冠心病稳定型心绞痛中药临床试验方案设计的变化趋势

目的：从近年冠心病稳定型心绞痛中药新药临床试验项目着手，探讨冠心病稳定型心绞痛中药临床试验方案设计的变化趋势。方法收集自2000—2014年间中药临床试验方案共60项，分析各项临床试验的方案设计变化趋势。结果 自2007年《慢性稳定型心绞痛诊断与治疗指南》出台后参照了1979年《缺血性心脏病的命名及诊断标准》的基础上又参照了2007年《慢性稳定型心绞痛诊断与治疗指南》，占34.6℅。纳入标准的变化：2000—2014年冠心病稳定型心绞痛临床试验方案纳入标准要求变化趋势越来越科学和严格。而在年龄的要求上，年龄上限从早期的65岁或70岁为主到75岁和80岁逐渐放宽。证型的变化：以气虚兼其他证候为主的临床试验项目共计22项，占全部项目数的36.7℅，其次是心血瘀阻证20项，占33.3℅。疗程设计：注射液临床试验疗程以2周为主，口服剂型则以4周为主。从疗程变化来看，2010年开始疗程为8周的项目开始增加。合并用药：从2007年开始在冠心病稳定型心绞痛临床试验中合并用药方面规定可使用硝酸甘油且合并疾病在不增加原用药剂量下可继续应用（如钙离子拮抗剂、β受体阻滞剂）。冠心病稳定型心绞痛临床试验导入期及随访期设置变化：导入期或洗脱期的时间以1周、2周为主，而设置随访期的项目从2007年开始在临床试验中设置且只占项目总数8.3℅。疗效指标：冠心病稳定型心绞痛临床试验中主要以心绞痛疗效、心电图疗效、中医证候疗效、硝酸甘油停减率、运动平板试验作为疗效评价指标，而西雅图心绞痛量表为近几年比较盛行的一项检查项目。安全性指标：从2004年开始在安全性指标中增加了凝血四项，随后2006年开始又增加了心电图、血糖、血脂、血 K +、Na +等检查项目，且每年的比例逐年增加。结论中药临床试验的方案设计更加趋于科学规范与严谨。

Coronary heart disease stable angina change trend of traditional Chinese medicine

Objective Stable angina pectoris of coronary heart disease clinical trials of new drugs oftraditional Chi-nese medicine in recent years,discussion on stable angina pectoris ofcoronary heart disease of traditional Chinese medi-cine clinical trial design trends. Methods Collected from 2000 to 2014 total 60 clinical trials of traditional Chinese medicineprogrammes,analysis of each clinical trial design trends. Results changes in diagnostic criteria:Since The year 2007“Guidelines for diagnosis and treatment of chronic stable angina”After the referenceThe year 1979“Ischemic heart disease nomenclature and diagnostic criteria”On the basis of the reference The year 2007“Guidelines for diagnosis and treatment of chronic stable angina”Accounted for 34. 6℅ . changes in inclusion criteria:In 2000 to 2014 stable angina pectoris of coronary heart disease clinical trial programmesinto the standard trend of more and more scientific and strict. In the age of therequirements,age limit from the early age of 65 or 70 to 75 and 80 years graduallyrelaxed. type change:With syndrome of Qi deficiency and other clinical trial projects a total of 22,36. 7℅ of the total number of items,fol-lowed by cariac blood stasis syndrome 20,33. 3℅ . About course design:2 weeks-oriented injection treatments in clinical trials,oral dosage form is dominated by4 weeks. From the course changes,starting in 2010 for 8-week program began to increase. combination:Starting from the 2007 drug combination in stable angina pectoris of coronary heart disease in clin-ical trials provides for the use of nitroglycerin and concomitant diseaseswithout increasing the original medication dosage may continue to be used(such as calciumantagonists,β-blockers). stable angina pectoris of coronary heart disease clini-cal trial setting changes duringthe import period and follow-up:Import or Washout period in 1 week,2 weeks of time. Set the follow-up project since 2007in the clinical trial setting and only the total number of project 8. 3℅ . outcome measure:Stable angina pectoris of coronary heart disease in clinical trials primarily to angina pectoris,electrocardiogram,TCM curative effects,nitroglycerin stopped reducing rate,exercise treadmill test outcome assessment indicators,and the Seattle anginaquestionnaire for a check of the more prevalent in recent years. Security indicators:Starting from 2004 on security increases in coagulation of blood,then beginning in 2006 increased the ECG,blood glucose,blood lipid and blood check project such ask + ,Na + ,and the annual percentage increase year by year. Conclusion Traditional Chinese medicine clinical trial design tends to be more scientific and standardized and rigorous.