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用于治疗因蝎子蜇伤导致神经毒性的危重症儿童的抗蛇毒血清。

Antivenom for critically ill children with neurotoxicity from scorpion stings.

作者信息

Boyer Leslie V, Theodorou Andreas A, Berg Robert A, Mallie Joanne, Chávez-Méndez Ariana, García-Ubbelohde Walter, Hardiman Stephen, Alagón Alejandro

机构信息

VIPER Institute, University of Arizona Health Sciences Center, 1295 N. Martin Ave., Tucson, AZ 85721-0202, USA.

出版信息

N Engl J Med. 2009 May 14;360(20):2090-8. doi: 10.1056/NEJMoa0808455.

Abstract

BACKGROUND

Clinically significant scorpion envenomation by Centruroides sculpturatus produces a dramatic neuromotor syndrome and respiratory insufficiency that often necessitate intensive supportive care. We hypothesized that a scorpion-specific F(ab')(2) antivenom would promptly resolve clinical symptoms in children with this syndrome.

METHODS

In a randomized, double-blind study, the efficacy of scorpion-specific F(ab')(2) antivenom, as compared with placebo, was assessed in 15 children 6 months to 18 years of age who were admitted to a pediatric intensive care unit with clinically significant signs of scorpion envenomation. The primary end point was the resolution of the clinical syndrome within 4 hours after administration of the study drug. Secondary end points included the total dose of concomitant midazolam for sedation and quantitative plasma venom levels, before and after treatment.

RESULTS

The clinical syndrome resolved more rapidly among recipients of the antivenom than among recipients of placebo, with a resolution of symptoms in all eight antivenom recipients versus one of seven placebo recipients within 4 hours after treatment (P=0.001). More midazolam was administered in the placebo recipients than in the antivenom recipients (mean cumulative dose, 4.61 vs. 0.07 mg per kilogram of body weight; P=0.01). Plasma venom concentrations were undetectable in all eight antivenom recipients but in only one placebo recipient 1 hour after treatment (P=0.001).

CONCLUSIONS

Among critically ill children with neurotoxic effects of scorpion envenomation, intravenous administration of scorpion-specific F(ab')(2) antivenom resolved the clinical syndrome within 4 hours, reduced the need for concomitant sedation with midazolam, and reduced the levels of circulating unbound venom. (ClinicalTrials.gov number, NCT00685230.)

摘要

背景

雕刻异蝎蜇伤导致的具有临床意义的蝎毒中毒会引发严重的神经运动综合征和呼吸功能不全,常常需要重症支持治疗。我们推测,一种蝎毒特异性F(ab')(2)抗蛇毒血清能迅速缓解该综合征患儿的临床症状。

方法

在一项随机双盲研究中,我们评估了蝎毒特异性F(ab')(2)抗蛇毒血清与安慰剂相比,对15名6个月至18岁因蝎蜇伤出现具有临床意义体征而入住儿科重症监护病房的儿童的疗效。主要终点是在给予研究药物后4小时内临床综合征的缓解情况。次要终点包括治疗前后用于镇静的咪达唑仑总剂量以及血浆毒液定量水平。

结果

抗蛇毒血清组患者临床综合征的缓解速度比安慰剂组更快,治疗后4小时内,8名抗蛇毒血清组患者症状均得到缓解,而7名安慰剂组患者中只有1名症状缓解(P = 0.001)。安慰剂组患者使用的咪达唑仑比抗蛇毒血清组更多(平均累积剂量,每千克体重4.61毫克对0.07毫克;P = 0.01)。治疗1小时后,8名抗蛇毒血清组患者的血浆毒液浓度均未检测到,而安慰剂组只有1名患者检测到(P = 0.001)。

结论

在患有蝎蜇伤神经毒性作用的重症儿童中,静脉注射蝎毒特异性F(ab')(2)抗蛇毒血清可在4小时内缓解临床综合征,减少使用咪达唑仑进行镇静的需求,并降低循环中未结合毒液的水平。(临床试验注册号,NCT00685230。)

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