follow-up failure and 6 cases of the other reasons ,actually 528 cases were enrolled in the trial including 291 cases in Naoxintong group and 237 cases in control group .There was no significant difference in the effective rate of improving myocardial ischemia on the 4th week between two groups (18.1%vs 14.9%, P >0.05).However there were significant differences in the effective rates of improving myocardial ischemia on the 8th week and the 12th week between two groups (27.7%vs 14.3%,31.3%vs 16.9%,respectively, P <0.01).On the 12th week,the the proportion of decrease of NIHSS≥2 points was 77.7% in Naoxintong group,which was significantly higher than that (68.4%) in control group ( P <0.05),moreover, the proportion of decrease of mRankin≥1 point was 67.7% in Naoxintong group,which was significantly higher than that (56.1%) in control group ( P <0.05).Multiple-factor logistic regression analysis showed that Naoxintong capsule was independent influencing factor on the improvement of ECG ( P <0.01) and the decrease of AST on the 12th week (P <0.05).The influencing factors of improvement of neurological function included Naoxintong treatment , baseline systolic blood pressure , serum creatinine,previous history of heart disease or hyperlipidemia . Concluis on The therapeutic effects of Naoxintong on cerebral infarction complicated by myocardial ischemia are definited and satisfactory .