Cui Jian-Wei, Xu Yinyan, Wang Yibo, Gao Yan-Xia, Guo Shigong, Wang Meng, Lu Xin, Yu Shiyuan, Ma Yong, Yuan Ding, Che Lu, Sun Pei, Yu Xuezhong, Zhu Huadong, Li Yi
Emergency Department, Peking Union Medical College Hospital, Beijing, China.
Department of Neurology, Peking Union Medical College Hospital, Beijing, China.
BMJ Open. 2018 Jun 22;8(6):e021964. doi: 10.1136/bmjopen-2018-021964.
Paraquat (PQ) is a widely used herbicide which is inexpensive and easily accessible for people in rural areas. A small amount of PQ ingestion could be lethal, yet currently, the optimal treatment is still controversial. Extracorporeal therapies (ECTR) have been practised in PQ poisoning management, though limited evidence could be obtained to suggest its superiority over conservative therapy. Haemodialysis (HD) and haemoperfusion (HP) are most commonly used, while some institutions also choose HP-HD concurrent therapy. The object of the present trial is to investigate whether haemopurification therapy can reduce mortality compared with conservative therapy.
This is a planned single-centre, non-blinded, randomised controlled trial. Acute PQ poisoned adults who have orally ingested PQ within 24 hours would be recruited. A total of 360 patients would be recruited and randomly assigned to four groups, that is, HP, HD, concurrent HP-HD and control, at a 1:1:1:1 ratio. Subjects would be also stratified by their urine dithionite test results. Primary outcome is 28-day all-cause mortality. Secondary outcomes include survival time, all-cause mortality at the 3rd, 7th and 60th day, rate of major complications, Acute Physiologic and Chronic Health Evaluation score and Poisoning Severity Score, etc. ETHICS AND DISSEMINATION: The protocol and informed consent documents have been approved by the Ethics Committee of The First Affiliated Hospital of Zhengzhou University in September 2017 (approval number: 2017-KY-10). The result of this trial would be submitted to peer-reviewed journal.
NCT03314909; Pre-results.
百草枯（PQ）是一种广泛使用的除草剂，价格低廉，农村地区的人们容易获取。少量摄入百草枯可能致命，但目前，最佳治疗方法仍存在争议。在百草枯中毒的治疗中已采用体外治疗（ECTR），不过能证明其优于保守治疗的证据有限。血液透析（HD）和血液灌流（HP）是最常用的方法，而一些机构也选择血液灌流 - 血液透析联合治疗。本试验的目的是研究血液净化疗法与保守治疗相比是否能降低死亡率。
这是一项计划中的单中心、非盲、随机对照试验。将招募在24小时内口服百草枯的急性百草枯中毒成年人。总共将招募360名患者，并按1:1:1:1的比例随机分为四组，即血液灌流组、血液透析组、血液灌流 - 血液透析联合组和对照组。受试者还将根据其尿液连二亚硫酸盐试验结果进行分层。主要结局是28天全因死亡率。次要结局包括生存时间、第3天、第7天和第60天的全因死亡率、主要并发症发生率、急性生理与慢性健康状况评分系统（APACHE）评分和中毒严重程度评分等。伦理与传播：该方案和知情同意书于2017年9月已获得郑州大学第一附属医院伦理委员会批准（批准号：2017 - KY - 10）。本试验结果将提交给同行评审期刊。
NCT03314909；预结果。
