RTI International-University of North Carolina at Chapel Hill Evidence-based Practice Center2Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill3Department of Medicine, University of North Carolina at Chapel Hill.
RTI International-University of North Carolina at Chapel Hill Evidence-based Practice Center.
JAMA. 2016 Dec 20;316(23):2531-2543. doi: 10.1001/jama.2016.17138.
Genital herpes simplex virus (HSV) infection is a prevalent sexually transmitted infection. Vertical transmission of HSV can lead to fetal morbidity and mortality.
To assess the evidence on serologic screening and preventive interventions for genital HSV infection in asymptomatic adults and adolescents to support the US Preventive Services Task Force for an updated recommendation statement.
MEDLINE, Cochrane Library, EMBASE, and trial registries through March 31, 2016. Surveillance for new evidence in targeted publications was conducted through October 31, 2016.
English-language randomized clinical trials (RCTs) comparing screening with no screening in persons without past or current symptoms of genital herpes; studies evaluating accuracy and harms of serologic screening tests for HSV-2; RCTs assessing preventive interventions in asymptomatic persons seropositive for HSV-2.
Dual review of abstracts, full-text articles, and study quality; pooled sensitivities and specificities of screening tests using a hierarchical summary receiver operating characteristic curve analysis when at least 3 similar studies were available.
Accuracy of screening tests, benefits of screening, harms of screening, reduction in genital herpes outbreaks.
A total of 17 studies (n = 9736 participants; range, 24-3290) in 19 publications were included. No RCTs compared screening with no screening. Most studies of the accuracy of screening tests were from populations with high HSV-2 prevalence (greater than 40% based on Western blot). Pooled estimates of sensitivity and specificity of the most commonly used test at the manufacturer's cutpoint were 99% (95% CI, 97%-100%) and 81% (95% CI, 68%-90%), respectively (10 studies; n = 6537). At higher cutpoints, pooled estimates were 95% (95% CI, 91%-97%) and 89% (95% CI, 82%-93%), respectively (7 studies; n = 5516). Use of this test at the manufacturer's cutpoint in a population of 100 000 with a prevalence of HSV-2 of 16% (the seroprevalence in US adults with unknown symptom status) would result in 15 840 true-positive results and 15 960 false-positive results (positive predictive value, 50%). Serologic screening for genital herpes was associated with psychosocial harms, including distress and anxiety related to positive test results. Four RCTs compared preventive medications with placebo, 2 in nonpregnant asymptomatic adults who were HSV-2 seropositive and 2 in HSV-2-serodiscordant couples. Results in both populations were heterogeneous and inconsistent.
Serologic screening for genital herpes is associated with a high rate of false-positive test results and potential psychosocial harms. Evidence from RCTs does not establish whether preventive antiviral medication for asymptomatic HSV-2 infection has benefit.
单纯疱疹病毒（HSV）感染是一种常见的性传播感染。HSV 的垂直传播可导致胎儿发病率和死亡率。
评估无症状成人和青少年生殖器 HSV 感染的血清学筛查和预防干预措施的证据，以支持美国预防服务工作组更新推荐声明。
MEDLINE、Cochrane 图书馆、EMBASE 和试验登记处，截至 2016 年 3 月 31 日。通过 2016 年 10 月 31 日，对目标出版物中的新证据进行了监测。
与无症状人群的 HSV-2 血清学筛查试验的准确性和危害评估有关的无过去或当前生殖器疱疹症状的人群进行筛查的英语随机临床试验（RCT）；评估无症状 HSV-2 血清阳性者预防干预措施的 RCT。
对摘要、全文文章和研究质量进行双重审查；当至少有 3 项类似研究可用时，使用分层综合接收者操作特性曲线分析对筛查试验的敏感性和特异性进行汇总。
筛查试验的准确性、筛查的益处、筛查的危害、生殖器疱疹发作的减少。
19 篇文献共纳入 17 项研究（n=9736 名参与者；范围，24-3290）。没有 RCT 比较过筛查和不筛查。大多数筛查试验准确性的研究来自 HSV-2 流行率较高的人群（基于 Western blot 的流行率大于 40%）。制造商临界点最常用测试的汇总估计敏感性和特异性分别为 99%（95%CI，97%-100%）和 81%（95%CI，68%-90%）（10 项研究；n=6537）。在更高的临界点，汇总估计分别为 95%（95%CI，91%-97%）和 89%（95%CI，82%-93%）（7 项研究；n=5516）。在流行率为 16%（美国无症状人群的血清流行率）的 100000 人中使用该试验的制造商临界点，将产生 15840 个真阳性结果和 15960 个假阳性结果（阳性预测值，50%）。生殖器疱疹的血清学筛查与心理社会危害相关，包括与阳性检测结果相关的痛苦和焦虑。四项 RCT 比较了预防药物与安慰剂，两项在 HSV-2 血清阳性的无症状成年人中进行，两项在 HSV-2 血清不一致的夫妇中进行。这两种人群的结果均不一致且不一致。
生殖器疱疹的血清学筛查与高假阳性检测结果和潜在的心理社会危害有关。来自 RCT 的证据并不能确定无症状 HSV-2 感染的预防性抗病毒药物是否有益。
