疫情防控期间临床试验中慢性肝病受试者依从性影响因素分析

Analysis of Influencing Factors of Subjects'Compliance in Clinical Trials of Chronic Liver Disease During Epidemic Prevention and Control

目的探讨疫情防控期间临床试验中慢性肝病受试者依从性及影响因素。方法选取2020年1月~2023年10月洛阳市中心医院接受药物试验的154例慢性肝病受试者为研究对象,采用单、多因素分析慢性肝病受试者依从性影响因素。结果154例慢性肝病受试者依从率为79.78%(122/154),74例依从性好,48例依从性中等,32例依从性差,据此分为依从性佳组和依从性差组。依从性差组亲属陪同(无)、每日用药频次(>1次)、每日用药种类(>1种)、日记卡情况(有)、严重不良反应(有)、疾病知识知晓情况(差)患者比例高于依从性佳组,CLDQ评分高于依从性佳组(P<0.05)。无亲属陪同(OR=0.308,95%CI:0.126~0.754)、每日用药频次>1次(OR=3.511,95%CI:1.264~9.753)、每日用药种类>1种(OR=3.583,95%CI:1.467~8.752)、有不良事件发生(OR=3.309,95%CI:1.756~6.236)、疾病知识知晓情况差(OR=6.375,95%CI:2.754~14.756)、CLDQ评分升高(OR=5.001,95%CI:1.961~12.754)是疫情防控期间慢性肝病受试者依从性差独立危险因素(P<0.05)。结论疫情防控期间慢性肝病受试者依从性主要与亲属陪同、每日用药频次、每日用药种类、严重不良反应、疾病知识知晓情况差、CLDQ评分等有关,临床可针对上述因素采取针对性措施干预,以提高治疗依从性。

OBJECTIVE To investigate the subjects'compliance and influencing factors in clinical trials of chronic liver disease during epidemic prevention and control.METHODS A total of 154 patients with chronic liver disease who received drug trials in A certain hospital from January 2020 to October 2023 were selected as the study objects,and the influencing factors of compliance of patients with chronic liver disease were analyzed by single and multi-factor analysis.RESULTS The compliance rate of the 154 subjects with chronic liver disease was 79.78%(122/154).There were 74 cases had good compliance,48 cases with moderate compliance and 32 cases with poor compliance.They were divided into good compliance group and poor compliance group.The proportion of patients with poor compliance,accompanied by relatives(none),daily medication frequency(>1),daily medication type(>1),diary card status(yes),serious adverse reactions(yes),and poor knowledge of disease knowledge(poor)were higher than those in the good compliance group,and the CLDQ score was higher than that in the good compliance group(P<0.05).The independent risk factors for poor compliance in chronic liver disease subjects during the COVID-19 pandemic were no relatives accompanying(OR=0.308,95%CI:0.126-0.754),daily medication frequency>1(OR=3.511,95%CI:1.264-9.753),daily medication type>1(OR=3.583,95%CI:1.467-8.752),occurrence of adverse events(OR=3.309,95%CI:1.756-6.236),poor knowledge of disease knowledge(OR=6.375,95%CI:2.754-14.756),and increased CLDQ score(OR=5.001,95%CI:1.961-12.754,P<0.05).CONCLUSION During the epidemic prevention and control period,the compliance of chronic liver disease subjects is mainly related to family members'accompaniment,daily medication frequency,daily medication type,serious adverse reactions,poor knowledge of disease,and CLDQ score.Clinicians can take targeted measures to improve treatment compliance based on the above factors.