通过破伤风快速检测棒和既往史评估破伤风免疫状态：一项前瞻性双盲研究。

Assessment of tetanus immunity status by tetanus quick stick and anamnesis: a prospective double blind study.

作者信息

Orsi G B, Modini C, Principe M A, Di Muzio M, Moriconi A, Amato M G, Calderale S M

机构信息

Department of Public Health and Infectious Diseases, "Sapienza" University of Rome, Italy.

Emergency Department, Policlinico Umberto I of Rome, "Sapienza" University of Rome, Italy.

出版信息

Ann Ig. 2015 Mar-Apr;27(2):467-74. doi: 10.7416/ai.2015.2033.

DOI:10.7416/ai.2015.2033

PMID:26051145

Abstract

BACKGROUND

In patients with wounds admitted to Emergency Departments (ED) acquiring tetanus vaccination history by interview is very unreliable. Protected patients may receive unnecessary prophylaxis and unprotected nothing. Aim of the study was to evaluate tetanus immunity status comparing the traditional anamnestic method with the Tetanus Quick Stick (TQS), a rapid immunochromatographic test.

METHODS

A double-blind prospective study was carried out in the ED of the 1,000 bed teaching hospital Umberto I in Rome. Adult patients (≥18) with wounds attending at the ED were randomly included. Tetanus immunity status was evaluated by healthcare workers (HCWs) comparing the TQS test with the anamnesis. TQS test was performed by a trained HCW and afterwards the anamnesis about tetanus immunity status was collected by another HCW unaware of the TQS result. Also cost analysis was carried out.

RESULTS

Overall 400 patients (242 males and 158 females) were included, mean age was 46.7 ± 20.2 years (median 44 range 18 - 109), 304 (76.0%) were italians and 96 foreigners (24.0%). Overall, 209 (52.2%) resulted TQS +, and protective immunity level was associated to lower mean age (40.1 ± 16.8 vs 53.8 ± 21,1; p<0,01). Using the anamnestic method 336 (84.0%) patients resulted "unprotected", 52 (13.0%) "partially unprotected" and 12 (3.0%) "completely protected". TQS test results showed that 154 (45.8%) out of 336 "unprotected" and 45 (86.5%) out of 52 "partially unprotected" actually had a protective antibody level. Finally two (16.7%) out of 12 "completely protected" group presented a non protective antibody level. Following only the anamnestic method 201 (50.0%) patients would have received some inappropriate treatment. Adopting TQS test in all patients would also be cost-effective saving € 1.95/patient. As tetanus immunity is inversely related to age, for <51 years old patients unnecessary treatment would have been avoided in 57.1% of patients, with a mean reduction per patient of € 7.50/patient with the TQS vs. € 12.69/patient without.

CONCLUSIONS

The study showed that tetanus protective immunity prevalence among adult patients attending our ED is about 50% and is mainly influenced by class age. TQS use allowed to reduce drastically inappropriate tetanus vaccine and immunoglobulins booster treatment. Also TQS use reduced costs.

摘要

背景

在急诊科收治的伤口患者中，通过询问获得破伤风疫苗接种史的方法非常不可靠。已获保护的患者可能会接受不必要的预防措施，而未获保护的患者则得不到任何预防。本研究的目的是通过将传统的问诊方法与破伤风快速检测（TQS）（一种快速免疫层析检测）进行比较，评估破伤风免疫状态。

方法

在罗马拥有1000张床位的教学医院翁贝托一世急诊科进行了一项双盲前瞻性研究。随机纳入在急诊科就诊的成年伤口患者（≥18岁）。医护人员通过将TQS检测结果与问诊结果进行比较来评估破伤风免疫状态。TQS检测由一名经过培训的医护人员进行，随后由另一名不知道TQS检测结果的医护人员收集关于破伤风免疫状态的问诊信息。同时进行了成本分析。

结果

共纳入400例患者（242例男性和158例女性），平均年龄为46.7±20.2岁（中位数44岁，范围18 - 109岁），304例（76.0%）为意大利人，96例为外国人（24.0%）。总体而言，209例（52.2%）TQS检测结果为阳性，保护性免疫水平与较低的平均年龄相关（40.1±16.8岁 vs 53.8±21.1岁；p<0.01）。采用问诊方法时，336例（84.0%）患者被判定为“未获保护”，52例（13.0%）“部分未获保护”，12例（3.0%）“完全获保护”。TQS检测结果显示，336例“未获保护”患者中有154例（45.8%）以及52例“部分未获保护”患者中有45例（86.5%）实际上具有保护性抗体水平。最后，12例“完全获保护”组患者中有2例（16.7%）呈现非保护性抗体水平。仅按照问诊方法，201例（50.0%）患者会接受一些不恰当的治疗。对所有患者采用TQS检测也具有成本效益，每位患者可节省1.95欧元。由于破伤风免疫力与年龄呈负相关，对于<51岁的患者，使用TQS检测可避免57.1%的患者接受不必要的治疗，使用TQS检测时每位患者平均减少费用7.50欧元，而不使用时每位患者平均费用为12.69欧元。