MSM艾滋病暴露前预防用药临床试验队列保持影响因素分析

发布时间：2018-12-16 16:24

【摘要】：目的了解男男性行为人群(Men who have Sex with Men,MSM)艾滋病暴露前预防用药(Pre-exposure Prophylaxis,PrEP)临床试验的新发感染和队列保持情况,探讨影响MSM人群队列保持率的影响因素。方法 2013年7月开始通过"滚雪球"法等方式在成都地区招募HIV阴性的MSM。受试对象随机分为3组:时间组(每日口服TDF 300 mg)、事件组(同性性行为前48~24 h口服1次TDF 300 mg,在同性性行为后加服1次TDF 300 mg,24 h内服药量不超过300 mg)和对照组(不服用任何药物),3组人数的比例为1∶1∶1。每3个月进行1次随访,并进行相应的血液、体格等检查。对队列保持情况进行评价,并用Cox模型探讨可能的影响因素。结果时间组、事件组和空白组HIV阳转率分别是7.6/100人年、12.9/100人年和11.0/100人年。与对照组比较,时间组和事件组药物保护率分别为31.0%和-17.1%。37.5%(123/328)的受试者入组后即失访,队列保持率为29.9%(98/328)。多因素分析显示,30~39岁(RR=0.66,95%CI:0.48~0.91)、做过HIV病毒检测(RR=0.61,95%CI:0.44~0.84)的MSM的队列保持情况更好。结论本研究HIV阳转率较高,未显示出PrEP降低HIV新发感染的效果。队列保持率低,脱落主要发生在第一次随访。建议应关注队列中的高、低年龄段和未做过HIV检测服务的MSM,制定多种队列保持策略进行管理。
[Abstract]:Objective to investigate the status of new infection and cohort maintenance in (Men who have Sex with Men,MSM) pre-exposure prophylaxis drug (Pre-exposure Prophylaxis,PrEP) trials and to explore the influencing factors of cohort retention rate in MSM population. Methods in July 2013, HIV negative MSM. was recruited in Chengdu by "snowball" method. Participants were randomly divided into three groups: time group (TDF 300 mg), event group) (TDF 300 mg, once a day for 24 hours before same-sex, plus TDF 300 mg, after same-sex). The ratio of three groups was 1: 1: 1: 1. Follow-up every 3 months, and corresponding blood, physical examination and so on. The queue retention was evaluated and the possible influencing factors were discussed by Cox model. Results the HIV positive conversion rates in time group, event group and blank group were 7.6 / 100 person-years, 12.9 / 100 person-years and 11.0 / 100 person-years, respectively. Compared with the control group, the drug protection rates in the time group and the event group were 31.0% and -17.1.37.5% (123 / 328), and the retention rate of the cohort was 29.9% (98 / 328). Multivariate analysis showed that MSM, 30 to 39 years old (RR=0.66,95%CI:0.48~0.91) and tested for HIV virus (RR=0.61,95%CI:0.44~0.84), had better cohort retention. Conclusion the positive conversion rate of HIV in this study is high, and the effect of PrEP on reducing the new infection of HIV is not obvious. The retention rate of the cohort was low and the shedding occurred mainly at the first follow-up. It is suggested that the MSM, with high, low age and no HIV detection service should be concerned about the management of multiple queue retention strategies.
【作者单位】：四川大学华西公共卫生学院(华西第四医院);
【基金】："十二五"国家艾滋病和病毒性肝炎等重大传染病防治专项(项目编号:0040405419044)
【分类号】：R512.91

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