脑心通胶囊治疗胸痹（冠心病心绞痛）气虚血瘀证的临床疗效观察

目的评价脑心通胶囊治疗胸痹（冠心病心绞痛）气虚血瘀证的临床有效性和安全性.方法以通心络胶囊为对照,进行随机、双盲、对照、多中心试验.采用区组随机化将264例病例按实验组与对照组3∶1的原则随机分成两组,试验组198例,对照组66例.试验组给予脑心通胶囊,对照组给予通心络胶囊.连续服用28 d.观察比较两组心绞痛疗效、中医证候疗效、硝酸甘油停减率、心电图改善、心绞痛症状积分、中医证候积分变化等.结果心绞痛疗效总有效率在试验组和对照组分别为90.4%和78.8%,两组间比较差异有统计学意义（P〈0.05）;心电图疗效总有效率在试验组和对照组分别为39.1%和34.9%,硝酸甘油停减率在试验组和对照组分别为88.8%和89.4%,中医证候疗效总有效率在试验组和对照组分别为88.8%和86.4%,两组间比较差异均无统计学意义（P〉0.05）,且两组均未发现明显的不良反应.结论脑心通胶囊治疗胸痹（冠心病心绞痛）瘀血闭阻证安全有效.

Clinical Observation of Naoxintong Capsule in the Treatment of Angina Pectoris of Coronary Heart Disease with Syndrome of Qi Deficiency and Blood-stasis

Objective To access the clinical efficacy and safety of Naoxintong capsule（NXT） in the treatment of angina pectoris of coronary heart disease with syndrome of qi deficiency and blood - stasis. Methods A randomized, positive drug parallel controlled, doubleblind, multi-center clinical trial was conducted. Two hundreds and sixty eligible patients were allocated into treatment group （n= 198） and control group （n= 66） by using block randomization technique with a fixed ratio of treatments （3 ： 1） and 10% of dropout. Patients in treatment group were given Naoxintong capsule while patients in control group were given Tongxinluo capsule for 28 days. The therapeutic effectiveness of angina pectoris and traditional Chinese medicine （TCM） symptoms,reduction of nitroglycerin,electrocardiogram, scores of angina pectoris symptoms,and TCM symptoms were evaluated. Results The effective rates of angina pectoris are 90.4% in treatment group and 78.8% in control group（P〈0.05）. The effective rates of electrocardiogram was 39.1 % in treatment group and 34.9% in control group,the percentage of reduction or stop using nitroglycerin was 88.8% in treatment group and 89.4 % in control group, the effective rates of TCM symptoms was 88.8 % in treatment group and 86.4 % in control group. There was non-statistical significance （P〉0.05） of the differences of indexes about therapeutic effectiveness and improvement of scores between the groups,and neither of the two groups has been found significant adverse reactions. Conclusion Naoxintong capsule was effective and safety for treatment of angina pectoris with syndrome of qi deficiency and blood - stasis.