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Clin Toxicol (Phila). 2018 Jul;56(7):633-639. doi: 10.1080/15563650.2017.1394465. Epub 2017 Nov 3.

High-dose immunosuppression to prevent death after paraquat self-poisoning - a randomised controlled trial.

Author information

1
a Department of Medicine, Faculty of Medicine , University of Peradeniya , Peradeniya , Sri Lanka.
2
b South Asian Clinical Toxicology Research Collaboration, Faculty of Medicine , University of Peradeniya , Peradeniya , Sri Lanka.
3
c Department of Pharmacology , University of Sydney , Sydney , Australia.
4
d Royal Prince Alfred Hospital , Sydney , Australia.
5
e Peradeniya Hospitals , Peradeniya , Sri Lanka.
6
f Anuradhapura Hospitals , Anuradhapura , Sri Lanka.
7
g Rathnapura Hospitals , Rathnapura , Sri Lanka.
8
h Faculty of Medicine , University of Ruhuna , Galle , Sri Lanka.
9
i Therapeutics Research Centre, School of Medicine , University of Queensland , Brisbane , Australia.
10
j Department of Forensic Medicine, Faculty of Medicine , Chiang Mai University , Chiang Mai , Thailand.
11
k National Drug and Alcohol Research Centre , Sydney , Australia.
12
l Causation Limited , Macclesfield , UK.
13
m Swiss Centre for Applied Human Toxicology , University of Basel , Basel , Switzerland.
14
n Department of Pharmacology, Toxicology and Therapeutics , University/BHF Centre for Cardiovascular Science, University of Edinburgh and National Poisons Information Service - Edinburgh Unit, Royal Infirmary of Edinburgh , Edinburgh , UK.

Abstract

CONTEXT:

Intentional self-poisoning with the herbicide paraquat has a very high case-fatality and is a major problem in rural Asia and Pacific.

OBJECTIVES:

We aimed to determine whether the addition of immunosuppression to supportive care offers benefit in resource poor Asian district hospitals.

MATERIALS AND METHODS:

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.

RESULTS:

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.

CONCLUSIONS:

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.

KEYWORDS:

Paraquat; acute self-poisoning; immunosuppression; randomised controlled trial

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