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鞘内免疫球蛋白治疗破伤风成人的安全性和可行性初步研究。

A Pilot Study to Assess Safety and Feasibility of Intrathecal Immunoglobulin for the Treatment of Adults with Tetanus.

机构信息

Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.

Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.

出版信息

Am J Trop Med Hyg. 2018 Aug;99(2):323-326. doi: 10.4269/ajtmh.18-0153. Epub 2018 Jun 14.

Abstract

Tetanus remains a significant burden in many low- and middle-income countries. The tetanus toxin acts within the central nervous system and intrathecal antitoxin administration may be beneficial, but there are safety concerns, especially in resource-limited settings. We performed a pilot study to assess the safety and feasibility of intrathecal human tetanus immunoglobulin in five adults with tetanus before the conduct of a large randomized controlled trial. Intrathecal injection via lumbar puncture was given to all patients within a median 140 (range 100-165) minutes of intensive care unit (ICU) admission. There were no serious adverse effects associated with the procedure although three patients had probably related minor adverse events which resolved spontaneously. Median ICU length of stay was 14 (range 5-17) days. Two patients required mechanical ventilation and one developed a deep vein thrombosis. Within 240 days of hospital discharge, no patients died and all patients returned to work.

摘要

破伤风在许多低收入和中等收入国家仍然是一个重大负担。破伤风毒素在中枢神经系统内起作用,鞘内抗毒素给药可能是有益的,但存在安全性问题,特别是在资源有限的环境中。我们进行了一项试点研究,以评估在进行大型随机对照试验之前,5 名破伤风成人患者鞘内使用人破伤风免疫球蛋白的安全性和可行性。所有患者在入住重症监护病房(ICU)后中位数 140 分钟(范围 100-165 分钟)内通过腰椎穿刺进行鞘内注射。尽管 3 名患者出现可能与该程序相关的轻微不良事件,但均自发缓解,未发生与该程序相关的严重不良事件。ICU 中位住院时间为 14 天(范围 5-17 天)。2 名患者需要机械通气,1 名患者发生深静脉血栓形成。出院后 240 天内,无患者死亡,所有患者均恢复工作。

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