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鞘内注射人抗破伤风免疫球蛋白治疗破伤风的随机双盲假对照研究

A randomized double-blind sham-controlled study of intrathecal human anti-tetanus immunoglobulin in the management of tetanus.

作者信息

Agarwal M, Thomas K, Peter J V, Jeyaseelan L, Cherian A M

机构信息

Department of Gastroenterology, Christian Medical College, Tamil Nadu, India.

出版信息

Natl Med J India. 1998 Sep-Oct;11(5):209-12.

PMID:10997166
Abstract

BACKGROUND

Tetanus is a major cause of mortality and morbidity in developing countries. Various modalities of treatment to prevent progression of the disease and alter its outcome have been tried. This study was designed to evaluate the role of intrathecal human anti-tetanus immunoglobulin (TIG) in the management of tetanus.

METHODS

Thirty-six adult patients presenting to an university-affiliated teaching hospital were stratified based on the severity of disease into mild and severe disease, and subsequently randomly allocated to receive either 250 i.u. of TIG intrathecally or a sham procedure mimicking the lumbar puncture.

RESULTS

In mild tetanus, TIG administration significantly retarded the rate of progression (p = 0.05), reduced the duration of hospital (p = 0.01) and intensive care unit stay (p = 0.05), need for tracheostomies (p = 0.03) and the dose of sedatives required for control of spasms (p = 0.01). In mild tetanus, the mortality rates were 20% and 30% in the treated and control groups, respectively.

CONCLUSION

We suggest that TIG is useful in reducing the morbidity, progression of disease and mortality in patients presenting with mild tetanus.

摘要

背景

破伤风是发展中国家死亡和发病的主要原因。人们尝试了各种治疗方法来预防疾病进展并改变其结局。本研究旨在评估鞘内注射人抗破伤风免疫球蛋白(TIG)在破伤风治疗中的作用。

方法

36名到大学附属医院就诊的成年患者根据疾病严重程度分为轻症和重症,随后随机分配接受鞘内注射250国际单位TIG或模拟腰椎穿刺的假手术。

结果

在轻症破伤风患者中,注射TIG显著延缓了疾病进展速度(p = 0.05),缩短了住院时间(p = 0.01)和重症监护病房停留时间(p = 0.05),减少了气管切开需求(p = 0.03)以及控制痉挛所需的镇静剂剂量(p = 0.01)。在轻症破伤风患者中,治疗组和对照组的死亡率分别为20%和30%。

结论

我们认为TIG有助于降低轻症破伤风患者的发病率、疾病进展和死亡率。

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