复方丹参滴丸治疗冠心病心绞痛的临床研究(英文)

Clinical Investigation of Composite Danshen Pill for the Treatment of Angina Pectoris

复方丹参滴丸由丹参、三七和冰片组成 ,具有活血化瘀 ,理气止痛之功效 ,是临床治疗冠心病、心绞痛、胸闷的常用中成药。与片剂等口服制剂相比 ,滴丸剂采用固体分散技术和工艺 ,大大缩短了药物起效时间 ,提高了药物的生物利用度 ,从而降低药物临床使用剂量。本文着重选择了复方丹参滴丸与硝酸甘油、消心痛 (二硝酸异山梨酯 )、以及复方丹参片的几个临床比较试验 ,介绍复方丹参滴丸对冠心病心绞痛治疗的临床疗效和特点。临床研究显示复方丹参滴丸与硝酸甘油一样对冠心病心绞痛有相似的快速止痛效果 ,其止痛时间略慢于硝酸甘油。采用随机双盲试验 ,复方丹参滴丸在减少心绞痛发作次数和减少硝酸甘油使用量方面均优于消心痛。复方丹参滴丸用药量仅为复方丹参片的四分之一的一个多中心、随机分组、单盲临床试验中显示 ,滴丸对冠心病心绞痛的治疗有效率为 95 3% ,明显高于片剂的 76 0 %。

Composite Danshen Pill (CDP) is a herbal drug for the treatment of angina pectoris, which consists of herbal ingredients extracted from Salvia miltiorrhiza, Panax notoginseng , and Cinnamomum camphora. The product is prepared by blending herbal extracts and excipients under thermal conditions and dripping the mixture into an insoluble cooling liquid in which the droplets are rapidly solidified. It appeared in clinical studies that CDP is similar to nitroglycerin in its ability to relieve pain rapidly. Clinical results also indicated that the long term administration of CDP can increase the pain relief rate and electrocardiogram (ECG) improvement rate, and that it overall curative effect is superior to isosorbide dinitrate. A multi center clinical investigation showed that this new dosage form of composite Danshen is more effective in treating coronary heart disease than the tablet form due to the improved bioavailability.