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为探讨中药安慰剂质量的评价方法,检索近10年发表的中药安慰剂制备及质量评价相关文献,对目前安慰剂制备和质量评价方法进行总结分析,在此基础上提出了一些思考。质量评价方法有内在指标成分测定和外观评价(人工打分法和电子仿生测评法)等,但尚无统一标准,多数研究报告内容不详。因此,制定科学、规范的质量评价标准,从中药安慰剂质量评价的客观指标、主观使用感受等方面综合评价安慰剂质量,对安慰剂的真实作用和临床试验的可靠性都有重要意义。
In order to explore the method of evaluating the quality of placebos in traditional Chinese medicine, we searched the literature about placebo preparation and quality evaluation of traditional Chinese medicine published in recent 10 years, and summarized the present placebos preparation and quality evaluation methods. Based on this, some suggestions were put forward. Quality evaluation methods have intrinsic index composition and appearance evaluation (manual scoring method and electronic bionics evaluation method), but there is no uniform standard, and most of the research reports are not clear. Therefore, it is of great significance to formulate a scientific and standardized quality evaluation criteria, and to evaluate the quality of placebos in terms of the objective indicators of the quality evaluation of placebos and the subjective use of traditional Chinese medicines, both for the true effect of placebo and the reliability of clinical trials.