复方血栓通软胶囊治疗冠心病稳定性心绞痛血瘀兼气阴两虚证30例临床观察

目的评价复方血栓通软胶囊治疗冠心病稳定性心绞痛血瘀兼气阴两虚证的临床疗效及安全性。方法采用随机、双盲、安慰剂平行对照方法 ,将符合纳入标准的60例患者随机分为治疗组30例,对照组30例。筛选导入期2周给予硝酸甘油治疗。筛选导入期后,治疗组予复方血栓通软胶囊,对照组予安慰剂软胶囊。均为每次1粒,每日3次口服,观察8周。观察治疗前后心绞痛疗效、中医证候积分、心电图疗效、硝酸甘油使用量,以及安全性指标。结果治疗组在心绞痛总有效率,心绞痛发作频率减少及持续时间减少,中医证候总有效率、总积分,心电图总有效率,硝酸甘油停减率等方面,与对照组比较,有统计学差异。安全性指标基本同前,未见不良反应和不良事件的发生。结论复方血栓通胶囊能有效减少冠心病稳定性心绞痛血瘀兼气阴两虚证患者的心绞痛发作次数及持续时间,改善中医证候,减少硝酸甘油用量,无明显毒副作用,是治疗冠心病稳定性心绞痛血瘀兼气阴两虚证的有效药物。

Curative effect of Fufang Xueshuantong Softgels on stable angina pectoris of CHD (syndrome of blood stasis combining dual deficiency of qi and yin) in 30 cases

Objective To review the curative effect and safety of Fufang Xueshuantong Softgels on stable angina pectoris（SAP） of coronary heart disease（CHD,syndrome of blood stasis combining dual deficiency of qi and yin）.Methods The patients（n=60） were randomly divided into treatment group and control group（each n=30） by applying randomized,double- blind and placebo— parallel control method.All patients were treated with nitroglycerin during screening and lead- in period for 2 w,and then treatment group was given Fufang Xueshuantong Softgels and control group was given placebo softgels 1 softgel a time and 3 times a day for 8 w.The curative effect on SAP,integrals of TCM syndromes,ECG outcomes,dosage of nitroglycerin and safety indexes were observed before and after treatment.Results The comparisons in the total effective rate on SAP,decrease of attack rate and duration time of angina pectoris,total effective rate and decrease of total integrals of TCM syndromes,improvement rate of ECG and reducing rate of nitroglycerin dosage had statistical differences between 2 groups.The safety indexes had no changes and there were no adverse reactions and adverse events observed.Conclusion Fufang Xueshuantong Softgels can effectively reduce the attack rate and duration time of SAP,relieve TCM syndromes and cut down the dosage of nitroglycerin,and had no obvious toxic and side effects in the treatment of SAP of CHD（syndrome of blood stasis combining dual deficiency of qi and yin）.