Platt Lucy, Minozzi Silvia, Reed Jennifer, Vickerman Peter, Hagan Holly, French Clare, Jordan Ashly, Degenhardt Louisa, Hope Vivian, Hutchinson Sharon, Maher Lisa, Palmateer Norah, Taylor Avril, Bruneau Julie, Hickman Matthew
Department of Social and Environmental Health Research, London School of Hygiene and Tropical Medicine, 15 - 17 Tavistock Place, London, UK, WC1H 9SH.
Cochrane Database Syst Rev. 2017 Sep 18;9(9):CD012021. doi: 10.1002/14651858.CD012021.pub2.
Needle syringe programmes and opioid substitution therapy for preventing hepatitis C transmission in people who inject drugsNeedle syringe programmes (NSP) and opioid substitution therapy (OST) are the primary interventions to reduce hepatitis C (HCV) transmission in people who inject drugs. There is good evidence for the effectiveness of NSP and OST in reducing injecting risk behaviour and increasing evidence for the effectiveness of OST and NSP in reducing HIV acquisition risk, but the evidence on the effectiveness of NSP and OST for preventing HCV acquisition is weak.
To assess the effects of needle syringe programmes and opioid substitution therapy, alone or in combination, for preventing acquisition of HCV in people who inject drugs.
We searched the Cochrane Drug and Alcohol Register, CENTRAL, the Cochrane Database of Systematic Reviews (CDSR), the Database of Abstracts of Reviews of Effects (DARE), the Health Technology Assessment Database (HTA), the NHS Economic Evaluation Database (NHSEED), MEDLINE, Embase, PsycINFO, Global Health, CINAHL, and the Web of Science up to 16 November 2015. We updated this search in March 2017, but we have not incorporated these results into the review yet. Where observational studies did not report any outcome measure, we asked authors to provide unpublished data. We searched publications of key international agencies and conference abstracts. We reviewed reference lists of all included articles and topic-related systematic reviews for eligible papers.
We included prospective and retrospective cohort studies, cross-sectional surveys, case-control studies and randomised controlled trials that measured exposure to NSP and/or OST against no intervention or a reduced exposure and reported HCV incidence as an outcome in people who inject drugs. We defined interventions as current OST (within previous 6 months), lifetime use of OST and high NSP coverage (regular attendance at an NSP or all injections covered by a new needle/syringe) or low NSP coverage (irregular attendance at an NSP or less than 100% of injections covered by a new needle/syringe) compared with no intervention or reduced exposure.
We followed the standard Cochrane methodological procedures incorporating new methods for classifying risk of bias for observational studies. We described study methods against the following 'Risk of bias' domains: confounding, selection bias, measurement of interventions, departures from intervention, missing data, measurement of outcomes, selection of reported results; and we assigned a judgment (low, moderate, serious, critical, unclear) for each criterion.
We identified 28 studies (21 published, 7 unpublished): 13 from North America, 5 from the UK, 4 from continental Europe, 5 from Australia and 1 from China, comprising 1817 incident HCV infections and 8806.95 person-years of follow-up. HCV incidence ranged from 0.09 cases to 42 cases per 100 person-years across the studies. We judged only two studies to be at moderate overall risk of bias, while 17 were at serious risk and 7 were at critical risk; for two unpublished datasets there was insufficient information to assess bias. As none of the intervention effects were generated from RCT evidence, we typically categorised quality as low. We found evidence that current OST reduces the risk of HCV acquisition by 50% (risk ratio (RR) 0.50, 95% confidence interval (CI) 0.40 to 0.63, I = 0%, 12 studies across all regions, N = 6361), but the quality of the evidence was low. The intervention effect remained significant in sensitivity analyses that excluded unpublished datasets and papers judged to be at critical risk of bias. We found evidence of differential impact by proportion of female participants in the sample, but not geographical region of study, the main drug used, or history of homelessness or imprisonment among study samples.Overall, we found very low-quality evidence that high NSP coverage did not reduce risk of HCV acquisition (RR 0.79, 95% CI 0.39 to 1.61) with high heterogeneity (I = 77%) based on five studies from North America and Europe involving 3530 participants. After stratification by region, high NSP coverage in Europe was associated with a 76% reduction in HCV acquisition risk (RR 0.24, 95% CI 0.09 to 0.62) with less heterogeneity (I =0%). We found low-quality evidence of the impact of combined high coverage of NSP and OST, from three studies involving 3241 participants, resulting in a 74% reduction in the risk of HCV acquisition (RR 0.26 95% CI 0.07 to 0.89).
AUTHORS' CONCLUSIONS: OST is associated with a reduction in the risk of HCV acquisition, which is strengthened in studies that assess the combination of OST and NSP. There was greater heterogeneity between studies and weaker evidence for the impact of NSP on HCV acquisition. High NSP coverage was associated with a reduction in the risk of HCV acquisition in studies in Europe.
用于预防注射吸毒者丙型肝炎传播的针具交换项目和阿片类药物替代疗法
针具交换项目(NSP)和阿片类药物替代疗法(OST)是减少注射吸毒者丙型肝炎(HCV)传播的主要干预措施。有充分证据表明NSP和OST在降低注射风险行为方面有效,且越来越多证据表明OST和NSP在降低感染HIV风险方面有效,但关于NSP和OST预防HCV感染有效性的证据不足。
评估针具交换项目和阿片类药物替代疗法单独或联合使用对预防注射吸毒者感染HCV的效果。
我们检索了Cochrane药物与酒精注册库、CENTRAL、Cochrane系统评价数据库(CDSR)、效果评价文摘数据库(DARE)、卫生技术评估数据库(HTA)、英国国家医疗服务体系经济评价数据库(NHSEED)、MEDLINE、Embase、PsycINFO、全球健康数据库、护理学与健康领域数据库(CINAHL)以及科学引文索引数据库,检索截至2015年11月16日。我们于2017年3月更新了检索,但尚未将这些结果纳入本综述。对于未报告任何结局指标的观察性研究,我们要求作者提供未发表的数据。我们检索了主要国际机构的出版物和会议摘要。我们查阅了所有纳入文章的参考文献列表以及与主题相关的系统评价以寻找符合条件的论文。
我们纳入了前瞻性和回顾性队列研究、横断面调查、病例对照研究以及随机对照试验,这些研究测量了接受NSP和/或OST与未干预或较低暴露水平相比的情况,并将HCV发病率作为注射吸毒者的一项结局指标进行报告。我们将干预措施定义为当前的OST(在过去6个月内)、终身使用OST以及高NSP覆盖率(定期参加NSP或所有注射均使用新针具/注射器)或低NSP覆盖率(不定期参加NSP或新针具/注射器覆盖的注射次数少于100%),并与未干预或较低暴露水平进行比较。
我们遵循Cochrane标准方法程序,并纳入了用于评估观察性研究偏倚风险的新方法。我们根据以下“偏倚风险”领域描述研究方法:混杂因素、选择偏倚、干预措施的测量、干预措施的偏离、缺失数据、结局指标的测量、报告结果的选择;并且我们为每个标准给出一个判断(低、中、严重、关键、不清楚)。
我们识别出28项研究(21项已发表,7项未发表):13项来自北美,5项来自英国,4项来自欧洲大陆,5项来自澳大利亚,1项来自中国,共包括1817例HCV感染病例和8806.95人年的随访。各研究中HCV发病率范围为每100人年0.09例至42例。我们仅判断两项研究总体偏倚风险为中度,而17项为严重风险,7项为关键风险;对于两个未发表的数据集,没有足够信息评估偏倚。由于没有干预效应来自随机对照试验证据,我们通常将质量归类为低。我们发现有证据表明当前的OST可将HCV感染风险降低50%(风险比(RR)0.50,95%置信区间(CI)0.40至0.63,I² = 0%,来自所有地区的12项研究,N = 6361),但证据质量低。在排除未发表数据集和被判断为存在关键偏倚风险的论文的敏感性分析中,干预效应仍然显著。我们发现样本中女性参与者比例存在差异影响的证据,但未发现研究的地理区域、主要使用的毒品、研究样本中的无家可归或监禁史存在差异影响的证据。
总体而言,基于来自北美和欧洲的五项涉及3530名参与者的研究,我们发现极低质量的证据表明高NSP覆盖率并未降低HCV感染风险(RR 0.79,95% CI 0.39至1.61),异质性高(I² = 77%)。按地区分层后,欧洲的高NSP覆盖率与HCV感染风险降低76%相关(RR 0.24,95% CI 0.09至0.62),异质性较小(I² = 0%)。我们发现来自三项涉及3241名参与者的研究的低质量证据表明,NSP和OST高覆盖率联合使用的影响是将HCV感染风险降低74%(RR 0.26,95% CI 0.07至0.89)。
OST与HCV感染风险降低相关,在评估OST和NSP联合使用的研究中这种关联得到加强。研究之间的异质性更大,NSP对HCV感染影响的证据较弱。在欧洲的研究中,高NSP覆盖率与HCV感染风险降低相关。