摘要
世界卫生组织正致力于发展安全、有效、实用的传统医药。中医药等替代医学已逐渐得到世界的认可。但其确切疗效有待科学的临床研究加以评估。安慰剂对照与阳性药物对照、空白对照等其他临床试验方法一样,是中药临床试验重要的研究手段之一。本文简要评述了安慰剂对照在临床试验中的意义以及中药临床试验中的安慰剂对照应用现状,并就安慰剂的使用提出了一些初步建议。我们应当强调在人用药品注册技术要求国际协调会(International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use)指导下的科学合理的安慰剂制备以及安慰剂对照研究。科学的临床试验方案可避免后继试验中许多不必要的浪费,并为患者提供真正安全有效的治疗。
World Health Organization aims to develop safe,effective and practical traditional medicine.Traditional Chinese medicine （TCM） and other complementary and alternative medicine are being recognized in the whole world nowadays.However,the definite effect of Chinese medicine is still in need of scientific research proof.Placebo control is of equal importance to active control and blank control in clinical trial of TCM.This article briefly reviewed the importance of placebo control and commented on its present situation in clinical trial of TCM.This article also brought up the preliminary proposals of placebo application in TCM clinical trial.We should emphasize scientific placebo preparation and good design of placebo-controlled trial,which are directed by International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.A good clinical trial project will avoid unnecessary wastes and provide safe and effective treatment for people.
出处
《中西医结合学报》
CAS
2010年第10期906-910,共5页
Journal of Chinese Integrative Medicine
关键词
临床试验
安慰剂
中草药
clinical trials
placebos
drugs
Chinese herbal
