HIV感染者固定性伴侣暴露前预防用药临床试验依从性分析  

Compliance analysis of pre-exposure prophylaxis clinical trial in fixed sexual partners of HIV-infected individuals

作　　者：高菲菲[1] 钟晓妮[1] 彭斌[1] 张燕[1] 梁浩[2] 邹云峰[3] 戴江红[4] 刘倩萍[5] 宋本莉[5] 黄文祥[6] 黄爱龙[7] 

机构地区：[1]重庆医科大学公共卫生学院卫生统计教研室,重庆400016 [2]广西医科大学公共卫生学院流行病与卫生统计教研室,广西南宁530021 [3]广西医科大学公共卫生学院毒理学教研室,广西南宁530021 [4]新疆医科大学公共卫生学院流行病与卫生统计教研室,新疆乌鲁木齐830000 [5]西昌市皮肤病性病防治站,四川西昌615000 [6]重庆医科大学附属第一医院,重庆400016 [7]重庆医科大学感染性疾病分子生物学教育部重点实验室,重庆400016

出　　处：《中国新药与临床杂志》2013年第1期34-41,共8页Chinese Journal of New Drugs and Clinical Remedies

基　　金：国家科技重大专项(2008ZX10001-016)

摘　　要：目的了解HIV感染者固定性伴侣（PAR）暴露前预防用药（PREP）临床试验的依从性及其可能的影响因素。方法采用非随机抽样筛选出163位PAR进入研究队列，随机决定其每日1次或每周2次服药方式，分别在第0、4、8、12、16、20、24、28周进行随访观察．从队列保持和药物漏服两个方面了解其依从性情况。利用X^2检验进行单因素分析，多因素分析采用logistic回归分析。结果本次PAR人群PrEP临床试验中，79．8％（130／163）完成了28周的观察期，药物漏服者所占比例在随访期间始终波动在30％左右，平均每4周药物的漏服次数为2次，总体依从性得分（85．66±25．98）分．中位数97．40分。经logistic回归分析，影响队列保持的因素为年龄、月收入水平、试验期间是否有担心和困难、试验期间是否有医疗服务需求；影响药物漏服的因素为月收入水平、服药方式、随访管理模式、试验期间是否有担心和困难；影响总体依从性得分的因素为年龄、月收入水平、随访管理模式、试验期间是否有医疗服务需求。结论本次PAR人群PrEP临床试验的整体依从性高，影响因素多，在后续研究中应特别加强低年龄、高收入人群的依从性管理，并继续推广由专人随访的队列管理模式和不同特征个体分类管理，从而确保临床试验的高依从性。AIM To investigate the influencing factors of compliance of pre- exposure prophylaxis （PREP） clinical trial among the fixed sexual partners of HIV-infected individuals （PAR）. METHODS Totally 163 PAR were non-randomly selected into the cohort, each subject randomly adopted a medication method either once daily or twice a week. To understand the compliance status, follow- ups concerning the cohort maintenance and drug omit were conducted every 4 weeks from 0 week to 28 week. X2 test was employed to conduct univariate analysis. Logistic regression was adopted to take multiple viarables analysis. RESULTS In this PrEP clinical trial among PAR population, 79.8% （130/163） of the subjects sustained the whole 28 weeks＇ observation period. The omitting drug percentage of these individuals fluctuated around 30%, drugs were omitted twice every 4 weeks, the compliance scores averaged to （85.66 -＋ 25.98） points, and the median of the scores was 97.40 points. Logistic regression suggested that age, monthly income, whether had worries or difficulties during the trials, and whether had medical service needs were the influencing factors of cohort maintenance in the PrEP clinical trials among PAR population; monthly income, medication method, management model of follow-up, and whether had worries or difficulties during the trial were the influencing factors of drug omit; age, monthly income, management model of the follow-up, and whether had medical service needs during the trial were the influencing factors of the overall compliance scores. CONCLUSION The compliance of this PrEP clinical trials among PAR population was good, which had multiple influencing factors. Compliance management toward low age and high income population should be reinforced in further study, cohort management model of specialist follow-up should continue to be promoted, and classified management should be implemented toward individuals with different characters, thus to ensure the good compliance of the clinical trials.

关 键 词：HIV感染者 性伴侣 暴露前预防用药 临床试验 病人依从 

分 类 号：R512.91[医药卫生—内科学]