安慰剂在中药新药临床试验研究中的应用及思考

Application and Consideration of Placebo in Clinical Trial Researches of New Traditional Chinese Medicine

安慰剂对照临床试验的药效灵敏度和检测灵敏度佳、所需样本量少,可明确反映药物的绝对和真实疗效。在中药新药临床试验研究中应用安慰剂对照可证明中药的真实疗效和安全性,同时积累为国内外主流医药所认可的、可供新药试验选择的阳性中药。科学合理的方案设计和GCP规范管理下的含安慰剂对照的中药临床试验,是中药现代化和国际化的必由之路。安慰剂是随机对照试验中能证明中药临床真实疗效的有效对照之一,在医学伦理能够接受的最大限度内,理应在中药新药临床试验中得到广泛应用。

In placebo-controlled clinical trials, less sample size required, the absolute and real efficacy of a drug can be reflected clearly with good sensitivity of efficacy and detection. Application of placebo-controlled study of traditional Chinese medicine clinical trials can prove the true efficacy and safety of tested traditional Chinese medicine （TCM）, and effective positive TCM, recognized by mainstream medicine organizations domestically and internationally, can be found and accumulated in the process. Under scientific and rational protocol design and the GCP management, the placebo-controlled clinical trials of TCM can be the only way leading to TCM modernization and internationalization. Placebo as one of the effective control in randomized controlled trials to prove the real efficacy of TCM should be widely used in new TCM clinical trials, as long as the studies do not violate medical ethics.