目的：探讨中药临床试验项目受试者用药依从性的影响因素。方法：收集2017年9月～2019年12月在内蒙古自治区国际蒙医医院完成的7项中药临床试验项目资料。将收集的资料中可能对依从性产生影响的变量设为观察变量，进行依从性不合格的单因素分析。将单因素分析中有统计学意义的变量纳入二元Logistic回归模型中，进行多因素分析。结果：共纳入受试者113例，依从性合格89例，不合格为24例。因受试者个人因素而导致不合格的为18例，占比为75.00%，因发生AE而退出试验导致不依从为6例，占比为25.00%。二元Logistic回归结果显示家属陪同、用药频次为受试者依从性不合格的独立危险因素。提示研究者在入组及筛选受试者时应关注受试者的心理因素，争取家属配合参与临床试验，同时试验方案应当尽量简化，提高依从性。

Abstract: Objective To explore the factors influencing of subject compliance in Chinese medicine clinical trial projects. Methods Seven Chinese medicine clinical trial projects completed at the Inner Mongolia International Mongolian hospital from September 2017 to December 2019 were collected. The variables that may have an effect on compliance in the collected data as the observed variables，and compliance as dependent variable were analyzed by univariate analysis. The variables with statistical significance in univariate analysis were included in the binary logistic regression model for multivariate analysis. Results A total of 113 cases were enrolled, including 89 cases compliant, and 24 cases non-compliant. The causes of noncompliant were subjects’ factors in 18 cases (75.00%), presence of AE in 6 cases (25.00%). Binary Logistic regression analysis showed that accompanied by family members and frequency of administration were the influencing factors of subject compliance. In order to improve compliance, the investigators should pay attention to the psychological factors of the subjects and strive for the family members to participate in the clinical trial. At the same time, the trial protocol should be simplified as much as possible.