摘要
目的探讨补肾祛邪方联合恩替卡韦治疗慢性乙型肝炎多中心临床研究中患者临床依从性及影响因素。方法选择2012年6月至2016年8月参加国家中医临床研究基地(湖北)重点病种的全国13个临床研究中心的慢性乙型肝炎患者,给予恩替卡韦和补肾祛邪方治疗。回顾性分析受试者的临床依从性,以"到诊率法"对受试者依从性进行评估,应用Logistic回归分析临床依从性的影响因素。结果本研究共纳入受试者620例,随访48周,脱落59例(9.5%),完成所有访视者561例(90.5%),其中按时到访并按要求完成相关检查及试验相关临床资料填写者356例(63.5%),超窗到访或未按要求完成相关检查及试验相关临床资料填写者205例(36.5%)。不同区域受试者4、8、12、24、36、48周依从性均逐渐下降(P<0.01)。单因素分析显示,家族史、研究中心配备临床研究协调员(CRC)、慢性肝病生存质量问卷(CLDQ)、健康状况问卷(SF-36)、健康变化、中医证候积分6项临床依从性差异有统计学意义(P<0.05);回归分析显示,研究中心配备CRC、SF-36得分对临床依从性的影响比较突出,其中CRC与临床依从性呈正相关(P<0.05),SF-36得分与临床依从性呈负相关(P<0.05)。结论随着随访时间的延长按时到访率逐渐下降,研究中心配备CRC、SF-36得分可能是影响受试者临床依从性的重要因素。
Objectives To analyze the clinical compliance and the influencing factors of patients with chronic hepatitis B in the clinical research of traditional Chinese medicine（ TCM）. Methods The participants from 13 clinical research centers nationwide who participated in the National TCM Clinical Research Base（ Hubei） from June2012 to August 2016 were selected to retrospectively analyze the clinical compliance of the subjects. By using the＂arrival rate＂method,the assessment of subject compliance was conducted. Logistic regression was used to analyze the influencing factors of clinical compliance. Results A total of 620 cases were included in the study. After follow-up for 48 weeks,59 cases（ 9. 5%） were lost. 561 participants（ 90. 5%） completed all visits,including 356 participants（ 63. 5%） that visited on time and completed relevant examinations and tests,and 205 participants（ 36. 5%） that visited over the deadline or did not complete the related clinical data as required. The compliance of subjects in different regions decreased gradually in 4,8,12,24,36,and 48 weeks（ P 〈 0. 01）. Univariate analysis showed statistical difference（ P 〈 0. 05） in 6 clinical compliance differences including family history,clinical research coordinator（ CRC）,chronic liver disease quality of life questionnaire（ CLDQ）,Short Form 36 Health Survey Questionnaire（ SF-36）,health changes,and TCM syndrome scores. Regression analysis showed that the impact of CRC and SF-36 scores on clinical compliance was prominent. CRC was positively correlated with clinical compliance（ P 〈 0. 05）,and SF-36 scores was negatively correlated with clinical compliance（ P 〈 0. 05）. At the same time,the results showed that the patient’s family history,CLDQ,health changes,TCM syndrome scores,etc. did not show a correlation with compliance. Conclusion The on-time visit rate gradually decreases with the extension of follow-up time. CRC and SF-36 scores are important influencing factors of clinical compliance.
作者
陶军秀
李晓东
梁海莉
何堂清
任朦
卢晨霞
余曼琪
鄢灯莹
皇甫炎林
TAO Junxiu;LI Xiaodong;LIANG Haili;HE Tangqiang;REN Meng;LU Chenxia;YU Manqi;YAN Dengying;HUANGFU Yanlin(Hubei Provincial Hospital of Traditional Chinese Medicine,Wuhan 430061;Hubei Academy of Traditional Chinese Medicine;Hubei University of Chinese Medicine)
出处
《中医杂志》
CSCD
北大核心
2018年第19期1661-1666,共6页
Journal of Traditional Chinese Medicine
基金
国家中医临床研究基地业务建设科研专项(JDZX2012051)
关键词
慢性乙型肝炎
中医药临床研究
临床依从性
chronic hepatitis B
traditional Chinese medicine clinical research
clinical compliance
