Pawar Kirti S, Bhoite Ramesh R, Pillay Chandrakant P, Chavan Sujata C, Malshikare Dhananjay S, Garad Saraswati G
Giriraj Hospital and Intensive Care Unit, Baramati, Pune, Maharashtra, India.
Lancet. 2006 Dec 16;368(9553):2136-41. doi: 10.1016/S0140-6736(06)69862-0.
The role of oximes for the treatment of organophosphorus pesticide poisoning has not been conclusively established. We aimed to assess the effectiveness of a constant pralidoxime infusion compared with repeated bolus doses to treat patients with moderately severe poisoning from organophosphorus pesticides.
200 patients were recruited to our single-centre, open randomised controlled trial after moderately severe poisoning by anticholinesterase pesticide. All were given a 2 g loading dose of pralidoxime over 30 min. Patients were then randomly assigned to control and study groups. Controls were given a bolus dose of 1 g pralidoxime over 1 h every 4 h for 48 h. The study group had a constant infusion of 1 g over an hour every hour for 48 h. Thereafter, all patients were given 1 g every 4 h until they could be weaned from ventilators. Analysis was by intention to treat. Primary outcome measures were median atropine dose needed within 24 h, proportion of patients who needed intubation, and number of days on ventilation. The study is registered at http://www.clinicaltrials.gov with the identifier NCT00333944.
100 patients were assigned the high-dose regimen, and 100 the control regimen. There were no drop-outs. Patients receiving the high-dose pralidoxime regimen required less atropine during the first 24 h than controls (median 6 mg vs 30 mg; difference 24 mg [95% CI 24-26, p<0.0001]). 88 (88%) and 64 (64%) of controls and high-dose patients, respectively, needed intubation during admission to hospital (relative risk=0.72, 0.62-0.86, p=0.0001). Control patients required ventilatory support for longer (median 10 days vs 5 days; difference 5 days [5-6, p<0.0001]).
A high-dose regimen of pralidoxime, consisting of a constant infusion of 1 g/h for 48 h after a 2 g loading dose, reduces morbidity and mortality in moderately severe cases of acute organophosphorus-pesticide poisoning.
肟类药物在有机磷农药中毒治疗中的作用尚未最终确定。我们旨在评估持续输注氯解磷定与重复推注剂量相比，在治疗中度重度有机磷农药中毒患者中的有效性。
200例因抗胆碱酯酶农药导致中度重度中毒的患者被纳入我们的单中心、开放随机对照试验。所有患者均在30分钟内给予2g氯解磷定负荷剂量。然后将患者随机分为对照组和研究组。对照组每4小时在1小时内给予1g氯解磷定推注剂量，共48小时。研究组在48小时内每小时持续输注1g，共1小时。此后，所有患者每4小时给予1g，直至可以撤掉呼吸机。分析采用意向性分析。主要结局指标为24小时内所需阿托品剂量中位数、需要插管的患者比例以及机械通气天数。该研究已在http://www.clinicaltrials.gov注册，标识符为NCT00333944。
100例患者被分配至高剂量方案组，100例被分配至对照组。无患者退出。接受高剂量氯解磷定方案的患者在最初24小时内所需阿托品比对照组少（中位数6mg对30mg；差值24mg[95%CI 24 - 26，p<0.0001]）。对照组和高剂量组分别有88例（88%）和64例（64%）患者在入院期间需要插管（相对风险=0.72，0.62 - 0.86，p = 0.0001）。对照组患者需要机械通气支持的时间更长（中位数10天对5天；差值5天[5 - 6，p<0.0001]）。
高剂量氯解磷定方案，即在2g负荷剂量后持续48小时每小时输注1g，可降低中度重度急性有机磷农药中毒病例的发病率和死亡率。
