摘要
目的:观察银丹心脑通软胶囊治疗稳定性心绞痛的疗效和安全性。方法:2013年1月—2013年12月,选择16个临床中心诊断为慢性稳定性心绞痛患者394例,随机分为银丹心脑通软胶囊组(试验组)196例和复方丹参滴丸组(对照组)198例。通过2周的导入期后,进行历时8周的双盲治疗期,观察心绞痛缓解率、运动试验、HCY及安全性指标。结果:试验组心绞痛总缓解有效率63.4%大于对照组56.3%,但差异无统计学意义(P>0.05);两组运动试验改善差异无统计学意义(P>0.05);对基线HCY异常者进行亚组分析,治疗后试验组HCY下降率21.4%优于对照组6.3%,两组差异具有统计学意义(P<0.05)。试验组未发生不良反应,对照组发生3例次不良反应,发生率为1.5%,差异无统计学意义(P>0.05)。结论:银丹心脑通软胶囊治疗稳定性心绞痛安全有效。
AbstraCt：Objective：To observe the clinical efficacy and safety of Yintan Xinnaotong Capsule in treatment of chronic stable angina. Methods： A total of 394 patients who were diagnosed as chronic stable angina were enrolled from 16 centers from January to December 2013. Patients were randomly assigned to the trim group and the control group. And then all patients would receive a 2 - week leading period and the following 8 - week double - blinded treatment. The alleviating angina pectoris,exercise test, HCY and safety index were observed. Results：The trial group was superior to the control group after treatment in aspects of the therapeutic effects on angina（63. 388% VS 56,316% ） , but with no statistical difference （P 〉 0.05）. The improvement of two groups in aspects of exercise test had no statistical difference （P 〉 0.05 ）. Analyze the subgroup of patients with abnormal HCY before their treatment. After treatment, the HCY of experimental group decreased at the rate of 21.4% ,which was higher than 6.3% in control group with significant difference between two groups （ P 〈 0.05 ）. There was no ADR in experimental group while there were 3 ADRs in control group, whose incidence was 1. 515%. There was no statistical difference in adverse reaetion among these two groups （P 〉 0.05）. Conclusion： Yindan Xinnaotong Capsule was safe and effective in treatment of stable angina. Key words： Yindan Xinnaotong Capsule; stable angina; randomized clinical research
出处
《中华中医药学刊》
CAS
北大核心
2016年第10期2537-2541,共5页
Chinese Archives of Traditional Chinese Medicine
