%0 Journal Article
%T 统计显著、临床显著和药政批准上市的基础概念——复方丹参滴丸国际化研发解读<br>Basic concepts of statistical significance, clinical significance, and regulatory marketing approval—Interpretation of global development of Compound Danshen Dripping Pill
%A 钟耀兴
%J 医学争鸣
%D 2018
%X 临床试验是一个用随机取样的小样本试验替代大样本临床的过程，统计学P值在某一观察点是否小于 设定值取决于本次试验的实际可纳入统计分析的样本量、组间差异大小和组内变异量的大小。临床显著是评价一 个药物实际临床意义的重要指标，两者综合评价并确认可重现是药政批准上市的基本要求。复方丹参滴丸的美国 Ⅱ期和Ⅲ期临床试验结果显示：该药物临床使用安全、疗效显著，各类有效性证据成链，互相佐证；拆方研究证 明其药物配伍的科学性与合理性，并且不同生产批次的药品质量具有一致性与可控性。<br>Clinical study is a testing process that surrogates the large clinical samples by a study in small sample size. Whether the P value is less than a pre-defined value at a given timepoint is correlated with actual sample size for statistical analysis, between-group difference, and intra-group variation. Clinical significance is a key profile to justify the actual clinical value of a drug, and the dual evaluation on both statistical and clinical significance with reproducibility acts as the essential requirement for marketing approval. The results of US PhaseⅡandⅢclinical trials of Compound Danshen Dripping Pill demonstrate that the drug has good safety profile and significant efficacy in patients with chronic stable angina, as supported by all efficacy endpoints and evidences. Herbal compatibility study also evidences the contribution of Danshen and justifies the composite of the drug. In addition, there was no apparent difference in efficacy profiles among multiple manufacture batches, indicating its superior quality controllability and consistency
%K 复方丹参滴丸
%K 统计学显著
%K 临床显著
%K 药政批准<br>Compound Danshen Dripping Pill
%K statistical significance
%K clinical significance
%K regulatory marketing approval
%U http://yxzm.paperonce.org/oa/DArticle.aspx?type=view&id=201802002