中药新药Ⅱ、Ⅲ期冠心病心绞痛临床试验的风险与对策

Risks and Countermeasures in Clinical Trials of New Drug of Chinese Medicine in Treatment of Coronary Heart Disease in Patients with Coronary Heart Disease

随着冠心病心绞痛的发病率日益升高,目前有关冠心病心绞痛的中药临床试验越来越多。结合目前国内中药新药Ⅱ、Ⅲ期冠心病心绞痛临床试验的实际情况,在遵循医学伦理原则前提下,综合分析风险的特点,提出意见和建议,减少和规避风险,保证试验顺利进行。

With the increase of the incidence of angina pectoris of coronary heart disease,the clinical trials of traditional Chinese medicine in the treatment of angina pectoris of coronary heart disease are more and more. Based on the actual situation of the clinical trial of new drug of Chinese medicine in the second and third phase of coronary heart disease,under the premise of the principle of medical ethics,the characteristics of risk are analyzed and the suggestions are put forward to reduce and avoid risks and ensure the smooth progress of the trial.