心痛口服液的临床与实验研究

Clinical and Experimental Researches on Oral Solution for Checking Heart Pain

本文报道为治疗胸痹心痛(冠心病心绞痛)研制的心痛口服液,分补心和养心两种制剂。经协作组临床验证818例,其中治疗组662例,其止痛总有效率为84.87%;对心悸等主要伴随症状的总缓解率为86.60%;318例使用硝酸甘油患者的停减率为82.95%,心电图总改善率为44.92%。随机双盲对照组299例中,中药组156例,其止痛疗效、心悸等主要伴随症状缓解率均明显优于消心痛(p<0.005)。其中,补心口服液组的硝酸甘油停减率明显优于消心痛(p<0.05),对心电图疗效相仿(p>0.05);养心口服液组的硝酸甘油停减率两者相仿(p>0.1),而心电图疗效则明显优于消心痛(p<0.025)。又经动物急性和长期毒性试验,均未发现毒副作用,证明心痛口服液是安全制剂。

This article reported that oral solution was made for treating the pain in the heart, in which the solution was divided into tonifying heart solution and nourishing heart solution. 818 cases were verified by the cooperating group in clinic, Of which 662 cases of treatment group were observed, its total effective rate for checking pain was 84.87%; the total alleviatory rate for palpitation, the main complication, was 86.60%; of which the stopping and decreasing rate of 318 cases with nitroglycerin was 82.96%, its total improvement rate of ECG was 44.92%. 299 cases of the double blind control group (of which Chinese herbs group was 156 cases)selected with random sampling. The effective rate for checking pain and the alleviatory rate for palpitation in Chinese herbs group were all apparently superior to the control group with Isosorbide Dinitrate (p< 0.005). Among which the stopping and decreasing rate of nitroglycerin in the group with oral tonifying heart solution was markedly superior to the control group with Isosorbide Dinitrate (p<0.05), and its improvement rate of ECG was the same as the control group. The stopping and decreasing rate of nitroglycerin in nourishing heart solution group was similar to the tonifying heart solution group, while the improvement rate of ECG of it was markedly superior to the control group (p<0.025). Furthermore, It was not found that the oral solution had toxicity and side-effect after the short-term and long-term toxicant experiments in animals had been taken, and it was proved that the oral solution is a safe preparation.