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抗地高辛Fab片段治疗夹竹桃中毒所致心脏毒性的随机对照试验。

Anti-digoxin Fab fragments in cardiotoxicity induced by ingestion of yellow oleander: a randomised controlled trial.

作者信息

Eddleston M, Rajapakse S, Jayalath S, Sjöström L, Santharaj W, Thenabadu P N, Sheriff M H, Warrell D A

机构信息

Centre for Tropical Medicine, Nuffield Department of Clinical Medicine, University of Oxford, UK.

出版信息

Lancet. 2000 Mar 18;355(9208):967-72. doi: 10.1016/s0140-6736(00)90014-x.

DOI:10.1016/s0140-6736(00)90014-x
PMID:10768435
Abstract

BACKGROUND

Severe cardiac glycoside cardiotoxicity after ingestion of yellow oleander seeds is an important problem in rural areas of Sri Lanka. Currently, patients must be transferred to the capital for temporary cardiac pacing. We did a randomised controlled trial to investigate whether anti-digoxin Fab could reverse serious oleander-induced arrhythmias.

METHODS

After a preliminary dose-finding study, 66 patients who presented to hospital with a serious cardiac arrhythmia were randomised to receive either 1200 mg of anti-digoxin Fab or a saline placebo. A 12-lead electrocardiogram, 3 min rhythm strip, and blood sample for measurement of electrolytes and cardiac glycosides were taken before treatment and at 12 timepoints thereafter.

FINDINGS

34 patients received anti-digoxin Fab and 32 received placebo. The presenting arrhythmia had resolved completely after 2 h in 15 antibody-treated patients and two controls (p<0.001); 24 and five patients, respectively, were in sinus rhythm at 8 h (p<0.001). Kaplan-Meier analysis of time to first reversal showed a significant response to anti-digoxin Fab. The heart rate increased in cases, from 49.1 per min at baseline to 66.8 at 2 h, but not in controls (50.6 per min at baseline to 51.5; p<0.001). Mean serum potassium concentrations decreased from 4.9 mmol/L to 4.1 mmol/L at 2 h in cases; no such decrease occurred in controls.

INTERPRETATION

Anti-digoxin Fab fragments are a safe and effective treatment for serious cardiac arrhythmias induced by yellow oleander. Their use in small rural hospitals in Sri Lanka should minimise costly transfer of patients and reduce the numbers of deaths; however, further study will be required to confirm this reduction.

摘要

背景

摄入黄花夹竹桃种子后出现严重的强心苷心脏毒性是斯里兰卡农村地区的一个重要问题。目前,患者必须被转运至首都进行临时心脏起搏。我们进行了一项随机对照试验,以研究抗地高辛Fab片段是否能逆转黄花夹竹桃引起的严重心律失常。

方法

在一项初步的剂量探索研究之后,66例因严重心律失常入院的患者被随机分配接受1200mg抗地高辛Fab片段或生理盐水安慰剂。在治疗前及之后的12个时间点采集12导联心电图、3分钟节律条图以及用于检测电解质和强心苷的血样。

结果

34例患者接受了抗地高辛Fab片段治疗,32例接受了安慰剂治疗。15例接受抗体治疗的患者和2例对照组患者的心律失常在2小时后完全缓解(p<0.001);分别有24例和5例患者在8小时时恢复窦性心律(p<0.001)。对首次逆转时间的Kaplan-Meier分析显示,抗地高辛Fab片段有显著疗效。治疗组患者的心率从基线时的每分钟49.1次增加到2小时时的每分钟66.8次,而对照组未增加(基线时每分钟50.6次至51.5次;p<0.001)。治疗组患者的平均血清钾浓度在2小时时从4.9mmol/L降至4.1mmol/L;对照组未出现这种下降。

解读

抗地高辛Fab片段是治疗黄花夹竹桃引起的严重心律失常的一种安全有效的疗法。在斯里兰卡的小型农村医院使用该疗法应能尽量减少患者昂贵的转运费用并降低死亡人数;然而,还需要进一步研究来证实这种死亡人数的减少。

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