a Department of Medicine, Faculty of Medicine , University of Peradeniya , Peradeniya , Sri Lanka.
b South Asian Clinical Toxicology Research Collaboration, Faculty of Medicine , University of Peradeniya , Peradeniya , Sri Lanka.
Clin Toxicol (Phila). 2018 Jul;56(7):633-639. doi: 10.1080/15563650.2017.1394465. Epub 2017 Nov 3.
Intentional self-poisoning with the herbicide paraquat has a very high case-fatality and is a major problem in rural Asia and Pacific.
We aimed to determine whether the addition of immunosuppression to supportive care offers benefit in resource poor Asian district hospitals.
We performed a randomised placebo-controlled trial comparing immunosuppression (intravenous cyclophosphamide up to 1 g/day for two days and methylprednisolone 1 g/day for three days, and then oral dexamethasone 8 mg three-times-a-day for 14 days) with saline and placebo tablets, in addition to standard care, in patients with acute paraquat self-poisoning admitted to six Sri Lankan hospitals between 1st March 2007 and 15th November 2010. The primary outcome was in-hospital mortality.
299 patients were randomised to receive immunosuppression (147) or saline/placebo (152). There was no significant difference in in-hospital mortality rates between the groups (immunosuppression 78 [53%] vs. placebo 94 [62%] (Chi squared test 2.4, p = .12). There was no difference in mortality at three months between the immunosuppression (101/147 [69%]) and placebo groups (108/152 [71%]); (mortality reduction 2%, 95% CI: -8 to +12%). A Cox model did not support benefit from high-dose immunosuppression but suggested potential benefit from the subsequent two weeks of dexamethasone.
We found no evidence that high dose immunosuppression improves survival in paraquat-poisoned patients. The continuing high mortality means further research on the use of dexamethasone and other potential treatments is urgently needed.
有意自服除草剂百草枯中毒的病死率极高，是亚洲和太平洋地区农村地区的一个主要问题。
我们旨在确定在资源匮乏的亚洲地区医院中，在支持性治疗的基础上增加免疫抑制治疗是否有益。
我们进行了一项随机安慰剂对照试验，比较了免疫抑制治疗（静脉注射环磷酰胺每天 1g，连用两天，甲基强的松龙每天 1g，连用三天，然后口服地塞米松 8mg，每天 3 次，连用 14 天）与生理盐水和安慰剂片剂，除了标准治疗外，还在 2007 年 3 月 1 日至 2010 年 11 月 15 日期间在斯里兰卡的六家医院收治的急性百草枯中毒患者中进行。主要结局是住院死亡率。
299 例患者被随机分为接受免疫抑制治疗（147 例）或生理盐水/安慰剂（152 例）。两组的住院死亡率无显著差异（免疫抑制组 78[53%]与安慰剂组 94[62%]（卡方检验 2.4，p=0.12）。免疫抑制组（147 例中的 101 例[69%]）和安慰剂组（152 例中的 108 例[71%]）在三个月时的死亡率也没有差异；死亡率降低 2%，95%CI：-8 至+12%）。Cox 模型不支持大剂量免疫抑制治疗的获益，但提示地塞米松随后两周的治疗可能有益。
我们没有发现高剂量免疫抑制治疗能改善百草枯中毒患者的生存率。持续高死亡率意味着迫切需要对地塞米松和其他潜在治疗方法的使用进行进一步研究。
