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目的:了解男男性行为者(men who have sex with men,MSM)在艾滋病暴露前预防用药(pre-exposure prophylaxis,Pr EP)临床试验中的队列保持力及其影响因素。方法:采用非概率抽样法招募并筛选出297名MSM进入研究,随机分为每日用药组、高危行为前后用药组和空白对照组,每3月进行临床随访和问卷调查。利用Kaplan-Meier估计的生存曲线描述不同试验组的累积队列保持率,单因素和多因素Cox回归用于分析队列保持的影响因素。结果:43.1%(128/297)的MSM完成了本研究的随访,队列平均保持时间(5.85±3.99)月。高危行为前后用药组相对空白对照组(AHR=0.62,95%CI=0.42~0.91)、年龄30岁以上(AHR=0.65,95%CI=0.47~0.90)的MSM有更高的队列保持力。结论:本研究中MSM人群Pr EP临床试验队列保持力不高,在后期研究中需加强空白对照组和低年龄MSM的队列管理,以提高临床试验的队列保持力。
Objective: To investigate the cohort retention and its influencing factors in men who have sex with men (MS-M) in pre-exposure prophylaxis (Pr EP) clinical trials. Methods: 297 MSM patients were enrolled and screened by non-probabilistic sampling method and randomly divided into daily medication group, high-risk medication group and blank control group. Clinical follow-up and questionnaire survey were conducted every 3 months. Survival curves of Kaplan-Meier estimates were used to describe the cumulative cohort retention rates of different groups. Univariate and multivariate Cox regression was used to analyze the influence of cohort maintenance. RESULTS: 43.1% (128/297) of the MSMs completed the follow-up of this study with an average retention time of 5.85 ± 3.99 months. Compared with the blank control group (AHR = 0.62, 95% CI = 0.42-0.91), the MSM of patients aged 30 years and older (AHR = 0.65, 95% CI = 0.47-0.90) had higher cohort retention. CONCLUSIONS: In this study, the PrP clinical trial cohort retention was not high in the MSM population. In the later study, cohort management of the blank control group and the low-age MSM should be strengthened to improve the cohort retention of the clinical trial.