口服抗肿瘤药物临床试验受试者用药依从性的影响因素研究

Study on the Influential Factors of Drug Complianceamong Subjects Participating in Oral Antineoplastic Drug Clinical Trials

目的:探讨口服抗肿瘤药物临床试验受试者用药依从性的影响因素。方法:本研究采用调查问卷的形式对受试者进行信息收集,单因素分析采用秩和检验,多因素分析采用多元线性回归。结果:最终纳入323例受试者,MMAS-8得分中位数为8(6,8)分。单因素分析结果表明:常住地、疾病程度、口服抗肿瘤药上市情况、随访形式、既往是否参加过临床试验、服药期间是否出现不良反应及药学干预对本研究MMAS-8得分的影响有统计学意义(P<0.05)。多因素分析结果表明:进行药学干预(β=-0.198,P<0.001)、常住地为本市(β=-0.197,P<0.001)、口服抗肿瘤药已上市(β=-0.431,P<0.001)、住院受试者(β=-0.203,P<0.001)、既往参加过临床试验(β=-0.155,P=0.001)的受试者依从性较高;服药期间出现不良反应(β=0.101,P=0.028)受试者依从性较低。结论:受试者依从性与口服抗肿瘤药上市情况、随访形式、药学干预、常住地、既往是否参加过临床试验及服药期间是否出现不良反应相关联,抗肿瘤药物临床试验项目可通过采取相应干预措施,提高受试者用药依从性,促进临床试验的顺利开展。

Objective:To analyze the influential factors of drug compliance of subjects in clinical trials of oral antineoplastic drugs.Methods:Questionnaires were used to collect the information of the subjects.Rank sum test was used for single factor analysis and multiple linear regression was used for multi-factor analysis.Results:323 participants were included with a median MMAS-8 score of 8(6,8).The results of univariate analysis showed that permanent address,degree of disease,whether the oral antineoplastic drugs is on the market,way to follow-up,whether participated in clinical trials in the past,adverse reactions during medication and pharmaceutical intervention had statistically significant effects on MMAS-8 score in this study(P<0.05).The results of multi-factor analysis showed that:Pharmaceutical intervention(β=-0.198,P<0.001),permanent residence in Guangzhou(β=-0.197,P<0.001),oral antineoplastic drugs are on the market(β=-0.431,P<0.001),hospitalized subjects(β=-0.203,Patients who had participated in clinical trials(β=-0.155,P=0.001)had higher drug compliance;Patients with adverse reactions during medication(β=0.101,P=0.028)had lower compliance.Conclusion:Subjects′drug compliance is related to whether the oral antineoplastic drugs is on the market,way to follow-up,pharmaceutical intervention,permanent address,whether participated in clinical trials in the past,and adverse reactions during medication.Clinical trials of antineoplastic drugs can improve subjects′drug compliance and promote the smooth development of clinical trials by taking appropriate intervention measures.