Coronary Heart Disease Angina Pectoris Clinical Trials Of Clinical Efficacy Of 15 Years Of Changes In The Law

Purpose：To analyze the variation of effective observation indexes and thedifferences of effective evaluation indexes used in TCM clinical trials of anginapectoris in fifteen years based on2007Angina guiding principles(draft)introduced.Method：59projects about Angina medicine clinical trials between1999and2013werecollected, which were conducted and participated by47National drug clinicaltrial institutions approved by the State Food and Drug Administration. Here weanalyze the related effective observation indexes and evaluations from the59projects’ programs and summary reports.Results：1Compared with the year before2007,now the effective observation indexes onTCM clinical trials of angina pectoris showed the following characteristics,1.The projects of exercise treadmill testing as the primary efficacy indexincreased by13.91%,while the projects of ECG efficacy, TCM syndrome efficacy,angina pectoris efficacy and discontinue rate of nitroglycerin as the primaryefficacy index decrease by29.54%,26.09%,15.06%,6.09%in sequence.2.Theprojects containing only one primary effective observation index increased by29.21%.The projects which are not divided into primary efficacy index andsecondary efficacy index decreased by5.63%.2Compared with the year before2007,now the common effective evaluationindexes of test group on TCM clinical trials of angina pectoris showed thefollowing characteristics,1.The significantly effective rate, effective rateand total effective rate of the ECG efficacy decreased5.08%、5.97%、11.04%.The significantly effective rate, effective rate and total effective rate ofthe discontinue rate of nitroglycerin decreased3.94%、3.01%、6.95%.2. The total effective rate of angina pectoris efficacy and TCM syndromes efficacy did notchange significantly,but ECG efficacy and the discontinue rate of nitroglycerinfell by an average9.00%compared to the previous.Conclusion：1. With the Angina guiding principles (2007draft) unveiled, the primaryefficacy observations are more accurate and put even more emphasis on exercisetreadmill test efficacy and quality of life.2. TCM clinical trials in angina pectoris increasingly focused on selectingonly one primary efficacy observation.3. In angina pectoris TCM clinical trials，the confirmatory trial is moreemphasis on the selection of primary efficacy index and the division of primaryor secondary efficacy observations than pilot trial.4. Reduction of ECG efficay may be due to the quality control of traditionalChinese medicine clinical trials increasingly stringent.5TCM clinical trial of angina pectoris should be strengthened to improveangina and TCM syndromes and other subjective criteria indicators.6. With the Angina guiding principles (2007draft) unveiled，TCM clinicaltrials of angina pectoris have improving the inclusion and exclusion criteria,increasing the placebo-controlled, etc，so that the analysis of clinical efficacyof traditional Chinese medicine are more accurate, the results are morereasonable.